A Maryland hospital has reportedly been sued by health insurers that allege that some spinal fusion patients who had their surgeries at the hospital may have been implanted with counterfeit spinal hardware. A spine surgeon who operated at the Maryland hospital has also been named in lawsuits, which allege that he received kickbacks pursuant to allegedly sham consulting contracts to use the spinal hardware at the hospital, which had spent over $1 million for the fake products.
The Maryland hospital has sent letters to about 250 former spinal surgery patients who may have received the fake spinal hardware provided by a California company that was required by the FDA to recall some of its spinal products in 2013, and later filed for bankruptcy protection. The Maryland hospital reportedly began its own investigation covering the years 2007 to 2012 but has not uncovered evidence that any fake spinal products were implanted in patients treated at the hospital. The Maryland hospital noted that the recalled spinal implant products were used in a very specific type of spine surgery that represented only a very small percentage of the total spine surgeries performed at the hospital.
One particular difficulty in determining whether counterfeit products were implanted in patients is that the counterfeit products may have been commingled with legitimate products and may be difficult if not impossible to visually distinguish from the genuine products.
The health insurers’ lawsuit reportedly alleges that hospitals and surgeons willfully failed to insure the material was genuine and FDA approved. The insurers claim that they were overcharged for the counterfeit products and that they paid for genuine products when fakes may have been used. The concern for patients is that their safety may have been compromised if they received fake spinal products, and those involved in the alleged counterfeit surgical products scheme had little regard for the health and well-being of spine surgery patients who received the unapproved products, which include fake screws and fake rods used in spinal surgery. If the counterfeit screws and/or rods fail within the first six weeks to six months after surgery, the bones may not heal properly, causing pain and requiring further surgery.
To read an exhaustive investigative report by The Center for Investigative Reporting, which is an independent nonprofit newsroom based in the San Francisco Bay Area of California, regarding the California company allegedly involved with the counterfeit spinal screws, click here.
If you or a loved one had spinal surgery in Maryland or elsewhere in the United States and you suspect that you may have received counterfeit spinal hardware, you should promptly find a Maryland medical malpractice lawyer, or a medical malpractice lawyer in your U.S. state, who may investigate your medical malpractice claim for you and represent you in a medical malpractice case, if appropriate.
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