Should Drug Manufacturers have immunity from legal liability if their drugs get FDA approval?
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Well for the health and safety of American consumers I certainly hope not. However, don't take my word for it, even top doctors at the head of the New England Journal of Medicine agree. According to a recent article in the Insurance Journal, knowledgeable medical experts familiar with the devastating side effects and damage caused by certain drugs pre-approved by the FDA (a la Vioxx), feel strongly that consumer lawsuits are a critical part of the necessary checks and balances in the system to keep society safe. Based on historical experience, it is clear these manufacturers have found a way to suppress or, more often than we would like to believe, simply hide key information from the FDA and consumers.
The system requires necessary protections; check and balances. One of those checks and balances is consumer litigation in order to discourage Chief Executives and Boards of Directors of major corporations who lose their moral compass and sadly choose the seductive path of profits over safety.
Surprisingly, but thankfully, the New England Journal of Medicine felt so strongly about the effort to shield pharmaceutical medical device manufacturers from liability, they filed an unsolicited brief with the United States Supreme Court in a case called Wyeth v. Levine. This is a tragic case where Diana Levine, a Vermont guitarist who developed gangrene and lost her right arm below the elbow after she was injected with Phenergan, a medicine for nausea. Levine sued the manufacturer, Wyeth, contending the company suppressed key information and neglected its duty to warn consumers that such injections could have horrific side effects. A Vermont jury agreed with Ms. Levine and awarded her almost $7 million dollars. Of course, Wyeth continues to appeal. Interestingly, Wyeth argues that, regardless of the complications from their product, they should be shielded from any liability because the FDA approved the drug.
Sadly, the Bush administration is supporting Wyeth's position. Fortunately, the good doctors at the New England Journal of Medicine know what most of us can figure out from our own common sense. The FDA is not staffed or funded adequately to review the massive amount of new drug submissions or the changes to existing drugs approved. Nor like any other oversight entity is the FDA immune from influence peddling and/or cronyism. In fact, most of the FDA’s funding comes from the pharmaceutical and medical device manufacturers. This is a cardinal example why the civil court system was designed by our fore fathers to protect us, us as in "we the people".
I have held a unique vantage point in the belly of the corporate beast for the past 20 years and while I already knew from a very young age that absolute power absolutely corrupts, I slowly learned absolute immunity is a recipe for an absolute disaster for consumers in the free market system. I had spent 20 yrs in the insurance industry and most recently 4 yrs in the legal system representing plaintiffs in their pursuit of justice. In the past I too have been lured by the elixir touted by many eloquent tort reformers who see stripping legal rights from consumers, or inserting arbitrary caps on the scales of justice as an answer to an occasional disturbing verdict. Unfortunately, most if not all don't ever have the full picture to even make that assessment. I too have had the deceivingly cool and refreshing tort reform Kool Aid close to my lips, but I have learned first hand that our jury system was, and still is, the right design. There is no need to tamper with what is still the best, albeit imperfect, system in the world.
To my tort reformer friends, rest assured, the ability to bring a law suit does not mean the plaintiff automatically wins. In fact, the statistics demonstrate quite the opposite. Also, understand both physics and the free market system applies equally on both sides of the fence. The civil prosecution or the proverbial "frivolous" case will leave a firm on the extinction chart right between the dinosaurs and the Dodo bird. The economics of prosecuting cases without merit sorts itself out by good old fashion economics. Have faith in your well founded core vocal belief of the "rugged individualism" of the American people; the very same people who serve as jurors to "call them like they see them". Trust me when I tell you that jurors are smarter than corporate executives, media talking heads and yes, even lawyers