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.
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”
Over the last four months, we have tracked the District of New Jersey’s proposal and adoption of a new Local Civil Rule – L. Civ. R. 7.1.1 – requiring lawyers to disclose details about third-party litigation funding. The Clerk of the District of New Jersey has now issued a Notice to the Bar clarifying that this new Rule only requires the filing of a statement where third-party litigation funding exists.
Increasingly popular online “lead generation” services offering to connect attorneys with potential mass tort plaintiffs may expose counsel to ethics violations, the New Jersey Advisory Committee on Professional Conduct cautioned in two recent advisory opinions.
New Jersey attorneys are charged with the affirmative responsibility to “question whether the marketing company is improperly labeling its services,” the committee stated in a June 21, 2021 joint opinion with the Committee on Attorney Advertising. On the same date, the Advisory Committee issued another joint opinion with the Committee on the Unauthorized Practice of Law offering further insight on the circumstances in which a permissible client lead becomes an improper for-profit referral.
Continue reading “New Jersey Ethics Committee: Beware Marketers that “Lead” to Ethics Violations”
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.
The U.S. District Court for the District of New Jersey has adopted new Local Civil Rule 7.1.1, requiring lawyers to disclose details about third-party litigation funding. On June 21, 2021, Chief Judge Freda L. Wolfson signed the order formally amending the Rule to include Section 7.1.1.
