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

Mealey's Drugs & Devices

May 21, 2024
GenBioPro: W.Va.’s Law Banning Abortion Does Not Protect Citizens’ Health

RICHMOND, Va. — GenBioPro Inc., the maker of generic mifepristone, one of two drugs used to induce early termination of pregnancy, on May 20 told the Fourth Circuit U.S. Court of Appeals that the West Virginia Unborn Child Protection Act (UCPA), which bans abortion in almost all cases, is not protected by the state’s power to guard its citizens’ health.
May 20, 2024
Texas High Court: Judicial Estoppel Bars Fen-Phen Lawyer’s Arguments In Fee Case

AUSTIN, Texas — The Texas Supreme Court on May 17 found that a plaintiff law firm in a long-running fen-phen fee dispute is “judicially estopped from establishing an essential component” in its motion for summary judgment, affirming a ruling by the state appeals court that reversed the summary judgment order of the trial court.
May 17, 2024
McKinsey MDL Judge Allows Claims Over Neonatal Abstinence Syndrome To Move Forward

SAN FRANCISCO — The California federal judge presiding over the McKinsey & Co. opioid promotion multidistrict litigation on May 16 partially granted and partially denied McKinsey’s motion to dismiss an amended complaint filed on behalf of minors born with neonatal abstinence syndrome (NAS).
May 16, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
May 16, 2024
Paragard IUD MDL Judge Makes Changes To Plaintiff Counsel Leadership

ATLANTA — The Georgia federal judge overseeing the Paragard IUD (intrauterine device) multidistrict litigation revised the plaintiffs’ leadership structure in a recent order, removing eight members from the Plaintiffs’ Steering Committee (PSC), among other changes.
May 16, 2024
Judge Affirms Dismissal Of Warranty Claims In Post-Surgical Complication Suit

STATESVILLE, N.C. — A North Carolina federal judge affirmed a magistrate judge’s finding that processed human tissue used during a woman’s spinal surgery is a service under a state statute and that certain defendants cannot be held liable for warranty claims.
May 16, 2024
OptumRx Asks 6th Circuit To Order Disqualification Of Motley Rice In Opioid MDL

CINCINNATI — OptumRx Inc. filed 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 the pharmacy benefits manager (PBM) in the opioid MDL.
May 15, 2024
Judge Overrules Abbott’s Objections To Discovery Order In FCA Suit Over Kickbacks

SAN DIEGO — A California federal judge on May 14 overruled Abbott Laboratories’ objections and affirmed a magistrate judge’s discovery order that denied Abbott’s motion to compel production of certain documents in a suit alleging violations of the False Claims Act (FCA) and state false claims laws regarding Abbott’s alleged kickback scheme to induce hospitals and physicians to use an Abbott cardiac medical device, finding that Abbott is not entitled to discover certain documents, which are considered privileged work product.
May 15, 2024
Parties Submit Joint Bellwether Deadline Schedule In Tepezza Hearing Loss MDL

CHICAGO — The parties in the Tepezza hearing loss multidistrict litigation filed a joint proposed schedule setting deadlines for discovery, expert disclosures and briefing ahead of the first bellwether trial, which is slated to begin March 9, 2026.
May 14, 2024
Philips Says SoClean Should Chip In For Settlement Of CPAP Injury Claims

PITTSBURGH — SoClean Inc., a manufacturer of equipment that uses ozone to clean and disinfect continuous positive air pressure (CPAP) sleep apnea devices and respirators, should contribute to the $1.1 billion settlement reached between Philips Respironics and the plaintiffs in the multidistrict litigation involving personal injuries caused by deteriorating sound insulation in Philips’ CPAP devices, Philips argues in a third-party complaint filed in the MDL.
May 13, 2024
Woman Will Appeal Refusal Of Taxotere MDL Judge To Reconsider Her Dismissed Case

NEW ORLEANS — A woman whose case in the Taxotere hair loss multidistrict litigation was dismissed for failure to comply with a court-ordered deadline to properly serve her complaint filed notice that she will appeal to the Fifth Circuit U.S. Court of Appeals the judge’s denial of her motion to reconsider the ruling that ended her case.
May 13, 2024
NECC Pharmacy Founder Barry Cadden Sentenced In State Involuntary Manslaughter Case

LANSING, Mich. — Former New England Compounding Center (NECC) founder Barry J. Cadden on May 10 was sentenced in a Michigan state court to 10 to 15 years in prison after pleading no contest in March to 11 counts of involuntary manslaughter in connection with a 2012 fungal meningitis outbreak traced to a contaminated drug compounded by his company, Michigan Attorney General Dana Nessel announced.
May 13, 2024
4 Lawyers Appointed To Co-Lead Plaintiffs In Diabetes And Diet Drug MDL

