Mealey's Drugs & Devices
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June 18, 2019
Manufacturing Defect Claim Out, Warnings Claims In In IVC Injury Case
SAN JOSE, Calif. — A California federal judge on May 13 dismissed a manufacturing defect claim with prejudice in an inferior vena cava (IVC) filter case but said the plaintiff’s failure-to-warn claim survives dismissal (Sandra Broge v. ALN International, Inc., No. 17-7131, N.D. Calif., San Jose Div., 2019 U.S. Dist. LEXIS 80507).
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June 14, 2019
Opioid MDL Judge OKs Tribes’ Claims Except For Negligence Per Se
CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on June 13 adopted almost all of a magistrate judge’s recommendations preserving the right of two Native American tribes to sue manufacturers, distributors and pharmacies (In Re: National Prescription Opioid Litigation, [Muscogee (Creek) Nation v. Purdue Pharma L.P., et al., No. 18-op-45749, and The Blackfeet Tribe of the Blackfeet Indian Reservation v. AmerisourceBergen Drug Corporation, et al., No. 18-op-45749], MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).
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June 14, 2019
Florida Objects To Certain Insys Payments Listed In Bankruptcy Petition
WILMINGTON, Del. — The state of Florida on June 11 filed limited objections in the Insys Therapeutics Inc. Chapter 11 bankruptcy case and asked the court to require the opioid maker to provide a more detailed analysis of payments the company wants the court to approve (In Re: Insys Therapeutics, Inc., et al., No. 19-11292, U.S. Bkcy., Del.).
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June 14, 2019
Judge In Mirena Brain Injury MDL Grants Summary Judgment For Lack Of Causation
NEW YORK — The New York federal judge overseeing the Mirena brain injury multidistrict litigation on June 11 granted summary judgment to defendant Bayer Corp. after he rejected the plaintiffs’ argument that they can still prove causation even after the court excluded their experts (In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation [No. II], Nos. 17-md-2767, S.D. N.Y., 2019 U.S. Dist. LEXIS 97904).
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June 14, 2019
Connecticut Opioid Appeals Go To State High Court; Settlement Talks ‘Ongoing’
HARTFORD, Conn. — The appeal by two Connecticut cities of a trial court’s dismissal of their lawsuits against several opioid makers and drug distributors was transferred June 11 from the state’s Appellate Court to the Connecticut Supreme Court (New Haven, et al. v. Purdue Pharma L.P., et al., No. S.C. 20313, Conn. Sup.).
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June 13, 2019
Medical Device Maker Pleads Guilty To ‘Silent Recall,’ Pays $15M In Settlements
BALTIMORE — Medical device maker ACell Inc. on June 11 pleaded guilty to a federal misdemeanor charge of failing to report a device recall and agreed to pay $15 million in criminal and civil penalties (United States v. ACell, Inc., No. 19-cr-282, United States, ex rel. John J. Murtaugh v. ACell, Inc., No. 13-1820, D. Md.).
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June 11, 2019
Minnesota Appeals Court Affirms Preemption Summary Judgment In Heart Device Case
ST. PAUL, Minn. — The Minnesota Court of Appeals on June 10 affirmed preemption summary judgment in a Medtronic Inc. heart device case and the exclusion of a plaintiff expert’s testimony about whether the manufacturer complied with requirements of the Food and Drug Administration (Donna Delfino v. Medtronic, Inc., No. A18-1462, Minn. App., 2019 Minn. App. Unpub. LEXIS 530).
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June 10, 2019
2 NECC Defendants Acquitted: Unclear FDA Regulation Created Legal Impossibility
BOSTON — The Massachusetts federal judge presiding in the New England Compounding Center (NECC) criminal case on June 7 acquitted two previously convicted defendants because “unclear” regulation of the compounding drug company by the Food and Drug Administration at the time of the defendants’ alleged offenses was a “legal impossibility” (United States v. Gregory Conigliaro, et al., No. 14-cr-10363, D. Mass., 2019 U.S. Dist. LEXIS 96453).
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June 10, 2019
Opioid Maker Insys Files Voluntary Chapter 11 Bankruptcy Petition
WILMINGTON, Del. — Opioid maker Subsys Therapeutics Inc. on June 10 filed a voluntary petition for bankruptcy reorganization and said it intends to sell “substantially all” of the company’s assets and address its “legacy legal liabilities,” including $243 million owed to the United States and millions owed to 21 law firms that make up most of its top 30 unsecured creditors (In Re: Insys Therapeutics, Inc., No. 19-11292, D.Del. Bkcy., Del.).
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June 07, 2019
Federal Circuit Reverses Denial Of Gardasil HPV Vaccine Injury Petition
WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals on June 5 reversed and remanded a vaccine court denial of a claim that a girl was injured by the Gardasil human papillomavirus (HPV) vaccine, finding that dismissal was an abuse of discretion by a special master (Patrice Moczek, et al. v. Secretary of Health and Human Services, No. 18-2341, Fed. Cir., 2019 U.S. App. LEXIS 16902).
