Mealey's Drugs & Devices : Mealey's : Legal News & Analysis

Mealey's Drugs & Devices

October 29, 2024
Tepezza MDL Judge Dismisses 1 Bellwether Case, Says It Will Not Be Replaced

CHICAGO — The Illinois federal judge overseeing the Tepezza hearing loss multidistrict litigation on Oct. 28 granted a motion to dismiss a woman’s complaint that was selected as an initial bellwether discovery case but refused to allow the drug manufacturer to choose a replacement case.
October 28, 2024
SoClean: Philips Shows No Economic Loss; CPAP Class Action Should Be Tossed

PITTSBURGH — SoClean Inc., a manufacturer of equipment that uses ozone to clean and disinfect continuous positive air pressure (CPAP) sleep apnea devices and respirators, moved to dismiss a putative class action filed by a manufacturer of recalled CPAP machines that reached a settlement in a related multidistrict litigation to resolve economic losses and argues that it should represent the MDL plaintiffs’ interests in its suit against SoClean.
October 28, 2024
MDL Judge Reaffirms Ruling To Hold Off Discovery Into GLP-1 Marketing Plans

PHILADELPHIA — The Pennsylvania federal judge newly appointed to oversee the multidistrict litigation involving diabetes and diet drugs that consumers allege cause gastrointestinal and other injuries declined to reconsider her case management order that barred the plaintiffs from pursuing discovery into the drug makers’ marketing campaigns.
October 28, 2024
6 Bellwether Cases Selected In Valsartan MDL

CAMDEN, N.J. — The special master presiding over the valsartan/losartan/irbesartan hypertension drugs multidistrict litigation pending in a New Jersey federal court announced that the first six bellwether cases have been selected.
October 28, 2024
6th Circuit Refuses To Order Opioid MDL Judge To Disqualify Motley Rice

CINCINNATI — The Sixth Circuit U.S. Court of Appeals denied a petition for a writ of mandamus ordering the Ohio federal judge overseeing the opioid multidistrict litigation to disqualify Motley Rice and its attorneys from representing plaintiffs who sued OptumRx Inc., a pharmacy benefits manager (PBM), in the opioid MDL.
October 25, 2024
Preemption Under FDCA Dooms Some Claims In Defective Birth Control Device Suit

AMARILLO, Texas — A Texas federal magistrate judge partially granted motions for dismissal filed by the manufacturer, distributor and parent company of a birth control device that a woman alleges failed and caused her to become pregnant, finding that certain claims are preempted by federal law.
October 24, 2024
N.J. High Court Agrees To Create Multicounty Litigation For Bard Port Cases

TRENTON, N.J. — The New Jersey Supreme Court posted a notice to the state bar that the court has designated as a multicounty litigation (MCL) state court cases alleging injuries caused by C.R. Bard Inc.’s implanted port catheter products.
October 23, 2024
Victims Of Opioid Crisis: Purdue Bankruptcy Court Focus Should Be On Resolution

NEW YORK — The Ad Hoc Group of Individual Victims (Ad Hoc PI Group), which represents more than 60,000 individuals in Purdue Pharma LP’s bankruptcy case who have suffered from opioid addiction or are family members of individuals who died from drug overdoses, tells the U.S. Bankruptcy Court for the Southern District of New York that it supports the Official Committee of Unsecured Creditors’ (UCC) motion for standing to pursue estate claims.
October 23, 2024
Indiana Woman Says Use Of Depo-Provera Caused Her To Develop Brain Tumors

INDIANAPOLIS — The manufacturer of Depo-Provera, a long-lasting injectable contraceptive, concealed the risk that using the product increases the risk of developing meningioma brain tumors, a couple alleges in a complaint filed in an Indiana federal court.
October 22, 2024
D.C., 17 States To 4th Circuit: N.C.’s Mifepristone Restrictions Are Preempted

RICHMOND, Va. — A district court’s ruling that found that parts of North Carolina’s abortion laws are preempted by federal law protected “patient access to essential reproductive health care without trammeling states’ rights,” the District of Columbia and 17 states say in an amicus curiae brief filed in the Fourth Circuit U.S. Court of Appeals in support a doctor who sued the state over its laws regulating mifepristone, one of the two drugs prescribed for medication abortions, and the state’s attorney general, who did not object to the doctor’s arguments.
October 21, 2024
Insurer, Medical Product Manufacturer Settle Coverage Dispute

CONCORD, N.H. — Attorneys for an insurer and a medical product manufacturer insured notified a New Hampshire federal court that they have settled the insurer’s declaratory judgment lawsuit pertaining to 10 underlying class actions alleging that the insured manufactured and marketed medical devices used to clean positive airway pressure (CPAP) and bi-level positive airway pressure (biPAP) devices that were not safe or effective.
October 17, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
October 17, 2024
FiberCel Maker Wins Bid To Dismiss Breach Of Warranty Claims In Injury Case

CINCINNATI — An Ohio federal judge granted a manufacturer’s partial motion to dismiss, finding that certain claims asserted by a man who says he suffered postsurgical complications due to a medical product that was contaminated with tuberculosis are barred under the state’s blood and tissue shield statute.
October 17, 2024
High Court Denies Petition Filed By Executives Convicted Of Off-Label Marketing

