Peter Rudd-Clarke, legal director at RPC, explains why the Coronavirus illustrates the litigation risks for manufacturers and healthcare providers when responding to an epidemic or pandemic
Coronavirus serves as a reminder that the scientific community has been consistent in warning that it is a matter of ‘when’, not ‘if’, the next epidemic or pandemic emerges. A new virus presents challenges to companies in the healthcare sector. If they make mistakes, they could be sued by patients, members of the public or their families. Businesses and hospitals will benefit in the long run by taking the opportunity to stress-test their responses to the threat of emerging and little understood contagious diseases.
Every time a new virus emerges, whether SARS, Ebola or now Coronavirus, there is an increased risk that the virus could spread further and faster than the last outbreak. Pathogens such as Coronavirus thrive in 21st-century conditions. Cities are increasingly crowded, the world’s population is ageing and international air travel is becoming more common. These conditions increase the prospect of a new virus emerging in one part of the world and soon presenting problems elsewhere. We have seen well-documented examples of Coronavirus spreading quickly between continents. When a new and little understood virus appears in a new country, the authorities must scramble to respond to its challenges. Inevitably, this puts pressure on manufacturers to provide equipment and new drugs. Hospitals must be prepared for an influx of patients.
Although it is early days, medical equipment is proving to be a key part in developing an effective response to Coronavirus. Facemasks are ubiquitous in Asia, although the scientific community is split over their effectiveness. Surgical facemasks are in demand by hospitals. Kits are being developed to speed up the diagnosis of Coronavirus, in recognition of the fact that laboratory testing is relatively slow and expensive. Public officials are using hazmat suits when decontaminating areas or interacting with people suspected of carrying the virus.
PROFIT FROM AN
Innovative companies that can respond quickly to demand could profit from an increased need for protective equipment. Experience suggests, however, that manufacturers need to exercise caution in responding to frantic demands for products to be brought to the market more quickly than normal.
Protective equipment or diagnostic kits can fail for any number of reasons, sometimes due to user error or unforeseeable circumstances. Nevertheless, in cases where failure leads to cases of infection, hospital staff and members of the public could bring claims against manufacturers if the equipment was poorly designed or the manuals accompanying the equipment were not fit for purpose. Importers or distributors could also face claims, particularly if they assume responsibility for the effectiveness of equipment, or if claimants consider them to be the easiest target to sue.
Manufacturers should ensure that the limitations of protective equipment and diagnostic devices are properly explained. They should also prepare training materials that are easily understood by users.
Hospitals might not escape liability if protective equipment failed because they did not provide adequate training to their staff, or if they failed to warn patients or staff of the risks associated with such equipment. Litigation, where equipment fails, is, therefore, likely to focus on the chain of causation to pinpoint where failures occurred and who was to blame.
Healthcare providers should stress-test the guidance and disclaimers that accompany the equipment. These documents need to be updated to ensure that they are easy to understand, track the current state of knowledge on the ways that Coronavirus can be transmitted and guarded against, and clearly spell out how the equipment is to be used.
In normal circumstances, vaccines can take years to develop. Often, it can take around 12 years for a new medicine to be developed from its research phase through to marketing authorisation being granted. However, in the case of Coronavirus, experimental drugs are being developed at a much greater speed.
Clinical trials are needed to test whether new medicines are safe and effective. Industry guidelines provide for compensation for patients in the event of injury sustained due to clinical trials. The agencies and companies involved in clinical trials will need to ensure that the risks of participation in clinical trials for a Coronavirus vaccine are made clear to trial subjects, particularly regarding unknown side effects, and that all patients involved receive a high standard of care.
Ebola provides an interesting counterpoint to Coronavirus. Urgent research and manufacturing of a vaccine for Ebola proved effective. In the case of Ebola, the urgency was sparked by statistics showing that the fatality rate was around 70%. The fatality rate
associated with Coronavirus is much lower (believed to be around 2%). Pharmaceutical companies may, therefore, take a more cautious approach to rushing production of a vaccine, at least until the side effects of a new drug are better understood.
Hospitals and doctors
Hospitals may be particularly exposed to litigation. Healthcare workers in China have contracted the disease after treating patients. This serves as a warning that healthcare workers elsewhere may contract the disease if an outbreak of the virus occurs in their countries. Equally, failures in hospital systems could lead to avoidable cases of Coronavirus in patients or members of the public.
Fast-moving circumstances, where the authorities lack a full understanding of a disease, increase the risks of litigation.
If there are claims, the claimant population could include members of the public, patients and hospital employees. Where a member of the public visiting a hospital, or a nurse treating a patient, is infected, claimant lawyers may see opportunities to bring claims against hospitals, doctors and health agencies. Hospitals could be sued if they do not train staff to respond to a Coronavirus case. Individual doctors who do not spot symptoms could also face claims.
If there is litigation, it may be difficult to resolve due to the unique challenges presented by Coronavirus. A hospital has a duty of care to protect its staff, patients it treats, and potentially, members of the public who visit the hospital.
A claim against a hospital or doctor will hinge upon determining whether the defendant was in breach of that duty of care. Determining the standard of care, however, could prove difficult as healthcare agencies across the world continually update their protocols for dealing with the disease. In the initial stages, the standards healthcare agencies must adhere to are not clear-cut, particularly where difficult triage decisions need to be taken.
Extraordinary circumstances can make determining whether defendants were in breach of their duty of care difficult to resolve.
If not now, when?
Ultimately, it is hoped that the current outbreak of Coronavirus will be contained and businesses, and the public in general, will be spared the consequences of a ‘worst case’ scenario that could lead to litigation. By appreciating where liability risks lie, however, manufacturers and hospitals can put in place policies to reduce the risk of being sued where errors over treatment or use of medical products could cause infection, injury or loss of life.
What is certain is that there will be further challenges, even after Coronavirus is contained.
In September 2019, just weeks before the current outbreak, the World Health Organization warned that the world was facing ‘an acute risk of devasting disease pandemics’ which would kill millions.
Coronavirus is a reminder that robust policies to cater for the risk of infectious diseases should be kept under constant review.