Bartlett: A nonsensical result required by neither law nor policy
By Claire Prestel, Staff Attorney
I know everyone is eager for the Supreme Court’s rulings on gay marriage and voting rights. But don’t let the Court’s alarming ruling today on generic drugs get lost in the shuffle: By a 5-4 vote, reflecting the typical right/left split, the Court held in Mutual Pharmaceutical Co., Inc. v. Bartlett that a woman horrifically injured by the generic drug sulindac cannot recover any money from the drug’s manufacturer even though she proved to a New Hampshire jury that the drug is defectively designed, and the jury awarded her more than $21 million.
In Bartlett today, and in a 2011 decision called PLIVA, Inc. v. Mensing, the Supreme Court ruled that the plaintiff consumers could not recover for injuries caused by generic drugs in circumstances when they would have been able to recover for the same injuries if they had taken the drugs’ brand-name versions. To give you an example of the injustice that results from this regime, drawn from Bartlett’s facts: If you are left permanently disfigured by a pain-relief drug that is no more effective than similar drugs but is much more likely to burn 60-65 percent of your skin off and cause you to experience what a surgeon calls “hell on earth,” and you prove to a jury that you have incurred medical costs and other damages to the tune of millions of dollars, you can recover for your injuries if you happen to have taken the brand-name version of the drug but will be left with nothing if you happen to have taken the generic.
As even Justice Thomas said in 2011, this kind of result “makes little sense” to all of us consumers who may be dealt the “unfortunate hand” of being injured by a generic drug. And it is a nonsensical result required by neither law nor policy.
As for law, the conservative majority says the results in Bartlett and Mensing are mandated by a federal statute. But that statute has remained largely unchanged for decades, and no one ever thought it required these results before. As our Executive Director Arthur Bryant put it, “The Court blames Congress for this result, but Congress acted only to protect consumers, not eliminate their rights. This result is solely of the Court’s making.”
As for policy, generic-drug makers may say they need to be immunized from liability in order to compete while selling cheap drugs. But they have succeeded dramatically in the last few decades notwithstanding that everyone assumed they faced all the same liability as brand-name manufacturers. Plus, many generic-drug makers are now owned by brand-name companies anyway, and according to a brief filed by economists and health policy experts in Mensing, generic-drug manufacturers have very healthy profit margins.
Public Citizen issued a report today documenting health risks posed by generic drugs and has also asked the FDA to make regulatory changes that could lead to different results in future cases. The FDA should take action, and it should do so soon.