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Swimming with sharks: Liability in an age of transparency, rising standards of care
Going beyond 'deny and defend' on infection-related claims
Hospitals may become more liable to infection-related lawsuits as patients gain greater access to information and expect higher standards of care to prevent infections once considered inevitable, a legal scholar warns.
Diane Hoffman, JD, director of the law and health care program at the University of Maryland School of Law, addressed the changing legal landscape recently in Baltimore at the annual meeting of the Society for Healthcare Epidemiology of America (SHEA). Though data are limited because many cases are settled out of court and sealed from further discussion, the case law files that are open for review suggest that hospitals historically have fared well in legal battles with patients, she noted. "Those of you who work in this area know as a medical or scientific matter, it is very difficult to figure out the cause of some of these infections," Hoffman said. "Also, patients may have difficulty getting access to some of the information that might help them show causation. Virtually every state statute protects from discovery various records of peer review or quality assurance-type committees."
However, patients are gaining new access to information from a variety of sources and there is some question whether traditional protections could be under siege. Once a little-known field marked by arcane terms and a low profile in the hospital, infection prevention is entering a new age of transparency that includes mandated rate disclosure laws, consumer activism, and patient empowerment. State legislatures are even discussing codifying clinical practice in proposed laws that would require active surveillance cultures (ASC) for pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). At the same time, a new wave of studies reporting dramatic reductions in infections is raising the standard of care expected by patients and their attorneys.
"Not only are hospitals going to be unable to argue that these infections can not be prevented, they will be expected to incorporate techniques to reduce infections," Hoffman said. "Things like enforcement of hand washing procedures, administration of prophylactic antibiotics within an hour of performing an incision during surgery, reducing the risk of infection by bathing or showering patients with chlorhexidine soap daily before their operation, testing patients for MRSA on admission and isolating them appropriately if they are positive. These may in fact become the standard of care. The legal landscape is changing, but in such a way that hospitals may be at greater risk if they don't implement these techniques for reducing infections."
Such trends ultimately may raise the stature of infection prevention, enhance program funding, and strengthen the ICP's mission to protect patients and health care workers. In the interim, however, hospitals may be open to increased liability. Hoffman joined several other attorneys in advising SHEA members about liability, accountability, and transparency. Concerning the latter, making an impassioned plea for full disclosure rather than "deny and defend" was Richard Boothman, JD, a former trial attorney who now is the chief risk officer at the University of Michigan Health System in Ann Arbor.
"Doing the right thing — being open and honest with your patients — [has] intrinsic benefits [and] actually pays off financially," he told SHEA attendees. "It is absolutely the most ironic thing to me that a medical industry that despises the legal system entirely relies on the legal system to [defend] it. Deny and defend does nothing but push people into the courthouse. We have taken the bull by the horns and said, 'We are not going to do that.'"
On the other (unwashed) hand, hospital leaders may find it hard to get away from the deny and defend position when they look at the hand hygiene compliance rates within their facility. Hand hygiene studies historically have often found rates in the 50% range, meaning patients have a coin-flip's chance that their caregivers practiced the cardinal principle of infection control. In that regard, one attorney had an audience that included many physicians looking less than comfortable when he put a couple of well-known facts about health care-associated infections into jarring juxtaposition.
"You guys are the experts, but what you tell me is that 100,000 lives a year are lost just due to hospital-acquired infections," said David Marks, JD, a consultant with Outcome Engineering in Plano, TX. "Yet I've seen hospitals with corporate goals — corporate goals — of 75% [hand hygiene compliance] for something that leads to 100,000 [deaths] a year. It raises the issue of who is accountable. Is it the nurse who is perhaps choosing not to wash her hands? Is it the organization, the board of directors? Who is accountable to the patient?"
Historically, patients have faced an uphill battle making anyone accountable for infections. In general, plaintiffs have to prove negligence or violation of a standard of care, factors that have often protected hospitals in past claims. "To bring a successful malpractice case, the plaintiff has to first prove causation — that an infection caused injury or death," Hoffman said. "That typically requires showing that the patient contracted the infection while he or she was in the hospital. [In addition], the infection was contracted from a source within the hospital as opposed to family members who were visiting. They also have to show negligence, [for example that] health care professionals were aware or should have been aware of the infectious source within the hospital and did nothing to address it. Or that health care professionals negligently exposed the patient to the infection by inappropriate procedures. In a medical malpractice case, the plaintiff has the burden of proof."
Hospital attorneys make that burden all the heavier by arguing, for example, that the patient was informed of the risk of infection prior to medical treatment. Likewise, hospitals will call their own experts to show that the practice or policy in question met the relevant standard of care. "Hospitals have been able to argue that sometimes nosocomial infections can not be eradicated despite the greatest of care," she said.
Jury sends message
A possible sign that juries may be swinging toward the patient's side of the legal arguments came last year in West Virginia in the form of a staggering $10 million verdict against a hospital for a nonfatal nosocomial infection. Though state statutory cap laws reduced the award to $1 million, the message was loud and clear, Hoffman said. The case involved a 14-year-old girl who developed a protracted Serratia infection after undergoing knee surgery at Ruby Memorial Hospital at the University of West Virginia in Morgantown.