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June 06, 2019
On Same Day Mallinckrodt Settles For $15.4M, United States Sues Over Drug Co-Pays
On the same day Mallinckrodt plc said it reached a $15.4 million agreement-in-principal to settle a U.S. Justice Department investigation into improper sales and marketing by subsidiary Questcor Pharmaceuticals Inc., the Justice Department on June 5 filed a federal complaint alleging that Mallinckrodt contributed to a drug co-pay program at the same time it increased a drug’s price from double to quintuple digits (United States of America, ex rel. Charles Strunck, et al., No. 12-175, E.D. Pa.).
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June 06, 2019
Opioid Maker Insys Pleads Guilty, Pays $225M In Fines, False Claims Settlement
BOSTON — A subsidiary of opioid manufacturer Insys Therapeutics Inc. on June 5 pleaded guilty to mail fraud and the parent company agreed to pay $225 million in fines, forfeiture and civil settlement of five whistleblower lawsuits alleging that the company paid kickbacks to doctors to prescribe the fentanyl-based pain drug Subsys (United States of America v. Insys Therapeutics, Inc., et al., No. 19-cr-10191, D. Mass.).
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June 05, 2019
Internal Probe Of Graft Maker MiMedx Finds Inflated Sales, Retaliation By Execs
MARIETTA, Ga. — Surgical graft processor MiMedx Group Inc. on May 23 released an internal audit investigation report that showed that the company’s former executives inflated sales figures, secretly recorded and retaliated against whistle-blowers, set an inappropriate “tone at the top” and possibly violated the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b).
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June 05, 2019
Suit Alleging Gilead Held Back Safer HIV Drug Partially Dismissed, Can Be Amended
SAN FRANCISCO — A California federal judge on May 10 granted in part and denied in part a motion by drug maker Gilead Sciences Inc. to dismiss a 140-plaintiff complaint that the company knowingly delayed the introduction of a less toxic HIV drug ingredient to preserve sales of earlier versions (Adrian Holley, et al. v. Gilead Sciences, Inc., No. 18-6972, N.D. Calif., 2019 U.S. Dist. LEXIS 79620).
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June 05, 2019
Spanish Drug Company Pays $7.51M To Resolve Federal, California Kickback Claims
PHILADELPHIA — Spanish pharmaceutical company Almirall LLC has agreed to pay a combined $7.51 million to the United States and California to settle allegations that one of its acquisitions, Aqua Pharmaceuticals LLC of Pennsylvania, paid kickbacks to physicians to prescribe the companies’ dermatology drugs, a U.S. attorney’s office announced May 29 (United States, ex rel. John Doe v. Aqua Pharmaceuticals LLC, et al., No. 15-5086, E.D. Pa.).
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June 05, 2019
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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June 05, 2019
Valsartan MDL Judge Names Plaintiff, Defense Leadership
CAMDEN, N.J. — The New Jersey federal judge overseeing the valsartan multidistrict litigation on May 6 appointed plaintiff and defense counsel to leadership positions (In Re: Valsartan Products Liability Litigation, MDL Docket No. 2875, No. 19-md-2875, D. N.J., Camden Vicinage).
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June 05, 2019
Gadolinium Claim Time-Barred By Plaintiff’s Admission To FDA Committee
CLEVELAND — An Ohio federal judge on May 15 dismissed a woman’s gadolinium contrast agent injury lawsuit as time-barred after defendant Bayer Healthcare Pharmaceuticals Inc. turned up the plaintiff’s public testimony that she knew her physical problems were allegedly caused by Magnevist (Lori Combs v. Bayer Healthcare Pharmaceuticals Inc., et al., No. 18-802, N.D. Ohio, Eastern Div., 2019 U.S. Dist. LEXIS 82268).
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June 05, 2019
Zofran MDL Birth Defect Parties Debate Effect Of Albrecht Preemption Ruling
BOSTON — Parties in the Zofran birth defect multidistrict litigation on June 3 submitted briefs on the applicability of the U.S. Supreme Court’s recent ruling in Merck Sharp & Dohme v. Albrecht, 587 U.S. ____ (2019) (In Re: Zofran [Ondansetron] Products Liability Litigation, MDL Docket No. 2657, No. 15-md-2657, D. Mass.).
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June 04, 2019
Taxotere MDL Magistrate Finds No Improper Facebook Posts, Quashes Defense Subpoena
NEW ORLEANS — A special master in the Taxotere hair-loss multidistrict litigation on May 29 said his in camera review of emails about an alleged request to delete Facebook comments about the chemotherapy drug and hair loss in female patients showed “no improper communications, instructions or guidance provided by counsel” and that the documents are not discoverable by defendant Sanofi-Aventis U.S. LLC (In Re: Taxotere [Docetaxel] Product Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La.).