Preview: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News
LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News
Headline Emerging Drugs & Devices Legal News from LexisNexis®
1st Circuit Affirms Dismissal Of Actos Prediabetes Off-Label False Claims Lawsuit
BOSTON - The First Circuit U.S. Court of Appeals on Nov. 22 affirmed dismissal of an Actos off-label whistle-blower lawsuit, agreeing with a lower court judge that the relator failed to plead that the alleged actions resulted in false claims being filed with state Medicare programs (Peter W. Lawton, ex rel. United States of America v. Takeda Pharmaceutical Company, Ltd., et al., No. 16-1382, 1st Cir.; 2016 U.S. App. LEXIS 20943).
11th Circuit: Hip Plaintiff Missed Deadline By Withholding Service
ATLANTA - The 11th Circuit U.S. Court of Appeals on Nov. 28 agreed with a lower court that in filing a DePuy hip lawsuit but withholding service in hopes of a settlement, a plaintiff's claim was actually not initiated until after the applicable two-year statute of limitations (Maeola Goldthrip, et al. v. DePuy Orthopaedics, Inc., et al., No. 16-14002, 11th Cir.; 2016 U.S. App. LEXIS 21192).
Insured Did Not Comply With Policy's Consent-To-Settle Provision, Appeals Panel Says
CINCINNATI - An excess liability insurer has no duty to reimburse an insured for underlying settlements related to defective knee implants because the policy's consent-to-settle provision clearly required the insured to seek the excess insurer's consent and the insured failed to do so, the Sixth Circuit U.S. Court of Appeals said Nov. 18 in reversing a Michigan federal judge's ruling (Stryker Corp., et al. v. National Union Fire Insurance Company of Pittsburgh, Pa. et al., Nos. 15-1657 and 15-1664, 6th Cir.; 2016 U.S. App. LEXIS 20653).
6th Circuit Denies Appeal Of Dow Breast Implant Order By Korean Claimants
CINCINNATI - A Sixth Circuit U.S. Court of Appeals panel on Nov. 23 affirmed a consent order that resulted in certain Korean women being denied injury claims from the Dow Corning Corp. silicone breast implant settlement (In Re: Settlement Facility Dow Corning Trust, Korean Claimants v. Debtor's Representatives, et al., No. 15-2548, 6th Cir.; 2016 U.S. App. LEXIS 21167).
1st Circuit Won't Grant New Trial In Nexium Antitrust Case For Alleged Errors
BOSTON - The First Circuit U.S. Court of Appeals on Nov. 21 said a district court judge committed no errors in a Nexium generic antitrust case that ended in a defense verdict for defendant AstraZeneca LP (In Re: Nexium [Esomeprazole] Antitrust Litigation, American Sales Company, et al. v. AstraZeneca LP, et al., Nos. 15-2005, 15-2006, 15-2007, 1st Cir.; 2016 U.S. App. LEXIS 20845).
U.K. Investigation Material About Paxil Expert Excluded From Suicide Trial
CHICAGO - Evidence about a United Kingdom investigation into plaintiff antidepressant expert witness Dr. David Healy will be excluded from a Jan. 17 suicide trial after an Illinois federal judge on Nov. 21 said the investigation resulted in no action against Healy and is not relevant to his testimony or to the case (Wendy Dolin, et al. v. SmithKline Beecham Corporation, et al., No. 12-6403, N.D. Ill., Eastern Div.).
Kimberly-Clark Wants Surgical Gown Class Stayed Pending 9th Circuit Petition
LOS ANGELES - Kimberly-Clark Corp. on Nov. 18 asked a California federal court to stay a certified class action involving the company's surgical gowns while it waits for a circuit court to rule on a petition for interlocutory appeal (Hrayr Shahinian, M.D., et al. v. Kimberly-Clark Corporation, et al., No. 14-83390, C.D. Calif.).
