August 31, 2018 Practice Points

Impossibility Preemption Mandates Reversal of $3 Million Verdict Against Pharmaceutical Company

The case involves GlaxoSmithKline and a negligent omissions on drug labels.

By Jeffrey B. Greenspan

Following U.S. Supreme Court precedent, the Seventh Circuit found that federal law preempted a widow’s state law claims that GlaxoSmithKline’s (GSK) negligent omissions in the drug label for Paxil caused the death of her 57-year old husband, Stewart Dolin.

In Dolin v. GlaxoSmithKline LLC, Case No. 17-3030, 2018 WL 4001208 (7th Cir. Aug. 22, 2018), a doctor prescribed Paxil, the brand-name version of paroxetine, to treat Stewart’s depression and anxiety. However, his prescription was filled with generic paroxetine manufactured by another company. Six days later, Stewart committed suicide. It was determined that paroxetine was in his system.

At the time of Stewart’s death in 2010, GSK manufactured Paxil and was therefore responsible under federal law for the content of the drug’s label, including any generic versions of paroxetine. In 2004, the labels for paroxetine warned that it was associated with suicide in patients under the age of twenty-four, but they did not warn about any association between the drug and an increased risk of suicide in older adults. In April 2006, GSK unilaterally changed the labeling under the “Changes Being Effected” (CBE) regulation, which allows such changes without advance FDA approval based on newly acquired information. GSK’s amended label stated that the risk of suicidal behavior may extend beyond the age of twenty-four. However, the FDA effectively rejected GSK’s unilateral change in 2007 when it implemented new class-wide labeling for all antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which included paroxetine, stating that there was a risk of suicide in patients under 24 but that studies did not show an increase in the risk of suicide in adults beyond age 24. Nonetheless, Mrs. Dolin sued GSK in Illinois state court, alleging that it negligently failed to include warnings that paroxetine was associated with suicide in patients older than 24.

After removing the case to the Northern District of Illinois, GSK argued that Mrs. Dolin’s claim was preempted under the Supreme Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009), because the FDA had rejected the paroxetine-specific warning that Illinois law allegedly required and that was requested by GSK. The district court denied GSK’s motion for summary judgment and the case proceeded to trial, wherein Mrs. Dolin was awarded $3 million by a jury. GSK appealed.

On appeal, the court analyzed whether Mrs. Dolin’s claim should be dismissed based on “impossibility preemption,” which occurs when there is an actual conflict between state and federal law such that it is impossible for the person to obey both. The court explained that when that is true, federal law controls and the state-law tort claims must be dismissed. It stated that Mrs. Dolin’s claim against GSK would be preempted if GSK could not have added the adult-suicide warning using the CBE regulation. It further explained that while GSK needed newly acquired information to add a warning through the CBE regulation, GSK could still succeed on its preemption defense if there was clear evidence that the FDA would have rejected the adult-suicide warning in any event.

After analyzing the evidence presented in the district court, the appellate court found that, as a matter of law, there was clear evidence that the FDA would have rejected GSK’s warning in 2007, and that GSK lacked new information after 2007 that would have allowed it to add an adult-suicide warning under the CBE regulation. The court recognized that after the FDA implemented new class-wide labeling for all SSRIs, GSK made four requests to reconsider and to allow it to warn about the risk of suicidal behavior beyond the age of 24 specifically associated with paroxetine, and in each instance, the FDA instructed GSK not to add the warning. The court further found that Mrs. Dolin failed to offer any evidence that GSK acquired new information after 2007 that would have supported a change in the warning pursuant to the CBE regulation.

Based on its findings that the FDA would not allow GSK to modify the paroxetine label, the court held that federal law preempted Mrs. Dolin’s Illinois claim that GSK should have warned of a risk of adult suicide on the label in 2010.

Jeffrey B. Greenspan is a member at Cozen O’Connor in Chicago, Illinois.