*Updated August 3, 2012, with a statement from Pomona Valley Hospital Medical Center.
Lawyers for the plaintiff in a lawsuit against the medical device companies and the hospital claim that at least 17 patients were involved in a secret "research project" at the Pomona Valley Hospital Medical Center in Pomona, Calif., in which they were randomized to receive experimental treatment with Stryker’s OP-1 Putty without their knowledge.
Although the hospital originally claimed that its investigational research board had not granted approval for any experimental procedures, documents produced by Stryker during the course of the lawsuit suggested otherwise, according to the plaintiff’s law firm.
The original complaint, filed by April Cabana, targeted the medical device companies for alleged off-label promotion of their bone growth products, as well as the hospital and surgeon Dr. Ali Mesiwala for failing to inform her that they were using the experimental products.
In light of the new developments, the lawsuit further alleges that "Ms. Cabana went to the hospital expecting routine surgical treatment and was instead converted into an unwitting guinea pig in a secret ‘research project.’" Internal hospital memos suggest that at least 16 other patients were involved in the study.
"Pomona Valley Hospital Medical Center strongly disputes both the allegations of the complaint and the assertions made by the plaintiff’s counsel in the media," according to a statement sent to MassDevice.com by Pomona spokeswoman Katherine Roche. "We believe that the allegations are unfounded and have released a statement to the media that have inquired."
Lawyers for the plaintiff called on the state Dept. of Public Health to investigate the "non-consensual ‘research project’" and asked that Pomona Valley Hospital be "publicly admonished and appropriately sanctioned," after which they were directed to an office within the FDA, lead attorney Bijan Esfandiari, who works at at Baum Hedlund Aristei & Goldman in Los Angeles, told MassDevice.com today.
California authorities are investigating Pomona Valley, Calif. Public Health Dept. spokesman Ralph Montano told us, but due to the ongoing nature of the case the agency is unable to disclose any details. When the investigation is complete, the findings will be made public, Montano said.
Esfandiari said he has not been contacted about any investigations.
Cabana received Stryker’s OP-1 Putty in combination with a Calstrux bone-filler during surgery to relieve her back pain. Stryker’s OP-1 Putty had clearance under a humanitarian-use exemption, which requires hospital board authorization prior to use. The combination of the putty and Calstrux bone-filler had never been examined by the FDA, according to the complaint.
"She thought she was going in for a routine surgical procedure," Esfandiari claimed. "The doctor informed her that it’s something he does 20 times a month and she thought it was something routine. The words ‘OP-1 putty’ or ‘humanitarian use device’ were never uttered to her. The 1st time she even heard the term ‘OP-1 putty’ was when she received her medical records more than 2 years after the fact."
Cabana claims the mixture of the 2 products caused excessive bone growth in her lower back, resulting in nerve compression and debilitating pain that required additional surgery.
In a 2nd procedure, surgeons removed the excess bone and fused the remainder using Medtronic’s Infuse bone graft, again in an off-label manner, according to legal documents. Infuse had FDA clearance for use during an anterior procedure, but Cabana claims her surgeon opted for a posterior procedure.
Cabana claims she was never informed in either case that she was receiving experimental treatment, and that the procedures left her in "agonizing pain" and forced her into permanent disability.
"Pomona Valley Hospital Medical Center complies with all state and federal laws and has procedures in place to oversee studies conducted at the hospital," according to the hospital’s statement. "We adhere to the regulations and guidance of the Food and Drug Administration."
The suits against Stryker and Medtronic have not changed in light of Pomona’s alleged experimentation, Esfandiari said. The law firm deposed its 1st Stryker sales rep a few weeks ago and expects to speak to a 2nd soon. The initial round didn’t go well, with the rep, who is awaiting sentencing after pleading guilty to a felony, opting to take the 5th amendment on every question, according to Esfandiari.
Earlier this year Stryker copped to a misdemeanor charge and paid $15 million on charges that the company ran an off-label promotion scheme, including falsifying hospital records to authorize use of the OP-1 products, which were cleared only for humanitarian use. Stryker later sold its OP-1 assets to Olympus (TYO:7733).
Medtronic was cleared of wrong-doing just months later when the U.S. Justice Dept. closed the books on its investigation. The medical device company is still in the midst of lawsuits related to the case, including a whistleblower case which accuses Medtronic of installing a crony at a spine journal to promote Infuse.