First Vioxx Trial

Jury Awards $253.4 Million

2005-08-19T17:35:00.000-07:00

Angleton, TX—Unless you have been hiding under a rock, you already know that the jury awarded plaintiffs $253.4 million in the nation’s first Vioxx trial. Merck has told the media that it plans to appeal.

The award includes punitive damages of $229 million and $24.4 million in actual damages. Under Texas law, punitive damages of $229 million will be reduced by operation of law to less than $2 million. Assuming costs of $1 million and attorneys’ fees of 40%, the plaintiffs could receive as much as $15 million.

The verdict will impact the momentum of the more than 4200 pending Vioxx cases. Likely more will be filed and demands for settlement will increase. The next trial is set for September in Atlantic City, New Jersey. If that trial is also lost, we may see a shift in emphasis by Merck from litigation to settlement.

Following the verdict, Merck's stock traded down more than 8%.

Many thanks to everyone who read this blog and to those at the trial site who shared their views, thoughts and notes about the trial. I have received numerous E-mails from around the country about the blog and knowing that people were reading made blogging worthwhile.

Parties’ Deliver Closing Statements to the Jury

2005-08-18T17:14:00.000-07:00

Angleton, TX—The fate of Merck & Co. now rests in the hands of 12 Brazoria County residents who heard the parties’ closing arguments on Wednesday in a standing room only courtroom filled with TV cameras, reporters, attorneys and local citizens.

Judge Reads Jury Charge

Judge Hardin began the proceedings by reading the jury charge. He directed the jurors to answer yes or no to a list of questions. In summary, they read as follows: (1) Did Merck fail to adequately warn physicians about the dangers of Vioxx ; (2) Was Vioxx defectively designed; (3) Did Merck’s negligence proximately cause Bob Ernst’s death; (4) If the jurors answered yes to (1), (2), or (3), what sum of money compensates Carol Ernst for her pecuniary loss, loss of companionship, and mental anguish; (5) If the jurors answered yes to (1), (2), or (3), is there clear and convincing evidence that Merck acted with malice; and (6) If Merck acted with malice, what sum of money should be assessed as exemplary damages. On the hotly contested issue of causation, the Judge instructed the jury that it must only find that Vioxx was a contributing cause and not the sole cause of Bob Ernst’s death.

Lanier Interprets Jury Charge

Lanier highlighted portions of the charge for the jury. While he believed that the plaintiffs easily met their burden of proof in this case, he explained what was meant by a “preponderance of the evidence.” He gave several examples, but the most effective was his description of 500 sheets of paper on two side of a scale. He told jurors that the scale needed to be tipped by only a single sheet of paper for plaintiffs to meet their burden in this case.

The jurors can make their decision based on both direct evidence and circumstantial evidence. It would be physically impossible for plaintiffs to show precisely how Vioxx caused the clotting in Mr. Ernst’s body, which lead to his heart attack, explained Lanier. That is why plaintiffs called experts to explain how Vioxx creates clotting problems. This is the circumstantial evidence upon which the jury must rely to make a decision in the case, according to Lanier.

Lanier emphasized that the jury has an extremely important job. There is a reason that the courtroom was filled with TV cameras and reporters. Lanier told jurors, “When David fought Goliath, there were two armies that watched.” Everybody wants to know if somebody is “going to step up to the plate and say stop doing business this way:”

Merck Engaged in a Scheme of Denial, Deception and Damage

Lanier argued that Merck denies knowing that Vioxx increased the risk of cardiovascular events. Yet as early as the 1970s, scientists hypothesized about the mechanism of action through which Cox-2 inhibition, which is the means by which Vioxx alleviates pain, interferes with the body’s ability to control clotting. A Dr. Fitzgerald published a study in 1982 about that hypothesis, which later became known as the Fitzgerald Hypothesis. Merck’s own physicians’ desk reference, called the Merck Manual, explained the hypothesis until that section was deleted from later versions of the manual in 1992 when it began developing Vioxx. Lanier also showed the jury several Merck studies that found an increased risk of cardiovascular events in patients taking Vioxx as well as internal correspondence documenting Merck’s concerns about cardiovascular events.

Lanier made much of the fact that Merck failed to produce any witnesses with knowledge about Vioxx. He argued that Merck’s corporate representative, Dr. Nancy Santanello, Merck’s epidemiologist who did not work directly on Vioxx, knew little about most of the issues in this case such as marketing and sales. Dr. Reicin, Merck’s vice president of clinical research, was tasked with defending Vioxx, but had little experience with the actual development of the drug.

Lanier revisited Merck’s VIGOR study results. That study showed an increased cardiovascular risk in patients taking Vioxx compared to patients taking naproxen. In a midnight Email from Dr. Reicin to Ed Scolnick, Merck’s top scientist, Dr. Reicin theorized that the difference in events was explained by the cardioprotective effect of naproxen. Lanier argued that Merck concocted this theory with little to no support in the scientific literature. He intimated that Merck knew the results confirmed that Vioxx caused cardiovascular problems, but denied it.

Merck deceived the medical community, the FDA, consumers, and its own researchers into believing that Vioxx was safe. Merck’s sales representatives were trained to dodge questions about Vioxx’s cardiovascular risks. Safety data about cardiovascular adverse events was buried inside boxes of documents dumped onto the underresourced FDA. And Merck’s Vioxx ads never warned consumers about Vioxx’s cardiovascular risks (Merck’s attorneys objected to Lanier’s discussion of consumer ads arguing that Merck is only required to warn doctors; yet Merck’s failure to provide fair and balanced warnings to consumer supports plaintiffs’ argument that Merck was engaged in an overall scheme of hiding the dangers of Vioxx). Finally, instead of adding a warning about cardiovascular risks in the package insert, Merck buried its description of cardiovascular adverse events in the least critical section of Vioxx’s package insert, the adverse events section. When Merck eventually added a warning about cardiovascular risks in June 2001, it was more than 14 months after receiving the results of its VIGOR study, which showed an increase in cardiovascular events.

When assessing damages, Lanier asked the jury to hold Merck liable for its actions and to send a message not to do this again. He reiterated the economic loss figure of plaintiffs’ expert economist of between $200,000 and $400,000. He asked the jury for one million dollars for every year of Bob Ernst’s lost life or 20 million dollars; the equivalent to the cost of one Vioxx launch party per year. Without directly stating a number for mental anguish, Lanier also told the jury that the figure that sticks out for him is $229 million; the sum, according to Merck’s own documents, that Merck saved by delaying its change in Vioxx labeling from October 2000 to February 2001. Merck actually delayed its labeling change until June 2001, but that was too late for Bob Ernst who died in May 2001.

Defense Attacks Lanier

Merck’s attorney, Gerry Lowry, set her sights on Mark Lanier. She asked the jury to do three things while deliberating: (1) use common sense; (2) ask questions; and (3) make a fair judgment. She reminded the jury about their duty to make an unbiased decision in this case. “Look through the lawyering and make a decision based on the facts in this case,” she told jurors. Look past Lanier’s use of props like cartoons. “This is a court of law . . . not Saturday morning TV.”

She asked the jury to question Lanier’s statements and theories. Lowry asked the jury to ask themselves why Merck, a hundred-year-old company with a good reputation, would all of a sudden decide to kill people. And what was Merck supposed to do after it killed people taking Vioxx? She asked the jury to question whether Merck really duped the FDA, its own scientists, doctors and consumers as Lanier suggested. If Merck was worried about safety, why did it continue to study Vioxx even after it supposedly discovered a risk of cardiovascular adverse events (one answer to this question might be that Merck was looking for new indications to extend its patent and period of exclusivity)?

She asked the jury to question Lanier’s concocted theory about Bob Ernst’s death. There is no evidence that Vioxx causes arrhythmias she told the jury. She also reminded them that there is no evidence, as conceded by plaintiffs’ own experts, that Mr. Ernst died from a heart attack; there is no evidence that a clot caused Mr. Ernst to suffer a heart attack.

Many of plaintiffs’ experts told the jury that they were donating portions of their fees to local hospitals. Lowry asked the jury to question why they would make such donations. She inferred that their transparent donations reflect just how little Lanier thought of the jurors’ intelligence.

Merck’s attorney, David Kiernan, also addressed the jury during closings. He walked through Merck’s studies, showing the jury tables and graphs from such studies, and explained why they did not establish an increased risk of cardiovascular events in patients taking Vioxx.

While overall Merck’s closing was persuasive, I question whether they were simply cornered by Merck’s documents and ultimately the facts in this case. While it would be tempting to attack and vilify Lanier, which Lowry did in an effective manner, such a strategy would seem one of last resort. In a strong case, a defendant need not rely on such tactics.

Lowry made another argument that seemed out of character for such a seasoned defense attorney. She reminded the jury that Mrs. Ernst felt guilty about having suggested to Bob Ernst that he take Vioxx. She asked the jury to rid Mrs. Ernst of that guilt by finding for Merck. Needless to say, her argument shocked the gallery. This must have been a last minute thought because their jury research consultant would have never supported such an argument.

Continue to log onto www.firstvioxxtrial.blogspot.com for daily coverage of the nation’s first Vioxx trial.

"The Defense Rests"

2005-08-16T18:24:00.000-07:00

Angleton, TX—Dusk settled over the nation’s first Vioxx case today as the jurors heard the last of the evidence from the parties. After hearing no testimony whatsoever on Monday, the defense started today by resting its case, leaving plaintiffs to offer a short rebuttal witness, Dr. Lucchesi, plaintiffs’ expert pharmacologist. Closing arguments are scheduled to begin tomorrow at 9:30 a.m. after which the parties along with the entire product liability legal community will wait with bated breath while a group of Brazoria County residents decides the fate of Merck & Co.

Lanier spent most of the morning questioning Dr. Lucchesi about blood clotting, which plaintiffs contend caused Bob Ernst’s death. At issue is when Merck learned about the potential mechanism through which Vioxx causes clotting problems. Dr. Lucchesi explained that as early as 1982 a Dr. Fitzgerald hypothesized that blocking the Cox-2 enzyme interferes with the body’s ability to control clotting through a chemical called prostacyclin. His theory is called the Fitzgerald Hypothesis. Merck argues that Vioxx, a Cox-2 specific inhibitor, was not potentially linked to clotting problems in the literature until at least 1997. Dr. Lucchesi testified that while a direct link between Cox-2 specific inhibitors like Vioxx may not have been drawn in the literature until 1997, the Fitzgerald Hypothesis was well known in the medical community well before then and established the link necessary to appreciate the link.

Dr. Lucchesi reiterated his opinions about why the coroner found no evidence of a clot during the autopsy of Mr. Ernst. He explained that during CPR, the compressions on Mr. Ernst’s chest might have dislodged the clot. Another explanation is that the body’s own enzymes may have dissolved or lysed the clot. And yet another explanation might be that smaller clots or microemboli, which can easily mobilize, created the blockage that caused Mr. Ernst’s death. On cross-examination, Dr. Lucchesi admitted that there is no evidence of CPR dislodging a clot, Mr. Ernst’s body lysing a clot, or microemboli in this case.

Merck’s attorney, David Kiernan, made much of the fact that Dr. Lucchesi is not a clinician who sees patients. As has been his style throughout this trial, Mr. Kiernan rapidly read a series of questions highlighting Dr. Lucchesi’s lack of experience in cardiology and pathology. While his initial questioning appeared to dilute Dr. Lucchesi’s opinions, as the questioning droned on, Dr. Lucchesi effectively responded that he was a researcher and not a clinician, and his opinions were based on his some 40 years of research.

Log onto www.firstvioxxtrial.blogspot.com tomorrow to read about the parties’ closing arguments in the nation’s first Vioxx trial.

Merck’s Expert Cardiologist Testifies Vioxx Did Not Cause Death

2005-08-13T08:38:00.000-07:00

Angleton, TX—On Friday, jurors heard testimony from Merck’s expert cardiologist, Dr. Craig Pratt.

Dr. Pratt attended UCLA as an undergraduate and UC Davis medical school. He serves on the Methodist Hospital Research Committee and runs its coronary care unit. Dr. Pratt is a clinician who has seen more than 10,000 myocardial infarctions in the last 25 years and has extensive experience with clinical trials, including trials of clot-busting drugs.

On cross-examination, Dr. Pratt conceded that he earns about 20% of his income and up to $100,000 per year from testifying as an expert. He also acknowledged consulting for a company associated with Merck and having worked on Baycol cases with Merck’s attorney, Gerry Lowry.

Dr. Pratt addressed how Bob Ernst, who was a marathon runner, could have died in his sleep as opposed to during stressful exercise like running. While it may seem counter-intuitive that an active person like Bob Ernst died in his sleep instead of during exercise, a “significant number” of people die under such circumstances. Mental anguish, stress, and anxiety can lead to more alterations in coronary flow than peak exercise.

As one might anticipate, Dr. Pratt testified that Mr. Ernst died of an arrhythmia. Disagreeing with the ER Report and the coroner who testified that Mr. Ernst died of an MI, Dr. Pratt testified, “I don’t think this patient had an MI [myocardial infarction] or a clot.” None of the medical evidence in this case suggests that Mr. Ernst died from a myocardial infarction, according to Dr. Pratt. Since Mr. Ernst died so suddenly, one would expect to have seen evidence of a clot if that in fact caused his death. There was no evidence of a clot and Dr. Pratt knows of no evidence that Vioxx causes arrhythmias.

Dr. Pratt and Lanier argued about the results of several articles about the amount of blockage necessary to cause death without a clot. According to the coroner’s report, Bob Ernst’s heart arteries were blocked by a build up of plaque in some areas up to 75%. Merck argues that this build up alone lead to Mr. Ernst’s death. The plaintiffs argue, however, that Vioxx caused Mr. Ernst’s body to form a clot, which lodged between the wall of a heart artery and a build up of plaque in that artery leading to his death. In support of this argument, plaintiffs argue that a blockage of 90% or greater is required to cause death without a clot, which Mr. Ernst did not have.

