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

Mealey's Drugs & Devices

October 16, 2023
Man Sues Walgreens For Sale Of Ineffective Decongestants, Seeks Class Action

CHICAGO — A man filed a putative class action in an Illinois federal court against pharmacy chain Walgreens for selling its brand of decongestant products that contained an active ingredient that a Food Drug and Administration advisory panel recently agreed is not effective as advertised.
October 13, 2023
14 Amicus Briefs Filed Urging High Court To Grant Cert In Abortion Drug Case

WASHINGTON, D.C. — A group of 24 states, a coalition of faith-based organizations and the generic manufacturer of the abortion drug mifepristone were among 14 entities that filed amicus curiae briefs with the U.S. Supreme Court on Oct. 12, urging it to grant a writ of certiorari to determine whether a circuit court erred in upholding a district court’s stay of the U.S. Food and Drug Administration’s 2016 amendments to mifepristone’s approval and the agency’s 2021 decision not to enforce its regulations during the COVID-19 pandemic.
October 13, 2023
Summary Judgment Denial In Vaccine Antitrust Case Wins Interlocutory Appeal

PHILADELPHIA — A Pennsylvania federal judge has granted Merck & Co. Inc. certification of an interlocutory appeal of his decision to deny its motion for summary judgment in an antitrust complaint by three health care providers that Merck engaged in anti-competitive behavior to thwart a competitor and caused the providers to pay more for the mumps vaccine.
October 13, 2023
MDL Judge: Experts Can Opine Only On General Causation In Vaccine Injury Case

PHILADELPHIA — Experts retained by a man who alleges that his shingles vaccine caused him to develop Guillain-Barré syndrome (GBS) can speak on general causation but are barred from opining on specific causation, the Pennsylvania federal judge overseeing the Zostavax multidistrict litigation ruled.
October 13, 2023
North Carolina Judge Dismisses Set Of Insureds’ Claims In Opioid Coverage Dispute

WINSTON-SALEM, N.C. — A North Carolina judge found that one set of insureds in a coverage dispute arising from the opioid epidemic filed their declaratory relief lawsuit in an attempt to avoid their home state of Ohio and the Ohio Supreme Court’s holding in Acuity v. Masters Pharm., Inc., partly granting insurers’ motion to dismiss.
October 12, 2023
High Court Announces Oral Arguments In Bankruptcy Release Of Sackler Family Case

WASHINGTON, D.C. — The U.S. Supreme Court will hear oral arguments Dec. 4 on whether the U.S. Bankruptcy Code allows for a plan of reorganization that releases nondebtor third parties from liability, a dispute stemming from the multibillion-dollar Purdue Pharma LP opioid bankruptcy settlement that included a liability release for members of the formerly controlling Sackler family, the court announced Oct. 12.
October 11, 2023
Pfizer Will Pay $50 Million To Resolve Antitrust Claims Involving EpiPen

KANSAS CITY, Kan. — Pfizer Inc. has agreed to pay $50 million to settle claims that it conspired with others in an attempt to delay entry of generic competitors for the EpiPen epinephrine autoinjector (EAI) into the market, according to a memorandum filed by the plaintiffs’ counsel on Oct. 10.
October 11, 2023
Motion To Disqualify Opioid MDL Special Master For Reply-All Email Error Fails

CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on Oct. 11 denied a motion filed by two pharmacy benefit managers (PBM) to disqualify the special master who was accused of bias after he inadvertently sent a personal email to the parties.
October 10, 2023
Wrong Zimmer Named In Defective Device Case, Defendant Asserts In Answer

DES MOINES, Iowa — Zimmer U.S. Inc. removed a case alleging that Zimmer designed, manufactured and sold a defective hip implant device to the U.S. District Court of the Southern District of Iowa and filed an answer on Oct. 9, asserting 45 affirmative defenses.
October 10, 2023
Claims That IUD Increased Cancer Risks Partially Survive Motion To Dismiss

SAN JOSE, Calif. — A woman’s class claims that an intrauterine device is not suitable for birth control because it increases the risk of breast cancer in users partially survived a motion to dismiss, with a California federal judge refusing to consider the merits of the studies the woman cited at the pleading stage of the case.
October 09, 2023
MDL Judge: Causation Expert Out In Zostavax Injury Bellwether Case

PHILADELPHIA — The Pennsylvania federal judge overseeing the Zostavax multidistrict litigation found that proposed testimony from the causation expert retained by the next bellwether plaintiff is inadmissible under Daubert v. Merrell Dow Pharmaceuticals Inc.
October 09, 2023
FDA ‘Unsatisfied With The Status Of’ CPAP Device Recall; New Website Launched

WASHINGTON, D.C. — The U.S. Food and Drug Administration voiced its dissatisfaction with the process for the recall of continuous positive air pressure (CPAP) devices, bi-level positive air pressure (Bi-PAP) devices and ventilators made by Philips Respironics and announced the launch of a new website “to ensure consumers have the latest information on the Philips' recall.”
October 06, 2023
Magistrate Denies Relator’s Bid To Reopen Discovery In FCA Suit Against Medtronic

KANSAS CITY, Kan. — A Kansas federal magistrate judge on Oct. 5 denied a relator’s request to reopen discovery in his qui tam suit alleging that Medtronic and its related company and a hospital violated the False Claims Act (FCA) by participating in a scheme to provide medically unnecessary treatment resulting in the submission of false claims for payment to federal health care programs, finding that the relator failed to establish good cause to reopen discovery.
October 05, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
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.”