Carol McGrew and eight other patients implanted with Stryker Corporation’s CerviCore cervical disc filed suit against Howmedica, owned by Stryker on April 11, 2014 in an Illinois federal court for alleged damages caused by the disc.
Source: Howmedica Complaint
The Plaintiffs claim the disc was “unreasonably dangerous due to design defects, manufacturing defects and insufficient warnings.” Their case rests on similar metal ion poisoning arguments used in the DePuy ASR metal-on-metal hip lawsuits, with an additional claim of improperly using OP-1 during some of the surgeries.
CerviCore Disc
The CerviCore disc was initially developed by SpineCore, Inc. In 2004, Stryker purchased SpineCore for $120 million in cash, plus up to $265 more when CerviCore and another SpineCore product, FlexiCore, gained FDA approval and were launched.
SpineCore was founded in 2001 by Thomas Errico, M.D. and J.P. Errico. In the 2004 Stryker press release announcing the acquisition, the company said after completion of enrollment in a clinical study, a two-year patient follow-up was planned prior to submission of a premarket approval (PMA) application to the FDA. The company said it expected to submit an IDE (investigational device exemption) application to the FDA for the CerviCore before year end and begin a clinical study in 2005 which would lead to submission of a PMA application in 2008.
The company recruited the Plaintiffs, along with 391 other people to take part in the study. The patients signed “Consent to Participate in a Research Study” forms.
Dangerous Metals Alleged
According to a description in Motion Preservation Surgery of the Spine, published by Elsevier, Inc. in 2008, the device is “composed of two opposing cobalt-chromium-molybdenum bearing surfaces backed with a titanium plasma spray coating to enhance osseous fixation. Two fins on each baseplate, each with three spikes, help achieve initial fixation. An anterior vertebral body stop decreases the chance of posterior placement or migration.”
Source: The Cervicore artificial cervical disc/ www.spine-health.com
The Plaintiffs allege the company portrayed the disc as a device made entirely of titanium.
However, according to their claims, the company used cobalt, chromium, molybdenum, titanium, and nickel to construct many of the discs implanted in the patients, who were not told of the “dangerous” metals contained in the disc.
One of the patients, Colleen Jaeger’s original consent form contains the following description of the CerviCore unit: “The CerviCore Disc is made of two saddleshaped plates and it is implanted in place of the degenerated disc after it is removed. It is made entirely of metal (a cobalt/chrome/molybdenum alloy with a titanium coating).”
Drs. Jonathan Stieber, Jeffrey Fischgrund and Jean-Jacques Abitbol co-authored a book chapter entitled “The CerviCore Cervical Intervertebral Disc Replacement,” in which they listed one of CerviCore’s contraindications as: “Allergy to components of the device, including cobalt, chromium, molybdenum, titanium, or nickel.” James Yue, et al., MOTION PRESERVATION SURGERY OF THE SPINE: ADVANCED TECHNIQUES AND CONTROVERSIES, p. 238, Saunders, 2008.
In 2011, according to the suit, Stryker took out a full page ad in the program for the April Las Vegas meeting of the SAS International Society for the Advancement of Spine Surgery that, “bragged…CerviCore was ‘[c]omprised of CoCrMo – biocompatible material with a history of safety and proven durability with low metal ion release and wear rates in orthopedic implants.’”
Jaeger claims she was informed that she was one of the few who would have her metal levels monitored. She says the company “flatly refused to conduct metal ion tests in many patients and flatly refused to provide most with the results of any tests it had conducted.”
The patients claim to suffer from symptoms consistent with metallosis.
The company’s manufacturing processes were “so faulty they increased the metal-on-metal CerviCore device’s likelihood of emitting metal ions into the subject’s body,” says the suit.
The company produced CerviCore at one of its traditional Stryker Spine plants in Cestas, France, that was used to heat-treating non-articulating products and, according to the suit, was unfamiliar with producing articulating cobalt chromium products.
Rate of Failure Disputed
The Plaintiffs also claim that Stryker misled the public about CerviCore’s rate of failure.
For instance, in 2010, they say through four “affiliated” doctors (Drs. Abitbol, Maroon, Edwards and Fischgrund), the company “bragged that at two years, there were fewer device-related surgical interventions in the CerviCore group (2%) than in the Control group (4%).” 2-Year Results from Four IDE Study Sites: CerviCore Intervertebral Disc vs. Fusion, The Spine Journal, Volume 10, issue 9 Supplement, Pages S139–S140, September, 2010.”
However, they argue that the article’s sample size was only 49 CerviCore patients and the authors admit they lost track of 18 of the patients, so even one surgical revision would be 3.2% of the population.
