Dale Andrade

Legal Issues of the 21st Century.

Legal Research “Other Biotech”. 

Biotechnology can greatly change our lives.    In particular, it may have a great effect on what form our bodies take in the relatively near future.  In this future, we may have great leeway in choosing our physical characteristics.  Body altering technologies offer an interesting window to legal issues that may crop up when more advanced forms of biotechnology become available.  A major issue in body altering technology arises from elective surgery.  Two of the newest forms of elective surgery are laser eye surgery and hand transplants.   

Laser eye surgery involves the alteration of the cornea of the eye with an extremely accurate surgical laser in order to improve ones vision.  Hand transplants are performed by grafting a cadaver’s hand onto a living limb.  This process gives the patient a largely functional hand but requires them to endure daily injections of powerful immunosuppresant drugs which may be harmful to the patient. 

 Both procedures are relatively new and potentially harmful to the patient and are entirely elective.  Current regulation of these technologies may offer us insight by analogy into future regulation of elective appearance altering biotech.  Hand transplants and laser eye surgery illustrate how the law may deal with potentially dangerous technologies that remedy physical wrongs that is non-essential to survival.  The body of law regulating these technologies is relatively young but is beginning to take form…

Statutory Law

Elective Surgery:

            The California Business and professions code provides two statutes, one dealing with collagen and one with silicone breast implants.  These statutes require that physicians provide a written summary of the procedure the patient will undergo in addition to any possible risks or side effects of the surgery.  These provide a duty to give the patient all necessary information before undertaking the procedure.  (Collagen: Cal Bus & Prof Code 2259. (2003), Silicone: Cal Bus & Prof Code 2259 (2003).) 

            The California Health and Safety Code has a special code section dealing with experimental medial procedures (like hand transplants).  This section requires full disclosure of all relevant information and all risks associated with the experimental process.  (Cal Health & Saf Code 24173 (2003). 

            After someone has all the information, how will they pay for it?  The California Welfare and Institutions Code has sections detailing medical aid for reconstructive surgery.  One section provides that medical procedures like a mastectomy are not considered reconstructive surgery and implies that surgical restoration of the breast may be covered.  The traumatic loss of a breast may be analogized to the loss of a hand, potentially netting Medi-Cal coverage.  Another part of the same code includes “abnormal structures of the body” that have been caused by trauma among other things.  A common trend in hand transplants is the loss of the hand through some form of accident induced trauma.  (Cal Wel & Inst Code 14132.62 (2003) and Cal Wel & Inst Code 14132.6 (2003). 

            Acquisition of cadaver hands and or other parts necessary for these new transplant operations will likely be covered by the California Government Code  which details the “retention and removal of parts for transplant or theraputic, or scientific purposes.  (Cal Gov Code 27491. 

            In the event the procedure is botched by the doctors, there may be an action based on negligence.  The statute listed here covers professional negligence actions including most breaches of a doctors duty of care. (3-30 California Torts 30.00). 

Laser Eye Surgery:

            Laser eye surgery would also be covered by the relevant duty to inform, negligence and informed consent standards listed above.  In addition, there is a separate statute under the California Government code specifically detailing the removal of corneal eye tissue from a body in the coronor’s custody for transplantation or scientific study.  This may provide an interesting crossover whereby the corneal tissue of a cadaver could be grafted onto a normal persons eye (and adjusted by laser?).  (Cal Gov Code 27491.47 2003). 

            Oklahoma appears to be the first state to official’s incorporate the “Lasik” process by name into its “practice of optometry” definition.  59 Okl. St. 581 (2003). 

            There is very little in the way of official regulation of the laser eye surgery industry.  However, there has been some degree of controversy over this procedure.  Many laser eye clinics pay their salespeople on commission, so there have been complaints filed for high pressure sales tactics and instances where people have been persuaded to have eye surgery that they really didn’t need.  Problems have also arisen where doctors have failed to warn their clients of the risks involved in laser surgery.  Many people even win their eye surgeries in lotteries (see Lasik home page for more (link provided at end of this document).   While the vast majority of patients see marked increases in their vision, some have had severe problems including blindness.  Very little in the way of official statutory regulation exists at the moment but strong statements have been made by some government agencies warning laser eye clinics to halt their use of commission payment systems and other high pressure sales tactics. 

                                                               Case Law 

Elective/hand transplant surgery: 

            Billebault v. Dibattiste states that “although the physician explained the risks of both procedures, he did not assume the duty to inform the patient of all the risks involved in the procedures…and he had no duty to obtain informed consent under govt regulation”.  This case covers situations in which an unforseen complication arises during the medical procedure.  Aside from this, the law is fairly scanty.  1998 U.S. Dist. LEXIS 7399.

Laser Eye Surgery:

            In Gregg v. Kane a lady underwent laser eye surgery and sued the hospital, manufacturer of the laser and her doctors of the reduction in her vision that resulted.  The trial revealed that her Dr. had not negligently performed the operation and that Mrs. Gregg had given her informed consent to it.  Gregg’s motion for a new trial was denied.  1998 U.S. Dist. LEXIS 8437. 

            In Dejean v. Wade an eye surgery was performed to prevent the retina from detaching.  This procedure failed resulting in the puncturing of the patients eye and blindness.  The trial revealed that the physician had failed to warn his patient of the risk of partial or total vision loss and the court directed a verdict against him.  44 S.W.3d 141; 2001 Tex. App. LEXIS 1490. 

            In New York v. Capital District Physicians Health Plan, Inc the plaintiff had laser eye surgery performed without the consent of his insurance agency.  The court found that laser eye surgery is purely cosmetic and that since plaintiff’s vision was correctable with glasses/contacts he was not entitled to be reimbursed by his company.  2002 N.Y. App. Div. LEXIS 545.

                                                            Conclusion

            As can be seen there is still quite a ways to go in the development of elective transplant/surgery law but at least there are some firm precedents for informed consent, disclosure of relevant risks and negligence for injuries caused.  

                                                            Other Useful Information

Elective transplants:

  1. http.handtransplant.org:  Excellent overview of American hand transplants.
  2. cnn.com has many relevant stores on hand transplants sprinked throughout their history section. 
  3. October 1999 issue of Popular Science: This magazine provides a superior overview of hand transplant technology in addition to other types of human body effecting biotechnology.  It also has a great discussion of the potential dangers of this technology.

Laser Eye Surgery:

  1. www.lasiksurgery.com: Laser eye surgery site.
  2. www.2020eyesite.com: This is the site of Dr. Gary Kaywich.  Based locally, renowned nationally.  This site contains a huge amount of information about Lasik surgery in addition to providing an article from the Washington Post critiquing laser eye clinics.  The site also provides a great example of the freewheeling nature of Lasik surgery by providing a lottery for free eye surgery on its opening page.