Innovator Liability

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Massachusetts Court Ruling Welcomes Generic Medication Lawsuits

Last week the Supreme Judicial Court of the state of Massachusetts made a ruling that changes how the state handles product liability lawsuits pertaining to generic medications. Before the ruling and in most other states, claimants who suffered adverse reactions to generic drugs cannot make any legal claims against the generic drug manufacturer nor can they make claims against the manufacturers of the brand-named version of the medication on which the generic medications is based. The Massachusetts Supreme Court ruled that the brand-named drug manufacturer “that controls the contents of the label on a generic drug owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury.”

In other words, since the generic drug maker cannot alter the formula of the branded medication they are copying, the generic drug maker cannot be held liable, however, the branded drug maker who first “innovated” the medication is liable. This ruling is known as “innovator liability” and is currently only enforceable in CA, IL, MA, and VT. Massachusetts, however, made a distinction in the law and limited the scope of liability to focus only on “reckless disregard of the risk of death or grave bodily harm.”

Today, more than 80% of prescriptions filled in the United States are generic. Generic formulas must be virtually identical to the brand name version by law, however, the cost difference between the two are usually tremendous. Furthermore, the vast majority of health insurance plans will only cover and discount generic versions of medications, leaving patients to bear the high costs of brand name versions. The obvious choice of a generic over a branded drug is clearly a decision of affordability, rather than each patient weighing liability and recourse in the event that there has been negligence, failure to warn or “reckless disregard.”

A good example is the high profile birth injury case surrounding Zofran, GlaxoSmithKline’s nausea drug. Although it was not approved by the FDA for morning sickness, brand named Zofran was being prescribed off-label to expectant mothers for years until a link was found between the medication and significant heart-related birth defects and cleft palate in infants. Mothers who had been prescribed Zofran, or the much cheaper generic version known as Ondansetron, had a much higher likelihood of giving birth to infants with these birth defects that at times became fatal. The difference, however, is that mothers who took Ondansetron have no right to hold the manufacturer accountable for the injuries that occurred to their children. Only those who could afford to buy GSK’s branded Zofran can make a claim.

The question that needs to be asked, then, is should wealthier individuals who can afford top-tier cadillac health insurance plans be the only ones with the exclusive right to take action when they are wrongfully injured by their medication? Can it be construed as a discriminatory act against lower-income families who cannot afford these health plans nor the brand named version of these drugs?

Pharmaceutical companies, distributors and practitioners need to be aware that innovator liability is now not only limited to California, Illinois and Vermont, and since this ruling, there will likely be a huge influx of new claims being filed in Massachusetts. While innovator liability claims are currently only viable in 4 states, this new ruling might be an indication that the law is beginning to change to encompass a much larger pool of product liability claims against manufacturers who were previously untouchable regarding their generic offshoots. It only makes sense, however, that true negligence and recklessness that results in an injury or death to another ought to be punishable, regardless of whether or not a medication bears the brand name or the less expensive generic compound that is covered by most insurance plans.