The Legal Side of Side Effects with Generic Drugs

When it comes to buying medication, many of us would rather choose the less expensive generic version over the name brand; in fact, over 70 percent of prescriptions in the US are filled with generics. For people who do well on these medications, it makes little sense to pay more for the same drug. Those who experience unlisted side effects, however, should be aware of a few legal anomalies.

Normally, if you take a medication and suffer from a side effect or complication that isn’t listed on the drug’s safety label, the manufacturer is liable and you have the right to file a lawsuit. This is not the case for someone who takes a generic drug.

Last year, the Supreme Court ruled in the Pliva v. Mensing case that patients cannot sue a generic drug maker because these companies are not able to change the label independently, and therefore cannot be liable for failing to warn about a new complication. By law, a generic drug has to carry the same warning as its brand name equivalent. Unlike brand name manufacturers, generic drug makers cannot update the safety information if a new side effect is discovered. The most they can do is propose a change, which, if accepted, would also change the brand name label.  

Take Plavix (clopidogrel) for example-the blockbuster blood thinner, which was originally manufactured by Sanofi-Aventis and Bristol-Myers Squibb, lost its patent in May. If a patient takes Plavix and suffers a new side effect, then these companies may be named in a personal injury lawsuit. However, if a patient suffers the exact same side effect but happens to be taking a generic version manufactured by Teva Pharmaceuticals, for instance, it is nearly impossible for them to sue. Furthermore, if Teva Pharmaceuticals were to discover this new complication, they lack the power to independently warn users.   

Currently, a Senate bill titled “Patient Safety and Generic Labeling Improvement Act” seeks to reverse the Supreme Court’s decision, allowing generic manufacturers the right to change a drug’s safety label. Advocates of the bill, such as the National Association of Attorneys General (NAAG), feel that the current law is unfair to generic users. In a letter to Senators Patrick Leahy and Al Franken, the NAAG stated that, “Consumers whose prescriptions happen to be filled with the brand-name version of a drug are protected by state law from inadequate warnings, but consumers whose pharmacists fill their prescriptions with the generic versions are now denied this protection. The adverse consequences are magnified by the fact that over 70% of prescriptions in the United States are filled with generic drugs.”