Health effects litigation, by Pepper Hamilton

Pepper Hamilton give a snapshot of life as a health effects litigator

In a nutshell

Health effects litigation concerns legal claims and issues associated with products alleged to have damaged the health of their users. The products at issue are primarily pharmaceutical medicines and medical devices, although the practice also handles claims involving tires, building products, nuclear energy and a host of consumer products.

Attorneys in this practice handle  personal injury cases, as well as cases consolidated in federal multi-district litigation and in state court coordinated proceedings. While products liability litigation is an important part of what health effects lawyers do, it’s by no means the only thing. In today’s world, products liability claims are just one part of the 'perfect storm' that confronts manufacturers and sellers of products. Other issues include: civil and criminal investigations by the government; congressional hearings, actions by state attorneys general under consumer protection and Medicaid fraud statutes; class actions by consumers and third-party payors seeking reimbursements; and securities claims by shareholders.

Equally important is the litigation prevention and risk management counseling aspect of the practice. By identifying and mitigating potential future litigation risk from the earliest stage of developing products and technologies, lawyers can offer solutions before any claims are filed.  An in-depth understanding of the scientific, medical and/or technological issues underlying the product are critical to this aspect of the practice.

Current issues

  • Patent litigation settlement agreements in which a branded drug manufacturer pays a generic drug manufacturer to delay the entry of a generic product to the market are a continuing source of additional litigation, particularly antitrust actions by purchasers of the products or by the Federal Trade Commission.
  • Consumer fraud class action litigation related to drugs and devices continues to increase. Typically, if product liability actions or government investigators have targeted a prescription drug, class actions follow alleging that patients are entitled to a refund of what they paid for the medicine, under the theory that the manufacturer misrepresented the safety or efficacy of the medicine, violating consumer protection statutes. 
  • Increasingly, state attorneys general also are filing suit under consumer protection, unfair trade practices and/or Medicaid fraud statutes seeking civil penalties, restitution and injunctive relief for alleged misleading marketing of prescription products. Frequently, AGs  conduct these cases with privately retained, contingent counsel.
  • The federal government continues to focus on pharmaceutical and medical devices in investigations related to pricing, manufacturing and marketing their products. 
  • Discovery continues to be a very hot issue in this field, as it is a major contributor to the cost of litigation. Companies are reexamining document preservation policies and procedures in light of highly publicized court rulings to ensure they follow best practices.

What lawyers in this practice do

  • Factual investigation and discovery
  • Interview company witnesses and assist in preparing a strategy for the defense
  • Prepare and argue pre-trial motions, including Frye and Daubert motions to challenge plaintiff experts
  • Prepare, brief and argue evidentiary, class action, summary judgment and other pre-trial motions
  • Take and defend fact and expert witness depositions
  • Try cases and handle appeals
  • Respond to inquiries, subpoenas and other investigations by federal and state authorities. Claims are brought under a host of laws, including the False Claims Act, the Anti-Kickback Act, Medicare and Medicaid regulations, the Food, Drug and Cosmetics Act, the Prescription Drug Marketing Act, health care fraud statutes, the Foreign Corrupt Practices Act, and more
  • Counsel clients regulatory and risk management issues, including FDA regulatory requirements, potential litigation risks in R&D processes and procedures, due diligence of contract research organizations and other business partners, and more. 

Realities of the job

While you don’t have to be a scientific expert to be a health effects litigator, you will have to be able to develop an in-depth understanding of the products and the medical/scientific issues involved in their development and use, and be able to clearly communicate this to courts and juries. As a lawyer in this practice, you frequently will be working with top scientists and medical experts in preparing the defense of cases.

The future

Health effects litigation is a significant and growing practice, and likely will remain so for the foreseeable future. The plaintiffs’ bar shows no signs of moving away from targeting the pharmaceutical and medical device industries; indeed, it is investing heavily in its outreach and marketing efforts to build more cases. The federal government also continues to show heightened interest in investigating and prosecuting industry companies for alleged violations of numerous fraud and abuse laws, health care fraud statutes and other laws.

About Pepper’s health effects litigation practice

Pepper’s health effects litigation practice is one of the largest and strongest teams in the country devoted to representing pharmaceutical and medical device companies in complex litigation, investigations, and counseling on lowering litigation risk. The group’s 90-plus professionals represent some of the world’s leading pharmaceutical and medical device companies. Clients and competitors rank our team among the top products liability firms in the country in such publications as Chambers USA, and many of our lawyers are recognized as masters in their field by Chambers and other industry watchers.