By: Rubén Martinez, Ph.D.


Two critical features of the ideology of neoliberalism are the emphases placed on innovation and the time that it takes to get products to market in today’s economy.  Innovation is emphasized as important for societal adaptation to change and critical for economic competitiveness and growth.  Time to market, or speed, is always critical to market competitiveness. It  is a feature of capitalism that has intensified with neoliberalism’s globalization policies (i.e., trade agreements).  Both of these features of neoliberal ideology have become important rationales for the passage and implementation of new laws and policies over the past four decades.
One such policy is Michigan’s drug immunity law which protects manufacturers of prescription drugs from product liability under the State’s tort laws.  Passed into law under the leadership of Governor John Engler in 1995, the law, also known as the drug shield law, became effective in 1996 and made Michigan the first and only state to have such a law.  Since then similar laws have been proposed and rejected in other states.  For example, a similar law was proposed and rejected in Wisconsin in 2011 that was based on a model law proposed by the American Legislative Exchange Council, an ultraconservative non-profit organization funded by major corporations.  What the law does is protect prescription drug manufacturers from lawsuits by persons who were harmed by a particular drug while, at the same time, putting public health and safety at risk.
The 1995 law in Michigan revised the Judicature Act of 1961 and today is codified in section 600.2946, which addresses product liability action and specifies admissible evidence.   It states, for instance, that:
[a] “manufacturer or seller is not liable unless the plaintiff establishes that a product was not reasonably safe at the time the product left the control of the manufacturer or seller, and that…a practical and technically feasible alternative production practice was available that would have prevented the harm without significantly impairing the usefulness or desirability of the product to users and without creating equal or greater risk of harm to others (Sec. 600.2946, subsection 2). …Evidence of compliance or noncompliance with a regulation or standard not relevant to the event causing the death or injury is not admissible (subsection 4).
Products approved by the Food and Drug Administration (FDA) are seen as reasonably safe.  Actions exempted from the protections of the law are intentionally misleading the FDA to gain approval of a drug, which otherwise would have been disapproved under federal codes, and bribing FDA officials to get a drug approved.
In only one case has a plaintiff prevailed against a manufacturer, but it was on having to address a product in which it was difficult to draw the boundaries between a drug and a medical device.  That case involved the narcotic pain drug fentanyl delivered through a transdermal pain patch made by Mylan Inc.  The case involved the death of Beth Ann Kelly, and her estate sued Mylan alleging that her death was caused by the fentanyl patch device.  Mylan argued that it was immune from suit under Michigan’s immunity law, and the judge determined that fentanyl was a drug rather than a medical device and dismissed the case.  
However, on appeal, the Sixth Circuit Court held that the patch appeared to have both a mechanical and a chemical function, and that if such was the case, the manufacturer was not immune under Michigan’s drug shield law.  The Court, however, was not prepared to decide whether or not the fentanyl patch was a “combination product,” but it rejected the lower court’s decision and remanded the case back to the District Court to determine if the fentanyl patch should be viewed only as a drug with regard to Michigan’s immunity law.  And to do so within the frame of the Circuit Court’s decision.
What were the rationales given to the citizens for the enactment of Michigan’s drug shield law?  The historical record shows that Governor Engler had a history of supporting restrictions on the rights of consumers and calling for limits on the legal rights of consumers injured by products.  In the case of the drug shield law the public was told that the law would reduce frivolous lawsuits and move drugs approved by the FDA to the market faster, and consumers would thereby be the beneficiaries.  
The law, the public was also told, would reduce the cost of prescription drugs and at the same time save and protect jobs in the state.  However, costs did not and have not gone down, and the company the law was intended to protect at the time, Upjohn Co., a Kalamazoo-based pharmaceutical company, merged with Pharmacia and moved its headquarters out of Michigan, cutting hundreds of jobs in the process.  In April 2000, Pharmacia & Upjohn completed a merger with Monsanto and Searle, and when another merger occurred with Pfizer in 2003, over a thousand more jobs were cut in Michigan.  Moreover, in 2009, Pfizer had $2.3 million levied as penalties for criminal and civil violations tied to the illegal marketing of its products.  At the time the drug shield law was passed in Michigan, not everyone was, and today not everyone is, sold on the rationales that were given.
The Michigan drug shield law has been controversial since its enactment, raising important questions about consumer rights and public health.  Moreover, implementation of this law occurred as neoliberalism was reducing the size of government agencies at the federal level, not to mention state government agencies.  In particular, the FDA, like many other federal enforcement agencies, suffered substantial budget cuts, eroding its scientific base and limiting its capacity to provide a stringent approval process that protects the nation’s citizens.  Further, with regard to drug approval, the FDA has implemented an “accelerated approval” process that may not provide enough time to see some negative effects.  This is occurring under a political climate in which there is great pressure to get prescription drugs and medical devices to market as quickly as possible.
As in other societal sectors, neoliberal policies are generating tensions between public health and commercial interests.  Michigan’s drug shield law essentially prevents litigation that reveals risks that were not identified by the FDA through its approval process.  Such litigation provides the FDA with a valuable feedback loop that enables it to better carry out its function, that of protecting public health and safety.  Further, without this important element within our tort system Michigan consumers are left without critical access to relief when they suffer personal injury from prescription drugs.
Consider, for example, the plight of Michigan consumers who have suffered severe personal injury from prescription drugs, yet they cannot seek relief through the courts.  Patients have suffered strokes and died after taking Vioxx, a prescription drug that ultimately was taken off the market because it radically increased the risk of blood clots, stroke and heart attack.  Or, consider the case of an adolescent who has a severe case of acne and treats it with Accutane, a prescription drug that has several negative side effects, including inducing ulcerative colitis and Crohn’s disease, lifelong ailments that limit the quality of life.  Those adolescents and their families do not have any legal recourse to relief under the drug shield law when they develop those side effects.
Efforts have been launched by concerned legislators to repeal this law, but in each case conservative legislators have defeated them, leaving Michigan the only state in the country in which residents cannot seek relief through the courts even as residents of other states are able to do so.  Today, readers may have noticed, pharmaceutical companies are providing a long list of potential negative side effects in their prescription drug advertisements.  Is that enough, however, to protect consumers and public health in Michigan?  Are innovations in new drugs and increased speed to market to be favored over consumer rights and public health?