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

Mealey's Drugs & Devices

November 01, 2023
Bard Port Catheter MDL Judge Sets Rules For Common Fees, Expenses

PHOENIX — The federal judge overseeing the multidistrict litigation involving C.R. Bard Inc.’s implanted port catheter device has released two case management orders involving common fees and expenses and instructions on keeping him abreast of developments in related cases.
November 01, 2023
PBMs To 6th Circuit: Order Recusal Of Special Master Over Reply-All Email Error

CINCINNATI — Two pharmacy benefit managers (PBMs) involved in the opioid multidistrict litigation have filed a petition for a writ of mandamus asking the Sixth Circuit U.S. Court of Appeals to order a district court judge to disqualify the special master who is accused of bias after he inadvertently sent a personal email to the parties.
November 01, 2023
FDA Announces Recall Of Surgical Device; 1 Death Reported

SILVER SPRING, Md. — The U.S. Food and Drug Administration has announced a recall of the Olympus High Flow Insufflation Unit, a device used during medical procedures, because the unit may over-insufflate (inflate) air into the body with no warning or alarm.
October 31, 2023
Alabama Federal Judge Tosses Remanded Taxotere Case For Failure To State a Claim

BIRMINGHAM, Ala. — An Alabama federal judge agreed to dismiss a woman’s claim that her use of a cancer drug caused permanent hair loss after finding that she failed to plead her claims and that they are barred by the statute of limitations.
October 31, 2023
Lilly Asks Judge To Toss Case Alleging Stomach Injury From Diabetes Drug

LAKE CHARLES, La. — Eli Lilly & Co. moved to dismiss a complaint alleging that it failed to warn of risks associated with the Mounjaro diabetes drug, arguing that the claims in the “shotgun” pleading are preempted by federal and Louisiana laws.
October 31, 2023
N.J. Appeals Court Overturns Summary Judgment For Pharmacies In Overdose Case

TRENTON, N.J. — A lower court erred in granting summary judgment to a group of pharmacies accused by a New Jersey father of committing malpractice in filling his daughter’s prescriptions, which resulted in her death, an appellate court ruled, remanding the case.
October 31, 2023
Massachusetts Federal Judge: Statute Of Limitations Bars Pelvic Mesh Injury Case

BOSTON — A federal judge in Massachusetts found that a woman who claims injury caused by pelvic mesh was on notice at least by the date the U.S. Food and Drug Administration issued its second public health notification warning of complications, making her complaint “untimely by six years.”
October 30, 2023
Purdue Asks For Divided Arguments In Supreme Court Case Over Bankruptcy Plan

WASHINGTON, D.C. — Purdue Pharma L.P. and the creditors that are part of the multibillion-dollar opioid bankruptcy settlement that included a liability release for members of the formerly controlling Sackler family filed a joint motion in the U.S. Supreme Court on Oct. 27, asking that time for arguments be divided between them.
October 30, 2023
Company Moves To Dismiss Case Alleging It Is Selling Lilly Drug Knock-Off

TAMPA, Fla. — A company alleged to be selling unauthorized drugs in violation of Florida law moved to dismiss the complaint in a Florida district court because neither Florida nor federal law allows a private cause of action.
October 30, 2023
Boston Scientific Wins Partial Dismissal In Faulty Device Suit In Washington

SEATTLE — A Washington federal judge agreed to partially dismiss a lawsuit filed against a medical device manufacturer alleging that a faulty bladder device leaked and needed to be replaced but granted the couple leave to amend their complaint.
October 26, 2023
Direct Purchasers, Suboxone Maker Reach $385M Settlement Agreement In Antitrust MDL

PHILADEPHIA — Direct purchaser plaintiffs in the Suboxone/buprenorphine multidistrict litigation on Oct. 25 asked a Pennsylvania federal judge to grant preliminary approval of a $385 million settlement to resolve a 10-year-old complaint that drugmaker Indivior Inc. engaged in anti-competitive behavior that caused them to pay higher prices for Suboxone brand buprenorphine, a drug used to treat opioid use disorder.
October 26, 2023
Self-Administered Flu Vaccine May Be Available Next Year, AstraZeneca Says

The U.S. Food and Drug Administration has accepted for review AstraZeneca’s Supplemental Biologics License Application (sBLA) to approve its self- or caregiver-administered option for a needle-free nasal spray flu vaccine, the biopharmaceutical company announced.
October 24, 2023
Bankruptcy Settlement Plan Needs To Be Upheld, Purdue Pharma Tells High Court

WASHINGTON, D.C. — The U.S. Supreme Court should affirm the Second Circuit U.S. Court of Appeals’ approval of a multibillion-dollar Purdue Pharma LP opioid bankruptcy settlement that included a liability release for members of the formerly controlling Sackler family or dismiss the writ of certiorari as improvidently granted, Purdue Pharma argues it is respondent brief.
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.