The U.S. Supreme Court is set to consider a case that has caught the attention of many southern California drug recall attorneys due to its potentially far-reaching consequences for patients who are harmed by generic medications, according to a recent article in The New York Times.
The case the Supreme Court will hear involves a New Hampshire woman who suffered severe injuries after experiencing a rare allergic reaction to sulindac, a non-steroidal anti-inflammatory medication (NSAID) often prescribed to treat mild to moderate pain. The sulindac she took was manufactured by Mutual Pharmaceutical Company and was a generic version of a medication originally marketed by Merck under the brand name Clinoril. Clinoril was approved by the Food and Drug Administration (FDA) in 1978.
In a case two years ago, the Supreme Court ruled that patients injured by generic drugs could not sue the manufacturer on the basis of the fact that the warning label was inadequate, because manufacturers of generic drugs do not control what information the warning label contains. In this case, however, the injured plaintiff is not arguing that the warnings on the sulindac were insufficient, but that the drug itself was defectively designed.
The decision could have serious consequences for injured people. If the Supreme Court rules that generic drug manufacturers cannot be sued for defective drug designs, people injured by these medications will have even fewer avenues of legal recourse when serious harm occurs. Supporters of the manufacturers, however, note that if patients are allowed to bring lawsuits, the decisions of juries might override the conclusions of the FDA, knocking many drugs off the market.