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Supreme Court Protects Generic Drugmakers from Warning Label Liability Lawsuits

July 10, 2013

The pharmaceutical industry in the United States is massive. According to a report from the IMS Institute for Healthcare Informatics, Americans spent $325.8 billion on prescription drugs last year alone, which totals about $898 per person. While these figures may be staggering on their own, what may be even more surprising is the fact that about 80 percent of pharmaceuticals sold are generic.

A generic medication is defined by the United States Food and Drug Administration as “a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.” These generics are often significantly less expensive than their brand-name counterparts, but they may also be less safe.

Reuters reported on June 24 that the United States Supreme Court decided in a 5-4 decision to not allow drugmakers to be “sued under state law for adverse reactions to their products.”  The case, Mutual Pharmaceutical Co. v.  Bartlett, involved a woman named Karen Bartlett, who suffered tremendously painful and life-altering complications after taking Mutual Pharmaceutical’s Sulindac, a generic counterpart of Merck’s non-steroidal anti-inflammatory drug Clinoril. After three weeks on the medication, Bartlett began to develop “burn-like lesions over two-thirds of her body,” which left her “severely disfigured” and “nearly blind.” A New Hampshire jury awarded the victim a $21 million verdict, which Mutual appealed, resulting in the case being heard before the highest court in the land.

The condition that affected Bartlett, toxic epidermal necrolysis, is a very severe form of Stevens-Johnson syndrome, about which this blog published an article last November (“What You Should Know About Stevens-Johnson Syndrome”). We pointed out that adverse reactions to non-steroidal anti-inflammatory drugs like Sulindac and Clinoril are among the leading causes of the ailment.

Justice Samuel Alito held in the majority opinion that a state law could not contradict a federal law in this type of case and that a federal precedent already exists. A 2011 Supreme Court decision established that while a pharmaceutical company is responsible for errors and omissions in its products’ safety warnings and labels (and may be held responsible for them), companies making cheaper generic versions are not. This decision is (depending upon the metaphor of your choice) an arrangement known as “blanket” or “umbrella” coverage, in which as long as generic drugmakers do not alter medications or warnings, they are completely shielded from lawsuits.

When Bartlett filled her prescription for Sulindac, its label included no warnings of toxic epidermal necrolysis, but because the Supreme Court had previously established that manufacturers of generic drugs could not be sued for label warnings (or lack thereof), the Justices reversed the original New Hampshire jury decision and Bartlett’s monetary award was stripped from her.

Consumer advocates are nervous about this ruling and rightfully so. Michael Carome, the director of Public Citizen’s Health Research Group, told Reuters, “Today’s court decision provides a disincentive for generic makers of drugs to monitor 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.”

While Bartlett’s loss of this expected award is tragic and disheartening, it stands as a warning for all those patients taking generic drugs (which, again, make up 80 percent of pharmaceuticals purchased in this country). It is of course, crucially important to check the warnings on one’s medications, but this ruling makes it necessary to check with doctors and pharmacists about warnings on a drug’s generic and name-brand counterparts. A case like this shows us how tenacious, vigilant, and persistent citizens, consumer advocates, and attorneys must be in order to keep individuals protected from corporations whose main concern is the bottom line, sometimes at the expense of patient safety.

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