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Preview: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News

LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News

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Mylan Pays $465M To Settle False Claims Suit Alleging Underpaid Medicaid Rebates
WASHINGTON, D.C. - Ten months after Mylan Inc. first announced a settlement and seven months after the federal government said there was no such agreement, Mylan and the U.S. Justice Department on Aug. 17 finalized a $465 million settlement of claims that the EpiPen maker violated the False Claims Act by misclassifying the drug/device combination as generic to avoid paying higher rebates owed primarily to Medicaid (United States, ex rel. Sanofi-Aventis US LLC v. Mylan Inc., No. 16-11572, D. Mass.).

Specialty Pharmacy To Pay $13M To Settle False Claims Suit Over Chelation Drug
NEW YORK - Specialty pharmacy US Bioservices Corp. (US Bio) will pay $13.4 million to settle the federal government's allegations about US Bio's role in a Novartis Pharmaceuticals Corp. scheme to reward pharmacies for the number of prescriptions they filled for Novartis' Exjade iron chelation drug, according to a letter filed Aug. 22 with a New York federal court (United States v. US Bioservices Corp., No. 17-6353, S.D. N.Y.).

Novo Nordisk Pays $58.65M To Settle Claim It Downplayed Victoza Cancer Risk
WASHINGTON, D.C. - Drug maker Novo Nordisk Inc. on Sept. 5 agreed to pay $58.65 million to settle federal allegations that it instructed sales representatives to downplay a federally required warning about the risk of medullary thyroid carcinoma (MTC) from the company's diabetes drug Victoza (United States of America v. Novo Nordisk, Inc., No. 17-cv-1820, D. D.C.).

Insys To Pay $4.45M To Illinois, Agrees To Restrict Opioid Marketing
CHICAGO - Insys Therapeutics Inc. on Aug. 17 agreed to pay $4.45 million to Illinois and agreed to restrictions on how it markets its opioid drugs in the state, according to a final judgment and consent decree in the state's consumer fraud lawsuit against the drug maker in Illinois state court (Illinois v. Insys Therapeutics, Inc., No. 2016-CH-11216, Ill. Cir., Cook Co.).

States, Cities, Counties File Opioid Lawsuits Against Drug Makers, Distributors
Between Aug. 14 and Aug. 22, at least 12 complaints were filed by a state, cities and counties against various opioid manufacturers and distributors.

FDA Pediatric Committee To Discuss Opioid Cough Drugs At Sept. 11-12 Meeting
SILVER SPRING, Md. - The Food and Drug Administration on Aug. 21 announced that its Pediatric Advisory Committee on Sept. 11-12 will discuss the use of prescription opioid products containing hydrocodone or codeine to treat cough in pediatric patients.

Defense Verdict Returned In Illinois State Court AndroGel Heart Attack Trial
CHICAGO - An Illinois state court jury on Aug. 28 returned a defense verdict in an AndroGel heart attack case (James Couch v. AbbVie Inc., No. 2014-L-005859, Ill. Cir., Cook Co.).

AbbVie Wants $150M Punitives Verdict Struck Since Compensatories Weren't Awarded
CHICAGO - AbbVie Inc. and Abbott Laboratories on Aug. 21 asked an Illinois federal judge to strike a $150 million punitive damage verdict in the first AndroGel multidistrict litigation bellwether case to go to verdict because the jury awarded the plaintiff no compensatory damages (In Re: Testosterone Replacement Therapy Products Liability Litigation, No. 14-01748, Jesse Mitchell v. AbbVie, Inc., et al., No. 14-9178, N.D. Ill.).

Defense Verdict Returned In 3rd Xarelto Multidistrict Bellwether Trial
JACKSON, Miss. - A Mississippi federal jury on Aug. 18 returned a defense verdict in the third Xarelto bleeding trial, finding that defendants Janssen Research & Development LLC and Bayer Healthcare Pharmaceuticals Inc. did not fail to adequately warn the plaintiff's doctor about the safe use of the anticoagulant and did not defectively design the drug (In Re: Xarelto [Rivaroxaban] Products Liability Litigation, No. 14-md-2592, Dora Minto v. Janssen Research & Development, LLC, et al., No. 15-3469, E.D. La.).

