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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®



 



U.S. High Court Strikes State Court Specific Jurisdiction In Plavix Injury Cases
WASHINGTON, D.C. - In an 8-1 opinion, the U.S. Supreme Court on June 19 said California state courts do not have specific jurisdiction over the claims of 592 non-state residents who sued Bristol-Myers Squibb Co. (BMS) in state court, alleging that the antiplatelet drug Plavix caused gastrointestinal bleeding (Bristol-Myers Squibb Co. v. Superior Court of California, et al., No. 16-466, U.S. Sup., 2017 U.S. LEXIS 3873).



2nd Xarelto Bellwether Trial Ends With Defense Verdict
NEW ORLEANS - A federal jury in Louisiana on June 12 found that the manufacturers of the blood thinner Xarelto adequately warned about the risk of unstoppable bleeding and that the drug did not cause a woman to suffer a stroke in 2015 that led to her death (In Re: Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, Joseph Orr Jr. v. Janssen Pharmaceuticals, Inc., et al., No. 15-3708, E.D. La.).



Plaintiff In 1st Xarelto Bellwether Says Judge Excluded Crucial Evidence
NEW ORLEANS - The plaintiff who lost the first Xarelto bellwether trial on June 12 filed a motion for a new trial in Louisiana federal court, arguing that the judge erred by excluding crucial evidence regarding information in the drug's label in other countries and evidence from global medical associations (In re: Xarelto [Rivaroxaban] Products Liability Litigation, MDL 2592, Joseph Boudreaux Jr. v. Bayer Corp., et al., No. 14-cv-02720, E.D. La.).



3rd Circuit Affirms Expert Exclusion, Summary Judgment In Most Zoloft MDL Cases
PHILADELPHIA - The Third Circuit U.S. Court of Appeals on June 2 affirmed the exclusion of plaintiffs' only general causation expert witness in the Zoloft birth defect multidistrict litigation and also affirmed summary judgment that, at the time, ended 93 percent of the cases (In Re: Zoloft [Sertraline Hydrochloride] Products Liability Litigation, No. 16-2247, 3rd Cir., 2017 U.S. App. LEXIS 9832).



Jury Awards Boy $15M For Depakote Birth Defects, Awards No Punitive Damages
EAST ST. LOUIS, Ill. - A federal jury in Illinois on June 9 awarded $15 million in compensatory damages to a boy who was born with spina bifida as a result of his mother's use of Depakote during pregnancy, after finding that the drug maker failed to warn doctors about the risk, but the jury found that the company's conduct did not warrant punitive damages (E.G., et al. v. Abbott Laboratories Inc., No. 15-702, S.D. Ill.).



9th Circuit Reverses Expert Exclusion, Judgment In Immunosuppressant Cancer Case
SAN FRANCISCO - The Ninth Circuit U.S. Court of Appeals on June 2 reversed summary judgment for Teva Pharmaceuticals USA Inc. in drug-caused cancer case, ruling that the plaintiffs expert was erroneously excluded by a district court (Stephen Wendell, et al. v. GlaxoSmithKline LLC, et al., No. 14-16321, 9th Cir., 2017 U.S. App. LEXIS 9787).



1st AndroGel Bellwether Trial Ends Due To Mistrial
CHICAGO - The first bellwether trial in a multidistrict litigation for suits involving injuries allegedly caused by the use of testosterone replacement therapy ended June 12 when a federal judge in Illinois granted the plaintiff's oral motion for a mistrial (In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Jeffrey Konrad v. AbbVie, Inc., No. 15-966, N.D. Ill., Eastern Div.).



Interlocutory Appeal Sought For Warning Claims In Testosterone MDL
CHICAGO - AbbVie Inc. and Abbott Laboratories on May 30 asked the testosterone replacement therapy multidistrict litigation court to certify its order denying summary judgment on failure-to-warn claims for interlocutory appeal, saying there is an open question about whether the claims are preempted (In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill.).



