Attorneys Robert Sanfilippo and John Ratkowitz publish Two Part Article Discussing the Relevance of "Never Events" in Medical Malpractice Litigation.

October 2010

The National Quality Forum is a nonprofit organization which aspires to set priorities and goals for improvement in healthcare in the United States. To pursue its mission it established the concept of "Never Events," a list of serious complications that should never occur in a safe hospital. Arnold Milstein, Ending Extra Payments for “Never Events” – Stronger Incentives for Patients Safety, 360 (23) New Eng. J. Med. 2388, 2388-90 (2009).

On February 8, 2006, President Bush signed the Deficit Reduction Act of 2005, Section 501(c) of Pub. L. 109-171, instructing the Department of Health and Human Services (the Department) to create its own list of Never Events, so that Medicare payments could be decreased when preventable complications occur in hospitals. On October 1, 2008, the Centers for Medicaid and Medicare Services (CMS) identified eight categories of complications for which it would no longer reimburse hospitals if they developed during a hospital admission: foreign objects left in the body after surgery, air emboli, infusion of incompatible blood, falls and traumas, catheter associated urinary tract infections, mediastinitis after coronary-artery bypass grafting, certain infusion associated infections, and pressure ulcers. Sharon K. Inouye, et al., Medicare Nonpayment, Hospital Falls, and Unintended Consequences, 360 (23) New Eng. J. Med. 2390, 2390-92 (2009). This list was later expanded to include poor glycemic control, deep-vein thrombosis or pulmonary embolism associated with knee or hip replacement surgery, and certain orthopedic and bariatric surgical-site infections. Milstein, supra, at 2388. In January 2009, CMS went further and indicated that it would cease payments to hospitals and physicians when surgery was performed on the wrong patient, when the wrong surgical procedure was performed, or when surgery was performed on the wrong side or wrong body part. Id. at 2388. These actions of federal regulators were said to be an effort to "align financial incentives with the quality of care, thereby promoting both quality and efficiency." Inoye, et al., supra, at 2391.

Major private insurers have decided to follow the lead of the federal government by adopting similar reimbursement denials when patients have been harmed in hospitals through categories of preventable medical errors. Among these insurers are Aetna Inc., Cigna HealthCare, Anthem Blue Cross Blue Shield in New Hampshire, Blue Cross Blue Shield of Massachusetts and WellPoint. Rachel Morgan, R.N., National Conference of State Legislatures, Medicare Nonpayment For Medical Errors, (2008), http://www.ncsl.org/Portals/1/documents/health/MCHAC.pdf. Additionally, in July 2008, CMS contacted all State Medicaid Directors and urged them to adopt policies echoing its denial of payments for Never Events in order to avoid the potential negative fiscal impact that non-payment of Never Events by Medicare might have on states, given the problem of dual eligibility under these plans. Id. Clearly, refusing payment for avoidable medical expenses is a public policy trending towards expansion.

Commentators have questioned the wisdom of Medicare's policy decision to refuse to pay for Never Events. See Inouye, et al., supra; See also, See also Peter J. Pronovost, et al., The Wisdom and Justice of Not Paying for “Preventable Complications,” 299(18) J. Am. Med. Ass’n. 2197, 2197-99. Even critics of the policy, however, have characterized Medicare's decision not to reimburse for costs related to leaving objects in the body after surgery as “wise and just." Id. at 2199. When discussing the propriety of including retained foreign objects as one of the original eight categories of Never Events in its non-reimbursement policy, the Department pointed out that in the field of health care, "there are widely accepted and clear guidelines for the prevention of [these] events." 72 Fed. Reg. 426,206 (Aug. 22, 2007). Consequently, according to the Department, this kind of mistake "should not occur." Id.

In 2006, there were 764 instances in which Medicare was billed for care related to retained objects following surgery. Id. Although there is not a comprehensive database that sets forth information about every medical malpractice case filed involving allegations of a retained foreign object, Westlaw does contain a national database of verdicts, judgment and settlements compiled from regional and national jury verdict reporters. However, articles submitted to these reporters are strictly on a voluntary basis. Further, medical malpractice defendants almost always require confidentiality as part of any settlement agreement. Thus, Westlaw's database is no doubt a very small sample of cases filed and litigated. At the same time, it is also one of the only tools available (to plaintiffs' lawyers) to examine how categories of certain types of claims are handled from inception to resolution.