Plavix Warning, Defect Claims Fall To Learned Intermediary, Lack Of Alternative
TRENTON, N.J. - A New Jersey federal judge overseeing the Plavix multidistrict litigation on Aug. 17 granted summary judgment in one case after finding the plaintiff's failure-to-warn claim barred by the learned intermediary doctrine and his defect claim unproven with evidence of an alternative design (In Re: Plavix Marketing, Sales Practices and Products Liability Litigation [No. II], No.13-02418, Roger D. Hopkins, et al. v. Bristol-Myers Squibb, et al., No. 13-4521, D. N.J., 2017 U.S. Dist. LEXIS 131334).

Divided 5th Circuit Says Appeal Is Adequate Remedy For MDL Venue Dispute
NEW ORLEANS - A divided three-judge panel of the Fifth Circuit U.S. Court of Appeals on Aug. 31 denied DePuy Orthopaedics Inc. and Johnson & Johnson's request for mandamus relief that would halt an upcoming bellwether trial over the companies' Pinnacle hip prosthesis, finding that a pending appeal is an adequate remedy for a dispute over personal jurisdiction (In Re: DePuy Orthopaedics, Inc., et al., No. 17-10812, 5th Cir., 2017 U.S. App. LEXIS 16809).

10th Circuit Affirms Ruling Finding Woman's Mesh Sling Suit Was Untimely
DENVER - A woman who sustained injuries as a result of mesh sling that was implanted to treat stress urinary incontinence should have known of her claims against the maker of the product in 2007 when her doctor informed her that she would need a second surgery to excise some of the material, a 10th Circuit U.S. Court of Appeals panel said Aug. 25 in affirming a ruling dismissing the suit as untimely (Gerry Adams v. American Medical System, Inc., et al., No. 14-4057, 10th Cir., 2017 U.S. App. LEXIS 16250).

Multiplaintiff Essure Suit Again Remanded To State Court On Citizenship
EAST ST. LOUIS, Ill. - Ignoring a recent U.S. Supreme Court jurisdiction ruling and its progeny, an Illinois federal judge on Aug. 22 said nondiverse citizenship governs and granted remand a second time of an Essure multiplaintiff lawsuit to Illinois state court (Christy Rios, et al. v. Bayer Corporation, et al., No. 17-758, S.D. Ill., 2017 U.S. Dist. LEXIS 134222).

Most Risperdal Claims Stand After Expert Causation Testimony Allowed
NEW YORK - A man who says an anti-psychotic drug he took during his teens caused enlargement of his breasts can pursue most of his products liability claims against the drugmaker, a New York federal judge ruled Aug. 30 after finding that the causation opinions of the man's medical expert are admissible and raise a triable issue of fact (Jamal Adeghe v. Janssen Pharmaceuticals, Inc., No. 16-2235, S.D. N.Y., 2017 U.S. Dist. LEXIS 139913).

Multiplaintiff Amiodarone Cases Remanded; Federal Question Jurisdiction Lacking
SAN FRANCISCO - A California federal judge on Aug. 23 remanded 113 amiodarone injury lawsuits to two California state courts, finding that they didn't meet the tests for federal question jurisdiction (Edwin Street, et al. v. Eon Labs, Inc., et al., No. 17-2609, John W. Blackford, et al. v. Wyeth Pharmaceutical, Inc., et al., No. 17-3825, N.D. Calif., 2017 U.S. Dist. LEXIS 135368).

Riata Heart Lead Complaint Partially Dismissed With Leave To Amend
SAN JOSE, Calif. - A California federal judge on Aug. 23 denied in part and granted in part a motion by defendants to dismiss a heart lead complaint but granted the plaintiff leave to file an amended complaint by Sept. 8 (Richard Connelly v. St. Jude Medical, Inc., et al., No. 17-2066, N.D. Calif., 2017 U.S. Dist. LEXIS 13541).

Viagra/Cialis MDL Judge Allows In Extremis Depositions For Near-Death Plaintiffs
SAN FRANCISCO - The California federal judge overseeing the Viagra/Cialis skin cancer multidistrict litigation on Aug. 1 issued an order allowing for in extremis depositions of plaintiffs who are "reasonably near the end of life" (In Re: Viagra [Sildenafil Citrate] and Cialis Products Liability Litigation, No. 16-2691, N.D. Calif., San Francisco Div.).