Continue to log onto www.firstvioxxtrial.blogspot.com for daily updates about the nation’s first Vioxx trial.

Merck’s Clinical Research VP Says Studies Showed No CV Risk

2005-08-12T21:22:00.000-07:00

Angleton, TX—Merck called its vice president of clinical research, Alise Reicin, to testify on Wednesday and Thursday about her work with Vioxx.

Dr. Reicin received her B.S. in biochemistry from Barnard College, attended Harvard medical school, and is board certified in internal medicine. Before joining Merck, she served as an assistant professor at Columbia University. She has published several peer-reviewed articles about Cox-2 inhibitors including Vioxx and has worked extensively on the development and postmarketing studies of Vioxx for Merck.

Although she did not work at Merck when it performed much of the premarketing Vioxx studies, Dr. Reicin reviewed the results of those studies with the jury. Merck performed 41 pre-clinical and 58 clinical trials on close to 10,000 patients before submitting its Vioxx New Drug Application or NDA to the FDA for review. Its clinical studies included 34 phase 1 studies, 11 phase 2 studies and 13 phase 3 studies. On cross-examination, Dr. Reicin conceded that clinical trials do not provide all relevant safety information for appropriate uses of drugs like Vioxx.

Dr. Reicin also reviewed several postmarketing studies, including VIGOR, which plaintiffs contend showed an increased cardiovascular risk in patients taking Vioxx. Dr. Reicin testified that none of these studies signaled an increased cardiovascular risk. Specifically with regard to VIGOR, in which people taking Vioxx experienced more cardiovascular events than patients taking naproxen, she parroted other Merck witnesses’ responses—naproxen was assumed to protect the heart. Since Naproxen protected the heart or is cardioprotective, patients taking Vioxx experienced more cardiovascular events than patients taking Vioxx. On cross-examination, Dr. Reicin confirmed that the authors of an article on which Merck relies to support its cardioprotective theory have received compensation from Merck for consulting. The plaintiffs contend that the difference in cardiovascular risks is explained by the increased cardiovascular risk in patients taking Vioxx.

Contrary to testimony by plaintiffs’ witnesses that Merck hid the VIGOR results, Dr. Reicin testified that Merck distributed the results promptly. Merck received the preliminary VIGOR results on March 9, 2000, which were faxed to the FDA on March 23, 2000. Merck issued a press release about the results on March 27, 2000. The results were also distributed in a letter to its clinical investigators, discussed in the lay press, and presented at Digestive Disease Week between March and May 2000. The New England Journal of Medicine published the VIGOR results in November 2000. But in response to Dr. Reisin’s testimony that Merck trumpeted the VIGOR results, Lanier showed the jury a video press release about VIGOR, which mentioned nothing about cardiovascular risks.

In October 2001, the FDA proposed adding a warning about Vioxx’s risk of heart attacks into the warnings section of the Vioxx label. Lanier showed the jury proposed edits to the FDA’s proposed label in which Merck argued to move any warning about heart attacks to the less conspicuous precautions section, which in the scheme of labeling carries less weight than placing it in the warnings section. Ultimately, Merck delayed adding any warning whatsoever until April 2002.

On cross-examination, Lanier showed Dr. Reicin several documents evidencing that 2001 was an important year for Vioxx. That was also the year that Bob Ernst died while taking Vioxx. Merck’s 2001 Vioxx Profit Plan reads, “The future growth of Vioxx requires that more patients are brought into the prescription market.” Other documents, most of them marketing documents with which Dr. Reicin was not familiar, confirmed that Merck went to great lengths to increase its profits in 2001 by increasing the number of patients taking Vioxx.

By almost all accounts, Dr. Reicin held her own against the skilled cross-examination of the Great Lan-tini. She provided explanatory context to the plaintiffs’ views of documents and statements that otherwise show a company hiding cardiovascular risks. The lingering question is whether the jury was listening. Much of Dr. Reicin’s testimony reached a jury bored and likely tired of revisiting issues and facts. But in the end, without the unintended repetition, the quagmire of studies and results would otherwise make little if any sense to the untrained ears of this Brazoria County jury. If the evidence ultimately proves that one of the world’s largest drug companies hid life-threatening dangers of its drug, or exonerates that company from reckless accusations, the repetition and boredom will have served its purpose.

Continue to log onto www.firstvioxxtrial.blogspot.com for daily updates about the nation’s first Vioxx trial.

Merck’s CEO Says Company Needed Vioxx to Grow

2005-08-10T17:32:00.000-07:00

Angleton, TX—Lawyers in the nation’s first Vioxx case continued their examination on Tuesday of Dr. Thomas Wheeler, Merck’s expert pathologist. They also showed the jury excerpts from the deposition of Merck’s former CEO, Ray Gilmartin.

Merck’s Expert Pathologist Says No Evidence of Heart Attack

Merck’s expert pathologist, Dr. Wheeler, testified on redirect that a heart attack cannot be diagnosed without any evidence as the plaintiffs contend. Plaintiffs have presented no evidence to suggest that Bob Ernst died of a heart attack; they have presented no evidence of characteristic symptoms, EKG, or enzyme levels indicative of a heart attack, or gross or microscopic evidence of a clot that could have caused a heart attack. He opined that a heart attack could not be diagnosed by process of elimination, as plaintiffs suggest.

On Monday, plaintiffs’ chief trial counsel, Mark Lanier, cross-examined Dr. Wheeler about a textbook, which he uses to teach medical students at Baylor University. It effectively corroborates the plaintiffs’ argument that Mr. Ernst died of a heart attack even though his body showed no evidence of a clot leading to a heart attack. In response, Dr. Wheeler testified on Tuesday that he would never use a textbook to diagnose a patient. Strangely, Merck’s attorney continued to cite the textbook as authority in support for Merck’s argument that Mr. Ernst died of an arrhythmia and not a heart attack.

Using the flip chart that has served him so well in this trial, Lanier listed the doctors with whom Dr. Wheeler disagreed. They included: (1) the coroner who examined Mr. Ernst, Dr. Araneta, who testified that Mr. Ernst likely died of a heart attack; (2) Dr. Wiener, plaintiffs’ expert cardiologist, who testified that Vioxx caused Mr. Ernst to suffer a heart attack; (3) Dr. Lucchesi, a pharmacologist, who testified about the enzymes in Mr. Ernst’s blood that may have dissolved the clot that caused his heart attack before it could be seen by the coroner; and (4) the emergency room doctor who wrote that Mr. Ernst suffered a heart attack. Dr. Wheeler reaffirmed that he disagrees with the opinions of each of these doctors.

Lanier and Dr. Wheeler sparred about how severely Mr. Ernst’s heart arteries must have been blocked to cause him to suffer arrhythmia-induced sudden cardiac death without a clot—Merck’s theory about Mr. Ernst’s death (Plaintiffs’ contend Mr. Ernst suffered a heart attack as a result of a clot, which blocked a heart artery causing him to suffer a heart attack). Mr. Ernst suffered from arteriosclerosis, which is a plaque build up in his arteries. The coroner confirmed that his heart arteries were 75% blocked by plaque in some places. According to sources cited by Lanier, to suffer arrhythmia-induced sudden cardiac death without blockage by a clot, Mr. Ernst’s heart arteries must have been blocked by 90%. Lanier asked Dr. Wheeler what made up for the difference between Mr. Ernst’s existing 75% blockage and the 90% blockage required to cause his death. Dr. Wheeler testified that a 75% blockage alone could lead to an arrhythmia-induced death, but he could not cite a single study to support his opinion.

Former Merck CEO Defends Merck’s Actions

In video excerpts from the deposition of Ray Gilmartin, Merck’s former CEO, he explained the events leading up to the withdrawal of Vioxx. He testified that Vioxx’s cardiovascular risks first became apparent after Merck completed its APROVE study. That study was designed to evaluate the effectiveness of Vioxx on colon polyps and showed that patients taking Vioxx experienced cardiovascular adverse events at a much greater rate than patients taking placebo. Merck assembled scientists to evaluate the results, some of which recommended that Vioxx be withdrawn from the market. Mr. Gilmartin testified that Merck opted to do what was best for patient safety and voluntarily withdrew the drug.

Plaintiffs showed the jury excerpts from Mr. Gilmartin’s deposition in which he talked about Merck’s economic goals. He acknowledged that Merck was in the “middle of the pack” when he began as CEO in 1994. Merck needed a drug to become a more profitable company. And Vioxx, according to Mr. Gilmartin, was intended to help Merck achieve that goal. He testified that Merck “would’ve been a very different company had it not sold Vioxx and sold it well.”

On redirect, he explained that new information about the entire class of cox-2 drugs, including Pfizer’s competing drug, Celebrex, had come to light. Consequently, Merck spoke with the FDA about bringing Vioxx back to the market, but no decision had been made as of the time of his testimony.

Continue to log onto www.firstvioxxtrial.blogspot.com for daily updates about the nation’s first Vioxx trial.

Merck’s Pathologist Says Merck Manual Is Wrong

2005-08-09T14:31:00.000-07:00

Angleton, TX—Merck continued its daunting task on Monday of rebuilding its defense after days of crippling testimony from its own witnesses. Merck’s expert pathologist, Dr. Thomas Wheeler, took the stand to explain to the jury that Bob Ernst, whose widow and children have sued Merck in the nation’s first Vioxx case, that Vioxx did not cause Mr. Ernst’s death.

Merck’s Pathologist Disagrees With Coroner’s Testimony

Not surprisingly, Dr. Wheeler is well credentialed in the area of pathology. He attended Baylor University medical school where he completed a residency in pathology and currently serves as the associate chairman of the pathology department. (Click here to see Dr. Wheeler: http://www.bcm.edu/pathology/Ayala-Wheeler/index.htm.) Dr. Wheeler has received awards recognizing his achievements in pathology, and has published several peer-reviewed articles and book chapters about pathology. While his current research focuses on prostate cancer pathology, he does have some experience in the area at issue in this litigation—cardiac pathology.

After his review of Mr. Ernst’s autopsy report and the deposition testimony of the coroner, Dr. Maria Araneta, Dr. Wheeler opined that Mr. Ernst’s cause of death was “cardiac arrhythmia secondary to coronary arteriosclerosis.” Just days before, Dr. Araneta testified that while her autopsy report noted the cause of death as cardiac arrhythmia, Mr. Ernst most likely died of a heart attack. The distinction is important because Merck claims Vioxx does not cause arrhythmias. Consequently, Merck argues that Vioxx could not have caused Mr. Ernst’s death. Plaintiffs argue that Vioxx causes heart attacks and that Mr. Ernst died of a heart attack, but died so suddenly that his heart showed no evidence of a heart attack, such as damage to his heart tissue. Alternatively, plaintiffs have shown the jury several Merck studies, which support their argument that Vioxx does indeed cause arrhythmias.

If Mr. Ernst died of a heart attack caused by a clot or blockage in his heart arteries, Dr. Wheeler testified that the coroner would have seen evidence of a clot. She did not. Dr. Araneta testified that she did not see any evidence of a clot because it likely dissolved or dislodged during CPR. Dr. Wheeler categorized Dr. Araneta’s explanation as “absolutely false” and “preposterous.” Dr. Wheeler concluded that Mr. Ernst did not die from a heart attack and instead died of a cardiac arrhythmia. He added that he can say “with almost complete confidence” that Vioxx did not cause Mr. Ernst’s death.

Pathologist Says Merck Manual and Textbook Are Wrong

On cross-examination by chief plaintiffs’ counsel, Mark Lanier, Dr. Wheeler acknowledged that he has testified for the defense in a series of tobacco, asbestos, and drug cases. Lanier also established that Dr. Wheeler’s main area of expertise is prostate pathology and that while he does have experience in several areas of pathology, his focus is not on cardiac pathology.

Using the Merck Manual, Merck’s physician desk reference, Lanier cornered Dr. Wheeler about Mr. Ernst’s cause of death. Mr. Ernst suffered cardiac arrest because of electrical dysfunction of the heart or ventricular fibrillation. The causes of ventricular fibrillation, according to the Merck Manual, range from hypothermia to vasoactive drugs to heart attack. Lanier reviewed each potential cause with Dr. Wheeler and ruled out every cause except heart attack. Although two doctors from Dr. Wheeler’s Baylor medical school sit on the editorial board for the Merck Manual, Dr. Wheeler responded that the list of causes from the Merck Manual was “incorrect.”

Lanier also cross-examined Dr. Wheeler with excerpts from the textbook he uses when teaching pathology courses. It corroborates the plaintiffs’ argument that Mr. Ernst died of a heart attack even though his body showed no evidence of a clot. It provides that most arrhythmias are associated with heart attacks, many heart attacks are associated with clots, and many clots resolve. Dr. Wheeler was left to question the wording of the textbook and characterized the wording as a “typo” yielding laughter and eye rolling from the gallery.

Dr. Wheeler is far and away Merck’s best witness to date. His demeanor is calm and collected—never appearing agitated by cross-examination. He made concessions when necessary, but with a confidence and decisiveness such that he did not appear to be making any concessions at all. While Lanier effectively raised questions about Dr. Wheeler’s opinions, he conveyed a cohesive alternative opinion about the cause of Bob Ernst’s death for consideration by the jury.

Continue to log onto www.firstvioxxtrial.blogspot.com to follow the daily events of the nation's first Vioxx trial.

Merck’s Top Vioxx Doc Testifies He Would Do Nothing Differently

2005-08-06T15:30:00.000-07:00

Angleton, TX—For most of the country, Friday, August 05, 2005 was business as usual. But for the participants and observers of the Vioxx case in Angleton, Texas, it was like Thanksgiving Day. Only it wasn’t tom turkey on the carving block, it was Dr. Alan Nies, the head of Merck’s Vioxx development team, whom plaintiffs’ attorney, Mark Lanier, thoroughly filleted this afternoon while the jury watched in rapt attention.