5th Circuit Affirms Abbott Defense Verdict In Off-Label Stent Trial
NEW ORLEANS - The Fifth Circuit U.S. Court of Appeals on May 31 affirmed a defense verdict for Abbott Laboratories in a whistle-blower trial alleging that the company's off-label promotion caused false claims to be presented for biliary stents used in the vascular system (United States of America, ex rel. Kevin N. Colquitt v. Abbott Laboratories, et al., No. 16-10814, 5th Cir., 2017 U.S. App. LEXIS 9563).



FDA Asks Endo To Pull New Opana ER Off Market Due To Blood-Borne Infections
SILVER SPRING, Md. - The Food and Drug Administration on June 8 asked Endo Pharmaceuticals to voluntarily take Opana ER off the market because the manufacturer's changes to make the opioid less resistant to abuse by snorting it resulted in abusers injecting the drug and causing outbreaks of HIV and hepatitis C.



3 Tennessee District Attorneys General Sue Opioid Makers Over Addiction Epidemic
KINGSPORT, Tenn. - Three district attorneys general in Tennessee and the guardian ad litem of a baby born addicted to opioids on June 13 sued the three leading manufacturers of the drugs, as well as two convicted dealers of the drugs, blaming them for the opioid addiction epidemic in their portion of the state (Barry Staubus, et al. v. Purdue Pharma, L.P., et al., No. C41916, Tenn. Cir., Sullivan Co.).



State Attorneys General Launch Probe Into Opioid Makers
BOSTON - Massachusetts Attorney General Maura Healey on June 15 announced that an unspecified number of state attorneys general are conducting an investigation into whether manufacturers of opioid drugs have engaged in unlawful practices.



67 Ethicon Physiomesh Lawsuits Sent To MDL In Atlanta
WASHINGTON, D.C. - A federal judicial panel on June 2 centralized 67 federal lawsuits alleging injuries allegedly caused the Physiomesh Flexible Composite Hernia Mesh made by Ethicon Inc. (In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, MDL Docket No. 2782, JPMDL).



New Jersey Centralizes Stryker LFIT Hip Cases In Bergen County Court
TRENTON, N.J. - New Jersey's chief justice on May 16 designated state court lawsuits involving the Stryker LFIT Anatomic Cobalt Chromium (CoCr) V40 femoral heads as a multicounty litigation and assigned the cases to Judge Rachelle Harz of the Bergen County Superior Court (In Re: Stryker LFIT Anatomic CoCr V40 Femoral Heads Litigation, No. 624, N.J. Super., Bergen Co.).



No MDL For 3 Lawsuits Alleging Brazilian Bribery By 5 Medical Device Makers
WASHINGTON, D.C. - A federal judicial panel on May 31 denied a motion by 142 Brazilian health insurers to centralize three lawsuits filed against five medical device manufacturers accusing them of using bribery to gain market share in Brazil (In Re: Brazilian Prosthetic Device Bribery Litigation, MDL Docket No. 2780, JPMDL).



MicroCool Judge Threatens Sanctions For Nondisclosure Of Related Lawsuits
LOS ANGELES - A California federal judge who presided over a MicroCool surgical gown state class action that resulted in a $454 million verdict on June 2 ordered plaintiffs' counsel to show cause why she should not sanction them for failing to report a related False Claims Act lawsuit and another case against the defendant (Bahamas Surgery Center, LLC v. Kimberly-Clark Corporation, et al., No. 14-8390, C.D. Calif.).



EpiPen MDL Motion Will Be Heard On July 27
WASHINGTON, D.C. - A federal judicial panel on June 14 scheduled a hearing on a motion to centralize four federal class actions alleging that Mylan N.V. engaged in anticompetitive and unfair business conduct in its sale and marketing of the EpiPen Auto-Injector epinephrine injector device (In Re: EpiPen [Epinephrine Injection, USP] Marketing, Sales Practices and Antitrust Litigation, MDL Docket No. 2785, JPMDL).



Proton Pump Inhibitor MDL To Get 2nd Look At July 27 Hearing
WASHINGTON, D.C. - A federal judicial panel will consider a new motion to centralize proton pump inhibitor (PPI) drugs in a multidistrict litigation, according to a June 14 order by the panel (In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2789, JPMDL).



