CHARLESTON -- The state Supreme Court has declined to expand West Virginia's products liability law, saying a plaintiff has no cause of action against a brand-name drug manufacturer when the drug used was made by a generic manufacturer.

In the May 11 ruling, the Justices answering a certified question upon request of the Fourth Circuit Court of Appeals with a 3-2 ruling in McNair v. Johnson & Johnson et al. Justice Allen Loughry wrote the majority opinion, which also was signed by Justice Menis Ketchum and Justice Beth Walker. Chief Justice Margaret Workman issued a dissenting opinion, which also was signed by Justice Robin Jean Davis.

Loughry

The question was whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer. The issue commonly is known as innovator liability.

Petitioners Kimmy and Larry McNair had asked the court to reformulate the certified question to replace the term “negligent misrepresentation” with the term “negligence.” In the McNairs’ brief on appeal from the federal district court, they framed the issue as “whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer.”

"We find that a consumer allegedly injured by a generic drug cannot bring a strict liability failure to warn claim against the brand manufacturer who did not manufacture that drug," Loughry wrote in the majority opinion. "We, likewise, find that a negligent misrepresentation claim against a brand manufacturer for injuries allegedly caused by a generic drug is not viable under our products liability law.

"Notably, all federal circuit courts that have considered the question have held, under the laws of different states, that a brand manufacturer does not owe a duty to a consumer who uses a generic drug."

The McNairs originally filed an action in Kanawha Circuit Court against Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, in 2012 alleging the wife McNair developed acute respiratory distress, or ARDS, after ingesting the generic drug levofloxacin that was manufactured by Dr. Reddy’s Laboratories Limited.

Janssen originally trademarked and sold levofloxacin under the brand Levaquin. Thus, Janssen produced the warnings on the label that accompanied the distribution of Levaquin, which were subsequently used by generic manufacturers of levofloxacin.

The McNairs claim Janssen was aware that ARDS had been linked to the use of levofloxacin but negligently failed to include a warning, knowing this omission would exist not only in its distribution of Levaquin, but also in the warnings accompanying generic versions of the drug.

The McNairs’ claim that even though the wife took a generic version of the drug, Janssen had exclusive control of the content of the warnings that were published to the public and to health care providers for both the brand-name and the generic forms of the drug. Therefore, the McNairs contend Janssen is liable for their alleged injuries.

The dissenting opinion called the case an "extremely significant liability matter."

"This is, at its very essence, a reasonably straightforward failure to warn and negligence case," Workman wrote. "Although the facts are unique, the concepts certainly are not unfamiliar to the jurisprudence of this state. We have long held inviolate the rights of the citizens of this state to be protected from negligence of manufacturers.

"The failure to impose liability will necessarily invite inattention and neglectfulness by brand-name manufacturers, a transgression for which our citizens will have no legal recourse. The majority’s decision is short-sighted and ill-advised. Consequently, I dissent and would have answered the certified question in the affirmative."

Many states have ruled similarly to West Virginia, but a few have ruled in favor of being able to name the brand-name company as a defendant. Massachusetts, California, Illinois and Vermont all have ruled that way.

The driving force behind such acceptance is that the U.S. Supreme Court ruled in an earlier case that product liability claims generally cannot be brought against manufacturers of generic drugs because the manufacturer is not free to change the warnings on a generic drug without permission from the federal Food and Drug Administration. The court reached the opposite conclusion with respect to branded drug manufacturers, finding product liability claims can generally be brought because the branded drug manufacturer can change its warnings without prior FDA approval.

As a result, plaintiffs’ attorneys have sought to make a branded drug manufacturer pay for alleged harm to persons taking a generic drug made by another company, arguing that the branded drug manufacturer should be responsible for any and all liability stemming from the drug, including a generic version of the drug made by one of the branded manufacturer’s direct competitors.

West Virginia Supreme Court of Appeals case number 17-0519

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