Two medical device manufacturers have been charged with selling defective knee and spine products, injuring patients throughout the country. The knee manufacturer, OtisMed Corp., recently pled guilty to distributing knee replacements rejected by the FDA and agreed to an $80 million fine. The spine and neck product maker, Spinal Solutions, is reported to be toxic and may break in patients.
The defective medical device lawyers at Pintas & Mullins Law Firm are currently investigating cases of serious injury from faulty products like these, along with defective hip implants and transvaginal mesh implants.
The CEO of OtisMed recently admitted to intentionally selling knee replacements after the FDA rejected their application. The lawsuit played out in federal court, resulting in various fines for civil liability, criminal forfeiture, and other charges in the amount of $80 million. The CEO pled guilty to three counts of introducing adulterated medical devices into the marketplace.
The company’s knee product, OtisKnee, did not receive clearance from the FDA, however, the company continued to market and sell the device. OtisKnee was used in thousands of total knee replacement surgeries between 2006 and 2009, until it was bought out by Stryker Corp. (which has been named in thousands of injury lawsuits itself over its faulty hip devices).
Counterfeit Screws Implanted in Spines
Spinal Solutions LLC, based in Southern California, was recently charged with copying medical-grade titanium screws to be used in spinal fusions and other surgeries. It took years for someone within Spinal Solutions to alert the FDA to the counterfeiting, and by 2013 the company had sold millions of dollars in toxic screws to surgeons throughout the country.
One company insider stated that Spinal Solutions would mix in authentic screws with knockoffs in surgical kits. Spinal Solutions would incentivize doctors to use their hardware with private jet trips, cash, and other monetary deals. The company particularly targeted surgeons in Wisconsin, California, Texas, Nevada, and Maryland.
The company’s president has gone missing, but many of his employees have found themselves unknowingly wrapped up in the scandal. One of whom, an elderly machinist, admitted to making copies of surgical screws for the company for less than half of what the medical-grade screws cost.
Many patients injured by these fraudulent screws have filed injury lawsuits. One of those most devastatingly injured, Derika Moses, lost her job and her home from the pain and illness caused by the toxic screws. A former softball star, she threw her back out in 2007 while setting up a grocery store display. She underwent spinal fusion surgery, which only caused chronic pain and infections.
In 2012 Derika had most of the hardware removed from her spine, but asked if she could keep the rods and screws. She had nearly forgotten about them until March 2014, when she received a letter stating that she may have been the victim of medical fraud. She is now one of dozens of patients who have filed lawsuits against Spinal Solutions for selling counterfeit implants, and incentivizing doctors with kickbacks.
During a meeting with the medical-grade screw manufacturer whose products were being imitated by Spinal Solutions, a General Manager identified four of the spinal screws as fakes. Derika remains angry from what happened to her: she lost her job and her home because of her debilitating pain and infections, while the Spinal Solutions CEO lived a life of luxury.
One of the doctors who bought into Spinal Solutions’ perks was Dr. Cully White from Pewaukeee, Wisconsin. White took Spinal Solutions private jets to ski resorts and Mexican beaches, taking along his sales representative, who believed the company’ s CEO was unsavory at best. Despite repeated warnings, Dr. White continued to use Spinal Solutions’ hardware. More than a dozen operative reports confirm this.
White was federally indicted and investigated in 2013 in an unrelated incident, pleading guilty to billing for services he did not provide. He was sentenced to six months in prison. Another surgeon in Baltimore, Maryland estimated that he used the company’s hardware in several hundred procedures, accepting hundreds of thousands of dollars in cash.
The Spinal Solutions sales representative who ultimately contacted the FDA said that he repeatedly saw screws that were blatantly inferior, with metal shavings and burrs in the threads. He set up a meeting with the FDA in 2011, handing over an array of false screws to take back to federal offices. The FDA merely sent a warning letter. Ultimately, in 2013, Spinal Solutions shut down because of overwhelming debt. Its fraudulent screws, however, remain in patients from coast to coast.