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LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News
Headline Emerging Drugs & Devices Legal News from LexisNexis®
Washington Supreme Court: Da Vinci Robot Maker Must Warn Hospitals
OLYMPIA, Wash. - The manufacturer of the da Vinci surgical robot had a duty to warn a hospital about the risks of the device to credential the physician who used it, the Washington Supreme Court ruled Feb. 9 in vacating a 2013 defense verdict for Intuitive Surgical Inc. in a wrongful death trial (Josette Taylor, et al. v. Intuitive Surgical, Inc., No. 92210-1, Wash. Sup., 2017 Wash. LEXIS 200).
Master Settlement Reached In Tylenol Liver Injury Cases; Terms Are Undisclosed
PHILADELPHIA - The McNeil Consumer Healthcare division of Johnson & Johnson has agreed to pay a confidential amount to settle more than 200 Tylenol liver injury lawsuits, according to two documents filed Feb. 10 in the Tylenol multidistrict litigation court (In Re: Tylenol [Acetaminophen] Marketing, Sales Practices and Products Liability Litigation, MDL Docket No. 2436, No. 13-md-2436, E.D. Pa.).
4th Circuit Asked To Rehear Whether 510(k) Evidence Belongs In Pelvic Mesh Trial
RICHMOND, Va. - Ethicon Inc. and parent company Johnson & Johnson on Feb. 9 petitioned the Fourth Circuit U.S. Court of Appeals to grant an en banc rehearing on the issue whether any evidence about Food and Drug Administration dealings with 510(k)-cleared medical devices is admissible in a product liability case (Jo Huskey, et al. v. Ethicon, Inc., et al., No. 15-2118, 4th Cir.).
Non-Employment, Retirement Don't Spare Ethicon Witnesses From Pelvic Mesh Trial
CHARLESTON, W.Va. - The intervening departure of two Ethicon Inc. employees does not preclude them from being called to testify live via videoconference in an upcoming consolidated pelvic mesh trial, a West Virginia federal judge ruled Feb. 8 (Terreski Mullins, et al. v. Ethicon, Inc., et al., No. 12-2952, S.D. W.Va., Charleston Div., 2017 U.S. Dist. LEXIS 17555).
Kidney Dialysate Wrongful Death Trial Under Way In Fresenius MDL
BOSTON - A wrongful death bellwether trial involving the dialysate NaturaLyte got under way Feb. 8 in the U.S. District Court for the District of Massachusetts (Florella Dial, et al. v. Fresenius Medical Care Holdings, Inc. et al., No. 14-11101, D. Mass.).
Failure To Ask Doctor About Paxil Risks Warranted Nonsuit, Pennsylvania Judge Says
PHILADELPHIA - A Pennsylvania state court judge on Feb. 7 said he was forced to grant a nonsuit in a Paxil birth defect case because the plaintiffs failed to ask the prescribing physician what he would have done if he had known that the antidepressant is a potential teratogen and that it can cause fetal death (Braden Rader, et al. v. SmithKline Beecham Corporation, et al., No. 11090367200535, Pa. Comm. Pls., Philadelphia Co., No. 2144 EDA 2016, Pa. Super.).
Judge: Claims Against Drug Manufacturer Fail In Absence Of Reliable Expert Testimony
BRIDGEPORT, Conn. - In the absence of reliable medical expert opinion on specific causation, no reasonable fact finder could come to the conclusion that Paxil, an antidepressant drug, caused a baby's birth defect, a Connecticut federal judge ruled Feb. 1, granting summary judgment to the drug's manufacturer on numerous claims (K.E., a minor by his parent and natural guardian, Nichole El-Massri v. GlaxoSmithKline LLC formerly SmithKline Beecham Corp. d/b/a GlaxoSmithKline, No. 14-1294, D. Conn., 2017 U.S. Dist. LEXIS 13705).
Proton Pump Inhibitor MDL Motion Denied By Federal Judicial Panel
WASHINGTON, D.C. - A federal judicial panel on Feb. 2 denied a motion to centralize 39 federal lawsuits alleging kidney injury from proton pump inhibitor (PPI) drugs because they involve four groups of competing manufacturers and because discovery will be "defendant-specific" (In Re: Proton Pump Inhibitor Products Liability Litigation, MDL Docket No. 2757, JPMDL).
