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
• Contraceptive Implants
• Hernia Mesh
• Hip Implants
• Opioids
• 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
• The Best Lawyers in America
• Martindale-Hubbell
• Super Lawyers

Representative Engagements

Below are just a sampling of our team's recent representative matters.

• 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
• 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
• Tried multiple prescription drug and device cases to verdict and assisted in dozens of trials involving many other prescription drug and medical device cases
• Played key roles on national counsel teams in nationwide serial product liability litigation involving prescription weight loss, birth control, diabetes, lactation, Parkinson's medications, hernia repair devices, pelvic mesh devices and other medical products
• Won a defense verdict in a 2½-week trial in District of Columbia Superior Court for a pharmaceutical company that sponsored a clinical trial
• Served as part of a defense team that secured the first low plaintiff verdict in a primary pulmonary hypertension diet drug case
• Won a defense verdict and a low plaintiff verdict in first multi-plaintiff diet drug trial in the Philadelphia Court of Common Pleas