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

Mealey's Drugs & Devices

November 04, 2024
Louisiana Sued Over Law Classifying Abortion Drugs As Controlled Substances

BATON ROUGE, La. — A Louisiana law that classifies misoprostol and mifepristone — two drugs used to induce early termination of pregnancy — as controlled dangerous substances is unconstitutional because it “threatens access to lifesaving medications for certain patients, and improperly interferes with timely and appropriate access for others with a range of physical conditions,” a doula practice in the state and others alleges in a complaint filed in state court.
October 31, 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 31, 2024
New York Federal Judge Finds State Claims Preempted In OTC Cold Medicine Case

BROOKLYN, N.Y. — A New York federal judge dismissed a streamlined complaint filed by consumers who allege that over-the-counter cough and cold medications containing the active ingredient phenylephrine (PE) are ineffective at relieving nasal congestion after finding that the claims are preempted by federal law.
October 31, 2024
Michigan Sues PBMs For Role In State’s Opioid Crisis

LANSING, Mich. — The attorney general for Michigan alleges that pharmacy benefit managers (PBMs) “had a central role in facilitating the oversupply of opioids through contact that has the intended purpose of ignoring necessary safeguards to increase the prescribing, dispensing and sales of prescription opioids” and sued two of the nation’s largest PBMs in a state court, asserting violations of the state’s public nuisance laws and other claims.
October 30, 2024
Judge: Motley Rice Can Represent Boston In Public Nuisance Suit Against OptumRX

BOSTON — Citing a decision by the judge overseeing the opioid multidistrict litigation that rejected similar arguments, a Massachusetts federal judge denied a motion filed by a pharmacy benefit manager to disqualify Motley Rice LLC from representing Boston and others in a suit alleging public nuisance.
October 30, 2024
Hologic Announces Voluntary Recall Of Implantable BioZorb Marker Devices

MARLBOROUGH, Mass. — Hologic Inc., facing litigation from cancer patients who allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries, announced that it is voluntarily removing all lots of unused BioZorb Marker and BioZorb LP Marker.
October 30, 2024
Judge Bars Economics Expert In Avandia Third-Party Payer’s Bid For Class Action

PHILADELPHIA — The Pennsylvania federal judge overseeing the Avandia multidistrict litigation agreed with GlaxoSmithKline PLC (GSK) that an economic expert retained by third-party payers who bought the diabetes pill and are seeking class certification cannot testify under Daubert v. Merrell Dow Pharmaceuticals Inc.
October 29, 2024
Remand Denied In Defective Heart Device Case Removed To New York Federal Court

NEW YORK — A New York federal judge denied a motion to remand a wrongful death suit filed against the manufacturer of a heart a defibrillator device, finding that the manufacturer properly removed the case from a New York state court on the basis of diversity jurisdiction.
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.