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Alabama High Court Ruling on Generic Drugs Sparks Backlash

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by Publius
Posted February 25, 2013, 8:04 AM

The Wall Street Journal reports:

Business groups are urging Alabama's highest court to reconsider its recent ruling that name-brand drug makers can be held liable for injuries caused by the generic versions of their products.

The decision in January cleared the way for a 2010 lawsuit against Pfizer Inc. over the generic version of an acid-reflux drug called Reglan developed by a different company decades ago. The U.S. Chamber of Commerce, the pharmaceutical industry's trade group and other business groups fear the theory of liability, rejected by dozens of other courts, could open the door to a flood of lawsuits seeking to hold companies liable for products they didn't make.

Hundreds of Reglan cases are pending throughout the country, ballooning to 3,500 from 250 last year, according to court documents. There are at least 250 plaintiffs in Alabama.

Pfizer's lawyers asked the Alabama Supreme Court to reconsider the decision. If left to stand, Alabama's decision would allow generic-drug makers "to reap the profits of drug sales while leaving brand manufacturers with the liability" and violate the basic legal tenet that a manufacturer is liable only for its products, said Kevin Newsom, a Birmingham lawyer who is representing Pfizer.

In a court brief, Pfizer also jabbed at Alabama's history as a plaintiff-friendly venue, saying the ruling would once again make the state a "magnet for novel personal-injury lawsuits."

Mit Spears, general counsel of the Pharmaceutical Research and Manufacturers of America, expressed concern that brand-name drug makers might decide to withdraw their products once generic versions dominate sales because the companies would otherwise be wholly responsible for monitoring and ensuring the safety of drugs made by generic companies. "By essentially absolving [generic-drug makers] of any responsibility, you're saying they don't have to perform that job very carefully," and remove an important incentive for protecting patients, Mr. Spears said.

The Chamber of Commerce warned in a separate court brief last week that the ruling "eviscerates basic tort limitations" and "threatens to unleash the plaintiffs' bar on all manufacturers doing business in Alabama." Similar sentiments were expressed by the Alabama Policy Institute, a free-market think tank, and the Business Council of Alabama.

Pfizer could still appeal to the U.S. Supreme Court, which is already considering a case this term involving drug-maker liability.

The case at issue in the Alabama ruling involves Danny Weeks of New Brockton, Ala., who says he developed tardive dyskinesia, a disorder characterized by involuntary movements, after taking the generic version of Reglan. Mr. Weeks took the drug from 2007 to 2009, the year the U.S. Food and Drug Administration required all manufacturers to augment their warning labels to explain the link between the disorder and long-term use of the drug.

Mr. Weeks and his wife, Vicki, accused the generic manufacturers of the drug, Teva Pharmaceuticals USA and Actavis Elizabeth LLC, of failing to adequately warn of the risks. They also sued Pfizer, which acquired brand-name Reglan's maker Wyeth in 2009, and Schwarz Pharma Inc., which bought the rights to Reglan in 2001. . . .

 

 

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