Capabilities
Product Liability Litigation

Pharmaceuticals

Arnold & Porter is a leader in defending companies in product liability litigation involving pharmaceutical products and medical devices. The firm regularly serves as national counsel, managing the defense of large-scale, high-stakes drug and device product liability litigation. We have successfully handled cases in many of the toughest jurisdictions in the country and against some of the most prominent plaintiffs' attorneys.

Experience. Our substantial experience in pharmaceutical drug and device litigation includes class actions, MDL proceedings, and state coordinated proceedings. Our lawyers have years of experience in the major issues companies face in pharmaceutical product liability litigation, including electronic discovery, making the most of the learned intermediary defense, defending against consumer fraud claims, federal preemption defenses, and innovative settlement strategies.

Strategic thinking. We recognize that there is no recipe for handling pharmaceutical mass tort litigation, and we approach each case from a fresh and creative perspective. We apply an innovative mindset at every juncture, including strategies for early case disposition, minimizing burden in discovery, and using the available legal tools to maximize chances of success at trial.

Trial focus. We have deep trial experience, with a proven record of successfully defending our clients at trial in pharmaceutical product liability cases. We plan our trial objectives early and approach every phase of a case with those objectives in mind.

Multidisciplinary approach. We litigate from a broad base of knowledge about the regulatory and business issues facing pharmaceutical and medical device companies. Our litigators work closely with and are able to draw from our firm's wide-ranging FDA and healthcare practice.

Business savvy. Our lawyers have a solid understanding of the technical, regulatory, and business issues that affect our pharmaceutical and device clients. Based on this foundation, we partner with our clients to develop litigation strategies that best serve their business priorities and minimize costs.

Representative Pharmaceutical/Medical Device Product Liability Matters

Our firm has been a leader in pharmaceutical and medical device product liability cases for nearly three decades. Representative matters include:

  • National counsel to Bayer Corporation and Bayer Healthcare Pharmaceuticals Inc. in MDL and state court litigations against product liability claims involving their prescription medicine, Xarelto, a new oral anticoagulant to treat and prevent stroke, blood clots, pulmonary embolism, and DVT in several different patient populations.
  • National counsel to Bayer in litigation involving Cipro and Avelox, two flourquinolone antibiotics used to treat a variety of serious bacterial infections.
  • National counsel to Endo Pharmaceuticals Inc. in product liability litigation, including an MDL involving TRT (Testosterone Replacement Therapy) products defending against claims of heart attack, stroke, and related cardiac issues.
  • National counsel to Bristol-Myers Squibb and Sanofi-Aventis US in litigation related to Plavix.
  • National counsel to Bristol-Myers Squibb in litigation related to Abilify, including consumer fraud claims.
  • National counsel to Sanofi-Aventis US in Thalidomide litigation.
  • National counsel to Hologic on medical device product liability matters.
  • Co-lead national coordinating counsel for AstraZeneca in thousands of product liability lawsuits alleging that its atypical antipsychotic drug, Seroquel, causes diabetes and related injuries. Also regional counsel defending AstraZeneca against product liability cases alleging that its anesthetic, administered via a shoulder pain pump, caused chondrolysis.
  • Counsel to Wyeth in the diet drug litigation. More than 80 state and federal jury and bench trials, many first-chaired, throughout the United States. Many resulted either in defense verdicts or nominal recoveries for plaintiffs.
  • Co-lead trial counsel for Pfizer units Wyeth, Inc. and Wyeth Pharmaceuticals Inc. in US District Court (Connecticut), obtaining a defense verdict on all counts related to a wrongful death suit involving Wyeth's hormone therapy (HT) medications Premarin and Prempro. After a three-week trial, the jury dismissed all four of the alleged claims.
  • Member of Pfizer's national counsel team in defense of its prescription anti-depressive medicine, Zoloft, against claims that it causes birth defects
  • National counsel for Pfizer Inc. in the Feldene litigation.
  • National counsel to Pfizer in the Reglan litigation. More than 7,000 claims have now been brought against Pfizer's Wyeth subsidiary and other defendants, alleging that the drug caused movement disorders.
  • National counsel to Novartis in respect of the Tekturna/Valturna product liability litigation, in which there are claims that these Novartis blood pressure medications cause kidney damage.
  • National counsel for Hoffmann-La Roche in the Versed litigation.
  • Counsel for Scientific Protein Laboratories and American Capital in Heparin litigation, including international fact investigation.
  • National counsel to American Red Cross in the HIV litigation. Defended hundreds of cases nationwide, including trying five cases to defense verdicts.

Experience

Auxilium Pharmaceuticals Holtsclaw v. Auxilium

Obtained jury verdict in bellwether trial case for multidistrict litigation involving testosterone replacement therapy.

Bristol-Myers Squibb and Sanofi-Aventis In Re: Plavix Marketing, Sales Practices and Products Liability Litigation
Bristol-Myers Squibb and Sanofi-Aventis in obtaining final summary judgment victory that ended 12 years of Plavix product liability litigation without a single trial.
Vintage Pharmaceuticals LLC Product liability: Houston v. USA
Achieved a significant win for the client when the 7th Circuit Court of Appeals affirmed dismissal of a generic prescription product liability case, alleging a variety of state-law claims, including failure to warn, defective design, negligence, consumer fraud, breach of warranty and battery, on preemption grounds under the Supreme Court’s decisions in PLIVA, Inc. v. Mensing and Mutual Pharm. Co., Inc. v. Bartlett.
Auxilium Pharmaceuticals Product liability litigation
Achieved a significant win for this affiliate of Endo Pharmaceuticals by successfully securing a preemption victory on a motion to dismiss for ANDA-approved product in testosterone replacement therapy litigation.
Vintage Pharmaceuticals d/b/a Qualitest Pharmaceuticals Product liability
Successfully secured a decision from the US District Court for the Northern District of Georgia denying class certification in a case related to the recall of certain birth control pills by our client.
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Perspectives

INSIGHT: The Prospects for Pharmaceutical Preemption in the Supreme Court (pdf)
Bloomberg Law
West Virginia High Court Reaffirms Traditional Limits on Innovator Liability for Brand Manufacturers
Advisory
The Tricky Business of Balancing Public Health Interests with Timely Authorization of Generics
Pink Sheet
Brands, Generics, and Biosimilars—Who's Liable for What and Where?
International Association of Defense Counsel Annual Conference, Quebec City, Canada
Boston to Moderate Daubert Dos and Don’ts Panel
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Recognition

The Legal 500 US
Product Liability, Mass Tort and Class Action: Pharmaceuticals and Medical Devices – Defense (2007-2009, 2014-2018)
LMG Life Sciences Guide
Non-IP Litigation & Enforcement: Product Liability (2012-2014)
Overview

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