Healthy Skepticism Library item: 10218
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Judge approves $64 million settlement over drug Paxil
Associated Press 2007 May 24
http://www.suntimes.com/business/400176,paxil052407.article
Full text:
ST. LOUIS—— Parents who bought the antidepressant drug Paxil for their children may begin seeking reimbursements under a $64 million class-action deal to settle claims that the drug’s maker misled consumers about the medication’s safety.
Under the deal, announced in April and granted final approval last week by a judge in Madison County, Ill., parents with proof that they bought GlaxoSmithKline PLC’s Paxil and Paxil CR, a controlled-release version of the drug, for their children can recoup out-of-pocket expenses.
Parents who no longer have pharmacy records or receipts can get up to $100 refunded by signing a claim form that carries penalties for lying.
Claim forms, which must be filed by Aug. 31, are available online at www.paxilpediatricsettlement.com.
The settlement eliminated a previously proposed $15 maximum payment to parents who didn’t have proof of purchase and a $300,000 cap overall to those without proof. The individual reimbursement was increased and the cap removed after plaintiffs’ attorneys and the Washington-based advocacy group Public Citizen objected, saying the proposed caps could discourage consumers from filing claims.
In settling the 2004 lawsuit, Britain-based GlaxoSmithKline denies claims it promoted the drug to children while withholding information about negative side effects, including increased suicidal behavior.
‘‘We believe we were responsible and admitted no wrongdoing,’‘ Mary Anne Rhyne, a U.S. spokeswoman for the company, said Thursday. ‘‘This case was settled to bring closure.’‘
Any money left over in the settlement fund is to be returned to GlaxoSmithKline.
Anyone with a personal injury claim, including the parents of teenagers who took their own lives while taking Paxil, still can sue GlaxoSmithKline, as can insurers and governmental agencies who actually paid the bulk of the money.
The settlement does not require GlaxoSmithKline to notify those who may be eligible for reimbursement, so it is important that consumers help spread the word, Public Citizen’s Jennifer Soble said Thursday.
‘‘The only way that this improvement (in reimbursements) is meaningful is if class members know they have money coming to them,’‘ she said.
Plaintiffs’ attorneys can claim more than $16 million in fees, which will be deducted from the settlement fund, with the remaining money available for payments to consumers.
Telephone and e-mail messages left Thursday for Stephen Tillery, the lead plaintiffs’ attorney, were not immediately returned.
In a letter to doctors last year, GlaxoSmithKline and the Food and Drug Administration warned that an analysis of clinical trial data on nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug.
The FDA reported 11 suicide attempts — none resulting in death — among patients given Paxil in the trials. Just one of the patients who took a placebo attempted suicide.
Given that small number, the FDA said then, the results ‘‘should be interpreted with caution.’‘ Eight of the 11 attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.
The FDA stressed that all patients, especially young adults and those who are improving, should be carefully monitored when treated with Paxil.