Merck Complete Initial Examination of Top Vioxx Doc

Dr. Nies began his testimony late Thursday afternoon. A medical doctor and board-certified specialist in internal medicine, Dr. Nies now lives in Richmond, Texas, having retired form Merck in September 2002. Dr. Nies was schooled at Stanford University and then on to Harvard Medical School and Vanderbilt University for the remainder of his medical training. He also served in the U.S. Army during the Vietnam conflict, working to develop a drug to combat malaria. He was recruited to join Merck and was particularly piqued by the new work on COX-2 drugs. According to his testimony, “the buck stops [with him]” when it came to the development of Vioxx. He is in the best position to come to Merck’s defense in this case as few know more about the development of Vioxx than the head of the project.

Dr. Nies started his testimony, however, with an apparent handicap; from all outward appearances he had not been thoroughly prepared for his examination. This is not the first time that this has happened. Dr. Santanello, Merck’s head epidemiologist, also appeared unprepared to respond to plaintiffs’ cross-examination. The testimony of doctors and scientists is difficult to listen to and comprehend under even the best of circumstances. The language is usually technical and laced with acronyms and jargon that are generally unfamiliar to jurors. Trial lawyers normally work diligently to make sure that the testimony of expert witnesses specializing in an advanced field is set forth in the least confusing and most straightforward manner that is possible.

Dr. Nies and examining counsel, Mr. Pierowski, seemingly made little effort to take Dr. Nies’ testimony out of the realm of the unintelligible and into the courtroom for judge, jurors, and attorneys to fully comprehend. The result was that much of Dr. Nies’ important points and testimony were lost on a jury that could not keep pace with the staccato examination and rapid display of fine print documents. Certainly Dr. Nies and Mr. Pierowski knew what points that they wanted to make and seemed to converse together and move the testimony at a quick clip without concern, but that relationship ultimately serves Merck little purpose in this trial where the jury are the people who need to recognize the importance of testimony.

Defense counsel seemed to want to make just a few overarching, yet very important points with Dr. Nies:

Merck did not put Vioxx on the market without sufficient and proper testing;
Merck did not act irresponsibly in putting Vioxx on the market when it did;
Merck did not withhold or artificially influence any of the Vioxx testing procedures or resulting data;
Merck was actively looking for severe cardiovascular events that occurred in conjunction with the use of Vioxx, but did not find any; and
The FDA was substantially involved in the development/testing of Vioxx before it issued its approval to market the drug.

Again, these are cogent points that are integral to Merck’s defenses in this trial and, if true, its salvation from a multitude of litigants angling to bring Merck to its knees for its inexcusable indiscretions regarding Vioxx. Dr. Nies cited famous hypotheses, blind clinical trials and studies with fancy names and numbers like VIGOR, VALOR, 010, and CV Outcome in an effort to support his testimony. But in the end, the technical speech was too much to grasp without assistance and a thorough explanation that never came.

Dr. Nies ended his testimony by asserting that compared with other NSAID drugs, like ibuprofen, aspirin, and Naproxen, Vioxx was just as safe and offered a better risk-free alternative considering that it did not cause gastrointestinal problems. Dr. Nies exclaimed that, as head of Vioxx and even using hindsight, he cannot “think of anything that the Vioxx team would have done differently.” He attested that Merck’s highest priority was to have a safe and effective drug on the market and vehemently denied that Vioxx was rushed to market or that it was made available to consumers before adequately and thoroughly testing for safety.

Lanier Asks Tough Questions of Merck’s Head of Vioxx

And then Mark Lanier leaped to the pulpit and in the brash manner that has become his hallmark, he began to put on a clinic in cross-examination of an adverse witness. Most observers and jurors could see Mr. Lanier during the direct examination of Dr. Nies at times smiling widely, other times shaking his head in disbelief at the testimony, many times rifling through prior testimony or documents, and often simply taking silent notes.

To attempt to depict in a paragraph or two the events that transpired during cross-examination today would fail to do those events justice and could not accurately describe the manner nor the extent to which Mr. Lanier categorically discredited most, if not all, of Dr. Nies’ testimony. From the outset, Lanier used Merck’s own documents and the testimony of its own witnesses to skewer the seemingly baseless claims of the witness. Everything from the witnesses statement that he was “retired,” to his bias as a witness because of his financial links to Merck, to the Vioxx studies themselves, to his exaggerated claims during direct examination regarding the safety of the Vioxx product, to his dealings with the FDA, to the reason for getting the Vioxx product to market efficiently, to how many people would be “helped” with Vioxx…and the list goes on… were fair game for Mr. Lanier with this witness. The witness even said that he couldn’t remember the data in his own report on Vioxx and tried to find his way around his own memo written to Merck brass that implicated Merck on rushing studies and failing to follow the suggestion of world-renowned scientists!

In a poor move by the witness, he was contrite and argumentative from the outset and would not admit to even seemingly harmless concessions. Again, had he been properly prepared he would have known better than to argue so emphatically on nearly every point. However, each time that Dr. Nies failed to agree with Mr. Lanier’s position, Mr. Lanier was armed and ready with a transcript, study, the Merck Manual, or some other document to demonstrate the impropriety of the Dr. Nies’ answer.

In the end, what progress may have been made with the witness during direct examination and the important points that Merck needed to get across to this jury were lost in the firestorm of Mr. Lanier’s lengthy and effective cross-examination. Although the jurors were seemingly taking few notes, they, along with the attorneys, judge, and observers, will not likely soon forget the spectacle of Friday’s proceedings.

Merck needs to regroup and finish strong. If this is the A-list with which they intend to win this trial, Merck and its team of highly paid defense lawyers, consultants, and representatives might want to rethink their strategy. The instant case has its problems and a win by the plaintiffs is far from guaranteed even with the excellent team that Lanier has gathered. But there are thousands of cases knocking on the door and many other good, if not better, trial attorneys waiting to take their turn and expose the heinous actions of Merck.

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Carol Ernst Testifies Vioxx Risks Unknown

2005-08-05T12:30:00.000-07:00

Angleton-TX—It came without warning and without fanfare, but three weeks after plaintiffs commenced their historic action in a Texas courtroom, chief trial counsel, Mark Lanier, matter-of-factly proclaimed on Thursday the magic words, “plaintiffs rest, your honor,” bringing plaintiffs’ case-in-chief to a close. Subject to objections and rulings by the court on testimony and evidence, Mr. Lanier and his team of attorneys should feel good about wrapping up their case, especially after the testimony provided by the lead plaintiff, Carol Ernst.

Plaintiffs’ Conclude Case With Examination of Ms. Ernst

One of the most difficult examinations that faces any trial attorney is the presentation of a grieving widow. Even the best sometimes stumble in their quest to present the witness with a mixture of just enough facts coupled with emotion to sincerely show a jury the repercussions of the loss of a loved one. However, if all witnesses testified as naturally as Carol Ernst, it would make the job so much easier.

Ms. Ernst was the first to take the stand on Thursday morning. She gave dramatic and compelling testimony about her childhood when she worked in a camp for disabled children, getting married and divorced to her first husband, being a single mom, a full-time worker, and full-time student. She also testified about her interest in working as a hospice counselor and helping to heal the grief of others. Of course, her testimony also included passionate statements about her late husband, Bob Ernst. She testified about how they first met at a fitness center, and that they ate at Olive Garden, went to the mall, and then to ice cream on a first date that seemed destined from that moment to last a lifetime.

Unfortunately, that lifetime was cut dramatically short one Sunday night several years ago when Ms. Ernst awoke from a light slumber thinking that her husband was snoring, but only to learn that he was breathing his last gurgled breaths as his life was startlingly extinguished. Despite the best efforts of doctors and emergency room personnel, Bob Ernst could not be revived and passed away. Since then, Ms. Ernst testified that she has suffered from depression (she saw a counselor who has not been allowed to testify on objection of defendant) and insomnia, and greatly missed her active life with Bob Ernst.

Mr. Lanier showed Ms. Ernst the warning label that came on the Vioxx product. Ms. Ernst testified that she and her husband read it, but that none of the described symptoms applied to him. There was nothing on the label regarding cardiovascular risks. Yet even today she still feels guilty about his death and believes that she was the one who directed him to seek out Vioxx from his treating physician. She believes that he might still be living if not for her suggestion to consider Vioxx after seeing a commercial or advertisement.

Merck Cross-Examines Ms. Ernst

Much to the surprise of several members of the press, and even some veteran lawyers, lead counsel for Merck, Gerry Lowry, elected to cross-examine Ms. Ernst. And an even bigger surprise was the two-hour vigorous attack on seemingly innocuous portions of Ms. Ernst’s testimony, her character, and her late husband’s character and life. Much of the cross-examination seemed to serve plaintiff by reinforcing the Ms. Ernst’s loss. Lowry’s cross-examination did show, however, that Merck was not about to lie down for any witness even with the looming risk of offending everyone in the courtroom, including the jurors. Many (including some defense counsel) wondered whether this was the appropriate tactic to employ in this situation.

In a discreet signal to the jury that the venue of this case is suspect, Ms. Lowry outlined the fact that neither Mr. Ernst before his death, nor the Ernst family after they were married had at any time ever lived or worked in Brazoria County. They had resided in Keene, Texas, Johnson County, and in Missouri for many years. The point being that despite the lack of contact with this area, the case is nevertheless occurring in a small courtroom fifty miles south of Houston for “some other reason.”

Ms. Lowry spent a significant amount of time questioning Ms. Ernst about Mr. Ernst’s smoking and drinking history. She testified that Mr. Ernst had only three glasses of wine during the whole time that she knew him, did not smoke, and ate healthily. Prior to their marriage, he was apparently a different sort of man who embraced life through his own recklessness and self-abuse at the sacrifice of his prior wife and family. Defense counsel showed Ms. Ernst a selected portion of Mr. Ernst’s medical records that alluded to a problem with Mr. Ernst’s hip, as well as becoming anxious and dizzy when exercising. But once again in a move that must have been anticipated by defense counsel, Mr. Lanier was given the golden opportunity during re-direct examination to show Ms. Ernst and the jury the rest of the medical report and deposition testimony of Dr. Wallace that explained the reason for Mr. Ernst’s dizziness was hypoglycemia and not any cardiac condition. Once again, Mr. Lanier was allowed to intimate that Merck was hiding the truth by not telling all of the story and only sharing those facts favorable to its defense, a recurring pattern and practice of a company that has something to hide.

Ms. Lowry’s cross-examination established a discrepancy in the amount of ibuprofen taken by Mr. Ernst. Ms. Lowry read Ms. Ernst’s prior deposition testimony in which she stated that her husband took four pills of ibuprofen four times daily. Merck is focusing on Mr. Ernst’s habitual ibuprofen regiment in an effort to resurrect their theory that ibuprofen caused Mr. Ernst’s heart condition and death, despite the fact that he stopped taking ibuprofen regularly well before his death in exchange for Vioxx and there was no ibuprofen found in his blood on autopsy. On re-direct, Mr. Lanier established using the Merck Manual that the administration of ibuprofen in doses even above that which Mr. Ernst was taking was acceptable.

Finally, Ms. Lowry questioned why it took only five months after the death of Mr. Ernst for the plaintiffs to seek out a lawyer and even after the death certificate proclaimed heart arrhythmia as the cause of death. Ms. Ernst parried that it had been something akin to a direction from an unknown spiritual source that she could not fully explain to check the internet for information on Vioxx and ultimately to contact a lawyer after learning of the risk factors form Vioxx on an internet website.

The examination of Ms. Ernst finally ended with her dramatic statement that it makes her lament her loss even more when listening to Merck’s claims in this trial. Ms. Ernst believes that Merck strategically chose not to share with patients and doctors the risks of Vioxx. She is resolute in her opinion that everyone would agree that they have a right to know of drug risks so that they can make a determination of whether to take a drug or not. She noted that if “…Merck had acted responsibly she wouldn’t have to be here…the jury wouldn’t have to be here….There is no reason for this to have to happen to anyone.”

The plaintiffs’ case ended on a strong and compelling note with the honest and sincere, yet not overly emotional or dramatic, testimony of the lead plaintiff. The jury listened acutely to the direct examination, drifted off somewhat during the exhaustive, and at times pointless, cross-examination, and then regrouped for the finale on re-direct.

Merck’s Case Begins With Head Vioxx Doc

Defendant may not feel as confident given the events of the past weeks, but they undoubtedly believe they still have a dog in this fight as they were given the opportunity for the first time to present their version of events late today. Merck commenced its case by calling Dr. Alan Niles, the lead doctor who directed the development of Vioxx. His testimony thus far elapsed less than an hour and so I will save the details to consolidate with tomorrow’s piece. As an aside, I mention that unless defense counsel finds a way to simplify the confusing and complicated testimony of an arrogant Dr. Niles for the jury and judge, they will more than likely encounter more snoozing jurors and uninterested observers within the same nine minutes that it took for that to occur today.

And on a final note, I remind my readers that unlike a piece of art, fine wine, or an Italian sports car, the examination of a witness at trial does not get better with age. Successful direct and cross-examinations exist in the moment and require an adept hand and a journeyman’s skill to be effective without being overbearing or exaggerated. Mark Lanier and many on his team are masters of their craft as has been demonstrated repeatedly throughout this trial. Merck’s hired counsel certainly have the pedigrees to seemingly meet the challenge, but despite several golden opportunities, their trial dogs have yet to seem worthy of their coin nor up to the challenge posed by plaintiffs’ counsel. Tomorrow is another day and there are many more days of trial still to come. I anxiously await defendant’s anticipated assault on plaintiffs’ claims and to see whether Lanier and his big guns can withstand and counter the attack.