Plaintiffs' Leadership Named In Physiomesh MDL
ATLANTA - Plaintiff leaders were appointed Aug. 16 by a Georgia federal judge in the Ethicon Physiomesh multidistrict litigation (In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, No. 17-md-2782, N.D. Ga., Atlanta Div.).

Arbitrator Issues Award In Drug Fee Dispute Between Plaintiff's Law Firms
FORT WORTH, Texas - An arbitrator has issued a binding arbitration award resolving a dispute over shared attorney fees between two plaintiff law firms in drug liability litigation, according to a motion filed by the plaintiff in a case it brought to compel arbitration (Steven M. Johnson, PC, et al. v. Girardi & Keese, No. 16-944, N.D. Texas, Fort Worth Div.).

Stryker Unit Recalls Products Possibly Contaminated With Toxic Chemicals By Supplier
KALAMAZOO, Mich. - Stryker Corp. on Aug. 23 announced that it has voluntarily recalled specific lots of its Oral Care products made by its Sage Products subsidiary because of possible cross-contamination with toxic car wash and car wax chemicals while being made by a third-party supplier.

Endo Takes $775M To Settle 22,000 Pelvic Mesh Cases, 'Virtually All Known' Claims
DUBLIN, Ireland - Endo International plc on Aug. 7 announced that it has reached agreements to resolve "virtually all known" pelvic mesh product liability claims in the United States and intends to increase its second quarter product liability accrual by $775 million to cover the settlements.

Judge Denies Bankruptcy Trustee's Bid For Debtor's Pelvic Mesh Settlement
TOPEKA, Kan. - A Kansas federal bankruptcy judge on July 19 denied a motion by a trustee to order a discharged debtor to turn over proceeds of her pelvic mesh injury settlement to her estate, finding that all events occurred after the debtor was discharged by the court (In Re: Kelly Sue Purcell [n/k/a Busby], No. 08-40224-13, D. Kan. Bkcy., 2017 Bankr. LEXIS 2074).

Insys Sets Aside $4.5M For Settlement Of Illinois' Opioid Off-Label Lawsuit
PHOENIX - Insys Therapeutics Inc. on Aug. 3 announced that it has taken a $4.5 million charge for a potential settlement of Illinois' consumer fraud lawsuit over the drug company's alleged off-label promotion of the fentanyl-based opioid Subsys.

Judge Trims Claims In Securities Class Action Against Drug Maker, Others
PHOENIX - A lead plaintiff in a securities class action lawsuit against a commercial-stage specialty pharmaceutical company and certain of its current and former executive officers has failed to show that a majority of the defendants' alleged misrepresentations concealing their involvement in an illegal kickback scheme with doctors were actionable and that seven of 10 alleged corrective disclosures had any causal connection to the alleged fraud, a federal judge in Arizona ruled Aug. 1 in granting in part and denying in part the defendants' motion to dismiss (Richard Di Donato, et al. v. Insys Therapeutics Inc., et al., No.16-0302, D. Ariz., 2017 U.S. Dist. LEXIS 120983).

Opioid Distributor's Authority Revoked By DEA After Circuit Court Petition Fails
WASHINGTON, D.C. - Pharmaceutical distributor Masters Pharmaceutical Inc. on Aug. 14 had its registration to distribute controlled substances revoked after the District of Columbia Circuit U.S. Court of Appeals lifted its stay of the revocation (Masters Pharmaceutical, Inc. v. Drug Enforcement Administration, No. 15-1335, D.C. Cir.).

West Virginia City's Opioid Lawsuit Against Distributors Will Stay In Federal Court
CHARLESTON, W.Va. - A West Virginia federal judge on Aug. 3 denied remand of a city's lawsuit against three opioid distributors because of diversity of citizenship and because there's no possible connection between the distributor's actions and those of a West Virginia doctor who was also named as a defendant (The City Of Huntington v. AmerisourceBergen Drug Corporation, et al., No. 17-1362, S.D. W.Va., 2017 U.S. Dist. LEXIS 124462).

