July 21, 2011 — -- The maker of a product designed to detect oral cancer is suing Johnson & Johnson, claiming the pharmaceutical giant prevented its product from reaching the marketplace amid concerns about a ubiquitous J&J product, Listerine.
The lawsuit by the company, Oral Cancer Prevention International Inc., claims J&J worried that consumers might link Listerine with oral cancer, a disease that affects 30,000 Americans every year, because of a 2008 study published in Australia.
According to the National Cancer Institute, the symptoms of oral cancer can include bleeding inside of the mouth and loss of teeth.
"The potential that could have to sales of Listerine for J&J would be absolutely devastating," said Philip Hoffman, an attorney for the plaintiff company, OCPI.
On July 6, OCPI sued J&J for at least $60 million for protecting the sales of Listerine over the distribution of its product, the OralCDx Brush Test, which helps to detect and prevent oral cancer, according to the OCPI lawsuit.
The OCPI website says that the BrushTest is used to determine if a common oral spot contains abnormal cells that may develop into oral cancer. The company claims that in the last 10 years, the BrushTest has helped to prevent more than 21,000 cases of oral cancer.
Johnson & Johnson spokesman Marcus Boston refused to comment on the case beyond a prepared statement emailed to ABC News.
"Johnson & Johnson is aware of the complaint that has been filed by OCPI," the statement read. "The company is confident that we have engaged in proper business practices and we look forward to the opportunity to resolve this matter through the legal system."
But according to the OCPI lawsuit, J&J took measures to thwart OCPI's product.
On the evening of Dec. 16, 2009, according to the lawsuit, OCPI was poised to sign an agreement with OraPharma Inc., then a J&J unit, that would give OraPharma exclusive rights to sell the Oral CDx Brush Test to all U.S. dentists.
But suddenly, Hoffman said, J&J advised OraPharma to "stand down" and not sign the sales agreement.
Hoffman alleged Johnson & Johnson was leery of highlighting a possible link between Listerine and oral cancer.
"They feared that if OraPharma would go to the same dentist [who bought Listerine] to sell a product that deals with oral cancer," he said, "the public may make the connection: 'I wonder why they are coming out with a brush test? Are they doing it because they are afraid that Listerine is causing oral cancer?'"
On Feb. 5, 2010, in an effort to avoid more bad press, Hoffman said, J&J advised OraPharma Inc. to sign the same sales agreement with OCPI that it was instructed not to sign in December.
"After the agreement was executed, they recommended that [OCPI] get rid of their sales force," Hoffman said. "OraPharma would be the exclusive force selling the product."
According to Hoffman, there were lists -- "lists of dentists that would be perfect for the brush test and lists of dentists who would be the least likely to buy the product."
OCPI claimed that J&J instructed OraPharma salesmen to sell the OralCDx Brush Test to those dentists who would be the least likely to buy that product, with the possibility of getting fired if the OraPharma employees did otherwise.
"Once that happened, nobody was buying the product at all," said Hoffman. "Since OraPharma had exclusive sales rights, there was no way to get the product out there. So what it effectively did is get the [OCPI] product off the market."
OCPI attorney James S. O'Brien wrote in a statement, "The effect of J&J's behavior, based on OraPharma's own projections, is that an estimated 7,300 cases of otherwise preventable oral cancer will occur in the United States over the term of the sales agreement."
Does Listerine Increase the Risk of Cancer?
In 2008, The Australian Dental Journal published an article on a study that found, "there is now sufficient evidence" that "alcohol-containing mouthwashes contribute to the increased risk of development of oral cancer."
The same article added, "It is inadvisable for oral healthcare professionals to recommend the long-term use of alcohol-containing mouthwashes."
Although the study did not mention Listerine or any specific brands, Listerine antiseptic mouthwash may contain up to 26 percent alcohol, according to the Listerine website.
After the 2008 article was published, the sale of Listerine in Australia tanked by 50 percent, said the OCPI lawsuit.
But in 2009, the American Dental Association released a statement that expressed the opposite conclusion.
In the statement, the ADA said "scientific experts generally agree that ... evidence does not support a connection between oral cancer and alcohol-containing mouthrinse."
The American Dental Association told ABC News that these findings still hold true in 2011.
According to the Listerine website, several Listerine products have been awarded the official ADA "Seal of Acceptance."
The ADA also endorsed OCPI's Brush Test, Hoffman said.
OCPI is accusing J&J on three separate counts, including fraud, for which it is seeking a minimum of $60 million and at least $10 million in punitive damages on each of the three counts.
Said Mark Rutenberg, the CEO of OCPI, "Our laboratory has data on thousands of patients whose life was saved only because an OraclCDx test was performed. It is an unspeakable tragedy that so many thousands of other patients will develop this devastating cancer as a result of a company's wrongful actions to defend their sales of a mouthwash."