53 Federal Eliquis Cases Centralized As 3rd Anticoagulant MDL
WASHINGTON, D.C. - The Judicial Panel on Multidistrict Litigation (JPMDL) on Feb. 7 centralized 53 federal Eliquis lawsuits before Senior Judge Denise L. Cote of the U.S. District Court for the Southern District of New York (In Re: Eliquis [Apixaban] Products Liability Litigation, MDL Docket No. 2754, JPMDL, 2017 U.S. Dist. LEXIS 16639).
Effient Bleeding Death Complaint Partly Dismissed By Kentucky Federal Judge
OWENSBORO, Ky. - A Kentucky federal judge on Feb. 10 dismissed in part a lawsuit alleging that Eli Lilly and Co. failed to warn that its anticoagulant drug Effient could cause uncontrolled bleeding like the kind that led to a patient's death (Estate of Jerry DeMoss, et al. v. Eli Lilly and Company, No. 16-103, W.D. Ky., Owensboro Div., 2017 U.S. Dist. LEXIS 19142).
Last Lipitor Diabetes MDL Cases Dismissed; Appeals Filed With 4th Circuit
CHARLESTON, S.C. - A South Carolina federal judge overseeing the Lipitor diabetes multidistrict litigation on Feb. 3 dismissed all 157 remaining cases for lack of causation testimony and, despite a plea by plaintiff attorneys, did so with prejudice (In Re: Lipitor [Atorvastatin Calcium] Marketing, Sales Practices and Products Liability Litigation, MDL Docket No. 2502, No. 14-mn-2502, D. S.C., Charleston Div.).
Farxiga MDL Sought By Plaintiff For 1 Of 3 Federal District Courts
WASHINGTON, D.C. - A plaintiff on Feb. 3 asked the Judicial Panel on Multidistrict Litigation (JPMDL) to centralize 18 federal cases in which plaintiffs alleged that they suffered diabetic ketoacidosis (DKA) or kidney injury from taking the diabetes drug Farxiga (In Re: Farxiga [Dapaglifozin] Products Liability Litigation, MDL Docket No. 2776, JPMDL).
2nd Circuit Partly Vacates Dismissal Of Antitrust Claims In Patent Dispute
NEW YORK - A New York federal judge's decision to dismiss allegations that Takeda America Holdings Inc., Takeda Pharmaceuticals U.S.A. Inc., Takeda Development Center Americas Inc. and Takeda Pharmaceuticals Co. Ltd. (Takeda, collectively) violated state law analogs of the Sherman Act, 15 U.S.C. § 2, by preventing competitors from marketing a generic version of the diabetes drug ACTOS was partly vacated by the Second Circuit U.S. Court of Appeals Feb. 8 (In re: ACTOS End-Payor Antitrust Litigaiton, No. 15-3364, 2nd Cir., 2017 U.S. App. LEXIS 2291).
'A Civil Action' Attorney Jan Schlichtmann Named In Avandia Malpractice Lawsuit
PHILADELPHIA - Noted plaintiff attorney Jan R. Schlichtmann and his law firm were sued Jan. 30 for legal malpractice and breach of contract by a trust company which claims that missteps by the defendants in an Avandia settlement cost them more than $2.5 million (ATG Trust Company v. Jan R. Schlichtmann, et al., No. 160802163, Pa. Comm. Pls., Philadelphia Co.).
Erie County Sues 4 Opioid Makers For Role In Addiction Epidemic
BUFFALO, N.Y. - New York's Erie County on Feb. 1 sued four opioid drug makers in state court, alleging that their deceptive practices under state law have caused an opioid abuse epidemic that costs the county in health and law enforcement services and addicts or kills its residents (The County of Erie v. Purdue Pharma L.P., et al., No. n/a, N.Y. Sup., Erie Co.).