Continue to log onto to www.firstvioxxtrial.blogspot.com for daily updates on the nation's first Vioxx trial.

Ernst’s Doctor Testifies He Never Knew Vioxx Risks

2005-08-04T11:30:00.000-07:00

Angleton, TX—While the Texas sun sizzled outside, the environment inside the courtroom was considerably more benign. The afternoon session of the country’s blockbuster trial was one of few surprises and neither the lawyers, jury, nor gallery seemed particularly engaged in the afternoon’s events that can only be characterized as generally less than compelling.

Jury Watches Deposition of Ernst’s Doctor

Immediately after lunch, in a move that veteran trial attorneys are usually loathe to make, the plaintiffs elected to offer the testimony of a Dr. Brent Wallace…via previously recorded videotape deposition testimony. Dr Wallace is Bob Ernst’s prior treating physician and the doctor who prescribed him the Vioxx in 2000. And while a treating physician is often a helpful witness, since he is normally seen as less-biased than retained expert witnesses, the lengthy videotape testimony of any witness is often difficult to endure…especially after lunch and into the afternoon.

The doctor looked as though he’d just been called from central casting, being schooled in Texas and Oklahoma, middle-aged, well-fed, and looking slightly jovial despite the circumstances. He only lacked the obligatory white coat and stethoscope to complete the standard uniform.

Plaintiffs’ counsel, Mark Lanier, examined Dr. Wallace initially. Of course, he chose not to play the entirety of his examination, but instead focused on a maximum of fifteen minutes of carefully chosen testimony, which demonstrated that Dr. Wallace was unaware of the health risks of Vioxx and that if he had known while treating the Mr. Ernst, he would not have prescribed him Vioxx.

Lanier also elicited testimony from Dr. Wallace that he was regularly and often visited by Merck sales representatives trying to sell the Vioxx product. Despite those sales visits, Dr. Wallace was, of course, not aware of the sales techniques of the Merck sales team, including “Dodge Ball” or “obstacle training.” Importantly, Dr. Wallace testified that he has historically relied on the sales pitches of drug company representatives, including those from Merck, to describe the benefits and hazards of drugs, but that at no time did anyone on Merck’s sales staff explain the health risks of Vioxx.

Dr. Wallace was cross-examined by Mr. Piorowski of the defense team on an exceedingly lengthy portion of videotape testimony. Dr. Wallace testified about his education and professional background, and that he is a specialist in Internal Medicine and is not a pathologist. In fact, he would always defer to a qualified pathologist in making pathologic diagnoses. Possibly previously unknown to most, Dr. Wallace was previously a defendant in this case, but was dismissed by the plaintiffs prior to trial. In a less important legal note, but of interest nonetheless, Dr. Wallace took Vioxx himself and may still be taking the drug in low doses.

Defendant’s obvious tactic was to demonstrate that any and all risks of Vioxx were contained on the package insert, which was included with the drug. Accordingly, no information about Vioxx’s risks were ever withheld by Merck. Dr. Wallace acknowledged that he initially prescribed without reservation many of the COX-2 drugs such as Vioxx, Celebrex and others, but he has now reduced and modified his prescription rates on those drugs in consideration of the hazards. Dr. Wallace has also gone back to utilizing some of the traditional NSAIDS, like Aleve, that apparently do not manifest in humans many of the health risks of the COX-2 drugs.

Defendant additionally prodded Dr. Wallace to admit that if, as the defendant contends, the health studies and the FDA demonstrate that the risks of Vioxx were actually similar to that of other drugs—including aspirin—then there is no reason not to prescribe Vioxx. The key, of course, to this reasoning is the dose of Vioxx and the individual susceptibility of patients to cardiovascular risks. Defense counsel showed him numerous documents and studies and pin-pointed language stating that Vioxx is demonstrated to have no excess risks and that any risks were fully disclosed to the FDA and doctors when Merck knew of them.

Dr. Wallace also testified that after the death of Mr. Ernst, his wife visited him to inquire about his death. Dr. Wallace could not recall the specifics of that conversation.

Finally, Dr. Wallace testified that a heart arrhythmia can be associated with or without a parallel heart attack and that both can cause death.

On redirect examination by Mr. Lanier, Dr. Wallace acknowledged that Merck sales representatives had told him that Vioxx was safe.

Dr. Wallace also testified that he previously attended a dinner at a restaurant in Houston (he ate filet mignon) where a roundtable discussion occurred regarding Vioxx. Unknown to Dr. Wallace, the doctor who was leading the discussion was paid $2500 by Merck in what was alluded to as nothing less than an obvious conflict of interest and possibly something much more conspiratorial.

It was also revealed that Merck had very detailed sales reports, including notes of conversations, numbers of Vioxx prescriptions, and percentage breakdowns of Dr. Wallace’s Vioxx use. While Dr. Wallace was aware of the sales data in general, he was surprised to learn that the records were so detailed.

Mr. Lanier finished his examination of Dr. Wallace with a flurry. Mr. Lanier showed Dr. Wallace the entirety of several documents of which Merck had only shown portions. Consistent with the plaintiffs’ theme throughout the trial, Mr. Lanier demonstrated that Merck did not show to Dr. Wallace the portions of the health studies evidencing cardiovascular risks and did not show Dr. Wallace the totality of the report of the medical examiner pertaining to Mr. Ernst. Why Merck would seemingly play into the plaintiffs’ strategy so easily is a question not easily answered. But without a doubt, the jurors were acutely aware of the testimony and the underlying messages contained therein.

Plaintiffs’ Economist Testifies

Plaintiffs also called a forensic economist, Dr. Ken McCoin. Dr. McCoin is a veteran witness who has testified in hundreds of cases. He is a local witness, schooled and practicing in the Houston area. The plaintiffs elected to have a New York attorney on their trial team question Dr. McCoin. Although the jury seemed less than receptive to some of his attempts at humor, he did a professional job of eliciting necessary testimony on the essential component of economic damages. The details of Dr. McCoin’s testimony are not as important as the fact that he ultimately provided a range of economic loss of approximately $212,000 to $284,000, depending on the income and benefits analysis utilized in the calculations.

As is most often the case, defendant chose not to substantially cross-examine the plaintiffs’ expert economist. Dr. McCoin did acknowledge that he did not consider any medical conditions specific to Mr. Ernst other than his death and that nearly all of the data used for the economic computations other than Mr. Ernst’s income were based on national averages. Obviously, this case is not about economic damages and if a verdict somehow accounted only for the economic losses to the Ernst family, it would be an outright victory for the defendant.

Continue to log onto to http://www.firstvioxxtrial.blogspot.com/ for daily updates on the nation's first Vioxx trial.

Texas Supreme Court Rules Coroner’s Testimony Admissible

2005-08-02T05:35:00.000-07:00

Angleton, TX—The jury heard from the coroner who examined Bob Ernst on Monday, Dr. Maria Araneta, after the Texas Supreme Court denied Merck’s appeal seeking to exclude her testimony.

Coroner Testifies Ernst Likely Died of Heart Attack

Merck began their battle to exclude the coroner’s testimony last week after plaintiffs flew her here from Abu Dhabi to testify as a surprise witness. Although Merck had listed Dr. Araneta on their witness list, Merck objected to her testimony because she was not listed on the plaintiffs’ witness list and had not been deposed during discovery.

Her testimony is critical in this case because it dilutes Merck’s most powerful evidence that an arrhythmia, and not a heart attack, cased Bob Ernst’s death. Dr. Araneta’s autopsy report, which Merck has repeatedly shown the jury, states Mr. Ernst’s cause of death as an arrhythmia. Merck contends that Vioxx has not been shown to cause arrhythmias. During her deposition last week, however, Dr. Araneta testified that despite her autopsy report, she believes that Bob Ernst most likely died of a heart attack, but died so suddenly that his heart showed no evidence of a heart attack.

Although Dr. Araneta suspected that Mr. Ernst’s death “had something to do with the heart,” she recalled that an autopsy was performed because Mr. Ernst’s cause of death was unknown. She did not conclude that Mr. Ernst died of a heart attack, but it is common knowledge that a heart attack can cause an arrhythmia. She testified that she could not diagnose a heart attack because it could not be “seen.” The clot that may have caused Mr. Ernst to suffer a heart attack could have dislodged during efforts to resuscitate him or may have simply dissolved. Her autopsy also found evidence of Mr. Ernst’s coronary arteriosclerosis, a build up of plaque in the arteries around his heart, which could have been the site of a blockage leading to his heart attack. Consequently, she concluded that Mr. Ernst most likely died of a heart attack.

Merck’s Head of Sales Testifies

The jury also saw the videotaped deposition of David Anstice, the head of Merck’s Human Health Division. Lanier focused many of his questions on why a division titled “Human Health Division” is responsible for sales and marketing. He also questioned Mr. Anstice, a salesman and not a doctor, about why he is responsible for the Human Health Division when he has no “human health experience.” He responded that he has experience in sales and that Merck’s scientists are responsible for the research department.

Mr. Anstice confirmed that Vioxx was a major drug for Merck. In 1994, when Ray Gilmartin assumed the role of CEO as the first non-doctor to hold that position, Merck was “in the middle of the pack.” By 1997, Merck gained the number one spot as the world’s leading pharmaceutical company. Mr. Anstice conceded that adding a warning about Vioxx’s cardiovascular risks would have negatively impacted Vioxx sales and the company's income. Lanier has repeatedly cited Merck’s sales goals as its motivation for hiding the cardiovascular risks of its blockbuster drug, Vioxx.

Continue to log onto to www.firstvioxxtrial.blogspot.com for daily updates on the nation's first Vioxx trial.

Merck Appeals Ruling to Texas Supreme Court

2005-07-30T11:50:00.000-07:00

Angleton, TX—While plaintiffs’ expert, Dr. David Egilman, continued his testimony on Friday, a flurry of activity was taking place behind the scenes to block crucial testimony from the coroner who examined Bob Ernst.

Merck Wants Coroner’s Testimony Blocked

On Tuesday, the parties deposed the coroner, Dr. Maria Araneta, who examined Bob Ernst. According to the Associated Press, Dr. Araneta lives in the United Arab Emirates where she works as a pathologist. Plaintiffs arranged for her transportation here and intended to call Dr. Araneta as a surprise witness on Tuesday. She was expected to testify that Bob Ernst likely died of a heart attack, but died so suddenly that his heart did not show any evidence of a heart attack. Merck objected to her testimony because she had not been deposed earlier and was not on the plaintiffs’ witness list.Likely anticipating that Dr. Araneta would not be called as a witness, Merck has relied heavily on her autopsy report, which lists Mr. Ernst’s cause of death as arrhythmia and arteriosclerosis, not a heart attack. The distinction is important for Merck because they contend that there is no evidence that Vioxx causes arrhythmias. Chatter in the legal community has routinely cited causation as the plaintiffs’ greatest hurdle. Dr. Araneta’s testimony would go along way towards establishing that Vioxx caused Mr. Ernst’s death.

Brazoria County’s Judge Ben Hardin ruled on Thursday that Dr. Araneta’s testimony is admissible. Merck appealed the ruling to the Texas Court of Appeals, which was denied on Friday. Illustrating just how much weight Merck has put on Dr. Araneta’s autopsy report, Merck filed a further appeal with the Texas Supreme Court on Friday.

Cross-Examination of Plaintiffs’ Expert Continues

Merck’s lawyer, David Kiernan, continued his cross-examination of Dr. Egilman. Kiernan showed the jury plaintiffs’ expert designation, which listed Dr. Egilman’s opinions in the case. That expert designation was filed with the court, however, before the time that Dr. Egilman testified he had reviewed any documents in the case. Dr. Egilman explained that plaintiffs’ expert designation merely anticipated his opinions. He cited examples of other cases in which he formulated opinions after reviewing documents contrary to the positions held by parties who had retained him. He testified that that could have happened in this case.

Kiernan read from an evaluation written by a student who had taken a course from Dr. Egilman at Brown University, where he teaches courses in medical ethics. The student wrote that you should only take Dr. Egilman’s course if you want to sit through three hours of him bashing “corporate America and science as we know it.” When Dr. Egilman asked Kiernan to read the entire evaluation, he refused. Effectively retracing any ground gained by Kiernan, Lanier read from several student evaluations praising Dr. Egilman and his courses on redirect.

Dr. Egilman was asked about his fees in this and other cases. He testified that he has earned between 2 million and 2.5 million dollars for his expert testimony over the last 25 years. On redirect, he explained that some of that money was used to pay his expenses and staff of researchers. He also testified, in what some might term a “setup,” that he donated his fees for testifying in this case to his non-profit global health foundation and to the cardiology wing at the local hospital.

Merck’s cross-examination of Dr. Egilman appeared at times poorly allocated. Instead of focusing on a random student evaluation, perhaps more time could have been spent exploring the basis of Dr. Egilman’s opinions about Merck’s studies or his years of testifying as an expert witness. While Dr. Egilman is no stranger to these types of attacks, these areas would likely have proven more fruitful for Merck. Instead, Merck’s “cheap shots” at Dr. Egilman leave a person wondering whether Dr. Egilman’s opinions are challengeable at all.

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Plaintiffs’ Expert Testifies That Vioxx Caused Death

2005-07-28T18:02:00.000-07:00

Angleton, TX—Plaintiffs’ expert, Dr. David Egilman, spent the entire day on the stand explaining how Merck’s studies, even early in Vioxx’s development, signaled an increased risk of cardiovascular risks. He also described to the jury how Vioxx contributed to Bob Ernst’s death.