Plaintiffs In Pinnacle Hip Bellwether Trial Will Seek State Consumer Law Penalties
DALLAS - Six plaintiffs in an ongoing DePuy Pinnacle hip multidistrict litigation bellwether trial on Nov. 28 told a Texas federal court that after the verdict, they intend to ask the court to determine that defendant DePuy Orthopaedics Inc. violated California's unfair competition law (UCL) and to order equitable relief (In Re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, MDL Docket No. 2244, No. 13-3631, Rosa Metzler, et al. v. DePuy Orthopaedics, Inc., et al., No. 12-2066, Michael Weiser v. DePuy Orthopaedics, Inc., et al., No. 13-3631, Judith Rodriguez v. DePuy Orthopaedics, Inc., et al., No. 13-3938, Linda Standerfer v. DePuy Orthopaedics, Inc., et al., No. 14-1730, Kathleen Davis, et al. v. DePuy Orthopaedics, Inc., et al., No. 15-1767, Marvin Andrews, et al. v. DePuy Orthopaedics, Inc., et al., No. 15-3484, N.D. Texas, Dallas Div.).
DePuy Can't Use Video Depositions Only In 3rd Pinnacle Hip Bellwether
DALLAS - DePuy Orthopaedics Inc. will have to find another way to present testimony of five experts in an ongoing Pinnacle hip multidistrict litigation bellwether trial after the presiding judge on Nov. 17 sustained a plaintiffs' objection to having testimony entered by video depositions (In Re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, MDL Docket No. 2244, No. 11-md-2244, Rosa Metzler, et al. v. DePuy Orthopaedics, Inc., et al., No. 12-2066, Michael Weiser v. DePuy Orthopaedics, Inc., et al., No. 13-3631, Judith Rodriguez v. DePuy Orthopaedics, Inc., et al., No. 13-3938, Linda Standerfer v. DePuy Orthopaedics, Inc., et al., No. 14-1730, Kathleen Davis, et al. v. DePuy Orthopaedics, Inc., et al., No. 15-1767, Marvin Andrews, et al. v. DePuy Orthopaedics, Inc., et al., No. 15-3484,N.D. Texas, Dallas Div.).
Judge In Fungal Meningitis Criminal Case Won't Reconsider 3 Dismissals
BOSTON - A judge overseeing the New England Compounding Center (NECC) criminal case on Nov. 16 denied the United States' motion to reconsider the dismissal of claims against three defendants, saying the federal government attempted to amend the indictment and add "one completely new argument" (United States of America v. Barry J. Cadden, et al., No. 14-10363, D. Mass.).
Fungal Meningitis MDL Documents Not Available To Criminal Defendant
BOSTON - A criminal defendant in the New England Compounding Center (NECC) fungal meningitis outbreak cannot access discovery material from the personal injury multidistrict litigation, but a co-defendant can share materials he got while he was part of the MDL, a Massachusetts federal judge ruled Nov. 17 (In Re: New England Compounding Pharmacy, Inc. Products Liability Litigation, MDL Docket No. 2419, No. 13-md-2419, D. Mass.).
Fungal Meningitis Defendant Wants Criminal Trial Continued To Review Evidence
BOSTON - A defendant facing federal murder charges in connection with the New England Compounding Center (NECC) fungal meningitis outbreak on Nov. 25 asked a Massachusetts federal court to continue his January trial, saying he is at a disadvantage because he only recently got access to discovery from the personal injury multidistrict litigation that is likely to be used against him (United States of America v. Glenn Chin, No. 14-cr-10363, D. Mass.).
Surgical Mesh Plaintiff Appeals Dismissal Of Suit Against 2 Manufacturers
CHATTANOOGA, Tenn. - A surgical mesh plaintiff on Nov. 22 filed a notice of appeal with the Sixth Circuit U.S. Court of Appeals of a Tennessee federal court's dismissal of his complaint for failure to plead specific defects or specific causation (Ronnie Moore v. C.R. Bard, Inc., et al., No. 16-161, E.D. Tenn.; 2016 U.S. Dist. LEXIS 156923).
Former FDA Deputy To Pay $127,496 For Insider Trading Role Involving Generics
NEW YORK - A former Food and Drug Administration deputy director turned industry lobbyist was enjoined Nov. 14 from violating the Securities Exchange Act for his role in giving FDA insider information to a hedge fund manager who reportedly made millions from the scheme (Securities and Exchange Commission v. Sanjay Valvani, et al., No. 16-4512, S.D. N.Y.).
Former Valeant, Pharmacy Executives Charged With Running Kickback Scheme
NEW YORK - Former Valeant Pharmaceuticals International Inc. executive Gary Tanner and former Phildor Rx Services LLC CEO Andrew Davenport have been charged with fraud for allegedly running a kickback scheme, the U.S. attorney for the Southern District of New York announced Nov. 17 (United States of America v. Gary Tanner, et al., No. 16-7338, S.D. N.Y.).