Ex-Bio-Rad VP Awarded $7.86M For Retaliation Over Bribery Allegations
SAN FRANCISCO - A California federal jury on Feb. 6 found that Bio-Rad Laboratories Inc. and five executives retaliated against a former executive vice president for reporting foreign bribery and awarded him $7.96 million in compensatory and punitive damages (Sanford S. Waldner v. Bio-Rad Laboratories, Inc., et al., No. 15-2356, N.D. Calif.).
FTC Says Shire ViroPharma's Abuse Of FDA Process Violated Antitrust Law
WILMINGTON, Del. - The U.S. Federal Trade Commission on Feb. 7 filed an antitrust complaint against Shire ViroPharma Inc., alleging that the company engaged in abusive petitioning of and litigation with the U.S. Food and Drug Administration to delay by two years the introduction of generic versions of the drug Vancocin (Federal Trade Commission v. Shire ViroPharma Inc., No. 17-131, D. Del.).
Biopharma Programmer Arrested For Trading On Insider Information
BOSTON - A former programmer for a Massachusetts biopharmaceutical company was charged Feb. 7 with insider trading for conspiring to commit securities fraud by trading insider information about successful drug trials (United States of America v. Songjiang Wang, No. 17-1005, D. Mass.).
Accutane Claim Not Time-Barred, New Jersey Supreme Court Says; $25M Verdict Is Back
TRENTON, N.J. - A unanimous New Jersey Supreme Court on Jan. 24 reinstated a $25.15 million Accutane bowel injury verdict after finding that New Jersey's statute of limitations and discovery rule apply to the plaintiff's claim and not Alabama's more restrictive law (Andrew McCarrell v. Hoffman-La Roche, Inc., et al., No. A-28 September Term 2015 076524, N.J. Sup.; 2017 N.J. LEXIS 19).
4th Circuit Affirms $3.27M Ethicon Pelvic Mesh Verdict; Evidence Sufficient
RICHMOND, Va. - The Fourth Circuit U.S. Court of Appeals on Jan. 26 affirmed a $3.27 million verdict in the second Ethicon pelvic mesh bellwether trial, finding that the plaintiffs offered sufficient evidence to support the verdict and that the trial judge committed no reversible error (Jo Huskey, et al. v. Ethicon, Inc., et al., No. 15-2118, 4th Cir.; 2017 U.S. App. LEXIS 1402).
Barr Laboratories To Pay $225M In Class Settlement For Delaying Generic Cipro
SAN DIEGO - Six plaintiffs on Jan. 25 asked a state court to approve a $225 million settlement with Barr Laboratories Inc. for civil claims that the generic drug manufacturer caused consumers to pay higher prices when it took a cash payment from Bayer Corp. to not compete with Bayer Corp. by selling a generic version of the antibiotic Cipro (Cipro Cases I and II, JPPC Nos. 4154 and 4220, Calif. Super., San Diego Co.).
Mallinckrodt Disgorges $100M, Licenses Competing Drug Under FTC/States Settlement
WASHINGTON, D.C. - British drug maker Mallinckrodt ARD Inc. will disgorge $100 million in profits to settle a complaint by the U.S. Federal Trade Commission and five states that it purchased the rights to a competing drug to have a monopoly, then raised the price of the drug by 85,000 percent, the FTC announced Jan. 18 (Federal Trade Commission, et al. v. Mallinckrodt ARD Inc., et al., No. 17-120, D. D.C.).
Sanofi Pasteur To Pay $61.5M To Settle Meningitis Vaccine Anti-Competitive Class Suit
NEWARK, N.J. - Three pediatric medical practices on Jan. 27 asked a New Jersey federal court to approve a $61.5 million cash settlement of claims alleging that drug maker Sanofi Pasteur Inc. and a subsidiary engaged in anti-competitive behavior by bundling its Menactra quadrivalent meningococcal vaccine (MCV4) with other pediatric vaccines to keep another meningitis vaccine from cutting into Sanofi's 100 percent market share (Adriana M. Castro, M.D., P.A., et al. v. Sanofi Pasteur Inc., No. 11-7178, D. N.J.).
