The U.S. Supreme Court this week asked the Obama administration to comment on whether it believes generic drug companies can be sued over allegations that they inadequately labeled their products. The question arose after an appeals court reinstated a lawsuit by a woman who claimed she developed a severe neurological movement disorder after taking generic versions of the heartburn drug Reglan (metoclopramide). The lawsuit had been previously dismissed by a trial judge.
Though the drugs have warning labels, the woman claims she was not adequately warned of the potential for serious side effects of the drug she was prescribed, in particular the severe movement disorder known as Tardive Dyskinesia.
Makers of generic Reglan, Teva Pharmaceuticals Industries Ltd., and Mylan Inc.’s UDL Laboratories said the lawsuit should be preempted by federal law because it would require them to write labels that stray from the brand-name drug’s label. The 8th U.S. Circuit Court of Appeals in St. Louis ruled against the generic drug makers, citing a 2009 Supreme Court decision against Pifzer Inc.’s Wyeth that said Food and Drug Administration drug regulations do not protect a drug company from being sued under state law or drug labeling. Congress could have made a provision that preempted drug-labeling lawsuits against generic drug companies but did not do so, the 8th Circuit said.
The Supreme Court is asking the U.S. Solicitor General’s office whether the Obama administration believes the court should consider the appeal.
Source: Wall Street Journal