A dangerous legal shield for drug makers

- News Tribune

04/08/2008 - Let’s say a drug company hides damaging findings during medical trials of a new cholesterol-lowering drug. Unaware of those health risks, the federal Food and Drug Administration approves the product.

Later the drug maker’s deception comes to light. The FDA receives reports of a significant number of deaths associated with use of the new product. Years later, the FDA requires a stronger product warning about the risks involved in taking the drug.

Should the drug maker be immune to lawsuits simply because the FDA had approved the new drug?

A legal doctrine known as pre-emption, strongly backed by the Bush administration and the FDA, would say “yes.”

Where’s the justice in that, you may ask. That is a compelling question – one the U.S. Supreme Court should take to heart in a key medical liability case it is set to hear this fall.

Many legal experts expect the court to endorse the pre-emption doctrine, handing drug makers and manufacturers of medical devices such as pacemakers a huge legal victory – and a major setback to the legal tort industry.

Companies that allow the profit motive to trump full disclosure would be protected from the legal consequences of causing harm to consumers. And that’s not right.

The hypothetical scenario described above closely resembles the circumstances involved in a lawsuit against Johnson & Johnson over the health risks associated with its Ortho Evra birth control patch.

During trials of the patch, the company’s researchers discovered that it released far more estrogen each day than the amount the FDA considered safe. Higher doses of estrogen are associated with increased risks for blood clots that can cause heart attacks and strokes.

Johnson & Johnson did not fully disclose the finding to the FDA or call attention to a data “correction” a company researcher had made. Six years later, after reports of several dozen deaths associated with the patch, the FDA finally required a strong risk warning. Patch prescriptions fell by 80 percent.

The company, now facing lawsuits from thousands of users or their families, denies any wrongdoing. In any case, it contends, the FDA’s unilateral declaration of pre-emption in 2006 shields the company from legal liability.

Pre-emption proponents argue that the FDA is a better judge of the safety of health products than trial courts. Without it, they also contend, drug makers face a crazy quilt of differing state liability standards. Those arguments have some merit.

But the FDA itself has acknowledged more than once that it does not have the funding or the staff to provide adequate oversight of drug companies. Repeated instances of questionable conduct in drug trials have surfaced in recent years.

The Supreme Court, increasingly favoring industry in liability cases, may well uphold pre-emption as a matter of legal principle. But without an effective cop on the job at the FDA, that would also jeopardize the safety of American medical consumers.