Friday, August 19, 2005
Jury Awards $253.4 Million
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.
Thursday, August 18, 2005
Parties’ Deliver Closing Statements to the Jury
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.
Tuesday, August 16, 2005
"The Defense Rests"
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.
Saturday, August 13, 2005
Merck’s Expert Cardiologist Testifies Vioxx Did Not Cause Death
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.
Friday, August 12, 2005
Merck’s Clinical Research VP Says Studies Showed No CV Risk
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.
Wednesday, August 10, 2005
Merck’s CEO Says Company Needed Vioxx to Grow
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.
Tuesday, August 09, 2005
Merck’s Pathologist Says Merck Manual Is Wrong
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.
Saturday, August 06, 2005
Merck’s Top Vioxx Doc Testifies He Would Do Nothing Differently
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.
Continue to log onto to www.firstvioxxtrial.blogspot.com for daily updates on the nation's first Vioxx trial.
Friday, August 05, 2005
Carol Ernst Testifies Vioxx Risks Unknown
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.
Thursday, August 04, 2005
Ernst’s Doctor Testifies He Never Knew Vioxx Risks
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.
Tuesday, August 02, 2005
Texas Supreme Court Rules Coroner’s Testimony Admissible
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.