Bayer, Plaintiffs Say They've Agreed To Settle Mirena IUD Perforation Claims
NEW YORK - Despite the parties' Aug. 11 disclosure that they have agreed to resolve Mirena intrauterine device (IUD) secondary perforation claims, the Second Circuit U.S. Court of Appeals that day denied a motion to adjourn Aug. 14 oral arguments about the exclusion of all plaintiffs causation experts and evidence by a New York federal multidistrict litigation judge (In Re: Mirena IUD Products Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals Incorporated, No. 16-2890 and 16-2012, 2nd Cir.).

Judge Ignores Bristol-Myers, Remands Multiplaintiff Essure Case To State Court
EAST ST. LOUIS, Ill. - An Illinois federal judge on Aug. 4 refused to consider rulings based on a recent U.S. Supreme Court jurisdiction decision and remanded an Essure birth control device case consisting of 86 plaintiffs to Illinois state court (Nichole Hamby, et al. v. Bayer Corp., et al., No. 17-17, S.D. Ill., 2017 U.S. Dist. LEXIS 123425).

Blood Tester Theranos Settles Walgreen Lawsuit For Confidential Amount
PALO ALTO, Calif. - Embattled blood testing company Theranos Inc. on Aug. 1 said it has reached a confidential settlement with Walgreen Co. and parent Walgreens Boots Alliance Inc. to resolve the pharmacy chain's claims against Theranos.

11th Circuit Affirms Dismissal Of Class Action Alleging Injury From Metal Particles
ATLANTA - The 11th Circuit U.S. Court of Appeals on Aug. 7 affirmed dismissal of a class action, agreeing that the two plaintiffs did not show that metallic particles found in their brains after heart surgery were from a medical device or that the particles constituted an injury (Gabriel Fernando Nassar Cure, et al. v. Intuitive Surgical Inc., et al., No. 17-10-978, 11th Cir., 2017 U.S. App. LEXIS 14463).

Celexa/Lexapro MDL Judge Denies Pediatric RICO Class Certification
BOSTON - A Massachusetts federal judge presiding over the Celexa/Lexapro multidistrict litigation on Aug. 15 denied certification of a class of adolescent users of the antidepressant, saying individual issues will predominate (In Re: Celexa and Lexapro, No. 09-2067, Delana S. Kiossovski, et al. v. Forest Laboratories, Inc., et al., No. 14-13848, D. Mass., 2017 U.S. Dist. LEXIS 129387).

U.S. High Court To Weigh On Sept. 25 If Heartburn Drug Maker Waived Jurisdiction
WASHINGTON, D.C. - The U.S. Supreme Court on Sept. 25 will consider a renewed certiorari petition by Teva Pharmaceuticals USA Inc. to find that a California state coordinating court does not have jurisdiction over metoclopramide failure-to-update claims brought by four out-of-state plaintiffs for prescriptions not written in California (Teva Pharmaceuticals USA, Inc. v. The Superior Court of San Francisco County, et al., No. 16-1364, U.S. Sup.).

Most Out-Of-State Risperdal Gynecomastia Plaintiffs Dismissed On Jurisdiction
ST. LOUIS - Citing the U.S. Supreme Court's recent jurisdiction decision, a Missouri federal judge on Aug. 10 dismissed without prejudice all but one Risperdal gynecomastia plaintiff from a multiplaintiff complaint (Annette Covington, et al. v. Janssen Pharmaceuticals, Inc., et al., No. 17-1588, E.D. Mo., Eastern Div., 2017 U.S. Dist. LEXIS 126641).

Actos Case Dismissed After Mistake Results In Defendant Not Being Timely Served
NEW CASTLE, Del. - A Delaware state court judge on Aug. 7 denied a plaintiff's motion to expand the time to serve her Actos bladder cancer complaint on the defendants, finding that the plaintiff's attorney should have noticed sooner that her complaint was filed for a plaintiff with the same last name (Elisha Ballard v. Takeda Pharmaceuticals America, Inc., et al., No. N16C-10-177, Del. Super., New Castle Co., 2017 Del. Super. LEXIS 385).

