FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule will go into effect on September 1, 2021.

The new rule may provide an end to a years-long process on knowledge-based labeling directives in the old regulations. Proposed amendments to clarify the “intended use” regulations began in 2015, which we discussed previously.

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FDA Approves First Interchangeable Biological Product Under BPCIA

On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine).

Under the Biologics Price Competition and Innovation Act (BPCIA), biological products (e.g., vaccines and therapeutic antibodies) may come to market by showing that they are “biosimilar” to or “interchangeable” with a “reference product,” which is a biological product that has already been approved by the FDA. A biological product is “biosimilar” if it is “highly similar to the reference product notwithstanding minor differences in clinically inactive components” and “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” 42 U.S.C. § 262(i)(2). To date, 28 biological products have been approved as biosimilars.

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Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review

A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.

On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer.  Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”).   Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.

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New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

Overview

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.

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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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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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