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®
Mentor Pelvic Mesh MDL Judge Disagrees With 11th Circuit Time-Bar Ruling
A Georgia federal judge overseeing the Mentor ObTape pelvic mesh multidistrict litigation on March 14 openly disagreed with a March 9 11th Circuit U.S. Court of Appeals decision reversing the MDL judge's statute-of-limitations ruling against 12 plaintiffs (Deborah Ann Rogers v. Mentor Corporation, et al., No 16-10119, et al., 11th Cir., 2017 U.S. App. LEXIS 4184, In Re: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 08-2004, M.D. Ga., Columbus Div., 2017 U.S. Dist. LEXIS 35833).
7th Circuit Vacates Class Certification In Eye Drop Size Suit, Orders Dismissal
CHICAGO - A Seventh Circuit U.S. Court of Appeals panel on March 6 vacated the grant of class certification in a lawsuit over the size of eye drops and remanded with directions to dismiss the lawsuit with prejudice, opining that there is no cause of action (Charlene Eike, et al v. Allergan, Inc., et al., No. 16-3334, 7th Cir., 2017 U.S. App. LEXIS 3954).
Fresenius Gets Defense Verdict In NaturaLyte MDL Wrongful Death Trial
BOSTON - A Massachusetts federal jury on March 3 returned a defense verdict for Fresenius Medical Care Holding Inc., finding that the plaintiffs failed to show by a preponderance of evidence that the company's NaturaLyte kidney dialysis solution was the proximate cause of the patient's death (Florella Dial, et al. v. Fresenius Medical Care Holdings, Inc., et al., No. 14-11101, D. Mass.).
Bristol-Myers Asks Supreme Court To Set Jurisdictional Standard For Plavix Cases
WASHINGTON, D.C. - Bristol-Myers Squibb Co. (BMS) on March 1 filed its opening brief urging the U.S. Supreme Court to rule that specific jurisdiction does not allow a group of out-of-state Plavix patients to sue the company in California state court (Bristol-Myers Squibb Company v. Superior Court of California, et al., No. 16-466, U.S. Sup.).
Jury Selection To Begin In Suicide Case Based On Paxil Warning Label
CHICAGO - Jury selection is scheduled to begin March 14 in a wrongful death case in which GlaxoSmithKline PLC (GSK) is accused of failing to update its Paxil label to warn about the risk of suicide (Wendy Dolin, et al. v. SmithKline Beecham Corporation, et al., No. 12-6403, N.D. Ill., Eastern Div.).
Biomet Hip MDL Judge Won't Sanction Plaintiffs For Not Preserving Explanted Hips
SOUTH BEND, Ind. - The Indiana federal judge overseeing the Biomet Magnum hip multidistrict litigation on March 1 denied a motion by defendant Biomet Inc. to sanction six plaintiffs with dismissal for failure to comply with a court order requiring the preservation of explanted devices (George Marous v. Biomet, Inc., et al., No. 14-768, et al., N.D. Ind., South Bend Div., 2017 U.S. Dist. LEXIS 28465).
Depakote Birth Defect Trial Off Due To Witness's Health
EAST ST. LOUIS, Ill. - An Illinois federal judge on March 3 vacated a March 27 Depakote birth defect trial date after ascertaining that an expert witness's health precluded him from testifying at trial (D.W.K., Jr., et al. v. Abbott Laboratories, Inc., No. 14-847, S.D. Ill.).
Judge Finds Medtronic Drug Pump Claims Are All Expressly Preempted
TOLEDO, Ohio - An Ohio federal judge on Feb. 2 dismissed as expressly preempted all claims by a plaintiff who says he suffered serious injury after a Medtronic Inc. drug pump leaked into his abdomen (Randy Warstler v. Medtronic, Inc., et al., No. 16-385, N.D. Ohio, Western Div., 2017 U.S. Dist. LEXIS 27972).
MDL Sought For Recalled Ethicon Physiomesh Hernia Mesh Patch
WASHINGTON, D.C. - Nine plaintiffs on March 9 asked a federal judicial panel to centralize federal lawsuits alleging injury from the Physiomesh Flexible Composite hernia patch (In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, MDL Docket No. 2782, JPMDL).
