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.

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