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Antibiotic Resistance from the Legal Perspective

February 16, 2016

Outline from the 2016 ABA Seminar

In 2015, President Obama signed an Executive Order outlining Federal efforts to combat antibiotic resistance in the United States as a matter of urgent national health safety. The National Strategy on Combating Antibiotic Resistant Bacteria, published by the Federal government in 2015, predicts by the year 2050 more deaths will occur from infection than cancer. Surgery will no longer be an option due to the risk of infection by bacteria that are resistant to all known antibiotics. Our healthcare efficacy will revert to pre-antibiotic days when acquiring an infection could be a death sentence with no known cure.

Bacteria have learned how to become resistant to antibiotics. Every time a new antibiotic is developed, the bacteria quickly becomes resistant, causing an even more virulent form of infection that quickly spreads throughout the body, causing significant loss of soft tissue and bond, sepsis and death. Consequently, pharmaceutical companies are less motivated to spend research and development dollars on new antibiotics because the bacteria swiftly learns to become resistant, thus making the antibiotic ineffective. As a result, we are losing the antibiotic war on bacteria.

A new national strategy for fighting antibiotic resistant bacteria

The National strategy to combat antibiotic resistance, developed over the last year, has changed from infection control and prevention, which was the first line of defense for the last 10 years, to a last line defense of buying time for science to catch up with the prospects of a medical world where antibiotics are no longer a weapon of defense against bacteria and infection.

The new strategy, outlined in the National Strategy on Combating Antibiotic Resistant Bacteria calls for:

  1. Judicious use of antibiotics
  2. Governmental required surveillance systems for hospitals and health care providers
  3. Development of rapid diagnostic tests to reduce unnecessary antibiotic use
  4. Research and development of new antibiotics
  5. International collaboration

From a legal perspective, this new strategy indicates that hospitals will berequired, within standard of care, to develop Antibiotic Stewardship Programs. A shocking 1/3 to ½ of all antibiotics prescribed are unnecessary or incorrect, according to the CDC. These programs will regulate and monitor the use of antibiotics.

New financial incentives will be implemented to require reporting and capturing of data of infections detected by labs and linked to regional networks for automatic data capture. This will eliminate faulty reporting and enable detection of regional and local outbreaks of resistant infections.

Hospital-acquired infections and medical malpractice liability

The legal development of liability theories and defenses has evolved with the threat of antibiotic resistance. In the past, liability for HAIs was often ignored by plaintiffs and defendants. Parties accepted the premise that infections were a known complication of surgery, hospitalization and illness. If an infection occurred, in 20th Century law, it could be easily treated with an antibiotic and the damages would be limited. Hence, it was not a well-developed or often filed case in medical malpractice.

In the 21st Century, as antibiotic resistant bacteria began winning the healthcare battle, cases began to emerge when clusters of infections were discovered in healthcare facilities. The damages to the patients became serious and sometimes catastrophic because infections were no longer easily treatable.

Plaintiffs needed the ability to prove clusters of infections within the facility in order to overcome the sometimes difficult task of proving causation. The Infection Control programs of hospitals came under scrutiny. The CDC published new guidelines for prevention of infections in 20032. The CDC published stricter definitions of HAI’s (Health Care-Associated Infections) that assisted Plaintiffs in connecting the infection to the hospital’s lack of infection control. SHEA (Society for Healthcare Epidemiology of America) and APIC (Association for Professionals in Infection Control and Epidemiology) developed guidelines for infection control. Case law emerged with the emergence of science allowing experts to give opinions linking the infection with the lack of infection control. Res Ipsa Loquitur, an evidentiary tool, used very sparingly by courts, allowed a jury to find causation without direct evidence of causation, was no longer a requirement to win infection cases.

Defendants raised numerous defenses arguing the infection could have been acquired outside of the facility and the Plaintiff could not meet its burden of proof of causation. The hospitals’ attorneys were able to successfully shield privileged infection control committee meetings and action notes from discovery. Mandatory reporting by hospitals of infections to governmental agencies through coding was reconfigured to order to avoid data retrievals that would damage their defenses.

The emergence of liability for transmitting antibiotic resistant bacteria in the hospital was difficult, expensive and time-consuming litigation, for even if the hospital’s infection control program was followed and within standard of care, infections would still occur. Reaching 0 as an infection rate, was, in short, impossible.

Hospitals were losing the healthcare battle with antibiotic resistant infections, and Plaintiffs lawyers were still not willing to take on these difficult cases. The Federal Government began to exact financial penalties to hospitals through Medicare non-reimbursement. Recently, a hospital system was penalized 1% of reimbursements in 2016 for failure to prevent hospital-acquired infections.3 Medicare classified certain infections as HAI’s and non-reimbursable. These penalties were designed to offer financial incentives to hospitals to reduce HAI’s, but often resulted in hospitals taking measures to reduce this financial risk through failing to own infections, non-reporting, transferring patients or refusal to accept patients with antibiotic resistant infections. Thus, Medicare penalties were in some instances having the opposite of the intended effect of reducing HAIs.

U.S. losing the battle against antibiotic resistant infections

In the meantime, the United States’ battle with the rapid and urgent need to stop the emergence of antibiotic resistant infections was being lost. We now are on the verge of reverting to the pre-antibiotic world, where surgery is too risky, chemotherapy is not possible and bacterial illnesses are untreatable.

Lawyers, from both the plaintiff and defendant sides of the fence, are in a unique position to assist this international and national battle against time. New theories of liability are emerging with the new strategy outlined by the president in 2015. Instead of focusing on infection control, which is still absolutely required within standard of care and must be followed by all healthcare workers and facilities, the new focus of liability will be failure to institute Antibiotic Stewardship Programs. Monitoring judicious use of antibiotics within the facilities will be the standard of care. This requires strict, controlled ordering of antibiotics by physicians. Preparation for required, automatic reporting of lab results indicating a positive culture for an antibiotic resistant infection will be implemented.

For physician practices, new liability has emerged for incorrect post- operative infection care, including failing to culture, prescribing incorrect antibiotics, failing to recognize and treat infection and failing to follow hospital rules (not guidelines) for ordering antibiotics.

The stakes are higher for the general public than simple monetary liability for providers. The current thought is overprescribing and incorrect prescribing of antibiotics is the root cause of resistance. Patients need to be educated on the correct use of antibiotics. But in the end, this measure will only be a front-line battle in a war that is being lost globally until new science emerges that does not rely on antibiotics to win. Emerging technologies designed to kill bacteria in the hospital Operating room and patient rooms will have to be invested into by the hospital in order to satisfy the standard of care.

Personal injury law and medical malpractice suits help to wage war on antibiotic-resistant bacteria

Financially, under the current trend of emergence of ARBs that we cannot treat, the number of surgeries will drastically decline, for the risk will outweigh the benefits. Hospitals and physician offices will be overrun with patients that are untreatable with even the most basic types of illnesses that before, in the pre-ARB world, would be cured with a simple office visit and a prescription for penicillin. Medicare costs will sky rocket, as patients become sicker and require drastic life saving measures. Hospitals will no longer be safe, and new facilities for patients with infections will emerge.

Lawyers will be involved with this battle, by suing for damages and advising the healthcare industry on how to avoid liability. These efforts could prove to be helpful, instead of a hindrance, in assisting the defeat of these microscopic bacteria that are quietly winning the race against time. New standards of care requiring hospitals to employ the newest science, technology and research will have to be implemented, if not to avoid liability, but to protect patient care and safety.

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