Practice Areas & Industries: Pepper Hamilton LLP

Practice Group Overview

Pepper's Health Effects Litigation Practice Group counsels clients and handles litigation involving claimed adverse health effects from ingestion of or exposure to pharmaceuticals, medical devices, radiation, chemicals, consumer goods, environmental substances and industrial equipment.

Services Available

Pharmaceutical, Vaccine and Medical Device Litigation

Pepper's pharmaceutical, vaccine and medical device litigation practice dates back to the defense of the first thalidomide actions in the United States in the early 1960s. Since then, we have defended litigation involving a range of pharmaceuticals and vaccines, including antibiotics, Avandia, Bendectin, Diethylstilbestrol (DES), Coumadin, Prozac, Thorotrast, Thorazine, Valium, Versed, Zomax, Zyprexa, many of the oral contraceptive products and a host of other pharmaceuticals. In the vaccine field, we have defended litigation involving various vaccines, including flu, poliomyelitis and the childhood vaccines against Diphtheria, Tetanus and Pertussis (DTP). Our medical device experience includes cranial drills, cardiac pacemakers, intrauterine devices, intraocular lenses, bone screws and other surgical implants. We also defend product liability claims involving investigational and experimental drugs, including gene therapies.

Clinical Research Counseling

Pepper has counseled a large number of pharmaceutical and medical device companies, biotech firms and CROs regarding the agreements attendant with clinical research, including Master Services Agreements, Clinical Study Agreements (with academic institutions and clinical researchers), Confidential Disclosure Agreements and agreements documenting delegation of duties to CROs. Issues addressed include intellectual property, indemnification and regulatory compliance, including safe harbors under fraud and abuse laws.

Defense of Professional Malpractice Litigation

We defend claims of malpractice against hospitals, medical practitioners, psychiatric care facilities, medical laboratories and other health care providers. We handle medical malpractice claims for a major children's hospital and its physicians in such specialties as oncology, cardiology, orthopedics and emergency care. The cases often involve death and catastrophic injuries. In addition to providing a team of experienced trial lawyers in the field of health care liability claims, our group has a comprehensive and wide-ranging knowledge of the increasingly complex health care industry and its many regulators and regulations.

Health Effects of Exposure to Toxic Substances

In the toxic tort field, we represent manufacturers of many chemicals, including petroleum products, in defense of individual claims and purported class actions for bodily injury and diminution of property value due to proximity to hazardous waste sites. The firm defends miners and manufacturers of asbestos-containing products in workplace personal injury claims and in defense of class actions by owners of public buildings demanding the removal of asbestos-containing building materials.

Commercial and Consumer Product Litigation

We are experienced in defending commercial and consumer products designed and manufactured by many companies, domestic and international. These matters ordinarily arise from one or more incidents involving serious, sometimes devastating, injuries. The firm has developed innovative and aggressive approaches to these types of matters, and we often help clients in early, comprehensive prophylactic efforts.

Supervisory and Coordinating Counsel in "Mass Tort" and Product Liability Litigation

The firm is experienced in supervising and coordinating the defense of mass tort and product liability litigation throughout the United States. Engagements in this area include:

• national counsel for pharmaceutical manufacturer with high-risk, high-profile products involving litigation and counseling regarding avoidance of litigation, including product and patent portfolio review, strategic analysis of marketing materials, prepublication review of medical literature, preparation of litigation database, response to regulatory inquiries, and development of key company and expert witnesses
• national coordinating counsel for litigation and regulatory proceedings arising out of problems in clinical trials of an investigational drug
• national coordinating counsel in litigation involving surgical screws used in connection with spinal implants, including appointment as defense liaison counsel in nationwide federal multidistrict litigation proceedings
• national defense counsel for manufacturer of anti-psychotic medication
• national defense representation for a client involved in the asbestos property damage litigation
• national defense team member for alleged product line successors, defending radioactive contrast medium said to cause cancer after use in neuroradiology procedures
• engaged by major pharmaceutical company to develop the defense of new anti-infective product following the filing of first four suits
• regional coordinating counsel for litigation against the manufacturer of materials used in a dental implant device
• defense of a chemical company in multiple occupational cancer claims resulting from on-the-job exposure to bis-chloromethyl ether
• defense of a rail company in multiple claims alleging injury caused by PCB exposure
• defense of a medical device manufacturer in design defect AIDS litigation
• advice to various clients on related public relations, insurance and regulatory issues arising in connection with mass tort litigation.

Health Effects of Radiation

The firm is experienced in the defense of claims of radiation-induced personal injuries as well as the defense of personal injury and class action claims for medical monitoring and property damage arising out of proximity to nuclear fuels processing facilities. These engagements involve intimate familiarity with radiation dosimetry and the literature regarding health effects of radiation, as well as the complex regulations relating to radiation safety. For example, the firm was involved in the public liability litigation stemming from the 1979 accident at the Three Mile Island nuclear power plant, an engagement that lasted more than 23 years.

Substantive and Procedural Reform

Expanding theories of product and related liabilities, combined with the too frequent absence of appropriate procedural discipline by the judiciary over the past several years, have placed many manufacturers and sellers at a disadvantage in their U.S. litigation. Several of our partners are active in efforts for legislative and systemic changes aimed at correcting this imbalance.

Unity of Health Effects Litigation Practice

Common strands underline and unite our activities in defending the variety of cases presenting health effects claims. We work with health effect "expert" witnesses examining questions of epidemiology and the causation of injury and disease and exploring the legal consequences of uncertain causation. There are recurring substantive and procedural questions, including class action certification, multi-district litigation, federal pre-emption of state law causes of action, and in limine hearings to exclude expert testimony. The practice group brings to bear our shared experience in each of these areas in defending and counseling clients.

Our Health Effects Litigation lawyers work closely with lawyers in many other practice areas, including:

• Commercial Litigation
• Construction
• Environmental Law
• Health Care Services
• Intellectual Property