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US Supreme Court: From now on, 80 percent of all drugs are exempt from legal liability.

Drug companies failed to warn patients that toxic epidermal necrolysis was a side effect. But the Supreme Court ruled they’re still not liable for damages.

(Reuters) The US Supreme Court made a ruling on lawsuits against drug companies for fraud, mislabeling, side effects and accidental death. From now on, 80 percent of all drugs are exempt from legal liability.

In a 5-4 vote, the US Supreme Court struck down a lower court’s ruling and award for the victim of a pharmaceutical drug’s adverse reaction. According to the victim and the state courts, the drug caused a flesh-eating side effect that left the patient permanently disfigured over most of her body. The adverse reaction was hidden by the drug maker and later forced to be included on all warning labels. But the highest court in the land ruled that the victim had no legal grounds to sue the corporation because its drugs are exempt from lawsuits.

The majority opinion, written by Justice Samuel Alito, said the state’s law could not run against federal laws on prescription medicines whose design has been approved by the U.S. Food and Drug Administration.

A Supreme Court ruling in 2011 found that pharmaceutical companies that make branded drugs are liable for inadequacies in safety warnings of a medicine’s label, but not the makers of cheaper copies of those medicines.

Consumer watchdog group Public Citizen said the Supreme Court decision on Monday undermines patient safety at a time when about 80 percent of U.S. prescriptions are filled with generic medicines.

“Today’s court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients,” Michael Carome, director of Public Citizen’s Health Research Group, said in an interview.

In the ruling, the justices said Bartlett’s situation was “tragic and evokes deep sympathy,” but added a straightforward application of pre-emption law requires that the judgment of the lower court be reversed.

At the time Bartlett filled her prescription, sulindac’s label did not specifically refer to the serious skin reaction known as toxic epidermal necrolysis, although the FDA later added the warning for drugs in that class of medicines.

Because the high court had previously ruled that generic companies could not be sued based on safety warnings in the label, Bartlett’s lawyers brought their suit under New Hampshire’s design-defect cause of action that says manufacturers have a duty to design products reasonably safely for the uses which they can foresee.

From Whiteout Press:

In other words, if the FDA says something is safe, it doesn’t matter if that decision is wrong or the result of lies, fraud or deception on the part of the world’s pharmaceutical companies. And there’s no way to sue the FDA for being wrong and costing millions of unsuspecting Americans their lives. That result leaves 240 million Americans unprotected from an industry responsible for more preventable deaths in the US than any other cause.

Senate Judiciary Committee Chairman Patrick Leahy (D-VT) was quick to react to the ruling by writing a stern letter to FDA Commissioner Margaret Hamburg, “A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug.”

But an attorney for the drug companies, Jay P. Lefkowitz, took the opposing position saying, “It makes much more sense to rely on the judgments of the scientific and medical experts at the FDA, who look at drug issues for the nation at large, than those of a single state court jury that only has in front of it the terribly unfortunate circumstances of an adverse drug reaction.”

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