Florida Statute Of Repose May Not Apply To Surgical Mesh Case, Judge Says
TAMPA, Fla. - A Florida federal judge on March 7 denied a motion to dismiss a surgical mesh case, saying that at this stage of the case, Florida's 12-year statute of repose may not apply to the plaintiff's claim (Judith Woodbury v. C.R. Bard, Inc., No. 16-3229, M.D. Fla., Tampa Div., 2017 U.S. Dist. LEXIS 31777).
Bayer Tells 2nd Circuit Mirena Experts, 'Admissions' Evidence Properly Excluded
NEW YORK - Bayer HealthCare Pharmaceuticals Inc. on March 8 told the Second Circuit U.S. Court of Appeals that the Mirena multidistrict litigation court did not err in excluding the plaintiffs' three causation expert witnesses and said the plaintiffs' "proof of general causation" is legally inadequate (In Re Mirena IUD Products, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals Incorporated, No. 16-3012, 2nd Cir.).
Medtronic Tells 5th Circuit That Plaintiffs' New Evidence Won't Make A Difference
NEW ORLEANS - Medtronic Inc. on March 9 told the Fifth Circuit U.S. Court of Appeals that a plaintiff failed to exercise due diligence about other possible causes of his injury and that his "newly discovered evidence" would not have changed the outcome of his case (Bryant Lyles v. Medtronic Sofamor Danek USA, Inc., Nos. 16-30517 and 16-31044, 5th Cir.).
6th Circuit Backs Trial Court Preemption Ruling In Depakote Birth Defect Case
CINCINNATI - The Sixth Circuit U.S. Court of Appeals on Feb. 21 affirmed a preemption ruling in a Depakote birth defect case and said the trial judge did not err in limiting plaintiff experts' testimony or failing to give the jury her proposed instructions about warnings (Pamela Rheinfrank, et al. v. Abbott Laboratories, Inc., et al., No. 16-3347, 6th Cir.).
New Jersey Appeals Panel Says Plaintiff Can Sue For Most Recent Recall Of Wipes
TRENTON, N.J. - A New Jersey appeals court on Feb. 16 said a plaintiff who claims that he was infected by recalled medical wipes missed the state statute of limitations for one lot but not the second (Kenneth Nicolosi, et al. v. Smith and Nephew, Inc., et al., No. 1-1108-15T2, N.J. Super., App. Div., 2017 N.J. Super. Unpub. LEXIS 389).
Florida Appeals Court Affirms Hospital Device Spoliation Ruling In Device Case
LAKELAND, Fla. - A Florida appeals court on Feb. 15 affirmed summary judgment against a couple's claim of spoliation of an explanted medical device by a hospital, saying that even if the couple had the device, their claim against the device manufacturer is preempted by federal law (Linda Wolicki-Gables, et al. v. Doctors Same Day Surgery Center, Ltd., et al., No. 2D15-2495, Fla. App., 2nd Dist., 2017 Fla. App. LEXIS 1952).
All Claims Involving Allegedly Failed Medtronic Drug Pump Dismissed As Preempted
FRESNO, Calif. - A California federal judge on Feb. 24 dismissed as preempted all of a plaintiff's claims involving a Medtronic Inc. SynchroMed II drug pump but gave the plaintiff leave to file an amended complaint within 21 days (Michael Martin v. Medtronic, Inc., et al., No. 15-994, E.D. Calif., 2017 U.S. Dist. LEXIS 26350).
U.S. Supreme Court Won't Hear Avandia Common Benefit Fee Appeal
WASHINGTON, D.C. - The U.S. Supreme Court on Feb. 21 denied review of a circuit court ruling that a plaintiffs law firm is obligated to pay a 7 percent common benefit fee from the settlement of its state court multiplaintiff lawsuit to attorneys who ran a federal multidistrict litigation (Law Offices of Steven M. Johnson, P.C., et al. v. Plaintiffs' Advisory Committee, No. 16-804, U.S. Sup.).
