Jury Awards $1.3 Million In Zometa Jaw Injury Trial After Botching 1st Verdict Form

Jury Awards $1.3 Million In Zometa Jaw Injury Trial After Botching 1st Verdict Form

ORLANDO, Fla. — (Mealey’s) A Florida federal jury on Sept. 20 found that Novartis Pharmaceuticals Corp. failed to warn a cancer patient about the risk of osteonecrosis of the jaw (ONJ) and awarded her $1.3 million in medical expenses and non-economic damages (Nancy Guenther, et al. v. Novartis Pharmaceutical Corporation, No. 6:08-456, M.D. Fla., Orlando Div.). 

The verdict was immediately controversial because the jury was told by Judge Gregory A. Presnell that one answer on its first verdict form received at 3:35 p.m. was inconsistent, and it was sent to deliberate again.  At 4:10 p.m., the jury returned an amended verdict correcting its one answer but still awarding plaintiff Nancy Guenther $300,000 in actual medical expenses and $1 million for physical or emotional pain and mental anguish. 

(Original verdict form available.  Document #28-131003-003V.  Amended verdict form available.  Document #28-131003-004V.) 

On the first verdict form, the jury in the U.S. District Court for the Middle District of Florida said that on the negligent failure-to-warn claim, it found that Novartis negligently failed to provide an adequate warning with respect to Zometa and that that failure was a legal cause of Guenther’s injuries. 

On the strict liability failure-to-warn claim, the jury initially said that there was not a preponderance of evidence that Zometa was defective for failing to warn about the risk of ONJ.  The jury then wrote “N/A” rather than “yes” or “no” to the next question about whether such a defect was a legal cause of Guenther’s injuries and went on to award damages. 

Judge:  Verdict Inconsistent 

According to the court’s minutes, after the verdict was read, Judge Presnell declared the verdict inconsistent and instructed the jury regarding its inconsistency.  The minutes say the jury returned to the jury room with an amended verdict form. 

When the court reconvened, the amended verdict was read and entered. 

Both verdict forms awarded the same amount of damages. 

Novartis New Trial Motion 

After the amended verdict was entered, Novartis made an oral motion for a new trial and followed it up with a brief filed Sept. 21.  The company said that when Judge Presnell told the jurors they had to answer “yes” or “no” to both strict liability questions, the judge was “thereby instructing the jurors to reverse themselves on one question.” 

(Novartis brief available.  Document #28-131003-005B.

“In the highly unusual circumstances presented here — where the inconsistency is irreconcilable and so fundamental that it affects the only liability issue in the case — the most appropriate remedy for an inconsistent verdict is a new trial,” Novartis writes.  It said the jury could follow the court’s instructions “only if they opted to reverse themselves on the sole liability issue.” 

Noting that the jury deliberated nine minutes after being told to resume, Novartis said “the Court’s attempted remedy deprived Novartis of its right to a fair trial; the further ‘deliberations’ were overtly a sham, culminating in the amended verdict returned after six jurors flipped their once unanimous vote in favor of Novartis in only nine minutes.” 

No Second Deliberations 

Noting that deliberations took place for about eight hours over two days, Novartis said “the jury could not and did not engage in similarly reasoned deliberations before rendering its verdict against Novartis on that same claim.”  It said the court’s instruction for the jury to “reverse themselves” was “framed by expediency and the jurors’ interest in starting their weekend on a late September Friday afternoon at the end of a lengthy, complex trial — not careful application of the law to the facts — obviously led  the jurors the second time around to act as scriveners, ignore the lengthy deliberations that led to their finding in favor of Novartis on Question 2(a), and simply edit that sequential response to make it the same as the jury’s response to Question 1(a).” 

In 1999, Nancy Guenther, now 61, was diagnosed with breast cancer and in 2001, her doctor found that the cancer had metastasized to her bones.  In 2002, she began receiving injections of Zometa to reduce the risk of bone fractures and received 46 injections until 2006. 

After she began taking Zometa, Guenther claims she developed bisphosphonate-related osteonecrosis of the jaw (BRONJ), a condition in which jaw bone dies. 

In 2008, Guenther sued Zometa Novartis in the Middle District of Florida.  Her case was transferred into the Aredia/Zometa multidistrict litigation in the Middle District of Tennessee and was remanded for trial in 2012. 

Defense:  Timely, Adequate Warnings 

Guenther’s claims at trial were strict liability, but not for manufacturing defect, and negligence, but not negligent manufacturing. 

Novartis argued that it provided timely, adequate warnings about the risk of jaw injury from Zometa to Guenther’s doctors and that any lack of warnings did not cause Guenther’s alleged injuries.  It argued that Guenther’s prescribing physician testified that a different warning would not have changed her decision to prescribe Zometa and that she still prescribes the drug. 

In addition, Novartis argued that Guenther’s claim is barred by Georgia’s two-year statute of limitations. 

Experts 

Guenther’s generic and specific causation expert witness was Robert E. Marx, D.D.S., of Miami, an expert in BRONJ.  Suzanne Parisian, M.D., of Phoenix testified about regulatory requirements. 

James M. Vogel, M.D., of New York, an oncologist, was designated as a plaintiff expert on the use of Aredia and Zometa. 

Novartis listed the following experts:  Armando Armas, M.D., of Boynton Beach, Fla., an oncologist; Janet Arrowsmith, M.D., of Ruidoso, N.M., a former FDA officer and regulatory expert; Paul Bunn, M.D., of Aurora, Colo., an oncologist; Robert Coleman, M.D., of Sheffield, U.K.,, an oncologist involved in the Aredia and Zometa clinical trials; David Feigal, M.D., of Santa Rosa Valley, Calif., a former FDA officers and regulatory expert; Kenneth Fleisher, D.D.S., of New York, an oral and maxillofacial surgeon and expert on ONJ; Teresa Guise, M.D., of Indianapolis, an oncologist; Allan Lipton, M.D., of Hershey, Pa., an oncologist involved in the Aredia/Zometa clinical trials; Shawn McClure, D.M.D., M.D., and oral and maxillofacial surgeon and expert in ONJ; Graham Russell, M.D., Ph.D., of Oxford, U.K., a medical doctor and professor of musculoskeletal pharmacology; and Larry Suva, Ph.D., of Little Rock, Ark., an orthopedic surgeon. 

9-Day Trial 

The trial began Sept. 9.  The jury first began deliberating Sept. 19. 

Guenther is represented by Bart T. Valad and John J. Vecchione of Valad & Vecchione in Fairfax, Va.; Ramon A. Rasco of Podhurst Orseck in Miami; John J. Beins of Beins, Goldberg & Hennessey in Chevy Chase, Md.; and S. Ranchor Harris III of Contangy, Brooks & Smith in Winston-Salem, N.C. 

Novartis is represented by Donald W. Fowler, Martin C. Calhoun and Rebecca Anne Womeldorf of Hollingsworth in Washington, D.C.; Michael J. Thomas of Pennington, Moore, Wilkinson, Bell & Dunbar in Tallahassee, Fla.; and Susan Kay Spurgeon of Pennington Moore in Tampa. 

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