An Illinois prescription drug case that originally had been dismissed due to issues of federal preemption, has been reinstated by the 7th Circuit Court of Appeals in Chicago. This case, Mason v. SmithKline Beecham Corp. d/b/a Glaxo SmithKline, No. 08-2265,___F.3d___, 2010 WL 605922 (7th Cir. Feb. 23, 2010) may be the first decision that addresses preemption with respect to prescription drugs.
The original Illinois prescription drug lawsuit was brought by the parents of 23 year-old Tricia Mason after she committed suicide just two days after being started on the prescription drug Paxil. The Illinois prescription drug lawsuit alleged that Paxil increases the risk in suicide in children and young adult, which the manufacturer should have known and therefore had a duty to warn its users.
The lawsuit alleged that GSK violated Illinois law by choosing not to warn Tricia Mason on its label that Paxil increases the risk of suicide for children and young adults. Two years after the decedent’s suicide, Paxil added a label warning of an increased risk of suicide among children taking the drug.
Mason was originally filed in the Central District of Illinois under diversity jurisdiction against Glaxo SmithKline (GSK), the manufacturer of Paxil. The U.S. District Court had granted a summary judgment motion brought by GSK on the ground that the alleged failure to warn claims were preempted by the Federal Food, Drug and Cosmetic Act.
The Act states that if the drug is approved by the FDA then it meets federal standards, which supersede any further state requirements on the drug manufacturer. So in essence, any drug that is FDA approved could not be held liable for any failure to warn claims made under state law. Fortunately, the US Supreme Court recently heard a case on federal preemption and opened up plaintiffs’ options to seek relief under state law.
In Wyeth v. Levine, 129 S. Ct. 1187 (2009), the US Supreme Court held that the Food and Drug Administration’s approval of the warnings on a prescription drug’s label does not necessarily preempt failure-to-warn claims brought under state law. The Supreme Court in that case went on to hold that such claims are preempted when there is “clear evidence” that the FDA would not have approved a particular warning.
Therefore, on its appeal to the Chicago US Court of Appeals, the plaintiffs in Mason cited the new decision in Levine in support of the its arguments. This new case law might have been the deciding factor in the Appellate Court’s decision, as the 7th Circuit Court of Appeals’ opinion stated that Mason’s parents were not preempted by federal law.
The original complaint in Mason alleged that Paxil’s drug manufacturer knew of its risks before the Mason daughter committed suicide and that they concealed that information. In addition, two years after this suicide, GSK voluntarily attempted to update Paxil’s label to include a warning that drug could increase the risk of suicide.
However, the FDA rejected GSK’s warning, stating that it wasn’t class-wide. This evidence was used to show that the FDA expressly rejected the very warning that the Mason’s alleged should have been in place on Paxil’s labels at the time their daughter received the drug. Also, if the warning of increased risk for suicide had been on Paxil’s label that Tricia Mason would be dead.
Looking at the 7th Circuit Court’s decision, this argument was the key element in the reversal of the federal preemption decision. The Court stated, that “in light of the extensive showings required by Levine, we conclude that GSK did not meet its burden of demonstrating by clear evidence that the FDA would have rejected a label change warning about the risk of suicide by young adults before Tricia’s life came to an end. . .Consequently, the plaintiff’s claims are not preempted.”
The reversal of the federal preemption claim in Mason marks the beginning of courts overturning federal preemption in prescription drug cases following the US Supreme Court’s decision in Levine. We can expect to see more of this in Illinois and nationwide as additional case law increases the burden on drug manufacturers in pharmaceutical litigation lawsuits.
Kreisman Law Offices has been handling Illinois pharmaceutical litigation cases for over 30 years, serving those areas in and around Cook County, including Naperville, Oak Park, Schaumburg, and Evanston.
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