…and how exactly was this tragedy allowed to happen, asks our US correspondent Mitchell Miller?
Thousands of people may be walking around with dangerous counterfeit surgical screws and rods in their bodies.
Blame the accused counterfeiting company's president if you wish, if you can find him. That is just what a dozen insurance companies did in a July lawsuit.
But more importantly: who else is accountable?
Tanika Moses felt that sickening pop in her back as she tried to lift cases of two-litre bottles at a warehouse in 2007. Only spinal fusion surgery, she was told, might cure her excruciating back pain but after the surgery and for five years Moses had nothing but more pain, infections and other medical issues. She had the screws and rods removed, and kept them.
Contacted by lawyers, Moses' story has become part of a nationwide scandal
, a years-long series of FDA investigations and individual lawsuits. In July, courts unsealed the harshest suit yet against hospitals and individual doctors by dozens of insurance companies.
Thousands of people, according to the suit, may be walking around with counterfeit screws and rods produced by a company called Spinal Solutions. The fakes, often crudely made of steel instead of FDA-approved titanium, could break, or cause infection or other injury.
The lawsuit claims Spinal Solutions, which collapsed under debt in 2013, "insidiously commingled fake implantable hardware with genuine parts." The company's former president, Roger Williams, was once known as a high roller, operating a fleet of private planes painted in Los Angeles Lakers colours, even as his company increasingly sunk into debt.
On one occasion, a pilot for the company says, Williams had him hand one out-of-state doctor an envelope stuffed with $20,000 in cash. On another, the pilot said he handed a doctor a bottle of wine in a canister packed with $100 bills.
Williams presently cannot be located.
In the suit, 17 hospitals and 15 individual surgeons are accused of accepting hundreds of thousands of dollars in cash, mostly in the form of "sham consulting fees," in the language of the suit. Some reports call them “kickbacks.”
Many hospitals and surgeons strongly object to the "kickbacks" moniker, as a representation of consulting fees. They say that consultations can represent a valuable collaboration between doctors and device and drug companies. Legitimate consultative arrangements are common in the medical field.
Hospitals also point out that they scrupulously complied with an FDA recall of certain Spinal Solutions products in 2012 for "quality" issues. Still, it's one thing to recall parts off the shelf. But what to do about spinal screws which are already inside patients' bodies?
The University of Maryland's Washington Medical Center is doing its best on this score, sending letters to about 250 spinal fusion patients who were implanted with Spinal Solutions hardware. An admirable gesture, but a drop in the bucket compared to the thousands who are walking around with the fake screws.
More broadly, the suit calls into question the management of a critical supply chain where accountability turns out to be very murky, to say the least. Are hospitals accountable for the authenticity of their medical devices and drugs? Are individual doctors? Is anything even in place - procedures or technologies - which could authenticate medical supply?
These are complicated by issues such as globalization: more than half of medical devices are now manufactured outside the US.
From an anti-counterfeiting point of view, the medical supply chain has got to be the wild west of logistics. How - and whether - stakeholders including the FDA succeed in managing all this will have great import for supply chain management going forward.
An in-depth investigation of Spinal Solutions, predating the current insurance company lawsuit, was carried out by Center for Investigative Reporting writers Christina Jewett and Will Evans. Their article is well worth reading.