Most Farxiga Diabetic Ketoacidosis Claims Dismissed In Federal Case
GREENVILLE, Miss. - A Mississippi federal judge on Feb. 22 dismissed without prejudice most of a plaintiff's Farxiga diabetic ketoacidosis (DKA) claims (Kamilah Young v. Bristol-Myers Squibb Company, et al., No. 16-108, N.D. Miss., Greenville Div., 2017 U.S. Dist. LEXIS 24730).
Plavix Forum Appeal To Be Heard April 25 By U.S. Supreme Court
WASHINGTON, D.C. - The U.S. Supreme Court on Feb. 17 said it will hear arguments on April 25 on whether Plavix injury claims can arise in California state courts when there is no causal link between Bristol-Myers Squibb Inc.'s forum contact and the plaintiffs' claims (Bristol-Myers Squibb Company v. Superior Court of California for the County of San Francisco, et al., No. 16-466, U.S. Sup.).
West Virginia Court Rules Zoloft Heart Defect Cases Need Labeling Expert
CHARLESTON, W.Va. - A West Virginia state judicial panel on Feb. 15 granted summary judgment to Pfizer Inc. in two Zoloft heart defect cases, ruling that the plaintiffs require expert testimony to establish failure to warn and that they cannot rely on record evidence or even the defendants' own witnesses to do so (In Re: Zoloft Litigation, No. 14-C-7000, J.C., et al., No. 12-C-146-WNE, I.H., et al., No. 13-C-229-WNE, W.Va. Cir., Kanawha Co.).
6 Claims Survive In Whole Or In Part In 5 Federal Cases Involving Essure Device
PHILADELPHIA - All or parts of six claims involving the Essure birth control device on Feb. 21 survived dismissal the second time around while defendant Bayer Corp. picked up dismissals of other counts or parts of them (Helen McLaughlin v. Bayer Corporation, et al., No. 14-7315, Ruth Ruble v. Bayer Corporation, et al., No. 14-7316, Melda Strimel v. Bayer Corporation, et al., No. 14-7317, Susan Stelzer v. Bayer Corporation, et al., No. 14-7318, Heather Walsh v. Bayer Corporation, et al., No. 15-384, E.D. Pa., 2017 U.S. Dist. LEXIS 24378).
Mirena Brain Injury MDL To Be Considered At March 30 Hearing
WASHINGTON, D.C. - The Judicial Panel on Multidistrict Litigation (JPMDL) on Feb. 14 said it will hear arguments March 30 on the centralization of federal lawsuits alleging that the Mirena intrauterine device (IUD) causes intracranial hypertension (IH) (In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation [No. II], MDL Docket No. 2767, JPMDL).
Brazil Orders Essure Off Market Due To High Risk
BRASILIA, Brazil - The Brazilian Health Regulatory Agency, known in Portuguese by its acronym ANVISA, on Feb. 17 ordered the Essure birth control device removed from the market in that country because of its high risk.
Heart Device Case Dismissed With Prejudice; No Parallel Claim Found
TRENTON, N.J. - A New Jersey federal judge on Feb. 27 dismissed with prejudice a heart device wrongful death complaint, finding that the plaintiff failed to assert a claim that parallels federal law and escapes federal preemption (Barbara A. Chester, et al. v. Boston Scientific Corp., et al., No. 16-2421, D. N.J., 2017 U.S. Dist. LEXIS 26676).
Fluoroquinolone MDL Judge Denies Statute Of Repose Dismissal In 4 Cases
MINNEAPOLIS - The Minnesota federal judge overseeing the fluoroquinolone multidistrict litigation on Feb. 21 denied dismissal of four plaintiffs for missing their states' statutes of repose but granted dismissal on the same grounds in two other cases (In Re: Fluoroquinolone Products Liability Litigation, MDL Docket No. 2642, No. 15-2642, Alan Henness, et al. v. Johnson & Johnson, et al., No. 15-3417, Michael Cepuran v. Bayer Healthcare Pharmaceuticals, Inc., et al., No. 15-3595, Rhonda Cervantes v. Bayer Healthcare Pharmaceuticals, Inc., et al., No. 16-1443, Deborah Haney v. Bayer Healthcare Pharmaceuticals, Inc., et al., No. 16-1501, Arturo Rendon v. Bayer Healthcare Pharmaceuticals, Inc., et al., No. 16-1515, D. Minn., 2017 U.S. Dist. LEXIS 24093).
