Life Sciences

  • May 4, 2015

    DaVita To Pay Record $495M To Settle Kidney Drug FCA Suit

    DaVita Inc. said Monday it set aside $495 million as part of a tentative deal to resolve a False Claims Act whistleblower suit for allegedly bilking taxpayers for reimbursement of intentionally overused dialysis drugs, which a plaintiff's attorney called the largest settlement for an FCA case brought without government intervention.

  • May 4, 2015

    Kirkland Takes Mylan's Teva Conflict Suit To Federal Court

    Kirkland & Ellis LLP on Monday removed to federal court a Mylan NV unit's suit accusing the law firm of a conflict of interest for representing Teva Pharmaceutical Industries Ltd. in its $40 billion hostile takeover attempt, which Mylan rejected last week.

  • May 4, 2015

    Heart Risk Claims Still Dog Pfizer Testosterone Drug

    Pfizer Inc. hid the risk of heart problems that come with Depo-Testosterone when it marketed the drug, a man told a New York court Friday in the latest suit over testosterone boosters that are also at the center of an ongoing multidistrict litigation.

  • May 4, 2015

    Bayer Wants Out Of One-A-Day Labeling Class Action

    Bayer AG told a California federal court Monday that it should toss a proposed class action against it over the labeling on its One-A-Day vitamins, arguing that the plaintiffs had not shown that it had made any impermissible "disease-prevention" claims on the products. 

  • May 4, 2015

    Lincare Says 'Arcane' FCA Suit Based on Unknowable Regs

    Medical supplier Lincare Inc. called on a Florida federal court to toss a False Claims Act suit alleging improper Medicare telemarketing calls and fraudulent billing, arguing Friday the whistleblower claims have no basis in enforceable regulation.

  • May 4, 2015

    Justices Won't Review Invalidation Of Bristol-Myers Patent

    The U.S. Supreme Court on Monday declined to hear Bristol-Myers Squibb Co.'s challenge to a Federal Circuit ruling that upheld the invalidation of the patent on its hepatitis B drug Baraclude.

  • May 4, 2015

    FDA Tries To Clear Path To Pediatric Device Approvals

    The U.S. Food and Drug Administration on Monday outlined criteria for relying on studies of medical devices in adults to support approval of their use in children, a bid to enhance understanding of when products are safe and effective for pediatric uses.

  • May 4, 2015

    1 Law Firm Dominates April IPO Activity

    A single law firm dominated April's IPO activity, popping up as underwriters' counsel on six of the month's 16 public debuts, which drew $2.34 billion, and offering a taste of its expertise in not only financial sponsor-backed deals but also the energy, real estate, retail and life sciences industries.

  • May 4, 2015

    AstraZeneca Urges Fed. Circ. To Find Asthma Inhaler IP Valid

    Pharmaceutical giant AstraZeneca PLC urged a Federal Circuit panel Monday to revive its pediatric asthma medication patent, saying the lower court disregarded evidence when it declared the patent's claims obvious in an infringement fight with Sandoz Inc., Apotex Inc. and other competitors.

  • May 4, 2015

    FTC Gets Restraining Order Against ‘Bogus’ Diet Pills Co.

    A California federal judge granted the Federal Trade Commission on Monday a temporary restraining order against a company it claims uses illegal spam emails and false news stories and celebrity testimonials to sell weight-loss pills.

  • May 4, 2015

    J&J, Ethicon Lose Bid To Toss $5.7M Pelvic Mesh Verdict

    Johnson & Johnson’s Ethicon Inc. unit won’t get a shot at a new trial after a $5.7 million jury verdict in favor of a California woman who claimed that she was injured by the company's pelvic mesh product.

  • May 4, 2015

    Teva's FDA Testing Violates Lovenox Patent, Fed. Circ. Told

    Momenta Pharmaceuticals Inc. urged the Federal Circuit to revive patent suits against Teva Pharmaceutical Industries Ltd. and Amphastar Pharmaceuticals Inc., saying Monday that the generics makers use U.S. Food and Drug Administration-required testing as a pretext for infringing Momenta's testing patent for the blood thinner Lovenox.

  • May 4, 2015

    Lupin Smacked With IP Suit Over Generic Paxil

    Apotex Inc. has gone to court to prevent Lupin Ltd. from selling a generic version of the popular antidepressant drug Paxil, telling a Texas federal court judge that allowing Lupin to move forward would infringe a patent owned by Apotex.

  • May 4, 2015

    IRS Balks At Natrol Liquidation Plan Over 11th-Hour Deal

    The Internal Revenue Service on Friday cried foul over changes to Natrol Inc.’s liquidation plan to divvy up the spoils from its $132.5 million sale to India’s Aurobindo Pharma Ltd., saying the last-minute inclusion of a settlement with the supplement maker’s former owner could shortchange the agency's tax claims.

  • May 4, 2015

    Patterson Cos. To Pay $1B For Animal Health International

    Patterson Cos. Inc. has agreed to acquire animal medicine distributor Animal Health International Inc. for about $1.1 billion, the companies said on Monday, as part of Patterson's plan to sharpen its focus on its dental and veterinary businesses.

  • May 1, 2015

    Mylan Sues Kirkland & Ellis Over Teva Takeover Bid

    A unit of Mylan NV lobbed a suit in Pennsylvania court against Kirkland & Ellis LLP on Friday accusing the law firm of a conflict of interest for representing Teva Pharmaceutical Industries Ltd. in its $40 billion hostile takeover attempt, which Mylan rejected earlier this week.

