(Source: MIRS.news, Published 10/18/2023) The Senate approved, 30-8, legislation stripping pharmaceutical manufacturers of their 28-year-old immunity from product-liability damages for U.S. Food and Drug Administration-approved drugs.
As someone who's been working on repealing the 1995 Michigan Product Liability Act for several years, Sen. Jeff Irwin (D-Ann Arbor), sponsor of this term's SB 410, said he's been contacted by residents from across the state who claim to have experienced harm or a loved one's death in connection to a drug's effects.
"I would always encourage them to contact their lawmakers, to contact legal help because I'm not qualified to give legal help . . . but, it has always been a little bit sad knowing that at the end of the line, when they do reach that lawyer, what that lawyer is going to tell them is 'no, I'm sorry,'" Irwin told members of the media following today's Senate session.
He said as the pharmaceutical industry has grown to become a larger part of how residents receive healthcare, "the importance of passing a law like this to restore accountability and to restore access to justice has just grown over the years.”.
SB 410 was opposed in the chamber today by Sens. Joseph Bellino JR. (R-Monroe), Jon Bumstead (R-North Muskegon), Roger Hauck (R-Union Twp.), Michele Hoitenga (R-Manton), Mark Huizenga (R-Walker), Dan Lauwers (R-Brockway), Aric Nesbitt (R-Lawton) and Roger Victory (R-Hudsonville).
According to a scientific article featured in the National Library of Medicine, the cost for a drug to obtain FDA approval through experimentation and optimization can be between $1 billion and $2 billion.
Among the approximately 90% of drugs to be rejected from acquiring FDA approval after completing the first phase of experimentation, 40-50% were due to poor or lacking clinical efficacy and 30% were because of "unbearable toxicity." Last year, the FDA listed 37 new drug approvals.
"It still is very challenging for a resident to actually prove against a multibillion-dollar pharmaceutical company that they were harmed and that they deserve compensation," Irwin said. "It's already an uphill battle. There's already a presumption in the law that these drugs are safe, and for residents to actually prove that they're unsafe, and prove that the company engaged in negligence is very, very challenging."
During the Oct. 5 Senate Civil Rights, Judiciary and Public Safety Committee hearing, Division Chief Jason Evans of the Attorney General's office, said that when A.G. officials pursue legal action against pharmaceutical manufacturers or sellers to recover tax dollars, they use the Michigan Medicaid False Claims Act dealing with fraud instead of filing product liability actions.
For example, Evans said when then-Michigan Attorney General Mike COX attempted to recover state Medicaid dollars spent on Vioxx – the arthritis and acute pain relief drug that was linked to increased heart attack and stroke risks – head company Merck & Co. cited the immunity statute, which was, and remains, exclusive to Michigan.
"We responded by pointing out that our action was based on a totally different theory and statute than product liability. Nevertheless, the last and final word from the Michigan courts was that this difference ultimately didn't matter. In 2011, the courts concluded that the claims were similar enough to invoke the immunity law, barring claims against Merck," Evans said.
A report affiliated with the Yale School of Medicine found that nearly 32% of 222 drugs approved by the FDA from 2001 through 2010 were either withdrawn, flagged with a "black box" warning involving possibly fatal side effects or required an updated safety announcement concerning new risks.
The study, which was highlighted by NPR in May 2017, found it took a median of 4.2 years following a drug's initial FDA approval for newer serious safety concerns to surface, with issues more commonly being discovered concerning psychiatric and biologic drugs and drugs that acquired special "accelerated approval."
However, an opponent to today's legislation was MichBio, a membership-based life sciences association.
When asked on the MIRS Monday Podcast if Michigan has gained anything from its unique immunity statute, MichBio Chief Executive Officer Stephen RAPUNDALO said he believes it provides some stability within the liability realm for both drug manufacturers and others in the healthcare system.
"Remember, there's no drug out there that does not have some kind of risk. I don't care if it's an aspirin or an over-the-counter drug or a biologic, every drug inherently has risks and it's the job of the FDA to ascertain that that benefit-risk ratio is appropriate for humans," Rapundalo said. "Just because they may have had an adverse effect, it would be very complex to prove that, in fact, the drug was (the culprit). It could be a lot of other things."
In other Senate news, the chamber unanimously approved SB 388 and SB 389, providing military members a five-year dormancy period to address properties overseen by the Uniform Unclaimed Property Act, like insurance payments or refunds or checking and savings accounts.
According to Ross Yednock, the financial services legislative liaison at the Michigan Department of Insurance and Financial Services, SB 388 and SB 389 will ensure military members who are serving overseas for longer than five years – and are part of a credit union – will not have their accounts closed due to inactivity.
The Senate also approved SB 351 by Irwin, prohibiting public accommodation and public service areas from banning someone from pumping breast milk. Before the bill passed 26-12, Sen. Michele HOITENGA (R-Manton) offered an amendment to change references to an "individual" expressing breast milk to a "woman" expressing breast milk.
"I must admit, this is not an amendment I ever thought I would have to offer in this Legislature. As far as I'm aware, women, specifically mothers, are the only people who can breastfeed or pump milk, and yet this bill removes the words 'woman' and 'she,'" Hoitenga said before her amendment failed 18-20.
Irwin asked colleagues to oppose the amendment, because SB 251 was about "supporting moms and babies, not about this simplistic culture war."
Sens. Thomas Albert (R-Lowell), John Damoose (R-Harbor Springs), Mark Huizenga (R-Walker), Ruth Johnson (R-Holly), Aric Nesbitt (R-Lawton) and Roger Victory (R-Hudsonville) joined Democrats in supporting SB 351.