WASHINGTON, D.C. — Two former Acclarent Inc. executives convicted of distributing and misbranding medical devices sold in interstate commerce lost their bid for a U.S. Supreme Court review of their convictions when the court on Oct. 7 denied their petition to review whether the U.S. Food and Drug Administration’s “intended use” regulations violated their constitutional rights.
October 17, 2024
Novartis To Appeal FDA’s Summary Judgment Award In Generic Drug Approval Case

WASHINGTON, D.C. — Novartis Pharmaceuticals Corp. filed notice that it intends to appeal a decision by a District of Columbia district court judge to deny its motion for summary judgment and find that the U.S. Food and Drug Administration did not violate federal law in approving a generic version of its heart failure drug Entresto.
October 16, 2024
Magistrate Finds Some Motions To Compel Documents Need Revising In Exactech MDL

BROOKLYN, N.Y. — A New York federal magistrate judge granted in part and denied in part motions to compel the production of documents filed by plaintiffs in the Exactech orthopedic device multidistrict litigation, finding that while some of the documents are relevant to the proceedings, other requests are overbroad and too burdensome.
October 16, 2024
States Opposing Mifepristone Restrictions Tell Court To Send Case To FDA

YAKIMA, Wash. — Washington and other states that sued the U.S. Food and Drug Administration over the agency’s decision to add Risk Evaluation and Mitigation Strategy (REMS) restriction on mifepristone, one of the two drugs prescribed for medication abortions, say summary judgment is warranted now that the case has restarted after being placed on hold awaiting the U.S. Supreme Court’s decision in a related mifepristone case.
October 16, 2024
Pa. Federal Judge Agrees To Trim Counterclaims Filed Against CPAP Equipment Maker

PITTSBURGH — A federal judge in Pennsylvania partially adopted a magistrate judge’s recommendation to deny a motion filed by SoClean Inc., a manufacturer of equipment that uses ozone to clean and disinfect continuous positive air pressure (CPAP) sleep apnea devices and respirators, to dismiss counterclaims filed by Koninklijke Philips N.V., Philips North America LLC and Philips RS North America LLC (collectively, Philips) but agreed to dismiss the Lanham Act trademark dilution counterclaim and found another claim time-barred.
October 16, 2024
Taxotere MDL Judge Won’t Reconsider Lone Pine Order Requiring Proof Of Diagnosis

NEW ORLEANS — The federal judge overseeing the Taxotere hair loss multidistrict litigation refused to reconsider her Lone Pine order requiring that plaintiffs, including representatives of plaintiffs who have died, show proof of a diagnosis of permanent chemotherapy-induced alopecia (PCIA).
October 16, 2024
Over-The-Counter Pill Labeled Maximum Strength Was Not, Man Alleges In Complaint

NEW YORK — A New York man filed a complaint in New York federal court seeking to represent a class action of consumers who purchased Target Corp.-branded gas relief pills and were led to believe that the product was “maximum strength” when in fact stronger products are on the market.
October 15, 2024
NECC Pharmacist Sentenced In Michigan State Court In Involuntary Manslaughter Case

HOWELL, Mich. — Former New England Compounding Center (NECC) chief pharmacist Glenn A. Chin has been sentenced to 7-1/2 to 15 years in prison after pleading no contest in a Michigan state court to 11 counts of involuntary manslaughter in connection with a 2012 fungal meningitis outbreak traced to a contaminated drug compounded by the company.
October 15, 2024
Sackler Family To Bankruptcy Court: Liability In Opioid Cases ‘Cannot Be Assumed’

NEW YORK — The Raymond Sackler family says in a statement filed Oct. 14 in a New York federal bankruptcy court that it takes no position on the Official Committee of Unsecured Creditors (UCC) motion for standing to pursue estate claims because it argues that the proposed claims “are utterly meritless regardless of who brings them,” citing rulings from various courts that found that state public nuisance laws don’t apply to the manufacturing of opioids.
October 15, 2024
Walgreens To Pay $80M In Settlement With Baltimore For Role In Opioid Crisis

BALTIMORE — Walgreens has agreed to an $80 million settlement to resolve Baltimore’s claims against the company for its role in fueling the opioid epidemic in the city, according to a press release from the city and Mayor Brandon M. Scott, bringing the total amount of recoveries for the city from opioid defendants to $402.5 million.
October 11, 2024
Doctor, North Carolina A.G. Say All Restrictions On Mifepristone Are Preempted

RICHMOND, Va. — A doctor who sued North Carolina over its laws regulating mifepristone, one of the two drugs prescribed for medication abortions, and the state’s attorney general, who did not object to the doctor’s arguments, on Oct. 10 filed separate opening briefs in the Fourth Circuit U.S. Court of Appeals, urging the appellate court to not only affirm that a district court was correct in holding that certain restrictions on mifepristone are preempted by federal law but also to expand the ruling and find that the restrictions that were upheld are also preempted.
October 10, 2024
GSK To Pay $$2.2 Billion To Settle Majority Of Zantac Cases In United States

LONDON — GSK PLC announced Oct. 9 that it has reached settlement agreements to end approximately 80,000 Zantac (ranitidine) state court product liability cases pending against the pharmaceutical company in the United States.