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Federal Preemption - Part VI - As a doctor should I be concerned?

By Steve Lombardi

Doctors unfortunately have much to lose with federal preemption. Doctors are put in a vice between the drug companies and their patients. While the FDA approves drugs for patient consumption, doctors exercise judgment to do what will not harm the patient. When they prescribe drugs for the patient it is with the understanding that the PDF warnings are complete. It’s the doctor who has to look the patient in the eye with continued treatment. So when the FDA research is incomplete or misleading often the doctor is shortchanged by giving advice that is faulty. Ultimately the patient suffers with adverse reactions of conditions that affect their lives.

In the case of the diet drug controversy most doctors didn’t warn they patients of heart valve problems because they weren’t informed the combination of diet drugs being prescribed was thought to be safe; when in fact the drug manufacturers knew otherwise. And why didn’t the FDA warn the doctors? And of those patients who suffered the consequences who had to take care of them long term or worse to bury them?

And in the case of VIOXX, pulled by Merck & Co. in 2004, why didn’t the doctors know that it increased the risk of a patient suffering a heart attack or stroke?

And when Bayer withdrew Baycol in 2001 because of muscle damage in patients where was the FDA and the drug manufacturer.

Pfizer too Rezulin off the market in the year 2000 due to liver damage in patients taking it.

And Avandia was linked to osteporosis and bone loss.

The packaging for Heparin caused confusion with even health care workers resulting in overdosing the patients. Baxter decided they needed to recall the packages.

And then heparin from China was contaminated causing deaths in America. Patients had difficulty with breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure.

Food products using dairy products found its way from China with melamine causing kidney stones, kidney failure that resulted in deaths, mostly of infants using baby formula.

“The 1976 law arose out of the Dalkon Shield disaster. Like all medical devices introduced before 1976, the Dalkon Shield intrauterine device underwent no premarketing assessment of safety or efficacy by any federal agency. In the wake of the thousands of deaths and serious injuries caused by the device, Congress took action, empowering the FDA to regulate all medical devices. To avoid conflict with state laws that, given the absence of any federal oversight, had been enacted to regulate medical devices, the 1976 law included a section that preempted certain state-law requirements that differed from federal (FDA) requirements with respect to the safety and efficacy of devices. This section, 360k(a), was used for two decades to prevent the enactment of state legislation that might conflict with FDA regulation.”

A Pivotal Medicine-Device Case, New England Journal of Medicine

In the end even the doctors agree that people need to be able to file state lawsuit claims against the drug manufacturers to insure continued accountability. The New England Journal of Medicine in its brief to the U.S. Supreme Court in Riegel vs. Medtronic, Inc. stated:

“The Food and Drug Administration is in no position to guarantee drug safety. Lawsuits serve as a vital deterrent and protect consumers if drug companies don’t disclose risks.”

Now you might not yet be convinced of the seriousness of this issue or that you should take time from your busy day to write or to think further about this issue. And that’s alright if you can live with the consequences of your inaction. If something does happen to you or to your spouse, it will be you who lives with the change in your lifestyle. At that point your neighbors other than saying how sad it is at your house probably won’t do much to help out. They too will go on about their busy lives doing what they always have done. So consider this in another context involving recent events. Just think about the loan crisis and how Wall Street used sub-prime mortgages with enormous risk, ahead of protecting your retirement savings. And Wall Street accepted those risks to make instant profits and multi-million dollar bonuses that lead to a financial crisis in this country not seen before. They did this at our expense.

“The decision of the justices in Riegel v. Medtronic will be critical for patients' rights and will have enormous impact on manufacturers' responsibilities and the safety of medical devices. Whether drug manufacturers might enjoy the same immunity that device manufacturers are claiming is a question that will also soon come before the Court. Next month the Court will hear a case (Warner-Lambert v. Kent)⁵ involving the diabetes drug troglitazone, which was withdrawn from the market in 2000 because of liver toxicity. The Court will be asked to decide whether FDA premarketing approval of the drug preempts liability claims in state court.^”

A Pivotal Medicine-Device Case, New England Journal of Medicine

Donna S. Riegel, Individually and as Administrator of the Estate of Charles R. Riegel, Petitioner, v. Medtronic, Inc.

If large companies will risk ruining this country for instance jackpot profit would a pharmaceutical CEO risk just a few ruined lives for the right to market a billion dollar block buster drug? I think you know the answer to this.

“If the Court expands the preemption doctrine and Congress does not rein it in, much closer scrutiny of the FDA's approval process will be required. Since the processes and judgments of drug and device manufacturers and the FDA will no longer be made public through litigation, all the documentation the FDA receives from manufacturers should be made available for scrutiny by the public and Congress. Safety data for drugs and devices should not be protected as trade secrets.”

The FDA, Preemption and the Supreme Court

New England Journal of Medicine

And if the current Administration believes regulation in any form is so bad that they will look the other way while the Wall Street crowd speculates on subprime borrowers with Main Streets retirement savings, will our government look the other way while a few seemingly insignificant lives are ruined? I think you know that answer as well.

Originally posted at InjuryBoard by Steve Lombardi

Full post as published by Des Moines Personal Injury Lawyer on October 11, 2008 (boomark / email).