June 27, 2008

Medspas and freestanding ERs stir controversy as alternative medicine providers.

As hospital emergency rooms fill up with patients and health care providers wrangle with insurance companies over reimbursement, many doctors are turning to alternate venues for treating patients. Controversial medical spas—known as medspas or medispas—are popping up in shopping centers across the nation, offering everything from foot massages to laser hair removal, and sometimes severely injuring their customers. Some providers are creating stand-alone emergency rooms, also often placed in shopping centers, in an effort to alleviate overcrowding in hospitals. While the freestanding emergency rooms are being embraced by some, medspas are increasingly coming under scrutiny for their lack of physician supervision.

Spa industry insiders say that even five years ago, medical spas were rare. But the easy access to Botox injections and the updated technology surrounding procedures such as laser hair removal have created a market for people looking to fight aging without going to a clinical setting. Estimates for how many medspas there are in the United States vary from approximately 1,250 to about 2,500, but all agree that the numbers are skyrocketing. Unfortunately, the medical procedures they provide—laser hair removal, Botox injections, dermal filler injections, microdermabrasion, and other skin treatments—are often not performed by doctors. Instead, procedures are performed by aestheticians, nurses, or other “trained” personnel. In many cases, the supervising physician may not even be on-site, making it difficult to rapidly treat any complications that arise.

According to an online survey performed by the American Society for Dermatologic Surgery (ASDS), 56 percent of its members said they had seen an increase in patients suffering from complications caused by a non-physician performing dermatologic procedures. Doctors reported burning, hyperpigmentation, and overlooked skin cancers. Patient Safety Campaign: Highlights, ASDS (2007 survey), available at www.asds.net. In 2004 and 2005, two women in their 20s died after being instructed to put a topical anesthetic on their legs before laser hair removal. The anesthetic, which had been compounded to contain dangerous levels of two pain-relief drugs, caused seizures in both women, who lapsed into comas and later died. The FDA subsequently issued warnings to the compounding pharmacies to stop creating the compounded anesthetic. Michelle Meadows, Warnings for Makers of Compounded Pain Products, FDA Consumer Mag. (Mar.-Apr. 2007), available at www.fda.gov.

A less controversial, but still contested, growing trend in providing alternatives to traditional hospital treatment is the advent of stand-alone emergency rooms (ERs). Although they can be found in shopping centers or amid office buildings, they are staffed with doctors and nurses and often have state-of-the-art equipment. There are only an estimated 179 facilities nationwide, with about a dozen more planned, but that number represents a 23 percent increase between 2005 and 2006, according to the American Hospital Association. Julie Appleby, More Emergency Rooms Open Away from Hospitals, USA Today (Apr. 24, 2008), available at www.usatoday.com.

Proponents of the ERs argue that the vast number of emergency room visits—115 million visits in 2005 alone—coupled with a decline in the number of ERs means hospital ERs are overrun with patients who are sometimes forced to wait hours before being seen by a doctor.

A big drawback to stand-alone ERs exists, however, because of their very nature: They are not connected to hospitals. If a trauma patient arrives, the facility can stabilize the patient but must then arrange for an ambulance to transport the patient to a hospital for further care. For that reason, some ambulance providers refuse to take patients to the stand-alone centers, arguing that the wait time can compromise care. The centers counter that freestanding ERs may be especially helpful in rural or suburban areas, where the nearest hospital may be miles away, and the quicker they can receive any type of care, the better. Many states and counties that have freestanding ERs are watching them carefully and placing limits on who can be taken by ambulance to the facilities. In Maryland, a pilot program was started with one facility in a suburban area, and the state health department has been tasked with developing standards.

Read the full news story in the July issue of the Professional Negligence Law Reporter – watch for it in your mailbox soon. For a subscription to PNLR, subscribe online(http://www.justice.org/subs/pnlrinform.aspx) or call the Membership Department, (800) 424-2727. AAJ members who subscribe are automatically enrolled in the Professional Negligence Section, which includes online access to current and back issues(http://www.justice.org/Publications/Tier3/ProfessionalNegligenceLawReporter.aspx) of the Professional Negligence Law Reporter.

Concerns about bisphenol A exposure lead to Canadian ban while U.S. companies halt production of products containing chemical.

The National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction—a division of the National Institutes of Health—issued a draft brief on the estrogenic chemical bisphenol A (BPA) in April that concluded that human exposure to BPA possibly affects human development or reproduction. Draft NTP Brief on Bisphenol A, Natl. Toxicology Program (Apr. 14, 2008), available at http://cerhr.niehs.nih.gov.

The brief also alleges that based on studies of laboratory animals, BPA exposure can possibly affect human development or reproduction. Animals exposed to "high” doses of BPA during pregnancy or lactation showed reduced survival, birthweight, and growth of offspring early in life and delayed onset of puberty in both sexes. Animals exposed to "low" doses showed effects related to neural and behavioral alterations, prostate and mammary gland development, and early onset of puberty in females. Together, the findings offer limited evidence that BPA has adverse effects on development, the brief says. It notes that the exposure at a low level is similar to what humans experience and thus “the possibility that bisphenol A may alter human development cannot be dismissed."

Bisphenol A is a chemical used mainly in the production of polycarbonate plastics and epoxy resins. The plastics are used in certain food and drink packaging such as water and infant bottles, compact disks, and medical devices, and epoxy resins are used to coat metal products such as food cans and bottle tops. Human exposure to BPA occurs 99 percent of the time through diet. One popular BPA-containing product is the Nalgene Outdoor line of polycarbonate containers. The company has announced that in response to consumer demand, it will phase out production of these containers. Additional companies working to eliminate products containing the chemical include Wal-Mart Stores, Incorporated, and Toys "R" Us, Incorporated, which plan on phasing out baby bottles with BPA.

A few days after the National Toxicology Program (NTP) issued the brief, Canada announced a proposal to ban the import, sale, or advertising of polycarbonate baby bottles that contain BPA, becoming the first country in the world to limit exposure to the chemical. The proposal is based on the results of a toxicity assessment of BPA that determined that the chemical may constitute a danger in Canada to human life or health. Government Notices: Department of the Environment, Can. Gaz. (Apr. 19, 2008), available at http://canadagazette.gc.ca. Commenting on the proposal, Tony Clement, Canada’s minister of health, said that the assessment concluded that "early development is sensitive to the effects of bisphenol A" and that although exposure levels of infants and newborns to the chemical are below the levels that cause effects, "it is better to be safe than sorry." Minister's Remarks on Bisphenol A, Health Can. (Apr. 18, 2008), available at www.hc-sc.gc.ca.

In response to the NTP's release of the draft, the FDA issued a statement that it has formed an agency-wide BPA task force to review current research and new information on the chemical for all FDA-regulated products. The agency highlighted, however, that FDA products that contain BPA and are currently on the market are safe, and does not recommend anyone discontinue using them while it conducts its risk assessment. Press Release, Bisphenol A (BPA), FDA (Apr. 2008), available at www.fda.gov.

Read the full news story in the July issue of the Products Liability Law Reporter – watch for it in your mailbox soon. For a subscription to PLLR, subscribe online (http://www.justice.org/SingleSignOn/OnlineRegistration.aspx)or call the Membership Department at (202) 965-3500. AAJ members who subscribe are automatically enrolled in the Products Liability Section which includes online access to current and back issues (http://www.justice.org/Publications/Tier3/ProductsLiabilityLawReporter.aspx) of the Products Liability Law Reporter.

 

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