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Parties Settle Paxil "Split Pill" Class Action

Alleged manufacturing defect in $28M settlement

By Jon Hood
ConsumerAffairs.com

March 26, 2009

• Parties Settle Paxil "Split Pill" Class Action • Improved Paxil Settlement Hits YouTube • Bigger Settlement for Paxil Parents • GlaxoSmithKline Settles Paxil Lawsuit • FDA Warns Paxil Users of Birth Defect Risk • Study Finds Stronger Link Between Paxil And Suicide • Paxil CR Back on Pharmacy Shelves • SmithKline to Pay $65 Million to Settle Paxil Antitrust Case • Glaxo Misled Doctors About Safety of Paxil, NY Charges --- • Consumer Complaints about Paxil

A proposed settlement has been reached in a case alleging a manufacturing defect in certain tablets of Paxil, the popular antidepressant drug manufactured by GlaxoSmithKline (GSK). If approved, the settlement will provide up to $28 million to claimants and their insurance companies.

The suit 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. In March 2005, armed marshals with the Food and Drug Administration (FDA) raided GSK plants in Puerto Rico and Tennessee after learning that some pills manufactured there had split apart. Two medications — Paxil and Avandamet, a diabetes medication — were being produced at the facilities. Although the investigation didn’t conclusively show that anyone had been harmed by the pills, the FDA said the burden was on the manufacturer to ensure that the medication was safe.

The FDA had originally discovered the problem at the Puerto Rico plant in February 2002, and the problem continued despite repeated warnings and inspections. GSK was unable to determine what was causing the problem, which concerned the FDA.

Paxil CR is a "controlled-release" version of the antidepressant, meaning that it releases medication slowly and evenly, in an attempt to deliver more consistent effects throughout the day. However, the CR version has not been compared to standard Paxil in lab tests, and some believe that any added benefits are negligible at best.

Split pills make it harder for patients to accurately estimate doses, and can render the "enteric coating," which controls the medication's time and rate of release, inactive. More importantly, the medically effective ingredients tend to remain in only one side of the pill after the split, making the other half comparable to a placebo. Taking a pill containing no medication could cause immediate withdrawal symptoms, as Paxil stays in the bloodstream for a shorter time than most other popular antidepressants.

Under the settlement, GSK denies liability and all of the claims in the lawsuit. 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. For a pill to be "defective" under the settlement, it must have split before it was removed from the container.

Potential class members who want to recover should fill out a claim form, available at the settlement Web site. Class members can also choose to exclude themselves from the settlement or object to its terms, but must do so by May 15 and July 1, respectively. A final approval hearing will be held on July 10, 2009. Plaintiffs are represented by the firms Strange & Carpenter and Salas & Co.

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