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

Mealey's Drugs & Devices

October 05, 2023
Counsel, MDL Special Master Respond To Motion To Recuse For Reply-All Email Error

CLEVELAND — The Plaintiffs’ Executive Committee (PEC) says it is unnecessary for a special master accused of bias by two pharmacy benefit managers (PBM) in the opioid multidistrict litigation to recuse himself after he inadvertently sent a personal email to the parties, while the special master separately pledged impartiality in an affidavit filed with the court.
October 05, 2023
California Federal Judge Grants Motion To Dismiss Vaccine Injury Case

LOS ANGELES — A California federal judge granted two vaccine manufacturers’ separate motions to dismiss claims that their vaccines caused a woman’s shoulder injuries.
October 04, 2023
$1.14M In Fees Requested In Settlement Over Alleged Deceptive Pain Reliever Label

NEW YORK — Counsel representing the plaintiffs who reached a class settlement with CVS Pharmacy Inc. over claims that it misrepresented that its nonprescription lidocaine pain products contain “maximum strength” of the drug asked the judge overseeing the case to approve their motion for $1,140,000 in attorney fees, costs and expenses.
October 04, 2023
Government: No Reversible Error In Trial, Sentence For Theranos’ Balwani

SAN FRANCISCO — The government told the Ninth Circuit U.S. Court of Appeals that a trial court did not err in admitting lay witness testimony, among other arguments, and that it should reject the appeal filed by former Theranos Inc. Chief Operating Officer Ramesh “Sunny” Balwani, who argued that the district court committed reversible errors.
October 04, 2023
Federal Judge Dismisses Defective Medical Device Suit, Denies Attempts To Amend

ALBUQUERQUE, N.M. — A New Mexico federal judge said efforts by a woman who alleges that she was injured by a birth control device to amend her complaint would be futile and untimely and ruled that her claims are preempted.
October 04, 2023
Presuit Induced, Willful Infringement Claims Tossed In Patent Row

WILMINGTON, Del. — A federal judge in Delaware said allegations of direct infringement of myriad patents directed to sleep disorder testing and therapy are sufficient to withstand a motion to dismiss but agreed with a defendant that a patent owner’s assertion of induced and willful patent infringement fails.
October 04, 2023
AstraZeneca To Pay $425M To Settle Claims Heartburn Drugs Damaged Kidneys

AstraZeneca on Oct. 3 announced that it has agreed to pay $425 million to settle claims that its Nexium and Prilosec products, used to treat heartburn, caused chronic kidney disease.
October 03, 2023
Judge Sets Deadlines For 1st Bellwether Trials In Covidien Hernia Mesh MDL

BOSTON — The federal judge overseeing the multidistrict litigation involving Covidien hernia mesh agreed with the plaintiffs’ proposed scheduling order to set deadlines for the first two trials, as opposed to six as requested by the defense, with the goal of setting the first bellwether trial date in January 2025.
October 03, 2023
Failure-To-Warn-Physician Claims Fail In Appeal To Minnesota Appeals Court

MINNEAPOLIS — There is not a separate duty on a drug manufacturer to warn physicians after it has fulfilled its duty to warn patients of potential injuries, a Minnesota appeals court ruled Oct. 2, affirming summary judgment issued to the manufacturer of a generic heart drug.
October 02, 2023
Gilead Wins Partial Summary Judgment In HIV Drug Suit For Bone, Kidney Injuries

OAKLAND, Calif. — A California federal judge has partially granted a motion filed by an HIV drug manufacturer for summary judgment on common issues in a case in which plaintiffs allege that they suffered injuries to their kidneys and bones while the company withheld a safer alternative.
October 02, 2023
FDA Proposes Regulating Laboratory Developed Tests As Devices Under The FDCA

WASHINGTON, D.C. — Because laboratory developed tests (LDT) are often used in making health care decisions, the U.S. Food and Drug Administration in a Sept. 29 press release proposed a new rule to designate in vitro diagnostic products as devices under the Food, Drug and Cosmetic Act (FDCA) to “help ensure that healthcare decisions are made based on test results patients can trust.”
September 29, 2023
Ankle Replacement Device Case Dismissed, Preempted By Federal Law, Judge Says

PHOENIX — An Arizona federal judge on Sept. 28 found that claims that a medical device used during an ankle replacement was defective are preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) and granted the manufacturer’s motion to dismiss.
September 28, 2023
Defective Medical Device Case Moves Forward In Illinois Federal Court

CHICAGO — An Illinois federal judge on Sept. 27 largely denied a manufacturer’s motion to dismiss a lawsuit alleging that a medical device implanted into a woman’s spine collapsed, requiring additional surgery to remove.
September 28, 2023
Lawsuit Claiming Target’s ‘Non-Drowsy’ Medicine Label Is Misleading Moves Forward

