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The U.S. Supreme Court is about to hear a landmark case that could result in a federal ruling that would essentially neuter drug liability lawsuits against drug makers in all states. Meanwhile, a group of doctors and academics fighting Michigan’s drug preemption law says a policy statement by Big Pharma’s industry lobby on the looming federal case is far less than transparent and straightforward.

A statement from the Pharmaceutical Research and Manufacturers of America (PhRMA) outlining why federal preemption for the drug industry would be good for the country is “false and misleading in a hundred ways”, says a prominent commenter at Ed Silverman’s Pharmalot blog.

A recent press release from PhRMA’s Senior Vice President Ken Johnson outlines the industry’s rationale for supporting preemption and a ban on state-level product liability lawsuits against drug makers. Lower courts should not try to second-guess the expertise of FDA regulators, PhRMA says, and FDA regs are all that’s needed.

But an informal group of doctors and academics, calling itself ‘Justice In Michigan’, says that the PhRMA release is basically smoke, mirrors, and lies in a series of comments at Ed Silverman’s Pharmalot blog. After reading Ed’s excellent blog, scroll down to see the Justice In Michigan comments. Speaking from the 13 years of experience with preemption in Michigan, the commenter states:

“. . . There is no polite way to say it, so I’ll just tell the truth: It is false and misleading in a hundred ways . . . [one] claim is: ‘State judges and juries may still levy damages against manufacturers that fail to comply with FDA standards.’ If preemption is upheld in the drug arena, that is horse manure.

“As has been explicated on Drug and Device Law — the premier site for lawyers defending preemption — plaintiff and juries that seek to make some case that manufacturers failed ‘to comply with FDA standards’ will be preempted by Buckman, the case which declares, in essence, that only FDA — not private legal actions — can make any claim based on whether a manufacturer was in compliance. . .

“PhRMA is, well, lying.”

Further down the page, the same commenter takes the PhRMA press release apart point by point — it’s too long to reproduce here, but a quick and very enlightening read.

According to a New York Times article last February, the government argues that the FDA competently oversees the drug and device markets, and should not be second-guessed by courts. But the Institute of Medicine, the Government Accountability Office and the FDA’s own science board have all issued reports saying poor management and scientific inadequacies make the agency incapable of protecting the country against unsafe drugs, medical devices and food.

Justice In Michigan was formed two years ago to try to get that state’s 13-year-old preemption law repealed. Michigan is the only state in the union to have a preemption statute, said to be a model of what could become federal law for the rest of the country if the Supreme Court finds in favor of preemption in the case Wyeth vs. Levine to be heard later this year.

So far, repeal of the Michigan law has remained out of reach. But recent surveys show 70% of the populace wants the law to disappear, and many lawmakers are close to making it happen.

Hank Greenberg, a co-founder of Justice In Michigan, is a social ethics lecturer and faculty scholar in integrated medicine at the University of Michigan Medical Center. Greenberg was interviewed not long ago by Ed Silverman about the Michigan preemption law. It’s a short, illuminating and highly recommended read for anyone interested in protecting this latest onslaught from the Bush government to annihilate America’s civil rights.

Emotionally-charged critics see federal preemption as anti-consumer, anti-patient-rights, even anti-democracy. But the issue really concerns the ability of a seriously underfunded and understaffed, politically-absorbed and industry-pervaded FDA to do the job that Congress charged with 70 years ago.

In a blog last week I addressed for the first time the issue of federal preemption, and the role that the U.S. Supreme Court is expected to have in deciding whether preemption will become the law of the land.

Preemption is the legal concept that federal (FDA) approval of a drug’s labeling or safety supersedes any claims of inadequacy or error made in a state court.

On Nov. 3, the Court will hear Wyeth vs. Levine, a federal appeal from drug-maker Wyeth Pharmaceuticals arguing that preemption protects it from a Vermont case that awarded $6.8 million to Diana Levine, a musician who lost her right arm below the elbow after being administered Wyeth’s anti-nausea drug Phenergan. Even though the drug’s label complied with FDA requirements, Levine claimed — and the court agreed — it inadequately warned of the dangers of a particular method of administering the drug.

Wyeth, the FDA, and Big Pharma in general argue that federal regulations are the final word on safety and effectiveness. On the flip side, a host of experts all arguing that Congress did not intend to displace state law through the 1938 Food, Drug, and Cosmetics Act that gave the FDA authority to regulate drug labeling and safety.

Many point out the FDA’s long history of failure to ensure proper safety and labeling. For example, a brief to the Court from the editors of the New England Journal of Medicine devotes an entire section to the subject, entitled “THE FDA’S LIMITATIONS AS THE SOLE MONITOR OF PHARMACEUTICAL RISKS ARE ILLUSTRATED BY DRUGS THAT HAD TO BE WITHDRAWN FOR SAFETY REASONS” — which then goes on to list drug withdrawals and other FDA failures.

And a brief from two former FDA commissioners, Dr. Donald Kennedy and Dr. David A. Kessler, eloquently argues against preemption, in particular citing the agency’s woeful lack of success, and Congress’s history of acceptance of the no-preemption status quo:

“In the face of the long and unbroken history of ‘failure-to-warn’ litigation over drug products, and Congress’s refusal to add a preemption provision to federal law, this Court should be especially wary of taking a step that Congress has refrained from taking.

“There can be no question that Congress is well aware of the dynamic between state failure-to-warn litigation and FDA regulation of drug labeling. And there can be no question that Congress has decided that the two systems ought to co-exist, notwithstanding any tension that might arise, because the benefits of permitting the systems to operate in tandem outweigh any costs that might be incurred. That decision is plainly one that Congress is empowered to make.”

Now, says Ed Silverman in his Pharmalot blog, an “ad-hoc group of individuals — who, we are told, coalesced while discussing the topic here at Pharmalot — have posted an Internet petition in hopes of generating enough public awareness to stir a societal debate and, possibly, influence the decision-making this fall.”

In recent years, the agency has grown increasingly underfunded and understaffed, and thereby increasingly unable to do the job. And until Congress provides significant additional support, it will never be able to. State-level tort law, which provides the balance needed to help protect American physicians and consumers, would be rendered powerless by preemption.