Recent decisions from the U.S. Supreme Court have allowed generic drug manufacturers to escape justice for the personal injuries and deaths caused by their dangerous and defective products. It is unjust that any company could market a defective product and not be accountable for the harm it causes. Yet, our law now provides generic drug manufacturers this protection.
And, our law has become arbitrary in closing the doors of justice to some injured consumers but not others. What do I mean? A generic drug is the same as its brand name equivalent. Yet, a patient injured by a defective brand name drug has access to the courts while a second patient injured by the same defect in the generic version of the drug does not. That’s arbitrary.
An editorial in The Journal of the American Medical Association (JAMA) questions recent court rulings denying justice for individuals injured by defective generic drugs. The author of the JAMA article, a doctor with Harvard Medical School, states the following:
The Supreme Court’s recent decisions have created a paradox of unequal recourse for patients harmed by serious adverse events caused by branded vs generic medications, even though these drugs are bioequivalent and freely substituted under state law.
That’s one way of stating the obvious – it’s unjust and unfair that two people could be injured by the same defective drug design or defective drug warning. Yet, one has access to our courts and the other does not. Generic drug manufacturers make money selling their pills to consumers. In fact, the vast majority of drugs dispensed are now generics. Yet, these companies have been granted broad immunity.
How did we reach this point? In 2011, the U.S. Supreme Court issued a decision in the case of PLIVA v. Mensing. In PLIVA, the plaintiffs were prescribed Reglan but received the generic version from the pharmacist. After taking the medication, plaintiffs developed a severe neurological disorder. The plaintiffs filed product liability claims under state law alleging a failure to warn. On appeal, the Supreme Court ruled that FDA regulations preempted state tort claims concerning the warning labels. And, since the generic manufacturers were required by the regulations to use the same label as the brand name manufacturer, they could not be held accountable for damages due to a failure to warn.
This summer, our Supreme Court issued its decision in Mutual Pharmaceutical Co. v. Bartlett. The group Public Justice called this summer’s Bartlett decision –"a nonsensical result required by neither law nor policy." Here is how Public Justice summarized the decision:
By a 5-4 vote, reflecting the typical right/left split, the Court held in Mutual Pharmaceutical Co. 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.
You can read more commentary about this terrible decision from the Public Justice blog. In addition, the New York Times called Bartlett a damaging decision for people harmed by generic drugs. In response to this bad decision, the FDA has been considering a change in its rules. Justice requires that companies be accountable for the harm they cause. The courthouse doors should not be closed.