Discusses The Dire Consequences Of Fraudulent Science, Federal Preemption, And Corporate Deregulation

(Posted by Tom Lamb at DrugInjuryWatch.com)

Thomas O. McGarity, of the University of Texas School of Law, is uniquely positioned to give us a history of the beleaguered antibiotic Ketek in his 2008 article, "Corporate Accountability for Scientific Fraud: Ketek and the Perils of Aggressive Agency Preemption", which was published in the Emory Law Journal, Volume 58, Number 2 (58 EMORY L.J. 287, 2008).

From an introductory footnote we get this background information about Professor McGarity and this 2008 law review article about Ketek:

This Article lies at the intersection of three major projects on which the author has labored for the past several years and will continue to pursue during the next two years. The first, an inquiry with my colleague Professor Wendy Wagner into the strategies that advocates in the private sector employ to “bend science” to support predetermined policy agendas, resulted in a recently published book….  The second project describes and analyzes the efforts of common law defendants, joined more recently by some regulatory agencies, to persuade courts to find that state common law claims against the manufacturers of federally licensed products and activities are preempted by federal regulatory action….  The final project, a forthcoming book, Freedom to Harm, examines the thirty-year project of free market advocates in corporate America, conservative think tanks, and academia to free companies of “unnecessary and burdensome” regulatory responsibilities and common law obligations.

I understand not many of you may have the appetite nor the time to consume all that Professor McGarity has to offer in his 58-page law review article.  Anyone wanting to learn about the various "irregularities" in how Ketek was approved by the FDA, however, should at least be aware that this McGarity article is available as a resource.

To give one a sense of what this Ketek law review article by Professor McGarity has to offer, I have excerpted the following from the Introduction section:

• Part I briefly describes the new drug approval process through which a manufacturer of a prescription drug must obtain approval from the Food and Drug Administration (FDA) for new products and for new uses of existing products.

• Part II provides a case study of the dramatic failure of this process to protect consumers by using recently uncovered information concerning the antibiotic Ketek.

• Part III briefly describes the role that state common law can play in providing a backup for ensuring that manufacturers behave responsibly during the drug approval process and are held accountable when they do not.

• Part IV describes the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee, in which the Court held, in a fairly unique factual setting, that the plaintiffs’ common law claims based upon the fraud allegedly perpetrated by a consultant for a medical device manufacturer was preempted by federal law.  [footnote omitted]

• Part V analyzes the arguments for and against preemption of fraud-on-the-agency claims in light of the Ketek experience and concludes that, on balance, preemption is a bad idea because federal enforcement alone provides inadequate incentives to companies that, because they face powerful economic pressures to show large profits to their shareholders, are inclined to cut corners.

• Part VI offers suggestions on how the lower courts should react to Buckman, how the Supreme Court can avoid extending Buckman when it next takes up the issue, and how Congress might go about reversing or limiting Buckman and empowering common law courts to reassume the vital backstop role that they have played in the past.

One may wonder why Professor McGarity chose Ketek as his example for depicting what is currently wrong with the FDA and its drug-approval process.  From the Conclusion section:

Why does Ketek matter? Because FDA broke its own rules and allowed Ketek on the market; because dozens of patients have died or suffered needlessly; because FDA allowed Ketek’s maker to experiment with it on children over reviewers’ protests; because FDA ignored warnings about fraud; and because FDA used data it knew was false to reassure the public about Ketek’s safety.  [footnote omitted]

For those of you who are not familiar with Ketek (telithromycin), it is in a class of drugs called ketolide antibiotics and is to be prescribed only for community-acquired pneumonia. Ketek has been associated with adverse side effects such as liver damage, liver disease, liver failure, and hepatitis.