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Many ASAPS members are called upon to testify whether they, or one of their colleagues, have practiced medicine below the standard of care. It is something of a trick question, because it suggests there is one standard, “the” standard, against which any given surgeon's performance, and legal liability, may be judged. Such a conclusion would be an error. There is no single standard of care, no uniform test, no absolute bright line against which a doctor's decisions can be evaluated. Instead, the standard of care is whatever a doctor, accepted by the trial judge as an expert, says it is. The same trial judge will permit other qualified doctors to render differing opinions. Ultimately the judge or the jury will decide which expert's opinion should be given greater weight, and thus, whether the defendant surgeon is innocent or guilty of malpractice. How can something as seemingly immutable as “the” standard of care be reduced to dueling opinions? The answer lies in the law of negligence, of which medical malpractice is one type. Most legal principles, including negligence, are uniform from state to state. That is why prospective lawyers, when taking their state's bar, must pass the Multistate Bar Examination, an identical day-long multiple choice exercise administered in 49 states (save Louisiana) and all US territories (save Puerto Rico). I am going to confine my discussion of medical negligence case law, and the standard of care, to its development in my licensed state of California. In 1858, when one miner's sluicing practices washed away another miner's pay dirt, the California Supreme Court defined negligence as the … Corresponding Author: Robert H. Aicher, Esq, 212 Glen Summer Road, Pasadena, CA 91105, USA. E-mail: aicher{at}sbcglobal.net

They called it Sunshine because legislators wanted to shed light on doctors receiving money from drug and device manufacturers. As I reported in Aesthetic Society News 3 years ago,1 the dawn of the Physicians Payment and Sunshine Act was Senators Grassley and Kohl introducing Senate Bill 301 in 2009. SB 301 failed to spark but was rekindled in the Affordable Care Act,2 which became law in 2010. Its catchy title was lost in translation. On February 8, 2013, the Centers for Medicare & Medicaid Services (CMS) published the final rule and renamed it the National Physician Payment Transparency Program: OPEN PAYMENTS. Everyone is still calling it the Sunshine Act, and so am I. So what is the sun shining on? Surprisingly, the Sunshine Act isn't focused on illegal kickbacks but on legal payments to doctors by industry that didn't necessarily rise to the level of Medicare fraud. Nevertheless, the genesis of the Sunshine Act arose from anti-kickback and False Claims Act prosecutions of hospitals, pharmacies, and manufacturers. For instance

Background: The current method of determining donor- and product-relevant parameters from donor serum and plasma do not only involve the safety-relevant risk of

The Cayman Islands have long offered safe harbor to financial institutions and tourists alike. (A British Overseas Territory, the Cayman Islands have no income tax, nonresident tax, capital gains tax, or corporate tax.1) Due to recent actions by the US Food and Drug Administration (FDA), the islands may, as well, enhance their reputation as safe harbor to companies developing stem cell treatments. More important, however, is the issue of whether actions by the FDA in relation to stem cell treatments mean that the agency has officially stepped over the line and, at least in this instance, is now regulating the practice of medicine. The FDA's primary charge is to ensure the safety, efficacy, and security of drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation.2 A drug includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”3 The FDA states that this broad definition also includes therapeutic biological products such as cells and tissues.4 For almost 20 years, stem cells have been harvested, preserved, and reinfused to help patients recover from cancer treatments.5–8 Although devices for separating stem cells are within FDA jurisdiction,9 the FDA acknowledges it is not authorized to regulate the practice of medicine.10 It is, however, authorized to regulate drugs.4 So how do stem cells become drugs subject to FDA oversight? That question has been answered by a case involving Regenerative Sciences, Inc, a Colorado-based clinic that offers bone marrow–derived stem cell procedures to treat injuries and degenerative joint conditions.11 On July 25, 2008, the FDA notified Regenerative Sciences that, “based on information posted on your website, mesenchymal stem cells utilized in your Regenexx™ procedure are drawn from a patient's bone marrow, sent to a …

Endorsements designed to sell products are most effective when the endorser is a celebrity or an expert. If such endorsements contain misrepresentations, the endorser risks personal liability. For products related to health and safety, endorsements are subject to evaluation by reliable independent sources. In a number of high-profile cases, the Federal Trade Commission determined that endorsers must have a reasonable basis for their representations. (Aesthetic Surg J 2001;21:373-374.).

