The April 6th edition of the New York Times reports that the Supreme Court is leaning towards a legal argument called “pre-emption” that would prevent companies from being sued for product liability once that product is deregulated by a government agency, in this case the FDA. Excerpt from article:
“For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.
But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.
This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.
The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.”
The courts leaning this direction will have obvious ramifications in the world of GMO’s as well. Transgenic crops are regulated by a ragged, moth-eaten quilt comprised of the EPA, FDA, and USDA – with all agencies acting separately and no interdepartmental communications. Each agency, as in the case with the FDA in this Johnson & Johnson suit before the Supreme Court, depends only on REPORTED testing from the companies seeking deregulation. If Monsanto or Bayer or J&J say their evaluations are positive it gets a gold star and the product goes out to the public. Not surprising with the revolving door between government agencies, the university community, and corporations. The regulatory agencies require no independent studies. “We’ll take your word for it.”
Now, when a product turns out to have a negative ramification, for example contaminating a neighbor’s crops with transgenic pollen and making them non-marketable, the companies can say – “Hey, the government approved it. Tough luck.” Even if you believe that there are useful biotech applications in crops, what ethical person can support a zero liability approach to any product, one in which we take the word of corporations as the gold standard? We as a public deserve better than this. Or maybe we should manage other public entities in the same manner. The DOT will just ask you to sign a statement saying you read the rule book and know how to drive. And do we really need contractors to get building permits and have inspections? I mean who would really build a substandard apartment complex for low-income persons just for the money?
Have we really gone this far towards a pro-corporate, anti-public, perilous and unethical regulatory climate? Undoubtedly. Paranoia? No. How many cases do we need to read about before we recognize the FDA, EPA and USDA are not doing their job? Do we allow our local institutions to behave so poorly? We need to demand that senate and congressional representatives investigate the irresponsible behavior of our federal agencies. If the courts back the agencies with pre-emption, the only way to protect ourselves is with complete reform of the agencies. As my Sicilian grandmother used to say when I tossed my toys about the living room without concern for her tripping on them: BASTA! You make the mess – you clean it up! Now!