Life Sciences

  • March 27, 2015

    A-Rod's Cousin Pleads Guilty In MLB Doping Scandal

    Yankees star Alex Rodriguez's cousin Yuri Sucart pled guilty Friday to his role in the Biogenesis of America LLC doping scandal that resulted in the suspension of more than a dozen Major League Baseball players, including Rodriguez.

  • March 27, 2015

    Provigil Pay-For-Delay Suit Survives Reconsideration Bid

    A Pennsylvania federal judge on Friday declined to reconsider his ruling that a handful of pay-for-delay suits against drugmaker Cephalon Inc. over its Provigil narcolepsy drug meets the U.S. Supreme Court’s Actavis standard allowing parties to sue drugmakers over settlements to delay the entry of generic drugs.

  • March 27, 2015

    Sandoz Can’t Dodge Cancer Drug Product Liability Suit

    A Florida federal judge on Thursday denied a bid by Sandoz Inc. to toss a product liability suit brought by a patient who claimed to have suffered injuries due to a contaminated cancer drug, ruling that the generic drugmaker’s preemption argument falls short.

  • March 27, 2015

    Insurers Won't Pay For $28M Pacemaker Suit, Other Defense

    Two insurers told an Oregon federal judge Thursday that they owe no coverage or duty to defend to Biotronik Inc. in two underlying suits accusing the company and a New Mexico doctor of implanting unnecessary pacemakers, one of which resulted in a $28 million judgment.

  • March 27, 2015

    Spectrum Pharmaceuticals Stuck With Shareholder Suit

    A Nevada federal judge on Thursday denied a motion to dismiss a consolidated amended proposed class action against Spectrum Pharmaceuticals Inc. and individual defendants, saying that the plaintiffs sufficiently pled that the biopharma company made misleading statements in the context surrounding its cancer treatment drug.

  • March 27, 2015

    Medical Products Distributor HSI Protests $68M Tax Bill

    Medical and dental products distributor Henry Schein Inc. has urged the U.S. Tax Court to overturn $67.8 million in back taxes and penalties it was ordered to pay by the Internal Revenue Service, telling the court the IRS had mischaracterized or miscalculated legitimate claims.

  • March 27, 2015

    FDA Hears Wide Debate On Generic-Drug Warning Label Plan

    Drugmakers, lawyers and consumers on Friday debated the U.S. Food and Drug Administration's controversial plan to let generic-drug makers independently update their warning labels, trading divergent views on how patient safety and company balance sheets would be affected.

  • March 27, 2015

    Plaintiffs Blast BioScrip's Use Of Omnicare In Shareholder Suit

    The lead plaintiff in a proposed securities class action on Friday blasted BioScrip Inc. for defending itself under the shield of the U.S. Supreme Court's recent Omnicare Inc. ruling, saying its letter to the New York federal judge “badly misstated” the court’s actual holding.

  • March 27, 2015

    Glucosamine Class Can't Back Out Of $5M Deal, Judge Says

    A California magistrate refused Thursday to allow plaintiffs suing Schiff Nutrition International Inc. for allegedly deceptively marketing its glucosamine supplement as an arthritis treatment to back out of their proposed $5 million deal, saying "possible" objections and a recent Seventh Circuit decision don’t justify their request.

  • March 27, 2015

    GSK Says Calif. Court Should Oversee Abbott HIV-Drug Suit

    GlaxoSmithKline has urged a California federal judge to rule that the court has jurisdiction over its suit against Abbott Laboratories, saying that although it dropped its federal antitrust claims over the raised price of an HIV drug it licensed, there is plenty to connect Abbott to the state.

  • March 27, 2015

    Reed Smith Atty To Testify On Novartis Kickback Advice

    A Reed Smith LLP partner who previously advised Novartis Pharmaceuticals Corp. on its compliance with anti-kickback laws will testify at an upcoming False Claims Act trial accusing the drugmaker of giving fraudulent rebates to pharmacies, a Novartis attorney said in New York federal court Friday.

  • March 26, 2015

    False Ads Juicing Up Rival's Profits, Supplement Co. Says

    An Arizona nutritional supplement company says one of its competitors is bulking up its profits by falsely advertising supplements containing synthetic steroids as all-natural products, according to a lawsuit filed in California federal court.

  • March 26, 2015

    Fed. Circ. Shields Some Patent App Revivals From APA Review

    The Federal Circuit ruled Thursday that third-parties to a patent cannot use the Administrative Procedure Act to challenge U.S. Patent and Trademark Office decisions to revive patent applications that were abandoned because of late filings, rejecting a challenge to an application covering the injectable pain reliever Ofirmev.

  • March 26, 2015

    GNC Asks JPML To Split Supplement MDLs, Consolidate In Pa.

    General Nutrition Corp. told the U.S. Judicial Panel on Multidistrict Litigation on Wednesday that the suits against it and other retailers over allegedly mislabeled herbal supplements should be consolidated in Pennsylvania but that they should be split into separate multidistrict litigations against each defendant.

  • March 26, 2015

    Deals Rumor Mill: SoftBank, Evonik, Union Bancaire

    Japanese telecom giant SoftBank Corp. may be ready to lay out as much as $1 billion to acquire a 20 percent stake in Indian handset maker Micromax Informatics Ltd., while Evonik Industries AG may try to take over rival Clariant AG in order to create a $21.8 billion chemicals company.

