Law Review Highlights:
Cases involving pharmaceutical torts have big stakes for both drug manufacturers as well as for the plaintiffs who have been injured. Three recent articles examine different issues that could have a significant impact on this type of litigation.
In recent years, the Food and Drug Administration has changed its position regarding pre-emption of state tort law by federal law regarding medical devices and pharmaceuticals. Marc C. Levy and Gregory J. Wartman, in their article Amicus Curiae Efforts to Reform Product Liability at the Food and Drug Administration." FDA's Influence on Federal Preemption of Class III Medical Devices and Pharmaceuticals, (1) posit that the amicus curiae briefs submitted by the FDA to assist courts with decision-making in medical device cases have, in effect, been reforming existing tort law. While historically the FDA has been against preemption of state law under the Medical Device Amendments of 1976, the current administration has taken the opposite view. The authors assert that this change in policy encouraging preemption has served to provide new protection to drug manufacturers and given pharmaceutical companies an argument against liability for state common law tort claims.
A second article argues that the presumption against certification of classes for immature torts is not an appropriate presumption in drug cases. Courts often deny class certification for mass torts where there is not yet enough evidentiary support to prove causation for a particular class of tort. In his Note, Beyond Gatekeeping: Class Certification, Judicial Oversight, and the Promotion of Scientific Research in "Immature" Pharmaceutical Torts, (2) Young K. Lee argues that the very nature of epidemiological evidence in pharmaceutical torts is not suited for determinations of individual causation. The author believes that in the case of tort cases involving pharmaceuticals, it may better serve the interest of plaintiffs to have more active judicial involvement in designing and supervising the scientific research necessary to make the links between drugs that have been approved by the FDA and causation for harm to users. The author asserts that allowing class certification would permit the courts to fill gaps in the current FDA regulatory scheme that sometimes allow risky drug to be approved.
In contrast, a third article, Bad Medicine: Good-Faith FDA Approval As a Recommended Bar to Punitive Damages in Pharmaceutical Products Liability Cases, (3) proposes that FDA approval itself should serve as a bar to assigning punitive damages to those manufacturers who have followed the FDA's regulations in getting approval for drugs that become the subject of tort suits. The author argues that defective design or failure-to-warn theories do not make sense in assigning damages to companies that have followed the law in seeking approval from the FDA.
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
Ronen Avraham, Should Pain-and-Suffering Damages Be Abolished from Tort Law? More Experimental Evidence, 55 U. TORONTO L.J. 941 (2005).
Volker Behr, Myth and Reality of Punitive Damages in Germany, 24 J.L. & COM. 197 (2005).
Jeremy Birch, Exemplary Damages for Breach of Fiduciary Duty, 33 AUSIL. BUS. L. REV. 429 (2005). Australian Business Law Review, Lawbook Co., P.O. Box 3502, Rozelle, NSW 2039, Australia.
Margaret Bloom, Should Foreign Purchasers Have Access to U.S. Antitrust Damages Remedies? A Post-Empagran Perspective from Europe, 61 N.Y.U. ANN. SURVEY AM. L. 433 (2005).
Stephen V. Bomse & Scott A. Westrich, Both Sides Now: Buyer Damage Claims in Antitrust Actions Involving "Two-Sided" Markets, 2005 COLUM. …