Plaintiff Says Law Firm Pressured Her Into Pelvic Mesh Settlement
CHATTANOOGA, Tenn. - A Georgia plaintiff's law firm on June 14 removed to Tennessee federal court a legal malpractice claim brought by a client who says she was pressured into accepting a $300,000 pelvic mesh settlement (Danna Morrison v. Blasingame, Burch, Garrard & Ashley, P.C., No. 21601, Tenn. Cir., Marion Co.; No. 17-165, E.D. Tenn.).



12 Claims Involving Theranos Dismissed By Judge With Leave To Amend
PHOENIX - A federal judge on June 13 dismissed in part a consolidated class action complaint by consumers alleging that they were defrauded by Theranos Inc. and Walgreens drug stores when unreliable blood tests were administered to them (In Re: Arizona Theranos, Inc., Litigation, Nos. 16-2138, 16-2373, 16-2660, 16-2775, 16-3599, D. Ariz., 2017 U.S. Dist. LEXIS 90965).



Conclusory Allegations Doom Hip Implant Case, Judge Says
SEATTLE - A man's conclusory allegations regarding the defects and dangers of a hip implant product are not sufficient to support a case against the manufacturer, a federal judge in Washington held June 9 (Michael Allen Staub v. Zimmer Inc., No. 17-508, W.D. Wash., 2017 U.S. Dist. LEXIS 89109).



Magistrate Judge Allows Strict Liability Claims Against Component Maker
MILWAUKEE - A federal magistrate judge in Wisconsin on June 9 ruled that plaintiffs can pursue claims for strict products liability against the manufacturer of a component in a hip replacement system after finding that the Wisconsin Supreme Court would not allow the contract specification defense to bar the plaintiffs' claims (Jerome Janusz, et al. v. Symmetry Medical Inc., et al., No. 15-CV-294, E.D. Wis., 2017 U.S. Dist. LEXIS 88895).



Supreme Court: BPCIA Provision Not Enforceable With Federal Injunction
WASHINGTON, D.C. - The requirement of Section 262(l)(2)(A) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), 42 U.S.C. 262(k), that a biologic applicant provide a sponsor with its applications and manufacturing information is not enforceable with a federal injunction, the U.S. Supreme Court ruled June 12 (Sandoz Inc. v. Amgen Inc., et al., No. 15-1039 and 15-1195, U.S. Sup.).



Pending Black Box For Invokana Amputation Risk Escapes Mention During Conference
SAN DIEGO - A month after the Food and Drug Administration required the maker of the diabetes drug Invokana to put a black box on the label to warn of a nearly doubled risk of lower limb amputations, that risk was mentioned only secondarily and the black box requirement not at all during an international diabetes conference in San Diego June 8-13.



SGLT2 Diabetes Drugs Associated With Doubled Risk Of Ketoacidosis
BOSTON - A cohort study of 140,352 diabetics showed that sodium-glucose cotransporter 2 (SGLT2) diabetes drugs were associated with an approximately doubled risk of diabetic ketoacidosis compared to dipeptidyl peptidase-4 (DPP4) diabetes drugs, according to letter to the editor published in the June 8 New England Journal of Medicine.






U.S. High Court Won't Review Appeal Standards For Denied Vaccine Claims
WASHINGTON, D.C. - The U.S. Supreme Court on May 30 declined to take up a case challenging the constitutionality of the review standard for appeals stemming from the National Childhood Vaccine Injury Act (the Vaccine Act), 42.U.S.C. 300aa-q, et seq. (Marek Milik, et al. v. Thomas Price, et al., No. 16-722, U.S. Sup.).



Federal Judge Denies Remand Of Zostavax Cases For Fraudulent Joinder
PHILADELPHIA - A Pennsylvania federal judge on May 26 ruled that a Merck & Co. Inc. employee was fraudulently joined to eight shingles vaccine injury cases and denied remand of the cases to Pennsylvania state court (Jorja Bentley v. Merck & Co., Inc., et al., No. 17-1122, et al., E.D. Pa., 2017 U.S. Dist. LEXIS 81314).



