We recently reported on the Alabama Supreme Court decision allowing brand-name drug manufacturers to be held liable for injuries sustained from generics. The decision has prompted a whole host of hand-wringing and a parade of horribles from places like The Wall Street Journal and Claims Journal. The three separate dissents in the case also insisted that the ruling was anti-business and would lead to more lawsuits.
If you're the GC of a drug company, should you be worried?
No, You Shouldn't Be Worried
Predictably, claims that the world is going to end arise whenever plaintiffs are allowed to go ahead and sue for something. In this case, it's a lot of hype.
A close reading of the majority opinion in Weeks reveals that it truly is a narrow decision. It applies only to situations where a consumer claims she was harmed as the result of taking a generic version of a brand-name drug, and even then, only when there was a labeling defect. The case turns on a federal requirement that generic labels match exactly their brand-name counterparts. A generic company couldn't change its label if it wanted to, even for a good reason -- unless it wanted to suddenly lose the ability to sell the drug.
If "innovator liability" opponents want to get up in arms, they should direct their torches and pitchforks at the FDA and Congress, which created these regulations in the first place. It might not be fair to hold a brand-name manufacturer liable for a product it doesn't control anymore, but neither is it fair to hold a generic manufacturer liable for a defect in a label that's not within its control.
Drug Company's Responsibilities
A generic drug's FDA certification is wholly and directly derivative of a brand-name's certification, including the brand-name's labeling. The only duty a generic manufacturer has is to make sure its labeling matches the brand-name's exactly. And the brand-name is still under the same duty it always was; namely, to make sure there's no fraudulent misrepresentation in the label.
When a consumer is injured by a pharmaceutical, someone is always going to get sued; it's just a question of whom. Prior to Weeks, it could have been the generic manufacturer. Now, it's the brand-name manufacturer. The risk of a lawsuit gets shifted; there's no new burden being created, here. A generic company that gets sued will get dismissed from the case: "Hey, we just followed their label because the law made us."
So, put your generic Xanax away. Everything's going to be fine.
- FDA Proposes Letting Generic-Drug Makers Change Labels (The Wall Street Journal)
- Alabama Supreme Court Adopts "Innovator Liability" (The Federalist Society)
- This Week in FDA Regulations: 40 States Ask for E-Cig Rules (FindLaw's In House)
- This Week in FDA Regulation: Celiac Disease and More Power! (FindLaw's In House)