Supreme Court Again Addresses Liability of Generic Drug Makers

As we reported a year ago, the U.S. Supreme Court prohibited injured patients from suing generic drug companies because such companies didn’t control the information on their labels-such information was held to be the exclusive responsibility of the pharmaceutical companies that developed the brand name drug. The court said that if the generic manufacturers are prohibited from printing warnings about drug side effects, patients shouldn’t be able to sue them when bad things happen after taking the drug.

Last week Pop Tort, the civil justice blog from the Center for Justice & Democracy, summarized where we are now in the responsibility game. The site used the example of one woman’s experience with sulindac, the generic version of Clinoril, an anti-inflammatory.

The patient was prescribed Clinoril for shoulder pain, and her pharmacist dispensed sulindac for insurance purposes. It wasn’t long before her skin started burning off. She spent two months in a burn unit in a medically induced coma. She spent a year on a feeding tube and survived only with severe disfigurement and permanent lung, esophagus and vision damage. She couldn’t read, drive, work or eat normally.

She sued for compensation because the drug was “unreasonably dangerous.” In the discovery process, she learned, according to Pop Tort, that there were more adverse event reports made to the FDA over sulindac than any other similar nonsteroidal anti-inflammatory drug; that it was known that sulindac’s rate of life-threatening conditions was comparable to another drug the FDA had recommended be removed from the market, but that this knowledge was not given to the FDA.

The jury in her trial awarded her $21 million.

Sulindac’s manufacturer, Mutual Pharmaceutical, appealed to the U.S. Supreme Court to deny the award and protect it from any harm its drugs cause patients. Mutual, says Pop Tort, has 80% of this market.

Mutual’s argument is based on last year’s case, Pliva v. Mensing, that held that generic drug manufacturers can’t be held responsible for failing to warn patients about a drug’s side effects. By federal law, generic drug manufacturers must use whatever label was approved for the brand-name drug.

“But the issue here is quite different,” says Pop Tort. “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).”

At least one Congressman, Henry Waxman of California, who has been instrumental in writing laws on generic drugs, supports the plaintiff’s case against Mutual. “[D]amage suits advance public health,” he said. “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.”

This is a simple concept. You cannot make informed choices, you cannot weigh risks against benefits, if you lack essential information. Product liability litigation yields information that helps patients and doctors make decisions, and enables drug companies to address product defects. Or it should anyway.

After the Mensing decision last year, Pop Tort notes, U.S. Senate Judiciary Chair Pat Leahy of Vermont introduced the Patient Safety and Generic Labeling Improvement Act to try to correct the injustice. He explained that now, “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.”

It’s about accountability. It’s about full disclosure. When you’re afraid of information, it seems to us, you have something to hide.