Enforcement Change Leads to Surge in Drug Recalls

DOTHAN, AL, August 28, 2010 (Press-News.org) Drug recalls soared by 300 percent to a record number of 1742 in 2009. One drug company--now defunct--accounted for over 1000 of those recalls, but the increase is still 50% over 2008. Although the marked increase has led some to speculate about a decline in product safety, according to pharmaceutical injury lawyers at The Cochran Firm, the difference is more likely an attitude shift toward increased enforcement than a sudden change in product safety.

Industry analysts cite a number of factors that led to the increase, including:

- Drug repackaging
- Rush to produce generic alternatives
- Manufacturing lapses
- Increased FDA scrutiny

According to Jock Smith, Senior Partner at The Cochran Firm, the last item is the primary driving force. "Under the Bush administration, the FDA was soft on drug safety. Not only did they not institute recalls, but they were prepared to be fooled on issues of safety, such as when GlaxoSmithKline attempted [in 2007] to conceal the dangers of Avandia by consolidating heart attacks, strokes, and heart failure under a single category of 'major adverse cardiac events', that made statistically-significant risks harder to prove. The FDA even wrote an amicus brief for Wyeth [in Wyeth v. Levine] that sought to make pharmaceutical companies immune to lawsuits brought in state courts. Under the Obama administration, public safety is a higher priority. The agency still has many insiders from large pharmaceutical companies, but at least it is taking its job more seriously."

Supporting the contention for the primacy of a sea change within the FDA is that none of the other factors are new to 2009. Drug repackaging has been a popular option with doctors and hospitals since at least the late 1980s. Drug patents are constantly expiring and manufacturers are always rushing to produce generic versions. Manufacturing lapses in the industry have always been problematic, but inspectors have not always had the backing they needed to suggest a recall.

In 2009, the FDA also instituted several initiatives that show its increased interest in regulating the safety of medical devices. This includes a comprehensive review of the safety and effectiveness of infusion pumps, and a study of the technology and practices of LASIK laser vision correction to ensure that the devices and procedure leads to a net increase in the quality of life for patients.

About The Cochran Firm

The Cochran Firm has established a nationwide reputation for being one of the premier plaintiffs' litigation and criminal defense law firms in the country. It was established over 40 years ago by Johnnie L. Cochran, Jr., and has built its reputation by winning cases for clients against some of the largest, most powerful opponents, including multinational corporations and government entities. It has offices nationwide, including New York; Washington, D.C.; Miami, Dallas, and Los Angeles.

Website: http://www.cochranfirm.com