TALLAHASSEE, Fla. (September 4, 2008) - Patients were the big winners last week as the Florida Supreme Court prevented a hospital from infringing on doctors' ability to safeguard high-quality medical care. The ruling in Lawnwood Medical Center v. Lawnwood Medical Staff ensures hospitals pursue an appropriate balance between patient care interests and corporate interests.

"The victory before the state Supreme Court reaffirms that medical staff bylaws are a binding contract and lays out precisely why these documents are an important part of preserving patient safety," said Cecil B. Wilson, M.D., a Winter Park internist and board member of the American Medical Association (AMA)."Hospital boards must work cooperatively with medical staffs to ensure that hospital policies related to financial management do not conflict with the best interests of patients."

The ruling strikes down a Florida statute passed in 2003 that would have eviscerated the rights,duties and responsibilities of physicians at Lawnwood Regional Medical Center. The "St. Lucie County Hospital Governance Law" allowed hospital board policy to unilaterally supersede medical staff bylaws in conflicts over privileging, contracting and quality issues. The Florida Medical Association (FMA) vigorously opposed this legislation when it was introduced in the state legislature.

Last year a Florida appeals court found the law unconstitutional. The recent decision by the Florida Supreme Court affirmed the lower court's ruling and noted the law "grants Lawnwood almost absolute power in running the affairs of the hospital, essentially without meaningful regard or the recommendations or actions of the medical staff."

"Physicians who comprise medical staffs are in the best position to make decisions on medical issues that affect patients' well-being, not hospital trustees," said Steven R. West, M.D., a Fort Meyers cardiologist and FMA president. "The rights, duties and responsibilities of the medical staff must be respected by hospital boards, not circumvented using legislative influence with lawmakers."

"The Lawnwood case is an important court victory, which will prevent hospitals from encroaching on medical staff autonomy and becoming embroiled in a legal tug of war over the division of responsibilities within the hospital," said Dr. Wilson.

The Litigation Center of the AMA and its state medical societies, along with FMA, joined in supporting the Lawnwood medical staff by filing "friend of the court" briefs before the Florida Supreme Court and a lower level appellate court. The AMA Litigation Center and FMA also provided substantial financial support to assist the medical staff in defraying its legal costs.

"This case shows yet again that when doctors enlist the help of organized medicine, the best outcome for patients and doctors can be achieved," said Dr. Wilson.

Florida Society of Dermatology and Dermatologic Surgery
Public Health Advisory on Para-phenylenediamine (PPD)

April, 2008

The FSDDS has written this notice to inform and warn the public that para-phenylenediamine (PPD), a common hair dye, is being added to henna to make black henna for use as temporary tattoos.  The Warning statement below recommends that this practice be stopped because there is the potential for long lasting allergy. 

Warning Information

Henna tattoo artists are currently adding PPD to henna to make black henna.  PPD has long been known to cause allergy and the concentrations used to make temporary black henna tattoos are significant.

Persons who become allergic to PPD may also demonstrate allergy to significant medically necessary medications (diabetic medications, hypertensive medications and anesthetics), in addition to hair dye and dyes used in clothing.

Health care providers should be aware of this adulteration of henna (which is brown) by PPD and warn patients and parents of the possibility of this long lasting allergy, which includes both anaphylactic and delayed types of allergy.  Furthermore, PPD can have detrimental and permanent skin adverse effects (such as blisters, pigment changes and scarring).

Heath care providers should carefully evaluate patients in whom reactions have occurred and provide educational information, so that persons do not receive these black henna applications in the future.

Background

Paraphenylenediamene (PPD) is an oxidative chemical frequently used as a permanent hair coloring agent.  Serious reactions to this chemical prompted a revision of the obsolete Food and Drugs Act of 1906 and development of the Food, Drug, and Cosmetic Act (c. 1938).  The new act extended regulatory control of cosmetics for the first time and its first action was to remove Lash LureTM (eyelash cosmetic with PPD) from the consumer market and the prohibition of PPD in cosmetics directly applied to the skin.  

A recent increase in pediatric consumers using PPD-adulterated henna for temporary tattoos has likewise come with an increase in serious cutaneous inflammatory and scarring reactions.  In addition to scarring, there is the potential for persons sensitized to PPD to have lifelong allergic intolerance of dyes in hair products, rubber chemicals, inks and textile dyes and to some medications to treat hypertension and diabetes (e.g. hydrochlorothiazide and sulfonylureas).  To draw attention to the practice of PPD-henna tattooing the journal Dermatitis, official journal of the American Contact Dermatitis Society (ACDS), named  PPD as the Allergen of the Year in 2007.  Despite this the temporary tattooing practice continues to flourish, unregulated.
Health Canada, the federal department responsible for helping Canadians maintain their health, has alerted its citizens to avoid “black henna” temporary tattoo ink and paste containing PPD. Section 16 of their Food and Drugs Act prevents the sale of cosmetics that may harm the consumer, including “black henna” temporary tattoos containing PPD.

The Scientific Committee on Cosmetic Products and Non-Food Products (SCCPNFP) has assessed the use of PPD and similar chemicals as hair coloring agents, and made appropriate recommendations on the use concentrations, restrictions, and warnings for such application in the European Community Cosmetics Directive.  This states that “When PPD and similar chemicals are used for skin staining (temporary tattoos), active sensitization may occur within a few weeks and the reactions can be very severe. Pigmentary variegation may persist for a prolonged period following such reactions. The sensitization will be life long.”  Notably “The SCCNFP is of the opinion that PPD and similar chemicals should not be used in skin stains (temporary tattoos)”.     

An American Academy of Dermatology Advisory Committee, the American Contact Dermatitis Society, and the Society for Pediatric Dermatology endorse the ban set forth by the Food and Drug Administration that paraphenylenediamine should not be applied to the skin and recommend that the practice of applying paraphenylenediamine-adulterated henna tattoos to the skin be stopped.

References

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