A search of medical malpractice cases involving the retention of surgical sponges in Westlaw’s national jury verdict data base reveals that there have been twelve medical malpractice cases involving retained sponges throughout 2008 and 2009. See An v. Shaw, No. 06 L 11100, 2009 WL 5091924 (Ill. Cir. Ct. Oct. 29, 2009); Anonymous Female Patient v. Anonymous Physician, Anonymous Nurse and Anonymous Clinic, 2009 WL 6366089 (Va. Cir. Ct. Oct. 5, 2009); Sneeze v. State of Louisiana, No. 154,568, 2009 WL 6528661 (La. Dist. Ct. Jul. 27, 2009); Edmondson v. Oakwood Healthcare, No. 07-721460-NH, 2009 WL 3699101 (Mich. Cir. Ct. Jun. 4, 2009); Anonymous 31 Year Old Female v. Anonymous OB/GYN And Anonymous Hospital; 2009 WL 6366051 (Ohio Com. Pl. Jun. 1, 2009); Khaulipour v. St. Ann's Hospital, Kington, and Jiricko, No. 07-CV-001264, 2009 WL 3748727 (Ohio Com.Pl. May 18, 2009); Davis v. Jacobs, No. 06-CV-3409, 2009 WL 1740332 (N.C. Super. Ct. Jan. 16, 2009); Haden v. Kramer, Patrick County Family Practice, P.C. and R. J. Reynolds Patrick County Memorial Hospital, Inc., No. CL07149, 2008 WL 6400289 (Va. Cir. Ct. Oct. 16, 2008); De La Cruz vs. Purdom, No. VC048742, 2008 WL 7165022 (Cal. Super. Ct. Jun. 16, 2008), Young v. Levitt, No. 277895V, 2008 WL 4614405 (Md. Cir. Ct. Jun. 16, 2008); Hanner v. Mark Jones, No. 02-VS-041911, 2008 WL 4614375 (Ga. State Ct. May 19, 2008); Green vs. Sheila Miller, No. CV-2004-1038, 2008 WL 4847169 (Ala. Cir. Ct. Feb. 27, 2008) and Lynch v. St. Vincent Hosps. and Health Servs., No. 49C01-0503-CT-10724, 2008 WL 4276346 (Ind. Cir. Ct. Feb. 28, 2008). In two of the cases, the plaintiffs did not seek compensation from the hospital or medical facility, but rather pursued causes of action exclusively against the treating physicians. In four of the other ten cases, the medical facilities settled without the necessity of a lawsuit. Of the six remaining cases, two of them were settled after suit was filed but prior to trial. The final four cases resulted in two verdicts against hospitals as well as two verdicts in which the hospitals prevailed. Thus, from the sample of the twelve cases appearing in Westlaw's national jury verdict data base in 2008 and 2009, despite the fact that Medicare and private insurance companies have concluded that retained sponges are entirely preventable events which should not occur and should not be paid for, these cases are still being litigated and defended by hospitals in a negligence setting.

In New Jersey, hospital protocols are admissible and can constitute evidence of the prevailing standard of care applicable to medical providers. Rosenberg v. Tovorath, 352 N.J. Super. 385, 406 (App. Div. 2002). Additionally, practice guidelines published by professional medical organizations have also been deemed evidence of what accepted standards of medical care are. Perna v. Pirozzi, 92 N.J. 446, 463-464 (1983). Similarly, if a statute sets forth the appropriate standard of care that should be followed by a medical provider, that statute is admissible as standard of care evidence. DiGiovanni v. Pessel, 104 N.J. Super. 550, 562-563 (App. Div. 1969). Pronouncements from administrative agencies pertaining to issues of medical care have also been deemed admissible to establish governing standards of medical care. Swank v. Halivopoulos, 108 N.J. Super. 120, 126-127 (App. Div. 1969).

It will be interesting to see how the decision by Medicare and the insurance industry, to declare certain categories of events non-compensable because they should not occur in safe hospitals will impact future medical malpractice litigations. Although commentators have suggested that it is "wise and just" to categorize retained foreign objects following surgery as Never Events, these cases are still being defended and litigated. Given the evidentiary nature of professional practice guidelines and administrative regulations, it is reasonable to expect that public policy decisions regarding the compensability of Never Events and the standard of care in medical malpractice litigations will eventually converge.

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