Another Court Mulls Brand-Maker Liability to Generic Drug User

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By Julie A. Steinberg

West Virginia’s top court is set to decide if consumers of generic drugs can impose warning liability on the makers of the corresponding name-brand products.

Most courts to consider the question have said patients can’t sue a company that didn’t make the drug they took. But some notable exceptions exist, including a California case currently before that state’s top court.

The Supreme Court of Appeals of West Virginia scheduled arguments for Jan. 18, 2018, in a suit involving a generic version of Levaquin, an antibiotic made by Johnson & Johnson unit Janssen Pharmaceuticals, Inc.

Kimmy McNair says a generic caused her acute respiratory distress. She told the West Virginia court in an Oct. 30 brief that she should be able to sue Janssen, which created the allegedly inadequate labeling that appears on branded and generic versions ( McNair v. Johnson & Johnson , W. Va., No. 17-0519, oral argument 1/18/18 ).

California Also Weighing Question

The California Supreme Court is also weighing whether brand-name drugmakers can be liable to patients who took generics, and heard argument Oct 2.

In that case, parents seek to hold Novartis Pharmaceuticals Corp. liable for their twins’ autisim, allegedly caused by the mother’s use of a generic version of the Novartis asthma drug Brethine to forestall premature labor in 2007.

Novartis, which sold the rights to Brethine in 2001, wants the California high court to overturn an appeals court decision that said the plaintiffs could proceed against it.

Drugmakers contend they can’t be held liable to product liability plaintiffs who didn’t use their products and most state courts have agreed with them.

But, in addition to the California case, a federal judge in Illinois also recently went the other way, allowing the widow of a Chicago attorney to sue Paxil maker GlaxoSmithKline LLC.

Wendy Dolin alleged her husband committed suicide in 2010, shortly after starting to use a generic form of the antidepressant, which carried the warnings created by GSK. That case, Dolin v. GlaxoSmithKline, LLC , yielded a $3 million verdict. GSK has appealed.

‘Simple’ Case, Plaintiffs Say

“Boiled to its essence, this case is simple,” McNair and her husband, Larry, argued. “Because brand-name manufacturers write the labels for generic drugs, they should be responsible when those labels hurt people,” the plaintiffs said.

In the West Virginia case, the McNairs contended Janssen was aware that acute respiratory distress had been linked to levofloxacin, the active ingredient in Levaquin. Yet the company failed to include this risk in the drug’s warning and knew the omission would exist in the warnings for branded and generic versions, they said.

Janssen maintained it can’t be held responsible under West Virginia product liability law for a product it didn’t manufacture. A trial court agreed with the drugmaker.

But liability under West Virginia law hinges on whether a product defect caused plaintiff’s harm and whether the injuries were foreseeable, the plaintiffs say.

Both are easy calls, they said.

The defect that caused harm is the inadequate label, which was the sole responsibility of Janssen, the plaintiffs said.

And it’s “100 percent” foreseeable to a brand-name drugmaker that an inadequate label will injure patients who use generics, their brief said.

Brand-name drugmakers know that the generic companies have to copy their labels word-for-word, the plaintiffs said.

They also know the generic drugs must be chemically equivalent to their branded counterparts.

Finally, they said, West Virginia, like most states, requires pharmacists to dispense generic drugs for brand-name prescriptions unless specifically directed not to.

The U.S. Supreme Court has held that generic drugmakers are generally immune from suit because they can’t change drug warnings that are legally required to mirror the warnings for the branded product.

If brand-name drugmakers are also shielded from liability, consumers will have no recourse, a result the court should reject, the McNairs said.

Public Citizen and the AARP submitted amicus briefs supporting the McNairs.

Janssen’s brief in response hasn’t yet been filed.

Public Justice, PC and Tabor, Lindsay & Associates represents the McNairs.

Thomas Combs & Spann, PLLC and Patterson Belknap Webb & Tyler LLP represent Janssen.

To contact the reporter on this story: Julie A. Steinberg in Washington at jsteinberg@bna.com

To contact the editor responsible for this story: Steven Patrick at spatrick@bna.com

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