Question

Health Law

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 discuss in your paper how these cases impact treatments.

Answer 1

New medical practice is the invention of new medical treatment and it is the responsibility of the physician to be liable to explain in detail about the procedures and the treatment to the patients. Its potential benefits and side effects to be taken consent in prior.The subject should enroll them in the clinical trail first for ne innovation treatmentThe physician cannot be blamed at one end if the consent is given by the patient. I do not think that a physician should be immune from a 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. That is because the potential risks that could affect their patients are numerable and can be different based on the patient. It is up to the physcians and by extension, the pharamaceutical companies to warn patients about the possible side-effects from taking new medications. The Perez case is a good example of this. In the 1990s, Wyeth Laboratories started advertising a new contraceptive that they created in which it had to be surgically implanted into a woman’s arm by a physician. During this campaign, the company failed to warn the consumers about any of the possible side effects from taking said drug. By 1995, women were filing suits in large numbers against Wyeth Laboratories, claiming that the manufacturer failed to adequately warn women about the drug's side effects, including, to name a few, headaches, nausea, diarrhea, acne, numbness in the arms and legs, and removal complications that caused scarring (Margolis). It was ruled in court that the physicians and not the company could be held liable. This is due to the New Jersey Products Liability act and it states that the company was only responsible to correctly advertise all known side effects to the physician and not the patients. There are actually rules that lists a manufacturer's compliance with Food and Drug Administration requirements for advertising, labeling, and warning creates a rebuttable presumption that the manufacturer satisfied its duty to warn consumers.

            Innovations in medical practice are critical to the advancement of medicine. Good clinicians constantly adapt and modify their clinical approaches in ways they believe will benefit patients. Innovative practice frequently is approached very differently from formal research, which is governed by distinct ethical and regulatory frameworks. Although opinions differ on the distinction between research and innovative practice, the production of generalizable knowledge is one defining characteristic of research. Physicians considering innovative practice must disclose to patients the purpose, benefits, and risks of the proposed treatment, including risks not quantified but plausible. They should attempt an innovative procedure only when familiar with and skilled in its basic components. A clinician should share results, positive or negative, with colleagues and, when feasible, teach successful techniques and procedures to other physicians. Practitioners should be wary of adopting innovative procedures or diagnostic tests on the basis of promotions and marketing when the value of the procedures or tests has not been proved. A practitioner should move an innovative practice into formal research if the innovation represents a significant departure from standard practice, if the innovation carries unknown or potentially significant risks, or if the practitioner's goal is to use data from the innovation to produce generalizable knowledge. If there is any question whether innovative practices should be formalized as research, clinicians should seek advice from the relevant institutional review board.

Reference:

B.R Greaney Furrow, T.L. Johnson, S.H. Jost. Health Law seventh edition. St Paul: Thomas-West, 2013.

Margolis, Melanie R. Drug Manufacturer Liability. 25 August 1999. 30 September 2016.