Legal Requirements for Innovation

In theory tissue engineering sounds like a great advancement for the healthcare industry, so what could possibly go wrong you may ask? Well like everything else in healthcare there is always some kind of risk that needs to be addressed.  Tissue engineering will eventually dissolve the need for organ transplants and in the process save millions of people’s lives. Like I stated in my previous two posts, tissue engineering will eliminate the need to wait for a transplant because a new organ will be created in only a short amount of time with that individuals cells. But before we start to sign our lives away in the process let’s look at what could go wrong and the legal issues that occur.

With new innovation comes new laws and regulations that have to be put into play to insure that someone will be held liable if something tragic occurs. In this case, tissue engineering is still new so there has not been many clinical trials to ensure that this procedure is safe and effective. Since tissue engineering is not in full effect in the healthcare industry quite yet the legal issues first have to start out in the trail stage.  In the journal “Liability Versus Innovation,” Keren-Paz, a student at Keele University School of Law in the United Kingdom discusses the legal process that has to be done to ensure that malpractice is not occurring in the clinical trial period. Keren-Paz states that their ultimate goal is to guarantee that both the “innovation is done responsibly” and that the “legal outcome is fair to the patients.” In order for clinicians to hold trials every patient much first be informed about the treatment they are receiving and the risks that could occur. With new innovation happening in healthcare the patient must know that the specific procedure is new and there are still uncertainties. By receiving an informed consent from the patient the clinician can now continue with the treatment. Next, even if the doctor informs the patient about all the risks and benefits of the treatment they can still be held liable for negligence if something goes wrong. Before a doctor can be labeled as negligent a court must first decide if the doctor was actually negligent or if they did everything correct and the procedure itself was negligent. Along with defining the negligent act the courts must also determine if the “unforeseeable risks to the patients are foreseeable benefits to the third party.” Lastly, Keren-Paz poses the question of whether these laws restrict the innovation of regenerative medicine.

Tissue engineering will one day save millions of people’s lives and the hope is one day people will not have to die waiting for a transplant. Since this innovation is still new it has to be tested and in the clinical trials meet the legal requirements above. Once that is done and the treatment is on the market, humans will then be able to live longer and healthier lives.


2 thoughts on “Legal Requirements for Innovation

  1. Jessica Thomulka

    I think the bigger picture here is the implications of medical malpractice on the entire healthcare industry. It is important to acknowledge all of the stake holders in this tissue engineering dilemma: the patient, the doctor, the research scientists, doctors, and professionals behind the innovation, and last but not least, the insurance companies. Medical malpractice claims form when healthcare professionals do not provide the standard quality of care, thus resulting in an injury or harm to the patient.
    As a patient there is a reasonable expectation that when seeking treatment, the most advanced and best practices will be used to help alleviate one’s ailment. An article published in the Journal of the American Medical Association reported that nearly 12,000 patient death occur due to unnecessary surgery. Tissue engineering presents an interesting case in this regard. Like the blog post mentions, with proper development, tissue engineering has the potential to save many lives. I know that currently with organ transplants there is a large risk of rejection of the transplanted organ. Hopefully, with engineering, doctors can design an organ with little or no chance of rejection. If there are such good prospects regarding tissue engineering, what is holding physicians back? Medical malpractice and the threat of liability.
    When a medical malpractice suit is brought upon a physician this can lead to mental distress, lost time from work and a damaged reputation. All three of these things can be deterrents when trying to employ the latest and greatest technologies.
    There are also inherent ethical issues that surround clinical trials and testing. Is it just to put a person at risk for the benefit of other? This is the major issue when looking at the implications of trials. The rules and regulations surrounding clinical trials must be strict to protect patients from abuse. This presents a double-edged sword: the trial is needed to continue the treatment development process but the trial itself is troublesome in regards to the risks it imposes on the subjects.
    Suppose a doctor performs hundreds of liver transplants each year and has a success rate of 85%. Some people may argue that this is a good statistic, but what about the other 15%? With the advent of tissue engineering this same doctor may be able to increase his success rate to nearly 100%, accounting for circumstances that are beyond anyone’s control. Imagine yourself to be in the doctor’s position. Today 85% is considered to be an acceptable success rate, would you risk medical malpractice and your reputation to save the other 15%? Say for example, out of 100 tissue engineered organ transplant 1 goes horribly wrong and the patient dies. The patients’ family sues for medical malpractice because of some procedural error committed by the doctor and the hospital. The court finds for the family and now this once esteemed physician now has a tarnished reputation all in the name of science and the advancement of medicine.
    I think the take away here is that something has to be done to protect the doctors and researchers from these crippling medical malpractice suits. If there are no protections for this class of professionals put in place it is going to be a long time before we see tissue engineering in practice.

  2. Alex Vovk

    In her blog post “Legal Requirements for Innovation”, Tessa Mecca discusses the pitfalls and risks scientific advances in the healthcare industry may bring to the treatment of patients and what can and should be done to minimize these risks. Specifically, the question concerns the cutting edge development in the fields of tissue engineering, transplantation, and organ generation. The impact of the increased availability of much needed organs for the thousands of patients in dire need of life-saving transplant procedures is difficult to underestimate. Instead of waiting weeks, months, or even years for the organs, with the continuing improvements in the process and better understanding of the mechanisms involved in tissue engineering, patients in need of donor organs will be accommodated in a matter of days or even hours.

    However, like most innovations, these new technologies will bring a whole number of issues, medical, ethical, and legal. Ability to 3D print tissues and organs on demand will undeniably be embraced by those whose health and lives depend on these procedures, as well as by the patients’ friends and families. But innovations, especially in the healthcare industry need to be carefully considered and their risks evaluated and disclosed to the potential clients.

    Even today, when the patients are enrolled in the clinical trials for new medicines and treatments still in various phases of research and development, they have to be fully informed of the methodology, technology, risks, and possible outcomes. Failure to do so may result in legal claims and malpractice suits, hindering the progress and damaging the adoption of the innovative treatments.

    With the rapid advancement of scientific, engineering, pharmaceutical, and bio-medical research and development, legal research and developments have to keep up with the pace to protect both the patients and the professionals who administer their care.

    Several decades back, when cloning was introduced, there were numerous protests and widespread fears that the practice would be used in illegal and unethical ways. It took years of legal research and debates for the issue to be properly studied and legal opinions to be formulated and codified into laws. Similar obstacles exist even today whenever the topics of stem cell therapies, genetic modifications, or tissue engineering are brought up. Unfortunately, these issues are often misinterpreted or misrepresented, and become the source of political debates and polarize the public opinion with the result that promising and potentially life-saving technologies are suppressed or outlawed. It is vitally important that there is an honest discussion to inform the public, as well as those in politics or government who can affect policy decisions. These discussions should be devoid of posturing and ulterior motives of political gains. Unfortunately, it is easier said than done, especially considering that many innovations are resisted by firms and businesses which stand to lose money from these new products, treatments, and procedures, and who would go to extraordinary lengths and spare no expenses to see these innovations delayed.

    Like most innovations that have the potential revolutionize society and to vastly improve the health of humans, enhance, and often prolong their lives, they cannot be stopped. The competition, scientific progress, market forces, eventually will prevail and make the new treatments available to the patients. As Stewart Brand, a renowned author and entrepreneur said: “Once a new technology rolls over you, if you’re not part of the steamroller, you’re part of the road.”


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