Capabilities
Life Sciences Industry

Product Liability

Arnold & Porter's Product Liability group is a life sciences litigation powerhouse. We have handled nearly every kind of products litigation in the life sciences space, from mass torts to individual lawsuits. We excel at helping life sciences clients take proactive measures to minimize the risks of product liability litigation and, if necessary, to succeed in the courtroom.

We have served as national counsel in some of the largest pharmaceutical products litigations of the past ten years, including litigations involving Xarelto®, Floroquinolones, Plavix®, Abilify®, Testosterone Replacement Therapy, Zoloft®, Reglan®, Hormone Replacement Therapy, Seroquel®, Viagra, Rezulin®, and PPA. In these matters, we have developed cutting-edge legal strategies, tried individual lawsuits, argued appeals, and brokered creative settlement agreements. We have also led many complex fact and expert development projects to learn the "company story" and communicate that narrative as part of the company defense.

National Coordinating Counsel

High-stakes litigation calls for in-depth analysis and seamless coordination of cases filed across the country and, increasingly, around the world. We frequently serve as national coordinating counsel, providing a coherent strategy and direction in multi-jurisdictional litigation. Our creativity and superior background in the factual work-up of the plaintiff's case, developing the company's defense strategy, the defense of company witnesses, expert development, expert cross examinations, and written advocacy place us at the top when it comes to winning Daubert/Frye and summary judgment motions.

Trials and Trial Strategy

The successful defense of product liability litigation requires counsel who are ready, willing, and able to try cases. We are nationally recognized for our depth of trial talent, with a proven track record of trial success in product liability litigation.

The firm, as both trial counsel and as national counsel supervising other trial lawyers, has achieved an outstanding track record in pharmaceutical/medical device product liability trials.

Reducing Exposure at the Pre-Trial Stage

According to The American Lawyer: "Narrowing down issues [before trial] has been an essential element of Arnold & Porter Kaye Scholer's success." The firm's work in the ProteGen® Sling litigation for Boston Scientific was cited: "Arnold & Porter Kaye Scholer did it all. [Plaintiffs'] strategy was to confuse and overwhelm. They couldn't do that because of how good [Arnold & Porter Kaye Scholer] was in discovery." The American Lawyer also cited the firm's experience in the Rezulin® litigation, where its lawyers won pretrial rulings that "significantly reduced the plaintiffs' arsenal."

Creative End-Game Solutions

We have been at the forefront of creative solutions to wrap up product liability and mass tort litigations, including a worldwide class action settlement involving more than 50,000 claimants, and in another case, the simultaneous settlement of 35,000 claimants represented by 23 plaintiffs' firms. We also have designed innovative business solutions to third-party payor litigation.

Teamwork and Collaboration

Because high-stakes litigation calls for the seamless coordination of cases filed across the country and around the world, the firm strongly believes in "partnering" with both the client and other law firms. We take full advantage of the talents of other lawyers and work hard to ensure that co-counsel and local counsel are fully engaged as cooperative participants in all matters.

Product Liability Counseling/Risk Mitigation

In the medical device industry there are two certainties: all devices have potential complications,and some patients will pursue litigation. Acknowledging in advance the likelihood of litigation can help a company take proactive measures to minimize the risks. Our attorneys are experienced in product liability counseling regarding measures which can be taken in a company's most vulnerable areas: promotion and marketing, labeling, and adverse event reporting. We also conduct product liability risk assessments for proposed acquisitions or product extensions.

Cost Containment

Arnold & Porter is adept at cost containment, using various creative methods such as flat fees, blended rates, outsourcing, pre-approved budgets with monthly tracking and analysis, task-based billing entries, and attention to client "cost-benefit" when settlement opportunities arise. For large litigations, we offer national, regional, and/or trial budget modeling, and vendor cost containment.

The firm has been a leader in pharmaceutical and medical device product liability cases for nearly three decades.

Representative matters include:

  • 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.
  • 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.
  • 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.
  • Co-national counsel to Pfizer Inc./Shiley Incorporated in the Bjork-Shiley Convexo-Concave (BSCC) mechanical heart valve litigation, including negotiation and implementation of a class action settlement.
  • National counsel for Hoffmann-La Roche in the Versed litigation.
  • National counsel for Pfizer Inc. in the Feldene litigation.

Experience

Auxilium Pharmaceuticals Holtsclaw v. Auxilium
Obtained jury verdict in bellwether trial case for multidistrict litigation involving testosterone replacement therapy.
Bayer Steen v. Bayer, et al.
Successfully obtained summary judgment, which was affirmed on appeal.
Pfizer Product liability MDL
Successfully excluded a series of key expert witnesses to secure a summary judgment order in US district court, effectively ending the pharmaceutical company’s Zoloft birth defects multidistrict litigation.
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.
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Perspectives

CPSC Notification Requirements, Recalls and Recent Enforcement Actions: Desk Reference for Section 15 of the Consumer Product Safety Act
Desk Reference
England & Wales High Court Judgment in metal-on-metal hip group litigation
BioSlice Blog
West Virginia High Court Reaffirms Traditional Limits on Innovator Liability for Brand Manufacturers
Advisory
How CPSC Late Reporting Penalty Trends Are Evolving
Appellate Law360, Consumer Protection Law360, Illinois Law360, Product Liability Law360, Retail & E-Commerce Law360, Texas Law360, Trials Law360
Recent Developments in European Product Liability
International Comparative Legal Guides
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Recognition

Chambers UK
Life Sciences: Product Liability (UK-wide) (2013-2018)
LMG Life Sciences Guide
Non-IP Litigation: Product Liability (2012-2017)
The Legal 500 US
Product Liability and Mass Tort Defense: Pharmaceuticals (2007-2009, 2014-2015)
Overview

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