Ethan A. Huff
July 10, 2013
You may want to think twice before taking any more generic copies of brand-name pharmaceutical drugs, thanks to a recent Supreme Court ruling that effectively eliminates manufacturer liability in injury cases resulting from negative side effects. In a 5-4 ruling, the Supreme Court recently overturned a $21 million judgment awarded to a New Hampshire woman injured by a generic pain drug, declaring in the process that generic drug manufacturers cannot be sued when the drugs they produce injure patients.
Since generic drugs are mere replicas of brand-name drugs that, at one time, were approved by the U.S. Food and Drug Administration (FDA) as “safe,” generic drug manufacturers are exempt from being held liable in the event of injuries caused by harmful side effects. This is the opinion of the majority of the Supreme Court anyway, which has now made it that much harder for members of the public to seek remedy for injuries caused by pharmaceutical drugs.
According to Reuters, the ruling affects lawsuits filed under state law, which allegedly conflict with federal regulatory guidelines as they pertain to safety approval for brand-name drugs. When it comes to federal versus state law, federal always tends to win these days, which means the big boys in the drug industry basically get to call all the shots. And if you are injured by a drug, in this case a generic drug, well then tough luck for you.
“The court has left a seriously injured consumer without any remedy,” wrote Justice Sonia Sotomayor, along with Justices Ruth Bader Ginsburg, Stephen Breyer, and Elena Kagan, in a dissent to the ruling.
It all started when Karen L. Bartlett of New Hampshire was prescribed a generic version of Merck & Co.’s anti-inflammatory drug Clinoril by her doctor for shoulder pain. Bartlett quickly developed a condition known as toxic epidermal necrolysis, which left her with burn-like lesions on two-thirds of her body. Bartlett had to be put into a medically-induced coma and be fed out of a tube for over a year while she underwent dozens of eye surgeries.
With the help of her lawyer, Bartlett filed a lawsuit against Mutual Pharmaceutical, the manufacturer of sulindac, the generic version of Clinoril that led to her injuries. The Supreme Court issued a ruling against Bartlett, which was eventually overturned by a Boston-based appeals court, according to the Wall Street Journal (WSJ). But the Supreme Court later overturned the ruling of the appeals court, claiming that federal law prohibits such lawsuits.
Shielding drug companies from liability will only further erode public confidence in Big Pharma
On the surface, the Supreme Court’s ruling on this matter appears as though it is just another win for Big Pharma, which as we all know takes every opportunity to leverage control over the federal regulatory scheme for drugs. But in the long run, the decision will end up hurting the drug industry, as the general public will put even less faith in the safety and integrity of drugs.
“Today’s court decision provides a disincentive for generic makers of drugs to monitor the safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients,” says Michael Carome, Director of the Public Citizen’s Health Research Group, as quoted by Reuters.
In other words, why perform routine and costly safety tests when there are no longer any consequences if patients are harmed by tainted drugs? Official FDA approval of the “parent” drugs is apparently all that is now needed to shield the generic drug industry from future liability for injuries, which means patients are basically being forced to take drugs at their own risk.
Sources for this article include: