Product Liability – Life Sciences

Product liability litigation can present a wide array of challenges to life sciences companies. The Product Liability – Life Sciences Team at Holland & Knight has experience in the full range of these issues. Our team members have successfully defended life sciences companies in high-profile product liability litigation in national, regional and trial counsel roles, including matters involving the following:

• Zantac
• NuvaRing
• Contraceptive Implants
• Gynecologic Mesh
• Hernia Mesh
• Hip Implants
• Opioids
• Vioxx
• Baycol
• Phenylpropanolamine
• Diet Drugs
• Hormone Replacement Therapy
• Drug-Eluting Stents
• Morphine
• Cancer Drugs

Applying Our Knowledge and Industry Experience to Safeguard Your Business

When you work with our product liability lawyers, you are backed by the resources of one of the country's largest law firms and a team that will effectively protect your interests in this area. Holland & Knight attorneys draw from the following capabilities and experience to inform any matter:

• deep trial bench, having tried major product liability cases in jurisdictions across the nation
• the resources to handle and manage complex, consolidated and large volume mass tort litigations for pharmaceutical and medical device companies
• a track record of responding to the full scope of related issues, including the reliability of scientific/medical expert testimony under Daubert, preemption, innovator liability, statutory presumptions under state product liability statutes, and the learned intermediary doctrine
• a thorough understanding of the life sciences industry and the regulatory framework, preclinical research and clinical trials, postmarket commitments and epidemiologic research, pharmacovigilance, and supply, manufacturing and distribution agreements
• defense and coordination of derivative litigation threats affecting life sciences companies, such as commercial disputes, consumer and third-party payer class actions, and government investigations

Limiting Exposure

Life sciences companies need product liability counsel with the ability and knowledge to help prevent claims, not just respond to them. A significant part of our practice involves advising clients on the following preventative measures:

• assessing product liability risks and creating programs and procedures to address those risks
• assisting with the communication of product safety information, including labeling, warnings, product literature and training activities
• engaging in due diligence when acquiring a business whose potential product liability risks need to be evaluated and addressed
• developing and adhering to proper record creation and management procedures, including programs to meet the challenges of electronic discovery
• implementing processes to ensure proper handling of potential evidence and avoidance of spoliation claims, including those related to chain of custody issues

Regulatory and Legislative Issues

Product liability matters often have close relationships to regulatory compliance issues. Working with our government and public law teams, our product liability attorneys can provide client protection on this front as well. We have extensive experience with the range of federal agencies relevant to these issues, such as the U.S. Food & Drug Administration (FDA), U.S. Department of Justice (DOJ), State Attorneys General, and Centers for Medicare & Medicaid Services (CMS).

Early Case Assessment and Risk Management Analyses

Our attorneys believe that providing sound, early case assessments of risks, potential outcomes and strategy for mitigation and defense in a given matter is one of the most significant duties performed by legal counsel. The ultimate goal of any effective product liability strategy is the management of risk and its attendant financial consequences. Circumstances will sometimes dictate aggressive litigation and trial strategies; at other times, creative resolution efforts and active pursuit of early settlement may be advantageous. Holland & Knight's product liability attorneys understand this, and we have experience with a full range of options along this continuum. Ultimately, we recognize that the client's reputation and overall costs, including litigation costs, are the measures of success of any product liability strategy.

Crisis Management

Product liability crises can emerge almost instantly and, when fueled by media attention, rapidly expand. Responses may be required simultaneously on public relations, governmental and litigation fronts. Holland & Knight's product liability team members have successfully handled such situations and can assist with means to control and stabilize them, so that clients can execute focused and well-coordinated, strategic decision-making.

Guidance You Can Trust

Clients depend on our Product Liability – Life Sciences Team to handle their legal needs – both routine and critical – because our attorneys offer thorough industry knowledge, extensive experience and a commitment to providing exceptional service. This combination of attributes has led to repeated recognition in national and international publications, including:

• Chambers USA – America's Leading Business Lawyers
• The American Lawyer
• Who's Who Legal: Life Sciences – Product Liability and Product Liability Defense
• The Best Lawyers in America
• Martindale-Hubbell
• Super Lawyers

Representative Engagements

• Served as co-defense liaison counsel to lead all 50-plus generic and repackager pharmaceutical defendants and won motions to dismiss plaintiffs' master personal injury and class action complaints in Zantac federal multidistrict litigation (MDL) involving over 50,000 plaintiffs
• Served as national and trial counsel for Merck, Schering-Plough and Organon in defense of litigation involving prescription contraceptive product NuvaRing and allegations of thromboembolic injuries and wrongful death; litigation involved more than 4,000 claims nationwide, federal MDL in Missouri, statewide coordinations in New Jersey, California and various state court actions; won dismissal of all cases in the initial bellwether pool, leading to national settlement and resolution of litigation
• Defended pharmaceutical manufacturer in brain injury case in Bronx, N.Y., state court, involving 17-year-old plaintiff with pulmonary embolism, cardiac arrest and brain damage, allegedly from use of the client's prescription drug product; in the face of plaintiff's $27 million settlement demand, won dismissal on all causes of action
• Served as lead counsel for pharmaceutical client in litigation in multiple jurisdictions involving U.S. Food and Drug Administration (FDA)-approved hormonal implants
• Defended pharmaceutical client in U.S. District Court for the District of Massachusetts in product liability case alleging stroke and permanent neurologic deficit, involving a $21 million plaintiff settlement demand; won dismissal on all causes of action
• Served as lead counsel for biotech company concerning safety, remedial assessments, and regulatory counsel relating to product manufacturing issues involving FDA-approved cancer treatment
• Served as defense liaison counsel for Merck in California statewide litigation involving nearly 4,000 cases alleging heart attack and stroke injuries from use of prescription pain medication Vioxx
• Served as defense counsel for pharmaceutical client in putative class actions brought by third-party payers over efficacy and safety of prescription medication
• Granted summary judgment on all warnings, design defect and manufacturing claims on behalf of a medical device manufacturer in multiple cases in New Jersey; argued successfully for the affirmance of the decision before the New Jersey Appellate Division and the Supreme Court of New Jersey
• In support of successful defendants, authored amicus curiae briefs submitted to the New York State Court of Appeals concerning medical monitoring claims and the Supreme Court of New Jersey concerning the adequacy of FDA-approved drug labels
• Won dismissal of "wrongful birth" product liability action alleging defect in long-acting contraceptive implant in U.S. District Court for the District of Maine, and successfully defended judgment in the First Circuit Court of Appeals
• Served as national counsel to pharmaceutical company after it faced dozens of individual wrongful pregnancy claims and two class actions for reimbursement damages resulting from a recall of mispackaged birth control pills
• Defended a branded pharmaceutical company in a putative national class action filed in New Jersey state court, which included claims for personal injury, off-label marketing, consumer fraud and medical monitoring arising from the antiarrhythmic product amiodarone
• Counseled and defended a pharmaceutical sales and marketing company named in more than 100 mass tort actions involving the pharmaceutical product Baycol, including the development of litigation strategy, retention and management of local counsel, overseeing the review and production of more than 1 million documents and the successful negotiation of a defense/indemnity agreement with the branded drug company
• Represented Wyeth in diet drug-related litigation throughout the United States. The representation involved trials in New Jersey, Pennsylvania, New Mexico and Texas, and leading a team in the eligibility process established by the New Jersey trial court overseeing thousands of cases; the eligibility process involved trial testimony from plaintiff, defendant and independent experts, resulting in the dismissal of hundreds of cases
• Represented Wyeth in hormone replacement therapy trials in New Jersey and Pennsylvania, including conducting depositions, working with experts, authoring briefs, arguing motions and leading the motion team that obtained summary judgment under the New Jersey Products Liability Act, resulting in the dismissal of all cases consolidated in the New Jersey multicounty litigation
• Represented a medical device manufacturer in lawsuits filed in New Jersey, New York, Rhode Island and West Virginia that claimed mesh used to treat prolapse and incontinence caused personal injury; the representation involved complete case workup and expert development as well as conducting and defending depositions of hundreds of witnesses, including plaintiffs, corporate employees, plaintiff and defense experts, and treating physicians
• Defended a medical device company in lawsuits filed in New Jersey, New York, Rhode Island and California against claims that hernia mesh caused personal injury, including complete case workup and expert development, resulting in a summary judgment being obtained in New Jersey and New York for several cases; the appeal was argued before the New Jersey Appellate Division and Supreme Court, both of which upheld the dismissal
• Serving as lead counsel for a major pharmaceutical client in litigation involving an FDA-approved implant
• Served as defense counsel for pharmaceutical client in class actions brought by third-party payers over efficacy and safety of prescription medication
• Serving as national product liability counsel to New Jersey-based pharmaceutical company faced with several individual failure to warn claims