And It Is Possible That Generic Zofran / Ondansetron - Birth Defects Cases Might Be Filed In California And Some Other State Courts
(Posted by Tom Lamb at DrugInjuryWatch.com)
On July 6, 2015 the drug company GlaxoSmithKline (GSK) filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting that a multidistrict litigation (MDL) be established for all Zofran lawsuits filed in the federal court system concerning Zofran's alleged association with birth defects.
From their legal document "BRIEF IN SUPPORT OF DEFENDANT GLAXOSMITHKLINE LLC’S MOTION FOR TRANSFER OF ACTIONS PURSUANT TO 28 U.S.C. § 1407":
Plaintiffs contend that their minor children suffered birth defects following the mothers’ ingestion of Zofran® prescribed for treatment of severe morning sickness during pregnancy (a condition that can threaten the health of mother and baby). Plaintiffs all claim that the drug they allegedly ingested was defectively designed, manufactured, and/or marketed by GSK, resulting in serious physical injuries to their children, and that GSK failed to provide adequate warnings of the risks and dangers posed by Zofran®. Plaintiffs also allege that GSK improperly marketed Zofran® “off-label” to doctors for treating morning sickness during pregnancy without FDA approval.
According to this same legal document, as of early July 2015 there were 12 Zofran lawsuits filed in 10 different federal court jurisdictions.
Further, Glaxo has requested that the federal court Zofran MDL be assigned to the U.S. District Court, Eastern District of Pennsylvania -- in part because its US headquarters are located in Philadelphia, which is in that court jurisdiction.
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We turn next to the possible birth defect lawsuits involving the many generic versions of Zofran, which are generally called Ondansetron. Unfortunately, back in 2011 the US Supreme Court basically gave legal immunity to generic drug manufacturers as regards state law "failure to warn" claims in products liability lawsuits involving any generic drug.
In more detail, the Pliva, Inc., et al. v. Mensing case was decided by the Supreme Court of the United States on June 23, 2011. Justice Clarence Thomas delivered the opinion of the Court, concluding that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state law claims.
First, there may be some federal legislation forthcoming that changes this current legal situation which negatively affects these generic Zofran / Ondansetron cases.
In addition, plaintiffs' attorneys have been discussing whether there is any way an Ondansetron - birth defect drug injury lawsuit could still be filed, and be successful, notwithstanding this Mensing case ruling.
For example, in three states — California, Illinois, and Vermont — either a state court judge or a federal court judge has held that the so-called "innovator liability" is a valid legal cause of action. In those states, at least, it is possible that an Ondansetron - birth defect lawsuit could be filed against GlaxoSmithKline (GSK).
Essentially this innovator liability claim is based on the contention that the brand-name drug manufacturer, e.g., GSK, had a duty to warn all users of the generic drug, e.g., Ondansetron, based on federal requirements that all generic labels must be identical to the brand-name drug label. This theory is founded on the premise that the label designed by the brand-name drug manufacturer is the one which doctors would rely on when prescribing the drug, regardless of whether it was the brand-name or generic which was prescribed -- then dispensed to and used by the patient.
In closing, be assured that we will watch for the federal court JPML decision on this possible Zofran MDL as well as monitor the future filings of birth defects lawsuits involving Zofran or Ondansetron.
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