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. Image courtesy Whiteout Press.

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. Image courtesy Whiteout Press.

by Whiteout Press


In case readers missed it with all the coverage of the Trayvon Martin murder trial and the Supreme Court’s rulings on gay marriage and the Voting Rights Act, the US Supreme Court also 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.

Karen Bartlett vs. Mutual Pharmaceutical Company

In 2004, Karen Bartlett was prescribed the generic anti-inflammatory drug Sulindac, manufactured by Mutual Pharmaceutical, for her sore shoulder. Three weeks after taking the drug, Bartlett began suffering from a disease called, ‘toxic epidermal necrolysis’. The condition is extremely painful and causes the victim’s skin to peel off, exposing raw flesh in the same manner as a third degree burn victim.

Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward.

Now, nine years after the tragedy began, the US Supreme Court overturned the state court’s verdict and award. Justices cited the fact that all generic drugs and their manufacturers, some 80% of all drugs consumed in the United States, are exempt from liability for side effects, mislabeling or virtually any other negative reactions caused by their drugs. In short, the Court ruled that the FDA has ultimate authority over pharmaceuticals in the US. And if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.

Immediately upon the Supreme Court’s ruling, both drug manufacturers and Wall Street investors were celebrating. As one financial analyst pointed out, drug company profits should skyrocket going forward. Not only do the pharmaceutical companies no longer have to worry about safety or side effects, they are exempt from the multi-million dollar court-imposed settlements awarded to victims of their drugs.

One industry critic was quoted by Reuters after the verdict. “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 told the news outlet.

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.”

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.

Read the Full Story Here: http://www.whiteoutpress.com/articles/q32013/supreme-court-rules-drug-companies-exempt-from-lawsuits/

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