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.
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.
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.
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).
The Texas Supreme Court is set to determine whether Amazon can be considered a “seller,” and thus held liable, for a defective product sold through its website, in the case of McMillan v. Amazon.com, Inc., No. 20-20108, 2020 WL 7417454, at *1 (5th Cir. Dec. 18, 2020), certified question accepted (Jan. 8, 2021).
Amazon.com Inc. is the nation’s largest online retailer, selling and shipping millions of products every day. With the COVID-19 pandemic altering shopping habits, Amazon has become even more ubiquitous than ever. While many stores and online retailers struggled in 2020, Amazon’s sales skyrocketed 37% to a record $96.2 billion in the third quarter of 2020. But what happens when a product purchased from Amazon harms a customer? Can Amazon be held liable even if it has no role in designing or manufacturing the product? Courts across the country are grappling with this question, which undoubtedly will impact online retailers like Amazon for years to come.
On April 11, 2019, the Texas Senate passed by a vote of 20-10 bipartisan Senate Bill 1189 regulating attorney advertising relating to prescription medication and medical device litigation.
The bill prohibits certain advertisements for legal services that use the phrases “medical alert,” “drug alert,” “public service announcement,” or other language to suggest that “the advertisement is offering professional, medical, or government agency advice about medications or medical devices rather than legal services.”
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