Merck’s Studies Found Cardiovascular Risk

Lanier questioned Dr. Egilman about how Merck may have manipulated its study data to hide Vioxx’s cardiovascular risks. In one of Merck’s preclincal studies, completed in 1996, patients taking Vioxx experienced a higher rate of cardiovascular events than patients taking placebo. This study “signaled” to Merck that Vioxx might be associated with an increased risk of cardiovascular events and should have prompted Merck to perform further cardiovascular studies, according to Egilman. But instead of studying cardiovascular risks, Merck simply omitted that study data from its future analyses of Vioxx’s cardiovascular risks.

Dr. Egilman reviewed several of Merck’s studies with the jury and described whether they showed an increased cardiovascular risk. Several of those studies, which were designed to assess Vioxx’s effectiveness for new indications such as the treatment of Alzheimer’s, found that patients taking Vioxx experienced more cardiovascular events than patients taking other drugs or placebo. Merck’s only study that was designed specifically to evaluate cardiovascular risks in humans, the VALOR study, was never completed, despite a year of research.

Merck Failed to Warn About Risks

Dr. Egilman explained how drug companies’ warn doctors about the risks of their drugs. Companies provide doctors with “package inserts” with their drugs. The package insert lists information about a drug’s risks in various sections of the insert and with varying degrees of importance. Those sections include a warnings section, which doctors pay the most attention to according to Dr. Egilman, a precautions section, and a section that lists adverse events experienced by patients taking the drug. Dr. Egilman was careful to point out that the adverse events section specifically states that there is no causal link between the drug and the listed adverse events.

Lanier asked Dr. Egilman to explain where in the Vioxx package insert Merck warned about cardiovascular risks. Dr. Egilman explained that Vioxx’s package insert does not warn doctors about those risks. Instead, the package insert issued in 2000, when Bob Ernst died while taking Vioxx, merely acknowledged cardiovascular adverse events in its adverse events section. Accordingly, Dr. Egilman opined that Merck’s package insert failed to adequately warn doctors about Vioxx’s cardiovascular risks.

Vioxx Caused Bob Ernst’s Death

Dr. Egilman linked Vioxx to Bob Ernst’s death. Vioxx lowers levels of prostacyclin in the body, which is a chemical in the blood that prevents clotting. Vioxx was present in Mr. Ernst’s blood when he died, which means that Vioxx may have reduced Mr. Ernst's ability to prevent clotting. Mr. Ernst showed evidence of arteriosclerosis or plaque build up in his arteries, which increased the likelihood of a blockage that, because of Vioxx, his body could not correct. Dr. Egilman also testified that the records show that Mr. Ernst suffered an arrhythmia. According to Merck’s own physicians’ desk reference, arrhymias are associated with heart attacks 90% of the time. Accordingly, Dr. Egilman concluded that Vioxx caused or contributed to Mr. Ernst’s death.

Plaintiffs’ argument about arteriosclerosis rides a fine line. Dr. Egilman testified that Bob Ernst was at greater risk for a heart attack while on Vioxx because he had arteriosclerosis. Merck argues, however, that Mr. Ernst’s arteriosclerosis along with his arrhythmia caused Mr. Ernst’s death, not Vioxx. Almost admitting that Mr. Ernst’s arteriosclerosis played a role in his death, plaintiffs have used Merck’s alternative cause to make Mr. Ernst an eggshell plaintiff. Consequently, Merck’s failure to warn put Mr. Ernst at greater risk because he suffered from arteriosclerosis.

Merck Cross-Examines Dr. Egilman

On cross-examination, Merck’s counsel, David Kiernan, established that Dr. Egilman has spent much of his career testifying as an expert against corporations. Dr. Egilman acknowledged that he has testified in approximately 300 depositions and at 150 trials. And much of that testimony was against corporate defendants in asbestos litigation.

Kiernan asked Dr. Egilman a series of questions about his experience with clinical trials. Dr. Egilman conceded that he had virtually no experience whatsoever coordinating clinical trials, but he explained that his testimony is instead based on his experience analyzing clinical trial data as a practitioner and medical investigator.

Similar to his opening statement, Kiernan appeared to be reading from a prepared list of questions. Several of Dr. Egilman’s responses left room for potentially damaging follow-up questions, but most of the time Kiernan simply moved to the next question. It is not clear whether Kiernan is confined to a script, approved and directed by Merck, or he is intentionally avoiding the pitfalls of an open discussion with Dr. Egilman. But much of his cross-examination appears too fixed to convey his points to the jury.

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Merck Scientist Admits Failure to Warn

2005-07-27T18:11:00.000-07:00

Angleton, TX—Today, the parties completed their examination of Merck’s head epidemiologist, Dr. Nancy Santanello. The volley of Dr. Santanello, who was passed between the parties multiple times, became tedious as foundation for each point was lost in the brevity of questioning. Nonetheless, the timeline of events congealed today and the plaintiffs extracted important testimony about Merck’s Vioxx warnings.

Merck Did Not Warn Until 2002

Plaintiffs cross-examined Dr. Santanello regarding Merck’s warnings about Vioxx’s cardiovascular risks. Dr. Santanello conceded that the Vioxx label did not warn about cardiovascular risks until April 2002, well after Bob Ernst had died while taking Vioxx in 2000. Merck failed to warn until 2002, according to Lanier, despite having completed its VIGOR study more than two years earlier, which showed an increased cardiovascular risk. Dr. Santanello responded that Merck did not believe that VIGOR demonstrated the increased cardiovascular risk alleged by plaintiffs.

During testimony about Vioxx’s hypertension warnings, Dr. Santanello testified that doctors should “monitor” their patients closely for hypertension. The Vioxx label warned doctors to monitor their patients in some instances, such as drug interactions. But it did not appear to warn doctors that they should monitor patients for Vioxx’s hypertension risk.

Lanier challenged Dr. Santanello’s prior testimony that the FDA must approve changes in Vioxx’s label. (See 21 CFR 314.70 at http://a257.g.akamaitech.net/7/257/2422/04nov20031500/edocket.access.gpo.gov/
cfr_2001/aprqtr/pdf/21cfr314.70.pdf Note: to access this document, you must copy the entire two lines of the address and paste them into the address bar of your browser) He challenged that Merck had every opportunity to strengthen its warnings about Vioxx’s cardiovascular risks without prior approval from the FDA. After objection by Merck’s counsel, the court prohibited Lanier from asking Dr. Santanello about the FDA’s regulations governing labeling. Instead, Lanier established that Dr. Santanello is not qualified to testify about the FDA’s labeling requirements. Dr. Santanello testified that Merck would produce a witness who can respond to questions about these and other regulatory issues.

Plaintiffs Challenge Merck’s Tactics

Lanier rereviewed a letter from Dr. David Fries, a professor at Stanford University’s medical school, without several of the redactions present when it was first shown to the jury. In the letter, Dr. Fries complained about Merck’s efforts to discredit several researchers who he identified by name. He wrote that Merck had contacted these researchers’ superiors threatening action if the researchers did not stop disseminating anti-Vioxx information. As support for Dr. Fires' allegations that Merck tried to discredit doctors who did not support Vioxx, Lanier reminded the jury of an internal Merck document shown earlier in the trial that identifies the physicians in Dr. Fries’ letter and details Merck’s “plan” to “discredit” them.

Lanier also questioned Dr. Santanello about the Larry King Live show. Bruce Jenner and Dorothy Hamill appeared on the show, which was coordinated by Merck, and talked about the benefits of Vioxx. The actors’ comments on that program prompted the FDA to convene a conference the following day to discuss the FDA’s concerns. Bruce Jenner, for example, stated that Vioxx actually “heals pain.” The FDA was concerned about how these and other statements were interpreted by the 1.5 million viewers who watched the show. While being questioned by Merck’s lawyers, Dr. Santanello told the jury that Merck circulated follow-up advertisements to correct any misconceptions from that program about the safety and efficacy of Vioxx.

Fuzzy Math

In earlier testimony, Dr. Santanello accused plaintiffs’ expert, Dr. David Egilman, of incorrectly calculating the cardiovascular risks associated with Vioxx. Lanier questioned Dr. Santanello about the appropriate calculations. Unfortunately, a statistician would have had difficulty following their exchange. And most of the jury did not appear to be following. The problem appeared to be less with the actual math and more with their disagreements about the appropriate calculations.

Coroner Deposed

After the jury was dismissed on Tuesday, the parties deposed the coroner, Dr. Maria Araneta, who examined Bob Ernst. According to the Associated Press, Dr. Araneta lives in the United Arab Emirates where she works as a pathologist. Plaintiffs arranged for her transportation here and intended to call Dr. Araneta as a surprise witness on Tuesday. She was expected to testify that Bob Ernst likely died of a heart attack, but died so suddenly that his heart did not show any evidence of a heart attack. Merck objected because she had not been deposed and was not on the plaintiffs’ witness list. The court has yet to rule on whether Dr. Araneta will be allowed to testify.

Merck has repeatedly argued that Bob Ernst died of an arrhythmia, not a heart attack. The distinction is important for Merck because they contend that there is no evidence that Vioxx causes arrhythmias. Plaintiffs contend that Mr. Ernst died of a heart attack, but died too suddenly for his heart to develop evidence of his heart attack. Plaintiffs have also presented evidence showing that Vioxx is linked to arrhythmias, which can alone cause a heart attack.

Patience Wearing Thin

From all outward appearances, the trial has begun to wear on the parties’ nerves. Dr. Santanello, who has been questioned on and off for more than a week, clearly had less patience for Lanier’s aggressive style of questioning today. And Lanier appeared repeatedly annoyed at Dr. Santanello’s attempts to interject Merck’s version of the facts into her responses. While plaintiffs are left with little choice of style when challenging an adverse witness, it remains to be seen how this southern jury will interpret today’s exchange between Dr. Santanello and Lanier.

Continue to log onto to http://www.firstvioxxtrial.blogspot.com/ for daily updates on the nation's first Vioxx trial.

Plaintiffs Accuse Merck of Hiding Safety Data

2005-07-26T17:37:00.000-07:00

Angleton, TX—In a dramatic display of courtroom theatrics, plaintiffs accused Merck of hiding evidence of Vioxx's cardiovascular risks from the FDA. Merck's head of epidemiology, Dr. Nancy Santanello, testified that Merck submitted safety data to the FDA about all cardiovascular adverse events that occurred in its premarketing studies when it submitted its application for approval of Vioxx. On cross-examination, Mark Lanier, chief plaintiffs' counsel, asked Dr. Santanello about the volume of material that Merck submitted to the FDA together with the documents that she testified contained Vioxx's cardiovascular safety data. Simultaneously, Lanier's assistants began hauling the 157 boxes of material submitted to the FDA by Merck, which according to Lanier contained Merck's cardiovascular safety data buried inside. Dr. Santanello responded that Merck's submission was electronic and could be easily searched, and that the FDA focuses on the summaries that Merck is required to provide. Nonetheless, the jury likely understood that given the volume of data submitted, the FDA relies heavily on drug companies like Merck to properly calculate and identify the risks of their drugs.

Before being cross-examined by Lanier, Merck's lawyers completed their questioning of Dr. Santanello about Merck's many Vioxx studies. Dr. Santanello continued her explanation from yesterday about how Merck's Vioxx studies captured and categorized cardiovascular events in patients taking Vioxx.

Dr. Santanello also wrote a timeline of events for the jury. Her timeline ran from the discovery of Vioxx in 1991, through approval of the drug in 1999, to its withdrawal in 2004. Dr. Santanello used the timeline to explain to the jury that Merck took reasonable steps to inform doctors promptly about its study data and the known risks of Vioxx.

In response, Lanier asked Dr. Santanello about plaintiffs' version of the timeline. In stark contrast to Merck's timeline written by Dr. Santanello on a flip chart, plaintiffs' timeline was colorfully displayed on a board, blown up on a large screen, and given to the jury as a handout. Plaintiffs' timeline indicated that Merck suspected that Vioxx was associated with increased cardiovascular events before its approval in 1999 and that Merck actually knew about Vioxx's cardiovascular risks shortly thereafter. It also highlighted that Merck received letters from the FDA warning it about its sales tactics for Merck's other products before Vioxx was marketed, which helped establish that despite these warnings, Merck continued to employ its prohibited tactics to sell Vioxx.

The parties' use of a timeline should help the jury understand what Merck knew and when they knew it. Up until this point, the parties have simply identified key events and corresponding dates, but have failed to sequence those events coherently. Since this is a failure to warn case, a critical issue is when Merck knew or should have known about Vioxx's cardiovascular risks. Plaintiffs' timeline should go along way at illustrating this point.

Lanier highlighted once again that Merck produced only one corporate representative in this case, Dr. Santanello. Although Dr. Santanello has consulted in several of the areas at issue in this case, she conceded that she is not considered the most qualified person at Merck to testify about areas such as marketing, sales, and regulatory matters. Lanier fingered several Merck executives that he asked Merck to produce at trial, but Merck refused. They include Merck's former CEO, Ray Gilmartin, its president of research, Ed Scolnick, and Merck's head of marketing, David Anstice.

Continue to log onto to http://www.firstvioxxtrial.blogspot.com/ for daily updates on the nation's first Vioxx trial.

Plaintiffs’ Expert Cardiologist Takes the Stand, Says Vioxx Was a Contributing Factor

2005-07-25T16:12:00.000-07:00

Angleton, TX—Monday morning began with questions about arrhythmias for plaintiffs’ expert cardiologist, Dr. Isaac Wiener. Mark Lanier, chief plaintiffs’ counsel, directed his questions at establishing that given the absence of other risk factors, Vioxx contributed to Bob Ernst’s death.

Lanier first asked Dr. Wiener about his background. He attended Columbia University where he received a B.S. in Chemistry and English. Thereafter, he attended Harvard University medical school. Dr. Wiener is board certified in internal medicine, cardiology, and internal electrophysiology, which is the study of arrhythmias or irregular heartbeats. Dr. Wiener has also conducted research, authored and edited journal articles, and lectured on arrhythmias. He currently teaches medical students and treats patients at the UCLA medical center in Los Angeles.