The practice of cosmetic surgery is surrounded by significant commercial pressures to remain competitive. One response successfully used by physicians has been to bring aestheticians into the office to provide skin care, makeup, and patient interface services. The next logical step is to carry product lines and market them to the patients before they buy similar products from salons and department stores. Such products do not provide a high risk of malpractice exposure because their safety is sufficient for over-the-counter sale by nonmedical personnel. Although endorsement liability for the physician is ever-present, because of the low concentrations of alpha-hydroxy acids and comparable acids used in most formulations, an adverse reaction by the patient becomes a low-probability event. Nevertheless, …

Robert H. Aicher is an associate of the law offices of Charles A. O’Brien. “You could have asked first…” is a phrase I heard occasionally (maybe more than occasionally!) while growing up. I had learned that it is often easier to receive forgiveness than to ask permission, and that an after-the-fact apology is generally sufficient for most transgressions. However, when it comes to asking forgiveness for exhibiting “before and after” photographs without consent, most patients don't want to hear it; therefore, obtaining prior written permission to use such photographs is essential. Of course, we don't usually ask patients for “permission” to use their photographs. We obtain their informed consent, and when photographs are involved, the consent form states the circumstances under which the pictures may be used. The classic language contained in many such forms is that the photographs may be used “for educational and scientific purposes,” and in discussing the form with the patient, the physician generally highlights the use of the photos in slide form as part of oral presentations made at scientific symposia. However, with media representatives attending many scientific sessions these days, identification of the patient is a possibility. Would a patient consider disclosure to the media under such circumstances to be a legitimate “educational and scientific purpose”? Use of “before and after” photographs in magazine articles, video productions, and television talk shows often represents thinly veiled advertising and seriously strains the “educational and scientific” purpose for which the patient thought he or she was giving consent. > “Recently, a California plastic surgeon did not consider the limits of the …

Dr Bengtson is appropriately concerned about erroneous public perceptions fostered by the Sunshine Act's currently imperfect reporting standards.1 …

The outcomes of lawsuits initiated by patients who fall on medical premises are determined by some general parameters. For example, a patient can recover against the owner only, not the physician tenant, for a defective parking lot deemed common area for the use of all building tenants. The author discusses the factors that courts consider in determining premises liability. (Aesthetic Surg J 2001;21:465-466.).

The National Provider Data Bank (NPDB) was created to restrict physicians from practicing “anonymously” across state lines. But a recent Government Accounting Office report stated that the NPDB is flawed because of underreporting, incorrect reporting, and limited access. For example, a private settlement between a physician and patient is not a reportable event because physicians are not defined as “eligible entities” under the law. The author discusses measures for improving the accuracy of Data Bank information and alternatives providing limited public access to physician information. ( Aesthetic Surg J 2001;21:277-278.)

In some states, recent consumer-driven legislation is putting health care providers under close public scrutiny. Physician profiling, effective in New York in April 2001 and already in effect in Massachusetts and Florida, will make information regarding such matters as criminal convictions, medical board disciplinary actions, restrictions of hospital privileges, and malpractice events involving indemnity payments available to the public.

