Mealey's Drugs & Devices
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July 26, 2019
Judge: FDA Pelvic Mesh Warning Didn’t Put Plaintiff On Notice Of Claims
DALLAS — A Texas federal judge on July 24 partially dismissed a plaintiff’s claims in a pelvic mesh lawsuit, ruling in part that three Food and Drug Administration warnings about the devices did not put a plaintiff on notice to file her claim earlier than she did (Carolyn Carpenter v. Boston Scientific Corporation, No. 18-2338, N.D. Texas, Dallas Div., 2019 U.S. Dist. LEXIS 122874).
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July 26, 2019
Opioid MDL Judge Asked To Respond To Mandamus Petition About Drug Database
CINCINNATI — The Sixth Circuit U.S. Court of Appeals on July 23 invited the judge overseeing the opioid multidistrict litigation to respond to an emergency mandamus petition filed by two drug distributors seeking to vacate the MDL judge’s order allowing access to older drug distributer data collected by the U.S. Drug Enforcement Administration (In Re: National Prescription Opiate Litigation, No. 19-3682, 6th Cir.).
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July 25, 2019
Opioid MDL Judge Allows Access To DEA Opioid Database From 2006 To 2012
CLEVELAND — The Ohio judge overseeing the opioid multidistrict litigation on July 15 lifted a protective order for ARCOS drug distribution data from before Dec. 31, 2012, saying there is “clearly no basis to shield the public view” of the data (In Re: National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).
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July 25, 2019
Insys Bankruptcy Judge Won’t Create Public Entity Committee
WILMINGTON, Del. — A Delaware federal bankruptcy court judge on July 24 denied a motion by four cities and counties to create an official committee of public entities in the Insys Therapeutics Inc. Chapter 11 bankruptcy proceeding (In Re: Insys Therapeutics, Inc., et al., No. 19-11292, D. Del. Bkcy.).
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July 24, 2019
Textured Breast Implants Recalled By Allergan Due To Lymphoma Risk
SILVER SPRING, Md. — The Food and Drug Administration on July 24 asked Allergan PLC to recall its Biocell textured breast implants due to the increased risk of anaplastic large cell lymphoma (BIA-ALCL), a rare type of non-Hodgkin lymphoma.
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July 24, 2019
Judge Won’t Sever Cases Of 3 New York Doctors In Opioid Kickback Scheme
NEW YORK — A New York federal judge on July 23 denied a motion by three doctors to sever their criminal cases involving kickbacks allegedly taken to prescribe the opioid Subsys (United States v. Gordon Freedman, et al., No. 18-cr-217, S.D. N.Y., 2019 U.S. Dist. 122647).
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July 23, 2019
DePuy Pinnacle Hip MDL Common Benefit Cut Back To 10 Percent For $950M Settlement
DALLAS — The Texas federal judge overseeing the DePuy Pinnacle hip multidistrict litigation on July 22 granted a joint motion to reduce the common benefit holdback from 25 percent to the original 10 percent but ordered defendant DePuy Synthes Cos. to chip in an extra $139.6 million in fees and disclosed that DePuy estimates that its settlement of the litigation totals $950 million (In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL Docket No. 2244, No. 11-md-2244, N.D. Texas, Dallas Div.).
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July 22, 2019
Pelvic Mesh Plaintiffs’ Claims Partially Dismissed In California Federal Court
FRESNO, Calif. — A California federal judge on July 18 partially dismissed a pelvic mesh injury case against Boston Scientific Corp., but allowed the plaintiff to refile certain claims (Autumn Zetz, et al. v. Boston Scientific Corporation, No. 19-451, E.D. Calif., 2019 U.S. Dist. LEXIS 120223).
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July 22, 2019
Pfizer Accused Of Not Warning Domestic Xeljanz Users Of Sepsis, Amputation Risk
FORT SMITH, Ark. — An Arkansas woman on July 18 sued Pfizer Inc., alleging that the drug maker failed to warn U.S. patients that the rheumatoid arthritis drug Xeljanz could cause sepsis that resulted in quadruple amputation (Marilyn Stube, et al. v. Pfizer, Inc., No. 19-6087, W.D. Ark.).
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July 19, 2019
Ohio Drug Distributor, 4 People Indicted By Grand Jury For Illegally Distributing Opioids
CINCINNATI — A defunct Ohio drug distributor, two of its former executives and two former pharmacy owners were indicted July 17 for conspiracy to illegally distribute and dispense the opioids oxycodone and hydrocodone (United States of America v. Anthony Rattini, et al., No. 19-cr-81, S.D. Ohio, Western Div.).
