Lawsuit puts imported dental work under scrutiny

An Ohio woman has filed a malpractice lawsuit against a large, multistate dental practice and two of its dentists, charging that dental restoration products allegedly imported from China have left her permanently injured and disabled.

The dental hardware was "defective and unsafe" and "contained toxic materials that are hazardous to the health of human beings," the lawsuit alleges.

The plaintiff -- Faye Lewis, a 73-year-old woman from Ravenna, OH -- sought care from Aspen Dental beginning in March 2007 after she chipped a tooth. Over the next few months, working with two dentists at Aspen's Stow, OH, office -- Johanna Hanchin, D.D.S., and Michael Crites, D.D.S. -- Lewis had her front teeth replaced and a partial bridge installed in her upper jaw.

However, even after being filed down, the "one size fits all" crowns were large, uncomfortable, and painful, she told an Ohio TV station earlier this year.

"There is a dental malpractice issue regarding whether or not the dental hardware in her mouth was installed in an appropriate fashion," Lewis' attorney, Gary Mantkowski, told DrBicuspid.com. "Others have claimed that the hardware was too large for her mouth, and that's what started this whole thing."

On a subsequent visit to Aspen Dental, Lewis discovered something that bothered her even more, Mantkowski said.

"She said to one of the people in the dental office that she'd like to talk to whoever made the dental work and was told 'You'll have a hard time doing that because it came from China,' " he said.

Having heard news reports about toxic materials being found in toys and other products coming out of China, Lewis "took it upon herself" to contact a dental lab to have her dental work analyzed, Mantkowski said. The lab found 160 parts per million (ppm) of lead in the hardware, according to news reports.

The U.S. Centers for Disease Control and Prevention (CDC), working with the ADA, has determined that trace amounts of lead at a level of 200 ppm are "extremely unlikely to cause adverse health effects," according to a press release issued by the ADA in April.

"While it would not be appropriate for me to comment on pending litigation, Aspen Dental takes this issue very seriously," said Mark Frank, marketing/communications manager for Aspen Dental Management, which oversees Aspen's 170 practices in 17 states, in a statement to DrBicuspid.com. "We began our efforts to follow the ADA recommendations on lead content in dental work, as well as procuring certifications from our suppliers regarding lead content, as soon as we were made aware of this issue and before the commencement of this lawsuit."

Dental lab regulation

While the issue of lead contamination is not specifically addressed in the lawsuit, this case has prompted the Ohio Legislature to adopt new regulations regarding mandatory disclosure of dental material content and point of origin. Those regulations took effect October 1.

Florida lawmakers passed similar legislation in May. That bill, which takes effect January 1, 2009, requires Florida dental labs to disclose to dentists (but not patients) where a product was manufactured and what materials were used in each restoration. Texas has approved similar guidelines that take effect in February, and other states -- including New York, Alabama, Indiana, and Michigan -- are beginning to follow suit, according to Bennett Napier, co-executive director of the National Association of Dental Laboratories (NADL).

"The problem is only four states in the U.S. currently regulate dental labs: Ohio, Florida, South Carolina, and Texas," he said. "Patients have a right to know where the products are made and what is in them. The key for us is standards; every dental lab should be following a minimum standard of competency."

Even if such standards are in place, however, there is no way to guarantee that products coming from outside the U.S. are adhering to them. According to the NADL, about 20% of the $8.8 billion U.S. dental lab market -- $1.2 billion annually -- is outsourced to dental laboratories in China, Mexico, India, and some 20 other countries. The FDA has the authority to inspect any dental lab manufacturing for the U.S. market, whether it is located in the U.S. or abroad, and any foreign lab importing to the U.S. must be registered with the agency.

But the system is not perfect. For example, some U.S. dentists and dental schools directly purchase their dental work from foreign dental laboratories, and they are not required to comply with the same disclosure requirements as a dental laboratory.

"There are certainly some very good foreign laboratories that supply to the U.S. and use the same materials the U.S. labs are supplying," Napier said. "But it is not an absolute, and that is the concern. What are the safeguards?"

Last month, after being contacted by Lewis and other individuals in Ohio regarding their concerns about lead poisoning from imported dental materials, Ohio Sen. Sherrod Brown sent a letter to FDA Commissioner Andrew von Eschenbach, urging the agency to explore its standards for domestic and foreign dental work and develop tracking mechanisms for contaminated dental work.

"As reports of tainted implants increase, it is essential that FDA take action to ensure the safety of these dental products," Sen. Brown wrote. "I am therefore requesting that FDA delineate the actions it is taking to assess the prevalence, source, and impact of lead-containing dental implants in the United States."

In the mean time, after enduring nine months of pain, Lewis sought corrective treatment from another dentist. She says her jaw still slips out of place and swells and that her teeth don't meet, and she now wears a special TMJ appliance. Her lawsuit states that "the Plaintiff … has incurred, and continues to incur, dental and medical bills, mental anguish, loss of ability to enjoy life, and permanent injury and disability."

Mantkowski wouldn't say exactly what monetary damages Lewis is seeking, only that "it costs a lot more to extract that kind of hardware than to put it in." And despite Lewis' assertions that her problems stem from defective dental work imported from China, "I don't know for a fact that it came from China. My client was just told that by someone from Aspen Dental," he admitted.

Aspen Dental, Dr. Hanchin, Dr. Crites, and the other defendants named in the complaint -- "John Doe Supplier, John Doe Distributing, John Doe Importer, and John Doe Manufacturing" -- have yet to respond to requests for documents disclosing the source of the dental work, he added.