Vermont, Illinois, California and Alabama are the only States that currently recognize “innovator liability,” a legal theory under which “brand name” pharmaceutical manufacturers can be held accountable for injuries caused by generic drugs.
Generic Zofran (Ondansetron) Birth Defect Lawsuits
GlaxoSmithKline’s Zofran, a powerful anti-nausea drug approved for the treatment of severe nausea and vomiting in cancer patients and those undergoing surgical anesthesia, is commonly prescribed “off label” as a morning sickness remedy.
But now that several major epidemiological studies have linked the drug to an increased risk for cleft palate and congenital heart defects, parents are beginning to file lawsuits. In at least 15 filed complaints, families claim that GlaxoSmithKline unlawfully marketed Zofran for use during pregnancy, while concealing evidence of its association to major birth defects.
Women who were prescribed ondansetron, the generic equivalent of Zofran, and delivered children with birth defects may still be able to file legal claims against GlaxoSmithKline in one of the four “innovator liability” states.
For Alabama Generic Zofran Claims, Time May Be Limited
California, Illinois and Vermont legislators have shown no signs of limiting “innovator liability” in the future. But Alabama Governor Robert Bentley recently signed a bill into law that would protect “brand name” manufacturers from lawsuits involving drugs that they did not produce. The new law is going into effect in October of 2015, leaving only four months for families to file legal claims involving generic ondansetron in Alabama.
Monheit Law, lead sponsor of Zofran.Monheit.com, has joined with an alliance of experienced plaintiffs’ attorneys to investigate potential Zofran and ondansetron claims. Our team is providing free consultations to families who believe that brand name or generic Zofran may have caused birth defects.
In response to Governor Bentley’s recent legislation, we have decided to prioritize claims originating in the “innovator liability” states: Alabama, California, Illinois and Vermont. For a case eligibility evaluation at no cost, call 1-877-620-8411.
From Innovators To Generics: How Competitors Enter The Drug Market
In the pharmaceutical industry, “innovators” are drug companies that research, develop and manufacture “new molecular entities” for the first time. After the US Food & Drug Administration’s long approval process, these entirely new chemical combinations are approved and introduced to the US market.
When we think of “brand name” drugs, we’re thinking of innovators.
In exchange for their innovation and expenditure, “innovator” companies are rewarded with patent protection: in most cases, no other company can produce the same drug for 20 years from the time of filing for the patent.
But once that patent has expired, a wave of generic drug companies are allowed to enter the market, advertising their own versions of the same chemical entity.
Generic companies, though, aren’t required to expend the same amount of effort and resources that an innovator did. Rather than developing an entirely new chemical from scratch, and holding an extremely expensive series of clinical trials to demonstrate its safety and efficacy, generic manufacturers only have to show that their version of a chemical is “bioequivalent” to a brand name drug. They have to demonstrate that their drug functions in the human body the same way.
Who Is Accountable For Injuries Caused By Generic Drugs?
This standard of “equivalence” extends all the way to a generic drug’s labeling. According to Federal Law (21 CFR 314.94(a)(8)(iv), a generic product’s labeling “must be the same as the labeling approved” for the innovator drug with which it is bioequivalent. While there are several exceptions to this rule, “same” generally means “identical.” As a result, generic drug companies are literally unable to alter the warning labels’ of their products, unless the brand name manufacturer does so first.
But what if a generic company becomes aware of a major safety risk before the “innovator” company does. What if the “innovator” company is unwilling to revise its own labeling? What if the innovator no longer exists, or decided to discontinue its own brand name product after losing a significant portion of revenue to generic competitors?
The “Generic Drug Loophole”
Critics have dubbed this problem the “Generic Drug Safety Loophole,” and it is not just an issue of public health, but also legal accountability.
When patients are harmed by prescription drugs, one of their primary options for recourse is through a “failure to warn” lawsuit, in which a plaintiff claims that a pharmaceutical company either was aware or should have been aware of a specific health risk, but failed to provide patients with sufficient warning in the drug’s labeling information.
So what happens when consumers are injured by generics? Can generic companies be held liable for failing to warn patients, if they are legally prohibited from altering their own warning labels?
Two recent Supreme Court decisions strongly suggest that the answer to that question is “no.” In both Pliva v. Mensing and Mutual v. Bartlett, injured plaintiffs had filed suit against generic drug manufacturers, who they argued had failed to warn patients of serious safety risks. Both cases made their way to our nation’s highest court, but the Justices ruled that federal laws preventing generic companies from altering their own labels preempted State laws requiring drug companies to adequately warn consumers of a product’s risks.
Is Change On The Horizon?
With generic pharmaceutical companies shielded from liability, patients severely harmed by generic drugs have little choice other than to file claims against innovator companies. But as we’ve already noted, only courts in California, Illinois, Vermont and Alabama retain the theory of “innovator liability,” and Alabama plans to phase the concept out soon.
In recent years, the FDA has acknowledged the problem of generic drug labeling, and proposed a new law to solve it. But under pressure from the generic drug industry, the agency postponed its ruling on a measure that would allow generic manufacturers to unilaterally alter their warning labels. Public health advocates and consumers strongly voiced their support of the tabled proposal, and the FDA is again considering a change that would close the “generic drug loophole.”
A final ruling is anticipated on September 30, 2015.