A settlement has been proposed in the so-called Paxil “split pill” class action lawsuit. According to a press release, if approved, the settlement will provide up to $28 million to claimants and their insurance companies.
Paxil is part of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Paxil was approved to treat symptoms of depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Paxil was the first antidepressant formally approved in the US for the treatment of social anxiety disorder.
The drug has been linked to a variety of problems, including birth defects, as well as suicide and suicidal tendencies when taken by young people and children. Yet in spite of these risks, by 2006 Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.
The Paxil “spit pill” class action lawsuit alleges that Paxil “controlled release” (CR) tablets made between April 1, 2002 and March 4, 2005, contained a manufacturing defect that caused them to split apart. According to the complaint, Paxil CR tablets are intended to deliver the active ingredient over a period of time, and not all at once. When one splits apart, the outside coat breaks up and the drug is released while the tablets are still in the stomach. Patients end up with all of the active ingredient, without the benefits of the controlled-release, and received the entire dose at once. Or they get only the controlled-release ingredient without the active ingredients, the complaint says.
In March 2005, armed marshals with the Food and Drug Administration (FDA) raided GlaxoSmithKline plants in Puerto Rico and Tennessee after learning that some pills manufactured there had split apart. The FDA had originally discovered the problem at the Puerto Rico plant in February 2002, and the problem continued despite repeated warnings and inspections, the complaint charges.
If approved, the $28 million settlement will be split between consumers who paid for their Paxil and insurance companies seeking to be reimbursed for their expenditures. The amount each class member recovers will depend on how many defective pills they bought, with a maximum recovery of $150 per person. A final approval hearing will be held on July 10, 2009.
Under the settlement, GlaxoSmithKline denies liability and all of the claims in the lawsuit.