Families from across the country are filing lawsuits against GlaxoSmithKline, claiming the company’s anti-nausea drug Zofran has the potential to cause major birth defects.
But almost two decades ago, Zofran was joined on the US market by a host of generic equivalents using the drug’s active ingredient ondansetron. Since generics are uniformly less expensive than branded pharmaceuticals, it’s extremely likely that many pregnant women and physicians have favored generics manufactured by Teva Pharmaceuticals and Mylan N.V., among other companies, over GlaxoSmithKline’s branded product.
But three major studies have now found an association between Zofran’s active ingredient and an increased risk for major birth defects, and those results apply to generic forms of ondansetron just as much as they apply to the branded version of Zofran.
Can Women Prescribed Generic Zofran File Birth Defect Lawsuits?
Yes. Under a legal theory called “innovator liability,” brand name pharmaceutical companies can be held liable for injuries or harm that may have been caused by generic drugs.
But currently, only 4 States recognize “innovator liability”:
While the legislatures of Vermont, Illinois and California have expressed no desire to restrict “innovator liability,” the Governor of Alabama, Robert Bentley, signed a bill into law on May 1, 2015 that will prevent claims of liability against manufacturers involving drugs they did not directly produce.
Alabama’s new law goes into effect in October 2015, leaving parents less than three more months to file Zofran birth defect lawsuits in relation to generic versions of ondansetron.
ZofranLegal.com is sponsored by a multi-state alliance of plaintiffs’ attorneys devoted to protecting the rights of parents and birth defect survivors. Led by Monheit Law, our experienced attorneys provide free consultations to families who believe that prenatal exposure to ondansetron may have caused a child’s birth defects. In light of Alabama’s new legislation, which will restrict families’ ability to file lawsuits involving generic Zofran equivalents, the team behind ZofranLegal.com has chosen to prioritize potential claims in Alabama, as well as the other “innovator liability” states: California, Vermont and Illinois.
To speak with an attorney about your legal options, at no charge, call 1-877-620-8411 or fill out our contact form.
From Branded Zofran To Generic Ondansetron
Approved by the FDA in 1991, GlaxoSmithKline’s anti-nausea drug Zofran soon became America’s foremost treatment for morning sickness, despite the fact that Zofran had only been approved to treat the severe nausea and vomiting experienced by cancer patients undergoing chemotherapy. While the drug’s initial approval was extended to include patients undergoing radiation therapy and operative anesthesia, Zofran remains unapproved for any use during pregnancy.
But since those early years of “off label” use, Zofran’s prescription as an unapproved morning sickness drug has only grown. According to researchers at Boston University’s Slone Epidemiology Center, Zofran use among pregnant women had overtaken every other “off label” medication traditionally prescribed to treat morning sickness by 2000. By 2006, the drug was being prescribed during pregnancy twice as often as its closest competitors, promethazine and metoclopramide.
Generics Flood The Market & Zofran Use Among Pregnant Women Skyrockets
In the same year, GlaxoSmithKline’s patent on Zofran’s active ingredient, ondansetron, expired, allowing numerous other manufacturers to begin producing their own generic versions of the drug. Recent estimates have placed ondansetron’s current “off label” prescription rate for pregnant women at around 1 million annually.
As we’ve reported before, this widespread usage during pregnancy has allowed teams of researchers to begin investigating Zofran’s potential effects on prenatal development. In three major studies, academics in the US, Denmark and Sweden have found that women who are prescribed ondansetron during the first trimester are between two and four times more likely to deliver children with cleft palate and congenital heart defects.
Can Manufacturers Be Held Liable For Injuries Caused By Generic Drugs?
“Brand name” drug manufacturers spend inordinate amounts of money and time researching and developing “new molecular entities,” chemicals intended for pharmaceutical use that have not been previously-approved by the FDA. But generic drug companies don’t have to.
Rather than developing a new molecular entity from square one, generic manufacturers only have to demonstrate that their version of an active ingredient is “bioequivalent” to an existing, approved “brand name” product. In essence, they need to show the FDA that their version functions similarly in the human body.
To learn more about the standard of bioequivalence, click here.
Generic Companies Can’t Revise Their Own Warning Labels, Until A Branded Company Does
But under Federal Law (21 CFR 314.94(a)(8)(iv), a generic’s “equivalence” to its branded precedent also applies to the drug’s labeling. As that Law is written, a generic’s label “must be the same as the labeling approved” for the original (also called “innovator”) drug that was approved before it:
- even if the generic manufacturer becomes aware of an emerging safety risk that the innovator manufacturer is unaware of
- even if the innovator company chooses not to revise its own labeling in light of a safety risk
- even if the innovator has since gone out of business, or stopped manufacturing its branded product
In short, generic companies are not able to revise their own warning labels, unless an identical revision is applied to the innovator product’s labeling first.
This inability opens what many critics have called the “Generic Drug Safety Loophole.”
Can Generic Drug Companies “Fail To Warn” Patients Of Health Risks?
Patients who are injured by dangerous pharmaceutical products often turn to legal action in their search for justice. Many file “failure to warn” lawsuits, in which they allege that a manufacturer “failed to warn” the health community and public of a safety risk of which the company was aware.
Most currently-filed Zofran birth defect lawsuits make allegations of this nature; Plaintiffs claim that GlaxoSmithKline failed to notify patients and physicians of Zofran’s association to increased birth defect risks. Their allegations are typical of a pharmaceutical “failure to warn” claim, contending that the company failed to revise the drug’s warning label in light of evidence Plaintiffs claim suggests Zofran’s link to major birth defects.
But could a similar allegation be leveled against manufacturers of generic ondansetron, since those companies are literally prevented from independently altering their warning labels by Federal Law?
Two US Supreme Court decisions, one in 2010 and another in 2012, indicate that the answer to this question is “no.” In Pliva v. Mensing, and again in Mutual v. Bartlett, patients filed suit against generic manufacturers, claiming the companies had failed to warn patients of significant safety risks. But the Supreme Court ruled that State laws compelling pharmaceutical companies to adequately warn of health concerns were “preempted” by Federal Laws restricting a generic manufacturer’s ability to revise their own warning labels.
Thus, generic manufacturers’ protection from liability claims based on “failure to warn” allegations has been upheld by the highest court in the US.
And even though branded companies control the wording of a product’s labeling, most States do not allow liability claims involving generics to be filed against companies who did not actually manufacture the drug. Again, only four States, Vermont, California, Illinois and Alabama, recognize claims involving generic drugs under the theory of “innovator liability,” and Alabama’s recent legislation will end the practice in October.