The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction to block the FDA from withdrawing a longstanding enforcement policy regarding homeopathic drug products.
Continue reading “New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal”
It’s no secret that the regulatory landscape of cosmetics and personal care products as we know it is changing. Over the last few years, Congress, along with industry and consumer groups, have made a combined effort to push for heightened regulation of these products. The latest effort, introduced in Congress on June 15, 2021, seeks to ban the addition of per- and polyfluoroalkyl substances (generally known as “PFAS”) in cosmetics and personal care products.
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.
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.
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.
Continue reading “The Prison Litigation Reform Act – A Product Liability Statute in Disguise”
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.
Continue reading “FDA Solicits Feedback to Create Consistent Process for Labeling Devices”