PHILADELPHIA — The federal judge overseeing the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries named four lawyers to serve as co-lead counsel for the plaintiffs and designated counsel to serve on the MDL’s executive and steering committees.
May 10, 2024
Pharmacy Distributor Appeals No Coverage Ruling In Suit Prompted By Opioid Epidemic

VALDOSTA, Ga. — A pharmacy distributor insured indicated to a Georgia federal court that it is asking the 11th Circuit U.S. Court of Appeals to review the court’s grant of summary judgment in favor of its commercial general liability and umbrella insurers in a coverage dispute arising from the opioid epidemic.
May 10, 2024
Federal Magistrate Judge Dismisses Suit Against CVS For Homeopathic Eye Drops

BUFFALO, N.Y. — A New York magistrate judge recommended that the court grant CVS Pharmacies Inc.’s motion to dismiss a proposed class action alleging violations of New York consumer protection laws in its sale of homeopathic eye drops after determining that a woman failed to state a plausible claim.
May 10, 2024
9th Circuit Agrees To Divide Arguments In Theranos’ Holmes, Balwani Appeals

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on May 9 agreed to modify the oral argument schedule in the appeals of the convictions and sentences of Theranos Inc. founder Elizabeth Holmes and former Theranos Chief Operating Officer Ramesh “Sunny” Balwani after they filed a joint motion requesting the change.
May 09, 2024
Judge Tosses Class Action Alleging Ovulation Kits Are Deceptively Labeled

NEW YORK — A New York federal judge dismissed without leave to amend a putative class action alleging that at-home ovulation test kits were deceptively labeled in violation of New York and California false advertising laws and California’s unfair competition law (UCL) after finding that the women who purchased the tests failed to show that a reasonable consumer of the products would be deceived.
May 09, 2024
Magistrate Denies Motion For Indicative Relief In FCA Suit Alleging Overcharging

SAN FRANCISCO — A California federal magistrate judge denied a relator’s motion for an indicative ruling that pursuant to the Ninth Circuit U.S. Court of Appeals’ decision in United States ex rel. Silbersher v. Valeant Pharms. Int’l, Inc., a similar False Claims Act (FCA) suit brought by the same relator, the magistrate judge should grant the relator “relief” from the judgment on appeal to the Ninth Circuit after dismissing his claims that pharmaceutical companies overcharged the federal government and states under Medicare and Medicaid.
May 08, 2024
Judge Dismisses 2nd Dispute Over Attorney Fees In Benicar MDL

CAMDEN, N.J. — A New Jersey federal judge on May 7 applied the doctrine of collateral estoppel in dismissing with prejudice claims that an improper amount of attorney fees were awarded to a law firm for its work in the Benicar multidistrict litigation.
May 08, 2024
New Expert Offers Same Opinions As Excluded Experts, ASD-ADHD MDL Defense Says

NEW YORK — The opinions of an expert retained by newly named plaintiffs in the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder “are a classic example of ‘made for litigation’ opinions that require heightened judicial scrutiny,” the defendants argue in a motion to exclude.
May 07, 2024
2nd Circuit Issues Mandate Regarding Dismissal Of FCA Claims Affirmed On Appeal

NEW YORK — The Second Circuit U.S. Court of Appeals on May 6 issued a mandate regarding its ruling affirming a district court’s dismissal of a relator’s claim against a pharmaceutical company for violations of the federal False Claims Act (FCA) but vacating and remanding the lower court’s dismissal of state law claims, finding that the district court correctly found that the relator failed to show that the pharmaceutical distributor acted willfully pursuant to the FCA when allegedly giving customers business management tools in exchange for their agreements to purchase drugs.
May 07, 2024
FDA Issues Final Rule Designating In Vitro Diagnostic Products As Medical Devices

SILVER SPRING, Md. — The U.S. Food and Drug Administration on May 6 issued a final rule amending a regulation “to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act . . . including when the manufacturer of the IVD is a laboratory.”
May 06, 2024
Opioid MDL Judge Denies Request To Certify Questions To Georgia Supreme Court

CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation denied a request by Publix Super Markets Inc. to certify to the Georgia Supreme Court a series of questions for the high court to determine how the state’s public nuisance law applies, noting that he previously denied its request to certify a similar question.
May 06, 2024
Generic Opioid Drug Manufacturer Agrees To $272.5M Multistate Settlement

NEW YORK — The New York attorney general on May 3 announced that generic opioid manufacturer Amneal Pharmaceuticals has agreed to a multistate settlement for its role in the nationwide opioid crisis by failing to monitor and report suspicious orders.
May 03, 2024
Federal Judge Enters Judgment Against Endo Health For Mislabeling Opioid Drug

DETROIT — A Michigan federal court judge on May 2 entered a forfeiture money judgment of $450 million against Endo Health Solutions Inc. (EHSI) in favor of the United States, representing the proceeds obtained by the company as a result of its violation of the Food, Drug and Cosmetic Act (FDCA) by marketing its opioid drug Opana ER as crush- and tamper-resistant.