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Report adverse events to FDA's MedWatch reporting system by completing a form on line at FDA's MedWatch
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Preventable Adverse Drug Reactions

Over 2 MILLION serious ADRs yearly

100,000 DEATHS yearly

ADRs 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths

Nursing home patients

ADR rate 350,000 yearly

Institute of Medicine, National Academy Press, 2000

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Keith Jensen obtained the largest verdict in NH history and that case is before the U.S. Supreme Court

By David Sell, Inquirer Staff Writer
POSTED: March 21, 2013

WASHINGTON - Supreme Court justices questioned and debated Tuesday the proper reach and power of federal law in the regulation of generic drugs and whether a Philadelphia company is liable for $21 million in damages for horrific injuries suffered by a New Hampshire woman who took one of the company's medications.

Mutual Pharmaceuticals Co. asked the justices to overturn a jury decision in favor of Karen Bartlett, 53, who had a rare reaction to the painkiller sulindac, in which her skin essentially peeled away and she was left nearly blind.

"No warning label would have made a difference," lawyer David Frederick said, arguing on behalf of Bartlett that patients should be able to sue drugmakers in state courts on the ground that a badly designed drug can cause harm.

The Mutual generic was a copy of a previously branded drug. Bartlett and her attorneys argue that the drug was badly designed. Mutual contends it was legally bound to retain that design in its generic version.

The nine justices probably will decide by the end of June when and whether federal law trumps state law regarding generic-drug design, and their ruling could change the landscape for patients, drugmakers, and regulators.

Generic drugs account for 80 percent of prescriptions written in the United States. To get approval to sell a brand-name drug in the U.S., pharmaceutical companies must do clinical testing and divulge the ingredients to the Food and Drug Administration. Generic drugs are essentially copies of the original, and the FDA requires manufacturers to adhere to the label and the formula of the branded version. Without the front-end cost, generic companies can sell the drug for much less money.

High court takes up generic-drug liability

Mutual was part of URL Pharma, which has two facilities in Northeast Philadelphia. Both companies are now owned by Sun Pharmaceutical Industries of India.

Bartlett, who took the drug for shoulder pain, originally sued in state court, but Mutual succeeded in having the case moved to federal court, hoping federal rules would offer protection. But a jury and the Boston-based U.S. Court of Appeals for the First Circuit sided with Bartlett, arguing that Mutual could have done more or simply stopped selling the product.

Mutual's attorney, Jay Lefkowitz, argued Tuesday that FDA rules say generic manufacturers must follow the formulation and label of brand-name drugs and that because it did so, Mutual should not be liable. He said a 2011 Supreme Court decision in Pliva v. Mensing, which said makers of generic drugs cannot be sued over labeling and how patients are warned, should apply in this case, too.

Brand-name drug companies are backing Mutual in this case, hoping for greater protection from liability suits in state courts.

"We're not really dealing only with generics, are we?" Justice Elena Kagan asked Lefkowitz. "They are all in the same boat."

Government attorney Anthony Yang spoke up for the FDA and its support of Mutual, in this case, stressing the need for conformity to FDA regulations.

With that idea in mind, Justice Samuel Alito asked, "What if 49 states passed a law that says you have to drive on the right side of the road, but New Hampshire passes a law saying you have to drive on the left?"

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Motrin can cause SJS & TEN, which can cause blindness, kidney failure, and death. What McNeil & J&J Have Never Told Parents.

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TEN in a Child

Can Cause Death
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Stevens Johnson Syndrome