9th Circuit Affirms Dismissal Of Zoloft Consumer Class As Untimely Filed
SAN FRANCISCO - A Ninth Circuit U.S. Court of Appeals panel on Nov. 9 affirmed a trial court's dismissal of a Zoloft consumer law class action, saying the plaintiff failed to show why she was prevented from filing her claims within the applicable statutes of limitations (Laura A. Plumlee, et al. v. Pfizer, Inc., No. 14-16924, 9th Cir.; 2016 U.S. App. LEXIS 20225).
California Appeals Court Affirms Summary Judgment In Cryoablation Case
LOS ANGELES - A California appeals court on Oct. 28 affirmed summary judgment in a case in which a family alleges that a cryoablation device killed a woman under treatment for recurring lung cancer (James Horton, Sr., et al. v. Endocare, Inc., et al., No. B265724, Calif. App., 2nd Dist., Div. 5; 2016 Cal. App. Unpub. LEXIS 8154).
11th Circuit: Relator Had No Direct Knowledge Of 'Overfill' Billing Of Medicare
ATLANTA - A panel of the 11th Circuit U.S. Court of Appeals on Nov. 8 said that while a relator had knowledge that a kidney clinic operator was using drug "overfill," he had no direct knowledge that the operator was fraudulently billing federal health care programs for the essentially free amount of drug (United States of America, ex rel. Chester Saldivar v. Fresenius Medical Care Holdings, Inc., et al., No. 15-15487, 11th Cir.; 2016 U.S. App. LEXIS 20148).
Wright Profemur Hip Trial Ends In Defense Verdict
ST. LOUIS - A Missouri state court jury on Nov. 3 returned a defense verdict for Wright Medical Technology Inc. in a Profemur metal-on-metal hip prosthesis trial, according to a court docket (Donald S. DeLine v. Wright Medical Technology, Inc., et al., No. 14SL-CC01443, Mo. Cir., St. Louis Co.).
Caldera Plaintiffs Say Liquidation Expert Is Unqualified
LOS ANGELES - Plaintiffs opposed to a limited fund of Caldera Medical Inc. pelvic mesh lawsuits on Nov. 7 renewed their objections to a proposed $20 million class settlement, saying a defense expert is unqualified to state that Caldera has a negative liquidation value (Federal Insurance Company v. Caldera Medical Inc., et al., No. 15-393, C.D. Calif.).
California Federal Judge: Birth Control Injury Cases Are Not A Mass Action
LOS ANGELES - A California federal judge on Nov. 14 granted a motion to remand a case alleging injuries caused by birth control, which had originally been filed as seven cases that were consolidated by a California trial court, finding that the sua sponte consolidation was a judicial mandate, not a proposal to have the cases tried jointly (Jacqueline Alexander, et al. v. Bayer Corp., et al., No. 16-6822, C.D. Calif.; 2016 U.S. Dist. LEXIS 157295).
Federal Judge Won't Dismiss Insurer's RICO Case Against GSK For 'Worthless' Drugs
PHILADELPHIA - A Pennsylvania federal judge on Nov. 9 denied a motion by GlaxoSmithKline LLC (GSK) to dismiss a Racketeer Influenced and Corrupt Organizations Act case alleging that the drug maker sold them defective and "worthless" drugs that were made at a now-closed manufacturing plant in Cidra, Puerto Rico (Blue Cross Blue Shield Association, et al. v. GlaxoSmithKline LLC, No. 13-4663, E.D. Pa.; 2016 U.S. Dist. LEXIS 155347).
Surgical Gown California Class Certified; Nationwide Class Denied
LOS ANGELES - A California federal judge on Nov. 14 certified a refund and injunction class of Californians who purchased allegedly defective surgical gowns from Kimberly-Clark Corp. but denied certifying a nationwide class of purchasers because of differences in state fraud laws (Hrayr Shahinian, et al. v. Kimberly-Clark Corp., et al., No. 14-8390, C.D. Calif., Western Div.).
Benicar MDL Judge Denies Plaintiffs Partial Summary Judgment On Causation
CAMDEN, N.J. - The New Jersey federal judge overseeing the Benicar multidistrict litigation on Nov. 9 denied without prejudice a plaintiffs' motion for partial summary judgment, saying that 14 deposition or document excerpts are not defense admissions that the hypertension drug causes sprue-like enteropathy (In Re: Benicar [Olmesartan] Products Liability Litigation, MDL Docket No. 2606, No. 15-2606, D. N.J.; 2016 U.S. Dist. LEXIS 156182).
