Injured By A Defective Generic Drug? Where Is The Justice?
Recent U.S. Supreme Court decisions allow generic drug manufacturers to escape justice for the personal injuries and deaths they cause. They can sell dangerous products, earn huge profits and avoid responsibility for harm. That is completely unjust. No company should be able to market dangerous products with no accountability for injuries. Yet, our law now provides generic drug manufacturers this special protection.
Our law has become completely arbitrary. It closes 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 patient injured by the generic version does not. That’s arbitrary.
An editorial in The Journal of the American Medical Association (JAMA) questions this unfairness. The author, 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 same defective drug warning. Yet, one victim has access to our courts but the other does not. Generic drug manufacturers make money selling their pills to consumers. They make lots and lots of money. In fact, the vast majority of drugs dispensed are now generics. Many states, like Alabama, have laws favoring generic drugs. Yet, generic drug makers have been granted broad immunity. Immunity to injure and kill patients without recourse.
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. The generic drug company can continue selling its defective product without accountability!
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. Patients and their families deserve safe drugs and medical devices.
At the Blackwell Law Firm, we represent people who have suffered a serious personal injury. Many of our cases involve dangerous and defective drugs. If you have questions about a personal injury, let us know. Consultations are always free and confidential.