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From Products Liability Law Daily, January 20, 2015

Physician prescribing trial drug may not qualify as learned intermediary

By Pamela C. Maloney, J.D.

Whether a physician who prescribed a drug for the treatment of hepatitis C as part of a clinical trial qualified as a learned intermediary was a question of fact for a jury, a federal district court in Texas concluded, denying the drug manufacturer’s motion to dismiss a participating patient’s failure-to-warn claims at the pleading stage. The court also found that a question of fact was raised as to whether the manufacturer was entitled to Texas’s presumption of non-liability for drugs approved by the FDA. However, because the patient failed to plead the existence of a safer alternative design for the drug, the court dismissed the patient’s design defect claims but gave the patient time to amend the complaint to correct his pleadings (Rodriguez v. Gilead Sciences, Inc., January 16, 2015, Ramos, N.).

Background. The patient, Elisandro Rodriguez, developed permanent heart damage allegedly as a result of participating in a clinical trial testing the investigational drug Sofosbuvir/Ledipasvir (S/L) for the treatment of hepatitis C (HCV). Gilead Sciences, Inc., the manufacturer of the drug, had conducted the trial as required for obtaining approval from the Food and Drug Administration for the drug’s sale and marketing. Rodriguez filed a lawsuit against the manufacturer alleging a number of theories of recovery that fell into two categories: (1) the product was not safely designed and (2) the product was not accompanied by sufficient warnings or it did not “live up to the literature used to market it.” The manufacturer moved to dismiss the complaint, arguing that the patient’s design-defect claims failed to allege facts that would support a finding of a safer alternative design, and that the learned intermediary doctrine and the presumption of non-liability associated with FDA oversight insulated the manufacturer from liability for any alleged failure to warn or inform.

Learned intermediary doctrine. In response to the manufacturer’s learned intermediary doctrine defense to the failure-to-warn claims, the patient argued that the physician who administered the drug was not a “prescribing physician” and was not acting within a physician-patient relationship during the clinical study. Instead, the patient argued that the physician was an extension of the manufacturer, incentivized to act as a drug marketer, not as a treating physician. Both parties offered competing case law on the issue of whether a physician associated with a clinical trial qualified as a learned intermediary, and the court found that the cases cited by the manufacturer, which were not opinions issued by Texas state courts or courts within the federal circuit, were distinguishable from the case at bar. The court also noted that each of the cases cited by the manufacturer arose out of summary judgment or trial proceedings where the question here was whether the evidence supported the application of the learned intermediary doctrine. None of the cases rejected the patient’s warning- defect claims at the pleading stage. The court concluded, therefore, that the issue raised a question of fact, subject to determination on the basis of the evidence presented.

Presumption of non-liability through FDA regulation. The manufacturer also argued that the clinical study in which the patient had participated was conducted pursuant to FDA regulation, including FDA approval of the warnings given to the treating physician and the patient. As a result, the manufacturer claimed it was entitled to the benefits of the presumption of non-liability provided by Tex. Civ. Prac. & Remedies Code §82.007, which provides in pertinent part that manufacturers are not liable with respect to allegations involving failure to provide adequate warnings or information if the warnings or information that accompanied the product was approved by the FDA for a product approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq.).

The patient argued that the drug was not “a product approved” by the FDA because it was still in pre-approval clinical trials. The court recognized that the patient was trying to construe the statute as meaning that only a product which had received final approval for marketing to the public was subject to the presumption of non-liability. Although the court explained that a plain language reading of the statute would indicate that any approval by the FDA pursuant to the FDCA would create the non-liability presumption in favor of the manufacturer, it cautioned that in explaining the requirements for an “investigation new drug” clinical trial, FDA regulations speak in terms of authorizations rather than approvals. As such, the court concluded that it could not make a fully informed decision on this question until it had reviewed precisely what materials were provided to the FDA and whether the warnings on which the manufacturer relied were “approved” by the FDA. Thus, the manufacturer’s motion to dismiss the patient’s failure-to-warn claims on the basis of the presumption on non-liability was denied.

Design defects – alternative design. With respect to the patient’s design defect claims, the court cited both the Texas products liability statute and the state court decisions construing the law as clearly establishing that evidence of a safer alternative design is a requisite element of a cause of action for defective design. Although the patient did not dispute that a safer alternative design was a necessary component of his design-defect claim, his complaint set out a litany of conclusory allegations, none of which related to this element of proof. Instead, the allegations addressed global dangerousness, poor quality, and/or marketing issues associated with the drug. In light of this determination, the court dismissed all claims, whether based on negligence, strict products liability, or breach of warranty, which related to alleged design defects. However, the court granted the patient’s motion for leave to amend his compliant to cure this defect.

The case is Civil Action No. 2:14-CV-324.

Attorneys: Robert C. Hilliard (Hilliard Munoz Gonzales LLP) for Elisandro Rodriguez. John Michael Gaddis (Fish & Richardson PC) and Darrell Lee Barger (Hartline Dacus Barger Dreyer LLP) for Gilead Sciences, Inc.

Companies: Gilead Sciences, Inc.

MainStory: TopStory DesignManufacturingNews WarningsNews DrugsNews TexasNews

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