Merck scored a much needed victory on Thursday when Atlantic City, New Jersey jurors decided that the drugmaker’s Vioxx painkiller did not cause a 68-year-old woman’s heart attack.
Vioxx was once a $2.5 billion-a-year blockbuster for Merck, who now faces more than 13,000 Vioxx-related lawsuits. Merck now has a 3-4 record after seven trials. An eighth trial is under way in Los Angeles.
My take on this litigation: Merck was painfully close to not only civil but criminal negligence in putting and keeping this drug on the market. But it does not make individual cases a slam dunk by any stretch because the vast majority of cases have significant causation problems. Reading between the lines of the facts in this New Jersey case, the jury found that the plaintiff, 68 years old, would have suffered the same heart attack even if she had not taken Vioxx.
Interestingly, the jury found that while Merck failed to warn the plaintiff about the heart risks of taking Vioxx, it did adequately warn her doctor of such risks. In Maryland and in most states, under the learned intermediary doctrine, the manufacturers of pharmaceutical drugs and medical devices are discharged of any duty of care to patients by providing warnings to the prescribing doctors.
This rule strikes many people as antiquated in 2006 because pharmaceutical companies are now ferociously marketing to the end users, as evidenced by turning on the television or opening up a magazine. New Jersey became the first court to accept this argument in Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999), ruling that advertising prescription drugs directly to end users “alters the calculus of the learned intermediary doctrine” such that the rule does not apply.
Apparently to provide some sense of balance, the court further ruled that if the pharmaceutical company complied with FDA advertising, labeling, and warning requirements, the rebuttable presumption will be that there was no failure to warn. A rebuttable presumption is a hard thing to overcome but the New Jersey jury in this Vioxx case apparently felt that the Plaintiff’s lawyers overcame this rebuttable presumption.
The Maryland Court of Appeals has adopted the learned intermediary doctrine. But in a case that sounds similar to Perez, the court in Rite Aid v. Levy-Gray, 391 Md. 608 (2006) declined earlier this year to extend the doctrine to those cases in which a pharmacy is disseminating information concerning the properties and efficacy of a prescription drug. Specifically, the Maryland Court of Appeals found that the learned intermediary doctrine does not preclude a pharmacy from being held liable when it provides a package insert that could provide the basis for such a warranty as a matter of law. In other words, a pharmacy may not use the learned intermediary doctrine as a shield. The logic of this case leads me to believe that the Maryland Court of Appeals rule similarly to the court in Perez.
Going back to the Vioxx litigation, because I think the plaintiff’s pharmaceutical lawyers have smartly pushed the best cases first, it pains me to say that I predict that Merck’s winning percentage will continue to increase over time. This is not because Merck was not negligent, but because of the difficultly in linking their negligence to heart disease, a common problem among individuals who were taking Vioxx because it is typically older people who needed Vioxx to combat arthritis. Because heart disease is so prevalent in older people, juries are going to struggle to determine whether the cause of a stroke or heart attack was from Vioxx or because of heart disease unrelated to the Vioxx.