Why Generic Drugs Won't Have to List All Their Side Effects

A Supreme Court decision has patient advocates in a tizzy over labeling laws

The Supreme Court just decided two cases of great interest to the pharmaceutical industry that are each a big deal to consumers in their own way--especially the one that says you can't sue a generic drug manufacturer for not putting the latest warnings on their product label. That decision, known as Pilva v. Mensing, stems from a lawsuit filed by two women who developed the neurological condition tardive dyskinesia after they took a generic acid reflux medication called metoclopramide. Brand names of the medicine include Metozolv and Reglan. According to the Los Angeles Times, "The drug had been on the market for many years before doctors realized that taking it for more than 12 weeks could trigger the neurological problem."

Name-brand drug makers must update their labels when such information becomes available, but the Supreme Court found that generics don't have to, because of a conflict between state liability laws and federal regulations. "Justice Clarence Thomas said that because the federal Food and Drug Administration must approve changes in the warning labels, the generic makers may not be sued under state liability laws for failing to warn patients of new dangers." Essentially, the problematic situation is that you have state statutes to enforce federal regulations. "We find impossibility here," Thomas said. He's not the only one.

The American Association for Justice issued a press release that called the decision "disastrous to patient safety" and claiming a double-standard, as federal law already requires brand-name drugs to list the latest side-effects.

This decision also means that brand-name manufacturers will be held to a different yet safer standard. The Supreme Court decided in Wyeth v. Levine, brand-name manufacturers are responsible for their warning labels and required to update them at all times.  

"Patients will now be taking generic drugs at their own risk," said American Association for Justice President Gibson Vance. "It is absurd that doctors and patients will have to make medical decisions knowing that only brand-name drug manufacturers – not generics – can be held accountable for their drugs' dangerous side-effects."

As the Los Angeles Times points out, "about 75% of the prescriptions written in this country are for lower-cost generic versions of brand-name drugs." If you're taking one, you'd better start keeping an eye on the warning labels of its brand-name equivalent.

Also today, the court decided not to ban drug companies from buying patients' prescription records in order to market to doctors. Most states allow this practice, but Vermont, Maine, and New Hampshire have laws against it. According to the Christian Science Monitor, "the pharmaceutical industry argued that drug companies have a constitutionally-protected right to discuss new drugs with physicians. The Vermont law infringed that right by restricting access to prescription data being used to engage in truthful speech about potentially life-saving medications, argued the industry's lawyers." The court agreed, with Justice Anthony Kennedy saying, "Vermont's statute could be compared to a law prohibiting trade magazines from purchasing or using ink."