GlaxoSmithKline Plc has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.
As part of the total, Glaxo, so far has paid $200 million to settle Paxil addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims, according to the people and court records.
About 450 suicide-related Paxil cases were settled. Only about a dozen haven’t been, the people said. The $1 billion total doesn’t include more than 600 claims that Paxil caused birth defects.
A Philadelphia jury on Oct. 13 found the drugmaker should pay $2.5 million to the family of Lyam Kilker, a 3-year-old boy born with a heart defect after his mother took Paxil while pregnant. Based on that outcome, an analyst estimated the company may potentially face additional verdicts in birth-defect cases waiting to be tried in Pennsylvania.
In comparison, Pfizer Inc., parent of Wyeth, the maker of diet-drug combination fen-phen, has had to set aside about $21 billion to resolve about 200,000 personal-injury claims over that medicine. Merck & Co. agreed to pay $4.85 billion to resolve more than 48,000 claims over the withdrawn painkiller.
“Paxil’s been different from most drugs,” said Pogust, a lawyer from Conshohocken, Pennsylvania, who is handling suicide and withdrawal cases. “You’ve had three major personal injury litigations over one drug — the suicide, the birth defect and the withdrawal cases. To have three significant problems with one drug is really unusual.”
Since at least 2003, Glaxo has faced claims in U.S. courts that some Paxil users were subjected to an undisclosed, higher risk for suicide and birth defects.
The suicide settlements included a suit over the death of a 14-year-old boy who had been taking Paxil for two months. The parents of Scott Cunningham, of Valparaiso, Indiana, sued after the boy hanged himself in 2001. They alleged Glaxo suppressed evidence that Paxil use was linked to the risk of suicide attempts by adolescents. Glaxo denied the allegations, according to court papers.The family settled its suit in May, according to court filings.
About 150 cases over suicides by Paxil users were settled for an average of about $2 million, and about 300 over suicide attempts settled for an average of $300,000, they said. Some of the claims were resolved before suits were filed, according to the people familiar with the matter.
Glaxo has settled about 10 birth-defect cases, Sean Tracey, a Houston-based lawyer who represented the family of a child victim, said in court Dec. 2. The settlements averaged about $4 million, the people familiar with the cases said.
The company hasn’t specified in regulatory filings the number of suicide, birth-defect and addiction cases settled.
In the same year, Glaxo agreed to pay $2.5 million to New York to resolve accusations the company withheld safety data about the antidepressant. The company, calling the claims unfounded, agreed to release safety studies on the medicine’s effect on children.
In 2005, the company added a black-box warning to its Paxil label that the drug increased the risk of suicidal thoughts among adolescents, following a request by the U.S. Food and Drug Administration to do so.
The drugmaker agreed last year to pay $40 million to settle suits by so-called third-party payers, primarily insurance companies that reimbursed parents for their children’s Paxil.
Insurers said Glaxo knew the drug “was neither safe nor effective for the treatment of depression in persons under the age of 18,” U.S. District Judge Michael Davis in Minneapolis said in a September 2008 order approving the accord.
In 2006, the company resolved similar claims by consumers for about $64 million, reimbursing parents of patients for money spent on Paxil prescriptions, in an Illinois class-action suit.
In 2001, a jury in Cheyenne, Wyoming, ordered Glaxo to pay $6.4 million to the relatives of a man who shot his family to death and then turned the gun on himself after taking Paxil. The case was settled on confidential terms while on appeal, according to Kevin Colgan, a Glaxo spokesman.
The Philadelphia case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 07-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Paxil Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 888-210-9693 or Contact Me Online.
The Dr. Shezad Malik Law is currently evaluating and accepting Paxil Birth Defect cases.