Supreme Court Hears Arguments Over Right to Sue Generic Drug Makers

The U.S. Supreme Court is hearing arguments today on whether generic drug manufacturers should be held responsible when medications they sell are defectively designed and unreasonably dangerous. 

The hearings come after a 2011 Supreme Court ruling in Pliva v. Mensing, which granted generic manufacturers immunity from failure to warn lawsuits, as long as they provided an exact copy the original brand-name drug’s label warnings.

This latest case involves a product liability lawsuit brought by Karen Barlett against Mutual Pharmaceutical Co., alleging that Barlett developed Stevens-Johnson Syndrome (SJS) from generic sulindac, a non-steroidal anti-inflammatory (NSAID) that is marketed by Merck under the brand name Clinoril.

Bartlett developed the severe skin reaction, which causes the skin to burn from the inside out, resulting in 70 days in the hospital, with 50 of those days spent in a burn unit. As a result of the side effects of sulindac, Bartlett claims that she required multiple surgeries, suffered two major septic shock episodes, has burns over 65% of body and is permanently blinded.

Following trial in December 2004, Bartlett was awarded $21 million by a jury, which found that Mutual’s sulindac medication was responsible for the development of Steven’s-Johnson Syndrome and defectively designed under New Hampshire law.

In Pliva v. Mensing, the Supreme Court ruled 5-4 down ideological lines that generic drug makers can not be held liable for failing to warn about risks associated with their medications, even if they knew or should have known that the warning label is inadequate.  The majority of the Court determined that FDA regulations that require generic drug labels to match their brand-name equivalents made it impossible for generic drug makers to comply with both federal and state law.

Mutual has challenged the damages awarded to Bartlett, arguing that the Mensing case should allow generic drug manufacturers to escape liability for damages caused by their drugs if the FDA approved the medication for sale.

A federal appeals court upheld the jury’s awarded in Bartlett’s case, since it was brought over alleged flaws in the design of the medication, as opposed to under a theory of failure to warn.

The Mensing ruling wiped out thousands of cases pending nationwide against generic drug manufacturers, even in cases where the dangers of a drug were not known until after the brand name had disappeared from the market. If the Supreme Court upholds the lower court rulings, it could provide individuals injured due to side effects of generic drugs an avenue to pursue compensation.

In January, the FDA announced in a brief filed in this case that it is considering the creation of new rules that would make generic drug manufacturers responsible for providing adequate warnings. Such a change may also allow consumers to once again hold generic drug makers responsible for damages caused when they provide misleading or inaccurate information about potential risks that are caused by medications.  However, there is no indication as to what the FDA’s final rules will look like, and concerns have been raised in the industry that it could result in different warning labels for the same generic drug when made by different manufacturers, which could confuse doctors and patients.