U.S. Supreme Court To Rule On Jurisdiction In California Plavix Injury Cases
WASHINGTON, D.C. - The U.S. Supreme Court on Jan. 19 granted certiorari to drug maker Bristol-Myers Squibb Co. (BMS) on whether Plavix injury claims can arise in California state courts when there is no causal link between BMS's forum contact and the plaintiffs' claims (Bristol-Myers Squibb Company v. Superior Court of California for the County of San Francisco, et al., No. 16-466, U.S. Sup.).
Kentucky Appeals Court Backs Infuse Off-Label Preemption, But Not For Hospital
FRANKFORT, Ky. - A Kentucky Court of Appeals panel on Jan. 13 affirmed that a patient's product liability claim over the off-label use of Infuse bone graft is preempted by federal law, but it reversed dismissal of a medical negligence claim against a hospital for failing to tell the patient that a doctor was going to use a device in an off-label manner (Joyce Cales, et al. v. Baptist Healthcare System, Inc., et al., No. 2015-CA-001103-MR, Ky. App., 2017 Ky. App. LEXIS 10).
Florida Appeals Court Orders Foreign Adverse Event Reports To Be Redacted
WEST PALM BEACH, Fla. - A Florida appeals court on Jan. 25 quashed a trial court order requiring Howmedica Osteonics Corp. to produce unredacted foreign adverse event reports about certain of its recalled hip prostheses (Howmedica Osteonics Corp. v. Joyce Trowbridge, et al., No. 4D16-2374, Fla. App., 4th Dist.; 2017 Fla. App. LEXIS 764).
5th Circuit Denies Plaintiffs' Motion To Consolidate DePuy Pinnacle Hip Appeals
NEW ORLEANS - The Fifth Circuit U.S. Court of Appeals on Jan. 25 denied without comment a plaintiffs' motion to consolidate appeals of two DePuy Pinnacle hip verdicts (In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, Jay Christopher, et al. v. DePuy Orthopaedics, Inc., et al., No. 16-11051, 5th Cir.).
MDL Sought For Stryker LFIT V40 Femoral Head Following Failures, Recall
WASHINGTON, D.C. - A plaintiff on Jan. 13 asked the Judicial Panel on Multidistrict Litigation to centralize six cases involving the now-recalled Stryker LFIT V40 CoCr Anatomic Femoral head orthopedic device in an MDL in the U.S. District Court for the District of Massachusetts (In Re: Stryker Orthopaedics LFIT V40 Femoral Head Product Liability Litigation, MDL Docket No. 2768).
California Appeals Court Affirms Exclusion Of Plaintiff Expert In Nexium Cases
LOS ANGELES - A California appeals panel on Jan. 26 affirmed the exclusion of a plaintiff expert causation witness in a multiplaintiff Nexium bone injury case, saying the trial court properly found the expert was not an epidemiologist and properly granted summary judgment (Joelena Wilson, et al. v. McKesson Corp., et al., No. B266990, Calif. App., 2nd Dist., Div. 3).
Pradaxa Death Case Escapes Summary Judgment On Question Of Age Testing
BOSTON - A Massachusetts federal judge on Jan. 23 granted partial summary judgment in a Pradaxa wrongful death case but said the plaintiff can go to trial on whether the anticoagulant's label adequately warned a doctor and patient about the risk of intracranial bleeding in an 80-year-old patient (Li Liu, et al. v. Boehringer Ingelheim Pharmaceuticals, Inc., et al., No. 14-13234, D. Mass; 2017 U.S. Dist. LEXIS 8959).
Judge Excludes Causation Expert Testimony In Reclast Lawsuit Against Novartis
BIRMINGHAM, Ala. - An Alabama federal judge on Jan. 26 excluded causation expert testimony in a medical liability lawsuit against Novartis Pharmaceutical Corp. over its drug, Reclast, finding that the experts did not use a reliable methodology (Ernesteen Jones v. Novartis Pharmaceuticals Corp., No. 13-624, N.D. Ala., 2017 U.S. Dist. LEXIS 10849).
