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®
Supreme Court Won't Revisit Daubert, Rule 702 Interaction In Denture Cream Case
WASHINGTON, D.C. - The U.S. Supreme Court on Oct. 17 denied a petition by 36 denture cream plaintiffs asking the high court to settle what they say is a conflict between the high court's expert testimony ruling in Daubert v. Merrell Dow Pharmaceuticals, Inc. (509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 ) and Federal Rule of Evidence 702 (Ellenie Steele, et al. v. Proctor & Gamble Distributing LLC, et al., No. 16-338, U.S. Sup.).
3rd Circuit: Law Firm Lacks Standing To Sue FDA Over Citizen Petition Denial
PHILADELPHIA - The Third Circuit U.S. Court of Appeals on Oct. 6 said a plaintiff's law firm lacks standing to sue the Food and Drug Administration because the agency's denial of the firm's citizen petition to restrict the use of Risperdal in children is being used against it by defendant Janssen Pharmaceuticals Inc. (Sheller, P.C. v. United States Department of Health and Human Services, et al., No. 15-3443, 3rd Cir.; 2016 U.S. App. LEXIS 18188).
3rd Circuit Affirms Jaw Injury Plaintiff Failed To Show Proximate Causation
PHILADELPHIA - The Third Circuit U.S. Court of Appeals on Oct. 5 affirmed summary judgment in an Aredia/Zometa osteonecrosis of the jaw (ONJ) case, agreeing with a trial court judge that the plaintiff failed to show causation (William M. Bock v. Novartis Pharmaceuticals Corporation, No. 15-3696, 3rd Cir.; 2016 U.S. App. LEXIS 18042).
5th Circuit Rejects Widow's Challenge To Vioxx Extraordinary Injury Award
NEW ORLEANS - A Fifth Circuit U.S. Court of Appeals panel on Oct. 11 said a physician's widow is bound by her signed release in the Vioxx settlement program and that her subsequent state consumer lawsuit alleging fraud about how large an award she was entitled to was properly dismissed by summary judgment (In Re: Vioxx Products Liability Litigation, Linda Isner, et al. v. Seeger Weiss, L.L.P., et al., No. 15-31070, 5th Cir.; 2016 U.S. App. LEXIS 18357).
7th Circuit Affirms Hormone Therapy Breast Cancer Claim Is Preempted
CHICAGO - The Seventh Circuit U.S. Court of Appeals on Oct. 18 affirmed judgment against a hormone replacement therapy plaintiff, finding that her claims are preempted by federal law and that she failed to timely assert her claim that generic manufacturer defendants failed to update their drug warning labels to warn of the risk of breast cancer (Kathleen A. Wagner v. Teva Pharmaceuticals USA, Inc., et al., No. 15-2294, 7th Cir.; 2016 U.S. App. LEXIS 18671).
3rd Circuit Affirms Summary Judgment In Zimmer Hip Failure Case
PHILADELPHIA - The Third Circuit U.S. Court of Appeals on Oct. 7 affirmed summary judgment for Zimmer Inc., finding that a plaintiff failed to show that a hip prosthesis he received was negligently designed or that Zimmer failed to warn that it could break in a patient of his size and activity level (Gregory Kline, et al. v. Zimmer Holdings, Inc., et al., No. 15-2854, 3rd Cir.; 2016 U.S. App. LEXIS 18270).
Mylan Says It'll Pay $465M To United States For Underpaying Medicare Rebates
HERTFORSHIRE, U.K. - Mylan N.V. on Oct. 7 said it has agreed to pay $465 million to settle "questions" by the U.S. Justice Department and other government agencies that the company misclassified its EpiPen epinephrine autoinjector as a generic drug to pay the government less under the Medicaid Drug Rebate Program.
Novartis Pays $35M To Settle Elidel Marketing False Claims Lawsuit
PHILADELPHIA - Novartis Pharmaceuticals Corp. will pay $35 million to resolve a whistle-blower's claim that the drug maker marketed Elidel for use with children under 2 and as a first-line drug, according to a settlement disclosed in Pennsylvania federal court on Oct. 5 (United States of America, ex rel. Donald R. Galmines v. Novartis Pharmaceuticals Corporation, No. 06-3213, E.D. Pa.).