Dr. Wiener explained the structure of the human heart to the jury and how it relates to arrhythmias. A normal heart pumps blood from various points in the body, through veins, and into the heart. The heart pumps that blood out of the heart and into arteries, which then return blood to the body’s organs. It also feeds oxygenated blood to itself through three critical arteries. That oxygen fuels the pumping mechanism of the heart, which is controlled by the heart's complex system of electrical impulses.

According to Dr. Wiener, a blockage in the heart’s arteries can cause arrhythmias and sudden cardiac death. Plaque can build up on the wall of a heart artery. When a clot passes through that artery, it can lodge against the plaque creating a blockage. The blockage can stop the flow of blood through that artery to the heart. Without blood flow, the heart does not receive enough oxygen. Starved for oxygen, the heart’s electrical system malfunctions causing an abnormal heartbeat or arrhythmia, and eventually leading to sudden cardiac death. Dr. Wiener cited a New England Journal of Medicine article linking clots and sudden cardiac death (Click here to read an abstract of the article: http://content.nejm.org/cgi/content/abstract/310/18/1137).

Mr. Ernst’s autopsy report noted evidence of moderate to severe build up of plaque in his arteries, which is also termed athereosclerosis. Dr. Wiener opined that a clot lodged in the plaque build up in Mr. Ernst’s heart artery causing him to suffer an arrhythmia and leading to his sudden cardiac death. Since Vioxx has been linked to producing clots in the blood, and given Mr. Ernst’s lack of other risk factors for a heart attack, Dr. Wiener opined that Vioxx was a contributing factor to Mr. Ernst’s death.

On cross examination, David Kiernan, counsel for Merck, asked Dr. Wiener about the tests run after Mr. Ernst’s death. Because Mr. Ernst died suddenly, the tests that are typically used to diagnose a heart attack could not be performed. Consequently, Dr. Wiener conceded that he could not tell the jury to a reasonable degree of medical certainty that Mr. Ernst suffered a heart attack. (Merck contends that Mr. Ernst suffered an arrhythmia, which is not linked to Vioxx, and not a heart attack, which has been linked to Vioxx. Plaintiffs dispute this contention.)
Despite Dr. Wiener’s admitted unfamiliarity with the subject matter, Merck cross-examined Dr. Wiener about an April 6, 2005 FDA memo concerning cardiovascular risks of NSAIDS (Non-Steroidal Anti-Inflammatory Drugs). Merck argued that the memo demonstrates that Vioxx carries no greater cardiovascular risk than other NSAIDS, which include prescription NSAIDS such as Pfizer’s Celebrex and non-prescription NSAIDS like Advil. (Click here to read 4/6/05 FDA Memo: http://www.fda.gov/cder/drug/infopage/COX2/NSAIDdecisionMemo.pdf) Dr. Wiener testified that he was not an expert in most of the areas covered by the memo and on that basis refused to agree with many of the statements in the memo.

Once again, lawyers’ styles of examination clashed in the courtroom today. Lanier focused on simplifying Dr. Wiener’s testimony by using analogies to help the jury understand. Whereas David Kiernan, who is also a medical doctor, specifically told Dr. Wiener on cross that he was using terms as they are defined medically. Mr. Kiernan made very little, if any, attempt to translate Dr. Wiener’s testimony for the jury. While Mr. Kiernan extracted critical concessions from Dr. Wiener, many of Mr. Kiernan’s more nuanced arguments may have been lost in their complexity. Adding this extra level of complexity may be a strategy for dealing with Lanier’s opposing style or simply a means of muddling the facts.

Thus far in this case, Plaintiffs have been able to simply point to Merck’s studies and exclaim that they show an increased risk of cardiovascular events in patients taking Vioxx. To respond to these allegations, however, Merck is forced to explain the details of its studies. Dr. Santanello and Merck counsel, Gerry Lowry, attempted this formidable task this afternoon.

Dr. Santanello, who rarely omits a detail from her testimony, parsed through Merck’s interpretation of a series of Vioxx studies. Accusing plaintiffs’ expert, Dr. Egilman, of lumping all cardiovascular events together in order to raise the total number of cardiovascular events associated with Vioxx, Dr. Santanello explained that a true examination of the data failed to show an increased risk. It was not until Merck completed its APPROVE study, which ultimately led to Vioxx’s voluntary withdrawal from the market, that an increased cardiovascular risk could be established.

Judge Ben Hardin asked the jury to return to court at 9:00 a.m. tomorrow.

Continue to log onto to http://www.firstvioxxtrial.blogspot.com/ for daily updates on the nation’s first Vioxx trial.

Plaintiffs' Expert Says Vioxx Caused Bob Ernst's Death

2005-07-23T19:09:00.000-07:00

Angleton, TX—Plaintiffs’ key expert, Dr. David Egilman, took the stand on Friday in the nation’s first Vioxx trial. There to convey his expert’s opinions through simple and easy to understand questioning was chief plaintiffs’ counsel, Mark Lanier.

To counter Merck’s contention in its opening statement that Dr. Egilman was a “professional expert” who would say whatever you paid him to say, Dr. Egilman testified extensively about his background. He attended Brown University where he received a B.S. in Molecular Biology and his medical degree. He also earned a master in public health from Harvard University. Dr. Egilman is board certified in both internal medicine and preventive medicine.

Comparing Dr. Santanello, Merck’s head of epidemiology who has already testified in this case, with Dr. Egilman, Lanier highlighted the differences in their qualifications. Dr. Santanello testified that she had allowed her medical license to lapse because as a researcher she no longer sees patients. Dr. Egilman, on the other hand, maintains medical licenses in Massachusetts, Mississippi and Rhode Island, and continues to treat patients. Dr. Egilman has also testified before Congress about research ethics and has advised the Senate whereas Dr. Santanello has done neither.

While Dr. Egilman has published a series of peer-reviewed articles, he has also written two book chapters relevant to this litigation. Dr. Egilman recently completed a chapter about drug warnings and relevant FDA regulations as well as a chapter titled “Antiwarnings.” He testified that his chapter about Antiwarnings describes warnings that do not convey the necessary and appropriate information to doctors and patients. Dr. Egilman characterized the warning in Merck’s television commercial starring Dorothy Hamill as an “antiwarning.” He testified that it failed to warn about the most important side effect associated with Vioxx, its increased risk of cardiovascular events. Even worse, by showing Dorothy Hamill figure skating, it conveyed a message to patients that they can exercise when taking Vioxx, which patients susceptible to cardiovascular risks should not attempt.

Lanier also questioned Dr. Egilman, known for his testimony in asbestos case, about his work as an expert witness. While Dr. Egilman has worked on several cases for Lanier’s firm, he has testified at trial for Lanier in only five cases. Dr. Egilman has also testified on behalf of both injured workers and corporations in asbestos and other litigation. Characterized by Lanier as a “medical detective,” Dr. Egilman’s testimony typically focuses on his research into corporate influence on medical research and warnings.

Before Dr. Egilman closed his clinic in Rhode Island, he testified that Merck sales representatives encouraged him to prescribe Vioxx. He testified that Merck “secretly” monitored his prescriptions and knew that he was not prescribing Vioxx. When asked by Lanier why he wasn’t prescribing Vioxx, he testified that he was concerned about the cardiovascular risks associated with all Cox-2 inhibitors, the class of drugs that include Vioxx. He recalled that Merck sales representatives assured him that Vioxx was not associated with cardiovascular risks.

While the theory of how Cox-2 inhibitors may increase cardiovascular risks has been discussed previously in this trial, Dr. Egilman’s explanation was the most coherent. Blood clots form through the binding of platelets. In the case of an open wound, the clot or thrombus stops the bleeding. At some point, the process of clot formation must stop, which is achieved through a process involving prostacyclin, a chemical in our blood.

Clots can form around the plaque on a blood vessel wall, which can ultimately block that blood vessel. Prostacyclin helps prevent that blood vessel blockage by regulating the clot formation. Cox-2 inhibitors like Vioxx, however, prevent the production of prostacyclin. Consequently, a blood vessel blockage is more likely in patients taking Vioxx, which explains why Vioxx is associated with an increased risk of cardiovascular events, according to Dr. Egilman.

Dr. Egilman challenged Merck’s interpretation of its VIGOR study results. That study showed that patients taking Vioxx experienced more cardiovascular events than patients taking naproxen. According to Dr. Santanello, Merck interpreted the VIGOR study results to mean that naproxen actually protects the heart. Merck based its conclusion on a reexamination of its controlled clinical studies, which showed no increased risk of cardiovascular events in patients taking Vioxx. Dr. Egilman explained that VIGOR was a more reliable measure of Vioxx’s cardiovascular risks because it contained more patients taking Vioxx over longer periods than Merck’s controlled clinical studies. Accordingly, Dr. Egilman opined that Merck should have recognized the cardiovascular risks associated with Vioxx based on the VIGOR data alone.

Dr. Egilman also challenged Merck’s postmarketing studies, which it claims were aimed specifically at measuring Vioxx’s cardiovascular risks. Two of those studies tested animals only, and in the third test, Merck studied healthy males over a seven-day period. Dr. Egilman testified that the animal tests could not be substituted for VIGOR’s human data. And the single cardiovascular study in humans was too short and tested a population that was not at risk for cardiovascular events. Consequently, none of these studies, according to Dr. Egilman, could trump the VIGOR study results.

Lanier asked Dr. Egilman if the obligation to warn doctors and patients about its drugs lies with Merck. He testified that Merck performs drug testing and controls the test data. Neither the FDA nor academic researchers who are not working with Merck are granted access to test Merck’s drugs. Doctors must weigh a drug’s risks against its benefits and advise their patients who make the ultimate decision about whether to take that drug. Consequently, Merck is obligated to warn doctors and patients about the risks attendant to their drugs like Vioxx.

At the end of the day, Dr. Egilman opined that Vioxx either caused or contributed to Bob Ernst’s death, whose widow and children have sued Merck in this case.

On Friday, the jury appeared to easily follow Dr. Egilman. It goes without saying that Dr. Egilman’s reputation precedes him. He is revered by many in the legal community and detested by others. Nonetheless, his witness stand manner was so appealing that one might even have characterized him as charming.

A professional expert sometimes testifies using scripted and disjointed responses, and typically lacks a personal connection to the facts of the case. That was not the case on Friday. From all outward appearances, Dr. Egilman has spent more time reviewing and analyzing the data in this case than the lawyers. His answers contained a level of detail incapable of scripting. And many of his responses stemmed from his own personal experiences as a practitioner adding an extra level of genuineness. After Friday’s testimony, it will be difficult for Merck to convince the jury that Dr. Egilman is nothing more than a professional expert.

Judge Ben Hardin asked the jury to return to court at 9:00 a.m. on Monday when plaintiffs will continue their examination of Dr. Egilman.

Continue to log onto to http://www.firstvioxxtrial.blogspot.com/ for daily updates on the nation’s first Vioxx trial.

Merck Makes Strides At Rehabilitating Its Witness

2005-07-21T19:54:00.000-07:00

Angleton, TX—A much more relaxed Dr. Santanello, Merck’s head of epidemiology, responded to questions from Merck’s lawyer, Gerry Lowry, aimed at rehabilitating her today after days of questioning by the plaintiffs. Jurors could be seen taking copious notes as Dr. Santanello attempted to explain fairly complex scientific theories to this group of Brazoria County residents.

Dr. Santanello described in great detail her educational and medical background for the jury. The first woman in her family to attend college, she worked as an art teacher in Baltimore’s public schools after graduating from Marymount College in New York. Following her childhood dream of being a doctor, she attended Howard University’s medical school and completed a residency in emergency medicine there. She also attended the University of Maryland where she completed a graduate degree in epidemiology and a second residency in preventative medicine. After working at the National Institutes of Health for many years, Dr. Santanello accepted a position at Merck in 1991 as an epidemiologist.

Laying a foundation for explaining Merck’s various Vioxx studies, Dr. Santanello described the “how” and “why” of epidemiology to the jury. Epidemiology, Dr. Santanello’s specialty, is the study of data from different populations to determine the various risks in those populations. When studying a drug, researchers may give groups of similarly situated individuals, for example groups of similar age and health, two different drugs. These studies are often “blinded” such that the patients and their doctors are unaware of what drugs they are taking. Sometimes patients are given two different drugs, or a drug and a placebo, she explained. How the two groups differ is analyzed as it relates to the two different drugs, or the drug and placebo. Using a mathematical formula, an epidemiologist can determine whether the differences between the two groups are the result of the drugs or merely the result of chance.

Dr. Santanello reviewed the specifics of several studies performed before Vioxx was marketed, which captured cardiovascular events. She testified that none of those studies showed an increased risk of cardiovascular events in patients taking Vioxx and that Vioxx was safe for marketing.

Contrary to statements made during plaintiffs’ questioning, Dr. Santanello testified that some of Merck’s premarketing studies of Vioxx also captured arrhythmias, the condition that Merck contends caused the death of Bob Ernst, whose widow and children have sued Merck in this case. Merck analyzed the data about arrhythmias from its premarketing studies and concluded that patients taking Vioxx were at no greater risk for arrhythmias, according to Dr. Santanello.

Dr. Santanello explained that one kidney study and one canine study raised questions about cardiovascular risks before Vioxx was marketed. Merck scientists did not, however, understand the results. To confirm that Vioxx was not linked to an increased risk of cardiovascular events, Merck scientists examined its controlled study data and determined that there was no increased risk.