The article by Wong et al addresses an important topic, but quality is a subjective term and, in the context of Web site advertising, particularly elusive. As such, it would have been helpful to have the term initially defined; without that frame of reference, the article tends to wander as it examines not just the quality but the evolution of physician Internet advertising. The authors do attempt to focus the inquiry by comparing a significant number of Web sites according to the information categories recommended by the American Medical Association (AMA) and American Society of Plastic Surgeons/American Society for Aesthetic Plastic Surgery (ASPS/ASAPS) …

Robert H. Aicher, Esq., Sonoma, CA , is general counsel to ASAPS. After winning a frivolous medical malpractice case, a doctor's thoughts often turn to revenge, historically the remedy of choice for wrongs unjustly inflicted. Because society's greater need is for civil stability in such matters, the doctor's only option is to file a lawsuit against the patient or his or her lawyer for malicious prosecution. Such lawsuits were originally designed to provide a remedy for defendants wrongly charged with crimes, inasmuch as dire consequences could result from the malicious prosecution of innocent citizens by the state. This right to redress was later expanded to include civil lawsuits. However, because civil litigants suffer only loss of property and not loss of life or liberty, as they do in criminal prosecutions, civil actions for malicious prosecution are disfavored to promote free access to the court system without fear of retribution if such a case is lost. Because of the unfavorable status of malicious prosecution, many states treat civil and criminal lawsuits equally and require doctors to prove that they have been arrested or have had their property seized in order for them to recover for damages. This is called the “English rule.” In such states, doctors lose, because only rarely in medical malpractice trials are doctors physically taken into custody for failure to comply with court orders, prevented from practicing medicine, or …

Robert H. Aicher Esq., Sonoma, CA, is general counsel to ASAPS. Nationwide statistics reveal that of all medical malpractice cases filed, fewer than 3% are resolved by trial.1 Of those cases in which plaintiffs sue doctors, 50% are dismissed without payment of either defense costs or compensation to the plaintiffs; in 40%, the plaintiff receives defense costs only, and in only 10% does the plaintiff receive any compensation at all. Of plaintiffs who, choosing not to settle, go to trial, 2 of every 3 receive nothing.2 That being the case, the question arises as to why more medical malpractice cases are not settled, the cost of trial and the potential for a catastrophic monetary loss to either side thereby being avoided. The 3-part answer to this question can be found in the …

Robert H. Aicher, Esq., Sonoma, CA , is general counsel to ASAPS. After suffering a heart attack, a patient in Texas switched physicians. After approximately 50 visits to this physician over the next 3 years, the patient presented at an emergency room complaining of chest pains. He was diagnosed with congestive heart failure but was not admitted, and his physician did not come to the emergency room. A few weeks later, the patient was referred to a cardiologist for a stress test. Although the electrocardiogram (EKG) demonstrated contraindication for a stress test, the specialist went ahead, even holding the patient up on the treadmill after he experienced difficulty in maintaining his balance. The patient eventually collapsed and died a short time later, after CPR had been administered unsuccessfully. Suit was brought against the hospital, the physician, and the specialist. The hospital and the specialist made settlement …

The U.S. Department of Labor is suing Time Warner for denying benefits and overtime to full-time workers by classifying them as independent contractors instead of employees. A group of New Jersey physicians is appealing the decision of the National Labor Relations Board regional director that they are not employees of a health maintenance organization (HMO) and thus cannot unionize. The Internal Revenue Service (1RS) is scrutinizing the widespread practice of failing to withhold taxes from campaign workers' paychecks. The common thread in these situations is the desire by employers to reduce the costs of employees. The issue is not salary, but benefits, which can add another 15% to 25% to the costs. Time Warner is representative of many information technology companies that want to control costs by hiring people without health insurance, workers' compensation, pension benefits, or required overtime pay. Workers, not surprisingly, want those benefits and sometimes are willing to sue for them, such as the former independent contractors of Microsoft who successfully sued in 1995. Nonprofessional workers are not alone in their desire to be classified as …

