California Lawsuit Alleges Counterfeit Spinal Hardware Used During Surgeries

162017_132140396847214_292624_nLawyers in California filed a lawsuit in February 2015, which was unsealed on May 28, 2015, alleging that 15 spine surgeons, 17 hospitals, and many others engaged in a health care fraud scheme and in a conspiracy by knowingly implanting counterfeit spinal hardware into patients in California, Maryland, Nevada, Texas, and Wisconsin that were not FDA-approved.

The lawsuit reportedly alleges that the surgeons, who were paid illegal kickbacks, agreed to use the fake spinal hardware in surgeries, including a spine surgeon in Maryland who allegedly received $458,962 in illegal kickback payments pursuant to what was described as a sham agreement, by arranging to have the unapproved spinal hardware implanted in patients in a Baltimore-area hospital that paid over $1 million for the counterfeit medical products. The lawsuit further alleges that the company that provided the counterfeit products went so far as to use a private jet to deliver the counterfeit hardware to insure that the fake products would be used in surgeries.

The lawsuit further alleges that two Nevada spine surgeons received illegal kickbacks as part of the scheme in Nevada – the fake spinal hardware was also delivered by private jet to the Nevada surgeons, according to reported allegations.

A Wisconsin spine surgeon, who had served a prison sentence for an unrelated health care fraud conviction, allegedly received illegal kickbacks for implanting the fake spinal hardware into patients at two hospitals in Wisconsin before he lost his medical license.

Nine California spine surgeons and a Texas spine surgeon have also been named in the California lawsuit. The lawsuit alleges that the spine surgeons named as defendants received cash payments, vacations, meals, free flights, as well as other forms of entertainment in exchange for referring patients to certain hospitals where the counterfeit spinal hardware would be implanted. The hospitals named as defendants in the lawsuit allegedly turned a blind eye to the scheme.

The California lawsuit seeks to have a fund established to pay for medical monitoring for patients who had non-FDA approved medical products implanted in them as well as to compensate patients who had unnecessary surgeries. Nonetheless, it may be difficult to identify those patients who had counterfeit medical products implanted in them due to the documentation regarding their surgeries.

A separate lawsuit filed by a whistleblower against the company that allegedly manufactured and distributed the non-FDA approved medical products alleges outrageous mark-ups for spinal hardware. In one example referenced in the whistleblower lawsuit, six screw caps provided by the company cost $2,850, yet hospitals were charged $17,370 and the hospitals billed a health insurance company $49,260 for the screw caps.

Source

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This entry was posted on Thursday, June 25th, 2015 at 5:39 am. Both comments and pings are currently closed.

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