Practice Leader: Nina M. Gussack
Pepper Hamilton LLP works with large and small medical device manufacturers to meet complex regulatory requirements, to manage the risks associated with the marketing and distribution of devices, and to defend against individual, class action and “mass tort” claims.
Whether in the R&D lab, the office of vice president for regulatory affairs, or in the courtroom in front of judge and jury, our lawyers have the background and experience to provide knowledgeable and skilled counsel and advice to medical device manufacturers. The nature of our practice and the scope of our engagements have covered a wide variety of medical products, from atherectomy devices to surgical sutures.
Representative engagements include the following:
- served as national counsel for the largest manufacturer of implanted spinal devices in the In re Orthopedic Bone Screw Products Liability Litigation, one of the few mass tort cases in which the defense could claim victory. On behalf of our client, we obtained summary judgments in more than 170 cases, and we obtained Daubert rulings excluding almost all of plaintiffs’ many experts. (A list of these cases is available). We continue to represent this manufacturer in product liability matters involving other spinal instruments.
- served as national counsel on preemption issues for manufacturer of pacemakers and pacemaker leads
- served as regional counsel for defendant in the TMJ Litigation, involving a jaw implant
- represented Medtronic Sofamor Danek, Inc. as amicus curiae in U.S. Supreme Court case establishing that common-law claims of fraud on the FDA are impliedly preempted by federal law: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001)
- defended manufacturers of hollow bore medical needles in individual and class action litigation involving needlesticks and possible HIV and hepatitis infection
- defended a catheter manufacturer in design defect suit arising out of contraction of HIV by health care worker
- successfully litigated in the First Circuit the right of a medical instrument manufacturer to use without consent the name of the developer of an instrument whose name had become descriptive of the product
- defended medical device manufacturers against product liability claims involving atherectomy devices, cranial drills, a fetal monitoring device, grafting material, guidewires, hip and knee prostheses, insulin infusion pumps, intermedullary rods, intraocular lenses, an intrapritanal drain, mitral heart valves, pacemakers, plaster of Paris, stents and surgical sutures
- represented manufacturer of intraocular lenses in successful claim against supplier of polymer after lenses had high rate of opacification and had to be recalled
- monitored litigation and provided risk counseling to bulk supplier of latex gloves.
The rapidly changing legal landscape facing the medical device industry demands creative individuals who are nonetheless able and expected to work in a team environment. The lawyers doing medical device work are part of our Health Effects Litigation Practice Group
, which handles cases involving pharmaceuticals and other products. Where appropriate, lawyers in this Group draw on the experience of lawyers in the corporate
, health care
, intellectual property
practice groups to assist in the analysis and resolution of our clients’ concerns. What We Do
We help clients focus on avoiding litigation and adverse regulatory actions. When litigation ensues or adverse government regulatory action looms, however, we aggressively assert and defend our clients’ interests in every appropriate forum. Preventive Counseling
— Legal review and input early in the product development process can help avert or minimize the consequences of adverse legal action in the future. To that end, we help clients:
- conduct company-wide document review and analysis of data and internal documents
- counsel quality assurance and quality control representatives on how to meet regulatory obligations
- evaluate regulatory submissions including the review of proposed product labels and label changes
- provide pre-publication review of abstracts and manuscripts
- identify key experts and opinion leaders in various fields as litigation consultants
- review marketing materials for liability and regulatory concerns
- analyze third-party arrangements to ensure fraud and abuse compliance
- apply and implement HIPAA privacy regulations.
— Individual claims, class actions and mass torts are part of the risk profile that every medical device manufacturer faces. Heightened government regulation also has led to increasing allegations of health care fraud. As national coordinating counsel, regional trial counsel or special counsel for particular cases, Pepper litigators have defended medical device manufacturers in state and federal courts around the country. Through an extensive network of other lawyers with whom we have worked on past cases, and use of the latest technology, we are able to manage major litigation with multiple claims in any jurisdiction. We recognize that a single case or two may be the harbinger of future action and that early and successful resolution of individual cases may help stem a flood of later litigation. We also recognize that effective litigation representation requires multiple skills. Our team approach means that we are ready to try cases in the courtroom, counsel senior management in the boardroom and negotiate with adversaries in an effort to minimize risk, where appropriate. Professional Associations, Speaking and Writing
— Nina Gussack
, chair of the Pepper Hamilton Health Effects Litigation Practice Group
, is chair of the DRI’s Drug and Medical Device Committee. Our lawyers are often asked to speak at seminars on medical device and related topics. A partner is co-author of the Drug and Medical Device Litigation Handbook
published by American Lawyer Media/Law Journal Press.