Proton Pump Inhibitor MDL Created, Assigned To Judge Cecchi In New Jersey
WASHINGTON, D.C. - About 195 federal lawsuits alleging that proton pump inhibitor (PPI) drugs cause serious kidney injury were centralized Aug. 2 by a federal panel before U.S. Judge Claire C. Cecchi of the District of New Jersey (In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2789, JPMDL).

EpiPen MDL Created, Assigned To Kansas Federal Judge
WASHINGTON, D.C. - Federal lawsuits alleging monopolistic and unfair trade practices by Mylan N.V. and other defendants in the marketing of the EpiPen epinephrine autoinjector were centralized Aug. 3 before Judge Daniel D. Crabtree of the U.S. District Court for the District of Kansas (In Re: EpiPen [Epinephrine Injection, USP] Marketing, Sales Practices and Antitrust Litigation, MDL Docket No. 2785, JPMDL).

States Sue 6 Generic Drug Makers For Conspiring To Drive Up Drug Prices
NEW HAVEN, Conn. - Four states and the District of Columbia on July 17 sued six generic drug manufacturers in Connecticut federal court, accusing them of conspiring to fix the price of a generic antibiotic and a generic diabetes drug (The State of Arkansas, et al. v. Aurobindo Pharma USA Inc., et al., No. 17-1180, D. Conn.).

Pharmacists In Fungal Meningitis Outbreak Say Prosecutors Backtracking
BOSTON - Three former pharmacists who worked for New England Compounding Center (NECC) during a 2012 fungal meningitis outbreak on Aug. 9 told the First Circuit U.S. Court of Appeals that it should not reverse dismissal of certain criminal claims against them (United States of America v. Alla V. Stepanets, Nos. 16-2402, 16-2403 and 16-2404, 1st Cir.).

Former CEO Shkreli Convicted On Securities Fraud, Conspiracy Claims
BROOKLYN, N.Y. - A federal jury in New York on Aug. 4 convicted former pharmaceutical company CEO and hedge fund manager Martin Shkreli on claims that he orchestrated a massive Ponzi scheme over a six-year span while CEO of Retrophin Inc. (United States of America v. Martin Shkreli, No. 15-637, E.D. N.Y.).

Compounding Pharmacy Isomeric Enters Consent Decree After Recalls, Violations
SALT LAKE CITY - Compounding pharmacy Isomeric Pharmacy Solutions of Utah on Oct. 3 entered into a consent decree of permanent injunction to resolve a civil complaint filed days earlier by the Food and Drug Administration for distributing adulterated, misbranded and unapproved new drugs (United States of America v. Isomeric Pharmacy Solutions, et al., No. 17-852, D. Utah).

American Pipe Tolling Does Not Apply To Claims In Securities Suit, Panel Rules
PHILADELPHIA - American Pipe & Construction Co. v. Utah tolling does not apply to claims in four related securities class action lawsuits against pharmaceutical companies and others that misrepresented the clinical trial results for a cholesterol treatment drug in violation of federal securities laws based on the U.S. Supreme Court's recent ruling in California Public Employees Retirement System v. ANZ Securities Inc., a Third Circuit U.S. Court of Appeals panel ruled Aug. 3 in reversing and remanding in a nonprecedential opinion (North Sound Capital LLC, et al. v. Merck & Co. Inc., et al., No. 16-1364, 3rd Cir.; GIC Private Limited v. Merck & Co. Inc., et al., No. 1365, 3rd Cir.; GIC Private Limited v. Merck & Co., et al., No. 16-1366, 3rd Cir.; and North Sound Capital LLC, et al. v. Merck & Co. Inc., et al., No. 16-1367, 3rd Cir.; 2017 U.S. App. LEXIS 14170).

FDA Reports 43 Eye Problems In Patients Given Drugs Compounded In Texas
SILVER SPRING, Md. - The Food and Drug Administration on July 28 warned health care providers that the agency has received adverse event reports about at least 43 patients who suffered eye injury after being injected with triamcinolone and moxifloxacin compounded by Guardian Pharmacy Services in Dallas.

FDA Reports 5 More Deaths In Patients Who Got Intragastric Balloons
SILVER SPRING, Md. - The Food and Drug Administration on Aug. 10 told health care providers of five reports of unanticipated deaths from 2016 to the present in patients who received liquid-filled intragastric balloons to treat obesity.