After Vioxx was marketed, Merck continued to study new indications for the drug. One such study was the VIGOR study, which plaintiffs contend showed an increased risk of cardiovascular events. The VIGOR study examined approximately 8000 patients, 4000 taking Vioxx and 4000 taking naproxen, a traditional NSAID (Non-Steroidal Anti-Inflammatory Drug). Merck completed the VIGOR study in March 2000, which found that more patients taking Vioxx experienced cardiovascular events than patients taking naproxen. Dr. Santanello explained that less patients taking Naproxen experienced cardiovascular events because naproxen protects the heart whereas “Vioxx is neutral” and has no effect on the heart. Consequently, Merck continued to believe that Vioxx was safe.

It was not until September 2004 that Merck discovered that Vioxx might be associated with increased cardiovascular events, according to Dr. Santanello. At that time, Merck completed its APPROVE study. That study compared patients taking Vioxx with patients taking placebo and showed, unlike the controlled studies before it, that more patients taking Vioxx suffered cardiovascular events than patients taking placebo. Merck convened a group of internal and external scientists, including Dr. Santanello, to examine the results. In the absence of similar data from other drugs in its class like Celebrex, another Cox-2 inhibitor, and despite recommendations from some scientists to leave Vioxx on the market, Merck chose to voluntarily withdraw Vioxx from the market in September 2004.

Merck made strides towards diffusing some of plaintiffs’ allegations today with Dr. Santanello’s testimony. While she sometimes struggled to communicate complex material at our level, she appeared to reach the jury who seemed attentive for most of the day.

Something that neither side has been able to convey is the overall timeline of events. Dates are used to describe points in time, for example when Vioxx was marketed or when a study was completed, but neither side has charted the timeline of evidence such that the sequence of events has crystallized.

Judge Ben Hardin asked the jury to return to court at 9:00 a.m. tomorrow when the defense will continue its questioning of Dr. Santanello.

Continue to log onto http://www.firstvioxxtrial.blogspot.com/ for daily updates on the nation’s first Vioxx trial.

Plaintiffs Conclude Their Examination of Merck’s Scientist

2005-07-20T17:07:00.000-07:00

Angleton, TX—If the jurors’ choices of beverages is any indication of their excitement about this case, the juror who brought an entire pot of coffee to his seat this morning, leading to a courtroom filled with laughter, might have been sending a message to the parties that things are getting a little dry. Nonetheless, jurors in the nation’s first Vioxx trial, for the most part, appeared focused on the sometimes intense questioning by chief plaintiffs’ counsel, Mark Lanier, of Merck’s head of epidemiology, Dr. Nancy Santanello.

Lanier questioned Dr. Santanello about the disputed cause of Bob Ernst’s death, whose widow and children brought this action against Merck, the makers of Vioxx. According to the coroner’s report, Mr. Ernst presented with moderate to severe arthereosclerosis, which is a build up of plaque in the blood vessels. There was no evidence, however, of a blood clot that could have lead to a heart attack. Merck contends that without evidence of a clot, Mr. Ernst died of an arrhythmia and not a heart attack. The distinction is important because Vioxx has been linked to an increased risk of heart attacks, but has not, according to Merck, been linked to an increased risk of arrhythmias. The plaintiffs contend that Vioxx has also been linked to an increased risk of arrhythmias.

Lanier challenged Dr. Santanello’s knowledge of cardiovascular events using Merck’s own physician’s desk reference titled the “Merck Manual.” She testified that once a clot lodges in a blood vessel, that clot remains there indefinitely. But according to the Merck Manual, in two-thirds of all patients who suffer a heart attack, those blood clots dissolve within 24 hours. Accordingly, plaintiffs contend that the clot, which they argue caused Bob Ernst to suffer a heart attack, actually dissolved before the coroner performed her examination, which explains why the coroner did not find any evidence of a clot.

Quite possibly the most effective demonstrative used by Lanier to establish causation in this case was a review of the American Heart Association’s risk factors for heart attacks. Patients at greater risk for heart attacks are: (1) 65 or older; (2) male; (3) with a family history of heart attacks; (4) smoke; (5) have high cholesterol; (6) engage in little physical activity; (7) obese; (8) have diabetes; and (9) take Vioxx (a Lanier-added factor with which Dr. Santanello agreed). Lanier reviewed with Dr. Santanello each factor as it related to Bob Ernst and crossed out each factor that did not apply. In the end, the only factors applicable to Mr. Ernst were that he was male and took Vioxx. This presentation was easy to understand and an extremely powerful illustration of how Vioxx may have lead Mr. Ernst to suffer a heart attack, helping plaintiffs chip away at their greatest hurdle in this case, causation.

While reviewing the above risk factors, Dr. Santanello stated, "You've got to die of something, right." To make matters worse for Merck, Dr. Santanello characterized, likely without thinking, the review of these risk factors as a “game.” Lanier seized the opportunity and reminded Dr. Santanello that “Bob Ernst is dead,” “his widow is sitting in the courtroom,” and this is “not a game.”

Lanier continued his questioning about Merck’s knowledge of Vioxx’s cardiovascular risks. The jury was shown documents and testimony from Merck’s leading scientist, Dr. Ed Scolnick, suggesting that Merck was concerned about cardiovascular risks even before it marketed Vioxx. During his deposition, Dr. Scolnick testified that he worried about a mechanism-based cardiovascular risk as early as 1998 before Vioxx was marketed. While Dr. Santanello admitted that some premarketing data indicated a risk for cardiovascular events, she explained that Merck did not understand how to interpret that data. Relying on the data from Merck’s premarketing controlled studies only, Merck concluded that there was no increased risk of cardiovascular events.

Merck did complete some studies specifically designed to measure Vioxx’s cardiovascular risks after Vioxx was already marketed. Dr. Santanello confirmed that some of those postmarketing studies showed that patients taking Vioxx were at an increased risk for cardiovascular events. Despite the fact that Merck went to the time and expense of performing these studies, however, Dr. Santanello discounted them because “they were not controlled studies.”

Lanier also showed the jury documents that he said establishes that Merck was showing Wall Street data that was incorrect. In one such document, Dr. Ed Scolnick, Merck’s head scientist, stated that he would “boil” one Wall Street analyst “in oil” if he circulated the results of his data reanalysis, which showed an increase risk of cardiovascular events in patients taking Vioxx. Dr. Santanello testified that Merck’s initial analysis of that data was proper and did not show an increased cardiovascular risk.

Lanier’s typically entertaining style was slightly muted today as he focused on extracting answers from Dr. Santanello who responded to many of his questions with what sounded to be scripted responses. Dr. Santanello attempted to avoid many of Lanier’s questions about cardiology and sales statistics simply by claiming ignorance on the topic. It is unlikely that Dr. Santanello fully appreciated what she was signing up for when she was drafted to answer all questions about Merck as its corporate representative in this case. Although the litigation advantage of avoiding testimony by multiple, high level company witnesses is obvious, to believe that Dr. Santanello could respond to questions about all issues in this case is unrealistic.

Given the amount of legal power behind Merck, it is inconceivable that they could not have anticipated plaintiffs’ areas of questioning, especially since all of the areas being covered with Dr. Santanello were covered during discovery. This suggests that Merck made a conscious decision not to educate Dr. Santanello about the areas with which she is unfamiliar and to either rely on its other non-company witnesses or risk being forced by the court to bring another corporate representative to trial, which the court at this juncture is unlikely to do.

Plaintiffs concluded their questioning of Dr. Santanello today and the defense began its initial rehabilitation of the witness by asking a series of background and introductory questions.

Judge Ben Hardin asked the jury to return at 9:00 a.m. tomorrow when the defense will continue its rehabilitation of Dr. Santanello.

Continue to log onto http://www.firstvioxxtrial.blogspot.com/ for daily updates on the nation’s first Vioxx trial.

Examination of Merck’s Scientist Continues

2005-07-19T17:02:00.000-07:00

Angleton, TX—Mark Lanier, chief counsel for plaintiffs in the nation’s first Vioxx trial, continued to drill Merck’s head of epidemiology today, Dr. Nancy Santanello, about Merck’s strategy to deal with doctors opposed to Vioxx.

Dr. Santanello was questioned about a Merck document containing its strategies to “neutralize” and “discredit” doctors who did not support Vioxx. In one case, the terms “show me the money” were used to describe Merck’s strategy for influencing a doctor with 40 clinics in New York where more Celebrex, Pfizer’s competing drug, was prescribed than Vioxx. Merck’s strategy also included a grant to the subject doctor’s clinics to analyze rheumatology treatments followed by the words “price tag is $25,000.” And in yet another strategy, Merck documented its plan to discredit a doctor who lectured about Celebrex for Pfizer (then Searle).

Lanier asked Dr. Santanello to confirm that Merck’s strategy was to discredit doctors who did not support Vioxx if those doctors could not be neutralized. Dr. Santanello testified that Merck did not have the influence over doctors that Lanier suggested. In response, Lanier recalled a letter shown to the jury yesterday in which a Stanford University Professor of Medicine, Dr. Fries, complained to Merck’s CEO, Ray Gilmartin, about receiving a phone call from Merck threatening consequences for him and Stanford if a doctor in his group did not stop giving anti-Merck and anti-Vioxx lectures.

While Dr. Santanello admitted to working on these types of strategies for Merck, she disagreed with Lanier’s characterization of them as “sinister.” Instead, she characterized the terms “neutralize” and “discredit” as marketing terms used to describe Merck’s attempts to convince doctors to appreciate Merck’s position on Vioxx as a good drug.

Dr. Santanello confirmed that Merck tracked doctors’ prescriptions of Vioxx. Included in those doctors whose prescriptions were monitored was Bob Ernst’s doctor, Dr. Brent Wallace. He appears listed on a document shown to the jury and titled “August 00 Coffin Nail High NSAID Hit List for VIOXX.” The document apparently lists doctors who prescribed large amounts of NSAIDS (Non-Steroidal Anti-Inflammatory Drugs), a competing class of pain relievers, instead of Vioxx, and describes Merck’s attempts to increase their Vioxx prescriptions.

Merck’s “Hit List” documents meeting after meeting between Merck’s sales representatives and Dr. Wallace, and the substance of those meetings. Merck representatives discussed with Dr. Wallace, among other things, the safety of Vioxx. At one point, Dr. Wallace requested additional safety information from Merck. In response, Merck wrote to Dr. Wallace about its recent study, the VIGOR study, and advised that .4% of the patients taking Vioxx in that study experienced “cardiovascular events.”

Referring to the actual VIGOR study report, Lanier asked Dr. Santanello to show the jury the study data to support that only .4% of the patients taking Vioxx in the study experienced “cardiovascular events.” Dr. Santanello explained that the “cardiovascular events” referenced in the letter to Dr. Wallace were limited to “cardiovascular thromboembolic events” and did not include all cardiovascular events. Instead, the VIGOR results showed that 14.6% of the patients taking Vioxx in the study experienced “cardiovascular events,” which included a series of various cardiovascular events including heart attacks, strokes, hypertension, and arrhythmias. Dr. Santanello admitted that the language used in Merck’s letter to Dr. Wallace was “not very precise,” but explained that enclosed with the letter was a copy of the New England Journal of Medicine article about the VIGOR results.

Over objections from Merck’s attorneys that direct-to-consumer advertising would mislead the jury because Merck is only required to warn doctors, not consumers, of the dangers associated with its drugs under Texas’s learned intermediary doctrine, the jury was shown a series of Vioxx television commercials. One ad featured ice skating Olympian Dorothy Hamill and was characterized in a Merck E-mail as creating the highest impact thus far on Vioxx sales. Although Merck had completed its VIGOR study, which showed an increase in cardiovascular events in patients taking Vioxx, the Hamill ad did not contain a warning about cardiovascular risks. Dr. Santanello confirmed that none of the six television ads shown to the jury included a warning about cardiovascular risks, but testified that the FDA approves all commercials before they run on television.

Lanier also reviewed the July 2000 Vioxx label with Dr. Santanello. She testified that the 2000 label contained neither the VIGOR study results nor a warning about cardiovascular events. Dr. Santanello explained that the FDA and Merck were engaged in discussions about what language should be included in the Vioxx label to explain the VIGOR results. Lanier showed the jury an E-mail from Merck’s president of science, Edward Scolnick, to Merck’s president of marketing, David Anstice, which characterized the labeling change proposed by the FDA to include the VIGOR results as “ugly.” He wrote, “It is ugly cubed. Thye (sic) are bastards.”

Once again attacking Merck’s opening statement, Lanier showed an excerpt in which Merck’s lawyer, David Kiernan, stated that Merck’s safety studies had not shown an increased risk of cardiovascular events. In response, Lanier showed the jury a study called the Ingenix study, which identified a 35% increased risk of cardiovascular events in patients taking Vioxx compared to patients taking ibuprofen and Celebrex. Dr. Santanello explained that the Ingenix study report shown to the jury was only preliminary, despite its title, “Final Report,” and contained “data errors.” She also testified that the Ingenix study was not a controlled study and therefore, did not identify “cause and effect.” The remarks made during Merck’s opening statement that none of its safety studies showed an increased cardiovascular risk, according to Dr. Santanello, concerned only controlled studies, despite the fact that such qualifying language was not used.

Judge Ben Hardin asked the jury to return tomorrow at 9:00 a.m. when questioning of Dr. Santanello will continue.

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Testimony Begins in Vioxx Trial

2005-07-18T17:25:00.000-07:00

Angleton, TX—Plaintiffs in the nation’s first Vioxx trial began presenting their case today by calling Merck’s corporate representative, Dr. Nancy Santanello—executive director and head of Merck's department of epidemiology. While the jury heard only about two hours of testimony from Dr. Santanello, Mark Lanier, chief counsel for the plaintiffs, pressed her about a series of documents, which Lanier told jurors illustrate Merck’s pattern and practice of hiding the dangers of Vioxx.

Lanier has repeatedly stated that he wants to question others from Merck, but lacks the subpoena power to force their appearance at trial. Consequently, plaintiffs are left with only one Merck representative to question on all topics, Dr. Santanello.

