Jun. 1, 2008
Both courts issued their opinions on Thursday, May 29. Texas' 14th Court of Appeals in Houston took the less-is-more approach and disposed of Carol Ernst's favorable judgment in nine pages. The New Jersey court took the opposite tack and issued a joint opinion in the McDarby and Cona cases that runs 126 pages.
The Texas court reversed and rendered on causation, holding that the evidence was legally insufficient to support a verdict that Vioxx, an antiinflammatory pain reliever the manufactured and sold by Merck, caused the death of Robert Ernst. Ernst had been taking the drug for only a few months before he suffered a fatal heart attack. The plaintiff's theory of the case was that the Vioxx promoted the formation of a blood clot which, in turn, led to the heart attack.
The plaintiff was forced to concede that there was no direct evidence of a blood clot but argued that there was nevertheless sufficient circumstantial evidence to support the verdict. The court noted that the circumstantial evidence relied on by the plaintiff was expert testimony that a clot could have been present, but could have disappeared through various means prior to the autopsy. The court rejected this as evidence that would support a verdict, terming it speculation and mere conjecture.
In the New Jersey cases, causation was an issue on appeal only in the McDarby case because the jury in the Cona case found no causal connection between the drug and the heart attack suffered by the plaintiff. However, unlike the Texas Court, the New Jersey court devoted little discussion to the issue and summarily concluded that that medical causation had been demonstrated.
The New Jersey court began its opinion with a lengthy recitation of the history of Vioxx, including the research relating to the drug, Merck's travails with the FDA concerning its purported downplay of the drug's pro-thrombotic properties., and the subsequent withdrawal of the product from the market. It followed this with detailed (and lengthy) analysis of federal preemption issues, the scope of the New Jersey Product Liability Act, and the potential for recovery under the New Jersey Consumer Fraud Act.
The court concluded that McDarby's state law claims were not preempted and that a compensatory award in his favor should stand under the state's product liability act. It reversed an award of punitive damages in favor of McDarby, as well as an award of attorneys fees and expenses under the state's consumer fraud statute. It found both of these awards to be preempted by the Federal Food Drug and Cosmetic Act (FDCA).
Although the jury in the Cona case failed to find causation, it did award the plaintiff over $2 million in fees and expenses under the New Jersey Consumer Fraud Act. As with the McDarby award for this element, the court reversed this award based on FDCA preemption.
In other Vioxx related news, Merck recently settled claims brought against it by 29 states and and the District of Columbia relating to its marketing of Vioxx. The claims alleged that Merck downplayed the risks related to the drug. The total settlment to be shared among the states and D.C. is $58 million. The settlement also puts future restrictions on Mercks marketing tactics.
Link to Ernst opinion. | Link to McDarby-Cona opinion.