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

Mealey's Drugs & Devices

August 16, 2023
8th Circuit: Pharmacies OK Denying Ivermectin, Hydroxychloroquine For COVID

ST. LOUIS — The Eighth Circuit U.S. Court of Appeals has affirmed that Minnesota law does not recognize a right of “self-determination” that overrides the judgment of the Food and Drug Administration, medical organizations and two pharmacies that ivermectin and hydroxychloroquine cannot be dispensed off-label to treat COVID-19.
August 16, 2023
Panel Refuses To Rehear D&O Coverage Suit Over Insured’s Settlement With Government

CHICAGO —The Seventh Circuit U.S. Court of Appeals refused to reconsider its finding that a directors and officers liability insurer owes the insured its $10 million policy limit for the $100 million the insured paid the U.S. government to settle potential claims that it violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), standing by its affirmation of a federal court’s summary judgment ruling in favor of the insured.
August 15, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
August 15, 2023
7th Circuit Affirms $3.3M Bard IVC Filter Verdict; 510(k) Properly Excluded

CHICAGO — The Seventh Circuit U.S. Court of Appeals affirmed a $3.3 million inferior vena cava (IVC) filter verdict against C.R. Bard Inc., ruling that the trial court did not err by excluding evidence about the device’s 510(k) approval or by reopening the plaintiffs’ case to hear testimony from the reluctant implanting physician.
August 15, 2023
CGL Insurers Dispute Coverage For Claims That Insured Contributed To Opioid Crisis

SPARTANBURG, S.C. — Commercial general liability insurers filed suit in a South Carolina federal court seeking a declaration that they have no duty to defend or indemnify against governmental entities’ underlying lawsuits alleging that their insured caused or contributed the opioid crises by improperly marketing, distributing and selling opioid medications.
August 15, 2023
Colorado Appeals Court: Split Verdict In Skin Resurfacing Case Not Inconsistent

DENVER — The Colorado Court of Appeals affirmed a $2.87 million judgment in a dermal resurfacing device injury case, finding that the learned intermediary doctrine did not bar verdicts for negligent marketing and misrepresentation and that the plaintiff’s claim of off-label marketing was not an attempt to enforce federal regulation of the device.
August 15, 2023
8th Circuit: Pelvic Mesh Expert’s Expanded Opinion Was Untimely

ST. LOUIS — The Eighth Circuit U.S. Court of Appeals has affirmed the exclusion of a plaintiff’s causation expert and summary judgment for the defendant in a pelvic mesh case, finding that the expert’s original opinion was insufficient, that an attempted supplement was untimely and that the plaintiff did not ask for a sanction other than summary judgment.
August 15, 2023
Brain Scan Maker, Founder Pay $445,000 For Giving Unfit Medicare Billing Codes

PHILADELPHIA — A medical device company and its co-founder will pay $445,000 to settle a False Claims Act complaint accusing them of promoting false billing codes for their eVox brain mapping device, according to a press release from the U.S. Attorney’s Office for the Eastern District of Pennsylvania.
August 15, 2023
Texas Settles Whistleblower Drug Fraud Claims Against Drugmakers For $42M

AUSTIN, Texas — The Texas Attorney General’s Office said in a press release that its Civil Medicaid Fraud Division has settled whistleblower claims involving the prescription drug Vyvanse against drugmakers Shire PLC, Baxter International Inc., Baxalta Inc., Viropharma Inc., Takeda Pharmaceuticals USA Inc. and Takeda Pharmaceuticals America for more than $42 million.
August 15, 2023
Teva, Acute-Care Hospitals Reach $126M Opioid, $49M Antidote Settlement

TEL AVIV, Israel — Drugmaker Teva Pharmaceutical Industries Ltd. told stockholders that it and acute care hospitals have reached an agreement in principle on the financial terms of a $126 million, 18-year settlement plus up to $49 million worth of the company’s naloxone overdose reversal drug for up to seven years.
August 15, 2023
Judge Tosses Qui Tam Action Alleging Government Misled By Merck’s Mumps Vaccine

PHILADELPHIA — A Pennsylvania federal judge found that “no reasonable jury could conclude that the alleged false claims were material to the [Centers for Disease Control and Prevention’s] purchasing decisions” and dismissed a qui tam action filed by two former Merck & Co. Inc. employees who allege that Merck violated the False Claims Act, 31 U.S.C. §§ 3729–3733, in its sale of its MMR-II and ProQuad mumps vaccines to the centers.
August 14, 2023
Federal Insulin Pricing Cases Centralized In MDL Before Judge Martinotti In New Jersey

WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) has centralized 13 federal insulin pricing lawsuits in a multidistrict litigation and assigned the MDL to Judge Brian R. Martinotti of the U.S. District Court for the District of New Jersey.
August 11, 2023
Judge In Acetaminophen Autism/ADHD MDL Denies J&J’s Interlocutory Appeal

NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation has denied a motion by Johnson & Johnson Consumer Inc. (JJCI) for certification of an interlocutory appeal of her orders denying two motions to dismiss on the grounds of preemption and lack of causation.
August 11, 2023
Pa. Federal Judge Pares Claims Against Manufacturer For Defective Breast Implant

PITTSBURGH — A woman asserting that a defective breast implant caused her to develop a rare cancer saw part of her complaint dismissed when a Pennsylvania federal judge ruled that she failed to adequately make a claim against the parent company and a subsidiary and that certain of her claims against the manufacturer are preempted by federal law.
August 11, 2023
Supreme Court Stays Purdue Pharma Bankruptcy Pending Sackler Liability Arguments

WASHINGTON, D.C. — In a single order granted after just 12 days of filings, the U.S. Supreme Court on Aug. 10 recalled and stayed the Second Circuit U.S. Court of Appeals' mandate approving the multibillion-dollar Purdue Pharma LP opioid bankruptcy settlement, granted a bankruptcy trustee’s suggestion to treat his application as a petition for a writ of certiorari and ordered a briefing schedule to hear arguments in December on whether the U.S. Bankruptcy Code allows claims against nondebtor members of the formerly controlling Sackler family to be released.
August 10, 2023
MDL For Bard Port Catheters Created, Sent To Judge Campbell In Arizona

WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) has centralized 48 cases alleging injury from C.R. Bard Inc.’s implanted port catheter device before Judge David G. Campbell of the U.S. District Court for the District of Arizona.
August 04, 2023
9th Circuit Reverses FCA Dismissal, Says Public Disclosure Bar ‘Not Triggered’

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Aug. 3 reversed and remanded an order dismissing a relator’s qui tam suit alleging violations of the federal False Claims Act (FCA) against pharmaceutical companies related to their alleged fraud by artificially inflating drug prices, finding that the suit was not precluded by the public disclosure bar because none of the public disclosures “made a direct claim” that the pharmaceutical companies committed fraud.
August 02, 2023
Motion To Compel Discovery Of Communications Granted In FCA Suit Against Medtronic

KANSAS CITY, Kan. — A Kansas federal magistrate judge granted Medtronic and its related company’s motion to compel discovery in a relator’s qui tam suit alleging that they violated the federal 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 requested communications are relevant and not privileged.
August 02, 2023
Abiomed Recalls All Impella Heart Pumps After 4 Reported Deaths, 26 Injuries

SILVER SPRING, Md. — Abiomed Inc. has recalled all 7,895 of its Impella Left Sided Blood Pumps due to defective instructions for use, with 26 reported injuries and four deaths, according to the Food and Drug Administration.
August 01, 2023
McKinsey MDL Judge: Drug Consultant Owed No Duty To Opioid Babies, Parents

SAN FRANCISCO — The California federal judge presiding over the McKinsey & Co. opioid promotion multidistrict litigation has granted the consulting company’s motion to dismiss the claims of eight sets of plaintiffs suing on behalf of minors born with neonatal abstinence syndrome (NAS), saying the plaintiffs failed to show that the defendant owed them a duty.
August 01, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
August 01, 2023
Abbott Withdraws Trifecta Heart Valves Due To Early Deterioration

SILVER SPRING, Md. — Abbott Laboratories on July 31 announced in a “dear doctor’ letter that it is withdrawing its Trifecta line of artificial heart valves due to early structural valve deterioration (SVD). The withdrawal was also announced by the Food and Drug Administration.
August 01, 2023
Washington Appeals Court Reverses Medicaid Data Order In Opioid Case

SEATTLE — The Washington Court of Appeals on July 31 reversed a state trial court’s ruling allowing the release of certain information about opioid-related Medicaid claims to defendants Johnson & Johnson and Janssen Pharmaceuticals Inc.
August 01, 2023
2nd Circuit Issues Mandate In Purdue Pharma Case 4 Days After High Court Appeal

NEW YORK — The Second Circuit U.S. Court of Appeals on July 31 issued a mandate in the Purdue Pharma LP bankruptcy appeal, sending the case back to a district court four days after the bankruptcy trustee asked the U.S. Supreme Court to stay the mandate pending his filing of a petition for a writ of certiorari.
August 01, 2023
Purdue Pharma Bankruptcy Trustee Asks Supreme Court To Stay 2nd Circuit Mandate

WASHINGTON, D.C. — U.S. Supreme Court Justice Sonia Sotomayor has given OxyContin maker Purdue Pharma LP and backers of its bankruptcy reorganization plan until noon on Aug. 4 to respond to an application by the bankruptcy trustee for a stay of a Second Circuit U.S. Court of Appeals mandate that would release Sackler family members from civil liability for their role in the opioid crisis.