Omnicare To Pay $28.12M For Role In Depakote Kickback Scheme
ABINGDON, Va. - Nursing home pharmacy Omnicare Inc. has agreed to pay $28.12 million to resolve its role in a Depakote kickback scheme with Abbott Laboratories Inc., the U.S. Justice Department announced Oct. 17 (United States ex rel. Meredith McCoyd v. Abbott Laboratories, et al., No. 07-81, United States ex rel. Thomas J. Spetter, Jr. v. Abbott Laboratories, Inc., et al., No. 10-6, W.D. Va.).
102 New Jersey Accutane Cases Dismissed Because Doctors Are Dead Or Missing
ATLANTIC CITY, N.J. - A New Jersey state court judge on Oct. 12 dismissed with prejudice 102 Accutane bowel injury cases because prescribing physicians in the 11-year-old litigation are deceased or cannot be located to testify that a different warning would have changed their decision to prescribe the acne drug (In Re: Accutane Litigation, No. 271, N.J. Super., Atlantic Co.).
Boston Scientific Asks 11th Circuit To Overturn $26.74M Verdict For 4 Plaintiffs
ATLANTA - Boston Scientific Corp. on Oct. 12 asked the 11th Circuit U.S. Court of Appeals to overturn a $26.74 million pelvic mesh verdict for four plaintiffs, saying a multidistrict litigation court erred in consolidating four cases for a bellwether trial, in excluding evidence of regulatory clearance of the device at issue and in finding that there was proof of design defect and inadequate warnings (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818-H, 11th Cir.).
GSK Seeks Dismissal Of 27 Zofran Birth Defect MDL Cases Involving Generics
BOSTON - GlaxoSmithKline LLC (GSK) on Oct. 13 asked the Zofran birth defect multidistrict litigation court to dismiss 27 cases in which plaintiffs allege injuries from taking one of the drug's generic versions (In Re: Zofran [Ondansetron] Products Liability Litigation, MDL Docket No. 2657, No. 15-md-2657, D. Mass.).
MDL Sought For 6 Cases Alleging Sperm Supplier Misrepresented Donor
WASHINGTON, D.C. - Arguments will be heard Dec. 1 by a federal judicial panel on centralizing six cases in which plaintiffs allege that they were sold sperm that came from a convicted felon with schizophrenia who did not go to college, according to an Oct. 14 order (In Re: Xytex Corporation Sperm Donor Products Liability Litigation, MDL Docket No. 2751, JPMDL).
MDL Sought For Atrium C-Qur Hernia Patches
WASHINGTON, D.C. - The Judicial Panel on Multidistrict Litigation (JPMDL) on Oct. 14 ordered arguments for Dec. 1 on a plaintiffs' motion to centralize 12 federal lawsuits alleging that the C-Qur hernia patch made by Atrium Medical Corp. is defective (In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation, MDL Docket No. 2753, JPMDL).
CDC Says Heater-Cooler Device Contamination May Have Started In Factory
SILVER SPRING, Md. - The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration on Oct. 13 issued updated warnings regarding the Mycobacterium chimaera (M. chimaera) infections associated with the use of the Stockert 3T Heater-Cooler System (3T) in patients in the United States who have undergone cardiothoracic surgeries.
Reducing Punitives In Pinnacle Hip MDL Trial Isn't Unconstitutional, Judge Says
DALLAS - A Texas federal judge on Oct. 3 denied a motion by five plaintiffs in a DePuy Pinnacle hip trial to find the Texas punitive damages cap unconstitutional and to reinstate their $360 million exemplary damages award (In Re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, MDL Docket No. 2244, No. 11-md-2244, Margaret Aoki v. Johnson & Johnson Services, Inc., et al., No. 13-1071, Jacqueline Christopher v. Johnson & Johnson Services, Inc., et al., No. 14-194, Donald Greer v. Johnson & Johnson Services, Inc., et al., No. 12-1672, Susan Klusmann v. Johnson & Johnson Services, Inc., et al., No. 11-2800, Robert Peterson v. Johnson & Johnson Services, Inc., et al., No. 11-1941, N.D. Texas, Dallas Div.).
3rd Pinnacle Hip MDL Bellwether Trial Gets Under Way In Texas
DALLAS - The third bellwether trial in the DePuy Pinnacle hip multidistrict litigation got under way on Oct. 3 in the U.S. District Court for the Northern District of Texas (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.).
Massachusetts Appeals Court: Ortho Evra Label Warned Of Blood Clot Risk
BOSTON - A Massachusetts appeals panel on Sept. 21 affirmed summary judgment in an Ortho Evra birth control patch death case, agreeing with the trial court that the product's labeling adequately warned about the risk of blood clots (Leslie Niedner, et ux. v. Ortho-McNeil Pharmaceutical, Inc., & others, No. 15-P-1272, Mass. App.; 2016 Mass. App. LEXIS 131).