Johnson & Johnson Pays $33M To Settle Consumer Protection Lawsuits By 42 States
HARRISBURG, Pa. - Johnson & Johnson on May 24 agreed to an injunction regarding recalled over-the-counter drugs and to pay $33 million to 42 states for violations of their respective consumer protection laws (Commonwealth of Pennsylvania, et al. v. Johnson & Johnson Consumer Inc., et al., No. 2017-cv-4007, Pa. Comm. Pls., Dauphin Co.).



$2.16M Verdict Returned In Pennsylvania Pelvic Mesh Trial
PHILADELPHIA - A Pennsylvania state court jury on May 26 awarded a plaintiff $2.16 million in an Ethicon Inc. pelvic mesh trial (Sharon Beltz, et al. v. Ethicon Women's Health and Urology, et al., No. 130603835, Pa. Comm. Pls., Philadelphia Co.).



Supreme Court Asked To Find That 510(k) Clearance Can Be Presented To Juries
WASHINGTON, D.C. - Ethicon Inc. on May 23 asked the U.S. Supreme Court to overrule a multidistrict litigation court and a federal appeals court and rule that the company can tell juries that the 510(k) clearance of its pelvic mesh devices is evidence that the Food and Drug Administration has found the products to be safe and effective (Ethicon, Inc., et al. v. Jo Huskey, et al., No. 16-1399, U.S. Sup.).



Teva Settles California Counties' Opioid Lawsuit For $1.6M, Marketing Restrictions
SANTA ANA, Calif. - Teva Pharmaceuticals Inc. has agreed to settle an opioid marketing lawsuit filed by Orange and Santa Clara counties for $1.6 million and marketing restrictions, according to a memorandum of understanding announced May 24 by Santa Clara County (State of California, et al. v. Purdue Pharma LP, et al., No. 2014-00725287, Calif. Super., Orange Co.).



5th Circuit Affirms That Abilify Tardive Dyskinesia Claim Is Prescribed By State Law
NEW ORLEANS - The Fifth Circuit U.S. Court of Appeals on May 17 affirmed a district court's finding that a plaintiff's neurological injury claim involving the atypical antipsychotic drug Abilify was filed too late (Cory Jenkins v. Bristol-Myers Squibb Company, et al., No. 16-31133, 5th Cir., 2017 U.S. App. LEXIS 8673).



Testosterone MDL Judge Denies Late Limitations Defenses In 1st Bellwether Case
CHICAGO - The Illinois federal judge overseeing the testosterone replacement therapy multidistrict litigation on May 22 struck defendant AbbVie Inc.'s motion for summary judgment in the first bellwether trial after ruling that the defendant waived its statute of limitations and statute of repose defenses by raising them only weeks before the June 5 trial (In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Jeffrey Konrad v. AbbVie, Inc., No. 15-966, N.D. Ill., E. Div.).



All Testosterone Replacement Therapy Defendants Must Replead Affirmative Defenses
CHICAGO - In the wake of the raising of statute of limitations/statute of repose defenses at the 11th-hour of the first bellwether case, the Illinois federal judge overseeing the testosterone replacement therapy multidistrict litigation on May 23 ordered non-AbbVie Inc. defendants to replead any affirmative defenses that they contend still apply to a bellwether case (In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill., Eastern Div.).



Birth Defects Claims Against Drugmaker Doomed By Insufficient Expert Opinions
BROOKLYN, N.Y. - Two medical experts lack the qualifications and reliable methodology to opine that a mother's use of an anti-epileptic drug linked to birth defects caused her son's severe birth defects, so summary judgment for the drugmaker is warranted on the mother's failure-to-warn claims, a New York federal magistrate judge held May 22 (N.K., an infant, by his mother and natural guardian, Tanja Bruestle-Kumra v. Abbott Laboratories, No. 14-cv-4875, E.D. N.Y., 2017 U.S. Dist. LEXIS 77461).



