Photo of Litigation Blog Mitchell P. Morinec mmorinec@smsm.com
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Mitch Morinec is a shareholder in the Chicago office of Segal McCambridge Singer & Mahoney and serves as chair of the firm's Life Sciences Practice Group. Mr. Morinec …

Showing 4 posts by Mitchell P. Morinec.

Illinois Appellate Court Says the Learned Intermediary Doctrine Does Not Shield a Device Manufacturer from Liability When a Doctor is Deceived About a Device’s Prior Testing and Suitability

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On Friday, October 30, the Appellate Court of Illinois, Second District, held that the Learned Intermediary Doctrine, which protects medical device manufacturers from liability if they provide physicians with proper warnings, does not shield product manufacturers from liability in situations where the physician is deceived about the subject device’s history of testing and suitability. 

The facts of the case are bizarre, to say the least. The Plaintiff allegedly suffered injuries to her left eye during a relatively routine cataract lens replacement procedure. Prior to the procedure, a sales representative for Defendant/Appellee Johnson & Johnson Surgical Vision, Inc. (“JJSVI”) allegedly brought a prototype lens injector device manufactured by another device company and showed it to the doctor prior to a day of surgical procedures. The Plaintiff alleged that the JJSVI sales rep knowingly misrepresented to the doctor that this prototype device had been approved by the Federal Food and Drug Administration and was being used by other physicians with great success. The doctor allegedly believed the JJSVI sales representative and used the prototype device on the Plaintiff that same day causing injury.  More »

What is Amy Coney Barrett’s Record on Federal Preemption and What Does it Mean for Future SCOTUS Rulings in Drug and Medical Device Litigation?

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Federal preemption has been the subject of numerous SCOTUS drug and medical device decisions in the past decade.  Several recent decisions have had a profound impact on liability in drug and device litigation cases.  With Amy Coney Barrett confirmed by the Senate and sworn on to the Court on Monday night, it is important to look at her record on federal preemption and how her addition to the Court might impact future rulings in this critical area of life sciences law.

I. Federal Preemption

The doctrine of federal preemption of state laws is rooted in the Supremacy Clause of the United States Constitution, which states that federal law is “the supreme Law of the Land...anything in the Constitution or Laws of any State to the Contrary notwithstanding.”  Essentially, preemption means that if state and federal law directly conflict, then state law must give way.  In making a determination on preemption, courts are to consider whether federal intent is to completely regulate the subject matter.  More »

Will Drug and Medical Device Manufacturers Combating COVID-19 be Subject to Tort Liability?

In an effort to combat the COVID-19 pandemic President Donald Trump has invoked the Defense Production Act (“DPA”), specifically ordering General Motors (“GM”) to manufacture ventilators. Of course, GM does not normally produce ventilators. Just this week the President, threatening to invoke the DPA, reached an agreement with 3M Company as to where and to whom it would deliver its protective face masks. As the number of diagnosed cases and deaths increase in the United States, it is likely that other companies will be under executive orders to produce products outside their areas of expertise. The DPA is a powerful law that was written in the spirit of the industrial mobilization that the United States implemented during World War II and could very well help to carry us through this pandemic. But what will happen if one of GM’s ventilators contains a manufacturing defect? What if a drug or medical device company under executive orders produces a product that harms a patient, medical treater, or someone else? Can those companies be subject to liability? The answer lies in the interplay between the DPA and the Public Readiness and Emergency Preparedness (“PREP”) Act. More »

LIFE SCIENCES CLIENT ALERT: United States Supreme Court holds that the judge, not the jury, makes pre-emption determination in failure-to-warn pharmaceutical cases.

It is the role of the district judge—not the jury—to determine if the FDA would have approved a drug’s warning label that state law requires when deciding whether a failure-to-warn claim is pre-empted, the United States Supreme Court held on Monday. The unanimous decision provides clarity to the high court’s “clear evidence” standard it introduced over a decade ago in Wyeth v. Levine, and resolves a split between the circuit courts in how to apply the standard. More »

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