Mealey's Drugs & Devices
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July 31, 2023
2nd Circuit Affirms Summary Judgment In Lexapro-Autism Case On Expert’s Exclusion
NEW YORK — The Second Circuit U.S. Court of Appeals on July 28 affirmed the exclusion of a causation expert and summary judgment in a Lexapro autism case brought by seven mothers, agreeing that the key expert’s opinion was not sufficiently reliable and without it the plaintiffs failed to show causation.
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July 31, 2023
3rd Circuit: Unapproved Drug Ingredient Doesn’t Create ‘New Drug’ Liability
PHILADELPHIA — The Third Circuit U.S. Court of Appeals affirmed a trial court ruling that a generic drugmaker’s failure to disclose active ingredients from an unauthorized supplier did not constitute the introduction of a “new drug” in criminal violation of the Food, Drug and Cosmetic Act.
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July 28, 2023
Summary Judgment Granted In Alleged Defective Medical Device Case, Expert Excluded
GREENEVILLE, Tenn. — A Tennessee federal judge ruled that a retained expert in a defective medical device case “either did not measure the suture or her measurements of the suture are impossible” and excluded the testimony and found that without her testimony, summary judgment is appropriate.
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July 27, 2023
16 Years On, Third-Party Payers Seek Certification Of Avandia Buyers Class
PHILADELPHIA — Nearly 16 years after Avandia litigation started, a motion has been filed in a multidistrict litigation court to certify a class of third-party payers who bought the diabetes pill.
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July 27, 2023
2nd Circuit Denies Stay Of Purdue Pharma Bankruptcy Mandate Pending Cert Bid
NEW YORK — The Second Circuit U.S. Court of Appeals has denied a motion by a United States bankruptcy trustee to stay the court’s mandate allowing the release of third-party claims against Purdue Pharma LP’s controlling Sackler family pending disposition of a petition for a writ of certiorari by the U.S. Supreme Court.
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July 26, 2023
New Jersey Supreme Court: 510(k) Evidence Should Be Allowed In Pelvic Mesh Trial
TRENTON, N.J. — In a 5-0 decision, the New Jersey Supreme Court on July 25 said evidence about the Food and Drug Administration’s 510(k) clearance of two pelvic mesh devices has significant probative value under the state’s rules of evidence and is not outweighed by the risk of prejudice and potential juror confusion.
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July 26, 2023
11th Circuit Affirms Summary Judgment In CoolSculpting Case Alleging Lumpy Result
ATLANTA — The 11th Circuit U.S. Court of Appeals affirmed summary judgment for CoolSculpting manufacturer Zeltiq Aesthetics Inc., agreeing with a district court that a plaintiff was warned about the risk of paradoxical adipose hyperplasia (PAH) and that the claim fails under the risk-utility or consumer expectations tests.
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July 25, 2023
3rd Circuit: Amiodarone Warning Claims Are Preempted By Federal Duty Of Sameness
PHILADELPHIA — The Third Circuit U.S. Court of Appeals on July 24 sidestepped a question about whether a generic drugmaker adequately warned about the risks of the heart drug amiodarone under New Jersey’s product liability law because it found that the claims are preempted by federal law.
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July 25, 2023
Federal Circuit: Vaccine Claimant Should Decide About Alternative Claim
WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals on July 24 reversed denial of an influenza vaccine injury claim, saying the plaintiff’s original attorney was grossly negligent to disclaim significant aggravation even after a vaccine court special master invited him to do so.
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July 24, 2023
10th Circuit Affirms Dismissal Of Levaquin Nerve Injury Case As Time-Barred
DENVER — The 10th Circuit U.S. Court of Appeals on July 21 affirmed dismissal of a Levaquin nerve injury complaint, saying that the plaintiff’s claim was not saved by Oklahoma’s discovery rule and that the plaintiff did not identify any evidence that would be found if the trial court conducted an evidentiary hearing.
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July 24, 2023
5th Circuit: Whether Device Claim Is Prescribed Is A Question For A Jury
NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on July 21 vacated summary judgment in a Biomet Inc. infected shoulder prosthesis case and remanded it for further proceedings after finding that the question of whether the plaintiff’s claim had prescribed under Louisiana state law is “best left for the jury to decide.”
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July 21, 2023
Device Maker’s Ex-Employee Pleads Guilty To Faking FDA 510(k) Clearance Letters
ALLENTOWN, Pa. — A former regulatory affairs specialist for a U.S. subsidiary of drug and medical device maker B. Braun AG pleaded guilty on July 20 in a Pennsylvania federal court to one count of violating the Food, Drug and Cosmetic Act (FDCA) by counterfeiting and forging FDA clearance letters for two medical devices and making the devices adulterated and misbranded.