Depakote Birth Defect Trial Under Way In Illinois
EAST ST. LOUIS, Ill. - A Depakote birth defect trial got under way on May 23 in an Illinois federal court (E.G., et al. v. Abbott Laboratories Inc., No. 15-702, S.D. Ill.).



Negligence Per Se Claim In Cook IVC Filter Bellwether Case Dismissed Under FDCA
INDIANAPOLIS - An Indiana judge overseeing the Cook Medical Inc. inferior vena cava (IVC) multidistrict litigation on May 17 granted judgment to the device maker on a bellwether plaintiff's claim of negligence per se (In Re: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Product Liability Litigation, MDL Docket No. 2570, No. 15-ml-2570, Elizabeth Jane Hill v. Cook Medical, Inc., No. 14-6016, S.D. Ind., Indianapolis Div.).



Metal-On-Metal Hip Case Out On Illinois Statute Of Limitations Based On Admissions
PEORIA, Ill. - An Illinois federal judge on May 22 granted summary judgment to hip maker Smith & Nephew Inc. because the plaintiff's deposition testimony showed that she was aware of possible fault prior to the expiration of the statute of limitations (Doris R. Cochran v. Smith & Nephew, Inc., No. 16-1121, C.D. Ill., 2017 U.S. Dist. LEXIS 77095).



California Lipitor Cases Remanded; Case Count Falls Under CAFA's 100 Threshold
SANTA ANA, Calif. - A California federal judge on May 23 granted remand in more than 100 Lipitor/diabetes cases because less than 100 plaintiffs have proposed that the court conduct a joint trial to trigger federal jurisdiction under the Class Action Fairness Act (CAFA), 119 Stat. 4 (In Re: Pfizer, No. 17-mc-00005, C.D. Calif., Southern Div., 2017 U.S. Dist. LEXIS 79714).



Xarelto MDL Judge Says Janssen Witness Must Testify By Remote, Live Transmission
NEW ORLEANS - The Louisiana federal judge overseeing the Xarelto multidistrict litigation on May 26 again denied a defense motion to quash a subpoena to have a company witness in New Jersey give live testimony at an upcoming New Orleans bellwether trial via remote transmission (In Re: Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, Joseph Orr Jr. v. Janssen Pharmaceuticals, Inc., et al., No. 15-3708, E.D. Pa., 2017 U.S. Dist. LEXIS 81047).



Summary Judgment Granted In Smith & Nephew Legion Knee Case
FRESNO, Calif. - A California federal judge on May 23 granted summary judgment in a Smith & Nephew Inc. knee case, saying that the plaintiff failed to present much evidence to support his claims and that his rebuttals fell short (Ruben B. Merancio, et al. v. Smith & Nephew, Inc., et al., No. 15-807, E.D. Calif., 2017 U.S. Dist. LEXIS 78352).



Hernia Patch Case Dismissed For No Showing Of Causation, Product Defect
NEW YORK - A New York federal judge on May 22 dismissed a hernia patch lawsuit because the plaintiff failed to show that the device caused her alleged injuries and because she failed to allege that the device was defective (Judith Rincon v. Coviden, et al., No. 16-10033, S.D. N.Y., 2017 U.S. Dist. LEXIS 77458).






HeartMate Heart Device Controllers Under Class I Recall After 26 Deaths
SILVER SPRING, Md. - The Food and Drug Administration on May 23 said Abbott-Thoratec has issued a Class I recall of its HeartMate II LVAS (left ventricular assist system) controller after receiving reports of 19 injuries and 26 deaths associated with the heart device.



1st Xarelto MDL Bellwether Trial Ends In Defense Verdict For Bayer, Janssen
NEW ORLEANS - The first Xarelto multidistrict litigation bellwether trial ended May 3 with a defense verdict for co-defendants Janssen Pharmaceuticals Inc. and Bayer Pharma AG (In Re: Xarelto Products Liability Litigation, MDL Docket No. 2592, No. 14-md-2592, Joseph Boudreaux Jr., et al. v. Janssen Pharmaceuticals, Inc., et al., No. 14-2720, E.D. La.).



