Academic journal article Defense Counsel Journal

The Learned Intermediary Doctrine after FDA's Drug Watch and PhRMA's Clinical Study Results Database: Shifting the Focus of Failure-to-Warn Claims

Academic journal article Defense Counsel Journal

The Learned Intermediary Doctrine after FDA's Drug Watch and PhRMA's Clinical Study Results Database: Shifting the Focus of Failure-to-Warn Claims

Article excerpt

THE learned intermediary doctrine is the cornerstone of almost every pharmaceutical and medical device products liability claim. Recognizing that information about a drug's risks can be conveyed outside a package insert provides fertile ground for debate over the implications of the Drug Watch Web site and Clinical Study Results Database in the context of failure-to-warn claims.

In an attempt "to develop and disseminate important emerging drug safety information concerning marketed drug products to healthcare professionals and patients,"(1) FDA published a draft document on May 4, 2005, entitled "FDA's 'Drug Watch' for Emerging Drug Safety Information," which included plans to create a Web page that would communicate this drug safety information. Seven months prior, the Pharmaceutical Researchers and Manufacturers Association ("PhRMA") launched a database with similar goals. PhRMA's plan, "Clinical Study Results Database," had the twin goals of providing a central, easily accessible database and "making clinical study results for U.S.-marketed pharmaceuticals more transparent." (2) These two sites are not the only sources of such information available on the Web. Both GlaxoSmithKline and Forrest Laboratories have posted clinical trial results on Web sites as a result of agreements with the Attorney General of the State of New York. (3) Other companies have made information available on their own Web sites, as well; (4) however, due to competitive concerns, some companies have been reluctant to post this information. Some companies have been particularly leery of publishing information related to Phase I and Phase II studies of clinical trials. (5) Despite the number of individual sites, FDA's Drug Watch and PhRMA's Clinical Study Results Database sites present two bases for comparison and inquiry with respect to how this medium will impact pharmaceutical products liability litigation. Although dissimilar in many significant respects, the proposed Drug Watch Web site and Clinical Study Results Database sites present a host of similar challenges, pitfalls, and opportunities in pharmaceutical products liability litigation for claimants, defendants (including manufacturers and prescribing physicians), and courts.

The Drug Watch Web site and Clinical Study Results Database are almost certain to impact pharmaceutical products liability litigation by impacting the learned intermediary doctrine. Despite PhRMA's stated intent not to impact prescribing decisions, the information provided on the Drug Watch Web site and Clinical Study Results Database can conceivably either supplement or undermine the warnings provided in the package insert and even create a viable common knowledge defense. In this regard, the Drug Watch program and Clinical Study Results Database present a challenge to traditional reliance on the package insert as the source of warnings in a way not contemplated by the American Law Institute ("ALI") in either the Restatement (Second) or Restatement (Third). Although both FDA and PhRMA caution against excessive reliance on their sites (albeit for different reasons), manufacturers may be able to find safe harbor in these media with respect to products liability suits because they provide warnings to prescribing physicians and patients in a manner that has greater flexibility, increased timeliness, and wider availability than the physician package insert. Claimants will no doubt point to the information on these sites not only to juxtapose it with perceived omissions in the package insert, Physician's Desk Reference, and marketing materials, but also to establish actual or constructive knowledge of certain risks and general causation. These sources pose important questions with respect to a prescribing physician's duty to consult them. In short, the proposed Drug Watch Web site and Clinical Study Results Database present a strong possibility of shifting the focus of failure-to-warn claims away from the physician package insert. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.