Friday, August 19, 2005

 

Jury Awards $253.4 Million

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

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

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

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

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

Thursday, August 18, 2005

 

Parties’ Deliver Closing Statements to the Jury

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

Judge Reads Jury Charge

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

Lanier Interprets Jury Charge

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

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

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

Merck Engaged in a Scheme of Denial, Deception and Damage

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

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

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

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

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

Defense Attacks Lanier

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

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

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

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

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

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

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

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

Tuesday, August 16, 2005

 

"The Defense Rests"

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

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

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

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

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

Saturday, August 13, 2005

 

Merck’s Expert Cardiologist Testifies Vioxx Did Not Cause Death

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

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

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

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

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

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

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

Friday, August 12, 2005

 

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

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

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

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

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

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

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

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

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

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

Wednesday, August 10, 2005

 

Merck’s CEO Says Company Needed Vioxx to Grow

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

Merck’s Expert Pathologist Says No Evidence of Heart Attack

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

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

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

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

Former Merck CEO Defends Merck’s Actions

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

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

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

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

Tuesday, August 09, 2005

 

Merck’s Pathologist Says Merck Manual Is Wrong

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

Merck’s Pathologist Disagrees With Coroner’s Testimony

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

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

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

Pathologist Says Merck Manual and Textbook Are Wrong

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

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

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

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

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

This page is powered by Blogger. Isn't yours?