Generic Drugs Protected From Litigation

By James Donahue

Most Americans are now covered by medical insurance that makes generic drugs the best if not the only choice when doctors prescribe medicine. But thanks to a recent ruling by the maverick "Gang of 5" on the Supreme Court, we swallow those pills at our own risk.

By the usual 5-4 vote, the high court ruled that drug companies that manufacture generic drugs are now exempt from litigation for fraud, mislabeling, side effects and accidental death. Only brand name drugs are subject to possible legal action if things go wrong.

The ruling is calculated to impact an estimated 80 percent of all drugs now sold in the United States. This means an estimated 240 million Americans are unprotected from the pharmaceutical industry, which statistically has been shown to be responsible for more preventable deaths than any other cause.

Don’t count on the U.S. Food and Drug Administration to keep you safe. Like nearly all of the federal departments (except the military) the FDA is suffering from financial cuts, is understaffed, and under pressure to accept new pharmaceuticals on the market and trusting the drug makers to have properly safety tested them. But the court ruling also protects the FDA from litigation because of bad generic drugs.

The court ruling states that the FDA has the ultimate authority over pharmaceuticals sold in the United States. And if this agency declares a drug to be safe, this takes precedent over whatever happens to the patient that takes the drug.

What is especially troublesome about this ruling is that about 80 percent of prescription drugs consumed in the United States are now manufactured in China or India. This has lowered costs, but it raises questions as to just how safe the drugs are, and whether the FDA is keeping on top of the quality of those drugs before they reach the market.

Of court the five troublesome judges on the high court, Justice John Roberts, Samuel Alito, Clarence Thomas, Anton Scalia and Anthony Kennedy voted together in support of the ruling.

The case involved a suit by plaintiff Karen Bartlett against Mutual Pharma over the generic anti-inflammatory drug Sulindac. The drug was prescribed to Bartlett for her sore shoulder. But the side effect was a permanent skin disease called toxic epidermal necrolysis. It is extremely painful; it has the effect of third degree burns and causes the skin to peel away.

Bartlett brought suit against Mutual in New Hampshire, arguing that the drug company issued no warning about the possible side effect. She won her case in the state court and was awarded $21 million in damages. Mutual appealed to the high court and the case was overturned.