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Spangenberg Shibley & Liber LLP | Jun 21, 2016

Generic Drug Manufacturers Still Immune from Lawsuits: Change to FDA Regulations Stalled Again

Categories: Product Liability, Medical Malpractice, Defective Drugs and Medical Devices, Supreme Court

You’re at the pharmacy filling a prescription. The pharmacist asks, “Generic okay?” Without giving it a second thought, you say, “Sure,” (like we all do) and you’re on your way. Not so fast.

If you had taken the brand-name drug, and it turned out that the drug was defective and caused you an injury (like cancer or a stroke) – you could bring a lawsuit against the brand-name drug company and make it pay restitution and reparations. But, if you took the generic form of the drug – you would have absolutely no recourse against the company that made and sold the defective drug.

Wait. What?

It sounds crazy, but it’s true. Under the current FDA regulations, generic drug manufacturers cannot be sued for manufacturing and selling a defective drug – even if it causes horrific injuries – and even if the generic company knew the drug was causing horrific injuries and did nothing to warn patients or doctors about the dangers of the drug.

That was what the United States Supreme Court held in both PLIVA v. Mensing (2011) and Mutual Pharma. V. Bartlett (2013). While brand-name companies are allowed to add new warnings to their drug labels without getting prior permission from the FDA, generic companies are not. If a generic drug company discovers a new side effect of one of its drugs, it is not permitted to tell patients or doctors about this new information. It must first contact the FDA and request that the brand-name label be changed. Only after the brand-name label is changed is the generic company allowed to change its label. In essence, generic manufacturers are prohibited from giving any warnings to doctors or to the public that have not already been given by the brand-name manufacturer.

Under this legal framework, the Supreme Court held in PLIVA v. Mensing that it was impossible for a generic company to comply with both a state tort-law duty to have a stronger warning label and its federal duty to have the exact same label as the corresponding brand-name drug (that is, state law required what federal law prohibited). Thus, state-law tort claims brought against generic drug companies are preempted by federal law.

In her dissenting opinion in Mensing, Justice Sotomayor said, wait a minute, the generic drug company didn’t even fulfill its federal obligation to reach out to the FDA and propose a label change when it became aware of safety problems with its warning label, so it wasn’t necessarily impossible to comply with both, it’s just that the company didn’t even try.

Justice Thomas countered Justice Sotomayor’s argument by focusing on what state law required:

“Although requesting FDA assistance would have satisfied the Manufacturer’s federal duty, it would not have satisfied their state tort-law duty to provide adequate labeling. State law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.”

In Mutual Pharma. V. Bartlett – a case involving a drug that caused over 60 percent of a woman’s skin to melt away, leaving an open wound – the Supreme Court used the same logic as it did in Mensing to hold that defective design causes-of-action were pre-empted because generic drug manufacturers could not have made the drug different than (or safer than) the brand-name drug. The Court also dismissed the argument that the generic drug manufacturer could have simply stopped selling the drug in order to comply with both state and federal law. The Court basically said the “stop selling” option doesn’t count as real option under a pre-emption analysis, and that’s that.

So now what?

Well, the FDA, to its credit, tried to fix this glitch in the regulations back in November 2013. It proposed a regulatory change that would allow generic drug companies to give new warnings to doctors without prior FDA approval (thus, they could be held accountable for failing to warn patients and doctors about the dangers of a particular drug). This is especially important when you consider that almost 80% of all prescription drugs that are sold are generics (which means that currently 80% of the entire pharmaceutical industry cannot be held accountable for selling a defective drug).

But the pharmaceutical industry would not go gentle into that good night. Lobbyists for Big Pharma stepped in and have successfully stalled the regulatory change for almost 3 years. The change was finally expected to be made by the FDA last month (May 2016), but even after receiving 23,000 comments from the public, the FDA again extended the comment period, this time until April 2017.

Most people have no idea that generic drug manufacturers are currently immune from civil liability, and when considering the purchase between a generic drug or a brand-name drug, the likely choice for most will continue to be the generic because it’s cheaper. Big Pharma will not get away with this, and we will continue to fight for ways to hold generic drug manufacturers accountable for the safety of their drugs.