An Ohio federal judge ruled last month that GlaxoSmithKline (GSK) must face a product liability suit brought by a woman whose child was born with heart defects after she took the antidepressant Paxil during her pregnancy. U.S. District Judge Edmund A. Sargus ruled that she had successfully pled fraud in her complaint. He denied GlaxoSmithKline LLC.’s motion for judgment on the pleadings. GSK argued that the claims were time-barred. Judge Sargus rejected that argument.
GSK contended that Plaintiff Kathryn Kiker’s claims accrued in September 2005, when the company told the medical community about the serious risks of birth defects, and are thus abrogated by the Ohio Product Liability Act (OPLA), which was amended in 2005 and abrogate common law liability claims in the state. However, Judge Sargus agreed with Ms. Kiker’s argument that her claims accrued when her child, referred to as C.S., was born in 2001.
Judge Sargus said that a provision in the 2005 Tort Reform Act incorporates a discovery rule so that a bodily injury claim may be extended to a date when it was reasonable for the injured party to have discovered her injury was related to a product. The judge said:
That is, the statute of limitations provision that includes the discovery rule relied upon by defendant does not dictate the date that plaintiffs’ claims arose for purposes of determining whether the 2005 amendments to the OPLA apply to their claims.
Judge Sargus also found that the fraud allegations in Ms. Kiker’s proposed amended complaint were sufficiently particular, and granted her leave to file the amended complaint. According to the proposed amended complaint, the baby suffered at birth from infant respiratory distress syndrome and ventricular septal defect, a serious heart defect. It was alleged by the Plaintiff:
At the time Paxil was prescribed to Ms. Kiker, GSK knew through pre-market studies and post-marketing studies and reports that Paxil was associated with a significant increased risk of cardiac birth defects in babies whose mothers ingested Paxil during pregnancy. Other studies showed that increased levels of serotonin, the primary human substance affected by Paxil, had profound effects on the pre-natal cardiac development of study animals.
Despite knowing these risks, GSK claimed that Paxil was safer and more effective than other selective serotonin reuptake inhibitors, (SSRIs), on the market, and made marketing misrepresentations that gave a false impression of the safety and efficacy of the drug to the medical community. The Plaintiff said GSK did not begin to inform doctors of the risk of cardiac birth defects until September 2005, when third party research was released that showed the association between Paxil and cardiac birth defects.
The entire time the drug has been on the market in the U.S., federal regulations have required GSK to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and Paxil. These FDA regulations specifically state that a causal link need not be proven to issue the new warnings and the company could issue such a warning without prior agency approval. It was alleged:
Thus, prior to Ms. Kiker’s pregnancy with C.S., GSK had the knowledge, the means and the duty to provide the medical community and the consuming public with a stronger warning regarding the association between Paxil and birth defects through all means necessary including but not limited to labeling, continuing education, symposiums, posters, sales calls to doctors, advertisements and promotional materials, etc. GSK breached this duty.
Ms. Kiker is represented by Benjamin Anderson of Anderson Law Offices LLC and Bryan F. Aylstock, James D. Barger, Bobby J Bradford, Roger P. Cameron and R. Jason Richards of Aylstock Witkin Kreis & Overholtz. The case is in the U.S. District Court for the Southern District of Ohio.
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