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From Products Liability Law Daily, July 2, 2013

Jury award on patient’s failure-to-warn claim stands in Fosamax® bellwether case

By Susan Lasser, J.D.

A federal district court in New York rejected a drug manufacturer’s challenge to a jury verdict awarding a patient $285,000 on her claim that the drug maker’s brand name bone loss drug’s warning label was inadequate (In re: Fosamax Products Liability Litigation (Scheinberg v. Merck & Co., Inc.) , July 1, 2013, Keenan, J.). The court ruled that the jury was reasonable in its assessment of the facts presented to it on the claim.

Background. Rhoda Scheinberg brought strict liability and negligence claims on theories of design defect and failure to warn, in addition to claims for fraudulent misrepresentation and concealment, and breach of express and implied warranty against Merck Sharp & Dohme Corp., the designer and manufacturer of the bone loss drug, Fosamax®. She also sought punitive damages. Scheinberg began taking Fosamax in 2000, and continued taking it through 2006. In October 2006, the patient had a tooth extraction, after which healing was delayed. One of the patient’s experts, Dr. Richard Kraut, opined that the delay Scheinberg experienced in healing from the tooth extraction was osteonecrosis of the jaw (ONJ), and that her use of Fosamax was the cause. A second expert proffered by the patient, Dr. Suzanne Parisian, testified that the Fosamax label was insufficient to warn of the risk of ONJ.

The patient’s case was the fifth case selected for trial as a bellwether case in the multidistrict litigation (MDL) involving claims that Fosamax caused users of the drug to experience ONJ.

Prior to trial, Merck moved for summary judgment on all claims, and the court granted the request as to the patient’s claims with the exception of her design defect and failure-to-warn claims. The case was submitted to the jury on these two claims. On February 5, 2013, the jury returned a verdict in favor of Merck on the design defect claim and in favor of the patient on the failure to warn claim, awarding her $285,000.

Following the verdict, on a motion pursuant to Federal Rule of Civil Procedure 50 (b), Merck argued that it was entitled to judgment as a matter of law on the patient’s failure to warn claim. The legal standard for the court on the motion was that it could grant it only if it found “that a reasonable jury would not have a legally sufficient evidentiary basis to find for” the patient, the non-moving party.

Drug manufacturer’s argument. Merck argued that it was entitled to judgment as a matter of law because the Fosamax label was sufficient under New York law. According to Merck, the label warned doctors of the “precise malady” incurred by the patient, pursuant to the legal standard in New York. As such, the drug maker maintained that no reasonable juror could have concluded that the label was inadequate, and cited nine cases in which labels which included the “precise malady” alleged by the plaintiff in the case were determined adequate as a matter of law.

Adequacy of the drug label warning and the reasonableness of the jury. While the court agreed with the drug manufacturer that courts applying New York law have held that prescription drug warning labels are adequate when information about “the precise malady incurred” was part of the prescribing information, the court also found that the Fosamax drug label needed to be evaluated as a whole as there were other requirements under New York law to take into consideration when assessing the adequacy of the warning label.

According to the court, a warning was not automatically sufficient because it included certain “magic words.” Although the language in the cases cited by Merck seemed to indicate that a manufacturer satisfied its duty to warn of a drug’s side effects by mentioning those side effects in the drug’s label, the court found that the courts also recognized that considering the “qualitative adequacy of the warning” was important. The court stated that in determining whether a warning is adequate as a matter of law, a court must evaluate a warning’s language “for its accuracy, clarity and relative consistency.” The trial court further noted that a warning is accurate if it is “correct, fully descriptive and complete, and … convey[s] updated information as to all of the drug's known side effects.” Clarity is reflected in a label using “direct, unequivocal and sufficiently forceful” language that conveys a particular risk, the court said, but added that clear warnings can be “obscured by inconsistencies or contradictory statements made in different sections of the package insert regarding the same side effect or from language in a later section that dilutes the intensity of a caveat made in an earlier section” of the warning material. The court observed that even if a warning had such contradictions, it still could be adequate if the language was “precise, direct, and unequivocal and ha[d] sufficient force.” The court emphasized that the entire warning should be evaluated because even labels containing sentences that are vague when read in isolation can convey a warning with unmistakable meaning when read as a whole.

The court ruled that Merck emphasized the phrase “precise malady” to the exclusion of other elements set forth under New York law. Merely because the Fosamax label mentioned the malady “osteonecrosis of the jaw” did not mean that the label was adequate as a matter of law, the court held, finding that whether the name of the malady incurred by the patient was included in the label was only one consideration when evaluating the label as a whole.

The court also pointed out that New York courts routinely advise that the sufficiency of a label is a factual determination to be made by a jury. Although under New York law, a jury does not need expert testimony to find a label inadequate, but can use its own judgment when assessing a warning, the jury in the current case was presented with testimony as to the Fosamax label. The patient’s prescribing physician between 2004 and 2006, Dr. Dunn, and one of the patient’s expert witnesses, Dr. Suzanne Parisian, testified on the issue of Fosamax’s efficacy for patients with low body mass but without vertebral fractures. Dr. Parisian testified that the label failed to include information about the “limited efficacy” of Fosamax, while Dr. Dunn testified that if she had been aware that the risk of ONJ in Fosamax users increased as the duration of use increased, she would not use Fosamax. She specifically stated that if she had known that Fosamax was less effective for patients with a T-score of better than 2.5, she would have taken Scheinberg off Fosamax.

The doctors also testified that the Fosamax label was inadequate. Dr. Parisian questioned whether the label properly conveyed the causal relationship between Fosamax and ONJ, noting that the label did not make clear that there had been reports of ONJ by patients taking Fosamax. Dr. Dunn also testified that the label did not inform her of the severity or seriousness of ONJ. This testimony was properly submitted to the jury as evidence of failure to warn, the court said.

Moreover, the jury was presented with testimony from Dr. Parisian about other drug labels which addressed ONJ and oral bisphosphonates. Under New York law, evidence that a manufacturer “diluted” a label or introduced confusion or inconsistencies was relevant to the failure to warn inquiry, and the patient introduced evidence to show that the FDA had suggested a label change to include language that most cases of ONJ “have been in patients treated with bisphosphonates intravenously, but some have been in patients treated orally.” The jury learned that Merck rejected the proposed change. Dr. Parisian additionally testified about labels used by Fosamax competitors and that those drug labels reflected the FDA’s proposed language nearly verbatim. In the trial court’s assessment, considering the competitors’ labels and the suggestions made by the FDA, a reasonable juror could have concluded that Merck's ONJ precaution was inadequate.

Finally, the court commented that the same jury that Merck claimed was unreasonable in concluding the Fosamax label was inadequate also had returned a verdict in Merck’s favor on the design defect claim. Even though the jury found Merck liable on a failure to warn theory, the jury awarded only a modest amount in damages, the court said, concluding it’s opinion by observing that “[i]t would be a gross abuse of discretion for the Court to find only a portion of the jury's verdict unreasonable, eschewing evidence that the jury prudently weighed the case presented to them.”

The case number is 06 MD 1789 (08 civ. 4119) (JFK).

Attorneys: Meghan E. McCormick (Levin, Papantonio,Thomas, Mitchell, Eschsner & Proctor, P.A.) for Rhoda E. Scheinberg. Andrew Thomas Bayman (King & Spalding LLP), David J. Heubeck (Venable LLP), and William Joseph Beausoleil , Jr. (Hughes Hubbard & Reed LLP) for Merck & Co., Inc.

Companies: Merck & Co., Inc.; and Merck Sharp & Dohme Corp.

MainStory: TopStory WarningsNews DrugsNews NewYorkNews

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