Michigan Pharma Shield Law Furthers Debate on FDA Preemption

The Michigan Legislature’s vote to repeal a one-of-a-kind law shielding drugmakers from liability lawsuits will force courts to balance consumer interests with the FDA’s authority, attorneys and drug industry groups say.

The measure (SB 410), which advanced out of the Michigan House and Senate with bipartisan support, would remove a portion of Michigan’s Product Liability Act that Democrats have long argued gave pharmaceutical companies a near-total defense against claims of injuries associated with products approved by the Food and Drug Administration.

Proponents of the legislation, which Michigan Gov. Gretchen Whitmer (D) is expected to sign into law, say it will put Michigan in line with product liability laws in other states. Even with a repeal, Michigan law would still include a presumption that a manufacturer or seller isn’t liable if the aspect of the product alleged to have harmed consumers was in compliance with relevant federal or state regulations.

But groups representing the pharmaceutical industry say the bill leaves it open to courts to interpret what consumers must show to overcome this presumption when arguing a company is liable for harm caused by an FDA-approved product. They argue this leaves uncertainty for the FDA’s safety monitoring authority, at a time when the agency’s decision making is also being questioned in a case on abortion medication before the US Supreme Court.

“A great amount of time and effort and resources are put into that FDA process of deciding what risks are backed by science, and how can we communicate those risks to doctors and patients,” said Cary Silverman, a partner at Shook, Hardy & Bacon LLP and counsel to the American Tort Reform Association. The organization, which pushes for changes to consumer tort laws in states, represents members of the pharmaceutical industry and other corporations.

“We think that process should be reflected when there are lawsuits that are essentially challenging the FDA decision making on those points,” Silverman said in an interview.

‘Unique Provision’

Michigan’s existing liability law, which is widely considered to be one of the strongest corporate liability shields in the country, dates back to 1995. Then-Gov. John Engler (R) signed it into law as a way to encourage pharmaceutical manufacturing and research in the state.

Michigan is home to Pfizer Inc.‘s largest manufacturing site. Other drugmakers that manufacture products in Michigan include AbbVie Inc. and Perrigo Co.

Since the law’s enactment, courts ruled in favor of drugmakers in several cases related to the opioid crisis and other prescription drug injury cases, including a $20 million lawsuit against Merck & Co. Inc. in 2011 over its previous anti-inflammatory drug Vioxx. Judges have cited a provision of the law that the legislation now seeks to repeal—a presumption that a drug manufacturer or seller isn’t liable if the drug was approved by the FDA and the drug’s labeling was in compliance with FDA requirements.

Michigan Attorney General Dana Nessel (D) has advocated for repealing the FDA provision of the state law, and said in a statement after the legislative passage that it’s been used “far too long to shield pharmaceutical companies from accepting responsibility when they knowingly defraud and harm the public.”

The bill, sponsored by Michigan state Sen. Jeff Irwin (D), keeps the law’s provision stating there’s a “rebuttable presumption” that a manufacturer or seller isn’t liable if “the aspect of the product that allegedly caused the harm was in compliance with standards relevant to the event causing the death or injury set forth in a federal or state statute.”

This language matches closely with the standard in neighboring Wisconsin, as well as other states across the country like Tennessee, Colorado, and Kentucky.

Federal Authority

A repeal means more product liability lawsuits are “inevitable,” said Silverman, who also testified against Irwin’s bill in an Oct. 25 hearing held by the Michigan House Judiciary Committee.

While the FDA typically doesn’t get directly involved in most state-level tort lawsuits involving FDA-approved products, the agency “feels strongly that it is and should be the only regulator of drug products in this country and is very protective of that role that Congress entrusted to it,” said Stacy Cline Amin, a partner at Morrison & Foerster LLP and former chief counsel at the FDA.

“It is counterproductive to their goal of promoting and protecting the public health to have state level litigation challenging products that FDA has reviewed extensively and determined meet FDA’s gold standards,” Cline Amin said in an email.

Irwin’s bill lacks details on what plaintiffs need to show to overcome the presumption protecting companies from liability, leaving it open to broad interpretation, Silverman said. He said provisions similar to what’s in Texas law would have been helpful here.

In the Lone Star State, plaintiffs may challenge the presumption that FDA-approved products are safe if they demonstrate a company took actions like withholding required information from the FDA or promoting the product for an indication for which it wasn’t approved by the agency.

The Michigan Manufacturers Association has taken a similar position, writing in testimony to the House Judiciary Committee that the role the FDA “plays in reviewing, assessing, and approving the safety of a pharmaceutical drug cannot be understated.”

One of several pharmaceutical companies in favor of amending the legislation said in an email that Irwin’s bill wouldn’t achieve a balance between ensuring patients can seek recovery and making sure decisions on a drug’s safety are made by the FDA and supported by science.

The FDA chief counsel’s office declined to comment on the Michigan law. The Pharmaceutical Research and Manufacturers of America, which submitted a card to the House Judiciary Committee sharing its opposition to Irwin’s bill, declined to share additional comments on its position. Pfizer is a member of PhRMA.

For Irwin, the repeal isn’t about challenging the FDA’s authority, but ensuring consumers aren’t barred from securing compensation from injuries associated with pharmaceutical products.

“When someone is harmed by a product, in this case, a drug, they should be able to go into court and say, ‘Hey, I’ve been harmed and I deserve compensation,” Irwin said in an interview.