Benicar Settlement Will Pay High Of $10,000 Per Claimant, More For Serious Injury
TOKYO - Japanese drug maker Daiichi Sankyo Co. Ltd. on Aug. 1 agreed to pay up to $300 million to settle claims that the company's blood pressure drug Benicar cause sprue-like enteropathy and other gastrointestinal conditions, according to a settlement agreement presented in the Benicar multidistrict litigation court (In Re: Benicar [Olmesartan] Products Liability Litigation, No. 15-2606, D. N.J.).

$150M In Punitives Awarded For Misrepresentation In 1st AndroGel MDL Bellwether
CHICAGO - An Illinois federal jury on July 24 found that AbbVie Inc. is not liable to an AndroGel plaintiff for his heart attack but said that the defendant fraudulently misrepresented the testosterone replacement therapy drug and awarded the plaintiff $150 million in punitive damages in the first multidistrict litigation verdict (In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Jesse Mitchell, et al. v. AbbVie, Inc., et al., No. 14-9178, N.D. Ill.).

Preemption Summary Judgment Denied In Xarelto Bellwether Trial; All Experts Stay In
NEW ORLEANS - The Louisiana federal judge overseeing the Xarelto multidistrict litigation on July 21 denied the defendant partial summary judgment in the third bellwether case on the basis of federal preemption and on the basis of design defect (In Re: Xarelto Products Liability Litigation, No. 14-md-02592 [Dora Mingo v. Janssen Pharmaceuticals, Inc., et al., No. 15-3469], E.D. La., 2017 U.S. Dist. LEXIS 114338, 2017 U.S. Dist. LEXIS 113872).

Xarelto MDL Judge Allows Mississippi's Punitives Law To Govern 3rd Bellwether Case
NEW ORLEANS - The Louisiana federal judge overseeing the Xarelto multidistrict litigation on July 24 denied a defense motion to apply more restrictive punitive damage laws to the upcoming third bellwether trial and denied summary judgment based on the learned intermediary doctrine (In Re: Xarelto, No. 14-md-2592 [Dora Mingo v. Janssen Pharmaceuticals, Inc., et al., No. 15-3469], E.D. La., 2017 U.S. Dist. LEXIS 115459, 2017 U.S. Dist. LEXIS 115461).

Design Defect Damages Hearing Ordered In Pennsylvania Pelvic Mesh Defense Verdict
PHILADELPHIA - The first defense verdict in Pennsylvania's pelvic mesh mass tort litigation was partially reversed July 19 when a judge granted the plaintiff's post-trial motion for a damage hearing on design defect (In Re: Pelvic Mesh Litigation [Kimberly L. Adkins v. Ethicon, Inc.], July Term 2013, No. 00919, No. 17062172, Pa. Comm. Pls., Philadelphia Co.).

New Jersey Appeals Panel Reinstates 2 Accutane Experts, 2,076 Dismissed Cases
TRENTON, N.J. - A New Jersey appeals court panel on July 28 reversed the exclusion of two plaintiff experts from the state's Accutane multicounty litigation, reinstating 2,076 cases that had been dismissed (In Re: Accutane Litigation, Nos. A-4698-14T1 and A-0910-16T1, N.J. Super., App. Div., 2017 N.J. Super. LEXIS 116).

New Jersey Appeals Court Reverses Summary Judgment In Accutane Warnings Cases
TRENTON, N.J. - The New Jersey Superior Court Appellate Division on July 25 reversed summary judgment in 18 of the state's multicounty Accutane litigation, saying that under New Jersey's product liability law, there remain questions on whether the post-2002 warning label for the acne drug adequately warned doctors and patients about the risk of permanent bowel injury (In Re: Accutane Litigation, Nos. A-4750-14T1 and A-0164-15T1, N.J. Super., App. Div., 017 N.J. Super. Unpub. LEXIS 1885).

Olympus Liable To Hospital For Deadly Infection Linked To Duodenoscope Design
SEATTLE - A Washington state court jury on July 24 found Olympus America Inc. liable to a hospital for the death of a patient who died of an infection linked to the company's duodenoscope, but not liable to the decedent's wife (Theresa Bigler, et al. v. Olympus America Inc., et al., No. 15-2-054472-SEA, Wash. Super., King Co.).

