Side-Effects of Drug Litigation The Fen-Phen Fiasco
Posted By Clod on December 20, 2011
Last week, the first of what is expected to be a cascade of unfavorable verdicts came down against the Wyeth-Ayerst division of the pharmaceutical giant American Home Products (AHP). This verdict follows the 1997 recall of two anti-obesity drugs, fenfluramine (Pondimin) and diphenfluramine (Redux), after reports were published concerning a possible association between their use and heart-valve damage.
One of these drugs without prescription was often prescribed in combination with an entirely different kind of appetite suppressant, phentermine (hence the term “fen-phen”). Such usage has never been sanctioned by the FDA. Despite alarming early case reports, several follow-up articles have revealed that the risk of significant adverse effects is actually quite small, especially with short-term use.
Too late, it seems, for AHP. Their attorneys chose to fight this case in court rather than settling out-of-court, as they had done in other cases, because they felt confident in a favorable outcome. As a result of this verdict, it is likely that the number of pending lawsuits will multiply from the current estimate of 10,000. Even if the average settlement or judgment of already-filed suits is “only” $1 million, the current costs of such lawsuits to AHP amounts to $10 billion. And that figure is conservative, since the number of plaintiffs will now be rising.
What does all this mean for you and me? Why should we care about AHP? Here’s why: The drugs involved here went through the same rigorous testing and FDA review that all American pharmaceuticals have to undergo before approval and marketing. It takes many years and millions of dollars to get a drug to the public, and many fall by the wayside during the process. This example will prove chilling to the pharmaceutical industry as a whole.
After all, who wants to expend years of scientific and technical expertise, millions of dollars, and other less well defined assets, to get a useful drug to market, only to have some completely unknown and unpredictable adverse reaction sabotage the product, and even perhaps the whole company? Innovation is the core reason why we have benefited from hundreds of new medications without prescriptions during the past 60 years, extending our life span and improving our health into the golden years. If pharmaceutical companies, fearing litigation for rare, unknown reactions, decline to develop and market beneficial unique products, the state of the art will stagnate, to the profound detriment of the public’s health.
And, most ironic of all, we have the opposite situation involving the tobacco industry, which has long evaded accountability for its dangerous products. In contrast to AHP and other pharmaceutical companies, whose intent has always been to produce safe and beneficial products — albeit, of course, profitable ones — Big Tobacco has consistently held profits to be the only goal.
Theirs is the only product that is harmful when used as intended, plus they have a 50-year history of deception and concealment concerning the health effects and addictiveness of their product. Until very recently they were seemingly immune from successful litigation, mostly due to the protection of the warning label and protectors in Congress. That is starting to change, at long last.
The liability system in this country functions well, usually, to force corporations to act responsibly; for if they do not, they risk huge financial judgments. In the case of fen-phen and AHP, the system has not worked to benefit the public. The combination of greedy attorneys and “junk science” has once more taken its toll. (A similar scenario played out in the 1992 silicone-implant settlements-the major difference being that the earlier claims have been thoroughly trashed as the junk science they were. Again, too late for Dow-Corning). Why won’t the same fate befall the lords of tobacco, who, in contrast to AHP, so richly deserve to learn this lesson?
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