Showing 7 posts in Pharmaceutical & Medical Device Litigation.
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
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?
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 »
As the world nears the end of the second decade of the twenty-first century, it should not come as a surprise that Artificial Intelligence (“AI”) will continue to impact a variety of business sectors. For proper context, AI has thus far been utilized primarily within consumer goods and technological sectors by familiar corporations such as Amazon, Apple, and Google. However, less familiar corporations in other business sectors have not been standing idly by. In the March 31st, 2018, issue of The Economist, the authors reported that in 2017, companies spent $22 billion dollars, 26 times more than they had in 2015, on AI-related mergers and acquisitions. Corporations, insurers, and attorneys that work in both the healthcare and life science industries would be wise to keep an eye on the next healthcare merger. The long-term benefits of AI in healthcare may be similar to the benefits that it has had on other sectors: lowering costs to consumers, creating a more efficient stream of services, and providing people with the ability to make more informed decisions. More »
LIFE SCIENCES CLIENT ALERT: Seventh Circuit Reverses $3 Million Judgment Against GlaxoSmithKline Citing Preemption
A three-judge panel for the Seventh Circuit reversed a verdict awarding the widow of a Chicago attorney $3 million following the death of her husband. Wendy Dolin alleged drug manufacturer, GlaxoSmithKline LLC (“GSK”), was negligent in failing to warn consumers about the potential increased risk of suicide associated with the drug Paxil.
In 2010, Mr. Dolin was prescribed Paxil, the brand-name of the drug paroxetine manufactured by GSK, for the treatment of his depression. Mr. Dolin’s prescription was filled with a generic form of paroxetine manufactured by Mylan, Inc. While on paroxetine, Mr. Dolin committed suicide. Mr. Dolin’s widow brought suit alleging that Mr. Dolin’s suicide was a result of GSK’s failure to warn that Paxil was associated with increased risk of suicide in patients over the age of 24. Mrs. Dolin filed suit against Mylan and GSK in state court, but the matter was removed to the Northern District of Illinois by GSK. At trial, Mrs. Dolin advanced a new theory of liability where brand-name drug manufacturers, who have control over prescription drug formulas and labels, are held liable for injuries caused by taking generic forms of the drug, also known as innovator liability. After a jury awarded Mrs. Dolin $3 million in damages at trial, GSK appealed to the Seventh Circuit arguing Mrs. Dolin’s state law failure to warn claims were preempted by federal law and that GSK owed no duty of care since Mr. Dolin took a generic form of paroxetine rather than the brand-name drug, Paxil. The Seventh Circuit ruled that that GSK should not have been held liable since Mr. Dolin did not ingest the brand name prescription medication and because Mrs. Dolin’s state law failure to warn claims were preempted by federal law. More »
LIFE SCIENCES CLIENT ALERT: The FDA and the Digital Age: FDA Releases Guidances on the Proposed Limits of its Regulation of Digital Health Technologies
In an effort to encourage innovation and bring efficiency and modernization to regulation, the U.S. Food and Drug Administration (FDA) has issued draft guidance documents that define the types of software functions that the FDA will not regulate. These documents come in response to the 21st Century Cures Act (Cures Act) which was legislation that removed certain low-risk health software from the jurisdiction of the FDA. These guidance documents represent clarity from the FDA regarding the applicability of FDA regulations to digital health technologies. To be clear, the FDA’s policy structure in this subject area is a work in progress. More »
Marking a potentially dramatic new direction, on December 18, 2017, the U.S. Food and Drug Administration (“FDA”) issued a press release and Draft Guidance announcing a new proposed enforcement policy regarding homeopathic drugs. If finalized, the new enforcement policy would change the existing compliance policy focusing on labeling requirements which has been in effect for about 30 years. The changes come about a year after the FDA found homeopathic teething products containing belladonna did not accurately state the actual amount of belladonna in the products and after some teething products were allegedly linked to reported injuries and deaths in children. More »
In other articles, we have discussed the importance of obtaining social media data in pre-suit investigations and how to conduct social media discovery in pending litigation. As we discussed there, photographs, video and the like information can all be used for evidentiary purposes to demonstrate state of mind, the existence of mental or cognitive disabilities (or the lack thereof) and the level of activity enjoyed by a litigant. In those articles, we have focused primarily on recovering such evidence from Facebook since it is one of the most prevalently used social media platforms and permits users to download (at least arguably) the most helpful data. However, Facebook is not the only source of social media data and any thorough investigation should also involve identifying and requesting photographs, video, status updates or comments from other social media platforms. More »
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- 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
- Remote Jury Selection by Video Conferencing
- Illinois Appellate Court Eliminates Key Defense to BIPA Claims
- 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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