Although the law ostensibly gives an exception to this immunity, to bring a case a drug company has to be found by the FDA to be guilty of criminal fraud charges as well as to have withheld information that would have necessarily resulted in the denial of approval for the drug. Despite many instances of drug withdrawals, and some egregious behavior on the part of drug companies, these conditions for the exception have not been met in at least the last 20 year. Instead of actual criminal prosecution, the FDA often alternatively takes the action of requiring a label or warning change, or simply prohibit certain dosages of the drug.

Indeed, there is an incredible array of appalling misconduct that cannot even hypothetically fall under the Michigan exception but which is usually held "unconscionable" and prohibited in other states including those with partial immunity.

As chronicled by Mr. Greenspan, Founding Board Member of Justice in Michigan, in his testimony to the state legislature, in Michigan alone there is no possibility at all of liability for any of the following types of misconduct:

"A company may submit raw data to the FDA, but the company's own interpretation of that data, and its potentially ominous significance, is left out. Or that company later acknowledges that an interpretation of data was faulty or incomplete. Or the most relevant safety data are present but camouflaged behind other data in a variety of ways, and certainly not red flagged."

"Deliberately misleading information about a drug is submitted, not to the FDA, but to physicians and the public."

"Negotiations over aiding or refining warnings on a drug's label are dragged out for months - not because of honest scientific disagreement, but because of pure market considerations."

"Going after academic researchers who question company claims, including the use of bald threat and intimidation."

"Manipulating endpoints and design studies after the fact in order to make the results look more favorable for the product than they were."

The 1995 law in question was passed by former Michigan Governor (and tort rollback champion) John Engler. John Engler is now the President of the National Association of Manufacturers (NAM), "the largest industry trade group in America, representing small and large manufacturers in every industrial sector and in all 50 states."

The rationale used to push through this one of a kind state law is both the promotion of business in Michigan, and an attempt to keep the cost of drugs down. However, this logic does not hold up to scrutiny.

Businesses making drugs in Michigan still ship their drugs to other states where the immunity does not apply. Therefore, having the immunity in Michigan will have little effect on businesses which manufacture drugs that are shipped nationwide. Indeed, the only real effect is to reduce the protections of residents of Michigan from unsafe drugs.

Moreover, even if drugs are cheaper when drug companies cannot be sued (an assertion that is far from certain), what use is a cheap drug that is dangerous and unsafe for human use?

The move by some members of the business community to reduce the ability of those harmed by unsafe products to have their day in court is especially unfortunate because they recently succeeded in reducing the safeguards previously put in place by the FDA.

"In 1994, after complaining about the spiraling costs involved in getting a drug approved by the agency, pharmaceutical companies convinced Congress to pass legislation forcing the FDA to approve drugs more quickly.

The legislation has enabled some groundbreaking new drugs, including some lifesaving new AIDS medications, to get on the market faster. But the changes have also resulted in the FDA overruling doctors who have legitimate concerns about safety. According to a 1998 survey by Public Citizen, for example, at least 27 drugs were approved during the late 1990s over the objections of the FDA's safety reviewers. Ten of them have been withdrawn from the market since Michigan's FDA shield law went into effect, including the diabetes drug Rezulin; the heartburn drug Propulsid; the painkiller Duract; and the anti-cholesterol drug Baycol." (click here for full article)

Pointedly, Vioxx, the drug responsible for the above tort victims injuries, was "fast-tracked" through the system FDA system.

Although laws partially shielding drug companies exist in Utah, New Jersey, Oregon, Colorado, and Arizona, none of these states grant complete immunity as in Michigan (although these state's laws should also be repealed).

While regulatory agencies like the EPA and FDA are a first line of defense against harms perpetrated by irresponsible people and corporations, they are one of two complementary lines of defense. The second is our civil justice system, and private suits by citizens.

As the former FDA Chief Counsel stated:

FDA's view is that FDA product approval and state tort liability usually operate independently of each other, each providing a significant, yet distinct, layer of consumer protection."

And as courts have held, an FDA determination:

"May be sufficient for federal regulatory purposes but still not be sufficient for state tort law purposes." - Witczak v. Pfizer (2005)

And that the:

"FDA does not shield a manufacturer from liability" - Witczak v. Pfizer (2005)

Please help Michigan residents receive the same protections as all other Americans so that miscarriages of justice like Dr. Cox and Ms. Richter can be avoided in the future. (to take action click here)

Moreover, please help yourself, because the threat of the application of this law in your state is very real. The anti-civil justice movement is attempting to get it pushed through all state legislatures. Please inform your friends and advocate to your legislators.

To see a complete listing of my previous posts on civil justice issues, click here.

If you are interested in taking action, email me to get more information on the status of the anti-civil justice system movement's efforts in your state.

Cyrus Dugger
Senior Fellow in Civil Justice
Drum Major Institute for Public Policy

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