  • March 26, 2015

    Walgreen, Others Sue Over Opana, Solodyn Generic Deals

    Continuing recent efforts to be part of pending pay-for-delay cases, a group of grocery chains including Walgreen Co. on Thursday filed joint complaints in Illinois and Pennsylvnia accusing the makers of opioid pain medication Opana ER and acne treatment Solodyn of standing in the way of generic competition. 

  • March 26, 2015

    Millennium Beats Off-Label Suit, But Free Speech No Factor

    A California federal judge on Thursday threw out a False Claims Act suit accusing Millennium Pharmaceuticals Inc. of illicit off-label promotion, but the ruling omitted any discussion of free-speech issues in the closely watched whistleblower case.

  • March 26, 2015

    FDA Approves Emergent's Inhalation Anthrax Treatment

    Emergent BioSolutions Inc. will receive $7 million from the federal government after winning U.S. Food and Drug Administration approval for a first-of-its-kind anthrax treatment, the company announced Wednesday.

  • March 26, 2015

    Omnicare Bolsters Case Against Ex-Merck VP, Investors Say

    Shareholders accusing Merck & Co. Inc.'s former vice president of lying about the study results on Vioxx's heart attack link told a New Jersey federal court Wednesday that the U.S. Supreme Court's recent Omnicare ruling "vindicates" their case theory and directly rejects the executive's summary judgment argument.

  • March 26, 2015

    FDA Rejects Amgen's Biosimilars Info-Sharing Petition

    The U.S. Food and Drug Administration in a letter released Thursday rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in litigation with Sandoz Inc.

Expert Analysis

  • Biomet Again Underscores FCPA Risks In Life Sciences

    Gary Giampetruzzi

    While few details have been disclosed relating to the historic extension of Biomet Inc.'s deferred prosecution agreement, its warning is clear — where prosecutors question a company’s candor, cooperation or remediation of issues, the grip of formal oversight will not be easily released, say attorneys with Paul Hastings LLP.

  • What Experts Can Say About Inadmissible Facts During Trial

    Jason McDonell

    For reliance material that is not admitted on the stand, consider bolstering the testimony by having the expert describe the evidence generally, but in a way that signals to the jury that the expert has a strong foundation of supporting facts and data. If done well, such testimony can open the door to admitting the evidence, say Jason McDonell and Heather Fugitt of Jones Day.

  • High Court May Take On Corporate 5th Amendment Privilege

    Ramzi Abadou

    A festering but virtually unnoticed circuit split over a legal doctrine the U.S. Supreme Court first recognized early last century may provide the Roberts court with the opportunity to grant corporate persons privilege against self-incrimination for the first time in U.S. history, says Ramzi Abadou of Kahn Swick & Foti LLP.

  • And Now A Word From The Panel: Just Say No (To MDLs)?

    Alan E. Rothman

    What will spring bring for the Judicial Panel on Multidistrict Litigation? Will it continue to close the door on new MDL proceedings? Will it decide to throw the baby out with the bathwater and decline to create a baby wipe MDL? asks Alan Rothman of Kaye Scholer LLP.

  • Biomet’s DPA Proves An Inescapable Device

    Amy Riella

    As just the latest in a series of companies facing additional scrutiny from U.S. regulators following the settlement of an enforcement action involving violations of the Foreign Corrupt Practices Act, Biomet Inc.’s current plight highlights the risks of continuing reporting and disclosure obligations contained in most deferred and nonprosecution agreements, say Amy Riella and Carla Jordan-Detamore of Vinson & Elkins LLP.

  • BPCIA: How Long Is The Party, And Do I Have To Dance?

    Leslie-Anne Maxwell

    A California federal court's recent ruling in Amgen Inc. v. Sandoz Inc. is the first to interpret two key provisions of the Biologics Price Competition and Innovation Act and, if upheld on appeal, will have a tremendous impact on the patent litigation strategies of both reference product sponsors and biosimilar applicants going forward, say attorneys with Cantor Colburn LLP.

  • A Texas Court’s Broad Reading Of FCA Public Disclosure Bar

    Allyson Singel Aldous

    A Texas federal court's recent decision in U.S. v. Solvay SA curtails whistleblowers’ ability to bring successful False Claims Act claims by expanding the scope of the public disclosure bar and the parameters of voluntary disclosure, says Allyson Singel Aldous of Buchanan Ingersoll & Rooney PC.

  • Medical Device Companies Face Increased TAA Scrutiny

    Lawrence Sher

    A spate of recent multimillion-dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act if they misstate the country of origin of their products in violation of the Trade Agreements Act, say attorneys with Reed Smith LLP.

  • NJ Supreme Court Clarifies Expert Testimony Rule

    Timothy Freeman

    Practitioners should take note of the New Jersey Supreme Court's recent decision in Townsend v. Pierre when seeking to exclude expert testimony that is based on factual scenarios that have no support in the record, says Timothy Freeman of Sedgwick LLP.

  • Post-Grant Proceedings Are Important For Biosimilars

    Paul Calvo

    In recent litigations, biosimilar applicants who have sought to circumvent the Biologics Price Competition and Innovation Act have been unsuccessful in their efforts to obtain early resolution of their patent disputes in district court. Thus, biosimilar applicants will increasingly look to post-grant patent challenges as a mechanism for obtaining early and fast patent certainty, say Paul Calvo and Eldora Ellison of Sterne Kessler G... (continued)