With 3,825 Claims Paid, Parties Suggest Remanding Remaining NuvaRing MDL Cases
ST. LOUIS - Saying that 3,825 claimants enrolled in the $100 million national settlement, the parties in the NuvaRing multidistrict litigation on Sept. 13 proposed that a Missouri federal judge suggest the remand of the remaining 52 cases to their transferor courts (In Re: NuvaRing Products Liability Litigation, MDL Docket No. 1964, No. 08-md-1964, E.D. Mo., Eastern Div.).
U.S. Supreme Court Won't Review Ketek Third-Party Payer RICO Class Denial
WASHINGTON, D.C. - The U.S. Supreme Court on Oct. 3 denied certiorari for three third-party payers that allege that Sanofi-Aventis U.S. Inc. violated the Racketeer Influenced and Corrupt Organizations (RICO) Act by fraudulently inducing doctors to prescribe the antibiotic Ketek (Sergeants Benevolent Association Health and Welfare Fund, et al. v. Sanofi-Aventis U.S., Inc., No.15-1525, U.S. Sup.).
Third-Party Payers' Class Actions For Alzheimer's Drugs Survive Dismissal
NEW YORK - A New York federal judge on Sept. 13 left unscathed two third-party payer lawsuits alleging that the maker of the Alzheimer's drug Namenda pulled their original version of the drug early and forced insurers to pay for a higher-cost follow-on drug (Sergeants Benevolent Association Health & Welfare Fund, et al. v. Actavis, PLC, et al., No. 15-6549, JM Smith Corporation, et al. v. Actavis, PLC, et al., No. 15-7488, S.D. N.Y.; 2016 U.S. Dist. LEXIS 128349).
JMOL, New Trial Denied In Boston Scientific $14.75M Pelvic Mesh Trial
CHARLESTON, W.Va. - The West Virginia federal judge overseeing the Boston Scientific Corp. (BSC) pelvic mesh multidistrict litigation on Oct. 3 denied the defendant's motion for judgment as a matter of law or a new trial in a consolidated trial that resulted in $14.75 million in compensatory and punitive damages for three women (Carol Sue Campbell, et al. v. Boston Scientific Corporation, No. 12-8633, S.D. W.Va., Charleston Div.; 2016 U.S. Dist. LEXIS 136669).
Pelvic Mesh Defendant Has Negative Worth, Class Settlement Parties Tell Judge
LOS ANGELES - Parties to a proposed $12.25 million limited-fund, mandatory class settlement for pelvic mesh injury claims against Caldera Medical Inc. on Sept. 19 told a California federal judge that after a court-ordered analysis of the company's liquidation value, it has a negative liquidation value and can contribute nothing more to the settlement (Federal Insurance Company v. Caldera Medical, Inc., et al., No. 15-393, C.D. Calif.).
Indictments Of 2 Pharmacists In Fungal Meningitis Outbreak Dismissed As 'Incidental'
BOSTON - A Massachusetts federal judge on Oct. 4 dismissed indictments against two pharmacists in the New England Compounding Center (NECC) fungal meningitis outbreak because the judge said their role in checking shipments of two compounded drugs marked for fictitious patients was incidental to alleged violations of the Food, Drug and Cosmetics Act (FDCA) (United States of America v. Kathy S. Chin, et al., No. 14-10363, D. Mass.).
Conspiracy Count Survives In Fungal Meningitis Outbreak Criminal Case
BOSTON - The judge presiding over a federal criminal case in Massachusetts stemming from the fungal meningitis outbreak on Sept. 21 denied a motion by five defendants to dismiss a charge of conspiracy to defraud the Food and Drug Administration (United States of America v. Barry Cadden, et al., No. 14-10363, D. Mass.; 2016 U.S. Dist. LEXIS 128933).
2 Defendants In Fungal Meningitis Outbreak To Go On Trial Jan. 5
BOSTON - The trial of two defendants facing murder and other federal charges in connection with the deadly fungal meningitis outbreak associated with the New England Compounding Pharmacy (NECC) was reset Oct. 4 to Jan. 5 in the U.S. District Court for the District of Massachusetts (United States of America v. Barry J. Cadden, et al., No. 14-cr-10363, D. Mass.).
