Washington Jury Finds For Defense In Medical Malpractice/Product Liability Action Surrounding Patient's Death From Unapproved Use Of Bone Cement In Spinal Surgery
In May of 2007, 67-year-old Reba Golden fell from the second story of her home and fractured her spine. The diagnostic workup showed that she had a recent burst fracture at L1 and two older fractures at T10 and L4. She was referred to Dr. Jens Chapman, who was a member of the University of Washington Medical School faculty and chief of the spine surgery service at Harborview Medical Center.
Golden met with Dr. Chapman on July 19, 2007, discussed the risks and benefits of the surgery, and indicated that she wanted to proceed. On Aug. 16, 2007, Golden signed a consent form for the procedure, which gave Dr. Chapman permission to perform a T9-L2 PSF, L1 corpectomy, and T9, T10, L2, L4 vertebroplasty. On Aug. 17, 2007, Golden underwent spine surgery at Harborview Medical Center. During the surgery, Dr. Chapman used Norian CRS bone cement to augment the vertebrae at T8, L3 and L4. About five minutes after injection of polymethylmethacrylate bone cement and placement of the screws at L2, Golden experienced a period where the oxygen level in her blood went down and the carbon dioxide level went up. The surgery was stopped while the anesthesia team administered aid. The operation resumed after a pause of 25-30 minutes, after Golden's blood gas levels and blood pressure improved. Surgery continued thereafter for about 45 minutes, during which time Dr. Chapman performed T12, L1, and L2 laminectomies, performed an L1 corpectomy, and installed a metal cage in place of the L1 vertebra. Towards the latter stages of the corpectomy, Golden began to bleed increasingly. Shortly thereafter the operation was stopped and resuscitation measures were commenced. The resuscitation efforts ultimately failed.
The King County Medical Examiner found that Golden's death was caused by Fat Embolism Syndrome (FES). The pathological findings showed bone, bone marrow, and fat emboli in pulmonary blood vessels. There was no evidence of bone cement in Golden's heart, lungs, or any pathological specimen. Golden's FES caused Disseminated Intravascular Coagulopathy (DIC), where the debris from surgery activates the blood's clotting factors, which are consumed and result in uncontrolled bleeding and death.
Golden's survivors, plaintiffs Cynthia Wilson, Individually and as Personal Representative of the Estate of Reba Golden, Victoria Marincin, and Paul D'Oyley, brought suit in King County Superior Court, WA, against Dr. Chapman, Harborview Medical Center, the University of Washington, the State of Washington, Synthes, Inc., Norian Corp., Synthes' former CEO, Hansjorg Wyss, Michael Huggins, Thomas Higgins, Richard Bohner, and John Walsh. Plaintiffs contended that Norian bone cement was defectively designed, not reasonably safe, and proximately caused Golden's death. Plaintiffs contended Dr. Chapman fell below the standard of care by using Norian, and that he failed to secure Golden's informed consent because he did not disclose to Golden that Norian bone cement was contraindicated for use in the spine. Additionally, according to CBS News, (Associated Press), Synthes and Norian, along with four top executives, were indicted in 2009 on charges of conducting unauthorized clinical trials of the bone cement in spinal surgeries despite warnings that the bone cement caused deadly blood clots. Norian agreed to pay a $22.5 million penalty, Synthes paid a $669,800 fine, and the executives went to prison.
Defendants argued that Norian bone cement was reasonably safe as used by Dr. Chapman, that all known complications with the use of Norian were during high pressure injections directly into vertebral compression fractures, resulting in complications immediately after its use, and that Golden was informed of the physical material risks of surgery, including the risks of embolism caused by bone cement, bleeding, and death, and provided her consent to the procedure. Defendants also argued that Norian bone cement was not a proximate cause of Golden's death.
The action proceeded to a jury trial on June 27, 2016, before Judge James Rogers. Synthes, Inc., Norian Corp., Wyss, Huggins, Higgins, Bohner, and Walsh settled with plaintiffs after five weeks of trial. On August 5, 2016, the jury returned a verdict, after four days of deliberation, in favor of Dr. Chapman, Harborview Medical Center, the University of Washington, and the State of Washington. The jury found that Golden would have been likely to go through with the surgery even if she had known all the risks.
Wilson was represented by Daniel Hannula of Rush Hannula Harkins & Kyler LLP and Rick Friedman of Friedman Rubin. Chapman and the University of Washington Harborview Medical Center were represented by William Leedom, Michael Madden, and David Norman of Bennett Bigelow & Leedom PS. Synthes executive Hansjorg Wyss was represented by Steven Boranian of Reed Smith LLP. Synthes was represented by James Smith of Blank Rome LLP and Christopher Tompkins of Betts Patterson Mines.
Lexis Advance subscribers can view the full summary, including expert information, here: Cynthia Wilson, Individually and as Personal Representative of the Estate of Reba Golden, and on behalf of statutory beneficiaries Victoria Marincin and Paul D'Oyley; Victoria Marincin and Paul D'Oyley, Individually, v. University of Washington, Harborview Medical Center, State of Washington, Jens R. Chapman, M.D., Synthes Inc., Norian Corp., Hansjorg Wyss, Michael Huggins, Thomas Higgins, Richard Bohner, and John Walsh; 2016 Jury Verdicts LEXIS 6087.
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