Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials

Does the learned intermediary doctrine apply in the context of a clinical trial?  According to the Southern District of Texas, it does.  The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case involving the death of a 19-year-old woman with terminal leukemia who died within days of receiving an experimental cancer drug as a participant in a clinical trial.

In 2015, Juno Therapeutics (Juno) was developing a treatment for advanced blood cancers involving Chimeric Antigen Receptor T-cell (CAR-T) therapy.  CAR-T therapy is designed to modify a patient’s white blood cells to target cancer cells with the goal of improving the patient’s condition so a bone marrow or stem cell transplant can be tolerated.  In October 2015, Juno entered into a Clinical Study Agreement with MD Anderson (and other hospitals) as part of a Phase 2 clinical trial (the “Rocket Study”) of a drug identified as JCAR015, a CAR-T therapy.  Drs. William Wierda and Michael Rytting were the principal investigators of the Rocket Study at MD Anderson.

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The Additional Cost of an Adverse Judgment: Illinois’ New Prejudgment Interest Act

Recent legislation will have a significant impact on the evaluation of personal injury and wrongful death cases across Illinois.  For many years, Illinois plaintiffs in personal injury and wrongful death actions have been entitled to statutory postjudgment interest, currently at a rate of 9% per year. (735 ILCS 5/2-1303(a)). Prejudgment interest, however, has not been available under the Illinois judgment interest statute. That is about to change. The Illinois legislature recently passed Senate Bill 72, the Illinois Prejudgment Interest Act, which goes into effect on July 1, 2021, and imposes prejudgment interest on defendants at a rate of 6% per year.

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The Prison Litigation Reform Act – A Product Liability Statute in Disguise

United States prisoners file an inordinate number of often frivolous lawsuits. In federal district courts alone, prisoners filed more than 28,000 last year. With time on their hands, and influenced by plaintiff attorneys’ advertisements and/or sensational media coverage of multimillion-dollar personal injury verdicts, many prisoners pursue baseless product liability actions. Their goal: winning an outsized verdict or, at least, a quick, nuisance-value settlement. They have had little to lose. Yet, defendant pharmaceutical companies are forced to litigate these cases, faced with the attendant costs of often-complicated inmate discovery. Many judges and/or magistrates, perhaps influenced by civil rights concerns, sometimes bend the rules of Civil Procedure for pro se prison plaintiffs. The result: Expensive litigation of often meritless lawsuits with virtually no chance of collecting costs as a prevailing party.

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FDA Solicits Feedback to Create Consistent Process for Labeling Devices

The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20, 2021, the FDA published a discussion paper titled Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework. With a goal of stimulating discussion among stakeholders, the paper outlines several factors to consider for labeling devices so that providers can make well-informed decisions about which devices may be most appropriate for their patients.

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Two District Courts Focus on “Gamesmanship” in a Double Dose of Rejection for Snap Removal

Faegre Drinker’s snap removal team closely monitors snap removal updates across the United States (for a basic explanation of snap removal and previous updates, see Faegre Drinker’s prior posts here; for a breakdown on which jurisdictions allow snap removal, see Faegre Drinker’s interactive snap removal map here).

In two recent decisions out of the District of Maryland and the Western District of Washington, both courts emphasized “gamesmanship” as a reason for rejecting the practice of snap removal in each jurisdiction. Interestingly, though, one district focused on gamesmanship by plaintiffs while the other district focused on gamesmanship by defendants.

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Summary of HB1125: Deceptive Lead Generation

Lawsuit advertisements—specifically ones that target prescription drugs and medical devices—can be dangerous.  Nationwide, dramatized and exaggerated legal ads have flooded both televisions and the internet, often masquerading as “medical alerts.”  Some estimates have total spending on legal advertisements at around $1 billion annually.  As a result, state legislatures are beginning to take action to combat deceptive advertising and come up with solutions, including in Indiana, which recently passed House Bill 1125.  House Bill 1125 places several limitations on the practice of lead generation – the use of commercial communications to initiate consumer interest or inquiry into legal services intended to redress an alleged injury from a medical device or legend drug – and provides a private right of action for manufacturers and sellers of medical devices and legend drugs against deceptive lead generators.

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