A federal judge in Indiana has reversed his prior ruling that the family members of a Paxil patient who committed suicide were preempted from suing SmithKline Beecham, the manufacturer of the drug.

The underlying case

The underlying case involves a 55 year old Indiana Catholic priest who committed suicide by shooting himself in the head after he began taking the anti-depressant drug Paxil for 22 days in 2000. The sister of the priest brought a lawsuit against SmithKline Beecham, now GlaxoSmithKline, alleging that her brother’s Paxil use caused him to commit suicide.

U.S. District Court Judge David Hamilton originally dismissed the case based on preemption – which states that a plaintiff cannot bring a claim against a drug manufacturer when the U.S. Food and Drug Administration (FDA) was ultimately responsible for approving the drug’s use in the marketplace. However, Hamilton reversed his own decision and allowed the case to move forward. In his opinion, he explained that he originally “failed to appreciate the significance of the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer.”

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What the case means

This case comes on the heels of a similar case to be decided by the U.S. Supreme Court this fall. In that case, Wyeth v. Levine, a Vermont woman lost her arm after taking Wyeth Pharmaceutical’s drug, Phenergan. She sued Wyeth in a case that ended up in the Vermont Supreme Court, which ultimately upheld a $6 million judgment in her favor. She alleged that the pharmaceutical giant had not established an adequate warning – even though it complied with the FDA’s requirements.

The ruling in the Indiana case lends further credence to the theory that pharmaceutical companies should be held liable for their products regardless of the FDA’s involvement. However, others – such as Bush Administration – disagree and believe that the FDA, and not pharmaceutical companies, should be responsible for drug safety. Unfortunately, patients cannot sue the FDA when it errs.

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