Michigan Passes Law against Federal Preemption

April 2, 2009
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

On March 26, the Michigan House of Representatives passed House Bill 4316, effectively repealing part of a 1996 law that provides drug companies immunity from liability lawsuits involving products that have been approved by the US Food and Drug Administration.

On March 26, the Michigan House of Representatives passed House Bill 4316, effectively repealing part of a 1996 law that provides drug companies immunity from liability lawsuits involving products that have been approved by the US Food and Drug Administration. The action stems from the recent Supreme Court ruling of the Wyeth vs. Levine case (see related ePT stories: Supreme Court Rules Against Wyeth in Federal Preemption Case and Wyeth Prepares for Supreme Court Preemption Case), in which the Court rejected the drugmaker’s claim that federal labeling requirements preempt those requirements at the state level (Vermont in this case).

The following is among the passages removed from Michigan's 1996 law: “In a product liability section against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug approved for safety and efficacy by the United States Food and Drug Administration….” Michigan’s passage of HB 4316 is retroactive to 1996, which means that people who have been injured by FDA-approved drugs since that time can file liability lawsuits against drug companies.

In a prepared statement, Michigan state representative Lisa Brown, who introduced the bill, claimed it would “empower [state] residents” and “give a voice to those who have suffered in silence for years.” Drug company organizations, including the Pharmaceutical Manufacturers and Researchers of America, have not issued a statement regarding this issue.