The Parlodel Trilogy

The Parlodel litigation has been described by commentators as “the first significant products liability causation debate of the 21st century” and one that “will serve as a guide to understanding the significant causation issues that will continue to be involved, at increased rates of complexity, in the 21st century products cases.”

Parlodel is an FDA-approved drug doctors still prescribe today for a variety of uses, but in 1995 the FDA withdrew approval of Parlodel for the prevention of postpartum lactation based on the agency’s conclusion that the possible risks outweighed the utility of the drug for this use.  A wave of lawsuits followed in which plaintiffs’ experts claimed that Parlodel causes vasoconstriction (a narrowing of blood vessels), which can result in stroke, seizures, myocardial infarction, and even death.

Hollingsworth LLP attorneys avoided jury trials for our clients in key Parlodel cases through skillful use of Daubert.  Persuaded in pre-trial hearings that testimony offered by plaintiffs’ expert witnesses lacked critical indicia of scientific reliability as set forth in the U.S. Supreme Court’s Daubert trilogy, judges struck it down and granted summary judgment.  In each case, the decisions were unanimously upheld in federal circuit courts, establishing what is now known as the “Parlodel Trilogy,” which has been cited nearly 2,500 times in cases, articles, and other court documents, and relied upon by other courts in limiting use of expert testimony unsupported by reliable science. Glastetter v. Novartis, 252 F.3d 986 (8th Cir. 2001); Hollander v. Sandoz, 289 F.3d 1193 (10th Cir. 2002); and Rider/Siharath v. Sandoz, 295 F.3d 1194 (11th Cir. 2002).

The key to success without trial lay in convincing trial courts to engage in a searching and careful analysis of each category of evidence relied upon by plaintiffs’ experts.  The ultimate result was a series of written opinions that not only obtained summary judgment for the client but also lay the precedential groundwork for future science-based defenses.

The judicial consensus that emerged, that plaintiffs’ expert causation testimony as to Parlodel does not pass Daubert scrutiny, was gained only by the client’s steadfast commitment to challenge weak causation evidence in the face of a few early district court opinions allowing plaintiffs’ causation opinions.  The Parlodel Trilogy shows the benefit of convincing courts to implement an exacting Daubert analysis even in the face of an adverse regulatory action or early unfavorable precedent.

Hollingsworth LLP represents some of the world’s largest pharmaceutical manufacturers in individual cases and serial litigation involving personal injuries alleged to be associated with prescription drugs.