Glaxo Looks To Bar FDA, Plea Evidence From Paxil Trial


Interesting article on the Paxil (seroxat) birth defect trials that GSK is trying to quash at the moment, particularly these parts-

“…The drugmaker also railed against evidence that lab notebooks from 1979 animal studies were destroyed in 1993, saying the claim “grossly distorts the regulatory practices in place at the time” and is “a manufactured controversy” likely to make jurors assume malfeasance….”

” GSK asked the judge to bar evidence about a 2012 plea agreement and three civil settlements; it pled guilty to one misdemeanor count of drug misbranding. This guilty plea carried no implication of fraud with it, the company said. And the misbranding had to do with Paxil’s use for patients under 18.”..


GSK’s attorneys are lower than gutter slime..

An Amoeba would have more depth of character …

https://www.law360.com/trials/articles/884297/glaxo-looks-to-bar-fda-claims-guilty-plea-from-paxil-trial

Glaxo Looks To Bar FDA, Plea Evidence From Paxil Trial

Law360, New York (January 24, 2017, 4:49 PM EST) — Jurors in an upcoming trial over birth defects allegedly caused by the antidepressant Paxil must not be told about drugmaker GlaxoSmithKline‘s alleged campaign to defraud the FDA, about destruction of study data or about its 2012 guilty plea on misbranding charges, the company insisted Tuesday.

The company filed a slew of motions seeking to box out evidence it said is irrelevant to mother Kathryn Kiker’s claims that taking the drug while pregnant caused her child’s ventricular septal defect, a serious heart problem. The trial is set for Feb. 21 in the Columbus, Ohio, courtroom of U.S. District Judge Edmund Sargus.

“GSK anticipates that plaintiffs will argue at trial that GSK committed ‘fraud on the FDA’ by not cooperating fully with, and by withholding information from, the FDA regarding adverse events, animal studies and/or clinical trials  … so that the FDA did not undertake regulatory action with regard to Paxil,” the company said. But the claims “are incorrect, irrelevant and inadmissible,” it said. “Furthermore, the U.S. Supreme Court has held that FDA — not a private plaintiff — has exclusive authority to police disclosures made to [the] FDA.”

The drugmaker also railed against evidence that lab notebooks from 1979 animal studies were destroyed in 1993, saying the claim “grossly distorts the regulatory practices in place at the time” and is “a manufactured controversy” likely to make jurors assume malfeasance.

And in another motion, GSK asked the judge to bar evidence about a 2012 plea agreement and three civil settlements; it pled guilty to one misdemeanor count of drug misbranding. This guilty plea carried no implication of fraud with it, the company said. And the misbranding had to do with Paxil’s use for patients under 18.

Even as information about character, the plea deal is not usable, the company said.

“Evidence regarding felonies and any crime whose elements require proof of a dishonest act or false statement may be admissible for impeachment. GSK’s plea to no-intent, strict-liability misdemeanors under the FDCA is inadmissible for impeachment purposes because it does not fall within either category,” it said.

And it requested oral argument on another motion seeking to bar evidence about other lawsuits, investigations or media reports.

In October 2015, an Ohio federal judge ruled that GSK must face the suit because the mother successfully pled fraud.

U.S. District Judge Edmund Sargus denied GlaxoSmithKline LLC’s motion for judgment on the pleadings, rejecting its argument that Kiker’s claims accrued in September 2005, when the company told the medical community about Paxil’s links to birth defects, and are thus abrogated by the Ohio Product Liability Act, which was amended in 2005 and curtailed common-law liability claims in the state.

But the judge sided with Kiker’s argument that her claims accrued when her child, referred to as C.S., was born in 2001.

The judge said that a provision in the 2005 Tort Reform Act includes 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 also found that the fraud allegations in Kiker’s proposed amended complaint were sufficiently particular, and granted her leave to file the amended complaint.

“At the time Paxil was prescribed to Ms. Kiker, GSK knew … that Paxil was associated with a significant increased risk of cardiac birth defects in babies,” Kiker said. “Other studies showed that increased levels of serotonin, the primary human substance affected by Paxil, had profound effects on the prenatal cardiac development of study animals.”

Despite knowing these risks, she said, GSK suggested Paxil was safer than other available selective serotonin reuptake inhibitors, or SSRIs, and misled the medical community as to its safety. Kiker said GSK did not begin to inform doctors of the risks until September 2005, when third-party research showing the association was released.

The entire time the drug has been on the U.S. market, federal regulations have required stronger warnings in the presence of evidence of a birth-defect link, Kiker said. These FDA regulations specifically state that the link need not be proven and that the company can issue the warning without agency approval.

Kiker is represented by Benjamin Anderson of Anderson Law Offices LLC and Bryan Aylstock, James Barger, Bobby Bradford, Roger Cameron and R. Jason Richards of Aylstock Witkin Kreis & Overholtz.

GSK is represented by Andrew Bayman, Halli Cohn and Meredith Redwine of King & Spalding LLP and William Darrell Kloss Jr., Adam Rusnak and Jessica Goldman of Vorys Sater Seymour & Pease LLP.

The case is Kiker v. Smithkline Beecham Corp., case number 2:14-cv-02164, in the U.S. District Court for the Southern District of Ohio.

–Additional reporting by Emily Field. Editing by Philip Shea.

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2 comments

  1. Eve Sounder

    This is very important, good news:
    “The judge said that a provision in the 2005 Tort Reform Act includes 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.” It used to be that the clock started when you discovered the injury. I guess you were supposed to immediately assume it was caused by a drug your doctor and the drugmaker said was perfectly safe.

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