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

Mealey's Drugs & Devices

November 09, 2023
Fla. Federal Judge: Claims Of Unapproved Compounded Drugs Preempted By FDCA

TAMPA, Fla. — A pharmaceutical company accused of selling unapproved compounded drugs containing semaglutide won its bid to dismiss the complaint, with a Florida federal judge finding Nov. 8 that Novo Nordisk Inc.’s claims against the company are preempted by federal law and that Novo Nordisk failed to state a claim under the Florida Deceptive and Unfair Trade Practices Act (FDUTPA).
November 08, 2023
Judge Allows Case Against AmerisourceBergen For Lax Opioid Monitoring To Continue

PHILADELPHIA — A Pennsylvania federal judge largely denied a motion to dismiss filed by drug distributor AmerisourceBergen Corp. and related entities facing allegations that they violated the Controlled Substances Act (CSA) by failing to monitor and control suspicious orders of opioids by pharmacies.
November 07, 2023
Man Alleging Injury Through CoolSculpting Appeals To U.S. Supreme Court

WASHINGTON, D.C. — CoolSculpting manufacturer Zeltiq Aesthetics Inc. on Nov. 6 waived its right to file a response to a petition for a writ of certiorari filed by a man who argues that an appellate court erred in granting the company summary judgment after finding that he was warned about the risk of paradoxical adipose hyperplasia (PAH) and that his claim fails under the risk-utility or consumer expectations tests.
November 07, 2023
Anti-Abortion States Move To Intervene In Texas Suit Opposing FDA Changes

AMARILLO, Texas — Missouri, Kansas and Idaho moved to intervene in a lawsuit challenging the U.S. Food and Drug Administration’s approval of mifepristone and misoprostol, arguing that the current plaintiffs cannot adequately represent the states’ interest and that “there is a serious risk of judicial inefficiency if not all interests are presented at once.”
November 06, 2023
Opioid Distributor Agrees To $12M Consent Decree For Improper Monitoring

SAN JUAN, Puerto Rico — The U.S. Department of Justice on Nov. 6 announced that one of Puerto Rico’s largest distributors of pharmaceutical drugs has entered into a consent decree to pay $12 million to settle allegations that it failed to report suspicious orders for opioids and other controlled substances.
November 06, 2023
Diabetes Drug Manufacturer Moves To Dismiss Suit In Louisiana Federal Court

LAKE CHARLES, La. — The manufacturer of Ozempic on Nov. 3 asked a Louisiana federal court to dismiss claims against it alleging that it failed to warn of risks associated with the diabetes drug.
November 06, 2023
High Court OKs Motion For Divided Argument In Purdue Bankruptcy Plan Dispute

WASHINGTON, D.C. — The U.S. Supreme Court on Nov. 6 approved a motion for divided argument filed by Purdue Pharma LP 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.
November 02, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
November 02, 2023
Parties Debate Whether Other States Can Intervene In Suit Filed Against FDA

SAN FRANCISCO — A group of states and the District of Columbia, which sued the U.S. Food and Drug Administration seeking to block any changes to the FDA’s approval or mifepristone and subsequent changes to its prescribing practices, tell the Ninth Circuit U.S. Court of Appeals in an appellee brief that a lower court correctly denied a motion filed by a group of anti-abortion states to intervene.
November 01, 2023
8th Circuit Denies Appeal Of Remand Order, Says It Lacks Jurisdiction

ST. LOUIS — The Eighth Circuit U.S. Court of Appeals dismissed an appeal filed by a woman who argued that a district court judge erred in denying her motion to remand her case alleging that she was injured by a defective hip implant.
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.