Thursday, February 28, 2008

Michigan drug immunity law: Court access blocked, promised economic benefits not realized, says new report

Michigan's drug immunity law received some national attention today in a report released by the Center for Justice & Democracy in New York.

The report's key assertions: the law keeps residents harmed by dangerous drugs out of the courtroom and has not delivered any the economic benefits promised by the law's backers.

The heavily footnoted report, "A Tragic Blunder: Michigan's Drug Industry Immunity Law", concludes the law should be repealed:

"In 1995, under the leadership of then Governor John Engler, the Michigan legislature passed an unprecedented law that prevents its residents from gaining access to the civil justice system if they were harmed by dangerous drugs approved by the Food and Drug Administration (FDA), with the limited exception that the drugmaker did not withhold information from the FDA. Michigan is the only state in the nation that has a drug industry immunity law which allows drug companies to escape accountability in this manner.

"Over the last 15 years or more, as drug companies have had an increasing amount of influence over FDA decision-making and policy, the FDA has fallen down on its job of protecting the public. The result has been perilous for all Americans, with the news now replete with reports of drug industry marketing unsafe drugs to the public with the FDA's knowledge - Rezulin, Vioxx, and Trasylol, recently featured on
60 Minutes, to name just a few. Yet unlike the residents of any other state, Michiganders have no legal recourse should they be hurt by these or other dangerous drugs that the FDA failed to keep off the market.

"What Michigan lawmakers accomplished with this law is exactly what the pharmaceutical industry has been trying to accomplish unsuccessfully for the last three decades in Congress and state legislatures around the country - eliminating their liability for marketing unsafe drugs, and shielding them from responsibility when their harmful products hurt or kill.

"With the problematic nature of the FDA, it is clear that Michigan needs the protection of its civil justice system. This law undermines public safety, is devastating to many people in Michigan and needs to be repealed."
The report also discusses the promised economic benefits that were touted by the law's supporters:
"The Michigan Manufacturers Association, a strong pro-business lobbying group, has stated that it supported the drug immunity law in order to 'encourage companies - including pharmaceutical companies - to stay in Michigan.' The high-paying pharmaceutical jobs, however, began trickling out of Michigan even as Governor Engler was signing the bill into law.

"In 1995, the Kalamazoo-based pharmaceutical company Upjohn Co., the company the immunity law was meant to protect, merged with the Swedish company Pharmeacia Corp. After the merger, the new company moved its headquarters and cut hundreds of jobs in Michigan. In 2003, Pharmeacia & Upjohn merged with Pfizer and cut over a thousand additional jobs in Western Michigan.

"In December 2006, responding to an effort to repeal the drug company immunity law, the
Detroit News ran an editorial praising Pfizer for providing so many good jobs in the state. Less than a month later, Pfizer announced it was closing the Kalamazoo and Ann Arbor research and development facilities - a move that affected thousands of jobs in Michigan. A year later, the Ann Arbor site was nearly abandoned and hundreds of Pfizer employees and their families had moved out of the state."
In an editorial last Sunday, the Detroit News again took to the stump to support the drug immunity law:
"State lawmakers should abandon efforts to repeal the Michigan law, which protects drug companies that comply with standards set by the U.S. Food and Drug Administration (FDA) and whose products were tested and approved by the agency. ...

"The whole idea of the FDA is to set and enforce national standards, including rules for drugs and medical devices. As a result, U.S. health care is one of the most advanced systems in the world. New and exotic procedures and drugs save lives even though most all carry some risk.

"To the extent there's a problem with FDA procedures, it belongs to Congress and the agency itself. If stricter or looser rules are needed for a product line, both federal lawmakers and FDA officials can make that happen."
But according to the center's report, the Michigan Senate, which has resisted repeal efforts, has tacitly admitted the FDA's oversight leaves something to be desired.
"[I]n late January 2008, just hours before Governor Jennifer Granholm's State of the State address in which she expressed support for repeal, the Senate passed a non-binding resolution calling on the FDA to 'establish stricter standards for the drug approval process.' This was an obvious concession that the FDA was failing in its job, yet the Senate continued to support immunity for those harmed by the FDA's failures."
The repeal legislation is still awaiting a hearing in the Senate. See this post: The Michigan Lawyer: Drug immunity law: politicos jockey for position

No comments: