Sunday, January 20, 2013

Plaintiff wants FDA amalgam settlement overturned


Plaintiff wants FDA amalgam settlement overturned

June 24, 2008 -- Just when it looked as though the FDA had calmed critics of mercury fillings, the hornet's nest has been stirred up again. Two weeks after the FDA negotiated a settlement in a lawsuit filed by anti-amalgam activists, one of them has moved to reopen the case.
In the settlement, the agency changed the way it describes amalgam on its Web site -- to imply that some patients may be at risk from the substance -- and agreed to reclassify it by July 2009.
Now one of the plaintiffs, Karen Palmer, a former dental assistant, claims she was not notified of the settlement agreement and would not have accepted it if she had been, according to her new attorney, Jim Love, who also serves as counsel for the International Academy of Oral Medicine and Toxicology. She is asking to be removed from the settlement and for the court to consider earlier petitions that call for a complete ban of amalgam.
"There was a mediation scheduled by the court that was attended not by the plaintiffs but plaintiff's counsel, and there was no authority to settle the case on any particular terms," Love said in an interview with DrBicuspid.com.
Charles Brown, the attorney representing the 11 plaintiffs in the original lawsuit against the FDA, says he is shocked by Palmer's sudden opposition to the settlement. He claims she originally agreed to it "until some lawyers started talking to her."
"We didn't anticipate getting a settlement that day, but I was in a settlement room [with the FDA] and we ended up getting the thing we have never had before: an agreement to reclassify," Brown told DrBicuspid.com. "The goal of the case was to get a date to classify and we achieved that, and even more. The FDA has actually gone from praising mercury to advising of its risks. The plaintiffs had a contract to accept reasonable settlement offers, and they were very excited about this settlement agreement. She [Palmer] was very excited about it. I have e-mails from her saying how much she praised the settlement."
But Love maintains that Brown and the FDA had no right to negotiate the settlement agreement without the plaintiffs knowing the details beforehand.
"The settlement was reached by the attorneys for FDA and by Mr. Brown, but you can't limit a plaintiff's or party's right to control the settlement through a fee agreement," he said. "Whether the settlement agreement was reasonable or not isn't the point. The point is that he [Brown] didn't go to Ms. Palmer to get her authority. She was never contacted concerning the terms of the agreement."
In her motion, Palmer says that if she had received notice of the settlement before it was reached, she would not have agreed to its terms. In particular, she "would have agreed to no more than three months for the completion of the classification process," the motion states.
Love says he has already had assurances from FDA counsel that it will go along with the motion to overturn the settlement. FDA spokespeople could not be reached. But Brown is confident that the settlement agreement will move forward as is.
"We will file a motion and we will win that motion," he said. "That settlement will not be overturned because there is no basis for it."

Patient swallows screwdriver, aspirates wrench


Patient swallows screwdriver, aspirates wrench
By Rabia Mughal, Contributing Editor
June 24, 2008 -- Florida dentists and their patients were puzzling this week over the case of a dentist who dropped both a screwdriver and a wrench -- in two separate appointments -- down the same patient's throat. The patient later died.
Standard precautions would have saved the 90-year-old patient's life, according to his daughter, who is suing the dentist, according to an Orlando Sentinel story.
The patient, Charles Gaal Jr., first went to Wesley Meyers, D.M.D., of Winter Park, FL, in September 2006 complaining that he was having some trouble with a set of lower dentures, according to a complaint filed with the Florida Department of Health. Dr. Meyers proposed a treatment plan to replace them with an implant-supported set of dentures.
Treatment began in October 2006. During a visit, Dr. Meyers dropped an implant screwdriver into the patient's throat. Gaal swallowed the object, which later had to be retrieved from his large intestine via a colonoscopy.
Despite the incident, Gaal wanted to continue treatment with Dr. Meyers, said Gaal's daughter Anne Marie Greer in theOrlando Sentinel story.
But during another visit in May 2007, Dr. Meyers dropped a miniwrench into the patient's throat. This time he unsuccessfully tried the Heimlich maneuver to dislodge the tool. An x-ray done later revealed that the patient had aspirated the miniwrench into his left lung, according to state documents.
Two emergency bronchoscopies were performed to remove the tool, but both were unsuccessful. More procedures followed and, even though the miniwrench was eventually removed, Gaal never regained his strength and died on June 19, 2007, from complications that included acute respiratory failure, pneumonia, and aspiration, according to his death certificate.
The complaint with the Florida Department of Health states that Dr. Meyers did not take necessary precautions while performing the implant procedures, failed to report the incidents to the state as required by law, and did not call 911 or engage in emergency protocol in both instances.
Dr. Meyers license was briefly suspended in January 2008. Last week the state fined him $17,000 and restricted from performing implant procedures until he completes further training. He will also reimburse all medical costs to Gaal's family, and has voluntarily agreed to practice only on patients who are 65 or younger.
Kim Gowey, D.D.S., past president of the American Academy of Implant Dentistry, said that such incidents are rare and that he has never heard of one that has been fatal.
However, he recommends some basic safety procedures to prevent such a tragedy.
Small implant instruments such as screwdrivers have little holes near the top, and dentists can put a piece of floss through them so they can be retrieved in case they fall down a patient's throat, Dr. Gowey explained.
For objects that cannot be tied to floss, placing a 4 x 4 piece of gauze on the tongue between the throat and the area being worked on is a good safety mechanism, he said.
Another precautionary measure is to have your patients sit upright, reducing the risk of anything falling down their throat.
"Having a patient lying flat on the back with an open throat is not a good idea," Dr. Gowey cautioned.
Finally, it is important to order an x-ray if you are certain something has fallen down the patient's throat.
"The minimum standard of dental performance while performing surgical implant treatment requires that a dentist utilize prophylactic measures to prevent a patient from swallowing or aspirating any foreign objects during the surgical placement and/or removal of implants," states the Florida Department of Health complaint. "Dr. Meyers failed to employ any of these measures on at least two separate occasions and failed to meet the minimal standard of dental performance in his treatment of patient CG [Charles Gaal]."
Dr. Meyers could not be reached for comment.