Dr. Fischgrund operated on Plaintiff Pepke to correct his CerviCore prior to this article’s publication. The suit also claims that long before the article was published, Plaintiff Zaretzka, “had repeatedly reported to her surgeon, Dr. Edwards, that she had unresolved neck pain, hears clicking and grinding noises, suffered from metallosis symptoms and wanted a surgical revision of her device.” She says he refused.
Plaintiff Good also claims that long before the article was published, she informed her surgeon, Dr. Fischgrund, the she had unresolved neck pain, suffered from metallosis symptoms and wanted a revision. The surgeon also allegedly refused. Another CerviCore patient, in a separate lawsuit, claims she told Dr. Maroon long before the article that she also had problems.
“Thus,” claims the suit, “prior to this article’s publication, these co-authors knew of at least five surgical interventions caused by the CerviCore device, which is 16% of the responding sample size, not 2%.”
Stryker Quality Control Problems
In November 2007, the FDA publicly warned Stryker about quality control problems at its Mahwah, New Jersey, plant. The lawsuit says that the FDA cited the company for taking complaints on failures of one of its hip products, “but not applying lessons learned from that failure to its other products (which would include CerviCore).”
The discs were allegedly manufactured at the French facility and then shipped to Mahwah, New Jersey, for final coating and packaging.
The company’s Mahwah facility, “had rampant quality control problems that caused unsafe, unreliable, and contaminant-ridden devices to be released into the market at the very time [Stryker] was manufacturing CerviCore in that facility,” states the suit.
OP-1 Use Claimed
Plaintiffs also argue that due to the fact that CerviCore did not have screws, it had to rely on “some” bone growth to hold it in place. To accomplish that bone growth, they say Stryker, “illegally used or promoted the use of its TCP putty (also called Calstrux, Osteogenic Protein-1, or OP-1) in CerviCore patients.
In April 2008, it was widely reported that the FDA warned Stryker Biotech that the company had violated the law by conducting human experiments without a proper IDE.
The FDA, states the lawsuit, discovered Stryker Biotech had illegally entered into contracts with clinical investigators to use OP-1 in combination with some investigational device study. The FDA did not specify which study OP-1 was used with because records remain sealed when a device has not been approved by the FDA. Plaintiffs say the warning, even if it didn’t specify CerviCore, “demonstrates Stryker’s propensity to conduct studies on human beings without an IDE and to use OP-1 in conjunction with some unapproved study.”
Plaintiff Jaeger claims she had to have a revision because, “among other things, she developed a large bone mass growing from the area of her CerviCore.” Good claims she was found to have a boney growth at the C5 vertebrae.
“Other Plaintiffs are suffering the ill effects of improper use of OP-1, but, since [Stryker] has consistently resisted providing more testing, providing proper and accurate information, providing proper medical care, and/or removing faulty units, it has concealed the true nature of whether it used OP-1 from Plaintiffs,” states the complaint.
Feeling Abandoned
The Plaintiffs say the company became aware of the device’s adverse events and its potential for causing metal poisoning during the study period and abandoned the product. They claim Stryker also abandoned them even though the company continued the human study, actively attended Plaintiff’s doctors’ appointments, and actively denied that the device was faulty.
They claim the company insisted each study participant sign study renewal agreements that contained further waivers in order to continue receiving medical care. Then, shortly after obtaining each renewal and waiver, the company, “abruptly ended its study early and informed Plaintiffs it would no longer provide any care for them.”
They say that the company has never provided them with accurate information about what was put in their bodies. Because of this “concealment”, they claim they could not have discovered any of this prior to the commencement of this action.
Summary of Allegations
In summary, the nine patients and their spouses allege that the company, knew of multiple dangers with CerviCore, including that it might not implant properly, that its design caused excessive wear, that it was prone to breaking down prematurely, that it was prone to delaminating, that they manufactured it using improper processes, that they manufactured it in a facility prone to contamination, that it was made from cobalt, chromium, molybdenum, titanium, and nickel, and that it was likely to cause metallosis.
They allege “Gross Negligence” because the company knew it operated a human trial outside the bounds of any regulatory approval it obtained; knew they did not have regulatory approval to use OP-1 in conjunction with CerviCore on Plaintiffs or other humans and proceeded nonetheless [and] knew CerviCore presented danger to patients, particularly those with allergies to certain metals but knew the study participants were not being tested for metal allergies.”
In a parting shot, the patients say Stryker’s conduct was “so despicable and so contemptible that it would be looked down upon and despised by ordinary decent people.”
Fishing for a “Smoking Gun”
Plaintiffs want a jury trial, compensatory damages, punitive damages, attorneys’ fees and any other relief the court deems proper.
The attorneys for the patients clearly want a chance to depose Stryker executives and go fishing—hoping to find a “smoking gun.” So far, plaintiffs have only circumstantial evidence. Stryker has not publicly responded to the allegations.
