Reducing Product Safety Lawsuits in the Pharma Industry

By: Suma Kallurkar, CIS Compliance Specialist
sumakallurkar@cis-partners.com

Most would agree that the US in modern times has become a highly litigious culture, with lawsuits ranging from the absolutely ridiculous to the very serious. The Bush administration has long been making efforts to reduce lawsuits and curb this litigious behavior. Now when it comes to product safety, most would probably agree that lawsuits are of the “very serious” nature and should be aggressively pursued. However, the Bush administration has recently been revising a number of regulations to incorporate language that serves to prevent lawsuits.

These regulations are related to a number of industries, and one of the most important is the pharmaceutical industry. In fact, a majority of the new lawsuit pre-emption rules have been introduced in the FDA. Many of the numerous product safety lawsuits have centered on a failure to provide adequate warnings. The pharma industry argues that one of the key problems has been inconsistency between state and federal product warning regulations. Pharma companies can have different standards to comply with, which is no doubt a serious problem when it comes to product labeling.

The pharma industry, however, does have the FDA on its side now when it comes to regulations aimed at pre-empting product warning lawsuits. FDA drug labeling rules basically make the FDA accountable for the language in product warning labels. If a drug maker complies with FDA product labeling regulations, then it can be protected from a product safety lawsuit. In addition, according to FDA regulations, federal safety standards take precedence over state standards. So in cases of inconsistency between state and federal standards, a drug company will be protected if it has complied with the federal regulation.

A good example is a case to be heard by the Supreme Court next month: Wyeth vs. Levine. Diana Levine developed gangrene after being administered an anti-migraine drug manufactured by Wyeth, which then caused her to lose an arm. Diana Levine is claming that Wyeth did not provide sufficient warning of the potential side effects under Vermont law. However, Wyeth is claiming that it followed federal standards in its warning label and is therefore not liable. The FDA is supporting Wyeth.

The Bush administration’s efforts to curtail product safety lawsuits are undoubtedly a positive for the pharma industry. However, it is tough to not look at both sides of this issue. Many feel that these efforts show that the administration is in favor of protecting corporate America at the expense of the common consumer. On the other hand, there is a legitimate need to protect corporations from unfair lawsuits. Some would argue, however, that when it comes to drug safety, all lawsuits designed to protect the public are fair. It will be interesting to see the long-term impacts of these recent and current efforts to curtail product safety lawsuits.

References:

Wall Street Journal
News Inferno
FDA