  • May 1, 2015

    Accredo To Pay $60M In Novartis Axjade Kickback Suit

    Specialty pharmacy Accredo Health Group Inc. will pay $14.9 million to resolve state regulators' claims it participated in a patient referral kickback scheme with Novartis Pharmaceutical Corp., U.S. Attorney Preet Bharara said Friday, on top of a $45 million settlement with federal authorities revealed Thursday.

  • May 1, 2015

    Ala. Undoes Brand Drug Liability For Generic Injury

    Alabama Gov. Robert Bentley on Friday signed into law a bill that inoculates brand pharmaceutical companies from tort claims over generic versions of their drugs, overturning a state Supreme Court ruling that had made Alabama one of the few states to have such liability.

  • May 1, 2015

    IPO Activity Set To Spring Back As 14 Cos. Target $2B

    A wave of 14 companies targeting $2 billion are expected to splash onto the market during the first full week of May, putting investor appetite for life sciences to the test with a surge of 10 offerings while a master limited partnership, a real estate investment trust, a loan provider and a restaurant chain also prepare to take the plunge.

  • May 1, 2015

    Sens. Ask FTC To Probe Supplements With Untested Ingredient

    Two U.S. senators are urging the Federal Trade Commission to investigate dietary supplements that contain an untested, amphetamine-like ingredient, according to Friday reports, adding to investigations already underway by the U.S. Food and Drug Administration. 

Expert Analysis

  • The Language Of The DQSA Contradicts Congressional Intent

    Benjamin L. England

    Congress’ intent in crafting the Drug Quality and Security Act was to address prescription drug shortages by allowing mass-compounding of shortage drugs. However, the statutory language of the DQSA directly contradicts congressional intent, say Benjamin England and Sung Won Park of England & Associates LLP.

  • FTC Is No Longer DOJ’s Little Brother In Antitrust Remedies

    Donald E. Lake III

    A Pennsylvania federal court's recent decision in Federal Trade Commission v. Cephalon Inc. and the Cardinal Health Inc. settlement indicate that the FTC now views its role as not only to prevent repeat antitrust violations through injunctive relief, but to more aggressively complement the U.S. Department of Justice and private plaintiffs for recovery of what it deems ill-gotten gains of anti-competitive behavior, say Donald Lake a... (continued)

  • The Satisfaction Of A Refund, Or Your Class Action Back

    James P. Muehlberger

    Whether a company’s refund policy is widely used or largely ignored by consumers, or only affects named plaintiffs, it can be a valuable tool for combating class actions. Defendants have successfully used refunds to argue that named plaintiffs lack standing, are not adequately protecting class interests, and that class actions are not the superior method for resolving disputes, say attorneys with Shook Hardy & Bacon LLP.

  • AstraZeneca And Damages In 'At-Risk' Generic Drug Launches

    Ryan Sullivan

    The Federal Circuit’s recent opinion in AstraZeneca AB v. Apotex Corp. confirms that sound economic principles and case-specific facts are the foundation for a reliable analysis of damages in the context of at-risk generic drug launches, say Ryan Sullivan and DeForest McDuff of Intensity Corporation.

  • TPP And The Next Frontier In International Arbitration

    Jeffrey Bleich

    If the Trans Pacific Partnership passes it will open up a new frontier in international trade and arbitration and offer an extraordinary opportunity for the legal community to help clarify, shape and enhance global trade law on digital technology, biotech, cleantech and other emerging markets through possible new dispute resolution provisions, say Jeffrey Bleich and Grace DiLaura of Munger Tolles & Olson LLP.

  • CGL Policies In 4th Circ. May Cover Intentional Conduct

    Jennifer E. White

    The Fourth Circuit's ruling in Liberty Mutual Fire Insurance Co. v. JM Smith Corp. illustrates that, even when faced with allegations of intentional conduct, general liability insurance coverage still may be available where the true import of the allegations is failure to exercise reasonable care, say Michael Levine and Jennifer White of Hunton & Williams LLP.

  • The Latest In The Neverending Story Of Bard V. WL Gore

    Paul Devinsky

    The Federal Circuit has written its last chapter in Bard Peripheral Vascular Inc. and C.R. Bard Inc. v. W.L. Gore & Associates Inc., but this case may yet alter the standard of appellate review on the issue of willfulness, says Paul Devinsky of McDermott Will & Emery LLP.

  • Bankruptcy Courts Remain Closed For Marijuana Businesses

    John M. Spires

    The matter of Medpoint Management LLC highlights the risks and difficulties faced not only by marijuana businesses, but by their creditors too. Despite Medpoint’s income not directly arising from marijuana and the Cromnibus Act limiting prosecution of marijuana-related offenses, the court still dismissed Medpoint’s case, says John Spires of Dinsmore & Shohl LLP.

  • An Update On Hatch-Waxman Personal Jurisdiction Cases

    Tedd Van Buskirk

    The first wave of post‐Daimler decisions suggests district courts will rely on new theories of general and specific jurisdiction to exercise personal jurisdiction in Hatch‐Waxman cases, say Tedd Van Buskirk and Mark Deming of Polsinelli PC.

  • Why REMS Abuse Doesn't Belong In Antitrust Litigation

    Anna Fabish

    When asked to identify the next generation of antitrust claims in the pharmaceutical industry, many would respond with an acronym: REMS. But these “risk evaluation and mitigation strategy” programs are a creature of the U.S. Food and Drug Administration, and thus the FDA — not the courts or the antitrust laws — is the more appropriate vehicle for addressing alleged REMS abuse, says Anna Fabish of O'Melveny & Myers LLP.