Saturday, July 30, 2005

 

Merck Appeals Ruling to Texas Supreme Court

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.

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

Thursday, July 28, 2005

 

Plaintiffs’ Expert Testifies That Vioxx Caused Death

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.

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

Wednesday, July 27, 2005

 

Merck Scientist Admits Failure to Warn

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.

Tuesday, July 26, 2005

 

Plaintiffs Accuse Merck of Hiding Safety Data

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.

Monday, July 25, 2005

 

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

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.

Saturday, July 23, 2005

 

Plaintiffs' Expert Says Vioxx Caused Bob Ernst's Death

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.

Thursday, July 21, 2005

 

Merck Makes Strides At Rehabilitating Its Witness

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.

Wednesday, July 20, 2005

 

Plaintiffs Conclude Their Examination of Merck’s Scientist

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.

Tuesday, July 19, 2005

 

Examination of Merck’s Scientist Continues

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.

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

Monday, July 18, 2005

 

Testimony Begins in Vioxx Trial

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.

Continue to log on to this site, http://www.firstvioxxtrial.blogspot.com/, for daily coverage of the nation’s first Vioxx trial.

Friday, July 15, 2005

 

Attorneys Deliver Heated Opening Statements Amidst Allegations of Jury Tampering

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.

Continue to log onto http://www.firstvioxxtrial.blogspot.com/ to follow the events of this trial.

Wednesday, July 13, 2005

 

Jurors Selected For First Vioxx Case

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.

Monday, July 11, 2005

 

Jury Questionnaires Circulated

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.

Continue to log onto this site to follow Keller · Fishback LLP's daily coverage of the trial.

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