Flap's Blog – FullosseousFlap's Dental Blog

Today, after receiving my neat new crown (thank you, Dr. Dovidio), I went over to my old mailbox at The UPS Store (where my wife has a mailbox) and received an old certified letter (from two weeks ago) from a Texas law firm. It was a cease and desist letter over a link I posted here some time ago.I won’t bore you with the details of the letter, nor scan it, but it essentially said stop publishing nasty stuff about our client Dr. Stephen Simpton. Unfortunately, sir, Mr. Jon Michael Smith, Attorney at Law in Austin Texas, a free press does not quite work this way – as I am sure you really know.Here is a video of Dr. Simpton being interviewed by a local San Antonio TV station:

Fair enough and here is the latest video from WOAI-TV and the some of the problems at the Smile Center.

Apparently, there are criminal and civil investigations of the Smile Center.

A criminal investigation is underway into a chain of dental clinics here in San Antonio that targets children on Medicaid. This comes after an investigation by News 4 WOAI Trouble Shooter Brian Collister uncovered complaints of poor treatment at The Smile Center.

The Texas Attorney General now confirms it has launched criminal and civil investigations into The Smile Center.

The Attorney General’s office wants to know if the clinics defrauded medicaid by billing for dental work that did not need to be done. The Trouble Shooters have been reporting since February about complaints from parents who say the clinics did unnecessary and shoddy work on their children.

These parents were unhappy with dental work done on their children and paid with millions of your tax dollars through Medicaid.

A representative from the Attorney General’s office confirms it’s Medicaid fraud control unit has 180 bankers boxes of records taken from The Smile Center locations here in San Antonio. The agency’s civil Medicaid department has also filed a complaint in civil court against the business. But we don’t know what’s in that complaint because it’s sealed.

A local law firm is also just weeks away from filing a massive lawsuit against The Smile Center on behalf of the parents of one hundred former patients.The Smile Center’s owner, Doctor Stephen Simpton, recently filed a lawsuit against WOAI and reporter Brian Collister. Simpton claims our stories defamed and disparaged him and his business. Simpton did not respond to a request for comment for this report.

The attorney for Dr. Simpton responded:

The attorney for The Smile Center said in a statement. “The investigation to which you refer is a routine Medicaid audit. It has no criminal implications and is not the result of any prior allegations against Dr. Simpton or The Smile Center.  In regard to the lawsuit to which you refer, Dr. Simpton has no comment other than the litigation will take care of itself.”

Now, a number of patients have filed lawsuits.

A chain of dental clinics here in San Antonio is hit with a massive lawsuit filed by parents who took their children to The Smile Center.

The court action is more fallout from my investigation into the clinics and allegations it did unnecessary work at taxpayers expense.

The lawsuit filed Wednesday on behalf of 23 children alleges the Smile center would routinely recommend unnecessary and excessive dental services.

The lawyer filing the suit says this is the first of many to come as they prepare to file on behalf of one-hundred children.

“The lawsuit alleges and we intend to prove with substantial evidence that a lot of the dental care received by these children was unnecessary and improper”, says Attorney Tom Crosley.

The lawsuit was filed against The Smile Center, owner Dr. Stephen Simpton and former Smile Center dentist Dr Mark Hong.

It alleges Smile Center and its dentists would – “recommend unnecessary and excessive dental services, most commonly consisting of pulpotomies (baby root canals) and stainless steel crowns”.

The lawsuit goes on to allege “The smile center subjected these children to its production machine for one primary reason — to bilk Medicaid for its financial gain”.

The suit also alleges the clinics made $55 Million from Medicaid from 2008 to 2010.

OK, now the reporting has been done on Dr. Simpton and the problems he is facing. If Dr. Simpton or his attorney wish to comment on these allegations, they are welcome to do so in the comments below or they can use the contact information above (please note, I have a new mailing address).

Heartland Dental Care has signed a consent order with the North Carolina Dental Board.

The Flap is about the illegal transfer of ownership of a dental practice, owned by a North Carolina dentist, Gary Cameron to Heartland Dental Care in violation of North Carolina law.

Here is the consent order.

This is the recommendation that came down today although the Food and Drug Administration does not have to accept the recommendations of its panels.

Bone drugs from Warner Chilcott Plc, Roche Holding AG, Merck & Co. and Novartis AG need labeling changes to reduce the risk of fractures, a U.S. panel said.

The companies should add clarifications on the length of time that osteoporosis patients may take the medicines, outside advisers to the Food and Drug Administration said today in a 17- 6 vote in Adelphi, Maryland. The FDA isn’t required to follow its panels’ recommendations.

The agency has evaluated the safety of the drugs, known as bisphosphonates, for almost four years and cited possible links to unusual thigh fractures and jawbone deterioration in 2010. The agency said in July it also was examining conflicting studies on whether bisphosphonate pills such as Warner Chilcott’s Actonel, Merck’s Fosamax and Roche’s Boniva raise esophageal cancer risks.

A revised label should “be very clear that efficacy may fall off after a period of time, perhaps five years,” panelist Lewis Nelson, director of the medical toxicology fellowship program at New York University, said after the vote. “Serious concerns have been raised about risk, and those need to be continually evaluated as well.”

There needs to be additional research, period.

Mere warning labels are not going to answer the questions from every day patients – how long do I take the medicine and what protocol do I use? Or, what is the chance my femur will fracture or will I develop osteonecrosis of the jaw (ONJ) if I have a tooth removed.

Another oral bisphosphonate (Fosamax with ONJ) lawsuit trial set.

The next trial date for a Fosamax lawsuit involving jaw necrosis is scheduled to begin early next month.

The Fosamax trial will involve a complaint brought by Linda Secrest, of Florida, who alleges that Merck failed to adequately warn that side effects of Fosamax, the popular osteoporosis drug, can lead to severe jaw bone decay. Trial is scheduled to begin on September 7, in the U.S. District Court for the Southern District of New York.

Fosamax is an osteoporosis drug that belongs to a family of similar medications known as bisphosphonates. Long-term use of oral bisphosphonates has been linked to an increased risk of serious and debilitating jaw problems, known as osteonecrosis of the jaw. The condition causes the jaw bone to decay and rot, often resulting in the need for surgery to remove portions of the jaw.

Merck currently faces more than 1,100 Fosamax jaw lawsuits, most of which have been consolidated and centralized for pretrial proceedings in the U.S. District Court for the Southern District of New York as part of an MDL or multidistrict litigation.

There have already been several trials for Fosamax jaw necrosis lawsuits that have been held in the federal MDL over the last two years. While Merck has successfully defended its medication in three cases, one lawsuit resulted in an $8 million jury award for Fosamax jaw damage last year, finding that Merck failed to adequately research the potential side effects of warn about the risk of jaw necrosis from Fosamax.

A few more cases and Merck will probably propose some industry-wide settlement agreement.

Next up will be the lawsuits over bone fractures from Fosamax.