Tentative Settlement Reached in Paxil “Split-Pill” Class-Action Lawsuit

A proposed settlement has been reached in the class-action lawsuit alleging the maker of the popular antidepressant Paxil made defective controlled-release tablets that were more likely to break in two, endangering patients.

If approved, the settlement would pay thousands of plaintiffs who sued GlaxoSmithKline over the defects and their insurance companies $28 million.

Paxil, a leading brand of antidepressant that belongs to the newer family of drugs called selective serotonin reuptake inhibitors (SSRIs), has also been linked to severe birth defects, including malformed hearts in fetuses whose mothers took the drug during pregnancy.

Glaxo was sued over Paxil tablets made between April 2002 and March 2005 which were defective and more likely to split in two while still in the bottle. The defective pills are designed to release the medication inside gradually over time, but when broken in two before taken, the coating on the tablets could fail to properly deliver the correct dosage.

The defective Paxil pills were made at Glaxo facilities in Puerto Rico and Tennessee. The defects were first noticed at the Puerto Rico plant in February 2002 and continued after that date despite repeated Food and Drug Administration warnings and inspections.

Under the settlement, the $28 million paid by Glaxo would be split between consumers who paid for their Paxil and insurance companies seeking to be reimbursed for their expenditures. Patients who are part of the class-action suit would be compensated individually depending on how many defective pills they bought, with a maximum recovery of $150 per person.

Paxil patients who belong to the lawsuit class can also choose to exclude themselves from the settlement by May 15, 2009 or object to the terms of the settlement before July 1, 2009. A final hearing to approve the deal is set for July 10, 2009.

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