Lanier questioned Dr. Santanello about her lack of marketing experience at Merck. He told Dr. Santanello that much of plaintiffs’ case revolved around Merck’s deceptive marketing tactics and yet Merck produced a scientist as its corporate representative at trial. Dr. Santanello conceded that she has little experience with marketing, but told the jury that this case is about whether Vioxx caused Bob Ernst’s death and not marketing, and that is why she is testifying.

During plaintiffs’ opening statements last Thursday, Lanier showed the jury a series of letters from the FDA, which warned Merck that its promotional materials for Vioxx and other drugs were false and misleading. In Merck’s opening statements, David Kiernan, counsel for Merck, responded that the FDA letters identified by plaintiffs merely addressed promotional technicalities such as inappropriate color, size and headlines in Merck’s advertisements. Lanier questioned Dr. Santanello about those FDA letters.

In an eight page warning letter shown to the jury, the FDA specifically warned Merck about its "false" and "misleading" Vioxx promotional campaign. (See 9/17/01 FDA Letter at http://www.fda.gov/foi/warning_letters/g1751d.pdf.) The FDA wrote, “You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious
cardiovascular findings that were observed in the . . . [VIGOR] study, and thus, misrepresents the safety profile for Vioxx.” Dr. Santanello disagreed with the FDA’s statements and characterized them as allegations.

A disputed issue of fact in this case centers on Merck’s VIGOR study. It compared 4000 patients taking Vioxx with 4000 patients taking prescription strength Naproxen; the compound found in the pain reliever Aleve. The results of that study showed that patients taking Vioxx experienced a higher rate of cardiovascular adverse events than patients taking Naproxen. Dr. Santanello testified that Naproxen thins the blood, like aspirin, thereby creating a cardiovascular “protective effect.” It is this protective effect, Dr. Santanello testified, which explains the increased incidence of heart problems in patients taking Vioxx.

The FDA disagreed with this explanation in its September 17, 2001 letter to Merck, writing, “[t]here is another reasonable explanation [for your study results], that Vioxx may have pro-thrombotic properties,” i.e. Vioxx may cause cardiovascular adverse events. Dr. Santanello conceded that the cardiovascular protective effect of Naproxen has not been confirmed in any controlled study. Instead, Merck bases its explanation on the fact that Vioxx has been shown in some studies to have no worse cardiovascular effects than placebo.

Lanier also questioned Dr. Santanello about a sales training piece entitled, “Dodgeball.” Dr. Santanello confirmed that the "Dodgeball" materials were used to train Merck sales representatives how to answer questions from doctors. Under the title, “Obstacle No. 4,” one such anticipated question from a doctor read, “I am concerned about the cardiovascular effects of Vioxx?” Merck sales representatives were taught how to answer just such a question. But Dr. Santanello confirmed that during the training exercise, sales representatives holding a card that read “Dodge” did not have to answer the question. Lanier suggested that sales representatives were encouraged to dodge this and other questions from doctors about Vioxx’s cardiovascular dangers.

Dr. Santanello was also questioned about a letter from Dr. James Fries, a professor of medicine at Stanford University. Dr. Fries wrote to Ray Gilmartin, the former CEO of Merck, and complained about a telephone call that he received from Merck’s Dr. Louis Sherwood. In his letter, Dr. Fries complained that Dr. Sherwood called him at home on a Saturday to complain about a physician in Dr. Fries' group, Dr. Gurkirpal Singh, who was giving “anti-Merck” and “anti-Vioxx” lectures. Dr. Sherwood told Dr. Fries, according to his letter, that Dr. Fries and Stanford University would face consequences for Dr. Singh’s statements.

Lanier asked Dr. Santanello whether Merck should have resorted to such intimidation of doctors to sell Vioxx. Dr. Santanello testified that if Dr. Fries’ statements were true, Dr. Sherwood’s actions were not appropriate. She doubts that Dr. Fries was intimidated, though, because researchers in academia tend not to be easily intimidated.

Judge Ben Hardin apologized to the jury for the delay in starting today and asked the jury to return at 9:00 a.m. tomorrow.

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Attorneys Deliver Heated Opening Statements Amidst Allegations of Jury Tampering

2005-07-15T14:11:00.000-07:00

Angleton, TX—Attorneys gave their opening statements to the jury on Thursday in the nation’s first Vioxx case. Their arguments, sometimes emotional and other times painfully dry, detailed why they believed their clients should prevail.

Even before opening statements began, attorneys engaged in a contentious exchange about possible jury tampering. Mark Lanier, chief trial counsel for plaintiffs, told the court that someone was calling Brazoria County residents, identifying themselves as calling from Merck, and surveying residents about the case. Residents were asked, for example, whether Merck should pay money to plaintiffs in this case simply because Merck is a big company. Mr. Lanier—all too familiar with efforts by rogue defendants to tamper with a jury—threatened to haul Merck attorneys into court over the matter. But Merck attorneys assured the court that the calls did not come from Merck. In response, Judge Ben Hardin told attorneys that he would again admonish jurors not to speak with anyone about the case, which he did prior to opening statements.

Mr. Lanier began his opening statement by introducing his client, Carol Ernst, to the jury whose husband, Bob Ernst, died of a disputed heart-related problem after taking Vioxx for eight months. Bob and Carol Ernst were married for about a year before Mr. Ernst died at age 59. The Ernsts were an active couple who rollerbladed and cycled together, Lanier explained while he showed jurors Ernst family photos. An avid runner who ran marathons, Bob Ernst was a “picture of health,” Mr. Lanier told the jury. But Carol Ernst lost her soulmate to Vioxx.

The plaintiffs’ case came down to four distinct issues according to Lanier: motive, means, death, and alibis. Merck was motivated by money, and the means to that end was Vioxx, which caused Bob Ernst’s death, and instead of accepting responsibility for Bob Ernst’s death, Merck was pointing fingers and laying the blame for his death on others.

Merck, a once ethical company, started its decline with the hiring of Ray Gilmartin, the now retired CEO of Merck. Lanier argued that when Gilmartin was hired, he changed Merck’s goal from patient care to profits. And in so doing developed what Lanier termed, “Merck-y” ethics. To illustrate his point, Lanier showed the jury a series of letters from DDMAC, the division at the FDA that regulates consumer advertising, in which DDMAC warned Merck to discontinue its false and misleading advertising of several of its drugs, including Vioxx.

He also explained that Merck’s pipeline of drugs was drying up in 2000-2001 and Merck bet everything on Vioxx making its success a win or lose for the company. Lanier added that Merck and Pfizer were in a race to get Vioxx and Celebrex on the market. Whichever company reached the market first was sure to maintain a market advantage. Merck won that race and Vioxx was the first to market, but only after pushing the drug through the FDA review process, according to Lanier.

The jury also received a science lesson on Cox-2 inhibitors, the class of drugs that includes Vioxx and its cousin pain relievers Celebrex and Bextra. Mr. Lanier explained that Cox-2 is an enzyme associated with inflammation and by inhibiting or blocking that enzyme, Vioxx relieved pain. Cox-2 inhibitors, like Vioxx, differ from other pain relievers like Advil and Aleve, so called NSAIDS (Non Steroidal Anti-Inflammatory Drugs). NSAIDS inhibit or block both the Cox-1 and Cox-2 enzymes. By blocking the Cox-1 enzyme, which is responsible for clotting of platelets in blood, NSAIDS can cause bleeding. As a Cox-2 inhibitor only, Vioxx was not associated with bleeding such as stomach bleeding. Lanier told jurors that Vioxx’s selective action—blocking the Cox-2 enzyme only and not the Cox-1 enzyme—damages the blood vessel walls, and causes blood clots and arrhythmias, leading to an increased risk of heart attacks and strokes.

Lanier accused Merck of deceiving the medical community about this increased risk of heart attack and stroke. He claimed that Merck tested around the problem by designing their studies to avoid finding the increased risk of cardiovascular problems. According to Lanier, Merck went so far as to delete a paragraph about Cox-1 and Cox-2 enzymes from its Merck Manual, a widely used desk reference for physicians published by Merck.

Lanier attacked Merck’s marketing and sales tactics. He accused Merck of paying off doctors to prescribe Vioxx through grants, and through payment for international speaking engagements and for bogus marketing feedback. Merck spent more to market Vioxx than Pepsi and Budweiser over the same period. Merck targeted doctors who were not prescribing enough Vioxx and according to sales logs shown to the jury, Merck even targeted Bob Ernst’s physician, Dr. Wallace, in an effort to persuade him to prescribe more Vioxx.

Bob Ernst died of a heart attack because of Vioxx, Lanier explained. He cautioned the jury that Merck would claim that Mr. Ernst died of an arrhythmia and not a heart attack, that Vioxx is not associated with arrhythmias, and therefore could not have caused Mr. Ernst’s death. Lanier explained that Mr. Ernst’s arrhythmia and heart attack cannot be separated and were caused by Vioxx.

Lanier closed his opening statements by altering Merck’s slogan for the jury from “Merck—Where Patients Come First” to “Merck—Where Profits Come First.”

David Kiernan, whose dry, mater of fact style helped to diffuse some of plaintiffs’ allegations, delivered Merck’s opening statement.

Contrary to plaintiffs’ allegations, Mr. Kiernan argued that Merck did not rush the development and testing of Vioxx. Instead, Merck started testing Vioxx and seeking FDA approval for the drug in 1991. Between 1991 and 1999, when the product was launched, Merck performed almost 100 studies of Vioxx, and submitted its findings to the FDA throughout the process. Mr. Kiernan highlighted for the jury that none of those studies established an increase risk of cardiovascular events associated with Vioxx. And after Vioxx was launched in 1999, Merck continued to test the drug.

Mr. Kiernan engaged in a painstaking review of Merck’s major postmarketing studies, which he argued, in the end did not establish an increased risk of cardiovascular events in patients taking Vioxx. Merck supplied those test results to the FDA and a subset of those results to the medical community through a press release, an article in the New England Journal of Medicine, and letters to physicians studying Vioxx, so called clinical investigators.

When Merck eventually pulled Vioxx off the market, it acted as a company should have acted, argued Mr. Kiernan. Faced with conflicting recommendations from scientists about the meaning of test results that pointed to an increased risk of cardiovascular events associated with Vioxx, Ray Gilmartin, Merck’s CEO, chose patient safety over continued marketing and ordered that Vioxx be withdrawn.

Mr. Kiernan also addressed Bob Ernst’s cause of death. He informed the jury that Vioxx has never been linked to arrhythmias, the listed cause of Mr. Ernst’s death on his autopsy report. The autopsy also found evidence of arteriosclerosis or plaque build-up in the arteries, which was a risk factor for Mr. Ernst’s arrhythmia and sudden cardiac death. Mr. Ernst did not die because of a heart attack, he argued, he died from an arrhythmia. Vioxx could not have caused Mr. Ernst’s death.

The day ended with as much excitement as when it began. Unaware that one of Merck’s scientists would be attending opening statements, Mr. Lanier demanded to question her before the jury. The judge denied his request and stated that she would be available for questioning on Monday.

The judge ordered Friday reserved for the parties to address legal issues related to trial exhibits and asked the jury to return on Monday at 1:00 p.m. for the first phase of evidence from the plaintiffs.

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Jurors Selected For First Vioxx Case

2005-07-13T18:38:00.000-07:00

Angleton, TX – Almost 100 potential jurors filled Brazoria County’s largest courtroom today for jury selection in the nation’s first Vioxx trial, Ernst v. Merck. Anxious jurors were called one by one into a courtroom teeming with lawyers, reporters and spectators.

Voir dire began with a set of typical instructions from Judge Ben Hardin. He instructed potential jurors not to speak with anyone about the case until after the case concluded. He admonished them not to seek any outside information about the case and to base their decisions solely on the evidence presented in court.

The ever animated and always entertaining Mark Lanier, the lead plaintiffs’ attorney in the case, began voir dire by gently prodding the jury pool about what they expect from a drug company. Many jurors stated that drugs should be tested thoroughly before a company like Merck markets them to the public. But the amount of time required for testing should fluctuate with the severity of the injury that drug is intended to treat such that drugs for more severe illnesses reach the market sooner. If a prescription drug is associated with side effects, regardless of the illness that drug is intended to treat, potential jurors agreed that drug companies should warn about those side effects.

While Merck’s attorney, Gerry Lowry, lacked the pulpit style of Mark Lanier, she maintained potential jurors’ interest by pressing them with pointed questions about their biases toward drug companies. Some potential jurors stated that Merck’s voluntary withdrawal from the market meant that Vioxx was unsafe. While others believed that if a drug is taken off the market, the drug company did not do enough research on the drug before sending it to market. Despite their apparent preconceptions about withdrawn drugs, many potential jurors admitted to a bias in favor of Merck without having heard anymore than the attorneys’ skeletal explanations of the case during voir dire.

Many of Ms. Lowry’s questions foretold what we could expect to see from plaintiffs’ attorneys in the case. She asked whether jurors would pledge to read documents in context and not hold the words of one Merck employee against the entire company signaling that we may see E-mails and other documents that incriminate Merck’s sales and marketing tactics in the face of an increased risk of cardiovascular events associated with Vioxx.

The judge held the jury pool until after 7:00 p.m. when he announced the 12 jurors and 2 alternate jurors selected for the case. Opening arguments begin tomorrow morning sometime after 10:00 a.m.

Log on to http://www.firstvioxxtrial.blogspot.com/ tomorrow for the latest details of this groundbreaking case.

Jury Questionnaires Circulated

2005-07-11T11:47:00.000-07:00

Today, attorneys for plaintiffs and Merck & Co. circulated jury questionnaires to potential Brazoria County jurors slated to hear the nation's first Vioxx trial, Ernst v. Merck & Co. Opening arguments in the case could begin as early as this Wednesday.

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