2 days agoMexican National Sues Over Exclusion From Roundup SettlementA lawsuit was filed in a Virginia federal court on Jan. 19 on behalf of a Mexican farmworker who claims she was illegally denied a Roundup weedkiller cancer claim settlement because she is not a U.S. citizen, Reuters reported. Elvira Reyes-Hernandez, 47, was diagnosed in 2019 with non-Hodgkin’s lymphoma, the…FDA2 min readFDA2 min read
3 days agoWV Opioid Suit Down to Final DefendantWalgreens has become the latest defendant to settle with West Virginia Attorney General Patrick Morrisey over claims related to multiple pharmacies’ roles in exacerbating the opioid crisis. During a Jan. …FDA2 min readFDA2 min read
3 days agoJudge Orders Pause to 3M MediationThe federal judge overseeing 3M Combat Arms Earplug Version 2 (CAEv2) multidistrict litigation (MDL) has ordered a pause in mediation efforts between the 3M Corp. and more than 200,000 plaintiffs who claim their hearing damage was caused by faulty military-issued earplugs that 3M formerly supplied to the government. U.S. District…FDA2 min readFDA2 min read
4 days agoJuul Settlement Receives Preliminary ApprovalA planned settlement for a multidistrict litigation (MDL) against Juul Labs and Altria has received preliminary approval. According to a Jan. 20 Civil Minutes document obtained by Law360, the court has found the preliminary settlement to be “fair, reasonable, and adequate.” The Juul MDL centers on claims that Juul marketed…FDA2 min readFDA2 min read
Jan 27CA Continues Trend of Suing Insulin ManufacturersFollowing on the heels of Kansas’ lawsuit against three insulin manufacturers and pharmacy benefit managers (PBMs) over illegal marketing practices and overcharging patients, California Attorney General Rob Bonta announced a similar lawsuit, Jan. 12. Both the lawsuit filed by Bonta and the one filed by Kansas Attorney General Derek Schmidt…FDA2 min readFDA2 min read
Jan 26FDA Issues Endoscope Warning LettersThe FDA’s Center for Devices and Radiological Health (CDRH) has issued two warning letters to Olympus Medical Systems Corporation and its subsidiary Aizu Olympus Co, Ltd. The Jan. …FDA2 min readFDA2 min read
Jan 25New Research Questions FDA Fast-Track Approval of Medical DevicesWhen medical devices that have been cleared under the FDA’s “fast track” 510(k) pathway are recalled, how often did the similar older versions (predicates) get recalled? That’s the question posed by three researchers whose findings on the subject were published as a cross-sectional retrospective analysis in the Jan. …FDA2 min readFDA2 min read
Jan 24Appeals Court Supports GSK’s Zofran Summary JudgmentA three-panel judge has upheld a motion for summary judgment in favor of GlaxoSmithKline (GSK), dismissing hundreds of lawsuits alleging that the manufacturer’s anti-nausea drug Zofran caused a number of adverse health effects for pregnant women including birth defects. In a 35-page opinion, U.S. Circuit Judge William J. Kayatta Jr…FDA3 min readFDA3 min read
Jan 20Opioid Distribution Lawsuit Filed Against AmerisourceBergenDespite the $26 billion global opioid settlement that has been approved by thousands of communities in the U.S. and several state attorneys general in 2022, opioid litigation continues, with the latest lawsuit filed by the U.S. Department of Justice (DOJ) against AmerisourceBergen, one of the nation’s largest pharmaceutical distributors. The…FDA2 min readFDA2 min read
Jan 19FDA Approves New MS TreatmentThe Food and Drug Administration (FDA) has approved a new treatment for adult patients with relapsing forms of multiple sclerosis (MS). The Dec. 28, 2022 announcement states that TG Therapeutics, Inc. has been authorized to manufacture the injectable medication Briumvi (ublituximab-xiiy). MS is a potentially debilitating autoimmune disease of the…FDA2 min readFDA2 min read
