Preemption Ruling In Paxil Case. Father Rick Tucker, an Indiana Catholic priest for over 26 years committed suicide after having taken the antidepressant Paxil in August 2000 for 22 days; he shot himself in the head with a .25 caliber pistol at age 55.
Tucker was prescribed Paxil by his family doctor. The case, which was originally brought by Tucker’s sister, Debra Tucker, is now re-opened following a move by US District Court Judge David Hamilton who has reversed his prior opinion in which he had dismissed the Paxil suicide case based on preemption.
Preemption says Food & Drug Administration (FDA) approval supercedes state law claims challenging safety, efficacy, or labeling. The FDA and drug makers argue preemption exists because FDA actions are the last word on safety and effectiveness.
In his opinion, Hamilton wrote that, in his prior ruling, he “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.”
Proper Labeling of Paxil
Hamilton also stated that Glaxo “has acknowledged that the regulations give it the responsibility for proper labeling of Paxil, and that it had the ability to make changes to Paxil’s label when there was “reasonable association” between a serious hazard and a patient’s ingestion of the drug … the FDA’s current position on preemption is not ‘long standing’ but is, in fact, a ‘180-degree reversal’ from its earlier stance … the court, on reconsideration, gives relatively little weight to the FDA’s opinion on the preemptive effects of its regulations….
Drug manufacturers have the authority to strengthen warnings without the advance permission of the FDA.
This coming fall, the US Supreme Court will also hear a preemption case involving Wyeth and a Vermont woman, Diana Levine who successfully argued before the Vermont Supreme Court that, even though labeling for Wyeth’s Phenergan complied with FDA requirements, the adequacy of the warning had not been established. Levine lost an arm and was awarded $6 million.
Levine’s attorneys maintain that Wyeth was neither prevented from adding nor strengthening the warning on the label, despite that the FDA rejected a proposed change. Because of this, the Supreme Court ruling could determine if patients can sue a drug maker through state law even when a product has received FDA approval.
Glaxo disagrees and one of its spokeswoman recently stated, “The decision in this case would allow a jury to determine whether an FDA-approved label adequately informs physicians about a medication’s risks and benefits, as the label generally has to be found to be inadequate before the manufacturer can be held liable.” Glaxo maintains, “The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm or suicidal thinking.”
Paxil has long been liked to suicide and violence in children and teenagers. A report issued by Britain’s Department of Health said evidence provided by Glaxo from nine studies based on over 1,000 youngsters showed an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil.
Following their British counterparts, Irish health officials issued a warning for Paxil in Ireland, and the FDA continues to investigate the suicide risk associated with Paxil and other antidepressants.