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

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



Headline Heart Drugs & Devices Legal News from LexisNexis®



 



Split 8th Circuit Panel Affirms Sprint Fidelis Preemption Ruling
ST. LOUIS - A day after the parties announced a $268 million settlement and an end to the appeal, a split panel of the Eighth Circuit U.S. Court of Appeals on Oct. 15 affirmed that the plaintiffs' claims involving the Medtronic Sprint Fidelis heart device leads are preempted and that the plaintiffs failed to plead that their state law claims parallel federal regulations (In Re: Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, No. 09-2290, 8th Cir.; See August 2010, Page 6). Full story on lexis.com



Medtronic To Pay $268M To Settle 3,700 Claims Involving Sprint Fidelis Leads
MINNEAPOLIS - Medtronic Inc. on Oct. 14 said it has agreed to pay $268 million to settle about 3,700 lawsuits and claims in the United States related to the recall of its Sprint Fidelis implantable cardiac defibrillator leads. Full story on lexis.com



California Appeals Court Rejects Challenge To Sprint Fidelis Preemption Ruling
LOS ANGELES - A California trial court did not err in finding that the claims of a group of plaintiffs who allegedly were injured by Medtronic Inc.'s Sprint Fidelis pacemaker/defibrillator leads were preempted by federal law, a state appellate court panel ruled Oct. 14 (Bagram Bagumyan, et al. v. Medtronic, Inc., et al., No. B219506, Calif. App., 2nd Dist., Div. 2; 2010 Cal. App. Unpub. LEXIS 8167). Full story on lexis.com



Supreme Court Grants Petition For Certiorari In Baycol Economic Class Action
WASHINGTON, D.C. - The U.S. Supreme Court on Sept. 28 granted a petition for writ of certiorari brought by a group of plaintiffs whose attempt to certify a Baycol economic class action before a state court was denied because the same issues already had been denied in federal court (Smith v. Bayer Corp., et al., No. 09-1205, U.S. Sup.; See January 2010, Page 4). Full story on lexis.com



Conn. High Court Affirms Defense Verdict In Medtronic Pacemaker Case
HARTFORD, Conn. - The Connecticut Supreme Court on Sept. 14 affirmed a defense verdict in a Medtronic pacemaker trial, finding that the trial court properly interpreted the high court's remand instructions, properly certified a unanimous verdict and committed harmless error by allowing evidence of medical negligence (Nicole Hurley, et al. v. The Heart Physicians, P.C., et al., No. SC 18423, Conn. Sup.; See February 2008, Page 7). Full story on lexis.com



Boston Scientific: Plaintiff Used Public Information In Heart Device Qui Tam Suit
BUFFALO, NY - Boston Scientific Corp. on Sept. 24 asked a New York federal court to dismiss a False Claims Act lawsuit involving the Guidant Prizm 2 DR Model 1861 implantable cardioverter defibrillator (ICD), saying the patient/whistle-blower bases his claims on publicly available information about problems with the heart device (United States of America, ex rel. James Allen v. Guidant LLC, et al., No. 08-514, W.D. N.Y.). Full story on lexis.com



Guidant MDL Judge Grants Motion For $1.3 Million In Attorney Fees
MINNEAPOLIS - The Minnesota federal judge overseeing the Guidant Corporation Implantable Defibrillators multidistrict litigation on Oct. 18 issued an order granting an additional $1.3 million in attorney fees and costs related to settlement of the litigation (In Re: Guidant Corp. Implantable Defibrillators Products Liability Litigation, MDL No. 05-1708, D. Minn.; See September 2010, Page 14). Full story on lexis.com



Government Says Label Change Not Grounds To Dismiss Lipitor False Claims Act Suit
BROOKLYN, NY - Although the federal government has declined to intervene in a Lipitor False Claims Act (FCA) lawsuit against Pfizer Inc., the United States on Sept. 24 told a New York federal court that it retains an interest in the case and that the court should deny a motion to dismiss 10 counts (United States of America ex rel. Dr. Jesse Polansky v. Pfizer, Inc., No. 04-704, E.D. N.Y.; See February 2010, Page 12). Full story on lexis.com



