Lawyers 'zeroing' in on infections Will juries see all as preventable?

'We keep people alive who would have died in the ER 30 years ago'

Arguing that the vast majority of hospital infections are preventable, the former lieutenant governor of New York is warning that nosocomial infections could be the "next asbestos" in terms of legal liability.

"It's clear that the hospitals are in a new legal situation," says Betsy McCaughey, PhD, a health policy expert at the Hudson Institute and founder of the Committee to Reduce Infection Deaths (RID) in New York City. "The assumption that infections are unavoidable shielded hospitals from liability for decades, but no more."

Part advocacy group and part consulting business, RID is making waves in the media as McCaughey calls for dramatic changes in the nation's hospitals. "We are having a major impact and for that reason more and more hospitals around the country are asking us to come in and tell them how to stop infections," she tells Hospital Infection Control. "We want to improve hospital procedures in order to stop infection deaths. We are taking the research that is well known to doctors and nurses — it has been well known for 20 years — and we're making it more prominent in the public dialogue. We have the knowledge to prevent this problem, what is needed is the will. We would like to get to the hospitals before the trial lawyers get there."

Asked whether infection control professionals were seen as part of the problem or part of the solution, she emphatically answered the latter. "Since I began this campaign to stop hospital infection deaths they have been my strongest allies," McCaughey says. "They are the dedicated frontline soldiers. Again and again, they come to me and say, 'Please help, we are regarded as a cost center.' I have been able to show hospital leaders that [infection control] is really a profit center. When you prevent infection you are a profit center because these infections are eroding hospital profits."

As opposed to Consumers Union — which has focused its campaign for infection rate disclosure laws on legislators and the public — RID is directly aiming at hospital chief executive officers. "That's where I bring my message," she says. "If the CEOs don't come to the forum, we don't come to the hospital. We are reaching the CEOs and the hospital board members. The board members are very vulnerable to these law suits. They are vulnerable if they fail to ask at the board meeting, 'What are we doing about infections?'"

One of the drivers of the liability issue is the increasing transparency about infection prevention as the public, press, and government officials become aware of the historic problem of nosocomial infections. "I don't think it makes [hospitals] any more liable, but it does make them a bigger target," says Julie Savoy, BSN, RN, JD, an attorney at Gachassin Law Firm in Lafayette, LA. "There is a potential litigation because it just raises awareness in certain circles that might want to capitalize."

A former infection control professional, Savoy's firm represents hospitals and other health care providers against infection-related lawsuits and other damage claims.

"The law has not changed in terms of the burden of proof," she explains. "It is always on the plaintiff. They have the standard elements of proof, which includes the standard of care — what is it that should have been done? They've got to show breach — that it wasn't done. They've got to show damages, which in this case would be a health care acquired infection."

Then follows the difficult task of convincing a jury that there was a causal link between the breach and the subsequent infection, Savoy adds. But McCaughey argues that the traditional burden of proof may be shifting toward the infected patient as it becomes increasingly clear that most hospital infections can actually be prevented.

"I hear from trial lawyers every single day," McCaughey says. "They are very much more aware. The compelling evidence that nearly all infections are preventable is the trial lawyers' sharpest tool."

While woeful hand-washing and other compliance breaches are well documented, there still is the argument that many nosocomial infections are a trade-off for keeping very sick patients alive with invasive devices. The only definitive study on the subject — the landmark Centers for Disease Control and Prevention's Study on the Efficacy of Nosocomial Infection Control (SENIC) — estimated in 1985 that a well-run program could prevent one-third of nosocomial infections. However, the old mindset of inevitable infections has been changed in part by the dramatic results of quality improvement projects like the Keystone initiative in Michigan, where at one point 57 ICUs went six months without a bloodstream infection. "I would say 90% [are preventable]," McCaughey says.

Ironically, the dramatic success stories achieved by some programs may now raise liability issues for others. "It will take a while for the courts to decide exactly what must be proved, but they will be using all of this new evidence that infections are preventable," McCaughey says. "It's too soon, the wheels grind slowly. But we will begin to see that evidence. The fact is that the cases are being brought now. There was a time when a trial lawyer wouldn't consider bringing a case based on a hospital infection. He or she would know that there was no chance of victory. Now many, many are being filed."

Citing the legal phrase res ipsa loquitur ("it speaks for itself"), she warns that even where there is no evidence that a hospital overlooked infection prevention measures, the plaintiff's attorney could argue that infection is evidence enough that the hospital is negligent.

"[Only] if the courts were to accept that a health care-associated infection is the type of injury that would never occur but for a negative act," counters Savoy. "That's basically what the concept of res ipsa loquitur means. It's an automatic presumption. It's a rebuttable presumption. It is not irrefutable, but it does at that point shift the burden. It's a presumption or inference that because this injury has occurred there was negligence. It is up to the defendant (hospital) to show there are other causes for this injury aside from negligence."

That would seem to open a way for legal arguments, for example, that the patient's infection was an unavoidable consequence of life- saving care or that it was actually acquired in the community prior to admission.

"I don't see a plaintiff as being successful at saying at this point that a nurse didn't wash her hands and that's why I got this infection," Savoy adds. "I don't see a jury buying that. You have [too many] occurrences of that kind of contact between personnel and patients to point to one failure."

Instead, plaintiffs attorneys will challenge policies and procedures if they appear to be below the standard of care for the particular patient's condition, she says. "The standard of care is a very fluid concept because it applies specifically to the given circumstances you're faced with," Savoy says. "The standard of care can be different from patient to patient even though it is the essentially the same act you are performing. The patient's condition dictates alterations in how you may perform a procedure, for example."

It is very important that policies — and actual practice — reflect the current state of the science in terms of infection prevention, she adds. "They love to get up there and say, 'This is what the hospital says to do and this not what they did,'" she says. "It is a very black-and-white example for the jury to understand."

Ultimately, many lawsuits may fall back into the elusive debate about whether the infection could have been prevented. Infection control has conceded much ground in this area in recent years. That is in part because some programs are achieving the aforementioned dramatic results, but also because the new culture of "zero tolerance" for infections sounds more proactive and defensible then reporting an infection rate within an established benchmark range. The CDC has moved away from the preventability argument — perhaps seeing it as a political liability — and now emphasizes the concept of zero tolerance for infections.

"Zero tolerance is not a new concept," Denise Cardo, MD, director of the CDC division of healthcare quality promotion, recently said in Tampa at the annual meeting of the Association for Professionals in Infection Control and Epidemiology. "It is a standard that has been aggressively used to fight problems such as crime, drunk driving and drug abuse. The question is, is it applicable to health care associated infections? I hope that many of you will see that it is applicable."

'Discomforted by our own words'

Few would argue with the sentiment behind intolerance of infections, but does the phrase also put a little bounce in the step of a personal injury attorney?

"The concept of zero tolerance — which I think was promulgated by the CDC and has found sympathetic echoes in APIC and SHEA — bothers me a lot," says William Schaffner, MD, chairman of the department of preventive medicine at the Vanderbilt University School of Medicine in Nashville, TN. "My colleagues and I have gone back and forth on this, but I remain concerned. We know what's intended: We should have no tolerance for doing anything less than the best in ensuring the safety of our patients. I understand that and I am very much in favor of it. However, zero tolerance can easily be understood by a lay person and an attorney as that there should be zero tolerance for any nosocomial infection. We may be seeing more of that over time. I am concerned that we are going to be discomforted by our own words."

Indeed, as the CDC and infection control groups conceded ground on the preventability issue the field found itself increasingly on the defensive. The price for abandoning benchmarks in favor of a more aggressive zero-tolerance mindset was the implicit admission that infection control had been complacent in the past. Accordingly, the CDC has been thoroughly lambasted for inaction at congressional hearings and by critics such as McCaughey. She is particularly critical of the CDC for not adopting the active surveillance approach advocated by the Society for Healthcare Epidemiology of America (SHEA) for detection and control of methicillin-resistant Staphylococcus aureus.

"I used to be a lieutenant governor; I am experienced in government," she says. "This is a classic example of a government body that has been co-opted by the industry it is supposed to oversee. Unfortunately, CDC personnel spend too much time listening to hospital administrators and not enough listening to grieving patients and families. The lax nature of the CDC guidelines on infection control is an excuse for hospitals to do too little."

Similar charges were aired in Congress during a March 29, 2006, hearing of the Committee on Energy and Commerce's Subcommittee on Oversight and Investigations. "What I read of the congressional testimony from my colleagues at the CDC was entirely defensive," Schaffner laments. "Nobody got out there and said, 'Infection control has kept hospitals safe and functional for the last 30 years. Patients are sicker now, we do more things to them, and our infection rates are still down where they were. We have much more pneumonia, which is one of the hardest infections to deal with. Why is that? All of our patients are sicker and more of them are on vents and on vents longer. We keep people alive in trauma units who would have died in the ER or died within 48 hours of being admitted 30 years ago. They're now with us for four weeks in the trauma unit. They get a pneumonia. Gee, that's amazing. If you're on a vent for a month you are going to get pneumonia. It's virtually impossible not to."

While arguing that infection control is entitled to a more spirited defense in the face of its critics, Schaffner is well aware of historic and ongoing problems. "Do I think we in infection control are assertive enough, aggressive enough, loud enough, effective enough? No," he says. "Do I think that hospital administration provides sufficient resources? No. Do I think people on the wards everyday take infection control into account? No. Do I think therefore that we have an opportunity to improve? You bet. How much? Frankly, I see us stuck there spinning, trying to do more — often without resources in wards sometimes insufficiently staffed with nursing personnel — and the criticisms continuing. I don't see a way out of this dilemma at the moment."