If there ever was a product that was slick before slick was a popular word in spine, it had to be the OptiMesh developed and marketed by Spineology. TSB remembers the first time Spineology presented its technology seeking an infusion of investment capital. The year was 2003. Since then, the company has gone through an up and down evolution. The OptiMesh was a deployable pouch inserted via a cannulated tube into stable vertebral defects. The objective was to contain grafting material in place. The material that this pouch was manufactured out of is PET which has since been used in the Dynesys System Cord. Unfortunately for Spineology things have changed.
On July 5th, a complaint was filed for damages and demand for jury trial in the United States District Court of Indiana against Spineology. The plaintiffs are Debra and Thomas Day and their civil action is brought on behalf of the the plaintiffs for personal injury and damages sustained as a direct result of negligent and otherwise wrongful conduct by the defendant, Spineology, Incorporated in connection with its design, development, manufacturing, testing, packaging, promotion, marketing, distribution, labeling and sale of OptiMesh what was implanted in the plaintiff.
The facts surrounding the case do not bode well for Spineology. Based on the law, "any person who seeks to introduce a medical device into interstate commerce must prove that it is safe and efficacious for its intended use or that it is substantially equivalent." The challenge that the Spineology legal team will have will be proving that its product was not used off label rendering it adulterer and misbranded, since manufacturing adulterating or misbranding a product into interstate commerce is prohibited under the law 21 U.S.C. Sec. 331 (9-c), (g), (2003).
The Medical Device Amendment to the Food, Drug, and Cosmetic Act of 1938 require medical manufacturers to undergo premarket approval by the FDA, mandating that manufacturers must design and implement a clinical investigation. As many of you know, the only way a device may by pass the PMA process is if there is a "substantially equivalent product," or predicated device in interstate commerce prior to May 12, 1976. As this complaint unfolds the contentions bring to light the many challenges that companies have in properly adhering to FDA requirements. Spineology sought to market OptiMesh without conducting trials and obtained approval via a 510(K). Their submission asserted that they intended to market the product to maintain the relative position of bone grafting material and that it did not impact the stability of the vertebral body and did not include the end plates.
Spineology was warned in November of 2003 by the Office of Device Evaluation that there were reasonable concerns that the device would be used for an intended use not identified in the proposed labeling, and such use could hold harm. Based on Spineology's labeling, the company did just that by indicating contradicted use of the OptiMesh. In August of 2007 Spineology received another warning letter for promoting OptiMesh for use in Kypho and Vertebroplasty. The complaint stated that since Spineology promoted and introduced OptiMesh into interstate commerce for uncleared indications the product was rendered adulterer under section 501(f)(1)(B) of the FDA. It was also misbranded because Spineology did not notify the FDA of its intent to introduce the device into commercial distribution.
From June 9, 2010 thru June 30, 2010 the FDA conducted an investigation at one of Spineology's clinical investigation sites. This investigation was performed to ensure the the Spineology data and information would be accurate and valid scientifically. On 9/22/10 a warning letter was sent to Spineology which revealed serious violations. The letter informed Spineology that its clinical investigator was not adhering to the study's protocol. Despite these warnings, it is alleged that Spineology conceded this information from its physician surgeons as well as the plaintiff.
The plaintiff was treated in December of 2009 with an XLIF for instability at L4-L5 presenting with right leg pain which was resolved with the surgical procedure. Nearly one year later, the plaintiff presented with left leg symptoms similar to her right leg pain. The surgeon treated her conservatively unexpectedly developing a L5-S1 asymptomatic disc herniation. On January 21, 2011, the plaintiff underwent a surgical revision which included the partial removal of her right posterior instrumentation and a TLIF using the OptiMesh, since and XLIF procedure was not amenable to implantation at L5-S1. After 4-6 weeks the plaintiff began experiencing right buttock pain and leg pain. A lumber CT verified extrusion of the bone graft into the right lateral recess with right nerve root compression at S1. On 4/26/11 the plaintiff underwent exploration of the epidural space. During the exploration it was determined that the OptiMesh had a tear posteriorly in the pouch. The surgeon notified Spineology. On 4/26/11 the plaintiff's pain returned. A subsequent CT on 6/7/11 demonstrated complete extrusion into the epidural space, with implant removal on 6/13/11.
There are many questions that need to be answered in order to determine whether or not Spineology acted accordingly in how they presented and marketed their product. Unfortunately, based on their track record with the FDA, Spineology may be swimming against the current. Corporations are no longer viewed as ethical or acting with integrity by juries, especially when it comes to adjudicating a product liability case involving loss of consortium. No one really knows why these events occur to some patients. Is it a quality issue? Is it a training issue? Is it an off-label issue? Is it surgical technique? But then it does raise our defense of the importance of having a properly trained sales rep in the room. These questions will be difficult to prove because the attorneys nor the jury were in the operating room at the time of the event. Yet, off-label use is a no brainer especially when there are issues concerning structural support. The plaintiffs attorneys have a substantial amount of negative facts as to how Spineology has managed its day to day business, it will be interesting to see where everyone lands at the end. In these types of cases no one wins, the patient suffers and the company loses credibility. TSB wants to know what our readers think? OptiMesh or OptiMess?
"Good Times, Bad Times......you know I had my share"