Federal Murder Trial In NECC Fungal Meningitis Trial Passes 1-Month Mark
BOSTON - The federal murder trial of the former president and chief pharmacist of the New England Compounding Center (NECC) on Feb. 21 passed its 30th day of testimony on Nov. 21 with the government presenting its 33rd witness (United States of America v. Barry J. Cadden, et al., No. 14-10363, D. Mass.).
Motion For LFIT Hip MDL To Be Heard March 30; Defendant Opposes
WASHINGTON, D.C. - The Judicial Panel on Multidistrict Litigation (JPMDL) on Feb. 14 scheduled arguments about whether federal lawsuits involving the Stryker Orthopaedics LFIT V40 femoral head hip device should be centralized (In Re: Stryker Orthopaedics LFIT V40 Femoral Head Products Liability Litigation, MDL Docket No. 2769, JPMDL).
Hearing March 30 For MDL Involving Smith & Nephew Metal-On-Metal Hips
WASHINGTON, D.C. - A federal judicial panel will hear arguments March 30 on centralizing 31 federal lawsuits alleging injuries from Smith & Nephew BHR and R3 hip implants (In Re: Smith& Nephew BHR and R3 Hip Implant Products Liability Litigation, MDL Docket No. 2775, JPMDL).
Sorin Opposes MDL For Cases For Blood Temperature Device; Hearing March 30
WASHINGTON, D.C. - The manufacturer of a surgical blood temperature device on Feb. 17 opposed centralization of 15 federal lawsuits alleging intraoperative infections because there are too few cases and too few common issues of fact (In Re: Sorin 3T Heater-Cooler System Products Liability Litigation, MDL Docket No. 2772, JPMDL).
Trades Council Appointed Lead Plaintiff In Securities Class Action Lawsuit
SAN FRANCISCO - A shareholder has met all statutory requirements to serve as lead plaintiff in a securities class action lawsuit against a pharmaceutical company and certain current and former executive officers over their alleged misrepresentations concerning their involvement in a generic drug price-fixing scheme in violation of federal securities laws, a federal judge in California ruled Feb. 15 (Greg Fleming v. Impax Laboratories Inc., et al., No. 16-6557, N.D. Calif., 2017 U.S. Dist. LEXIS 22147).
1st Circuit Asked To Decide Whether Court Properly Dismissed Securities Claims
BOSTON - Parties in a securities class action lawsuit against a drug maker and certain of its executive officers recently asked the First Circuit U.S. Court of Appeals to determine whether a federal district court erred in dismissing the lead plaintiff's amended complaint for failure to plead scienter and abused its discretion in denying the lead plaintiff's motion to vacate the dismissal order (In re Biogen Inc. Securities Litigation, No. 16-1976, 1st Cir.).
Washington Supreme Court: Da Vinci Robot Maker Must Warn Hospitals
OLYMPIA, Wash. - The manufacturer of the da Vinci surgical robot had a duty to warn a hospital about the risks of the device to credential the physician who used it, the Washington Supreme Court ruled Feb. 9 in vacating a 2013 defense verdict for Intuitive Surgical Inc. in a wrongful death trial (Josette Taylor, et al. v. Intuitive Surgical, Inc., No. 92210-1, Wash. Sup., 2017 Wash. LEXIS 200).
Master Settlement Reached In Tylenol Liver Injury Cases; Terms Are Undisclosed
PHILADELPHIA - The McNeil Consumer Healthcare division of Johnson & Johnson has agreed to pay a confidential amount to settle more than 200 Tylenol liver injury lawsuits, according to two documents filed Feb. 10 in the Tylenol multidistrict litigation court (In Re: Tylenol [Acetaminophen] Marketing, Sales Practices and Products Liability Litigation, MDL Docket No. 2436, No. 13-md-2436, E.D. Pa.).
