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

Mealey's Drugs & Devices

October 20, 2023
Partial Dismissal Granted In FCA Suit Against Suboxone Maker Over False Pricing

ABINGDON, Va. — A Virginia federal judge lifted a stay and granted partial dismissal in a relator’s qui tam suit alleging that a suboxone manufacturer violated the federal False Claims Act (FCA) and state law false claims acts by falsely reporting best price data for Suboxone, finding that the FCA claims of misreporting best price, making false statements and retaliation must be dismissed but that the relator’s conspiracy and reverse false claims may proceed.
October 19, 2023
Anti-Abortion Advocates: Justices, Hear The Whole Case On Abortion Drugs

WASHINGTON, D.C. — The U.S. Supreme Court should deny a petition for a writ of certiorari filed by the U.S. Food and Drug Administration and the manufacturer of the abortion drug mifepristone, in which it argues that an appellate court erred in finding that the FDA acted unlawfully in removing certain safety measures, but should the court decide to hear the case, then the justices must examine the entire FDA approval history of mifepristone, a group of anti-abortion advocates say in a conditional cross-petition for certiorari.
October 19, 2023
Federal Magistrate: Sales Representatives’ Testimony Irrelevant In Hip Implant Suit

MOBILE, Ala. — A woman suing for injuries connected to her Pinnacle hip implant failed to show how testimony from the manufacturer’s sales representatives is relevant to her claims, an Alabama federal magistrate judge said, denying her request to depose the two representatives who were in the room during her surgeries.
October 18, 2023
Okla. Federal Judge Won’t Bifurcate Class Briefing In Underfilled Drug Vial Case

OKLAHOMA CITY — An Oklahoma federal judge overseeing cases involving claims that a company underfilled vials of the breast cancer drug Herceptin denied a motion filed by the plaintiffs to bifurcate class certification briefing.
October 18, 2023
Settlement Preliminarily Approved For Economic Claims In Recalled CPAP Device MDL

PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million Philips continuous positive air pressure (CPAP) sleep apnea devices and respirators preliminarily approved a $479 million settlement announced in September by to end all economic claims.
October 18, 2023
3 Plaintiffs Lose Motion To Vacate Transfer Order In Bair Hugger MDL

WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) denied motions filed by three plaintiffs to vacate a conditional transfer order who argued that transferring their cases to the MDL pending in a federal court in Minnesota for cases alleging injuries caused by the Bair Hugger patient warmer would delay the proceedings.
October 18, 2023
Suboxone Use Caused Teeth Damage, Ohio Man Alleges In Federal Suit

CLEVELAND — An Ohio man has sued Indivior Inc. and its affiliates in an Ohio federal court alleging that the Suboxone manufacturer failed to warn him that the use of the drug would cause harmful damage to his teeth.
October 17, 2023
$193M False Claims Act Judgment Against Lilly Heads To 7th Circuit On Appeal

CHICAGO — Both parties are appealing a final judgment of $193 million against Eli Lilly & Co. stemming from a False Claims Act jury verdict, with the relator and Lilly suggesting in a joint status report that the Seventh Circuit U.S. Court of Appeals consolidate the proceedings.
October 17, 2023
Defense Verdict Delivered For Knee Implant Maker In Washington Federal Case

SEATTLE — A Washington federal jury returned a defense verdict for DePuy Synthes Sales Inc., rejecting claims that the medical device manufacturer negligently designed its knee replacement device or failed to warn users of associated risks.
October 16, 2023
Supreme Court Grants Certiorari In 2nd Challenge To Chevron Deference

WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 13 granted a petition for a writ of certiorari in a second case challenging the doctrine of Chevron deference and ordered that it be briefed on a schedule allowing argument “in tandem” with a pending case pertaining to the same issue, both of which involve challenges to regulations that require fishing vessels to pay federal monitors.
October 16, 2023
Arizona Man Pleads Guilty To Misclassifying Medical Device To Treat Migraines

SALT LAKE CITY — An Arizona man pleaded guilty to two misdemeanor counts in connection with the introduction of misbranded and adulterated medical devices into interstate commerce, according to a U.S. District Court for the District of Utah docket entry.
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.