(Summary: Paxil's manufacturer, GlaxoSmithKline (Glaxo) has lost its bid for immunity from suicidal behavior lawsuits. A Federal Court of Appeals in Chicago rejected Glaxo's attempt to throw out a case arising from the suicide of a 23-year-old university student who was taking Paxil at the time she died. Her parents claim that Glaxo failed to warn that Paxil causes suicidal behavior.

Glaxo argued that FDA approval of a drug should shield its manufacturer from fault even when the company learns of harmful negative reactions after FDA approval. This theory, known as "preemption," asserts that FDA approval "preempts" or nullifies any lawsuits against a drug. If Glaxo had succeeded, it would have made it extremely difficult for other injured consumers to seek compensation in Court.

In a unanimous opinion, the Court of Appeals rejected Glaxo's arguments and refused to give immunity to drug manufacturers. The Court confirmed that injured consumers should be allowed to have their claims tried in a court of law and manufacturers must be held accountable for failing to disclose harmful negative reactions to their drugs—the manufacturers retain their obligation to warn of risks even after the FDA approves the drug for marketing.)

The Seventh Circuit Court of Appeals has held that the failure to warn claims brought against Paxil-maker Glaxo SmithKline ("GSK") by an Illinois family are not preempted by federal law. In so holding, the Court of Appeals reversed the district court's contrary decision. The case, Mason v. SmithKline Beecham, Case No. 08-2265 (7th Cir. 2010), involves a 23-year old Illinois State University student who committed suicide while under the influence of Paxil.

The ruling is significant because it is the first time the Seventh Circuit has addressed the issue of preemption in the context of prescription drugs. Furthermore, it is the first appellate court in the country to address the issue of preemption in the context of antidepressants following the Supreme Court's seminal 2009 decision in Wyeth v. Levine ("Levine").

In Levine, the Supreme Court held that, for preemption to apply, a drug manufacturer must prove there is "clear evidence" the FDA would not have approved the labeling change the plaintiffs say was necessary. In Mason, GSK argued that, even after Levine, the regulatory history of the antidepressants (including Paxil and Prozac) provided a perfect example of when preemption should apply. The Seventh Circuit disagreed and held 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."

Specifically, GSK argued that the Masons' claims were preempted because 1) the FDA approved Paxil without requiring a suicide warning; 2) the FDA had been thoroughly reviewing data available on antidepressants for many years, particularly related to Prozac, and never required a suicide warning; 3) the FDA took no action to force a warning during the time period Tricia Mason took Paxil, thus, the FDA would not have approved a label change; and, 4) although the FDA ordered all manufacturers to include a suicide warning related to young adults in 2007, the methodology used to establish the suicide risk was not available until after Tricia Mason's death. The Seventh Circuit rejected each of these arguments and remanded the case back to the trial court.

While the record before the Seventh Circuit was limited due to the status of the case at the time, on remand, a more full and complete presentation of the evidence will now be possible at a trial on the merits.

According to the Masons' attorney, Bijan Esfandiari: 

"The Seventh Circuit's ruling is a significant achievement because it confirms that drug manufacturers are answerable for their misdeeds in a jury trial and will no longer be granted immunity under the guise of preemption. The ruling is not only a victory for the Masons, but a victory for all consumers of pharmaceutical drugs."

The Masons are represented by the national law firm, Baum, Hedlund, Aristei & Goldman, Pendley, Baudin & Coffin of Baton Rouge, Louisiana and Donald Farber of San Rafael, California. The appeal was briefed and argued by Bijan Esfandiari of Baum Hedlund.

Oral Argument: http://www.ca7.uscourts.gov/tmp/VH10XCYG.mp3

Opinion: http://www.ca7.uscourts.gov/tmp/VH10YNQ1.pdf

Baum, Hedlund, Aristei & Goldman has the longest track-record of handling SSRI (selective serotonin reuptake inhibitor antidepressants such as Prozac, Paxil and Zoloft) cases and is currently representing hundreds of antidepressant birth defect clients in addition to suicide cases.