Parties Want False Claims Heart Device Kickback Case Closed Pending Settlement
DENVER - A False Claims Act case that alleged that heart device maker Sorin Group paid doctors disguised kickbacks to buy their products is close to being settled, the parties told a Colorado federal judge Sept. 17 in asking that the case be administratively closed (United States of America, ex rel. Mary Jo Pfeifer v. ELA Medical, Inc., et al., No. 07-1460, D. Colo., Denver Dist.). Full story on lexis.com



Hospital Sues Astellas For Monopolizing Heart Test Drug
TAMPA, Fla. - A Florida hospital on Sept. 13 filed a class action complaint alleging that Astellas US LLC is violating antitrust laws by forcing health care providers to buy its adenosine drugs at a 450 percent markup compared to competitors' versions of the same drugs (Lakeland Regional Medical Center, Inc., et al. v. Astellas US LLC, et al., No. 10-2008, M.D. Fla.). Full story on lexis.com



Actelion Gets Subpoena For Tracleer Marketing Documents From U.S. Attorney
SOUTH SAN FRANCISCO, Calif. - Actelion Ltd. announced Sept. 20 that its U.S. subsidiary has received a federal subpoena for documents related to the sale and marketing of its Tracleer pulmonary arterial hypertension drug. Full story on lexis.com



Actelion Warned By FDA For Failing To Report Adverse Drug Events
ALAMEDA, Calif. - The Food and Drug Administration on Sept. 14 issued a warning letter to Actelion Pharmaceuticals US Inc. for failing to timely reports adverse events associated with its Tracleer, Ventavis and Zavesca drugs. Full story on lexis.com



Settlement Agreement Reached In Digitek Multidistrict Litigation
CHARLESTON, W.Va. - The parties in the Digitek products liability multidistrict litigation before a West Virginia federal court have reached an agreement to settle all the cases in the litigation, according to a pretrial order filed Sept. 1 (In Re: Digitek Products Liability Litigation, MDL No. 1968, No. 08-md-1968, S.D. W.Va.; See August 2010, Page 6). Full story on lexis.com



Supreme Court Grants Petition For Certiorari In Baycol Economic Class Action
WASHINGTON, D.C. - The U.S. Supreme Court on Sept. 28 granted a petition for writ of certiorari brought by a group of plaintiffs whose attempt to certify a Baycol economic class action before a state court was denied because the same issues were already denied in federal court (Smith v. Bayer Corp., et al., No. 09-1205, U.S. Sup.; See January 2010, Page 5). Full story on lexis.com



3rd Circuit Reverses Denial Of Summary Judgment On Medical Monitoring Claim
PHILADELPHIA - A panel of the Third Circuit U.S. Court of Appeals on Aug. 24 reversed a district court's finding in favor of medical monitoring for a minor plaintiff who allegedly was injured by an experimental heart stent, holding that even if Delaware law would allow medical monitoring, the plaintiffs have failed to establish the elements necessary for a standard medical monitoring claim (M.G., et al. v. A.I. Dupont Hospital for Children, et al., No. 09-1426, 3rd Cir.; See March 2010, Page 10). Full story on lexis.com



Panel: Dismissal For Failure To Plead Scienter, Misrepresentations Was Proper
ST. PAUL, Minn. - A federal court in Minnesota did not err in dismissing a securities class action against a medical device maker and certain of its officers because the shareholders who brought the action failed to plead any material misrepresentations or scienter in making their federal securities law claims, an Eighth Circuit U.S. Court of Appeals panel ruled Sept. 16 in affirming (Detroit General Retirement System, et al. v. Medtronic, Inc., et al., No. 09-2518, 8th Cir.; 2010 U.S. App. LEXIS 19370; See Sept. 2009, Page 10). Full story on lexis.com



AtriCure To Pay $2.75M To Settle Shareholder Suit For Off-Label Marketing
CINCINNATI - An Ohio federal judge on July 30 preliminarily approved a $2.75 million class settlement between AtriCure Inc. and shareholders who claim that their shares lost value because of a federal investigation of off-label marketing of a heart ablation device (In Re: AtriCure, Inc. Securities Litigation, No. 08-867, S.D. Ohio, W. Div.). Full story on lexis.com



Pennsylvania Judge Rules Investors Failed To Plead Scienter Against CardioNet
PHILADELPHIA - A Pennsylvania federal judge on Aug. 10 dismissed a class action brought by investors who allege that a manufacturer of heart monitors made overly optimistic statements about the reimbursement rate that Medicare and Medicaid would pay for its products, holding that the plaintiffs have not sufficiently pleaded scienter (Dianne Solomon-Shrawder, et al. v. CardioNet Inc., et al., No. 09-3894, E.D. Pa.; 2010 U.S. Dist. LEXIS 80544). Full story on lexis.com



