The US state of Michigan’s House of Representatives has voted to repeal an 11-year-old law which gives pharmaceutical manufacturers protection against “unreasonable” lawsuits.
The law was passed in 1996 as part of a package of tort reforms and has helped develop Michigan’s highly successful life sciences industry, which now includes around 540 companies, but critics claim that it has also meant that drug companies in the state have not been held to the same consumer protection standards as in the rest of the USA.
The 70-39 House vote for repeal means “we’re one step closer to making Michigan citizens no longer second-class citizens,” and making them “equal to the other 49 states in this country,” said the bill’s main sponsor, Democratic Representative Mike Simpson. “Michigan is the only state in the nation that gives pharmaceutical companies a free ride when their products harm or kill,” he added.
However, Republican Tonya Schuitmaker said the move was a “nail in the coffin” for jobs and affordable medicine in the state.
Repeal of the immunity bills has been a major priority for the Democrats since they took control of the House in January after eight years of a Republican majority. They say they have been trying to overturn the law since 2005, when claims by 187 state residents against Warner-Lambert, manufacturer of the diabetes drug Rezulin (troglitazone), were dismissed by a New York Federal Court judge because of the Michigan law. “The drug industry and its allies blocked every attempt to get these bills out of committee for nearly two years,” says Representative Paul Condino, chairman of the House Judiciary Committee.
The package of bills seeks to:
- repeal the 1996 law which gives manufacturers complete immunity from legal action so long as the drug in question has been approved for safety and efficacy by the Food and Drug Administration;
- make the repeal retroactive so that Michigan residents who claim to have been harmed by drugs since 1996 can seek legal recourse; and
- include big drugmakers in the Consumer Protection Act, from which they are currently exempted.
The legislation has been attacked by MichBio, the organisation representing the state’s life sciences industry, which claims that it “would create open season for our life science companies to look to more business-friendly states, and take their highly skilled workforce with them.” Since 1996, Michigan has been “been progressive in its balanced understanding of how best to protect consumers while demonstrating a positive business climate for life sciences companies,” according to MichBio’s executive director, Stephen Rapundalo. However, the state is already “bleeding life sciences talent” following Pfizer’s announcement to close its human health operations in Ann Arbor and Kalamazoo, he adds.
Moreover, Dr Rapundalo warns that making the repeal retroactive would “expose the industry to a backlog of product claims with a potential devastating impact that goes far beyond the pharmaceutical industry.” However, Representative Robert Jones, one of the 13 Republicans who voted for the reform package, said that only about 150 state residents would be eligible to make retroactive claims.
Also opposing the vote is the Michigan Manufacturers Association (MMA), which says it supports the current state law “because the exhaustive FDA approval process adequately protects consumers,” while Lisa Rickard, president of the US Chamber Institute for Legal Reform, described the move as “a giant step backwards” which will “discourage job growth in life sciences industries and will ultimately result in higher prices and fewer choices of life-saving medicines for all Michiganders.” She added: “only the plaintiffs’ lawyers stand to benefit.”
The bills will now go to the Senate, but it is not clear how they will fare there. However, the Kalamazoo Gazette quotes an aide to state Governor Democrat Jennifer Granholm as saying that she will sign the legislation if it is passed by the full legislature.