Big Pharma “Victory” May Actually Hold Generic Drugs Liable
Posted by Rob Jenner on Aug 18, 2015 in Legal
A recent federal court ruling may hold out some hope for patients seriously injured by generic drugs – a group that thus far has been prohibited under FDA rules from suing over their injuries.
The August 7th ruling in Amarin Pharma, Inc. et al v. United States Food & Drug Administration, is being hailed as a landmark decision in favor of drug makers and their ability to promote untested “off label” uses of their products. However, a careful examination of the case and the ruling shows it may prove to open the door to further consumer protections. It may, in fact, expand opportunities to sue over “failure to warn” against dangerous drug side effects that result in serious injury or death.
And the more a company is concerned about liability, the more likely it is to withdraw a dangerous product from the market or provide adequate warnings about dangers attendant to its use.
“Free Speech” Must Include Truth
The Amarin case involved its fish-oil derivative drug, Vascepa. The FDA previously had approved use of the Vascepa for patients with extremely high levels of triglycerides. However, the company was caught and fined for promoting Vascepa as safe and effective for patients regardless of their level of triglycerides, an action in direct violation of FDA regulations prohibiting such promotion. The company, in turn, sued the FDA claiming the FDA’ s ban on promoting off-label uses violated the company’s free speech rights under the Constitution. The judge agreed with Amarin.
But the ruling was very specific: promotion of off-label uses was limited to “truthful and non-misleading” information. This leaves the door wide open to legal challenges about whether the company’s information reflects all of the information the company has about potentially dangerous side effects. If a company has information that a drug may be used off-label for certain benefits, isn’t there a concomitant obligation to provide “truthful” information that there may be adverse side effects to the off-label use? At the very least, wouldn’t it require a manufacture to state that an off-label use has not been fully tested in appropriately styled clinical trials? It also begs the question of whom and what determines if language is “truthful and non-misleading.”
Most lawsuits involving drugs or medical devices include evidence that the manufacturer had knowledge of an unacceptable level of dangerous side effects, but didn’t report it. This evidence allows a claim of “failure to warn” to be included in a plaintiff’s lawsuit. I have blogged about many such cases where unreported side effects have disabled, killed or otherwise devastated whole families. Doctors who prescribed the medications also suffered from the knowledge that they were the unwitting victims of drug maker deception.
Generic Drug Makers Could Get Easier to Sue
If you combine the Amarin court decision with the FDA’s progress toward rule changes that would allow generic makers to carry updated warning information on their labels ahead of any label changes by their brand name counterparts – you get a scenario where generic drugs are open to lawsuit claims of “failure to warn.”
Even for brand name versions of the drug, the disclosure of that “new” information in promotional materials could put the company at risk of suit by the FDA for not previously reporting the information.
Long-Term Impacts Unknown
The court ruling in Amarin vs. FDA is still being analyzed and debated as to its real-life impacts. The ruling may turn out to be very narrow in its application; the judge based his decision partly on the fact that use of fish oil (the primary ingredient in Vascepa) has been widely promoted by nutritional supplements companies as being useful in lowering triglycerides. The decision may also turn out to be just a nuanced nudge and not a broad expansion of two previous court decisions relaxing constraints on drug company marketing. Certainly, further court decisions will follow this one in the years to come.
In summary, while Big Pharma may be celebrating its most recent “victory,” consumers have reason to be optimistic, as well. The Amarin ruling may cut both ways. As the saying goes, “Be careful what you wish for because you may get it.”