Clark Love and Hutson Law Firm is a nationally recognized Houston based law firm specializing in Defective Medical Device Litigation and has helped hundreds of clients over the years reach a settlement for numerous defective medical devices. The firm has also seen changes in the drug litigation over the years. They have done research on regulation, litigation, and innovation in the pharmaceutical industry and discovered an equation for safety. Pharmaceuticals present a complex challenge. The question itself is not easy to answer unless reference is made to the impact of the federal regulatory process that governs every aspect of the prescription drug cycle and makes reduction of liability risk intrinsic to new drug development. The firm questions, what is the relationship, between regulation, liability exposure, and pharmaceutical innovation? Research is ongoing into the development of new products in challenging categories such as birth control, or that thalidomide, perhaps the most notorious drug in history, is currently being “rehabilitated” for use against such devastating diseases as leprosy and AIDS.
Despite the safety of regulations, the threat of litigation demands constraints. Companies are carrying the heavy costs of litigation and must pay high insurance premiums. Regulation also adds a heavy toll on innovation through high costs. Today the drug development process typically runs 12 years. It is costly and complex. The regulated development phases include laboratory testing, clinical studies of the pharmaceutical profile of a new drug, its effectiveness and tolerability by patients. There are also extensive clinical trials to study the effects of the drug in humans over specified periods of time.
It is true that the U.S. regulatory process and tort liability system significantly affect the cost of drug development and the length of time to market. The only real opportunity for innovation is at the beginning of the 12-year regulatory process. The key benefit of this process is assurance of reasonably safe, effective prescription drugs. Large strides in medical science have occurred in the past few decades despite the constraints of the system. Diseases have been taken out. The diagnosis for patients with diseases such as cancer and heart disease has dramatically improved. Biotechnology guides in a new era of exciting possibilities, including the potential for safer, specifically targeted vaccines. The health of the industry seems to indicate that regulation, and innovation represent a logical equation instead of an impossible triangle. Ongoing medical progress is telling evidence of a system that works.