The term “sexual harassment” denotes a growing body of law frequently involving women suing in federal court under Title VII of the Civil Rights Act of 1964 (42 USC 2000e-2), which prohibits two recognized forms of sexual harassment: quid pro quo, which occurs when submission to sexual conduct is made a condition of employment benefits, and hostile environment, which has the purpose or effect of unreasonably interfering with an individual's work performance or creating an intimidating, hostile, or offensive working environment. Two celebrated cases in June before the U.S. Supreme Court were successfully brought under Title VII. Burlington involved hostile environment (“You know, Kim, I could make your life very hard or very easy at Burlington” and “I don't have time for you right now, Kim—unless you want to tell me what you're wearing”), while City of Boca Raton involved quid pro quo (“Date me or clean the toilets for a year”). Quid pro quo is automatically wrong, but a sexually hostile environment must be both objectively and subjectively offensive, that is, one that a reasonable person would find objectionable, and that the victim in fact found …

The 9th Circuit Court of Appeals, at the urging of the US Supreme Court, ruled that the California Dental Association may restrict its members' advertising regarding quality of care, comfort of treatment, and discounted fees. This ruling has wide application to other trade and professional associations.

The recent case of a 49-year-old cosmetic surgery patient who claimed that she suffered from body dysmorphic disorder∗ (BDD), which impaired her ability to assess the risks of scarring and the availability of alternative procedures, has created a situation with serious implications for plastic surgeons. The patient's proof consisted only of 1997 expert testimony, given by a psychiatrist and an osteopath specializing in plastic surgery, that her symptoms were consistent with BDD. She was never diagnosed with BDD, and her former psychiatrist—whom she had seen between 1986 and 1990 for depression and who had prescribed Prozac and Elavil—claimed to have no files because they had been either stolen or destroyed in an unreported office burglary. …

Robert H. Aicher, Esq., Sonoma, CA, is general counsel to ASAPS. Legislative action is being taken in California, Florida, and New Jersey, most prominently, to restrict physicians in their nonhospital surgical practices. These actions are largely due to safety concerns arising from several recent patient deaths involving multiple procedures and large-volume liposuction. Preceding these legislative changes was the fact that many states (including California) do not require physicians to carry malpractice insurance, or some (such as Florida) may allow the physician to maintain an escrow account or a letter of …

So, you have established a website with slick graphics, descriptive text, and color photographs. You are getting hits from all over the county; one out-of-state hit turns into an actual patient at your surgicenter. Even though you maintained the highest standard of care throughout the procedure, the patient is unhappy with the result. You get served with an out-of-state lawsuit, not for medical negligence, but for breach of warranty. How could this happen? The global nature of the Internet is partly to blame. To be sued out-of-state, courts require that the out-of-state party have “sufficient minimum contacts” so that exercising jurisdiction “does not offend traditional …

β-Thromboglobulin (βTG), platelet factor 4 (PF4), fibrinopeptide A (FPA), lactic dehydrogenase (LDH), and platelet count were evaluated in patients with bioprostheses and prosthetic heart valves. βTG and PF4 were significantly elevated in both patient groups (p < 0.001), whereas FPA was normal. There was no significant difference in plasma concentrations of βTG and PF4 between patients with prosthetic heart valves and bioprostheses. LDH levels were significantly (p < 0.001) higher and platelet count lower (p < 0.001) in patients with prosthetic cardiac valves. The data indicate that bioprostheses do not cause haemolysis or activation of the coagulation system. The findings that the plasma concentration of platelet-specific proteins were elevated, support the assumption that both types of valves cause platelet damage.

βTG, PF4, FPA (all measured by RIA), platelet counts and LDH were determined in 17 patients with PO bioprostheses and 23 patients with PR heart valves. All patients with PR valves and 4 with PO were under oral anticoagulant treatment. ßTG and PF4 were significantly (pA strong positive correlation of βTG and PF4 (R=0.8660) was found in the patient group well as in controls. βTG and PF4 were higher in patients with PR valves than with PO valves, the difference however was not significant. NO higher levels were found in patients with a history of thramboembolism. FPA was normal in PO and PR patients. LDH levels were significantly (p