Pharmaceutical and Medical Device Litigation

The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, is tasked with protecting the public health by assuring the public safety and effectiveness of human drugs, vaccines, other biological products, and medical devices, among others.  The FDA is charged with advancing the public health by ensuring the public gets accurate, science-based information they need to use medicines and devices to improve their health.  However, it has been widely acknowledged the FDA is underfunded and understaffed.  The FDA’s own Science Board concluded the agency “is at risk of failing to carry out its mandate, leaving our citizens at risk of grievous harm.”

To compound the problems facing the FDA, our regulatory system is designed so that pharmaceutical companies and medical device manufacturers are responsible for all testing of their products prior to receiving FDA approval.  These same companies are entrusted with the responsibility to monitor the safety of their products once on the market.  Unfortunately, as profit-driven corporations, often these companies spend more on marketing and advertising than they spend on safety surveillance.  One study, “The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” based upon the collection of data directly from industry and doctors, estimated the U.S. pharmaceutical industry spent almost twice the amount on promotion versus money spent for research and development.  The study’s conclusions confirmed that the U.S. pharmaceutical industry is market-driven rather than being motivated by researched lifesaving improvement to the public’s overall health.

Unfortunately, most adverse events and problems associated with medications and devices go heavily underreported.  However, once a device or drug’s devastating effects become recognized and understood, the FDA must communicate these dangers to the medical community and general public through an alert, public notice, or recall.  Regrettably, the FDA relies on these same profit-driven corporations to responsibly and timely report and warn physicians and patients alike of known complications, side effects, and adverse events.  But all too often, these corporations assume the injuries sustained are nothing more than a cost of doing business. 

In large part, this means the role of regulatory watchdog is left to lawyers like us who work tirelessly to hold drug makers and device manufactures accountable for injuring consumers.  In effect, such law firms like Clark, Burnett, Love & Lee level the playing field by pursuing these corporations in courts of law.