A Medical Device Daily

A Texas jury has found that Palomar Medical Technologies' (Burlington, Massachusetts) products do not infringe a Candela (Wayland, Massachusetts) patent, the companies reported this week.

The trial took place in U.S. District Court for the Eastern District of Texas. Palomar's Lux1540, Lux1540z, LuxIR and LuxDeepIR handpieces when used on the StarLux 500 and 300 systems were found non-infringing, the company said. In addition, the jury found that all of the claims at issue in Candela's patent were invalid over prior art.

Candela said in a statement that it "strongly disagree[s] with the jury's decision" and it is evaluating its options.

Candela accused eight Palomar handpieces when used with four different platform systems of infringing all of the claims of three Candela patents. Specifically, it accused Palomar's LuxY, LuxYs, LuxG, LuxB, Lux1540, Lux1540z, LuxIR and LuxDeepIR handpieces when used on the StarLux 500, StarLux 300, MediLux or EsteLux Systems of infringing U.S. patent Nos. 5,810,801; 6,120,497 and 6,659,999.

On June 20, Candela dropped its accusations against Palomar's LuxB handpiece. Then on September 22, just days before the start of trial, Candela dropped its accusations against Palomar's LuxY, LuxYs, and LuxG handpieces, dropped two of its patents from the lawsuit (6,120,497 and 6,659,999), and dropped from the lawsuit all method claims in 5,810,801.

Consequently, Candela went to trial on Sept. 29, accusing only Palomar's Lux1540, Lux1540z, LuxIR and LuxDeepIR when used with the StarLux 500 or 300 of infringement of only claims 11-14 of 5,810,801. In addition, Candela significantly reduced the amount of damages it was seeking, Palomar noted.

"We are very pleased with the jury's decision, said Palomar CEO Joseph Caruso. "The jury's verdict completes our win in this lawsuit by finding our products to be non-infringing and the patent claims at issue to be invalid. We are also happy that the costs associated with this trial are behind us. Importantly, we now move closer to [our] lawsuit against Candela for infringement of Palomar's hair removal patents: U.S. patent Nos. 5,595,568 and 5,735,844. Candela has admitted that it brought the lawsuit in Texas in retaliation for the hair removal lawsuit. In this just completed Texas trial, Candela's corporate representative testified under oath that the demand for hair removal was far greater than the demand for any other laser treatment. We agree. That trial is not yet scheduled, but we expect the trial to take place next year."

Palomar develops light-based systems for cosmetic treatments.

In other legalities, eight Florida residents have been charged in a 16-count indictment for their alleged roles in a Medicare fraud scheme involving fake HIV infusion treatments, Acting Assistant Attorney General of the Criminal Division Matthew Friedrich and U.S. Attorney for the Southern District of Florida R. Alexander Acosta reported.

Federal and state Medicare Fraud Strike Force (MFSF) agents arrested seven individuals in Miami. Another charged individual was already in custody at the Miami Federal Correctional Institution, based on a Medicare fraud conviction from 2007.

After the arrests, the Sept. 24 indictment was unsealed, charging one count of healthcare fraud conspiracy against Juan "Tony" Marrero, Orlando Pascual Jr., Belkis Marrero, Dr. David Rothman, Luz Borrego, Dr. Keith Russell, Eda Milanes, and Jorge Pacheco.

In addition to the conspiracy charge, Tony Marrero is charged with six counts of healthcare fraud, two counts of money-laundering conspiracy and four counts of money laundering. Pascual is also charged with six counts of healthcare fraud, two counts of money-laundering conspiracy and four counts of money laundering.

Belkis Marrero is additionally charged with six counts of health care fraud, one count of money-laundering conspiracy and one count of money laundering. In addition to the conspiracy charge, Rothman and Borrego are each charged with four counts of health care fraud, and Milanes, Russell and Pacheco are each charged with two counts of health care fraud. The indictment also seeks forfeiture from all defendants.

According to the indictment, Tony Marrero, Pascual and Belkis Marrero controlled the day-to-day operations of two Miami medical clinics: Medcore Group and M&P Group of South Florida. As medical assistants, Borrego (at Medcore), Pacheco (at M&P) and Milanes (at M&P) provided unneeded HIV infusion treatments to paid patients. The indictment charges that Pascual, Borrego and Milanes delivered cash payments to the patients.

Furthermore, the indictment charges Rothman with ordering the unnecessary treatments at Medcore, and Russell with ordering the unnecessary treatments at M&P. Rothman and Russell allegedly conducted cursory examinations of the beneficiaries and signed the required documentation, including medical and billing records, to make it appear that the injection and infusion treatments billed by Medcore and M&P were medically necessary and provided, when, in fact, they were not.

Juan Marrero, Pascual, Belkis Marrero, Rothman and Borrego allegedly caused Medcore and M&P to submit fraudulent claims to Medicare for more than $5.3 million. The indictment alleges that the defendants laundered a portion of the proceeds to acquire the cash necessary to pay the patients.