Stryker OP-1 Bone Filler Anything but Putty in a Surgeon’s Hands

February 22, 2016, 2:30PM. By Gordon Gibb

Washington, DCIn 2012, Online Legal Media senior writer Jane Mundy first recounted the story of April Cabana, who underwent what she thought to be routine back surgery in 2008. However, the procedure left her permanently disabled. Why? Allegedly due to the use of Stryker OP-1 Putty Linked to Adverse Events, in tandem with another product, Calstrux.

Both products, it is alleged, were used off label.

OP-1 Putty is described as void filler for bone within a class known as Bone Morphogenic Proteins (BMP). If any natural bone is lost during orthopedic surgical procedures - or for other related issues - bone putty or filler is often employed to fill the void, or to promote the growth of bone.

Cabana underwent two surgeries. The first, in 2008, was required after the plaintiff had suffered a herniated disc from a car accident. The initial procedure involved the use of Stryker OP-1 Putty combined with Calstrux, two products manufactured by Stryker Biotech LLC and both allegedly employed off label during the procedure.

According to Mundy, when Cabana’s pain worsened and her condition deteriorated following the procedure, a second procedure was undertaken using a product manufactured by Medtronic - Infuse bone graft. Again, Cabana’s condition worsened.

She subsequently sued Stryker and Medtronic for, amongst other allegations, illegally promoting their products off label. While surgeons have the authority to use products for uses not sanctioned by the US Food and Drug Administration (FDA), it is illegal for manufacturers to actively promote their products for off-label usage.

In her Stryker OP-1 Putty Linked to Adverse Events lawsuit, Cabana would, in 2014, drop Medtronic from the lawsuit. Medtronic had made a bid for summary judgment based on its position that Cabana had failed to adequately prove that a defect in the Infuse product had caused her alleged injuries. Cabana, in a strategic move, chose not to oppose Medtronic’s application for summary judgment. The lawsuit, thus, proceeded against Stryker Corp (April Christine Cabana v. Stryker Biotech LLC et al., case number BC465313, in the Superior Court of the State of California, County of Los Angeles).

As part of her Stryker OP-1 Putty lawsuit, Cabana alleges she received the Stryker OP-1 surgical putty without her prior knowledge or consent. It should be noted that Stryker OP-1 Putty was approved by the FDA in 2004 as a device for humanitarian use only, within the context that the true effectiveness of the OP-1 Putty had not been definitively established and is only approved for use in the treatment of rare conditions as specified by the FDA. Market approval of the product was also contingent upon permissions granted by the Institutional Review Board (IRB) prior to use, and only with the patient’s prior consent.

Cabana alleges she did not give prior consent, and was not aware of the specific risks and potential adverse events involved.

There have been other lawsuits alleging adverse reactions to the Stryker OP-1 Putty. One of the more recent actions was filed by plaintiff Isabel M. Lucas in December of last year (Isabel M. Lucas v. Stryker Biotech LLC, Case No. 1581-cv-06475, in the Commonwealth of Massachusetts, Middlesex County Superior Court). In her lawsuit, Lucas claims, amongst other allegations, that mixing the OP-1 surgical putty with other synthetic fillers could result in serious adverse reactions - and that Stryker had prior knowledge of this, yet actively promoted the mixing of such materials to doctors and the plaintiff’s own surgeon, or so it is alleged.

Mixing the Stryker OP-1 surgical putty with other synthetic fillers was never tested in clinical trials and, thus, remains an unapproved use by the FDA. The product label for OP-1 Putty appears to pull no punches:

“Inappropriate use of the product such as preparing it differently than described or mixing it with materials such as bone graft or bone void fillers may produce unexpected and potentially serious adverse events that may require surgical intervention,” the label states. “Reported events included altered handling characteristics, graft migration, delayed wound healing, non-union and osteolysis.

“The use of OP-1 Putty with synthetic bone void filler may lead to a risk of increase in local inflammation, infection and occasional migration of the implanted materials and is therefore not recommended.”