Copyright © 2008 DrBicuspid.com

FDA to reclassify amalgam by July 2009


FDA to reclassify amalgam by July 2009
By DrBicuspid Staff
June 23, 2008 -- The FDA has announced that it will reclassify dental amalgam by July 2009. This deadline has been set as part of a settlement between the FDA and the consumer group Moms Against Mercury, according to an ADA news article.
"The ADA supports the FDA's decision to reclassify amalgam and reinforces this support in a news release stressing that the recent settlement agreement and FDA's Web site do not mean that FDA has changed its position on dental amalgam," noted the ADA article. "Rather, FDA's final position will be determined through the ongoing regulatory process and call for public comments on that issue."
Copyright © 2008 DrBicuspid.com

The changing face of dentistry: Part I


The changing face of dentistry: Part I

June 23, 2008 -- Ah, the allure of entrepreneurship: Be your own boss. Set your own hours. Make a decent living and help people in need.
Surprisingly, despite dentistry being one of the most attractive small-business ventures around, in recent years there has been a shortage of dentists in the U.S. -- due in large part to a "generation gap" between retiring and incoming dentists, with not enough of the latter to replace the former. But now this trend is shifting, and with it the face of dentistry.
According to the American Dental Education Association (ADEA), the peak year for new dentists was 1983, when 5,756 dental students graduated. In 2005, total graduates only numbered 4,478, a 23% decrease.
"Those nearing retirement age were part of a big surge of graduating students in the mid-1970s to late 1980s, so actually too many dentists were being produced for the need," said Laura Neumann, ADA's senior vice president of education and professional affairs. "Now things have equalized and once again there's an increase in dental school applicants."
In fact, the ADA expects the number of dentists to increase by 8% between now and 2025, with many more women and minorities stepping into the lead role. In 2005, 12,287 students applied to dental school.
There still aren't enough seats for all the dental school applicants. In addition to a decline in the number of dental schools (56 in 2005, down from 60 in the 1980s), the capacity of those schools is restricted, said John Williams, D.D.S., dean at the University of North Carolina at Chapel Hill School of Dentistry.
"It's not like undergraduate schools where they only need to provide instructors and space," he said. "Huge infrastructure is needed for a new dental school, like labs and clinic spaces. So the small increases we're seeing in dental school enrollment is primarily due to new schools opening up."
But help may be on the way. Three new schools have opened in the past decade, and a new one in Virginia is under way.
The reasons why more people are opting to enter dental school these days vary, but the key seems to be the promise of independence and entrepreneurship. In 2006, when the ADEA polled people about to enter dental school and asked them why they chose that profession, more than 80% listed the top reasons as "ability to control my work time," "self-employment," "income potential," and "service to others."
The values of this generation coincide with dentistry, according to Anne Wells, ADEA's associate executive director for Education Pathways. "They value lifestyle. Income is important but not only the thing; they want control over their practice. It's much more significant to them to develop a meaningful philosophy in life."
Those are the reasons Rhett Raum, a 28-year-old senior at the University of Alabama School of Dentistry in Birmingham and vice president of the American Student Dental Association, went into dentistry. "I have a degree in business management and I used to run a B&B, so I have an entrepreneurial background. What drew me to dentistry was the ability to be a small-business owner, be my own boss, and have financial flexibility."
Raum is an anomaly of sorts, however, because he is purchasing a practice in a small Tennessee town with a population of 4,000. Most dental school graduates are opting to go to urban and suburban areas where there are already plenty of dentists, leaving sizable portions of the U.S. without access to oral care.
"It's less of a shortage and more of a maldistribution," Neumann said. That means dentists in inner cities, rural areas, and small towns who are planning to retire will have a harder time finding their replacements.
Some young people are being lured away from medical school when they hear about equally lucrative and less hectic careers in dentistry. In 2004, general practitioners earned an annual average of $186,000, while specialists averaged $315,000, according to the ADA.
"My physician friends send their kids to dental school because they don't like what's going on with the laws in their industry, whereas the dental industry has not been nearly as encumbered," said Paul Gruber, a 64-year-old dentist in Sheboygan, WI.
Who’s signing up
What will the next generation of dentists look like? In terms of demographics, one population that is taking off is women, who now account for 44% of all dental school graduates and 19% of all dentists, according to the ADEA.
While these numbers are expected to continue to increase, however, another trend is worth noting: a growing number of female dentists will work part time to balance career and family. According to the ADA, 14% of dentists now work part time; this number is expected to reach 19% by 2025, with most being female dentists.
