Recently, the Delaware Chancery Court and the Third Circuit issued three significant decisions on key issues affecting licensing and M&A transactions in the life sciences industry....more
On August 23, Johnson & Johnson (J&J) issued a written notice to disproportionate share hospitals that participate in the prescription drug discount program established under section 340B of the federal Public Health Service...more
On August 23, Johnson & Johnson (J&J) announced changes to its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of two of J&J’s most popular drugs, STELARA...more
Court: Circuit Court of South Carolina, Fifth Judicial Circuit - A South Carolina jury Aug. 16 returned a $64.4 million plaintiff’s verdict against product manufacturer Johnson & Johnson and supplier American International...more
Observers of filing trends in personal injury mesothelioma matters alleging exposure to talc contaminated with asbestos have noted that the bankruptcy filing of a predominant defendant in those matters did little to slow the...more
Blink Fitness files for Chapter 11 bankruptcy | Bloomberg - Blink Fitness, a gym chain owned by Equinox, filed for Chapter 11 bankruptcy protection in Delaware, citing assets and liabilities each ranging from $100 million...more
On July 24, two hospitals that participate in the Section 340B drug discount program—Oregon Health & Science University and Maine General Medical Center—filed separate lawsuits against the Health Resources and Services...more
On July 24, 2024, Bio-Thera Solutions announced the FDA acceptance of its aBLA for BAT2206 (ustekinumab), a proposed biosimilar of Janssen and Johnson & Johnson’s Stelara® (ustekinumab), with a request for interchangeability....more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •44 AGs Rally for AI Safeguards, Endorsing New Commission...more
A bipartisan coalition of 43 AGs has entered into a Final Judgment and Consent Decree with Johnson & Johnson to resolve alleged violations of consumer protection laws related to its marketing of talc-based baby powder, which...more
In April, the U.S. Food and Drug Administration (FDA) released the results of its 2023 sampling assignment, testing for asbestos in talc-containing products. The results confirmed the absence of asbestos in all 50 samples...more
Fourth Judicial District Circuit Court for Mulnomah County, Oregon (Portland) In this matter, plaintiff Kyung Lee claimed that she developed mesothelioma from her use of Johnson & Johnson baby powder, which she alleges was...more
I read the Lewandowski v. Johnson & Johnson class action complaint and couldn’t help but wonder – are plans and participants doomed, or can employers take proactive steps to satisfy their fiduciary duties and potentially...more
Under the Consolidated Appropriations Act of 2021 (“CAA”), employer-sponsored group health plans, including medical-only plans, must submit information about their prescription drugs and health care spending. This submission...more
Court: Circuit Court of Cook County, Illinois - On April 19, a Chicago jury ordered Johnson & Johnson to pay $45 million to the family of a Cook County woman named Theresa Garcia who died from mesothelioma, allegedly caused...more
Court: United States District Court, Middle District of Florida - On Thursday April 18, a Florida jury found the talcum powder in Johnson & Johnson’s baby powder product did not cause the ovarian cancer of deceased Sarasota...more
For the past few years, we have encouraged plan sponsors to focus on matters of fiduciary governance for their health and welfare benefit plans (see our 2021 blog post). Yet many plan sponsors overlook the fact that the...more
Johnson & Johnson (J&J) reported on April 5, 2024, that it has entered an agreement to acquire Shockwave Medical, a company in the cardiovascular medical device sector, in a deal totaling a reported $13.1 billion. The deal...more
Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more
Federal Rule of Evidence 702 - The admission of expert testimony in federal courts is governed by Rule 702 of the Federal Rules of Evidence. Effective December 1, 2023, Rule 702 was amended to clarify the “preponderance of...more
Many medical benefit plan fiduciaries contract with pharmacy benefit managers (“PBMs”) to administer the prescription drug portion of their health plans, placing the PBM in charge of day-to-day management of the programs....more
The first complaint was filed in what is expected to be a wave of litigation alleging breach of fiduciary duty in selecting and monitoring welfare plan vendors. While the facts of this particular case may make it somewhat...more
On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more
A novel proposed class action lawsuit was filed against Johnson & Johnson (J&J) earlier this month by a current employee for mismanagement of prescription drug prices. The lawsuit alleges, among other things, that J&J...more
A lawsuit filed on February 5, 2024, against Johnson and Johnson and its health plan fiduciaries is a good reminder that the fiduciary duties that exist under the Employee Retirement Income Security Act of 1974 (ERISA) do not...more