Last April (2008) we reported that the U.S. Supreme Court would be deciding in the next term whether drug companies could claim “pre-emption” from lawsuits for the consequences of their products. The concept lays all responsibility on the federal agency that approved the product, in this case the FDA. (See “FDA as final authority? U.S. courts may exempt pharmas from liability” April 15, 2008)

The court, by a 6-to-3 vote, upheld a Vermont jury verdict of $6.7 million in favor of a musician whose arm had to be amputated eight years ago after she was injected with an anti-nausea drug. Wyeth, the drug’s manufacturer, had argued (and lost in two state courts) that it had complied with FDA labeling requirements and, therefore, should be exempt from injury suits.

And the prognosis wasn’t looking positive for the patients/consumers. State and federal court decisions had been ruling in favor of corporations, not consumers. Last year, in Riegel v. Medtronic, the Supreme Court ruled by 8-1 that many state suits concerning injuries caused by medical devices were barred by the express language in a federal law. This case, Wyeth v. Levine, implied pre-emption, a different legal standard. The court’s decision said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators.

Supported by the Bush administration, drug companies and other businesses had hoped this Vermont case would establish broader protections, relying on implications from federal regulatory standards and policies. (Apparently, the Republican party doesn’t want Big Government –unless it protects their profits from injured consumers.)

Historically, the FDA has regarded state injury law suits as a useful complement to federal regulation until a recent change in policy under the Bush administration. Justice Stevens wrote in the majority opinion that the agency reversed that longstanding policy not withstanding the agency’s “limited resources to monitor the 11,000 drugs on the market.” Apparently knowing the shortcomings of the agency, Justice Stevens called this shift “a dramatic change in position” in 2006.

Why the FDA can’t be trusted
Congressman Bart Stupak (D-Michigan) advised the Obama administration not to fill the FDA Commissioner position with any current senior FDA employees. Stupak should know. From his position in the House Committee on Energy & Commerce he reported in PharmaTimes (a U.K. publication, which gives the issue some balance not found on the American side of the Atlantic): “The subcommittee’s investigations revealed how the current FDA senior management blocked clinical trials, drove dedicated medical professionals out of the agency and lined their pockets with outrageous bonuses.” CBS News reported the last point.

According to the NY Times, “A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money.” FDA commissioner, Andrew C. von Eschenbach, acknowledged in February (2008) that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.” No kidding.

Lawsuits reveal pharmas lie to the FDA
“In the last decade,” the NY Times reports, “suits over Zyprex, the withdrawn pain pill Vioxx, the withdrawn diabetes medicine Rezulin, the withdrawn heartburn medicine Propulside and several antidepressants have shown that companies played down the risks of their medicines and failed to disclose clinical trials to the public even as they have aggressively marketed their drugs.”

A spokesman for Merck, disappointed at the Wyeth v. Levine decision, told the NY Times, “We believe state courts should not be second-guessing the doctors and scientists at the FDA.” Indeed, it’s usually in the discovery process of those court cases that the obscured, fudged, and massaged data on the safety of drugs are brought to light. Too late for the injured and deceased patients.

One million annually injured or killed by pharmas
If any other industry wrecked as much havoc on the nation we would surely shut it down. The figure of 100,000 deaths annually due to the contraindications of drugs is widely known. When I first reported that in 2002, I asked what was the figure for those injured by drugs but who survived (maimed or not). My answer was provided by a study published in JAMA in October 2006. A study of American hospital ER visits found that 700,000 emergencies annually were due to interactions or contraindications of pharmaceutical drugs, and the researchers suspect that number is significantly underestimated because most ER visits are undiagnosed or misdiagnosed. These were just the known drug related cases.

Consumer Alert to next pharma move
Industries as varied as producers of antifreeze, fireworks, popcorn, cigarettes and light bulbs have argued that federal regulatory oversight should be their shield against consumer law suits. After this Supreme Court decision this argument is likely to work only if there is express language in a Congressional statute or a specific regulatory action that makes compliance with state requirements impossible. I can see the pharma lobbyists sharpening their pens to draft Congressional statutes to press on Congressional representatives. There probably is at least one whose sympathy isn’t with the one million annual victims.

As I always say, make drugs the medicine of last resort, the alternative medicine, after using homeopathic, herbs, etc. so that you or your loved ones aren’t among the one million headed to the ER or to the grave.

Salud!
Beverly A Jensen, Ph.D.
President, www.WomensMedicineBowl.com