All Eliquis MDL Plaintiffs Must Show Cause Why Their Cases Shouldn't Be Dismissed
NEW YORK - The New York federal judge overseeing the newly created Eliquis multidistrict litigation on May 9 ordered all plaintiffs to show cause why her May 8 dismissal of one case should not be applied to all cases (In Re: Eliquis [Apixaban] Products Liability Litigation, MDL Docket No. 2754, No. 17-md-2754, Charlie Utts, et al. v. Bristol-Myers Squibb Company, et al., No. 16-5668, S.D. N.Y., 2017 U.S. Dist. LEXIS 73017).



Zimmer Gets Defense Verdict In Texas Hip Implant Case
MARSHALL, Texas - A Texas federal jury on May 5 found that a Zimmer Inc. hip did not have a manufacturing defect and that the company did not engage in deceptive trade practices (Martha Hardy v. Zimmer Inc., et al., No. 16-242, E.D. Texas, Marshall Div.).



Johnson & Johnson Pays Oregon $406,100 To Settle Motrin 'Phantom Recall' Lawsuit
PORTLAND, Ore. - Johnson & Johnson on May 8 agreed to pay $406,100 plus interest, attorney fees and costs to settle Oregon's lawsuit that the drug maker violated state consumer law by conducting a "phantom recall" of Motrin brand ibuprofen without telling consumers there was an in-fact recall (State of Oregon, ex rel. Ellen F. Rosenblum, et al. v. Johnson & Johnson, et al., No. 1101-00494, Ore. Cir., Multnomah Co.).



Unfair Competition Claims OK'd, But Judge Says No Relief Due In Surgical Gown Case
LOS ANGELES - A California federal judge on May 15 said a class representative proved that two defendants violated California's unfair competition law (UCL) by selling defective surgical gowns, but denied the plaintiff's request for restitution and injunctive relief given a jury's $454 million compensatory and punitive damages verdict (Bahamas Surgery Center v. Kimberly-Clarke Corp., et al., No. 14-8390, C.D. Calif., 2017 U.S. Dist. LEXIS 73778).



Co-Defendant Wants Declaration Against Indemnification In $454M Gown Verdict
LOS ANGELES - Halyard Health Inc. on May 1 filed a lawsuit asking a California state court to issue a declaratory judgment that it does not have to indemnify Kimberly-Clark Corp. for a $454 million surgical gown state class action verdict (Halyard Health, Inc. v. Kimberly-Clark Corporation, No. BC659662, Calif. Super., Los Angeles Co.).



4th Circuit Denies Plaintiff 2nd Bite At Failure-To-Warn Claim In Pelvic Mesh Case
RICHMOND, Va. - The Fourth Circuit U.S. Court of Appeals on May 9 denied a pelvic mesh plaintiff's appeal of summary judgment against her failure-to-warn claim, saying she still presented no reliable evidence that she or her doctors were misled by the directions for use for the Boston Scientific Corp. device (Martha Carlson, et al. v. Boston Scientific Corporation, No. 15-2440, 4th Cir., 2017 U.S. App. LEXIS 8227).



Boston Scientific Has Pacts To Settle About 37,000 Pelvic Mesh Device Claims
MARLBOROUGH, Mass. - Boston Scientific Corp. on May 3 disclosed that as of April 26, it entered into master settlement agreements in principal or is finalizing settlements certain plaintiff attorneys to resolve about 37,000 of its 43,000 pelvic mesh lawsuits and claims.



California Appeals Court Affirms Defense Verdict In 'Fosamax Fracture' Case
SAN DIEGO - A California state appeals court on April 24 denied a plaintiff's appeal of a Fosamax femur fracture verdict, saying the trial judge did not err in not giving the jury an unadmitted exhibit and in admitting testimony from another case that the jury may have taken as expert testimony (In Re: Fosamax / Alendronate Sodium Cases, No. G052166, Calif. App., 4th Dist., Div. 3, 2017 Cal. App. Unpub. LEXIS 2849).



