Life Sciences

  • October 1, 2014

    BMS, Sanofi Lose Remand Challenge In Plavix MDL

    A New Jersey federal judge on Wednesday remanded 57 cases claiming injuries over the blood thinner Plavix despite arguments from Bristol-Meyers Squibb Co. and Sanofi-Aventis U.S. LLC that the suits fraudulently included drug distributor McKesson Corp. and unrelated plaintiffs to dodge federal jurisdiction.

  • October 1, 2014

    7th Circ. Asked To Revive Ciba Contact Lens Injury Suit

    An Illinois man urged the Seventh Circuit on Wednesday to resurrect his suit alleging contact lenses made by Novartis AG unit Ciba Vision Corp. injured his eyes, claiming the contacts were defective despite their exclusion from a massive recall.

  • October 1, 2014

    FDA Warns Hospira Over Injectable Drug Violations

    Hospira Inc. revealed on Wednesday that it has received a U.S. Food and Drug Administration warning letter after the agency discovered “significant violations” at the company's Mulgrave, Australia, facility.

  • October 1, 2014

    Philips Slammed With $466M Verdict In Masimo Patent Trial

    A Delaware federal jury on Wednesday awarded Masimo Corp. more than $466 million for Philips Electronics North America Corp.’s infringement of two patents for measuring blood oxygen levels, rejecting Philips’ arguments that the patents were invalid.

  • October 1, 2014

    AbbVie Can't Keep AndroGel Death Suit Out Of State Court

    A California federal judge on Monday remanded a wrongful death suit against AbbVie Inc. over its AndroGel testosterone drug to state court, rejecting the pharmaceutical firm's bid to stay the suit while waiting for it to be transferred to the multidistrict litigation in Illinois over alleged injuries from testosterone treatments.

  • October 1, 2014

    Takeda Shared Actos Cancer Data, Ex-FDA Official Testifies

    A former senior official with the U.S. Food and Drug Administration told a Philadelphia jury on Wednesday that Takeda Pharmaceutical Co. Ltd. had included all relevant information about potential links between its diabetes drug Actos and bladder cancer on labels for the medication.

  • October 1, 2014

    Blank Rome Adds Generic Drugs Pro From Reed Smith

    Blank Rome LLP is looking to grow its work in Hatch-Waxman Act patent disputes in New Jersey with the addition of a former Reed Smith LLP attorney with a background in life sciences litigation, the firm announced Wednesday.

  • October 1, 2014

    Covidien Unit Escapes FCA Suit Over Off-Label Marketing

    A Massachusetts federal judge on Tuesday tossed a whistleblower’s suit accusing Covidien Ltd. subsidiary of, among other things, promoting off-label uses for its blood-blockage device, saying the suit was precluded by the public disclosure bar and a lack of evidence.

  • October 1, 2014

    1 Mammoth Deal Helps 2 Firms Dominate September M&A

    Two renowned M&A practice groups barreled into fall, each breezing past their rivals with announced deals worth more than $32.5 billion, including a team effort on one of the biggest deals to hit the buzzing energy sector this year.

  • September 30, 2014

    BD Stuck With $114M Antitrust Verdict After New Trial Denied

    A Texas federal judge on Tuesday rejected Becton Dickinson & Co.'s bid to ax a $113.5 million damages verdict in favor of Retractable Technologies Inc. and send the syringe market monopolization case back to a jury for a new trial, ruling that evidence presented during trial supported the jury's findings.

  • September 30, 2014

    Del. High Court Reverses Appriva Investors' $250M Ev3 Win

    The Delaware Supreme Court on Tuesday ruled a trial court should not have allowed Appriva Medical Inc. shareholders to argue a nonbinding letter of intent affected a merger agreement with ev3 Inc., which was financially backed by Warburg Pincus, reversing a jury’s $250 million judgment against ev3 for breaching the agreement.

  • September 30, 2014

    Endo Settles 'Substantially All' AMS Vaginal Mesh Claims

    Endo International plc said Tuesday that it has reached settlements with several of the remaining plaintiffs suing Endo’s American Medical Systems Inc. subsidiary over allegedly harmful vaginal mesh products, resolving “substantially all” of the claims in the case without admitting any liability or fault.

  • September 30, 2014

    FDA Warns Valeant Over Wrinkle Jab Manufacturing Practice

    The U.S. Food and Drug Administration has warned Valeant Pharmaceuticals International Inc. over one of its wrinkle-treatment injection products, involving not its quality or safety but some of the practices of its contract manufacturers, the pharmaceutical firm said Tuesday. 

  • September 30, 2014

    9th Circ. Nixes Challenge To Calif. County's Drug Cleanup Law

    The Ninth Circuit on Tuesday refused to revive a suit accusing California's Alameda County of violating the U.S. Constitution's dormant Commerce Clause with a first-in-the-nation ordinance requiring prescription drug companies to dispose of unwanted prescription drugs, saying the rule doesn't discriminate against interstate commerce.

  • September 30, 2014

    Medical Device Makers See Decline In FDA Discipline

    The U.S. Food and Drug Administration on Monday reported a drop in warning letters related to quality-control violations during medical device production, a bright spot for manufacturers beset in recent years by aggressive enforcement.

  • September 30, 2014

    Novartis' FCA Suit Discovery Request Slammed By States

    California, New York, New Jersey and eight other states on Monday challenged Novartis Pharmaceutical Corp.’s bid for information on their medication adherence programs, saying the information is irrelevant to a whistleblower suit accusing Novartis of paying kickbacks to pharmacies.