Ex-Spectranetics Employees Indicted For Conspiracy To Skirt Import, FDA Laws
DENVER - The former chief executive officer of Spectranetics Corp. and three former employees were indicted Aug. 26 for conspiracy and for selling adulterated and misbranded medical devices (United States of America v. George John Schulte, et al., No. 10-cr-455, D. Colo.). Full story on lexis.com



Louisiana Federal Judge Grants Summary Judgment In Lipitor Injury Case
SHREVEPORT, La. - A Louisiana federal judge on Sept. 20 granted a motion by Pfizer Pharmaceuticals Co. Inc. for summary judgment in a Lipitor case, holding that the plaintiff has failed to disclose any expert testimony (Patricia Lewis v. Pfizer Pharmaceuticals Company, Inc., No. 09-0283, W.D. La.; 2010 U.S. Dist. LEXIS 99648; See July 2010, Page 9). Full story on lexis.com



Coverage Owed For Defective Heart Valves, Federal Judge Says
MINNEAPOLIS - An excess insurer must pay for claims arising out of defects in an insured's Silzone-coated heart valves because the insured filed a claim for coverage during the policy period and the policy's batch clause applies to all Silzone-coated products that were defective, a Minnesota federal judge said Sept. 20 (American Insurance Co. v. St. Jude Medical Inc., No. 08-13, D. Minn.). Full story on lexis.com



Guidant MDL Judge Amends Order To Reduce Holdbacks For Certain Claimants
MINNEAPOLIS - The Minnesota federal judge overseeing the Guidant implantable defibrillators multidistrict litigation on Sept. 23 amended his Aug. 7 distribution order to reduce the amount of funds that were held back for certain claimants (In Re: Guidant Corp. Implantable Defibrillators Products Liability Litigation, MDL No. 1708, D. Minn.; See June 2010, Page 6). Full story on lexis.com



FDA Approves 2 Boston Scientific Devices To Treat Heart Abnormality
WASHINGTON, D.C. - The U.S. Food and Drug Administration on Sept. 16 announced that it had approved three Boston Scientific Corp. cardiac resynchronization therapy defibrillators (CRT-Ds) for use in patients suffering with a heart abnormality known as a left bundle branch block. Full story on lexis.com



New Jersey Appellate Panel Reverses Stent Preemption Ruling In Part
TRENTON, N.J. - A New Jersey Superior Court Appellate Division panel on July 23 reversed dismissal of the manufacturing defect, failure to warn and breach of express warranty claims of a group of plaintiffs who claim to have been injured by Johnson & Johnson (J&J) and Cordis Corp.'s Cypher Sirolimus-Eluting Coronary stents, holding that these claims are not preempted by federal law (Vonnie Cornett, et al. v. Johnson & Johnson, et al., No. A-4694-08T1, A-5539-08T1, N.J. Super., App. Div.). Full story on lexis.com



Baycol Court Erred In Disallowing Substitute Parties, 8th Circuit Rules
ST. LOUIS - A district court abused its discretion in holding that the daughters of a woman who died several years after suing Bayer Corp. alleging injury from the recalled cholesterol drug Baycol failed to provide sufficient evidence to show that they were proper parties for substitution, a panel of the Eighth Circuit U.S. Court of Appeals ruled Aug. 10 (Melinda Torres v. Baycol Corp., No. 09-1964, 8th Cir.). Full story on lexis.com



Judge Issues Stay In Digitek Multidistrict Litigation Until Oct. 26
CHARLESTON, W.Va. - The West Virginia federal judge overseeing the Digitek multidistrict litigation issued an order Aug. 12 staying the litigation until Oct. 26 (In Re: Digitek Products Liability Litigation, MDL No. 1968, No. 08-md-1968, S.D. W.Va.; See July 2010, Page 4). Full story on lexis.com



Medtronic Tells 8th Circuit Preemption Ruling Supports Sprint Fidelis Dismissal
MINNEAPOLIS - Counsel for Medtronic Inc. on Aug. 10 filed a letter with the Eighth Circuit U.S. Court of Appeals, arguing that a recent holding by the Sixth Circuit that a district court erred in finding that there were no parallel claims in a medical device case involving a hip prosthesis is distinguished from the dismissal of the Medtronic Sprint Fidelis defibrillator lead product multidistrict litigation (Anna Bryant v. Medtronic, Inc., No. 09-2290, 8th Cir.; See April 2010, Page 9). Full story on lexis.com



