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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A Component Part Supplier’s Duty to Warn Following the U.S. Supreme Court’s Maritime Asbestos Decision

Under the Restatement (Third) of Torts: Products Liability § 5, Comment b (1998), the supplier of a product generally must warn about only those risks associated with the product itself, not those associated with the “products and systems into which [it is] integrated.”

However, in Air and Liquid Sys. Corp. v. DeVries, 139 S. Ct. 986 (2019), the Supreme Court created a different rule in the context of maritime asbestos claims.  In that case, the defendants produced “bare-metal” equipment, such as pumps, blowers, and turbines, for Navy ships that required asbestos insulation or asbestos parts to function as intended.  The manufacturers delivered the equipment to the Navy without asbestos, and the Navy later added asbestos to the equipment.  Two Navy veterans were exposed to asbestos on the ships and developed cancer.  The district court granted summary judgment for the manufacturers, finding no duty to warn.  In reversing, the Third Circuit Court of Appeals adopted a “more plaintiff-friendly” foreseeability rule, rejecting the “more defendant-friendly” bare-metal defense.

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Not All’s Well That Ends Well: The Seventh Circuit Misapplies Daubert, but Still Delivers a Victory

The nature of advocacy makes it hard sometimes for lawyers to focus solely on the outcome and the bottom line result.  How a court gets there may not matter much to the prevailing party in the dispute as they celebrate the win, but it may have an impact on later cases.  A recent example is the opinion in Burton et al. v. E.I. DuPont de Nemours and Co., Inc., 2021 WL 1422814 (7th Cir. Apr. 15, 2021).  The court found the winner’s circle, but it dented the car a bit along the way.

[Disclosure/disclaimer:  The author filed an amicus brief in support of defendants in the case.]

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Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim.  The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA).  Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines.  The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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Double Whammy: Fifth Circuit Affirms Dismissal of Suit Against Generic and Brand-Name Drug Manufacturers

Some product liability suits are dead on arrival. At least, that is the position the Fifth Circuit took late last week in affirming the dismissal of a pro se plaintiff’s suit against a collection of generic and brand-name drug manufacturers.

The case in question is Johnson v. Novartis Pharmaceuticals Corporation, et al., and concerns Mr. Johnson’s purported struggles with Peyronie’s Disease (PD), a connective tissue disorder that causes painful, bent erections, after he had ingested generic forms of the prescription drugs Minocin (an antibiotic) and Tegretol (an anticonvulsant).

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Preemption Torpedoes State Law Claims against Generics Makers in Zantac MDL

A judge in the United States District Court for the Southern District of Florida presiding over the In Re: Zantac (Ranitidine) Products Liability Litigation multidistrict litigation, MDL No. 2924, has held that state labeling and design defect claims against the makers, re-packagers, retailers, and distributors of generic forms for the popular heartburn medication Zantac were preempted by federal law.  The court subsequently dismissed these claims against 32 such Zantac generics makers and distributors.

The Zantac MDL was created by the United States Judicial Panel on Multidistrict Litigation on February 6, 2020.  The plaintiffs allege that ranitidine, the active ingredient in Zantac and its generic forms, breaks down into N-nitrosodimethylamine (“NDMA”), which is part of a group of compounds that have been shown to increase the risk of cancer. The plaintiffs allege a variety of product liability and related claims against the makers and distributors of Zantac and its generic forms under federal and state laws.

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