Diana Levine, a Vermont musician, won a settlement against pharmaceutical manufacturer Wyeth when she had to have part of her arm amputated due to an anti-nausea drug being improperly injected. Wyeth claims its product was sufficiently labeled, which included warnings about the potential risk of gangrene if the drug was improperly injected. The company has since appealed the case to the Supreme Court, creating a potential landmark ruling that would make it easier for drugmakers to protect themselves from product liability lawsuits. That’s because the majority of lawsuits against drugmakers involve the same issue, whether or not the company had proper warnings on its label. The Food and Drug Administration (FDA) approve these labels.
The case, along with a similar lawsuit regarding tobacco, centers on whether the federal government’s regulation on products can override state laws, including those that determine when a person or company can be held liable for another’s injury. Industries argue juries should not be allowed to overrule what experts in federal agencies conclude regarding the safety of products. Experts say that it is likely the Court will rule in favor of Wyeth, and if it does, other industries will likely follow suit; anything that any federal agency has anything to do with will be pre-empted. A ruling in favor of Wyeth could also lead to lower courts blocking suits filed against the drug companies since the FDA approved their labeling.
The justices, none of whom have reportedly tried a jury trial as an attorney, have already sided with businesses on two pre-emption cases. In one case, involving Medtronic Inc., the Court ruled 8-1 that the FDA’s approval of advanced medical devices prevents consumer lawsuits claiming improper labeling or design defects. However, bills are being sent through both houses of Congress that would potentially reverse the Court’s decision.