Life Sciences - Commercial and Product Liability Litigation

Overview

“Recognized for its strengths in product liability…”

Chambers USA

Given the critical work they do, life sciences companies are particularly vulnerable to the risks presented by government scrutiny and the product liability suits that arise in today’s litigious environment. Should a dispute arise as result of these volatile conditions, it is essential to bring in legal counsel with a deep understanding of the industry and the unique legal obligations of life sciences companies.

Blank Rome’s litigation team understands the complex challenges our clients face in their commitment to advancing healthcare and medical science. From developing drugs and devices to designing and delivering treatment, life sciences companies are at particular risk. When claims are brought against our clients asserting a drug or device has caused harm, we have the broad knowledge to protect and defend you.

We counter claims and resolve litigation by understanding as much as we can about the product, including development, regulatory history, and historic product performance. We then evaluate the factual and legal settings and formulate a strategy designed to resolve the dispute as quickly and efficiently as possible.

How We Can Help

We know that sometimes a pre-trial resolution of meritorious cases is in our client’s best interest. To that end, we prepare each case with an eye towards trial while identifying and seizing on opportunities to resolve a case short of that, if possible and if it best serves our client’s interests.

We also devote significant time to preventive counseling on behalf of our clients, from routine advice to custom training programs. By providing a thorough liability review and comprehensive legal input early in product development, our products liability attorneys can help avert or minimize the repercussions of adverse legal action in the future. Should a client receive a warning letter from the FDA, we mitigate adverse consequences and prepare for litigation defense before a suit is filed.

Our extensive experience in representing clients involves a broad array of medical devices, including artificial knee devices and prosthetics, and pharmaceuticals, opioids, antibiotics, and other medicines. Many of our attorneys have significant experience before federal agencies such as the National Institutes of Health (“NIH”), the Food and Drug Administration (“FDA”), the Centers for Medicare and Medicaid Services (“CMS”), the Department of Justice (“DOJ”), and the Office of the Inspector General (“OIG”).

What Sets Us Apart

  • ​​​​We advise on compliance strategies with respect to global data protection laws and the processing of human biological samples, including transparency initiatives in clinical research.
  • Our litigation team is comprised of nearly 30 former Department of Justice attorneys and five former judges and many of the team members are members of the prestigious American College of Trial Lawyers.
  • Law360 named Blank Rome a 2017 “Pennsylvania Powerhouse” and recognized “its prolific national litigation practice and deep bench strength.”
  • 2018 U.S. News & World Report-Best Lawyers (Woodward/White Inc.) national ranks: 
    • Tier 1: Commercial Litigation, Banking and Finance, Bankruptcy, Tax Law, and Labor and Employment
    • Tier 2: Intellectual Property, Patent, Real Estate, Securities, White Collar Litigation, and Environmental
  • Chambers USA editors state Blank Rome has a:
    • “Significant commercial litigation practice, offering sought-after representation across a range of cases including securities, antitrust, environmental, construction and cybersecurity disputes. Further highlighted for its federal appellate work and for its experience in class action defense.”
  • Chambers USA editors further remark:
    • “The litigation team was excellent. Each of the lawyers brought a very interesting element to the team and they blended together well. They were great and I would highly recommend them!"

Experience

Product Liability

  • Defended Actavis plc in numerous product liability cases, including:
    • Successfully defended a wrongful death case in which the plaintiffs alleged the decedent took a drug that was recalled.
    • National litigation counsel for claims related to alendronate sodium in two multidistrict litigations and two state mass tort coordinated proceedings.
    • Acted as national litigation counsel in cases filed across the United States and successfully obtained dismissal in all cases in which the plaintiffs alleged that birth defects arose out of use of paroxetine.
    • Served as regional coordinating counsel for Hormone Replacement Therapy cases which were consolidated in Pennsylvania’s First Judicial District.
    • Acted as national litigation counsel in cases filed across the country and successfully obtained dismissal in all cases in which the plaintiffs alleged that allopurinol caused Severe Cutaneous Adverse Reactions (“SCAR”) or Stevens–Johnson Syndrome (“SJS”).
  • Defended B. Braun Medical Inc. in several product liability cases, including:
    • Successfully defended a private label manufacturer as national coordinating counsel for claims that it promoted its “Pain Pump” for off-label uses.
    • Successfully defended the distribution of heparin in a case involving claims that the product did not have adequate warnings.
  • Represented Claris Lifesciences, LLC, an Indian drug manufacturer, in obtaining the successful dismissal of two cases in which the plaintiffs claimed they were injured by a drug that was recalled. We also represented the client in its voluntary product recalls in cooperation with the FDA.
  • Represented DePuy Synthes, as trial counsel for product liability cases, including:
    • Served as trial counsel for several product liability cases related to various internal fixation medical devices.
    • Successfully obtained summary judgment in a hotly-contested manufacturing defect case.
    • Served as trial counsel in a series of complex criminal, civil, and administrative proceedings involving off-label promotion of an innovative new medical device technology.
  • Represented DJO Global, as national litigation counsel for all cases related to artificial knee devices, including:
    • Successfully resolving a series of five cases consolidated for arbitration.
    • Obtained dismissal orders at the preliminary stage in cases pending in Georgia and California.
    • Currently serving as lead counsel in eight cases consolidated in federal court in Florida.
  • Represented Draeger Safety Diagnostics, in obtaining an order of dismissal in a putative class action lawsuit.
  • Represented Hanger Prosthetics and Orthopedics, a distributor of a custom-designed prosthetics and orthopedic device, in the successful defense of multiple design defect cases.
  • Represented Intuitive Surgical, a manufacturer of a robotically assisted, minimally invasive surgical system, in the successful defense of a case involving claims of design defect.
  • Represented Purdue Pharma L.P., as regional counsel for Purdue in all cases filed in Pennsylvania involving the marketing and sale of its blockbuster pain medication, OxyContin.
    • Successfully resolved all cases in state and federal court involving claims of negligence, breach of warranty, misrepresentation, and strict liability.
    • Successfully resolved one class action brought by a class of third-party payors alleging that they paid for medically unnecessary prescription drugs that were over-marketed by Purdue.
  • Represented Taro Pharmaceuticals, in the successful defense of a case involving a corticosteroid cream and claims of inadequate warnings.
  • Represented Ventracor plc, an innovative, start-up medical device manufacture, in the successful defense of a case arising out of claims that its Class III device failed and caused the death of a patient during a multi-study FDA-approved clinical trial.

Commercial and Other Litigation

  • Defended Apotex Inc., as trial counsel against claims of unfair competition, false advertising, and fraud related to Apotex’s importation of prescription drugs.
  • Defended a pharmaceutical company in five separate AAA hearings involving a contract dispute with a business partner.
  • Defended a national manufacturer of clinical pharmaceuticals in a multimillion dollar breach-of-contract action in federal court.
  • Represented officers and directors of a generic pharmaceutical company in a parallel state shareholders’ derivative lawsuit and a federal securities class action lawsuit, stemming from allegations that the issuer had issued false or misleading statements about its reserves, revenues, and income. We obtained a dismissal before the U.S. District Court, Northern District of California.
  • Represented a medical device manufacturer in an action against the director of product development who resigned and misled management regarding his future employment plans, and lured away engineers and a senior sales executive. We brought action after part of the scheme came to light, but uncovered the full extent of the scheme in discovery. The case settled in the third week of the trial for more than $13 million, including an agreement not to hire employees for a year.
  • Represented a pharmaceutical manufacturer in a SEC administrative trial to revoke the registration of its publicly traded securities.