Reviewing the law reviews.

• Author: Youngdale, Elizabeth M.
• Position: Bibliography

Law Review Highlights:

The Food and Drug Administration is tasked with, among other things, protecting the public health of the country by assuring the safety and efficacy of drugs. In that role, the FDA oversees approval and labeling of prescription drugs. A number of recent situations with drugs that were approved by the FDA and then later withdrawn from the market with resultant lawsuits has put the effectiveness of the FDA and its regulations in the spotlight. Three articles look specifically at the FDA's role in the approval of drugs.

In her article The Battle over Implied Preemption: Products Liability and the FDA, (1) Mary J. Davis explores the recent development of the FDA taking the position that its labeling requirements for prescription drugs preempt state tort law claims against drug manufacturers based on the adequacy of labeling. The article discusses recent cases (including Supreme Court cases) on this subject and provides historical background about the regulatory schemes for food and drug laws. Ultimately the article analyzes implied conflict preemption under the FDCA and how it interacts with the Supreme Court's jurisprudence on preemption and implied preemption.

A second article, Time for a Change: Why the FDA Should Require Greater Disclosure of Differences of Opinion on the Safety and Efficacy of Approved Drugs, (2) looks at requiring more disclosure to the public regarding differing opinions about the safety of prescription drugs. In her note, Karen Baswell begins with the description of several drug scandals over the last fifty years--DES, a drug used to prevent miscarriages, but that seems to have caused different types of cancer in the children of women who took it; VIOXX--an anti-inflammatory drug prescribed for arthritis pain that increased the risk of heart attack in those who took it; and Ortha Evra--a birth control pill that reportedly causes an increase in the risk of stroke for young women. In each of these situations, information was available that indicated the potential bad side-effects of these drugs, yet it still took years to get adequate warnings to the public. The note then goes on to analyze how best to deal with differences of opinion about drug effects in an effort to provide the public and doctors--with the best information possible.

Finally, Drummond Rennie, a doctor who has served as deputy editor for both the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA), writes of his experiences with drug research in When Evidence Isn't: Trials, Drug Companies and the FDA. (3) The author outlines the growing influence money--both from patents resulting from university research and pharmaceutical companies--has had on the integrity of research trials into the effects of drugs. He then argues that the FDA has, essentially, abdicated its responsibilities and powers to the drug manufacturers, thus putting the American people at risk. Finally, he proposes several steps to bring the FDA back into the role it should have in protecting the public from bad drugs.

The following list is a selective bibliography of current law review literature thought to be of interest to civil defense counsel

U.S. and International

Damages

Linda Allen, Meeting Daubert Standards in Calculating Damages for Shareholder Class Action Litigation, 62 BUS. LAW. 955 (2007).

Christian Andrelang, Damages for the Infringement of Art. 81 EC by Cartel Agreements According to Sec. 33(3) GWB: The Changes of Law Concerning the "Protective Law" Requirement and the "Passing On" De fence, 30 WORLD COMPETITION L. & ECON. REV. 573 (2007).

Scott Bloebaum, Comment, Past the Tipping Point: Reforming the Role of Willfulness in the Federal Circuit's Doctrine of Enhanced

Damages for Patent Infringement, 9 N.C. J.L. & TECH. 139 (2007).

J. W. Carter & Elisabeth Peden, A Good Faith Perspective on Liquidated Damages, 23 J. CONTRACT L. 157 (2007).

Lawrence A. Cunningham, Securitizing Audit Failure Risk: An Alternative to Caps on Damages, 49 WM. & MARY L. REV. 711 (2007).

Lord Scott of Foscote, Damages, 2007 LLOYD'S MAR. & COM. L.Q. 465.

Lori E. Iwan, Bad Faith: The Admissibility Defending Commercial Damages, 58 FDCC Q. 47 (2007).

Alexandra B. Klass, Punitive Damages and Valuing Harm, 92 MINN. L. REV. 83 (2007).

Tamara Larre, Pity the Taxpayer: The Tax Exemption for Personal Injury Damages As a Disability Policy, 33 QUEEN'S L.J. 217 (2007).

Jennifer D. Larson, Comment, RLUIPA, Distress, and Damages, 74 U. CHI. L. REV. 1443 (2007).

Pey-Woan Lee, Contract Damages, Corrective Justice and Punishment, 70 MOD. L. REV. 887 (2007).

Nathan B. Oman, The Failure of Economic Interpretations of the Law of Contract Damages, 64 WASH. & LEE L. REV. 829 (2007).

Anne Passino, The Confusion of Philip Morris: How the Supreme Court Came to Hold That Punitive Damages Cannot Be Used to Punish for Harm to Non-Parties, but That Jurors Are Allowed to Consider Harm to Non-Parties When...