Pennsylvania Appeals Court Affirms Exclusion Of Zoloft Birth Defect Expert
PHILADELPHIA - A Pennsylvania state appeals panel on May 8 affirmed summary judgment in a Zoloft birth defect case, agreeing with the trial court that one causation expert relied on peer-reviewed articles that did not necessarily support his opinion (Robert and Katherine Porter, et al. v. SmithKlineBeecham Corporation, et al., No. 3516 EDA 2015, Pa. Super.).



Judge Intends To Deny Acquittal, New Trial Motions By Convicted NECC Head
BOSTON - A Massachusetts federal judge on May 16 said he intends to deny a motion for acquittal or a new trial to the former head of the New England Compounding Center (NECC) on the grounds of government misconduct after examining two trial exhibits the defendant said prejudiced him (United States of America v. Barry J. Cadden, No. 14-10363, D. Mass.).



U.S. High Court Won't Review Denial Of FDA Citizen Petition Filed By Law Firm
WASHINGTON, D.C. - The U.S. Supreme Court on May 15 denied a plaintiff law firm petition to review the Food and Drug Administration's denial of its citizen petition seeking a black box warning about gynecomastia in adolescent males allegedly caused by two antipsychotic drugs (Sheller, P.C. v. United States Department of Health and Human Services, et al., No. 16-1097, U.S. Sup.).



Testosterone Claims, Experts Largely Survive In MDL Bellwether Cases
CHICAGO - The Illinois federal judge overseeing the testosterone replacement therapy multidistrict litigation on May 8 issued four opinions largely denying summary judgment on the issues of failure to warn and off-label marketing and largely allowing expert testimony on causation in seven upcoming bellwether trials (In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill., Eastern Div., 2017 U.S. Dist. LEXIS 69400, 2017 U.S. Dist. LEXIS 69399, 2017 U.S. Dist. LEXIS 69402).



DePuy Pinnacle Hip Appeal Stayed Pending Trial Court Post-Trial Rulings
NEW ORLEANS - The Fifth Circuit U.S. Court of Appeals on May 11 stayed briefing in an appeal of a $500 million multiplaintiff DePuy metal-on-metal hip verdict pending rulings by the trial court on the defendant's motions for a new trial and judgment as a matter of law (Rosa Metzler, et al. v. DePuy Orthopaedics, Inc., et al., No. 17-10017, 5th Cir.).



Participation In Stryker Hip Settlement Programs Hits 95 Percent, Company Says
MINNEAPOLIS - Stryker Corp. on May 8 announced that 95 percent of additional registered eligible patients have enrolled in the company's second settlement program for claims related to Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem devices that required revision surgery before Dec. 19, 2016.



Fraud-Based Claims Survive Dismissal In Zofran MDL
BOSTON - The Massachusetts federal judge overseeing the Zofran multidistrict litigation on April 24 denied defendant GlaxoSmithKline LLC's (GSK) motion to dismiss the plaintiffs' fraud-based complaint for failing to plead with the particularity required by Federal Rule of Civil Procedure 9(b), Fed. R. Civ. P. 9(b) (In Re: Zofran [Ondansetron] Products Liability Litigation, MDL Docket No. 2657, No. 15-md-2657, D. Mass., 2017 U.S. Dist. LEXIS 61701).



Final Dismissal Of Remaining False Claims Act Defendant Paves Way For Appeal
PHILADELPHIA - A Pennsylvania federal judge on May 4 granted partial final summary judgment in a nine-year-old False Claims Act lawsuit accusing several drug manufacturers of artificially lowering drug prices through the use of "discounts" or "service fees" (United States of America, ex rel. Ronald J. Streck v. Allergan, Inc., et al., No. 08-5135, E.D. Pa.).



FDA: 2 Studies Confirm Leg/Foot Amputation Risk From Invokana Diabetes Drug
SILVER SPRING, Md. - The Food and Drug Administration on May 16 issued a drug safety communication warning about an increased risk of leg and foot amputation associated with the diabetes drug Invokana.