Pharmaceutical

Supreme Court: patients cannot sue generic drug makers for inappropriate warning labels

Gavel Scales of Justice American flag square Supreme Court: patients cannot sue generic drug makers for inappropriate warning labels Makers of generic drugs cannot be sued by patients who experience side effects if the warning label on the drugs is the same as those on the brand-name product, the U.S. Supreme Court ruled. The ruling preempts state laws that require pharmaceutical companies to provide patients with updated information regarding adverse events.

The federal law could be detrimental to consumers, preventing them from suing generic drug companies regardless of the severity of their injuries. However, consumers of brand-name drugs can still file suit against the brand-name drug makers. The catch is that most insurance companies require patients to use a less expensive generic drugs instead of the brand name product.

One concern is that this ruling offers generic drug manufacturers no incentive to keep track of side effects associated with their drugs and adequately warn patients and doctors of the risks.

In a 5 to 4 vote, the court overturned a $21 million jury award to a New Hampshire woman who suffered serious injuries and nearly lost her vision after taking the anti-inflammatory medication sulindac. The plaintiff alleged that the drug company did not list the side effect she experienced on its safety label. Sulindac’s maker, however, said it was following federal law by using the same label information on its generic product as the brand name equivalent.

Earlier this week, Senate Judiciary Committee Chairman Patrick Leahy and six other senators and congressmen sent a letter to the Food and Drug Administration (FDA) asking that makers of generic drugs be required to provide doctors and patients with updated safety information as brand name drug makers do, and to be held accountable if they fail to adequately warn about the risks.

Source: The Plain Dealer