Zofran MDL Plaintiffs: Ask State High Courts If Misrepresentation Is Preempted
BOSTON - Plaintiffs in the Zofran birth defect multidistrict litigation on Jan. 19 asked the judge to certify questions to five state supreme courts about whether a brand-name drug maker that creates a market for an off-label use of a drug can be liable under state law for misrepresentation (In Re: Zofran [Ondansetron] Products Liability Litigation, MDL Docket No. 15-md-2657, D. Mass.).
Farxiga Diabetic Ketoacidosis Case Dismissed; Plaintiff Doesn't Amend
LOUISVILLE, Ky. - A Kentucky federal judge on Jan. 4 dismissed without prejudice a lawsuit filed by a woman who claimed that the diabetes drug Farxiga caused her to develop diabetic ketoacidosis (Anna House v. Bristol-Myers Squibb Company, et al., No. 15-894, W.D. Ky., Louisville Div., 2016 U.S. Dist. LEXIS 180869).
RICO Class Action Filed Against 3 Insulin Makers For Gaming Prices
BOSTON - Eleven diabetics on Jan. 30 filed a class action complaint alleging that Sanofi U.S., Novo Nordisk Inc. and Eli Lilly and Co. are raising their prices for insulin out of reach for some diabetics to create a "spread" between the drugs' "list price" and its wholesale price to stay on the formularies of pharmacy benefit managers (PBMs) (Donald Chaires, et al. v. Sanofi U.S., et al., No. 17-10158, D. Mass.).
Plaintiffs Leadership Named In Invokana MDL
TRENTON, N.J. - The New Jersey federal judge overseeing the Invokana multidistrict litigation on Jan. 24 appointed 14 plaintiff attorneys to leadership positions (In Re: Invokana [Canagliflozin] Products Liability Litigation, MDL Docket No. 16-md-2750, D. N.J.).
Health And Human Services Knows Of No $465 Settlement Of EpiPen Rebate Probe
WASHINGTON, D.C. - The Department of Health and Human Services (HHS) on Jan. 18 told the U.S. Senate Judiciary that the Justice Department has not agreed to settle an EpiPen misclassification/Medicaid rebate investigation and that "[i]t remains the case that there is no settlement with any potential party."
Texas Sues FDA For Release Of Detained Anesthetic For Lethal Injections
GALVESTON, Texas - Texas on Jan. 3 sued the Food and Drug Administration in federal court, seeking an order forcing the agency to release thiopental sodium for use in lethal injections (Texas Department of Criminal Justice v. United States Food and Drug Administration, et al., No. 17-1, S.D. Texas).
Drug Watchdog Identifies Many More Liver Injuries In Patients Taking Hep C Drugs
HORSHAM, Pa. - The Institute for Safe Medication Practices (ISMP) on Jan. 25 said in its QuarterWatch newsletter that it has identified 524 reports case of liver failure and 1,058 cases of severe liver injury associated with hepatitis C drugs, many more cases than first reported by the Food and Drug Administration in October.
Shire $350M Settlement Said To Be Largest For Medical Device False Claims
WASHINGTON, D.C. - In what the U.S. Justice Department calls the largest False Claims Act recovery in a medical device kickback case, Shire Pharmaceuticals LLC and certain subsidiaries will pay $350 million to settle federal and state allegations that the defendants paid remuneration to health care providers to use Dermagraft, a bioengineered human skin graft, according to a Jan. 11 department press release (United States ex rel. Vinca v. Advanced BioHealing, Inc., No. 11-176, United States ex rel. Harvey v. Advanced BioHealing, Inc., No. 16-303, United States ex rel. Medolla v. Advanced BioHealing, Inc., No. 12-575, United States, et al., ex rel. Petty v. Shire Regenerative Medicine, Inc., No. 14-969, United States ex rel. Webb v. Advanced BioHealing, Inc., No. 14-1055, and United States, et al., ex rel. Montecalvo v. Shire Regenerative Medicine, Inc., No. 16-268, M.D. Fla.).