  • September 30, 2014

    Brazilian Vet Products Co. Aims To Fetch $148M In IPO

    Brazilian veterinary products maker Ouro Fino Saúde Animal Participações SA set terms Tuesday for an up to 363.5 million reais ($148 million) initial public offering as the company seeks to tap into the public markets to fuel its domestic expansion, according to the company's preliminary prospectus.

  • September 30, 2014

    SEC Accuses Two Of Illegal Tips On Ackman's Herbalife Bet

    The U.S. Securities and Exchange Commission on Tuesday got tangentially involved in activist investor Bill Ackman’s public feud with Herbalife Ltd., when it accused two people of breaking insider trading rules in the run-up to Pershing Square Management LP’s $1 billion bet against the supplement maker.

  • September 30, 2014

    ACA Database Shows Pharma Paid $3.5B To Docs, Hospitals

    A long-awaited Affordable Care Act database revealing money paid to doctors by drug and device makers went live Tuesday, disclosing nearly $3.5 billion spent and potentially reshaping marketing and research efforts by spotlighting questionable financial relationships.

  • September 30, 2014

    $1.8B Alios Sale Marks Latham's 2nd Major Deal This Week

    Latham & Watkins LLP cemented its strong start to the week with its second billion-dollar deal in as many days, saying Tuesday that it steered viral disease specialist Alios BioPharma Inc. to its $1.75 billion sale to a Johnson & Johnson drug-development unit.

Expert Analysis

  • 11th Circ. Weighs In On Duty To Disclose Merger Talks

    William Foley

    The Eleventh Circuit found in Finnerty v. Stiefel Laboratories Inc. that a duty to disclose can, in fact, exist with respect to merger discussions. It is, however, not yet clear the extent to which Finnerty has altered the merger landscape, say attorneys with Orrick Herrington & Sutcliffe LLP.

  • And Now A Word From The Panel: ABCs Of JPML Practice

    Alan E. Rothman

    This week, as the Judicial Panel on Multidistrict Litigation embarks on a rare October hearing, we cannot resist mentioning an intriguing MDL petition that involves local rules governing attorney admission and several lawsuits naming members of the federal judiciary — including a JPML member who is also a D.C. district court judge, says Alan Rothman of Kaye Scholer LLP.

  • Drug-Device Applecart Upset Again

    Suzanne M. O'Shea

    In Prevor v. Food and Drug Administration, the D.C. District Court held against the FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act. Going on now for five years, the case raises the question — is it time for Congress to act? says Suzanne O'Shea of Faegre Baker Daniels LLP.

  • Good News For Originators Of Antibody Products

    Andrew Sharples

    In Eli Lilly and Company v. Human Genome Sciences Inc., the English Patents Court recently gave its interpretation of the EU Court of Justice’s most recent decision on supplementary protection certificates. In doing so, the court confirmed that SPCs are available based on patents with claims that define the product in functional terms only, say Andrew Sharples and Emma Muncey of EIP.

  • Are NY Practitioners, Pharmacies Ready For E-Prescribing?

    Brooke A. Lane

    New York health practitioners will be required to issue all prescriptions — including prescriptions for controlled substances — in electronic format by 2015, and it is unclear under what circumstances the New York State Department of Health will grant a waiver, say Laurie Cohen and Brooke Lane of Nixon Peabody LLP.

  • Standard Social Media Practices Are Risky For Big Pharma

    Sharon Roberg-Perez

    Despite the clear interest in social media engagement by two of its key stakeholders — patients and physicians — the pharma industry has been relatively slow on the uptake. Chief among the concerns is inadvertently violating U.S. Food and Drug Administration regulations that are in place to guard patient welfare, says Sharon Roberg-Perez of Robins Kaplan Miller & Ciresi LLP.

  • FOIA Is Not Freedom For Plaintiffs To Drug Trade Secrets

    James M. Beck

    Given the prevalence of corporate integrity agreements in the drug and medical device space, Public Citizen v. U.S. Department of Health and Human Services is a victory for industry — companies subject to such agreements will rely on this case when faced with plaintiffs seeking sensitive information with the Freedom of Information Act, says James Beck of Reed Smith LLP.

  • Opportunities And Pitfalls In The Legal Cloud

    David Houlihan

    Like "big data" and other effective software marketing buzzwords, “cloud” makes something that is very complex sound simple — and even friendly. Most attorneys are not prepared to dig into the distinctions between public, private and hybrid cloud models, or the niceties of how or where their data is transmitted and stored, says David Houlihan of Blue Hill Research Inc.

  • Invasion Of The Unannounced EU Notified Body Auditors

    Neelam Gill

    Despite lingering questions over recent changes in the European medical device regulatory framework, one thing is certain — manufacturers of Class I sterile or measuring, Class II, Class IIb or Class III CE-marked medical devices can expect to be audited by a notified body soon, say Neelam Gill and Jennifer Mountcastle of Thompson Hine LLP.

  • Purple Is The New Orange: A New Book On Biosimilars

    Christopher J. Betti

    While the U.S. Food and Drug Administration's Purple Book has been colloquially referred to as an “Orange Book equivalent,” the two contain distinct types of information — their differences reflect the unique nature of biologics and the 351(k) approval process, say attorneys at K&L Gates LLP.