mensing

Court Says Pfizer Can Be Sued by Man Who Took Generic

The Alabama Supreme Court ruled on Friday that a patient could sue a brand-name company for failing to warn about a drug’s risks even though he had taken a generic version of the product that the company did not make.

Although the decision applies only to Alabama, it is likely to be closely read by lawyers with similar cases pending around the country whose clients have been barred from suing generic companies because of a recent United States Supreme Court ruling.

“It has national implications,” said Bill Curtis, a Dallas lawyer who has filed hundreds of similar cases in several states. “I suspect that now, like most folks, if a client comes into my office, I’d be suing both the generic they took and the brand who’s responsible for the label.”

In the Alabama case, the plaintiff, Danny Weeks, claimed that he had developed a movement disorder known as tardive dyskinesia after taking generic versions of Reglan to treat his acid reflux. Mr. Weeks sued Actavis and Teva, the generic companies that made the drugs he took, as well as Wyeth, which developed the drug, for failing to adequately warn about Reglan’s risks.

In 2009, the Food and Drug Administration required all manufacturers of metoclopramide, the generic name for Reglan, to place stronger warnings on their labels detailing a link between long-term use of the drug and tardive dyskinesia. Hundreds of lawsuits have been filed by patients who claim that Wyeth failed to properly warn about Reglan’s risks.

The chances of those claims against the generic companies succeeding are unclear after a 2011 Supreme Court decision, Pliva v. Mensing, which ruled that generic drug companies had no control over what their labels said and so could not be sued for failing to alert patients about the risks of taking their drugs. With few exceptions, generic manufacturers are required to use the same labels as the brand names.

The suit was filed in a federal court in Alabama because Mr. Weeks lives in Alabama and the drug companies are based elsewhere. The federal court asked the Alabama Supreme Court whether a branded company could be sued in such a case.

In its decision on Friday, the Alabama Supreme Court ruled that “an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product.”

Kevin Newsom, a lawyer for Pfizer, which acquired Wyeth in 2009, described the decision as an outlier. He said more than 70 court decisions, including four from federal appeals courts, had taken the opposite view. Representatives for brand-name companies have argued that they cannot be held liable for injuries caused by products they did not manufacture. “It comes as something of a surprise because it is contrary to the overwhelming weight of authority on this issue nationwide,” he said. He said two other decisions have held similar views as the Alabama court.

The court ruled that Mr. Weeks could go ahead with his lawsuit based on what Mr. Newsom described as a “unique wrinkle” in Alabama state law: that third parties like Wyeth can be held liable for a person’s injury if that third party provided false or misleading information that led to the injury. Mr. Weeks is arguing that Wyeth misinformed his doctor, not Mr. Weeks himself.

Sheldon Gilbert, a lawyer with the National Chamber Litigation Center, which advocates for the Chamber of Commerce and filed a brief in the case, said plaintiffs’ lawyers were likely to see the Alabama decision as a lucrative opening. “What we’ve seen again and again and again is that the trial lawyers get a decision that they think is good and they all flock to that jurisdiction,” he said.

Chris Hood, a lawyer for Mr. Weeks, said, “When someone’s hurt by a generic tablet and that injury can be laid at the feet of misinformation about the drug, then there’s only one party who can be held responsible,” he said, “the branded company.”

Article source: http://www.nytimes.com/2013/01/12/business/court-says-pfizer-can-be-sued-by-man-who-took-generic.html?partner=rss&emc=rss

Justices Hear Arguments in Generic-Drug Lawsuit

On Wednesday, the justices heard arguments in a follow-up case that presented an interesting wrinkle: May the makers of generic drugs, whose products must use the same warning labels as the corresponding brand-name drugs and who cannot alter those labels, also be sued for failing to warn users about the risks posed by their products?

The answer to the question will have enormous financial consequences, said Jay P. Lefkowitz, a lawyer for the drug companies. “This would totally change the way generics do business,” he said of a ruling against his clients.

The three consolidated cases the court heard on Wednesday, including Pliva Inc. v. Mensing, No. 09-993, were brought by women who took the generic equivalent of Reglan for stomach ailments and developed a serious neurological disorder. Appeals courts ruled against the drug makers, saying that the federal regulatory regime did not block claims under state law.

Mr. Lefkowitz said the rulings put his clients in an impossible position.

“Generics can’t simultaneously comply with a federal duty to be the same and a state duty to be different,” he said.

He said the makers of generic drugs are in a fundamentally different business from the companies that created the original medications.

“Brand companies do safety and efficacy testing; generics do sameness testing,” Mr. Lefkowitz said. “Generics are required to make copies of the drugs and by definition make copies of the labels, because it wouldn’t make any sense to go into a drugstore to buy Advil and to see 15 different generic ibuprofen and to have 15 different sets of warnings.”

Justice Antonin Scalia echoed that point, likening the makers of generic drugs to “this guy who graduated from high school.”

“He doesn’t know anything about science,” Justice Scalia said. “He knows how to replicate this pill exactly. That’s all he really knows.”

But a lawyer for the plaintiffs, Louis M. Bograd, said that it would be odd to hold the two kinds of companies to different standards.

“The position that the generics are proposing here is one in which they would be immune from liability for selling a product with inadequate warnings,” he said, “even though the name-brand company selling the same drug with the same warnings would be liable.”

Mr. Bograd added that 70 percent of prescriptions were filled with generic drugs and that a third of generic drugs had no brand-name competitors.

“If generics are not responsible,” he said, “in many of these cases no one is responsible.”

Several justices said makers of generic drugs could take steps short of changing their labels, including urging the F.D.A to take action.

“You could propose a revision of the label, and if you did that, then you would be home free,” Justice Ruth Bader Ginsburg told Mr. Lefkowitz. “You would not be subject to the state suit.”

But Justice Samuel A. Alito Jr. seemed skeptical of lawsuits based on what he called “a duty to lobby the F.D.A.”

Justice Sonia Sotomayor said she doubted that Congress had intended a two-track system.

“Do you think Congress really intended to create a market in which consumers can only sue brand-named products?” she asked Mr. Lefkowitz. “Because if that’s the case, why would anybody ever take” a generic medicine?

Later in the arguments, Justice Alito proposed an answer to that question.

“I don’t know whether this is a good idea or not,” he said of allowing state suits, “but it does seem to me that it may significantly increase the costs for generic drug manufacturers, and therefore counteract one of the objectives of the statute, which was to provide generic drugs at a low cost.”

Article source: http://feeds.nytimes.com/click.phdo?i=37cbaa66e7ac20b889d75f36164ed8d0

Court Says Pfizer Can Be Sued by Man Who Took Generic

Justices Hear Arguments in Generic-Drug Lawsuit

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