Zimmer Biomet To Pay $30.4M To Settle Foreign Bribery Claims By United States
WASHINGTON, D.C. - Orthopedic device maker Zimmer Biomet Holdings Inc. and an indirect subsidiary will pay $30.4 million to resolve criminal charges that they violated the Foreign Corrupt Practices Act (FCPA) by paying bribes to people in Mexico and for violating a 2012 deferred prosecution agreement (DPA) for earlier FCPA violations, the U.S. Justice Department announced Jan. 12 (United States of America v. Zimmer Biomet Holdings, Inc., No. 12-cr-80, United States of America v. JERDS Luxembourg Holdings S.A.R.L., No. n/a, D. D.C.).
Baxter Healthcare Pays $18.15M For Manufacturing Violations, False Claims
ASHEVILLE, N.C. - Baxter Healthcare Corp. has agreed to pay $18.15 million in criminal and civil penalties to resolve allegations that it continued to manufacture and sell intravenous (IV) solutions made in a clean room outfitted with moldy air filters, the U.S. Justice Department announced Jan. 12 (United States of America v. Baxter Healthcare Corporation, No. 17-10, United States of America v. $8,000,000 in Funds, et al., No. 15-cv15, and United States ex rel. Christopher Wall v. Baxter International, Inc., et al., No. 13-42, W.D. N.C.).
2 Drug Distributors Pay $36M To Settle West Virginia Distribution Lawsuits
CHARLESTON, W.Va. - West Virginia on Jan. 9 announced that two drug distributors have agreed to pay a total of $36 million to resolve state court civil lawsuits alleging that the distributors were liable for supplying controlled substances to state pharmacies (State of West Virginia, ex rel. Darrell McGraw v. Cardinal Health Inc., No. 12-C-140, and State of West Virginia, ex rel. Darrell McGraw v. AmerisourceBergen Inc., No. 12-C-141, W.Va. Cir., Boone Co.).
Stryker Rejuvenate, ABGII Hip Settlement Expanded To Replacements Up To 2016
MINNEAPOLIS - The Minnesota federal judge overseeing the Stryker Rejuvenate and ABGII metal-on-metal hip multidistrict litigation on Dec. 19 approved an expansion of the earlier settlement program (In Re: Stryker Rejuvenate and ABGII Hip Implants Products Liability Litigation, MDL Docket No. 2441, No. 13-2441, D. Minn.).
DePuy Pinnacle Hip Plaintiffs Ask 5th Circuit To Consolidate Appeals
NEW ORLEANS - Five plaintiffs who last year won a $146.2 million judgment against DePuy Orthopaedics Inc. in a consolidated Pinnacle hip bellwether trial on Jan. 6 filed an opposed motion asking the Fifth Circuit U.S. Court of Appeals to consolidate their appeal with that of a $500 million judgment in a subsequent six-plaintiff bellwether trial (In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, Jay Christopher, et al. v. DePuy Orthopaedics, Inc., et al., No. 16-11051, 5th Cir.).
1st Circuit Affirms Dismissal Of Yasmin Blood Clot Suit For Attorney Neglect
CHICAGO - The First Circuit U.S. Court of Appeals on Jan. 13 affirmed dismissal of a Yasmin blood clot lawsuit, citing admission by the plaintiff's attorneys that they did "mostly nothing" to warrant keeping the lawsuit active (Jennifer Dzik v. Bayer Corporation, et al., No. 16-1333, 7th Cir.; 2017 U.S. App. LEXIS 684).
Jury Selection Begins In Fungal Meningitis Outbreak Federal Murder Trial
BOSTON - Jury selection is set to begin Jan. 6 in the federal murder trial of Barry J. Cadden in connection with a deadly fungal meningitis outbreak allegedly caused by contaminated compounded drugs made by Cadden's former company, New England Compounding Center (NECC) (United States of America v. Barry J. Cadden, et al., No. 14-10363, D. Mass.).
1 Pleads Guilty To Conspiracy In Fungal Meningitis Outbreak Criminal Case
BOSTON - One of the original 14 criminal defendants in the fungal meningitis outbreak on Dec. 19 pleaded guilty to conspiracy to defraud the United States by participating in a scheme to ship compounded drugs to health care facilities without the required patient names (United State of America v. Robert A. Ronzio, No. 14-cr-10363, D. Mass.).