Pinnacle Hip Manufacturing Defect Whistle-Blower Claim Reinstated By 1st Circuit
BOSTON - Two orthopedic surgeons who claim that DePuy Orthopaedics Inc. "palmed off" Pinnacle metal-on-metal hips with manufacturing defects had that claim reinstated to their False Claims Act case on July 26 by the First Circuit U.S. Court of Appeals, but their claims that the manufacturer made false statements to the Food and Drug Administration remain dismissed (United States, ex rel. Antoni Nargol, et al. v. DePuy Orthopaedics, Inc., et al., No. 16-1442, 1st Cir., U.S. App. LEXIS 13540).

Pinnacle Hip Defendants File Mandamus Petition To Limit MDL Court Jurisdiction
NEW ORLEANS - Defense counsel in the Pinnacle hip multidistrict litigation on July 25 petitioned the Fifth Circuit U.S. Court of Appeals for a writ of mandamus preventing the MDL judge from exercising jurisdiction over eight Texas plaintiffs in a Sept. 5 bellwether trial (In Re: DePuy Orthopaedics, Inc., et al., No. 17-10812, 5th Cir.).

1st Bair Hugger Bellwether Plaintiffs Can't Make Claim For Punitive Damages
MINNEAPOLIS - A federal magistrate judge in the Bair Hugger multidistrict litigation on July 27 denied a plaintiffs' motion to add a claim for punitive damages in the initial bellwether trial pool but said other plaintiffs can try to make their case for adding the claim to their cases (In Re: Bair Hugger Forced Air Warming Device Products Liability Litigation, No. 15-2666, D. Minn.).

NECC Head Says Forfeiture, If Any, Is $249,725, Not $76.1M Government Claims
BOSTON - The former head of New England Compounding Center (NECC) on July 26 said that the U.S. District Court for the District of Massachusetts lacks jurisdiction to order forfeiture, but if it does, he should forfeit only $249,725 and not the $76.11 million that the federal prosecutors suggest (United States v. Barry J. Cadden, No. 14-cr10363, D. Mass.).

Lipitor MDL Plaintiffs Tell 4th Circuit Judge Erred In Expert Testimony Rulings
RICHMOND, Va. - Plaintiffs alleging that the statin drug Lipitor caused diabetes on July 28 told the Fourth Circuit U.S. Court of Appeals that a multidistrict litigation judge erred when he excluded causation opinions of two experts and granted summary judgment against more than 3,000 plaintiffs (In Re: Lipitor [Atorvastatin] Products Liability Litigation, Nos. 17-1140[L], 17-1136, 17-1137, 17-1189, 4th Cir.).

Partial Dismissals Granted In Union's Average Wholesale Drug Price Class Action
PHILADELPHIA - A Pennsylvania federal judge on July 24 granted in part and denied in part motions by several generic drug companies to dismiss claims by a union health fund that they inflated their average wholesale prices (AWPs), costing the union money while providing a "spread" to pharmacies to dispense the companies' drugs (Plumbers' Local Union No. 690 Health Plan v. Apotex Corp., et al., No. 16-665, E.D. Pa., 017 U.S. Dist. LEXIS 114733).

Celgene Pays $280M To Settle Whistle-Blower Lawsuit Alleging Off-Label Marketing
The U.S. Justice Department and Celgene Corp. on July 25 announced that the company will pay $280 million to settle a False Claims Act lawsuit that it promoted the cancer drugs Thalomid and Revlimid for off-label uses (United State, ex rel. Beverly Brown v. Celgene Corporation, No. 10-3165, C.D. Calif., Western Div.).

Plaintiff Seeks Interlocutory Appeal On Expert Exclusion In Bypass Machine Case
SALT LAKE CITY - A Utah federal judge on July 18 vacated a trial date in a heart/lung bypass machine wrongful death case after the plaintiff indicated her desire to get an interlocutory appeal of the judge's order severely limiting the testimony of her causation expert at an upcoming trial (Buzzie Smith, et al. v. Terumo Cardiovascular Systems Corporation, Inc., et al., No. 12-998, D. Utah, Central Div., 2017 U.S. Dist. LEXIS 108205).