"The infection was finally abated after seven surgeries over four years," Hoffman said. "[The patient] alleged that the hospital was experiencing an epidemic of Serratia bacteria at the time of the surgery but never informed her of the outbreak and allowed her surgery to go forward. Moreover, she argued that the infection control department failed to monitor, prevent, and control the Serratia epidemic that caused her infection. The hospital on the other hand argued that the plaintiff did not acquire the infection at their facility and denied experiencing an epidemic. The journey awarded [her] $85,000 in medical expenses and $10 million in damages for pain and suffering."
Could such jury verdicts foretell a more perilous litigious future for infection control? "The number of nosocomial lawsuits does seem to have increased since 2000," Hoffman said. However, the spotty nature of the legal data makes it difficult to determine if more plaintiffs are winning such cases, she added.
In a search of legal documents and web sites for infection-related cases, she found 49 published legal opinions or settlements.
"Of the 49 cases, 35 were defense verdicts, 11 for the plaintiff, and three were settled," she said. "The paucity of data on plaintiff victories makes it difficult to say with any certainty what the average award is. But just based on our research — without any adjusting for inflation — it was about $538,000. "
In additional data presented by Hoffman, a 2005 study limited to the Philadelphia area found that the city of brotherly love is particularly friendly to plaintiffs. Philadelphia's rate of malpractice filings per capita more than doubles the national median, and plaintiffs prevail in 44% of verdicts in the city compared to a 20% rate nationally. In addition, 24% of the awarded verdicts in Philadelphia exceed $1 million, the researchers found.1 The study was based on a survey of risk managers representing 60 acute care hospitals, members of Pennsylvania Trial Lawyers Association, and a random sample of 560 lawyers representing plaintiff and defense cases obtained from the Philadelphia Court of Common Pleas database (1996-2002).
The survey looked at the number of health care-associated infections (HAIs) by specialty, body site, isolate, and outcome. The study netted 154 cases, with the highest numbers in the specialties of orthopedics (69), general surgery (20), and cardiothoracic (20). Sites infected most often were: knees (26), back (26), sternum (18), and harvest site (10). MRSA was responsible for 45 of cases, S. epidermidis for 27, and susceptible staph caused 14. Another major pathogen cited in the lawsuits was Pseudomonas, which was the infecting agent in 16 cases.
"Although 72% of HAI malpractice cases in Philadelphia were either withdrawn or settled, when brought to trial, the plaintiff was more likely to succeed with a verdict," the authors concluded. "Our findings also suggest that the most frequent type of infection [Class I-surgical site] and isolate [MRSA] are more likely to be seen as preventable HAIs because of national nosocomial infection surveillance data showing lower infection rates for this class of surgery and, therefore, seen as easier for the plaintiff to show that the defendant failed to adhere to the standard of care for infection control."
ASC trend opens up new liability
In contrast, Hoffman's review of the literature found hospitals winning MRSA cases. "We also looked at how many cases involved MRSA and we found nine, the earliest in 2001," she said. "Of those nine, hospitals prevailed in eight of them."
However, she warned that increasingly common practice of using ASC to detect and isolate MRSA carriers may open up a new avenue of liability. "If a patient tests negative and subsequently develops an infection, the patient may want to use that information to argue that he did not have an infection upon admission to the hospital or unit and, therefore, contracted it in the hospital," she said. "Given that this information would appear in a patient's record, it would be accessible to the patient. A hospital might still be able to argue that the test result was not wholly reliable, that it was a false negative, [or the infection was] the result of taking antibiotics or it was brought in by visitors. So there are many defenses that a hospital still has, but I think the bottom line is a negative test result may help a plaintiff prove causation."
Of course the other side of the ASC coin is that if the practice prevents more infections then overall liability may decrease, she added. "The hope is if you do implement these, there will be fewer cases of hospital-acquired infections and therefore a smaller pool from which lawsuits may be filed," she said. "Ideally, because of that, it is likely that the benefits in terms of reduced legal liability and other cost savings will outweigh the legal risks."
Another new concern on the liability front is the growing number of state laws that have been passed requiring hospitals to disclose infection rates. "One issue that has been a concern to hospitals regarding these laws is whether the information they provide will be discoverable in a lawsuit," Hoffman said. The legal boundaries could vary from state to state, as the discoverability issue may hinge on the specific language in the law. Regardless, plaintiffs' attorneys will likely try to use the data available to bolster cases against hospitals, she noted. "There are a number of ways in which this information could be used in a lawsuit against a doctor and a hospital even assuming there is no patient information available. Even data from which all personal and institutional identifiers have been removed could still be useful to prove some element such as causation in certain types of cases. A plaintiff may be able to show that injuries similar to the plaintiff's were [an established risk and should have been known]. A plaintiff may want to show that one hospital has an infection rate that is four times the state average or significantly above some recommended rate and that may be circumstantial evidence of negligence."
Moreover, there is some question if state infection data reported to the Centers for Disease Control and Prevention will be protected from legal discovery at the federal level. CDC surveillance data have traditionally been protected by a regulation called 308d, which forbids the agency from releasing identifiers. "It is my understanding that hospitals that report data through the state health department will not be covered by 308d, in which case those data would be discoverable [at the] CDC," warned William Jarvis, MD, a former CDC epidemiologist now in private consulting. Jarvis brought up the issue at the SHEA legal session to Hoffman, who responded, "I think that is accurate. My understanding of that provision is that it now is based on the specific state statute."