Louisiana Judge Dismisses Guidant Implantable Defibrillator Case In Part
NEW ORLEANS - A Louisiana federal judge on Aug. 5 granted a motion to dismiss by Guidant Corp. in a heart device case, holding that the plaintiff's state and federal law claims are barred by the exclusivity provision of the Louisiana Products Liability Act (LPLA) but that the plaintiff sufficiently pleaded the elements of an LPLA claim (James D. Ervin, Jr. v. Guidant Corporation, et al., No. 08-03783, E.D. La.; 2010 U.S. Dist. LEXIS 78886). Full story on lexis.com



Federal Judge Rules Pfizer's Repeated Violations Of Law Show Demand Futility
NEW YORK - Pfizer Inc.'s continued violations of federal law after paying fines and entering guilty pleas stemming from previous violations as well as the personal liability faced by its directors and executives demonstrate demand futility, a New York federal judge ruled July 14; the company had moved to dismiss shareholder derivative claims stemming from a $2.3 billion settlement the company entered into in 2009, saying the plaintiffs failed to make a demand on the board as required by securities laws (In re Pfizer Inc. Shareholder Derivative Litigation, No. 09-cv-7822, S.D. N.Y.; 2010 U.S. Dist. LEXIS 69593). Full story on lexis.com



Pennsylvania Judge Rules Investors Failed To Plead Scienter Against CardioNet
PHILADELPHIA - A Pennsylvania federal judge on Aug. 10 dismissed a class action brought by investors who allege that a manufacturer of heart monitors made overly optimistic statements about the reimbursement rate that Medicare and Medicaid would pay for its products, holding that the plaintiffs have not sufficiently pleaded scienter (Dianne Solomon-Shrawder, et al. v. CardioNet Inc., et al., No. 09-3894, E.D. Pa.; 2010 U.S. Dist. LEXIS 80544). Full story on lexis.com



New Jersey Appeals Court Allows Shareholders Access To Schering Board Minutes
TRENTON, N.J. - Two shareholders who are bringing a shareholder derivative lawsuit against Schering-Plough alleging that the company failed to timely disclose the results of a clinical trial on its cholesterol-lowering drug are entitled to examine the company's board of directors' minutes, but only those that are directly related to the clinical trial, a New Jersey appellate court ruled Aug. 17 (Mary E. Cain, et al. v. Merck & Co., No. A-2138-O8T2, N.J. Super., App. Div.). Full story on lexis.com



Federal Judge Dismisses Consumer Class Suit Over Pfizer Drugs
PHILADELPHIA - A federal judge in Pennsylvania on July 20 dismissed a putative consumer class action that alleged fraudulent marketing of 12 Pfizer Inc. drugs, saying the plaintiffs failed to demonstrate an injury or reliance upon the allegedly fraudulent marketing (Kathleen Zafarana, et al. v. Pfizer Inc., et al., No. 09-cv-4026, E.D. Pa.; See December 2009, Page 17). Full story on lexis.com



Sanofi-Aventis Challenges FDA Authority To Approve Lovenox Generic Application
WASHINGTON, D.C. - Sanofi-Aventis U.S. LLC on July 26 filed a complaint seeking an injunction against a generic version of its Lovenox anticoagulant, saying the Food and Drug Administration exceeded its authority in approving the Sandoz Pharmaceuticals Inc. generic because it is not equivalent to Lovenox (Sanofi-Aventis U.S. LLC v. Food and Drug Administration, et al., No. 10-1255, D. D.C.). Full story on lexis.com



Federal Magistrate Orders Guidant To Produce Documents In Qui Tam Lawsuit
NASHVILLE, Tenn. - A Tennessee federal magistrate judge on July 19 ordered Guidant Corp. to provide further responses to interrogatories and requests for production of documents requested by the plaintiffs in a qui tam lawsuit who allege that Guidant engaged in a fraudulent scheme that caused Medicare and Medicaid to pay inflated prices for Guidant's implantable medical devices (United States of America, et al. v. Guidant Corporation, et al., No. 3:03-0842, M.D. Tenn.). Full story on lexis.com