Generic Zofran Lawsuit Still Possible In Alabama Until October, Monheit Law Reports

August 06, 2015 – – Michael Monheit, Esq., the managing partner of Monheit Law, reports that some parents who were prescribed generic equivalents to the anti-nausea drug Zofran may still be able to file claims against Zofran’s manufacturer, GlaxoSmithKline. Monheit sponsors an informational resource for families interested in learning more about the potential link between Zofran and major birth defects, including congenital heart defects and cleft palate, at ZofranLegal.com.

Under a legal theory known as “innovator liability,” brand name pharmaceutical manufacturers can be held accountable for injuries potentially caused by generic drugs in four States. “Vermont, Illinois, California and Alabama currently recognize ‘innovator liability,’ “ Monheit says, noting that after GlaxoSmithKline’s patent on Zofran’s active ingredient expired, 34 different companies began manufacturing their own generic versions of ondansetron.

But Monheit says that time is running out for generic drug claims in one State: Alabama. “In May of 2015, Robert Bentley, the Governor of Alabama, signed a bill into law that will end liability claims involving drugs a manufacturer did not directly produce.

Alabama’s new law goes into effect October 2015, leaving families less than three months to file Zofran birth defect claims involving generic equivalents of the drug. “The legislatures in Vermont, California and Illinois have expressed no desire to limit ‘innovator liability’ in any way.”

“Without innovator liability,” Monheit continues, “patients harmed by dangerous generic drugs have little recourse.”

Under Federal Law, generics are required to be equivalent to the brand name product upon which they are based, but as Monheit points out, this equivalence doesn’t just apply to an active ingredient’s function in the human body. The standard of “equivalence” extends to a product’s labeling: according to 21 CFR 314.94(a)(8)(iv) of the Code of Federal Regulations, a generic drug’s label “must be the same as the labeling approved” for its “innovator” drug.

According to Monheit, this requirement leaves generic drug companies unable to revise their own labeling with new safety warnings, unless an identical warning is applied to the brand name drug first. He noted two Supreme Court decisions, in the cases Pliva v. Mensing and Mutual v. Bartlett, in which the nation’s highest court ruled that Federal Laws limiting a generic drug companies ability to revise warning labels preempted State Laws requiring manufacturers to adequately warn patients of risks.

“Since many personal injury lawsuits involving pharmaceuticals include ‘failure to warn’ allegations, the Supreme Court’s recent decisions have effectively eliminated those claims against generic drug manufacturers,” Monheit said.

Only four States currently recognize “innovator liability,” making it possible for patients to file suit against brand name companies for injuries caused by generic drugs: Vermont, California, Illinois and Alabama.

As time runs out for generic Zofran lawsuits in Alabama, Michael Monheit continues to offer free consultations to parents who believe that the anti-nausea drug caused a child’s major birth defects. In view of Alabama’s recent legislation, Monheit Law is prioritizing claims originating in that State, along with the three other “innovator liability” States.

Monheit Law is joined by a coalition of experienced plaintiffs’ attorneys dedicated to protecting the rights of parents and birth defect survivors. For a free case eligibility evaluation, call 1-877-620-8411.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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