Risk of Harm and Liability in New Medical Treatments


New medical treatments, by strict definition, are not the “current medical practice.” Should a physician be immune from liability for harm suffered from a patient who is among the first to be treated in a new and innovative manner in which the potential risks have not been discovered? Discuss this and then report on a new and possibly innovative medical treatment (i.e., medication or medical procedure, diagnostic tests, etc.) where there exist uncharted waters about the possible outcome. Review carefully the Perez case and the Hardi case ( p 389) as a starting point and state in your paper how these cases impact treatments.

Risk of Harm and Liability in New Medical Treatments

There is a significant risk of harm when physicians opt for new and innovative forms of treatment. Physicians may opt for new forms of treatment in order to improve patient outcomes. The innovations may range from new surgical procedures and drug prescriptions that are of unknown safety to the patient. Medical malpractice regulations aim at checking physician behavior with regard to the patients’ safety. The overriding goal is to deter physicians from putting their patients at significant and unnecessary risk of harm from new treatments. Further, medical malpractice regulations also aim at ensuring a balance between the risk posed by new treatments and physician innovation. Stringent medical malpractice laws may discourage physicians from developing new treatment plans that would best address the health needs of the patients.

The Perez case and Hardi case significantly influence treatments. The Perez cased revolved around whether the doctrine of the learned intermediary applied to the defendant (Furrow at al., 2013). The Supreme Court held that the doctrine of learned intermediary might not be applicable in situations where drug manufacturers engage in direct marketing of the various prescription drugs. As such, drug manufacturers have a duty to provide adequate warnings to consumers about the side effects of the prescription drugs. In Hardi case, a physician is liable for misconduct if there is evidence indicating mischief or wrongdoing on the side of the physician (Furrow at al., 2013). These cases illustrate that physicians enjoy immunity from liability to a certain extent. Physicians will enjoy immunity if they inform their patients of potential risks and where they act in the best interests of the patient. This is irrespective of the outcomes.

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Physicians should be immune from liability for harm suffered by a patient when using new medical treatments provided they follow certain standard procedures in administering treatment. Various legal concerns emerge when physicians abandon established practices in favor of innovative ones. Although the goal might be to advance medical practice, some new medical treatments could carry significant and unnecessary risks for the patient (Laakmann, 2015). The Belmont Report of 1979 highlights some of the ethical principles concerning research in healthcare settings (Laakmann, 2015). The Belmont Report makes a clear distinction between medical practice and research. Medical practice refers to those activities aimed at improving the health outcomes of a particular patient. In addition, medical practice involves activities that have a relatively high degree of success. On the other hand, research involves those activities that aim at improving the general knowledge in a particular field.

There is high degree of regulation in medical research. On the other hand, there is limited regulation in medical practice (Laakmann, 2015). Physicians face little regulation when applying innovative medical procedures. The most important consideration is the anticipated probability of success. There exists a thin line between medical practice and research (Laakmann, 2015). A physician may adopt a new procedure basing on the outcomes of a single treatment outcome. The repeated application of such a procedure basing on the outcomes mirrors many aspects of formal clinical research. As such, physicians who use new medical treatments that unfortunately result in harm should not face litigation provided they were engaging in practice and there was anticipation of high probability of success.

There are other factors may help in the exoneration of physicians who causes harm to patients. A physician who uses a new medical treatment to treat a life-threatening disease for which there are no alternative treatments is more likely to receive exoneration even though the treatment leads to harm (Laakmann, 2015). Further, the physician may reduce the risk of liability by seeking informed consent from the patient to use the new medical treatment. In this case, the physician should inform the patient about the new procedure, anticipated risks, and the uncertainties involving the procedure. The physician must inform the patient that the treatment procedure is unproven. In Goodman v. United States, the Ninth Circuit held that physicians were immune from liability since they did not reasonably believe there was a high risk of harm (Laakmann, 2015). The plaintiff filed for litigation following the death of his wife on receiving a toxic medical substance for surgical purposes. This judgement indicates that physicians are immune from liability provided they engage in medical practice with the aim of improving patient outcomes.

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A new and innovative medical treatment is in the prevention of transmission of human immunodeficiency virus (HIV). One of the new drugs is Tenofovir 1% gel (TFV), which will help in reducing incidences of HIV infections (Dobard et al., 2015). The gel targets the population at risk of HIV, including those who engage in anal sex. Some studies indicate that TFV shows great promise in reducing HIV transmission rates. According to Dobard et al. (2015), two studies have already shown that TFV is effective in reducing HIV transmission. The findings by Dobard et al. (2015) indicate that TFV can reduce rectal HIV infections. Nonetheless, some study participants have reported various side effects including cramps, abdominal bloating, and gastrointestinal symptoms. There is no conclusive evidence detailing the effectiveness of the gels in reducing vaginal and rectal HIV infections. There is need to evaluate the effectiveness as well as the side effects of the new forms of HIV prevention procedures.


Dobard, C. W., Taylor, A., Sharma, S., Anderson, P. L., Bushman, L. R., Chuong, D., . . .             Heneine, W. (2015). Protection against rectal chimeric Simian/Human immunodeficiency         virus transmission in macaques by rectal-specific gel formulations of maraviroc and        tenofovir. Journal of Infectious Diseases, 212(12), 1988-1995. 10.1093/infdis/jiv334

Furrow, B. R., Greaney, T., Johnson, S., Jost, T., & Schwartz, R.  (2013). Health law: Cases,       materials and problems. St. Paul, MN: West.

Laakmann, A. B. (2015). When should physicians be liable for innovation? Cardozo Law             Review, 36(3): 913-968. Retrieved from http://www.cardozolawreview.com/content/36-     3/LAAKMANN.36.3.pdf