New Paxil suits allege birth defect risk.
Although health risks associated with SSRIs have been under scrutiny for years, warnings related to congenital heart and lung defects have focused specifically on Paxil since September 2005, when its manufacturer, GlaxoSmithKline, first notified doctors of the potential hazard. The company told physicians that preliminary study results suggested an increased risk of congenital malformations associated with the use of Paxil during early pregnancy as compared with other antidepressants.
But this and other warnings came too late for many women, according to lawsuits filed in recent months.
"Many of the women who take SSRIs are in their childbearing years. Regardless of the condition for which Mom was prescribed Paxil, she was not given the opportunity to make an informed choice about the risks of taking Paxil during her pregnancy," said Karen Barth Menzies, a Los Angeles attorney who represents families whose children suffer congenital defects allegedly caused by the drug. "Glaxo took that opportunity away from her by hiding data and failing to include the warnings on their label. If you asked any of these moms if they would willingly put their baby at risk by taking Paxil, the answer would be an unwavering 'no,'" Menzies said.
The FDA has released three public health advisories concerning the risk. The first, in December 2005, advised that study results suggested that exposure to Paxil during the first trimester of pregnancy doubled the risk for congenital malformations, particularly heart defects. At the FDA's request, Glaxo raised Paxil's pregnancy-risk rating from C to D, indicating "positive evidence of fetal risk."
The FDA updated its data on Paxil and heart defects in March and April last year, advising health care professionals not to prescribe the drug to women who are in the first three months of pregnancy or are planning pregnancy unless other treatment options are not appropriate.
Then, on July 19, the FDA issued an alert warning that a study had found a sixfold increased risk of persistent pulmonary hypertension of the newborn (PPHN) in babies born to mothers who took an SSRI antidepressant after the 20th week of pregnancy. PPHN is a life-threatening disorder in which a newborn's arteries to the lungs remain constricted after birth, resulting in an abnormal blood flow through the heart and lungs and insufficient oxygen delivery throughout the baby's body. The PPHN alert involved the entire class of SSRI antidepressants.
In December, the American College of Obstetricians and Gynecologists recommended that any decision to use an SSRI for the treatment of depression during pregnancy be made on an individual basis after consideration of the risks and benefits. It also specifically advised that pregnant women or women who plan on becoming pregnant avoid taking Paxil.
Failure to warn
Lawsuits brought against Glaxo charge that the company deliberately withheld what it knew about Paxil's dangers to developing fetuses.
Menzies's clients include the family of Hannah and Taylor Mobley, identical twins born in October 2002 with congenital heart defects allegedly linked to their mother's Paxil use during pregnancy. The Mobley family's failure-to-warn suit against Glaxo is pending in Philadelphia. (Mobley v. SmithKline Beecham Corp., Nos. 000049, 000050 (Pa., Philadelphia Co. Com. Pleas filed Dec. 1, 2006).)
Hannah was born with a condition called Tetralogy of Fallot, involving several associated heart defects. She underwent four surgeries before dying at 15 months. Taylor was born with a ventricular septal defect that closed up without surgery, but her heart will need continuous monitoring as she grows up. The girls' mother had had two children born without birth defects when she was not on Paxil, according to Menzies.
The plaintiff in a Texas case, Lisa Collins, was prescribed Paxil by her general practitioner six months before she became pregnant. Her baby, Chase Steele, was born with a heart defect and has undergone open-heart surgery. (Steele v. GlaxoSmithKline, No. 37373 (Tex., Brazoria Co. Dist. filed Mar. 15, 2006).)
The family's complaint contends that Glaxo fraudulently sought to create the impression that Paxil was safe by withholding relevant information from users, misrepresenting the adequacy of drug testing and the severity and frequency of side effects, and manipulating statistics to downplay the risk of serious adverse health effects. As a result, Chase suffered catastrophic injuries and will need specialized care for his health problems all his life, said Sean Tracey, a Houston lawyer who represents the family.
Tracey said Glaxo started getting adverse drug event reports from patients and doctors documenting cardiac and other congenital malformations as early as 1992. There is "no good reason why by 1993 they weren't conducting a study or warning about the potential effects of Paxil in the first trimester and Paxil in pregnant women in general," he said.
In addition to failure to warn, the claims against Glaxo involve "pharmacovigilance"--a drug company's duty to continue testing its products even after FDA approval. Houston attorney Robert Kwok, cocounsel in the Steele case, noted that a negligent-pharmacovigilance claim arises "when these companies are making $12 billion a year on these drugs and haven't set aside much, if any at all, of the money to really research in-depth the adverse effects of these drugs down the road."
Paul Waldner of Houston is co-counsel for the family of Taylor Dismuke in its lawsuit against Glaxo. (Dismuke v. SmithKline Beecham Corp., No. 6:06-cv-03565-GRA (D.S.C. filed Dec. 18, 2006).) Taylor--born in 2000 with truncus arteriosus, a large ventricular septal defect--has had two open-heart surgeries and will need additional operations in the future. Her mother took Paxil during her first trimester of the pregnancy. The lawsuit includes claims of strict liability, negligence, unfair trade practices, and breach of warranty.
Long before Taylor was conceived, "Glaxo was aware of the fact that there were a significant number of birth defects in the offspring of patients who were taking Paxil during the pregnancy," Waldner said, "and Glaxo was encouraging physicians to continue to prescribe Paxil to pregnant women."
Similar lawsuits are being brought involving babies born with PPHN after their mothers took Paxil and other SSRIs. For example, Menzies represents the family of Eric Jackson, who has undergone several life-threatening surgical procedures since his birth with PPHN in 2004. Eric's mother took Paxil as prescribed by her treating physician while she was pregnant. The Jackson family's action includes claims of negligence, negligent pharmacovigilance, failure to warn, and breach of warranty. (Jackson v. SmithKline Beecham Corp., No. 002242 (Pa., Philadelphia Co. Com. Pleas filed Oct. 16, 2006).)
In addition, Kwok is preparing to file a birth defect case involving Forest Pharmaceuticals' Celexa. His client, Gavin Shore, was born with Shone's complex, a severe heart defect, in 2005; Gavin's mother took Celexa before, during, and after her pregnancy. Gavin survived open-heart surgery at two months, only to suffer three consecutive strokes and ongoing seizures.
Kwok said the liability theories in the case will mirror those in the Paxil cases, as the science backing up the risk of side effects is the same for both drugs.
Because of the SSRI antidepressants' popularity and the study data linking them to birth defects, lawyers say, these cases represent just the beginning of SSRI birth defect litigation. The Steele case is likely to be the first to go before a jury. It is scheduled to go to trial this summer.
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|Date:||Mar 1, 2007|
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