4th Circuit Asked To Rehear Whether 510(k) Evidence Belongs In Pelvic Mesh Trial
RICHMOND, Va. - Ethicon Inc. and parent company Johnson & Johnson on Feb. 9 petitioned the Fourth Circuit U.S. Court of Appeals to grant an en banc rehearing on the issue whether any evidence about Food and Drug Administration dealings with 510(k)-cleared medical devices is admissible in a product liability case (Jo Huskey, et al. v. Ethicon, Inc., et al., No. 15-2118, 4th Cir.).
Non-Employment, Retirement Don't Spare Ethicon Witnesses From Pelvic Mesh Trial
CHARLESTON, W.Va. - The intervening departure of two Ethicon Inc. employees does not preclude them from being called to testify live via videoconference in an upcoming consolidated pelvic mesh trial, a West Virginia federal judge ruled Feb. 8 (Terreski Mullins, et al. v. Ethicon, Inc., et al., No. 12-2952, S.D. W.Va., Charleston Div., 2017 U.S. Dist. LEXIS 17555).
Kidney Dialysate Wrongful Death Trial Under Way In Fresenius MDL
BOSTON - A wrongful death bellwether trial involving the dialysate NaturaLyte got under way Feb. 8 in the U.S. District Court for the District of Massachusetts (Florella Dial, et al. v. Fresenius Medical Care Holdings, Inc. et al., No. 14-11101, D. Mass.).
Failure To Ask Doctor About Paxil Risks Warranted Nonsuit, Pennsylvania Judge Says
PHILADELPHIA - A Pennsylvania state court judge on Feb. 7 said he was forced to grant a nonsuit in a Paxil birth defect case because the plaintiffs failed to ask the prescribing physician what he would have done if he had known that the antidepressant is a potential teratogen and that it can cause fetal death (Braden Rader, et al. v. SmithKline Beecham Corporation, et al., No. 11090367200535, Pa. Comm. Pls., Philadelphia Co., No. 2144 EDA 2016, Pa. Super.).
Judge: Claims Against Drug Manufacturer Fail In Absence Of Reliable Expert Testimony
BRIDGEPORT, Conn. - In the absence of reliable medical expert opinion on specific causation, no reasonable fact finder could come to the conclusion that Paxil, an antidepressant drug, caused a baby's birth defect, a Connecticut federal judge ruled Feb. 1, granting summary judgment to the drug's manufacturer on numerous claims (K.E., a minor by his parent and natural guardian, Nichole El-Massri v. GlaxoSmithKline LLC formerly SmithKline Beecham Corp. d/b/a GlaxoSmithKline, No. 14-1294, D. Conn., 2017 U.S. Dist. LEXIS 13705).
Proton Pump Inhibitor MDL Motion Denied By Federal Judicial Panel
WASHINGTON, D.C. - A federal judicial panel on Feb. 2 denied a motion to centralize 39 federal lawsuits alleging kidney injury from proton pump inhibitor (PPI) drugs because they involve four groups of competing manufacturers and because discovery will be "defendant-specific" (In Re: Proton Pump Inhibitor Products Liability Litigation, MDL Docket No. 2757, JPMDL).
53 Federal Eliquis Cases Centralized As 3rd Anticoagulant MDL
WASHINGTON, D.C. - The Judicial Panel on Multidistrict Litigation (JPMDL) on Feb. 7 centralized 53 federal Eliquis lawsuits before Senior Judge Denise L. Cote of the U.S. District Court for the Southern District of New York (In Re: Eliquis [Apixaban] Products Liability Litigation, MDL Docket No. 2754, JPMDL, 2017 U.S. Dist. LEXIS 16639).
Effient Bleeding Death Complaint Partly Dismissed By Kentucky Federal Judge
OWENSBORO, Ky. - A Kentucky federal judge on Feb. 10 dismissed in part a lawsuit alleging that Eli Lilly and Co. failed to warn that its anticoagulant drug Effient could cause uncontrolled bleeding like the kind that led to a patient's death (Estate of Jerry DeMoss, et al. v. Eli Lilly and Company, No. 16-103, W.D. Ky., Owensboro Div., 2017 U.S. Dist. LEXIS 19142).
