Medical Device Link.

Originally Published MX January/February 2005

GOVERNMENTAL & LEGAL AFFAIRS

Medtech executives have a lot to consider when searching for liability defense counsel.

Jon LeSage

When it comes to dealing with product liability matters, there's just no replacement for the specialized expertise offered by firms with a full understanding of issues related to medical product design and manufacture. Leading candidates offering specialized services to medical device companies include a number of well-known law firms with offices throughout the country. Nevertheless, when seeking expert legal counsel, it's important for company leaders to weigh and balance the various strengths and specialties that such firms can bring to the table.

Medical device product liability cases can be highly complex, involving a multitude of jurisdictions, state and federal laws, and interpretation of regulatory requirements. McCarter & English (Newark, NJ) offers clients this type of perspective and experience.

Tony Brazil

"We have developed and implemented strategies to respond to the range of issues confronted by pharmaceutical and medical device companies, including class-action certification, multidistrict litigation, defense of medical monitoring claims, federal preemption, product identification and market-share liability, punitive damages, epidemiological analysis of causation, proceedings to exclude dubious expert testimony, and other issues," says McCarter & English's David Cooner. The firm also provides strategic guidance to prevent cases from ever reaching the litigation stage, including advice with respect to informed-consent documents and procedures, and risk management and avoidance.

Companies thriving in the medical device design and manufacturing sector are among the most technologically advanced in the world, and should expect their legal representatives to be leading-edge in their thinking and implementation as well. Benesch, Friedlander, Coplan & Aronoff LLP (Cleveland and Columbus, OH) is a full-service firm that finds the heady environment of the profession stimulating and challenging.

"We are headquartered in a region brimming with rapidly growing biotechnology, biomedical, and medical device firms," says Eric Zalud, chairman of the litigation department at Benesch. "Our life sciences industry, academic and research institutions, and investing clients are researching, developing, investing in, or marketing diagnostic and therapeutic devices and products, drug-discovery platforms, and delivery systems. It is exciting to be assisting them in both the framework for development of these revolutionary technologies, and also the minimization of liability relating to those technologies."

Vivian Quinn

It's also reasonable to expect a product liability firm to provide medtech companies with access to experts who have published articles, given lectures, and established a solid reputation for being thought leaders in the field. The medical device team at Morris Polich & Purdy LLP (Los Angeles) includes more than 20 attorneys, paralegals, and support staff. The firm's clients range from medtech start-ups to a who's who of major device firms.

"At the outset of an assignment we discuss with a client its business, the claim, and the goals and objectives to be achieved," says Tony Brazil, a partner at Morris Polich & Purdy. "We then work closely with the client to develop a cost-effective litigation plan that satisfies the client goals and objectives." Team members of the firm are frequent authors and lecturers on such topics as off-label use, preemption, and other vital issues. A full list of the firm's publications and lectures—several available for downloading—and further information regarding the firm's expertise can be found on its Web site at www.mpplaw.com.

Some device companies appreciate the high-touch treatment they can receive when dealing with principals at a smaller, boutique law firm. However, there are times when size does matter—not only in terms of numbers of legal professionals available to assist a company, but also in terms of a law firm's depth of legal disciplines and subject areas.

Nixon Peabody LLP (Boston) is one of the largest multipractice law firms in the United States, with offices in 14 cities and more than 650 attorneys. In addition to providing product liability counsel, the firm offers comprehensive corporate legal services, including counsel for mergers and acquisitions, corporate finance, regulatory affairs, white-collar defense, and intellectual property issues. "Our medical devices team has developed a reputation in the preparation of scientific and medical experts for testimony at trial and for cross-examining and excluding opposing experts," says Vivian Quinn, a partner in Nixon Peabody's pharmaceutical, medical device, and life sciences team. "We played a critical role in the development of preemption of state tort claims based upon federal regulation."

Over the past 30 years, the medical device and diagnostic industry has been a leader in expanding patent and intellectual property law. Manufacturers that fail to adequately protect their proprietary content don't usually survive for very long. Stites & Harbison PLLC (Louisville, KY), has developed its own internal resources for this area of its practice. The firm's intellectual property group is an additional source of technical knowledge and advice for the medical device team. From an office in Alexandria, VA, near the U.S. Patent and Trademark Office, the firm's IP group provides patent-protection counsel to several major device manufacturers.

John L. Tate

Speaking to a national conference of drug and medical device defense lawyers, John L. Tate, senior member of Stites & Harbison's medical device practice, proposed that taking "appropriate steps to prevent the next lawsuit—or another one like the last—should be as commonplace as drafting a release and settlement." He added: "Our clients not only want to win in the courtroom, they also want to steer clear of design, labeling, marketing, and document misjudgments that exacerbate litigation risks."

Litigation surrounding medtech products frequently involves complex issues of medical science and cutting-edge technology. Getting judges and juries to grasp the complex scientific and technical characteristics of medtech products and their functions, so that they can render competent and fair decisions, can be a particular challenge. Ulmer & Berne LLP (Cincinnati), has a life sciences team comprising more than 85 legal professionals and support staff. The team routinely serves as national counsel in scientifically complex litigation. The firm strives to develop a team with both legal and scientific expertise. Joe Thomas, the group leader, holds undergraduate and doctoral degrees in pharmacy, has conducted clinical research, and has published scientific literature.

Of course, the issues described in this article aren't the only ones that medtech executives should take into account when choosing competent legal counsel for product liability defense work. Every medtech company has different priorities and may differently value the geographic proximity of the law firm, reputable clients the firm has represented, major cases it has won, cost-effectiveness, and other factors.

Jon LeSage is a freelance writer based in Southern California.

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