Plaintiffs Support, Oppose Eliquis Anticoagulant MDL Sought By Defense
WASHINGTON, D.C. - Two groups of plaintiffs on Nov. 4 said they support centralization of all federal Eliquis drug cases into a multidistrict litigation, but one group says voluntary coordination will suffice (In Re: Eliquis [Apixaban] Products Liability Litigation, MDL Docket No. 2754, JMPDL).
Husband, Wife Sentenced For Evasive Bank Transfers In Wake Of NECC Probe
BOSTON - A husband and wife in the New England Compounding Center (NECC) fungal meningitis outbreak criminal case were sentenced Nov. 9 for structuring financial transactions to avoid federal reporting requirements (United States of America v. Barry J. Cadden, et al., No. 14-10363, D. Mass.).
State Appeals Court's Offer: Have $12.69M Polar Care Verdict Reversed Or Take Cut
RIVERSIDE, Calif. - A California appeals court on Oct. 28 affirmed most of a jury's liability findings in a Polar Care 500 tissue injury case but reversed the compensatory and punitive damages awards totaling $12.69 million unless the plaintiff accepts a reduction to $1.45 million (Virginia Bigler-Engler, et al. v. Breg, Inc., et al., No. C063556, Calif. App., 4th Dist., Div. 1; 2016 Cal. App. LEXIS 921).
9th Circuit Affirms Exclusion Of Nexium Bone Loss General Causation Expert
SAN FRANCISCO - The Ninth Circuit U.S. Court of Appeals on Oct. 27 affirmed summary judgment in the Nexium bone injury multidistrict litigation, agreeing with the MDL court that the plaintiff's sole general causation expert was unreliable (In Re: Nexium Esomeprazole, Susan Orrell, et al. v. AstraZeneca Pharmaceuticals LP, et al., No. 14-56845, In Re: Nexium Esomeprazole, Janice Allen, et al. v. AstraZeneca Pharmaceuticals LP, et al., No. 15-56848, 9th Cir.; 2016 U.S. App. LEXIS 19508).
Punitives Award In ObTape Case Cut From $4M to $2M; No Specific Intent Present
COLUMBUS, Ga. - A Georgia federal judge presiding over the Mentor ObTape pelvic mesh multidistrict litigation on Oct. 20 said the plaintiff presented "ample" evidence to support a jury's punitive damages finding but said there was no evidence that Mentor Corp. had specific intent under Florida law to harm the plaintiff and capped the jury's $4 million punitive damages verdict at $2 million (In Re: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 08-md-2004, Teresa Taylor v. Mentor Corp., No. 12-176, D. Md.; 2016 U.S. Dist. LEXIS 145290).
Plaintiff Gets $449,639 In Fees, Costs In Mentor ObTape Pelvic Mesh Case
COLUMBUS, Ga. - The Georgia federal judge overseeing the Mentor Corp. pelvic mesh multidistrict litigation on Oct. 25 awarded a plaintiff $449,639 in attorney fees and expenses following a $2.4 million judgment in an ObTape pelvic mesh trial (In Re: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 08-md-2004, Teresa Taylor v. Mentor Corp., No. 12-176, D. Md.; 2016 U.S. Dist. LEXIS 147119).
West Virginia Mass Tort Panel Excludes Zoloft Expert, Grants Summary Judgment
CHARLESTON, W.Va. - A West Virginia state court mass tort panel on Oct. 5 excluded the specific causation opinion of a plaintiff expert in a Zoloft birth defect case and granted summary judgment for defendant Pfizer Inc. (In Re: Zoloft Litigation, No. 14-C-7000, D.B., et al. v. Pfizer, Inc., No. 12-C-164, W.Va. Cir., Kanawha Co.).
Michigan Appeals Court Reverses Sanctions, Dismissal Of Acetaminophen Case
DETROIT - A split Michigan appeals panel on Oct. 25 reversed sanctions and dismissal entered against a pro per plaintiff in an acetaminophen injury case, saying the trial court exceeded its authority on both issues (David Sutton v. Advance Pharmaceutical, Inc., No. 328038, Mich. App., 1st Dist.; 2016 Mich. App. LEXIS 1873).
