Recent Ohio lawsuits claim that Stryker implanted a dangerous device in a clinical study without sharing information regarding its risks.
|Court documents show that the CerviCore device design had been substantially redesigned to address FDA concerns about the device causing metal poisoning.|
Fourteen plaintiffs in Ohio have brought lawsuits against Stryker, alleging that its CerviCore artificial discs are so dangerous that the company abandoned a clinical trial related to the device involving approximately 260 people implanted with the device and abandoned plans to obtain a PMA for the product. After the fourteenth plaintiff filed a suit, Judge James D. Bates of Lucas County (Toledo’s county) ordered that all 14 lawsuits be made public, denying Stryker’s request to seal documents related to the case.
Manufactures and user-facilities (doctors and hospitals) are required to report any device-related injuries to the FDA. So far only two reports related to the device are found in the FDA Maude database, with one reported from a patient in 2008. “I have severe metal poisoning, tumors and metallosis and early signs of leukemia,” the patient writes. “The surgeon who implanted this rogue device refuses to follow up or report any of the adverse effects because it will raise red flags that he implanted a device that did not have an ide or any exemption or approval from the FDA.”
The lack of reporting claimed in the CerviCore lawsuits could provide more fodder for critics complaining of what a U.S. Senate report recently described as the “fallacy of a system that is primarily reliant on hospitals and device manufacturers to self-report information to FDA.”
This also is not the only time Stryker has been accused of iffy behavior when it comes to sharing medical device information: Recent lawsuits filed in Middlesex County in Massachusetts accuse Stryker of fraud, negligence, and breach of warranty related to its OP-1 putty.
The most recent CerviCore suit, brought by plaintiff Frank Aceste of Florida, alleges that he was injured a clinical trial for the CerviCore device. Acest claims that the device was “unreasonably dangerous” and that it had a defective design, manufacturing problems, and that he did not receive sufficient warnings about the device. The suit claims that the CerviCore device releases four times the metal debris that Stryker had initially claimed to FDA. Furthemore, Aceste alleges that Stryker improperly conducted the clinical trial related to the device and that Stryker falsely promoted the product.
Aceste also states that after the device was implanted, Stryker had, unbeknownst to him, halted the CerviCore study in late 2011 and that in the following year, stopped providing patient care related to the CerviCore device. In the interim, Aceste’s health has worsened and he demonstrates possible signs of metal poisoning. Aceste also learned that problems had been reported regarding the titanium coating shearing off the CerviCore device and that Stryker halted the study in part because it learned it “had made horrendous manufacturing mistakes,” the complaint alleges. The problem may be related to the titanium plasma spray process used to manufacture the devices.
Another patient, Angela Moneymaker, claims the CerviCore design was defective and that it thus dislodged in her neck. Her doctor filed an adverse event. Moneymaker indicates that she suffered so much nerve damage that she has been forced into early retirement.
The public may benefit from learning the details of the CerviCore litigation. Two hundred and fifty-nine other people received CerviCore devices and many may be watching the various lawsuits to learn about how harmful the device is. Still others may use the information to learn about the known or unknown dangers of metal-on-metal devices implanted into the cervical spine or the perils of participating in a clinical trial where the manufacturer will not provide medical care when the device later failed.
As a matter of company policy, Stryker does not comment on legal matters.
In 2011, UCSF produced a study cervical total disc replacement (cTDR) devices that concluded “Single-level cTDR is safe and effective in short and intermediate term follow-up … Newer technologies have a potential to be better but may create a new set of complications.” The lead investigator and director of the Cervical Program at UCSF, Praveen Mummanani, MD, has studied other novel devices extensively in the cervical spine like Medtronic’s stackable PEEK cages for cervical corpectomy. As yet, the FDA has never approved a cervical corpectomy cage, though it recently cleared NuVasives’ X-Core Mini amidst controversy over its predicate devices. Mummaneni has recieved payments of over $570,000 in the 16-month period (2013–2014) from DePuy-Synthes the manufacturer of the the Pro-disc which was included in the UCSF study.
Christopher Yeung, MD, a spine surgeon in Arizona was one of the Cervicore study lead investors. In the 16 month period between 2013–2014, the manufacturer Stryker behind the Cervicore device has paid Yeung over $427,000 dollars in royalties.
Several participants in the clinical trial have detailed the substantial adverse events related to the device on the website SteadyHealth.
In its marketing material, Stryker claimed that the CerviCore device could be used in any patient without a metal allergy. While allergies can trigger adverse events, any patient can suffer from metallosis from metal exposure.
Stryker obtained the rights to the CerviCore device through the 2004 acquisition of the company SpineCore for $120 million with promises of subsequent payments of up to $240 million in milestone payments. This provided the incentive to commercialize the company’s products to recoup the investment.
Stryker lacked the requisite PMA approval for the device to market it in the device, and FDA had repeatedly rejected the device. In response, the company made significant design changes to the CerviCore device and launched a clinical trial for it. Roughly 200 patients were initially implanted with the device as part of the clinical trial with 60 more added. There were 200 additional patients involved in the trial as control subjects.
FDA would never approve the device stating that the clinical trial was not sufficient to demonstrate that it was safe and effective.
Years after the clinical trial had begun, a number of patients had begun to complain of problems such as metal poisoning from the chromium, cobalt, molybdenum, and titanium debris shed by the device—a problem similar to that faced by many patients with metal-on-metal hip implants.
Five years after the trial had commenced, the company was still having difficulty convincing FDA to approve the device. The lawsuit then states that the company sought to extend the duration of the trial from five to eight years while excluding results from the patients exhibiting the most severe signs of metallosis. Furthermore, the suit claims that Stryker failed to warn patients of the growing body of evidence that showed that the CerviCore device could cause metal poisoning and other problems.
The suit alleges that Stryker had become aggressive with clinical trial participants, threatening to halt access to healthcare services unless they agree to agree to participate in the survey for eight years instead of the initially agreed upon five years.
Eventually, Stryker decided to abort the study, for which it had to obtain FDA approval. FDA denied the request on grounds that Stryker had not properly informed recipients of the device and physicians implanting it of the likelihood of the device to shed metal debris and cause metal poisoning. In addition, Stryker lacked a sufficient plan for tracking adverse events, according to FDA. Stryker eventually obtained approval to halt the trial after it agreed to disclose the known risks of metallosis, which, the lawsuit states, are so severe that reasonable physicians would not use the device if they knew of its risks.
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