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July 20, 2023
Texas Attorney General: Walmart Settles Opioid Claims For $168M
AUSTIN, Texas — The Texas Attorney General’s Office in a July 19 press release announced that it has finalized a $168 million opioid settlement with retail chain Walmart Inc.
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July 19, 2023
Judge Rules On Judgment Motions In FCA Suit Against Teva Over Co-Pay Kickbacks
BOSTON —A Massachusetts federal judge “allowed” the government’s motion for partial summary judgment in its suit alleging that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. violated the False Claims Act (FCA) and Anti-Kickback Statute (AKS) by using co-pay subsidies as kickbacks when selling a multiple sclerosis (MS) drug, finding in part that violating the “AKS is per se material” for claims under the FCA.
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July 19, 2023
Bankruptcy Trustee Seeks Stay To Appeal Purdue Pharma 2nd Circuit Ruling To High Court
NEW YORK — A United States bankruptcy trustee has asked the Second Circuit U.S. Court of Appeals to stay a mandate that releases third-party claims against Purdue Pharma LP’s controlling Sackler family, saying he intends to file a petition for a writ of certiorari this month with the U.S. Supreme Court at the authorization of the U.S. solicitor general.
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July 18, 2023
Mass Tort Cases For Drugs, Medical Devices
New developments in the following mass tort drug and device cases are marked in boldface type.
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July 18, 2023
Silicone Implant Lupus Complaint Dismissed As Time-Barred
EUGENE, Ore. — An Oregon federal judge has dismissed the complaint of a woman who claims that her ruptured silicone breast implant caused her to develop the autoimmune disease lupus, finding that she filed her complaint beyond Oregon’s two-year statute of limitations and that the claim was not tolled.
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July 18, 2023
Florida Appeals Court: Trial Court Must Finalize Pelvic Mesh Discovery Order
MIAMI — A Florida state appeals court has granted a petition for mandamus compelling a state trial court to enter an appealable final judgment in a pelvic mesh discovery lawsuit.
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July 18, 2023
Wholesale Opioid Exec Ends Appeal Of Criminal Conviction, Begins Prison Sentence
NEW YORK — Ex-wholesale drug distributor CEO Laurence F. Doud III has withdrawn his Second Circuit U.S. Court of Appeals appeal of his conviction for violating federal drug laws by allowing suspicious opioid orders by pharmacies and by misleading the Drug Enforcement Agency about those orders and has begun serving his 27-month sentence.
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July 18, 2023
Opioid MDL Judge OKs Plaintiffs’ Access To Updated DEA Drug Database
CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation has granted a motion by the Plaintiffs’ Executive Committee (PEC) to enforce a subpoena on the Drug Enforcement Administration to produce updated opioid drug distribution data from the agency’s ARCOS data base, saying it is relevant to pending litigation.
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July 18, 2023
Walgreens Settles Nevada’s Opioid Litigation For $295M, Attorney General Says
CARSON CITY, Nev. — The Nevada attorney general says the state has reached a settlement with pharmacy chain Walgreens Boots Alliance Inc. to settle the state’s opioid lawsuit for $285 million.
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July 18, 2023
Martin Shkreli Wants $93M In Indemnification From His Former Drug Company
WILMINGTON, Del. — Banned drug executive and convicted securities fraudster Martin Shkreli has filed a claim with the U.S. Bankruptcy Court for the District of Delaware in the Chapter 11 bankruptcy of Vyera Pharmaceuticals LLC and related entities for $93 million in employee indemnification.
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July 17, 2023
Gilead/Teva HIV Drug Patent Settlement Wasn’t Reverse Payment, Jury Finds
SAN FRANCISCO — A California federal jury has found that third-party payers and health insurers did not prove that an HIV patent settlement between Gilead Sciences Inc. and Teva Pharmaceuticals USA Inc. violated the federal antitrust law by including a reverse payment under which Teva delayed making and selling generic versions of the drugs Truvada and Atripla.
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July 17, 2023
Electronic Health Record Vendor NextGen Pays $31M To Settle False Claims Suit
BURLINGTON, Vt. — NextGen Healthcare Inc., an electronic health record (EHR) vendor, will pay $31 million to settle allegations by the United States and two whistle-blowers that it manipulated its product to avoid failure to meet federal requirements and paid kickbacks for health care providers to buy the company’s system, according to an intervention complaint and settlement filed in the U.S. District Court for the District of Vermont.
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July 17, 2023
Judge In BHR Hip MDL Denies Summary Judgment For Smith & Nephew
BALTIMORE — The Maryland federal judge overseeing the Birmingham Hip Resurfacing (BHR) metal-on-metal hip multidistrict litigation has denied without prejudice a motion by defendant Smith & Nephew Inc. for summary judgment in 40 “early implant cases” involving hips implanted before October 2009, saying a one-size-fits-all approach doesn’t serve individual cases.