Imagine you wake up with shoulder pain and go to your doctor who prescribes you an anti-inflammatory drug called Clinoril. Your pharmacist then gives you a generic version of this medication (sulindac), perhaps for insurance reasons. (We’ve all been there, right?) You take the generic medicine and suddenly, your skin starts burning off. You spend two months in a burn unit, months in a medically induced coma, a year on a feeding tube, and end up severely disfigured with permanent lung, esophagus, and vision damage. You can no longer read, drive, go to work, or even eat normally. So you bring a lawsuit, hoping to be compensated for being given a drug that was obviously “unreasonably dangerous” to you. And indeed, you find out that there were more adverse event reports to the FDA over sulindac than any other similar nonsteroidal anti-inflammatory medications on the market; that sulindac knew its rate of life threatening conditions was comparable to that of a drug the FDA recommended be removed from the market - but it never told the FDA this. And after a 14-day trial, the jury agrees that whatever benefits might exist for this drug, they were clearly outweighed by the risks, and awards $21 million.
Incredibly, this all happened to Karen Bartlett of Plaistow, New Hampshire, and today, the U.S. Supreme Court hears arguments from generic drug manufacturer Mutual Pharmaceutical, asking the Court to ignore all of these facts, wipe out the jury award, and immunize the entire generic drug for the harm its drugs – now 80 percent of the drug market - cause patients. Specifically, tomorrow the Supreme Court will hear arguments about whether the company that manufactured this “unreasonably dangerous” drug can be held accountable for making and marketing it.
In its argument, Mutual Pharmaceutical is relying on the recent Supreme Court case, Pliva v Mensing where the Court held that generic drug manufacturers can’t be held responsible for failing to warn patients about a drug’s side effects. That’s because under federal law, generic drug manufacturers are actually not allowed to put better warning labels on their medications. They are forced by law to use whatever label was approved for the brand-name drug.But the issue here is quite different. There’s no federal law that requires a company to sell a generic drug. The manufacturer could simply decide not to make and sell the drug they know to be unsafe – as they clearly did here (and as the lower court held).
Still, the Obama Administration is siding with Mutual Pharmaceutical on this one, arguing that generic manufacturers have no say over what the FDA approves so should not be on the hook when their drug nearly burns someone to death. Even if it knows the drug could nearly burn someone to death. Indeed, the key members of Congress on the issue strongly disagree with Obama on this, including Rep. Henry Waxman (D-CA), who “wrote almost all of the country’s laws on generic drugs.”
Rep. Waxman points out the importance of lawsuits such as Ms. Bartlett’s:
“[D]amage suits advance public health. Product liability lawsuits help to uncover information that can lead to safer products. Material produced in litigation can help the public and the FDA to identify problems with particular drugs and can add to physicians’ and public understanding of the risks of the products and flaws in the regulatory system.”
“Given that a drug’s safety profile is incomplete at the time of approval, the possibility of product liability lawsuits helps to protect patients by serving as a powerful incentive for drug companies (both brand-name and generic, prescription and OTC) to improve products as soon as a defect is identified and to remove from the market older products that do not provide the safety of newer ones.”
In fact, Supreme Court itself has said something similar. In Wyeth v Levine, the Court pointed out that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness’ and that state law serves as a ‘complementary form of drug regulation.’”
After the Mensing decision in 2012, Senate Judiciary Chair Pat Leahy (D-VA) introduced the “Patient Safety and Generic Labeling Improvement Act” to try to address this decision. He explained the impact: “If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be compensated for her injuries. The result is a two-track system that penalizes consumers of generic drugs – even though many consumers have no control over which drug they take, because state law and their health insurance plan require them to take generics if they are available.”
Let’s hope the Court doesn’t force the scope of Senator Leahy’s bill to be dramatically expanded. For Karen Bartlett and others who have suffered immeasurably from a generic drug, whether the drug was generic or brand name shouldn’t make any difference, as she states, “I think the generic companies as well as brand-name companies, they should be held accountable for the medicines that they put out there.”