2022 Significant Developments in the Tobacco Industry and What to Expect in 2023 (Part One) - Regulatory Oversight Podcast
Proposition 65 – Changes That Will Impact the Cannabis Sector
Comment Deadline Approaching: Proposed Amendments Restricting Use of Prop 65 Short-Form Warnings
Cannabis Counsel Cast: Proposed Prop 65 Regulation Would Require Cannabis Products to Warn About Impacts on Child Behavior and Learning
Cannabis Counsel Cast: What Cannabis Companies Need to Know About California’s Prop. 65 (Even if They Aren’t in California)
Key takeaways: The legal claims against Novo Nordisk are not about banning the drug. They are about accountability and informed consent. The core of these lawsuits is the product liability principle known as “failure to...more
Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more
Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more
The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to...more
MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more
Drug warning labels must comply with federal regulations and receive approval from the Food and Drug Administration (“FDA”) before going to market. Therefore, manufacturers may argue that state law actions related to the...more
Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more
Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more
Even as more felony charges may follow in drug epidemic, sleep med warning suggests pill popping stays too popular - Five top executives at a major drug maker have been convicted of criminal racketeering for their...more
Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more
Opioid Education - The U.S. Food and Drug Administration (FDA) crept cautiously closer to curbing the opioid crisis by approving sweeping changes as to how the prescription drugs are labeled. Going forward, such...more
Recently, the FDA released industry guidance regarding biosimilar product labeling, which is entitled “Labeling for Biosimilar Products” (“Biosimilars Labeling Guidance”). The Biosimilars Labeling Guidance provides...more
On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product...more
Today, the Massachusetts Supreme Judicial Court made an important ruling concerning innovator liability with respect to pharmaceuticals. Though precluding negligence and traditional product liability claims against brand-name...more
The West Virginia Supreme Court of Appeals recently upheld the Mass Litigation Panel’s grant of summary judgment against a class of Plaintiffs alleging birth defects resulting from the use of prescription medicine in...more
A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more
Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more
Massachusetts Federal Court In Prescription Drug Case Holds “Learned Intermediary” Rule Requiring Warnings Only To Prescribing Physician Applied Even Though Patient and Caregiver Were Physicians, But Experts’ Affidavits of...more
Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more
The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more
FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more
The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more
Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more
A seeming contradiction between two recent federal district court rulings on preemption and the U.S. Food and Drug Administration’s oversight of pharmaceuticals creates some uncertainty about whether evidence submitted by the...more
On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more