Supreme Court Blocks Product Liability Lawsuits against Makers of Generic Drugs

Dangerous drugs

In what many consumer watchdog groups are calling a victory for pharmaceutical manufacturers and a loss for patients who require prescription medications, the U.S. Supreme Court ruled Monday that the makers of generic drugs may not be sued under state laws for adverse reactions to their products.

The case in question—Mutual Pharmaceutical Co., Inc. v. Bartlett—centered on complications suffered by Karen Bartlett as a result of the generic drug sulindac, a nonsteroidal anti-inflammatory drug (NSAID) often used to treat chronic pain and relieve the symptoms of arthritis. Bartlett, who was prescribed sulindac for shoulder pain, developed Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), conditions that left Bartlett facing physical disabilities and her body severely disfigured.

Bartlett successfully sued Mutual Pharmaceutical, which produced sulindac. After being presented with evidence that sulindac is more likely to cause SJS/TEN than any other NSAID and is no more effective than other drugs in its class, a jury found in favor of Bartlett and the court ordered Mutual Pharmaceutical to pay more than $21 million in damages for Bartlett’s extensive medical expenses and the lifelong pain she will suffer.

Mutual Pharmaceutical, however, appealed on the basis of a 2011 Supreme Court ruling that determined pharmaceutical companies that manufacture branded drugs are liable for inadequate safety warnings regarding their products, not the makers of generic equivalents. In fact, generic drugmakers are not required to update safety labels unless changes are also made to safety warnings for the branded pharmaceuticals.

Groups including Public Watchdog decried Monday’s Supreme Court decision, which many feel encourages generic drugmakers to be lax in their safety monitoring. One of the problems with the decision is that potential complications often do not emerge until years—in some cases decades—after a drug has received Food and Drug Administration (FDA) approval; in these circumstances, the brand-name drug may no longer be available, replaced by cheaper generics.