Paxil Birth Defects Lawsuit

Paxil Birth Defects Lawsuit

Paxil® (paroxetine hydrochloride) is a selective serotonin reuptake inhibitor manufactured by GlaxoSmithKline (GSK).  The Food & Drug Administration (FDA) in December 1992 approved Paxil as an antidepressant, but after published studies reported increased risks of birth defects in fetuses exposed to Paxil the FDA ordered it labeled as an FDA Pregnancy Category D drug. [i]

According to Bloomberg by June 2010 GSK had agreed to pay more than $1 billion to settle paxil birth defects lawsuit800+ birth defect lawsuits.  For the severity of the injuries in those cases the average recovery was $1.2 million. [ii] GSK has not admitted liability for birth defect injuries, however, and continues to defend itself against allegations of wrongdoing.

GSK customers have joined in Paxil class actions alleging unlawful sales to persons under the age of 18 [iii] and false and deceptive marketing by failure to disclose that Paxil is habit forming or addictive with frequent and severe symptoms on withdrawal or discontinuation. [iv]  So far, however, there have been no class actions or multidistrict  litigation against GSK alleging birth defects cause by Paxil.  All such claims have been by individual plaintiffs.

Many law firms search online for potential Paxil birth defects plaintiffs but their messages are equivocal as to any class action.  Typical is this treatment of the class action option by Buckfire & Buckfire, PC in suburban Detroit:

A class action lawsuit is when a large number of individualized claims are represented by one lawsuit.  Filing this type of lawsuit may be beneficial in some scenarios because often times due to the large number of claims within the lawsuit, the efficiency of the legal process can increase as well as costs of litigation could become lower.

However, class action lawsuits can be detrimental in one’s case, and filing an individual claim may be more beneficial to a victim.  It becomes common with class action lawsuits that many class members are forced into a lower settlement, due to the fact that they are “grouped” in with everyone else, and their specific injuries may not stand out in the crowd.[[v]]

Lawyers ordinarily favor class actions as extraordinarily profitable.  Their apparently lukewarm pursuit of Paxil birth defect class actions may reflect perceived difficulties of proof and risks of financial disadvantage in the most severe cases.  Identified Paxil birth defects range from cleft lip or cleft palate to club feet, skull defects, spina bifida, protrusion of organs or intestines from the navel, delayed development of vital organs, autism, and persistent pulmonary hypertension of the newborn.  Such diversity might make the class certification prerequisite of “questions of law or fact common to the class” [vi] unusually difficult to satisfy, not an encouraging prospect for most lawyers.

A current Paxil class action lawsuit in Canada may clarify the difficulty.  A British Columbia Supreme Court decision has certified Canada’s first national class action lawsuit against GSK for birth defects in children born to women who took Paxil during pregnancy.  The ruling appointed a representative plaintiff on behalf of a class defined as “any person in Canada, born with cardiovascular defects, to women who ingested Paxil while pregnant, and the mothers of those persons.” [vii] Class counsel contends that GlaxoSmithKline knew or ought to have known of the risks and failed to give doctors and the public adequate and timely warning.  American Paxil lawyers will watch this case closely as a precedent for Paxil birth defects class actions here.


[i] FDA Category D description: “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks,” http://www.drugs.com/pregnancy-categories.html.  According to the GSK safety data sheet for Paxil, “The ingredient paroxetine hydrochloride hemihydrate has caused adverse effects on the development of unborn offspring in humans,” http://www.msds-gsk.com/0031240h.pdf.

[ii] “Status of Paxil Lawsuits,” http://www.drugwatch.com/paxil/lawsuit.php.

[iii] Carpenters and Joiners Welfare Fund et al v SmithKline Beecham Corporation, US District Court, Northern District of Minnesota, Civil Action #04-3500 MJD/SRN, Final Order entered 30 September 2008.

[iv] Grair v GlaxoSmithKline, Inc, California Superior Court, Los Angeles County, Case #BC288536, Final Order entered 7 February 2013.

[vi] See, for example, Rule 23, Federal Rules of Civil Procedure.

[vii] Bartram v GlaxcoSmithKline, Inc, 2012 BCSC 1804, Reasons for Judgment entered 3 December 2012.