If you owned a company that manufactured prescription drugs, what could be better than having complete immunity from legal action if any of your products caused harm? If you live in Michigan, that dream has already come true. But what if you are a consumer of prescription medications? Is it a good idea to give anyone, especially drug companies, absolute immunity? According to many Federal Courts, and possibly soon the United States Supreme Court, the answer is yes.
A recent New York Times article lays out the potential future of immunity for drug manufacturers, and the future is not bright for consumers. During litigation over the contraceptive Ortho Evra, it was determined Johnson & Johnson did not properly inform the public or the Food and Drug Adminsitration (FDA) about the actual amount of estrogen actually released by the Ortho Evra patch. In fact, Johnson & Johnson allegedly underreported the actual amount by nearly 40%. This only came to light after at least 50 people died, and more than 3,000 people suffered heart attacks and strokes.
It took the FDA six years to issue warnings about the dangerous levels of estrogen contained in Ortho Evra. After the labeling changed, sales of Ortho Evra decreased by nearly 80%. This prompted a number of lawsuits against Johnson & Johnson for causing harm and trying to cover up test results submitted to the FDA. Plaintiffs attorneys argue the drug manufacturers are taking advantage of an overworked and understaffed federal agency.
Defense attorneys for Johnson & Johnson argue the approval by the FDA gives them immunity from litigation, since Ortho Evra was approved for use. But does anyone really believe that federal approval is the same thing as ensuring the safety of any given product? Keep in mind the recent settlement over Vioxx, more than $5 billion. What about toys containing lead paint? These toys were supposed to be reviewed by a federal agency, but ended up in stores around the United States. Because of lax and ineffective national safety standards, many states are now passing their own safety requirements for children’s toys.
In a more perfect world, it would be nice to expect the drug manufacturers to be more forthcoming with problems about the drugs they are producing, and that the FDA would have enough money, time, and manpower to vigorously investigate each and every drug. Unfortunately, we don’t live in that fantasy land. Given the current circumstances, trusting the safety of drugs solely to the FDA would be foolish; in the event they mistakenly approved a drug, we the tax payers would be responsible for footing the bill. Why should we have to pay through the nose for drugs we don’t need, and then pay again when these “miracle” drugs cause more harm then good? If manufacture prescription drugs, it all makes perfect sense.