1st Tylenol Bellwether Trial Continued Indefinitely By MDL In Pennsylvania
PHILADELPHIA - The first Tylenol multidistrict litigation bellwether trial scheduled to start Sept. 19 was continued to a future date on Sept. 15 by the Pennsylvania federal judge overseeing the MDL (In Re: Tylenol [Acetaminophen] Marketing, Sales Practices, and Products Liability Litigation, MDL Docket No. 2346, No. 13-md-2436, Rana Terry, et al. v. McNeil-PPC, Inc., et al., No. 12-7263, E.D. Pa.).
Depakote Bellwethers Stricken; Judge Opts For Joint Trials
EAST ST. LOUIS, Ill. - Saying that bellwether trials and global settlement talks for Depakote birth defect cases have failed, an Illinois federal judge on Sept. 21 vacated the next three bellwether trial dates and said she will instead pursue joint trials for the 698 plaintiffs (In Re: Depakote, Rhealyn Alexander, et al. v. Abbott Laboratories, Inc., No. 12-52, S.D. Ill.).
Taxotere Hair Loss MDL Created, Sent To Eastern District Of Louisiana
WASHINGTON, D.C. - Plaintiffs in 89 federal lawsuits who allege that they suffered permanent hair loss from the chemotherapy drug Taxotere on Oct. 4 had their cases centralized in a multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana (In Re: Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, JPMDL).
Abilify Compulsive Behavior MDL Created, Sent To Florida
WASHINGTON, D.C. - The Judicial Panel on Multidistrict Litigation (JPMDL) on Oct. 3 granted a rare joint plaintiff-defense motion to centralize 42 federal Abilify lawsuits in a multidistrict litigation in the U.S. District Court for the Northern District of Florida (In Re: Abilify [Aripiprazole] Products Liability Litigation, MDL Docket No. 2734, JPMDL).
Blood Clot Timing Device Class Action Dismissed With Leave To Amend
SAN DIEGO - A California federal judge on Sept. 13 dismissed a class action involving a recalled device that measures patients' blood clotting times, but gave the plaintiffs leave to file an amended complaint (Dina Andren, et al. v. Alere, Inc., et al., No. 16-1255, S.D. Calif.; 2016 U.S. Dist. LEXIS 124252).
Plaintiffs Seek Invokana MDL For Kidney Injury, Ketoacidosis Injuries
WASHINGTON, D.C. - Plaintiffs in 29 Invokana kidney injury cases on Sept. 20 filed a motion asking the Judicial Panel on Multidistrict Litigation to centralize theirs and at least 27 other cases in the U.S. District Court for the District of New Jersey (In Re: Invokana [Canagliflozin] Products Liability Litigation, MDL Docket No. n/a, JPMDL).
Xarelto MDL Judge OKs Bayer Personnel Files For Plaintiffs' Rush-To-Market Theory
NEW ORLEANS - The Louisiana federal judge overseeing the Xarelto multidistrict litigation on Sept. 16 ordered defendant Bayer Corp. to give the plaintiffs two personnel files the plaintiffs say are relevant to their argument that the anticoagulant was rushed to market or that "aggressive compensation schemes" were used to market the drug (In Re: Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2591, No. 14-md-2592, E.D. La.; 2016 U.S. Dist. LEXIS 126946).
Judge Orders FDA To Produce Sovaldi, Harvoni FOIA Documents On Rolling Basis
NEW HAVEN, Conn. - A Connecticut federal judge on Sept. 20 granted summary judgment to the Food and Drug Administration in a Freedom of Information Act (FOIA) lawsuit involving the hepatitis C drugs Sovaldi and Harvoni, but he also ordered the FDA to immediately produce all responsive records it has gathered thus far (Treatment Action Group, et al. v. Food and Drug Administration, et al., No. 15-976, D. Conn.; 2016 U.S. Dist. LEXIS 127877).
Wolters Kluwer Dismissed From Zoloft Birth Defect Appeal In 3rd Circuit
PHILADELPHIA - Parties in a Zoloft birth defect appeal pending in the Third Circuit U.S. Court of Appeals on Sept. 16 stipulated to the dismissal of drug information provider Wolters Kluwer Health Inc. (In Re: Zoloft [Sertraline Hydrochloride] Products Liability Litigation, No. 16-2247, 3rd Cir.).
