Eighth Circuit affirms judgment against Novartis for inadequate ONJ warnings for Aredia, Zometa

by Charles Miller

Ruth Baldwin developed osteonecrosis of the jaw (ONJ) after two of her teeth were extracted. Baldwin filed suit against Novartis Pharmaceuticals Corporation alleging the drug company negligently failed to provide adequate warnings for two drugs she took, Aredia and Zometa. After a jury trial, the jury awarded $225,000 as Baldwin’s compensatory damages, plus certain costs. Novartis appealed to the Eighth Circuit, arguing among things, that the jury improperly found that inadequate warnings proximately caused Baldwin’s injuries. The court of appeals affirmed the judgment. Winter v. Novartis Pharmaceuticals Corp, — F.3d —-, 2014 WL 67756 (8th Cir. January 9, 2014).

On appeal, Novartis argued it should be entitled to judgment as a matter of law because Baldwin did not establish that her injuries were proximately caused by inadequate warnings. When considering such an argument, the court of appeals reviews the evidence most favorably to the party who prevailed below, drawing all reasonable inferences and resolving all factual disputes in its favor.

Under Missouri law, “it is incumbent upon the manufacturer to bring the warning home to the doctor.” Krug v. Sterling Drug, Inc., 416 S.W.2d 143, 146 (Mo.1967) (internal quotations omitted). To establish proximate causation in a failure-to-warn claim, a plaintiff “must show that a warning would have altered the behavior of the individuals involved in the accident.” Moore v. Ford Motor Co., 332 S.W.3d 749, 761–63 (Mo. banc 2011) (internal quotations omitted). Missouri presumes that a warning, if given, will be heeded. Id. Absolute certainty is not required to prove a causal connection between a defendant’s acts or omissions and the plaintiff’s injuries. Howard v. Missouri Bone & Joint Ctr., Inc., 615 F.3d 991, 996 (8th Cir.2010). A submissible case requires substantial evidence that the injury is a natural and probable consequence of the defendant’s behavior. Id. Absent compelling evidence that causation is wanting, causation is for the jury. Id.

Evidence at trial established that when Dr. James N. Hueser first prescribed Aredia for Baldwin in July 2003 (and Zometa in September 2003), the risk of ONJ was not mentioned in the package inserts. The company modified the inserts in September 2003, when ONJ was mentioned only in the “Post–Marketing Experiences” section, not in the “Warnings” section.

On appeal, Novartis focused on Dr. Hueser’s testimony that he did not read the inserts before prescribing the drugs (and in fact, claimed to never read inserts before prescribing any drugs). Novartis argued this severed any link between its duty to warn and Baldwin’s injuries. Novartis maintained that “[t]he majority of courts that have examined the issue have held that when a physician fails to read or rely on a drug manufacturer’s warnings, such failure constitutes the ‘intervening, independent, and sole proximate cause’ of the plaintiff’s injuries, even where the drug manufacturer’s warnings were inadequate.” Thom v. Bristol–Myers Squibb Co., 353 F.3d 848, 856 (10th Cir.2003) (emphasis in original).

The court of appeals disagreed, noting that “Novartis’s focus ignores the other ways Dr. Hueser would receive warnings.” In this case, the court of appeals found there was evidentiary support for other ways that warnings could have reached Dr. Hueser. While Dr. Hueser did not read drug inserts, there was testimony that he obtained pharmaceutical warnings through other means—continuing medical education, review of medical literature, discussion with other physicians, and statements by Novartis’s sales representative.

There was evidence at trial that Novartis knew of the risk of ONJ as early as 2002, but instructed its sales force not to mention the disease when making calls to physicians. The sales representative assigned to Dr. Hueser testified that he did not discuss the disease with Dr. Hueser until late September 2004. By then, Baldwin had been taking the drugs for 13 months, and ONJ had been triggered by the extraction of two of her teeth. Also, the “Dear Doctor” letter warning of ONJ was not sent to Dr. Hueser until September 2004, after ONJ had been triggered. By that time, Baldwin’s expert testified that ONJ had become a “growing epidemic.” The court of appeals concluded that, on these facts, a reasonable jury could find that Novartis prevented warnings about ONJ from reaching Dr. Hueser.

Novartis also argued that, even if Dr. Hueser had received a warning, he would still have prescribed Aredia and Zometa. According to Novartis, Baldwin should have submitted proof that Dr. Hueser would not have prescribed the drugs if he had received the warnings the company eventually provided. The Eight Circuit found that this argument failed “because a change in prescribing patterns after receiving a warning is enough to create a submissible case.” In this case, Baldwin introduced evidence that Dr. Hueser stopped prescribing the drugs once he learned of the risk of ONJ. Therefore, a reasonable jury could conclude that Dr. Hueser would not have prescribed the drug for Baldwin if he had been warned.

As we previously reported in another ONJ case, the United States Supreme Court recently denied a request from Novartis to review a $861,000 punitive damages award for the estate of Rita Fussman. In that case, as in the Baldwin case, Rita Fussman developed ONJ shortly after having two teeth extracted. The Fussman lawsuit against Novartis similarly alleged that Aredia and Zometa caused Mrs. Fussman’s ONJ, and that Novartis failed to adequately warn of any ONJ risk associated with the drugs.

The Fullman case went to trial in the Middle District of North Carolina. Following a fifteen-day trial, the jury awarded $287,000 in compensatory damages for Mrs. Fussman’s injuries and $12,600,000 in punitive damages. Applying North Carolina law, the district court reduced the punitive damages award to three times the amount of compensatory damages, or $861,000. Novartis petitioned the United States Supreme Court to review the award of punitive damages. Without issuing any comment, the Supreme Court decided not to review the case. As a result, the decision of the courts below in favor of the Fullman family will stand.

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