With the public reading and hearing about a possible—and previously undisclosed—relationship between long-term Vioxx use and greater risk of heart attack or stroke, there were calls in some quarters for the federal Food and Drug Administration (FDA) to order the removal of Vioxx from the market. Similar views were expressed regarding other firms' COX-2 Inhibitors. Merck decided, on its own, to cease Vioxx sales after a 2004 Merck study indicated a potential link between Vioxx use of at least 18 months and an increased heart attack or stroke risk. (The FDA later required the withdrawal from the market of Bextra, one of two COX-2 Inhibitors produced by Pfizer, Inc. As this book went to press, Pfizer's Celebrex remained on the market but was subject to a requirement to warn users of a possible increase in their heart attack and stroke risks.)
By mid-2005, Merck faced approximately 4,000 pending or threatened lawsuits in which former Vioxx users or their estates contended that Vioxx use had caused the users to experience heart attacks or strokes. In these product liability cases, the plaintiffs typically alleged that Merck had known of such a link as far back as 1997 but had failed to inform physicians and their patients of the potential danger. The first of these cases to go to trial resulted in an August 2005 verdict in favor of the estate of Robert Ernst, a Vioxx user who experienced a heart arrhythmia that proved fatal. The verdict of approximately $250 million in damages—$25 million compensatory and $225 million punitive—shocked Merck, whose spokespersons asserted that the jury had erred in finding the existence of adequate proof of a specific causation link between Vioxx use and Ernst's heart condition. In addition, Merck protested that no study had linked Vioxx use with heart arrhythmia, as opposed to other cardiac problems. Despite its vow to appeal the verdict, Merck found itself having to decide whether to continue following its previously announced policy of aggressively defending against all Vioxx cases instead of attempting to settle them.As you read this chapter, think about the preceding paragraphs and consider the following questions:
- On what product liability theory or theories would the plaintiffs in the Vioxx cases have been relying?
- What legal elements must the plaintiffs prove in order to win the Vioxx cases?
- Are punitive damages routinely awarded, in addition to compensatory damages, in product liability cases? What would the plaintiff in the Ernst case have had to prove in order for punitive damages to have been assessed against Merck?
- If a manufacturer's product works well for most users but the manufacturer is aware that some users may experience harm as a result of using it, what would utilitarians and rights theorists say concerning whether the manufacturer has an ethical obligation to warn about the risk of harm or to suspend sales of the product? (You may wish to consult the discussion of ethical theories in Chapter 4 as you answer this question.)