The Appellate Strategist : Appellate Lawyers & Attorneys for Updates on Trial Consultations, Amicus Briefs & Punitive Damage Awards

In Thomas, Melau, and Anderson v. Novartis Pharms. Corp., the Sixth Circuit Court of Appeals recently affirmed a trio of cases prohibiting the testimony of treating physicians as specific causation experts. Though the appellate court’s opinion was not recommended for full-text publication, it nonetheless offers a salient reminder of a Daubert rule well-enunciated in the Sixth Circuit: A physician’s presumed expertise is in the diagnosis and treatment of disease, not necessarily in the scientifically reliable determination of its underlying cause.

Thomas involved three plaintiffs who filed separate lawsuits, but whose claims were heard by the Middle District of Tennessee pursuant to consolidated MDL proceedings. They alleged they developed biophosphonate-induced osteonecrosis of the jaw after taking Zometa and Aredia, drugs manufactured by Novartis for the prevention of bone maladies, typically in cancer patients. The plaintiffs retained general causation experts, but relied for proof of specific causation upon their non-retained treating physicians. Each plaintiff’s treating physician was excluded, but it is the exclusion rationale in Thomas that is of interest here.

The court began its analysis by noting that Thomas’ physician, Dr. Johnson, “appears to have used some form of a differential diagnosis, or differential etiology, which we have previously recognized is a proper basis for determining the cause of a medical condition when done properly.” Id. at 5. The propriety of such a method, however, depends upon the underlying expertise of the practitioner. The court acknowledged that Dr. Johnson was “unquestionably an experienced oral surgeon with many years of practice and training. He treated other patients with osteonecrosis of the jaw, and has read literature and attended conferences on osteonecrosis of the jaw.” Id. at 6. However, “[b]ecause Thomas relied on Dr. Johnson to give an expert opinion on the cause of his osteonecrosis of the jaw, it is not enough to show that Dr. Johnson can recognize and treat osteonecrosis of the jaw.” Id. 

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Matrixx Initiatives, Inc. v. Siracusano (.pdf) was a securities fraud class action where claimants alleged that Matrixx failed to disclose reports of a potential link between its cold medicine, Zicam, and loss of smell. The district court dismissed the claim because the reports lacked statistical significance and, therefore, could not have formed a “material” omission under the Securities Exchange Act. The Ninth Circuit reversed the dismissal.

In a unanimous opinion, authored by Justice Sotomayor, the Supreme Court held that the district erred in employing a statistical significance requirement. Instead, the court should have considered the “total mix” of information available to investors. No single bright-line test of materiality is controlling, and the allegation taken as a whole permitted the inference that the adverse reports could have affected a reasonable investor.

Although the opinion does not concern the admissibility of expert testimony, the Court’s discussion of the reliability of a causation inference in the absence of statistically significant findings will doubtless be cited in future Daubert battles.

Also of general interest is the Court’s explanation of how the facts pleaded met the Twombly plausibility requirements. Indeed, the case may serve as a template for pleading fraud by omission.

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US Supreme Court Will Decide Fate of Preemption Defense for Generic Companies this Term

Since the decision of the Supreme Court in Wyeth v. Levine, 129 S.Ct. 1187 (2009), the Eighth Circuit (in Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009)) and the Fifth Circuit (in DeMahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010)) have both concluded that failure-to-warn claims against generic drug manufacturers are not automatically preempted by the federal Food, Drug and Cosmetic Act’s (FDCA) requirement that generic labeling conform to the approved labeling for the innovator drug.  Last Friday, the United States Supreme Court agreed to decide whether a plaintiff’s state-law failure-to-warn claim against a generic drug manufacturer for failing to modify its labeling to include warnings that differ from the name-brand equivalent is preempted by the FDCA’s requirement that the label for a generic drug be the same as the label for the brand-name counterpart.  Against the advice of acting solicitor general, Neil Katyal, the Court agreed to address the issue in three cases Pliva v. Mensing, 09-993; Actavis v. Mensing, 09-1039; and Actavis v. DeMahy, 09-1501 and consolidated them for review. 

Since a majority of all drug prescriptions (approximately 75 percent) are now filled with generic drugs, the impact of this decision will be widespread.  The stakes are enormous for consumers and the generic pharmaceutical industry alike.

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