Protect consumers' right to sue drugmaker
Legal action is a shield against lax regulators.
Sol Weiss is a lawyer with Anapol Schwartz in Philadelphia
Can you imagine what would happen if three jumbo jets crashed in one month? A thousand people dead. Uproar at the FAA. Planes grounded. Immediate comprehensive inspections of all aircraft. Congressional hearings and investigations. Everything possible would be done to immediately assure public safety.
But what if, within one month's time, a thousand people were seriously injured or died from a known side-effect of a prescription drug that, perhaps, should have never been on the market? In a recent case, nothing happened.
And, depending on how the Supreme Court rules in a case before it, individuals affected by such FDA-approved prescription drugs would have no right to sue, no right to hold a company accountable for a dangerous drug.
Consider the twisted saga of the drug Trasylol (generic name Aprotinin), used to prevent bleeding in heart-bypass surgery. Most people never heard of it until stories appeared on major TV networks recently.
Despite knowledge as early as 1993 from Bayer studies that Trasylol was toxic to the kidneys, the Food and Drug Administration approved the drug, and it went to market. What's worse, although the drug's initial use was for high-bleed bypass operations, the FDA in 1998 approved it for any type of heart bypass operation, triggering a rapid growth in its use, with an estimated 350,000 patients, often unknowingly, receiving it in 2005.
Yet the drug company and the FDA did little to investigate the problems with the drug. Not until Dennis Mangano, an independent researcher, published an article in the New England Journal of Medicine in 2006 demonstrating the higher risk of death from Trasylol than from cheaper generic drugs did the FDA issue a health advisory.
Bayer then decided to jump in, commissioning its own study to defend its product. Yet, even though Bayer had the study results, which supported Mangano, the findings and the study's existence were never mentioned at an FDA advisory committee meeting where a vote kept Trasylol on the market. You don't have to be on CSI to figure out the motives behind not mentioning your own study.
Another year and another FDA sign-off on this drug went by. Not until fall 2007 did an independent study in Canada prompt suspension of the drug - 14 years after the first red flags were raised. Mangano estimates that about 1,000 patients have died each month as result of Trasylol remaining on the market. One thousand a month, like three jumbo jets falling out of the sky every month.
The Trasylol story is just one of a dozen prescription drug stories we could tell.
You would think that if drug companies are not concerned about the FDA, they would be afraid of lawsuits. Wouldn't they ensure their products' safety before putting them on the market, so they would not be sued? If the FDA is not protecting the public well enough, at least individuals can sue drug companies and rely on their Seventh Amendment right to a trial by jury.
You would think so, but that's not the case anymore. After 40 years of supporting public health and safety, the FDA changed its position, now supporting an interpretation of the law eliminating an individual's right to bring a claim.
It's unbelievable to think that a court would accept this premise, but some have, explaining in great detail how the FDA should be in charge of protecting public safety. Yes, the same agency that ignored a red flag for 11 years and when reminded, took another year-and-a-half to evaluate, that same agency that does not want a jury of good citizens to do what the FDA was supposed to do. This issue, whether drug companies will have immunity from private lawsuits, is before the U.S. Supreme Court. Ultimately, if the Supreme Court decides that FDA regulations "preempt" your individual right to sue, you, the American citizen, have no options.
It's time for the public to rise up and demand Congress' action. It's time to take politics and lobbying out of the FDA. It's time that safety becomes more important than profits. Think about it. It's entirely possible that the FDA's delay on Trasylol resulted in four times as many deaths as occurred on 9/11. We need to do more than think about it.
|