Last Lipitor Diabetes MDL Cases Dismissed; Appeals Filed With 4th Circuit
CHARLESTON, S.C. - A South Carolina federal judge overseeing the Lipitor diabetes multidistrict litigation on Feb. 3 dismissed all 157 remaining cases for lack of causation testimony and, despite a plea by plaintiff attorneys, did so with prejudice (In Re: Lipitor [Atorvastatin Calcium] Marketing, Sales Practices and Products Liability Litigation, MDL Docket No. 2502, No. 14-mn-2502, D. S.C., Charleston Div.).
Farxiga MDL Sought By Plaintiff For 1 Of 3 Federal District Courts
WASHINGTON, D.C. - A plaintiff on Feb. 3 asked the Judicial Panel on Multidistrict Litigation (JPMDL) to centralize 18 federal cases in which plaintiffs alleged that they suffered diabetic ketoacidosis (DKA) or kidney injury from taking the diabetes drug Farxiga (In Re: Farxiga [Dapaglifozin] Products Liability Litigation, MDL Docket No. 2776, JPMDL).
2nd Circuit Partly Vacates Dismissal Of Antitrust Claims In Patent Dispute
NEW YORK - A New York federal judge's decision to dismiss allegations that Takeda America Holdings Inc., Takeda Pharmaceuticals U.S.A. Inc., Takeda Development Center Americas Inc. and Takeda Pharmaceuticals Co. Ltd. (Takeda, collectively) violated state law analogs of the Sherman Act, 15 U.S.C. § 2, by preventing competitors from marketing a generic version of the diabetes drug ACTOS was partly vacated by the Second Circuit U.S. Court of Appeals Feb. 8 (In re: ACTOS End-Payor Antitrust Litigaiton, No. 15-3364, 2nd Cir., 2017 U.S. App. LEXIS 2291).
'A Civil Action' Attorney Jan Schlichtmann Named In Avandia Malpractice Lawsuit
PHILADELPHIA - Noted plaintiff attorney Jan R. Schlichtmann and his law firm were sued Jan. 30 for legal malpractice and breach of contract by a trust company which claims that missteps by the defendants in an Avandia settlement cost them more than $2.5 million (ATG Trust Company v. Jan R. Schlichtmann, et al., No. 160802163, Pa. Comm. Pls., Philadelphia Co.).
Erie County Sues 4 Opioid Makers For Role In Addiction Epidemic
BUFFALO, N.Y. - New York's Erie County on Feb. 1 sued four opioid drug makers in state court, alleging that their deceptive practices under state law have caused an opioid abuse epidemic that costs the county in health and law enforcement services and addicts or kills its residents (The County of Erie v. Purdue Pharma L.P., et al., No. n/a, N.Y. Sup., Erie Co.).
Ex-Bio-Rad VP Awarded $7.86M For Retaliation Over Bribery Allegations
SAN FRANCISCO - A California federal jury on Feb. 6 found that Bio-Rad Laboratories Inc. and five executives retaliated against a former executive vice president for reporting foreign bribery and awarded him $7.96 million in compensatory and punitive damages (Sanford S. Waldner v. Bio-Rad Laboratories, Inc., et al., No. 15-2356, N.D. Calif.).
FTC Says Shire ViroPharma's Abuse Of FDA Process Violated Antitrust Law
WILMINGTON, Del. - The U.S. Federal Trade Commission on Feb. 7 filed an antitrust complaint against Shire ViroPharma Inc., alleging that the company engaged in abusive petitioning of and litigation with the U.S. Food and Drug Administration to delay by two years the introduction of generic versions of the drug Vancocin (Federal Trade Commission v. Shire ViroPharma Inc., No. 17-131, D. Del.).
Biopharma Programmer Arrested For Trading On Insider Information
BOSTON - A former programmer for a Massachusetts biopharmaceutical company was charged Feb. 7 with insider trading for conspiring to commit securities fraud by trading insider information about successful drug trials (United States of America v. Songjiang Wang, No. 17-1005, D. Mass.).