Jack Dillenberg, D.D.S., dean of the University Arizona School of Dentistry & Oral Health, worries about that figure. "Women make up half our class and they are great dentists, but they don't work as long and therefore won't be as productive overall."
But others argue that the flexible hours of dentistry will allow women to be at least as productive as men. That's the opinion of Laura Rammer, a 29-year-old general dentistry student who graduated from Marquette University Dental School in Milwaukee last summer. She mentored with Dr. Gruber in Sheboygan, and is considering taking over his practice when he retires.
"It's now an option for the woman to be a full-time worker and the husband a stay-at-home parent," she said. "I'm going to keep going to the office. Besides, I work four days, from 7 a.m. to 5 p.m. That's accommodating for families."
The flexibility of dental work is also attracting many women to become hygienists. The number of dental hygiene programs has steadily increased during the past decade, numbering 270 with 7,200 graduates in 2004. That's nearly twice the amount of dental school graduates -- and the education is half the cost of dental school.
Dental hygiene is the fifth fastest growing profession in the U.S., said Jean Connor, president of the American Dental Hygienists' Association (ADHA). "They are mostly women, often because hygienists stay licensed for their life cycle, so it's good for women who want to have kids and a flexible or part-time career. It's a good-pay salary. And you can be a healthcare professional, but unlike nursing you don't have to work nights or weekends."
Hygienists are expected to be on the front lines of expanding oral care to underserved populations. The ADHA is developing a curriculum to create a master's degree for advanced dental hygiene practitioner. Graduates would be able to do many services a dentist does -- such as cavity prep, extractions, and prescriptions -- and without a dentist's supervision. The goal is to have them serve in lieu of dentists in underserved areas.
"They can be a long arm reaching out to people in need," Connor said. "They'll be important because they can provide dental services and get people on the learning curve of oral health."
Serving the underserved
While the number of female dentists is on the rise, minority enrollment is lagging. More Asians are enrolling, which accounts for the vast majority of minority applicants. However, blacks and Hispanics currently comprise less than 10% of U.S. dentists, far below their numbers in the U.S. population.
This is where targeted minority recruitment of dental students and mentoring can play a key role. The ADEA found that dentists of an ethnic minority background, especially Asians and Hispanics, often chose the career because they wanted to serve their ethnic group or a low-income population in general.
"It's a priority for dental schools as well as for organized dentistry to raise those numbers," Neumann said. "It's a concern about our ability to meet the needs of the public because people want to go to a health provider that comes from their own background and speaks the same language."
In its numerous programs to boost minority representation, the ADEA is working with the Association of American Medical Colleges on the Summer Medical and Dental Education Program that identifies college freshmen and sophomores interested in dentistry and give them a summer-school education.
"This can enhance their chances to do well in both undergrad and dental school," Wells said. Nearly 1,000 students currently participate, along with 12 medical and dental schools.
In part II of this series on the future of dentistry, author Vanessa Richardson tells how dental education is changing, from revised dental school curriculums to targeted recruitment and mentoring.

Calif. prisons end controversial dental policy


Calif. prisons end controversial dental policy

June 23, 2008 -- The prison health program in California will discontinue a policy that forced female inmates to opt for multiple extractions in order to participate in popular programs that require a clean bill of health, the San Francisco Chronicle reported in a recent story.
The controversy started when a San Jose Mercury story revealed earlier this year that female inmates were choosing to have numerous teeth pulled rather than wait long periods for a prison dentist to treat their condition. Bad teeth disqualified them from participating in vocational-training and drug-rehabilitation programs, including one that allowed them to live with their children in special housing.
"Officials with the California Department of Corrections and Rehabilitation say the dental and health clearances are necessary because the specialized programs are based at smaller community prisons and don't have dentists or doctors on site," explained the San Jose Mercury story.
The policy has now been discontinued after Jeffrey D. Thompson, the director of California's prison health care programs, came under severe criticism by members of the Senate Rules Committee. Thompson told the San Jose Mercury News that his department is making plans to contract with dentists in locations near the programs that house the 71 participants in the "mother-infant" program.
Copyright © 2008 DrBicuspid.com