Subject: Prescription Drugs

FDA Approves First Interchangeable Biological Product Under BPCIA

Share

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.

Continue reading “FDA Approves First Interchangeable Biological Product Under BPCIA”

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

Share

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.

Continue reading “Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review”

New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

Share

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.

Continue reading “New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal”

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

Share

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.

Continue reading “Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials”

Summary of HB1125: Deceptive Lead Generation

Share

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.

Continue reading “Summary of HB1125: Deceptive Lead Generation”

Another Roadside Attraction: The Supreme Court’s Latest Route Guidance on Personal Jurisdiction in Products Liability Cases

Share

On March 25, the U.S. Supreme Court decided Ford Motor Co. v. Montana Eighth Judicial District Court, revisiting the issue of due process limitations on the exercise of personal jurisdiction, most recently addressed by the Court in 2017 in Bristol-Myers Squibb v. Superior Court, 137 S. Ct. 1783 (2017) (“BMS”).  A unanimous Court (8-0, with Justice Barrett not participating) held in Ford Motor that courts in Montana and Minnesota could hear claims by residents of those states alleging injuries sustained in accidents that occurred there involving Ford vehicles.  Relying on Ford’s extensive contacts with those states, which consisted of efforts to create and serve local sales and service and repair markets for the same kinds of vehicles, the Court concluded these plaintiffs’ claims were sufficiently “related to” Ford’s local contacts, even though the actual vehicles in the accidents were designed, manufactured and initially sold in other states.  (We commented here on the state court decisions in these cases before Ford sought certiorari.)

Continue reading “Another Roadside Attraction: The Supreme Court’s Latest Route Guidance on Personal Jurisdiction in Products Liability Cases”