FDA Proposes to let Generic Drug Makers Update Labels

In an exciting and unprecedented decision, the FDA recently proposed a new rule that would allow generic drug manufacturers to update labels independently from their brand-name counterparts. This has been an issue of hot debate over the past decade or so, as plaintiffs injured by generic drugs attempt to sue generic companies for failure-to-warn. Presently, generic companies are shielded from liability because they are federally-required to keep the exact same labels as brand names.

Drug injury attorneys at Pintas & Mullins Law Firm are anxious to see how this proposal plays out. If the rule goes through, victims will be able to sue generic manufacturers, opening the water gate for mass tort claimants throughout the country.

Is Taking a Generic Riskier than Brand-Name?

Currently, yes. Not because the chemical makeup or warning label of the medication is any different, but because victims of dangerous generic drugs have a substantially more difficult, nearly impossible time filing a legal claim. This has been particularly evident lately, as several decisions by the U.S. Supreme Court made very clear that generic companies are protected from liability under federal law.

Federal statutes and FDA regulations state that generic companies must provide the same exact language in their warning labels as the brand-name drugs’. There are a handful of states that have created opposing laws, however, since it would be impossible for generic companies to comply with both, federal law must prevail.

Among the most significant rulings regarding this issue is Pliva Inc. v. Mensing, a SCOTUS case that concluded in 2011. The plaintiff, Mensing, sued Pliva over its generic drug metoclopramide (brand-name Reglan) for causing her severe neurological disorder. In a 5-4 decision, SCOTUS confirmed that federal statutes preempted her claim of inadequate warning labels, protecting generic companies from all future failure-to-warn lawsuits. It was a major loss for injured victims of dangerous pharmaceuticals.

What the New Rule Would Mean

Many experts believe that the proposed rule is the FDA’s vehicle for aiding mass tort and injured plaintiffs. Mass tort lawsuits represent one similar injury among many plaintiffs caused by a single common product (femur fractures from the drug Fosamax, for example). Mass torts are an important tool in keeping Big Pharma in check, reminding it that patient safety cannot be compromised for pursuit of higher profits.

If they are successful, mass torts also force pharmaceutical companies to make significant changes, actions which the FDA would have been unable to take on its own. Knowing that individuals (hundreds, sometimes thousands of them) can sue them for not adhering to safety regulations changes their behavior so they err on the side of safety.

Should the rule pass, generic firms will be able to update their own labels when new safety data is made available, increasing their legal obligations to victims by making it more difficult for them to dismiss failure-to-warn claims. The liability, in fact, would be unlimited, which many believe will cause generic companies to significantly expand labels, potentially adding superfluous information to avoid lawsuits.

Like any long technical writing, few people would care to read the excessive labels, which would in turn decrease their effectiveness. There can be dozens of generics for one brand-name drug, and if only two of those companies include a label for a particular injury and the others do not, they could be sued for failure-to-warn by injured plaintiffs. Additionally, there are more than 430 generic drugs currently on market that do not have brand-name counterparts, so the new rule would open up that much more possibility for litigation.

Our team of dangerous drug lawyers will continue to update this blog as more information on the proposal is made available. If you or a loved one was seriously injured, sickened or killed by a pharmaceutical or medical device, contact our firm to be informed of your legal rights and avenues. Our legal consultations are offered free-of-charge to potential client nationwide.


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