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July 19, 2019
Unlicensed NECC Pharmacy Tech Sentenced To 2 Years’ Probation, $1,000 Fine For Mail Fraud
BOSTON — An unlicensed pharmacy technician who worked at the former New England Compounding Center (NECC) was sentenced July 18 to 24 months of probation, a $1,000 fine and restitution to be determined at a later date after he pleaded guilty last year to mail fraud (United States of America v. Scott Connolly, No. 14-cr-10363-6, D. Mass.).
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July 18, 2019
6th Circuit Affirms Dismissal Of Gardasil Vaccine Case On Contamination Grounds
CINCINNATI — The Sixth Circuit U.S. Court of Appeals on July 17 affirmed dismissal of a Gardasil human papillomavirus (HPV) vaccine injury case because the plaintiffs did not establish that the vaccine was contaminated or adulterated (Shannon Powers, et al. v. Merck & Company, Inc., et al., No. 18-4001, 6th Cir., 2019 U.S. App. LEXIS 21137).
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July 17, 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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July 17, 2019
Fen-Phen Fee Case Against Plaintiff Lawyer Chesley Ends With $19M Payment
CINCINNATI — A lawsuit against the corporate successors of former plaintiff attorney Stanley M. Chesley by Kentucky fen-phen plaintiffs was voluntarily dismissed June 26 when the parties filed a notice with an Ohio federal court that the $19.19 million judgment against the law firm has been paid (Connie McGirr, et al. v. Thomas F. Rehme, et al., No. 16-464, S.D. Ohio, Western Div.).
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July 17, 2019
Taxotere Hair Loss MDL Judge Grants Partial Summary Judgment In 4 Cases
NEW ORLEANS — The Louisiana federal judge presiding over the Taxotere hair loss multidistrict litigation on July 9 granted summary judgment and partial summary judgment in four cases on the grounds of the state’s statute of limitations and learned intermediary doctrine (In Re: Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La., 2019 U.S. Dist. LEXIS 113447).
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July 17, 2019
Pennsylvania Appeals Court Reverses Nonsuit In Risperdal Gynecomastia Case
PHILADELPHIA — The Pennsylvania Superior Court on July 16 reversed a trial court’s compulsory nonsuit in a Risperdal gynecomastia case and remanded the case for a new trial, saying that under applicable Texas law, the plaintiffs presented sufficient prima facie evidence to support their claim (T.M., et al. v. Janssen Pharmaceuticals Inc., et al., No. 184-EDA 2018, Pa. Super., 2019 Pa. Super. LEXIS 708).
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July 17, 2019
Medtronic Pacemaker Case Remanded After Judge Overrules Removal Claims
CLEVELAND — An Ohio federal judge on July 8 remanded a Medtronic Inc. pacemaker case to state court after determining that federal-question jurisdiction or a preemption defense cannot be used to assert federal court jurisdiction (Heather Lecce, et al. v. Medtronic, Inc., et al., No. 18-2720, N.D. Ohio, Eastern Div., 2019 U.S. Dist. LEXIS 112731).
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July 17, 2019
Zostavax Plaintiff Denied A ‘Second Bite At The Apple’ Through New Complaint
PHILADELPHIA — A Pennsylvania federal court judge on July 12 dismissed another attempt by a couple to bring a lawsuit alleging injury from the Zostavax shingles vaccine, this time agreeing with defendant Merck & Co. Inc. that the latest complaint is barred by the doctrine of res judicata (Chris Juday, et al. v. Merck & Co., Inc., et al., No. 19-2037, E.D. Pa., 2019 U.S. Dist. LEXIS 116369).
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July 17, 2019
$500,000 Compensatory Verdict Awarded In Pennsylvania State Pelvic Mesh Trial
PHILADELPHIA — A Pennsylvania jury on June 28 awarded $500,000 in compensatory damages to a women who says she suffered injuries from a Prolift pelvic mesh device made by the Ethicon Women’s Health & Urology Division of Ethicon Inc., an attorney source told Mealey Publications (Linda Dunfee, et al. v. Ethicon Women’s Health & Urology, et al., No. 151002736, Pa. Comm. Pls., Philadelphia Co.).
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July 17, 2019
Florida State Court Jury Finds For Zimmer In Defective Hip Implant Trial
TAMPA — A Florida state court jury on July 11 ruled in favor of Zimmer Inc. and a distributor in a hip prosthesis case, finding that the device was not defectively designed and was not the cause of the plaintiff’s injuries (Diane Noto, et al. v. Zimmer, Inc., et al., No. 17-CA-006630, Fla. Cir., Hillsborough Co.).