Drug Manufacturers' Group Wants In As Amicus In Off-Label Criminal Case
BOSTON - A drug manufacturers' organization on Sept. 17 asked a federal district court to allow it to submit an amicus curiae brief in support of an acquittal or new trial for two former drug company executives convicted of adulterating and misbranding a medical device (United States of America v. William Facteau, et al., No. 15-10076, D. Mass.).
Plaintiffs' Firm To Face Breach-Of-Contract Trial For $1.3M In Fees For 2nd Firm
CLEVELAND - An Ohio federal judge on Sept. 21 issued a summary judgment ruling that leaves for a January jury trial the question of whether a Florida plaintiffs law firm breached its contract with an Ohio plaintiffs' law firm and owes it $1.3 million in referral fees for Prempro (hormone replacement therapy, or HRT) cases (Misny & Associates Co. v. Aylstock, Witkin, Kreis & Overholtz, No. 15-681, N.D. Ohio, Eastern Div.; 2016 U.S. Dist. LEXIS 129239).
Judge Grants Preliminary Approval of $486M Settlement In Pfizer Securities Suit
NEW YORK - A federal judge in New York on Sept. 16 granted preliminary approval of a $486 million settlement in a securities class action lawsuit between shareholders and certain of its executive officers, ruling that the settlement is fair, adequate and reasonable (In re Pfizer Inc. Securities Litigation, No. 04-9866, S.D. N.Y.).
Massachusetts Appeals Court Reverses Boston Scientific Pelvic Mesh Defense Verdict
BOSTON - A Massachusetts appeals panel on Sept. 13 reversed a defense verdict in a Boston Scientific Corp. (BSC) pelvic mesh case, finding that the trial judge erred by excluding evidence about a material safety data sheet (MSDS) and two Food and Drug Administration letters that called the device's safety into question (Diane Albright v. Boston Scientific Corporation, No. 15-P-633, Mass. App.; 2016 Mass. App. LEXIS 123).
Judge In Mentor ObTape MDL Will Consider Sanctions In Nonmeritorious Cases
COLUMBUS, Ga. - Frustrated with cases that have "no good basis," the Georgia federal judge overseeing the Mentor ObTape pelvic mesh multidistrict litigation on Sept. 7 placed plaintiff attorneys on notice that they may face sanctions in the future (In Re: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 08-md-2004, M.D. Ga., Columbus Div.).
9th Circuit Affirms Doctor's Conviction For Conspiracy To Adulterate Devices
SAN FRANCISCO - The Ninth Circuit U.S. Court of Appeals on Sept. 9 affirmed the conviction of a Nevada urologist for conspiracy to adulterate medical devices with intent to defraud or mislead (United States of America v. Michael Stanley Kaplan, M.D., No. 15-10241, 9th Cir.; 2016 U.S. App. LEXIS 16570).
Missouri Wants En Banc Rehearing On 8th Circuit's Lethal Injection Ruling
ST. LOUIS - The State of Missouri on Sept. 7 petitioned the Eighth Circuit U.S. Court of Appeals for an en banc rehearing of a Sept. 2 panel decision denying mandamus to prevent the Missouri Department of Corrections (MDOC) from having to say how and from whom it obtains pentobarbital for lethal injection executions (In Re: Missouri Department of Corrections, No. 16-3072, 8th Cir.; 2016 U.S. App. LEXIS 16250).
Judge Won't Reopen Artificial Disc Case; Plaintiff Should Have Been More Diligent
MONROE, La. - A Louisiana federal judge on Aug. 31 denied a motion to reopen an artificial spinal disc case, saying that even though the plaintiff claims to have received new evidence, he could have and should have identified the device earlier in the litigation (Bryant Lyles v. Medtronic, Inc., et al., No. 15-0910, W.D. La., Monroe Div.; 2016 U.S. Dist. LEXIS 118382).
Manufacturing Defect, Warranty Claims Are Only Survivors In Drug Pump Ruling
PHILADELPHIA - Only a plaintiff's manufacturing defect and express warranty claim remain after a Pennsylvania federal judge issued a ruling on Aug. 31 finding that her negligence, implied warranty and state consumer claims involving a SynchroMed drug pump and catheters are preempted by federal law (Sandra White v. Medtronic, Inc., et al., No. 16-2638, E.D. Pa.; 2016 U.S. Dist. LEXIS 117101).
Bard Can Look Into Plaintiffs' Communications With FDA Regarding IVC Filters
PHOENIX - An Arizona federal judge overseeing the C.R. Bard Inc. inferior vena cava (IVC) multidistrict litigation on Sept. 6 said the defendant can conduct discovery into the plaintiffs' alleged efforts to influence the Food and Drug Administration, but not into the plaintiffs' communications with NBC Nightly News or third-party litigation funding (In Re: Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-md-2641, D. Ariz.).