Expert Out, Judgment Granted In 2nd NexGen Knee MDL Bellwether Case
CHICAGO - The Illinois federal judge overseeing the Zimmer NexGen knee multidistrict litigation on Oct. 21 excluded a plaintiff's sole specific causation expert in the second bellwether trial and granted summary judgment as a result (In Re: Zimmer NexGen Knee Implant Products Liability Litigation, MDL Docket No. 2272, No. 11-5468, Theodore Joas, et al. v. Zimmer, Inc., No. 13-9216, N.D. Ill., Eastern Div.; 2016 U.S. Dist. LEXIS 146008).
All Sperm Donor Plaintiffs Oppose Creation Of MDL
WASHINGTON, D.C. - Plaintiffs in all six federal cases against Xytex Corp. on Oct. 20 opposed the defendant's motion to centralize their sperm donor liability cases in a multidistrict litigation (In Re: Xytex Corporation Sperm Donor Products Liability Litigation, MDL Docket No. 2551, JPMDL).
Defendants Support MDL For C-Qur Surgical Mesh Patches
WASHINGTON, D.C. - Defendants in federal personal injury lawsuits involving the C-Qur hernia patch on Nov. 1 supported a motion by plaintiffs to centralize 14 cased in a multidistrict litigation (In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation, MDL Docket No. 2753, JPMDL).
Science Day Set For Jan. 17 By Fluoroquinolone MDL Judge
MINNEAPOLIS - The Minnesota federal judge overseeing the fluoroquinolone multidistrict litigation on Oct. 26 scheduled a science day for Jan. 17 (In Re: Fluoroquinolone Products Liability Litigation, MDL Docket No. 2642, D. Minn.).
Zofran MDL Plaintiffs Say GSK's Dismissal Motions Are Premature
BOSTON - Plaintiffs in the Zofran birth defect multidistrict litigation on Oct. 26 asked the court to strike defendant GlaxoSmithKline LLC's (GSK) motion to dismiss certain cases on the issue of innovator liability and for failure to plead fraud claims (In Re: Zofran [Ondansetron] Products Liability Litigation, MDL Docket No. 2657, No. 15-md-2657, D. Mass.).
Wright Hip Plaintiff Asks Appeals Court To Vacate New Trial, Reinstate $4.5M Award
LOS ANGELES - A plaintiff who underwent 11 surgeries after his Wright Medical Technology Inc. hip prosthesis fractured on Oct. 5 asked a California appeals court to reverse the trial court's order for a new trial and to reinstate his $4.5 million verdict (Alan Warner, et al. v. Wright Medical Technology, Inc., No. B26-7907, Calif. App., 2nd Dist., Div. 3).
3 Former Warner Chilcott Sales Managers Sentenced For Health Care Fraud
BOSTON - A former district sales manager for Warner Chilcott was sentenced Oct. 27 to one year of probation and fined $10,000 for health care fraud and violating the Health Insurance Portability and Accountability Act (HIPAA) by accessing protected patient information to fill out insurance claim forms to pay for his company's Atelvia osteoporosis drug (United States of America v. Landon Eckles, No. 15-cr-10320, D. Mass.).
Device Maker Suspends Operations After Founder's Death, FDA Warning
ST. LOUIS - Multidata Systems International Corp., a medical device maker that was the subject of an Oct. 20 warning by the Food and Drug Administration, has "suspended daily operations" due to the death of its founder and president, according to the company's website.
Pennsylvania Federal Judge Severs, But Won't Transfer, Antitrust Cases
PHILADELPHIA - Efforts by Endo Pharmaceuticals Inc., Watson Laboratories Inc., Allergan PLLC and Impax Laboratories Inc. to sever allegations that they violated the Federal Trade Commission and Clayton Acts by delaying market entry of two proposed generic drugs were successful on Oct. 20, when a Pennsylvania federal judge agreed that the challenged agreements, underlying circumstances and drugs "have nothing to do with each other" (Federal Trade Commission v. Endo Pharmaceuticals Inc., et al., No. 16-1440, E.D. Pa.; 2016 U.S. Dist. LEXIS 145329).
FDA: Hepatitis C Drugs Can Reactivate Hepatitis B
SILVER SPRING, Md. - The Food and Drug Administration on Oct. 4 warned that patients treated with direct-acting antiviral (DAA) drugs to treat hepatitis C are at risk of having an underlying hepatitis B (HBV) infection reactivated.