In a February 2016 ruling, Illinois District Judge James Zagel raised the stakes for branded drug labeling, requiring pharma companies to prove whether the FDA rejected heightened warnings of associated risks. Plaintiff Wendy Dolin alleged negligence on part of GlaxoSmithKline (“GSK”) over its antidepressant Paxil—a generic form of which she claims led to her husband’s suicide in 2010—and that GSK should have indicated on Paxil’s warning label that the drug had posed a risk of suicidal tendencies among adult patients. Judge Zagel ruled in accordance with evidence standards set by the Supreme Court in Wyeth v. Levine, in that GSK didn’t show “clear evidence” that the FDA would have rejected a heightened Paxil warning sought by Dolin. GSK had even turned down an invitation by the FDA to discuss the drug’s label in 2007, indicating that the drug giant failed to make a strong effort to see if the FDA would have rejected the label. The case will go to trial in September 2016.
Warning labels on several types of prescription drugs have come under great scrutiny in recent years, even receiving “black-box” warnings, the strongest categorization given by the FDA. Despite their classification, prescription drugs treating major depressive disorder, known as selective serotonin reuptake inhibitors, or SSRIs (like Paxil and Zoloft) have been linked to a multitude of unwanted side-effects—including heart defects in infants when taken during pregnancy. Morcellators, gynecological devices used to remove uterine fibroids, were given “black-box” warnings over their risk of spreading aggressive, sometimes fatal uterine cancer in women, calling into question why some of these potentially dangerous drugs and devices remain on the market today. Furthermore, over 200 lawsuits consolidated in Massachusetts over anti-nausea drug Zofran (ondansetron), also manufactured by GSK, allege the drug company engaged in “off label” marketing and failed to warn patients of the drug’s risk for causing birth defects. The ruling in the Paxil case may have a ripple-effect on the labeling of other dangerous drugs and devices, increasing awareness of potentially harmful side-effects.