Eliquis MDL Arguments Set For Jan. 29
WASHINGTON, D.C. - Arguments for the centralization of 34 federal Eliquis personal injury lawsuits will be heard Jan. 26 by the Judicial Panel on Multidistrict Litigation (JPMDL) (In Re: Eliquis [Apixaban] Products Liability Litigation, MDL Docket No. 2754, JMPDL).
2nd Mirena MDL Sought For Intracranial Hypertension Injuries From Levonorgestrel
WASHINGTON, D.C. - Ten federal court plaintiffs on Dec. 29 asked the Judicial Panel on Multidistrict Litigation (JPMDL) to create a second Mirena MDL for plaintiffs alleging that the hormone-coated intrauterine device (IUD) causes intracranial hypertension (IH) (In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation [No. II], MDL Docket No. 2767, JPMDL).
Taxotere Off-Label Claims Not Time-Barred, Aren't Free Speech, Judge Says
PHILADELPHIA - A False Claims Act lawsuit alleging off-label marketing of the chemotherapy drug Taxotere is not barred by the statute of limitations and is not aimed at "truthful, non-misleading" speech about off-label uses, a Pennsylvania federal judge said Jan. 9 in denying a new motion by defendant Aventis Inc. dismiss the 14-year-old case (United States of America, ex rel. Yoash Gohil v. Aventis, Inc., et al., No. 02-2964, E.D. Pa.).
Taxotere MDL Judge Says Brand Name, Generic Drugs Are Part Of Litigation
NEW ORLEANS - The Louisiana federal judge overseeing the Taxotere hair loss multidistrict litigation on Jan. 11 told liaison counsel that the Judicial Panel on Multidistrict Litigation (JPMDL) intends that claims against generic drug manufacturers be included in the MDL (In Re: Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La.).
No Settlement Of Surgical Gown State Class Action Ahead Of March 28 Trial
LOS ANGELES - Seventy-two days before the start of a California class action trial involving MicroCool surgical gowns, the parties on Jan. 16 reported to a California federal judge that "[d]espite the best efforts of the parties, they have been unable to settle the case" (Hrayr Shahinian, M.D., v. Kimberly-Clark Corporation, et al., No. 14-8390, C.D. Calif.).
Judge Dismisses Delay Claim In Suboxone Case, Allows Refiled Lanham Claims
PHILADELPHIA - A Pennsylvania federal judge on Jan. 4 dismissed claims by a generic drug manufacturer that Indivior Inc. engaged in anti-competitive behavior by delaying the introduction of a generic version of the opioid treatment drug Suboxone (buprenorphine and naloxone) but allowed the plaintiff to refile its false advertising claims (In Re: Suboxone [Buprenorphine Hydrochloride and Naloxone] Antitrust Litigation, MDL Docket No. 2445, No. 13-md-2445, Amneal Pharmaceuticals LLC v. Indivior Inc., No. 16-563, E.D. Pa.).
Supreme Court Grants Certiorari In Patent Dispute Over Biologics
WASHINGTON, D.C. - In its Jan. 13 orders list, the U.S. Supreme Court announced that it will hear a closely watched dispute between two drug makers over their competing interpretations of several provisions of the Biologics Price Competition and Innovation Act (BPCIA) (Sandoz, Inc. v. Amgen, Inc., No. 15-1039, U.S. Sup.; Amgen Inc. v. Sandoz Inc., No. 15-1195, U.S. Sup.).
Judge: Investor Failed To Plead Demand Futility Under Either Prong Of Aronson
LOS ANGELES - An investor in a shareholder derivative lawsuit against 17 current and former executive officers and directors of a drug company has failed to show that the defendants were interested in the outcome of the litigation or that their actions were in violation of the business judgment rule under Aronson v. Lewis, a federal judge in California ruled Jan. 10 in granting the company's motion to dismiss (Judy Durgin v. Kevin Sharer, et al., No. 07-3001, C.D. Calif.).