MINNEAPOLIS — Claims by consumers who allege that Target Corp. misled its customers by labeling its cold medicine as non-drowsy survived the retailer’s motion for dismissal when a Minnesota federal judge ruled that the claims are not preempted by the Food, Drug and Cosmetic Act (FDCA).
September 28, 2023
Certification Request Denied In FCA Suit Over Defective Knee Replacement Devices

TUSCALOOSA, Ala. — An Alabama federal judge denied a motion by an orthopedic device manufacturer to certify for appeal an order denying summary judgment in relators’ suit asserting that the manufacturer violated the federal False Claims Act (FCA) by submitting for reimbursement to government health care programs claims for knee replacement devices it knew were defective, finding that the motion is untimely and will not likely shorten the litigation.
September 27, 2023
Pa. Federal Judge Dismisses FCA Retaliation Claims By Fired Sleep Study Workers

PHILADELPHIA — While a Pennsylvania federal judge said it was “very unfortunate” that two longtime employees of Abington Memorial Hospital were terminated for “minor infractions” or possible retaliation for reporting that the hospital’s sleep center was using recalled continuous positive air pressure (CPAP) sleep apnea devices and respirators on its patients, the complaint failed to plead that the use could have defrauded the federal government, dooming their False Claims Act (FCA) retaliation claim.
September 27, 2023
Decongestant Makers, Retailers Face Class Claims For Selling Ineffective Products

SAN FRANCISCO — Two new putative class lawsuits filed in California federal court accuse multiple defendants of violating California’s unfair competition law (UCL) and other laws by selling decongestant products to millions of consumers that contained an active ingredient that a Food Drug and Administration advisory panel recently agreed is not effective as advertised
September 26, 2023
Woman’s Claims Against Birth Control Device Companies Survive Motions To Dismiss

CHICAGO — A woman’s claim that a defective birth control device can detach and migrate through the body on Sept. 25 survived three motions for summary judgment filed by the manufacturer, distributor and parent company of the device in an Illinois federal court.
September 22, 2023
Experts Out, Summary Judgment Granted In Multivitamin Lead Poisoning Case

CHICAGO — Testimony of causation experts retained by a man who alleges that he developed peripheral neuropathy after taking a multivitamin is inadmissible, and without the testimony, his claims fail, an Illinois federal judge ruled and granted summary judgment to the manufacturer.
September 22, 2023
Insured Failed To Provide Timely Notice Of Opioid Suits, 11th Circuit Affirms

ATLANTA — The 11th Circuit U.S. Court of Appeals on Sept. 21 affirmed a lower federal court’s ruling that an excess insurer has no duty to defend an opioid manufacturer insured against underlying lawsuits arising from the insured’s sale of prescription opioid medications, finding that the insured failed to provide timely notice of the underlying actions.
September 22, 2023
MDL Special Master Pledges Impartiality, Won’t Recuse After Replying All To Email

CLEVELAND — The special master whom two pharmacy benefit managers (PBM) moved to disqualify from the opioid multidistrict litigation responded Sept. 21 in an affidavit declaring that he does “not now have, and [has] never had, any disqualifying personal bias or prejudice toward them (or any other party in the Opioid MDL).”
September 20, 2023
Woman Sues Drug Manufacturers, Says OTC Cold Medicine Not Effective

KANSAS CITY, Mo. — A woman filed a putative class action in a Missouri federal court, alleging that she and others similarly situated purchased over-the-counter (OTC) decongestant products containing phenylephrine (PE) that were ineffective.
September 19, 2023
1st Circuit Says Lactaid Labeling Claims Are Preempted, Affirms Dismissal

BOSTON — The First Circuit U.S. Court of Appeals on Sept. 18 affirmed dismissal of a woman’s claim that she was misled into purchasing Lactaid products, with the appeals court finding that her claims are preempted by the U.S. Food and Drug Administration’s statutory enforcement authority under the Food, Drug and Cosmetic Act (FDCA)
September 18, 2023
Government Urges High Court To Uphold ‘Bedrock Principle’ Of Chevron Deference

WASHINGTON, D.C. — The U.S. secretary of Commerce, two National Oceanic and Atmospheric Administration (NOAA) officials and the National Marine Fisheries Service (NMFS) (collectively, the government) urge the U.S. Supreme Court in a Sept. 15 brief to not overrule the doctrine of Chevron deference in a challenge to fishery regulations that were upheld by the District of Columbia Circuit U.S. Court of Appeals, writing that doing so could “cause disruption” to complex federal regulatory schemes.
September 18, 2023
Expert In Alleged Faulty Knee Implant Case Can Testify, Wash. Federal Judge Rules

SEATTLE — A federal magistrate judge in Washington on Sept. 15 found that an expert retained by a patient who is suing a medical device manufacturer after a failed knee implant can base his conclusions on the notes of the surgeon and denied the manufacturer’s motion to exclude his testimony.