The Firm’s experience in products liability defense matters is diverse, ranging from representing manufacturers of heavy equipment, medical devices, and propane tanks to hair care products, pharmaceuticals, and the aviation industry.  While the Firm typically represents the manufacturer of the allegedly defective product, we have also represented the distributors and retailers utilized by these manufactures in bringing its products to market.  At the heart of the Firm’s product liability practice, however, is our experience in representing the manufactures and distributors of prescription and over-the-counter drugs and medical devices. 

In addition to having a comprehensive knowledge of the defenses available in this area, the Firm’s success in the drug and medical device litigation arena is directly attributable to our thorough understanding of the regulatory framework that may govern the product at issue.  The Firm is entirely familiar with the specific, and sometimes unique, defenses that apply to cases involving drugs and medical devices.  Some of the more common defenses that are typically involved include federal preemption, the learned intermediary defense, comment k to section 402A of the Second Restatement of Torts, the “state of the art” defense, the “off-label use” defense, and the “bulk supplier” defense. 

Our regulatory experience also provides the Firm with even greater depth and a more substantial understanding of the drug and medical device industry.  For example, one of the Firm’s partners, Tal Finney, had previously served as Director of Policy for over five years to the Governor of California, and in this capacity was responsible for directly advising the Governor on all matters involving the life sciences and healthcare industry.  Mr. Finney was also responsible for creating the Life Sciences Council, the advisory committee for the entire life science industry in California.  The members of the Council were comprised of various leaders from the life sciences community.  Acting as the liaison between the Council and the State, Mr. Finney found himself in the unique position of having to address a number of regulatory compliance and enforcement-related issues.  Before leaving State government, Mr. Finney was significantly involved in assisting the life science industry, and in particular bioscience, pharmaceutical and medical device companies, in implementing policies that attempted to reduce the regulatory hurdles associated with bringing their products to market.  This unique perspective on the various regulations facing the drug and medical device industry is a valuable asset when representing the manufacturer of a drug or medical device in litigation.

Further complementing this Firm’s drug and medical device litigation practice is its knowledge and experience with numerous state and federal regulatory issues facing the healthcare industry.  Several of the Firm’s partners have intimate knowledge of and have worked in the healthcare industry.  Accordingly, the Firm is well-versed with the various state and federal regulations associated with prescription medical labeling requirements, elder care, employment and labor issues, earthquake retrofit requirements, the Health Insurance Portability and Accountability Act (HIPAA), and Medi-care/Medi-Cal provider billings and reimbursements.  As a result of this regulatory expertise, a New York-based hedge fund retained the Firm to assess all of the regulatory issues associated with its prospective purchase of a portfolio of sixteen California hospitals.

In addition, several residential care-home facilities retained the Firm to assess the impact of various state and federal regulations on how drugs are administered to patients at such facilities, the adequacy of the warning labels provided with these drugs, and the responsibilities of both the doctors prescribing these drugs and the care-home facilities administering these drugs.  Although these cases do not necessarily involve defective products, they further demonstrate the Firm’s familiarity and understanding of the complex, and often interrelated, state and federal regulatory framework governing such matters.

At any given time, the Firm is currently handling several matters that involve either drugs, medical devices, or related products.  For example:

·        The Firm represents a manufacturer of radiation detection devices.  Our client sold these devices to a well known defense contractor, one of which was allegedly used by a former employee, turned plaintiff.  At issue is whether our client’s product was defective in its design in that it failed to provide the plaintiff with an accurate read of his exposure to radiation.  This matter is currently pending.

·        The Firm represents several of the largest manufacturers of shampoo and other hair care-related products.  At issue is whether our clients’ products caused or contributed to plaintiff’s leukemia.  The matter is currently pending.

·        The Firm represents a manufacturer of various portable medical devices.  Our client sold these devices through distributors and retailers nationwide.  One of these medical devices was being used by plaintiff when it allegedly failed causing significant physical injuries.  This matter is currently pending.

·        The Firm recently represented various manufacturers and distributors of various over-the-counter medicines and prescription pharmaceuticals.  Plaintiffs sued several defendants, including our clients, claiming that they sold mercury-containing products in violation of Proposition 65 and Business & Professions Code section 17200.  One of the many issues addressed by the court was whether the FDA’s warning label requirements for prescription drugs preempted Proposition 65 warning label requirements.  As to the distributor, we successfully obtained a dismissal with prejudice via summary judgment.  As to the manufacturer, we received a voluntary dismissal.

·        The Firm recently represented a manufacturer of various nutritional supplements.  At issue was whether our client included the appropriate FDA warnings on the nutritional supplements.  The matter was nationally publicized on CNN and ABC, and was featured in an editorial published by O, the Oprah Magazine.  The matter ultimately resulted in a defense verdict.