Doctors and surgeons have the authority to use FDA-approved products and medical devices for uses that fall beyond the approved boundaries as outlined by the FDA when a product is approved. It’s known as an off-label use, and to that end, the FDA defers to the expert and learned credentials of the medical professional to make a judgment call if the doctor or surgeon believes a product would benefit a patient - even if the product or device was not approved by the FDA for such an indication.
However, while doctors and medical professionals have that authority, manufacturers do not. It is illegal for a device or product manufacturer to promote any product to doctors or surgeons for off-label use.
Off-label promotion is but one of the allegations in a Stryker OP-1 Putty Adverse Events lawsuit recently filed by a woman from North Carolina.
According to court documents, plaintiff Isabel M. Lucas underwent a posterior lumbar interbody spinal fusion in order to treat pain arising from lumbar stenosis and severe degenerative disc disease, amongst other complications over time from previous fusion procedures. The procedure, conducted at Southeastern Regional Medical Centre in July 2009, involved fusion from L4-L5 and L5-S1 with the use of Stryker OP-1 Putty, otherwise known as a synthetic filler employed to compensate for voids in human bone.
The putty in question is a bone morphogenetic protein (BMP) whose effectiveness was never scientifically established, according to various sources, but whose use was nonetheless approved by the FDA through a special “Humanitarian Device Exemption” (HDE) that does not require a manufacturer to actually prove or establish the effectiveness of the product.
An HDE exemption holds that use of a product, amongst other stipulations, requires the consent of the patient. Lucas, in her Stryker OP-1 Putty Adverse Events lawsuit, claims she did not provide her consent and had no knowledge of the specifics inherent to the procedure that would eventually prove to negatively impact her health after the fact.
The issue, according to the lawsuit, is not necessarily the use of the Stryker OP-1 Putty, but the fact it was allegedly mixed with another synthetic bone void filler and autograft in an unapproved manner.
A mixture fraught with risk
As suggested above, mixing the Stryker OP-1 Putty with any other product was not approved by the FDA, a fact spelled out on the product label:
“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.”
Lucas asserts in her Stryker OP-1 Putty Adverse Events lawsuit that the OP-1 Putty was, indeed, mixed with other products during her procedure - but that Stryker had promoted the potential for such use to surgeons, or so it is alleged.
READ MORE STRYKER OP-1 PUTTY LEGAL NEWS
It should be noted that the same year in which Lucas underwent the spinal fusion procedure, Stryker faced a federal grand jury indictment that carried 13 felony charges related to its OP-1 Putty and other products. A single conviction on just one of the felony charges could have been disastrous for Stryker, as it would have precluded the device manufacturer from participation in federal health care programs.
Instead, the US Department of Justice agreed to stay the felony charges in exchange for a guilty plea on a single misdemeanor charge, along with a $15 million settlement.
Lucas’ Stryker OP-1 Putty lawsuit is Case No. 1581-cv-06475, in the Commonwealth of Massachusetts, Middlesex County Superior Court.