West Virginia Court: Zoloft Birth Defect Claims Barred By Michigan Shield Law
CHARLESTON, W.Va. - A West Virginia state court judge on Aug. 30 granted summary judgment in a Zoloft birth defect case, finding that the plaintiffs' claims of failure to warn and misrepresentation to the Food and Drug Administration are barred by Michigan's drug shield law (In Re: Zoloft Litigation, No. 14-C-7000, M.M., et al. v. Pfizer, Inc., et al., No. 12-C-149, W.Va. Cir., Kanawha Co.).
Common Benefit Fees In Ethicon Morcellator MDL Cut To Flat 6 Percent
KANSAS CITY, Kan. - Common benefit fees in the Ethicon power morcellator multidistrict litigation were all limited to 6 percent on Sept. 8 after the MDL judge said the Plaintiffs' Steering Committee (PSC) felt the fee of more than 6 percent is no longer appropriate (In Re: Ethicon, Inc., Power Morcellator Products Liability Litigation, MDL Docket No. 2652, No. 15-md-2652, D. Kan.).
Plaintiff Tells 11th Circuit There's No Error In $10.55M Wright Hip Verdict
ATLANTA - A plaintiff who won a $10.55 million verdict in a Wright Medical Conserve hip trial on Aug. 30 told the 11th Circuit U.S. Court of Appeals that the trial court did not err in its handling of the verdict, including sending the jury back after it first returned an inconsistent verdict (In Re: Wright Medical Technology, Inc., et al., Robyn Christiansen, et al. v. Wright Medical Technology Inc., No. 16-12162, 11th Cir.).
Plaintiffs Tell 9th Circuit Incretin Mimetic MDL Court Got Preemption Law Wrong
SAN FRANCISCO - The incretin mimetic multidistrict litigation court misinterpreted U.S. Supreme Court preemption law in dismissing the MDL, plaintiffs tell the Ninth Circuit U.S. Court of Appeals in a Sept. 6 reply brief (In Re: Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir.).
Kentucky Sues Fresenius To Recover Medicaid Costs From GranuFlo Injuries
FRANKFORT, Ky. - Kentucky on Sept. 1 filed a public interest lawsuit against Fresenius Medical Care Holdings Inc. to recover the Medicaid costs the commonwealth incurred for kidney dialysis patients who were harmed by GranuFlo dialysate made by Fresenius (Commonwealth of Kentucky, ex rel. Andy Beshear v. Fresenius Medical Care Holdings, Inc., et al., No. n/a, Ky. Cir., Franklin Co.).
St. Jude: Hacking Report Was Scheme To Profit By Short Selling
MINNEAPOLIS - Heart device maker St. Jude Medical Inc. on Sept. 7 sued a hedge fund and a cybersecurity research firm for defamation for issuing a report that St. Jude's devices can be hacked and that patients should disable remote monitoring devices (St. Jude Medical, Inc. v. Muddy Waters Consulting LLC, et al., No. 16-03002, D. Minn.).
Banking Defendants In NECC Outbreak Won't Face Victim Impact Statements
BOSTON - Victims of the 2012 fungal meningitis outbreak will not be allowed to submit victim impact statements when two principals of the defunct New England Compounding Center (NECC) are sentenced for illegal bank transfers, a Massachusetts federal judge ruled Aug. 18 (United States of America v. Carla R. Conigliaro, et al., No. 14-10363, D. Mass.; 2016 U.S. Dist. LEXIS 110020).
2nd Circuit Affirms: Pregnancy Test Claims Were False Advertising
NEW YORK - Findings by a New York federal judge that the marketer of a home pregnancy test committed false advertising under the Lanham Act by implying that the product measures weeks of pregnancy in a manner consistent with that used by doctors were affirmed Sept. 9 by the Second Circuit U.S. Court of Appeals (Church & Dwight Co. Inc. v. SPD Swiss Precision Diagnostics GMBH, No. 15-2411, 2nd Cir.; 2016 U.S. App. LEXIS 16625).
FDA Recommends Against Ovarian Cancer Screening Tests
SILVER SPRING, Md. - The Food and Drug Administration on Sept. 7 recommended that women and doctors not use currently marketed tests to screen for ovarian cancer, saying the tests are not sensitive enough to reliably screen for the disease.