PharmExec Blog

Mutual v. Bartlett: A Line in the Sand on Side Effects

The SupremJustice Sonia Sotomayore Court ruled last Monday in the case of Mutual Pharmaceuticals v. Bartlett that generic drug makers cannot change labeling or the formula of a drug after it has been approved by the FDA. The majority, which included Justices Alito, Roberts, Scalia, Kennedy, and Thomas, concluded that federal regulation trumps state tort liability law, in this particular case New Hampshire’s risk utility law, essentially shielding generic manufacturers from liability for side effects or adverse events that were not known at the time of the originator drug’s approval. While this ruling provides the certainty lacking in previous cases, some legal experts say plaintiffs will use dissents from the four opposing justices to make creative pleas. It also ensures that asking companies to shelve their products solely as a consequence of previously unknown side-effects will keep the issue of access to affordable meds front and center.

The story of Bartlett is something of a horror story. Prescribed generic Sulindac for shoulder pain, Karen Bartlett suffered a reaction to the drug known as toxic necrolysis, whereby her skin became hypersensitive and permanently disfigured. Initially, a jury awarded Bartlett a $21 million settlement. But the argument clearly extended beyond whether she was entitled to such damages, and into the realm of what generics companies are responsible for in preventing such events.

“In essence, what the court decided was that the FDA approval is a license. And it’s a federal license the state cannot ignore, and the state can’t punish companies for doing what they are federally licensed to do,” explained Bert Rein, partner at Wiley & Rein LLP. While New Hampshire’s 1st circuit federal court suggested in one of its footnotes that the manufacturer had the choice to remove the generic from the market, Rein made the point that, “If the federal government says a product is safe and effective in the judgment of the FDA, the company has a right to sell it.”

The ruling was met with dissent from justices who contended, with the backing of two former FDA commissioners that state tort liability law should supplement the FDA’s regulatory and enforcement activities. Justice Sotomayor considered the ruling to be in contrast to the decision in Wyeth v. Levine, where it was determined that state tort law does not necessarily obstruct FDA regulation. Rein sees this view as paradoxical, in opposition to a ruling that provided clarity: “Her dissent was that unless the federal government expressly says no lawsuits, then lawsuits are a separate matter from requirements. And that interstate and federal law can order you what to do even if they contradict each other. That doesn’t make a lot of sense to me.”

Victoria Davis Lockard, Vice-Chair of Pharmaceutical, Medical Device & Health Care Litigation Practice at Greenberg Traurig, LLP suggests that another footnote in the case may bring another creative pleading strategy into play. She referred to the issue of ‘parallel claims’ that has gained attention since being referenced in the medical device case Regal v. Medtronic. “A parallel claim asserts that a company failed to comply with the federal regulations regarding disclosure of new and significant information at the time of the approval of the drug,” Lockard explained, adding that plaintiffs will have to file under state tort law where the theory is parallel to the claim that the company in question failed to comply with the misbranding regulations under the FDA. However, she said, “It’s an indirect way to lay this claim, it’s hard to do, and plaintiffs have to be very creative and prove substantial evidence to the FDA, which almost never happens.”

On another note, Congress may be pushed to act by way of the vociferous dissent in this case, but if there is any reaction at all from legislators it remains to be seen. Lockard’s view on why negative public perception of this ruling may be wrong comes down to the issue of access. “The symptom caused by Mutual’s generic is also caused by a host of other drugs, some of which are critical lifesaving medicines. If you require the manufacturer to take the drug off the market as this happens to be one of the side effects, then you’re essentially saying that these other drugs should be pulled off the shelves as well.” Ultimately, while it can be seen as a harsh result, the Bartlett ruling can also be seen as a win for the future of cheap and readily available medications for the average consumer.

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