Drug & Device News

In a 34-page opinion in Wolfe v. McNeil-PPC Inc., U.S. District Judge Jan E. DuBois held that a doctor testifying as an expert witness may opine as to causation using a “differential diagnosis” ' in other words, he or she is permitted to testify that, because other causes have been ruled out, the pharmaceutical product at issue likely caused the condition. The case involves a child who was given ibuprofen, after which she developed Stevens-Johnson Syndrome (SJS), a life-threatening condition in which the epidermis separates from the dermis. The plaintiffs assert that the warning label for Children's Motrin, which contained the ibuprofen, was inadequate. Plaintiffs are also seeking punitive damages, claiming that the drug's manufacturer withheld evidence from the FDA showing that two previous users had developed SJS. The defense objected to the plaintiffs' proffer of testimony from three doctors, none of whom is an expert in or has studied the causes of SJS. In rebuffing the objections, Judge DuBois concluded that the U.S. Supreme Court's 1991 decision in Daubert v. Merrell Dow Pharmaceuticals Inc. does not require an expert's knowledge base to be as specialized as the defense urged. Experts need not be “the best qualified” or “have the specialization that the court considers most appropriate,” wrote Justice DuBois. An expert's deficiencies in knowledge, if any, go to the questions of credibility and weight, concluded the judge, not admissibility.

Hormone Replacement Therapy Suits Move Toward Settlement