Los Angeles, California, July 24, 2012 – – The Los Angeles-based law firm, Baum Hedlund Aristei & Goldman recently obtained documents in a lawsuit (Superior Court case no. BC465313) against two medical device manufacturers and Pomona Valley Hospital Medical Center that suggest the hospital may have conducted a non-consensual, uncontrolled, experimental “research project” that tested a humanitarian medical device designed to stimulate and regenerate bone growth in patients during back surgeries. Pomona Hospital is refusing to produce any information regarding the secret “research project” and has appealed a Trial Court’s order mandating that it produce the necessary information.
The appellate hearing is on Tuesday, September 11, 2012, at 2 p.m. in the Court of Appeal of the State of California, Second Appellate District, Division 5, 300 S. Spring Street, Los Angeles.
Three documents were recently produced to Baum Hedlund attorney Bijan Esfandiari by Stryker Biotech, LLC, the medical device company that made the medical device (OP-1 Putty) used during the research project at Pomona. Mr. Esfandiari’s law firm represents one of the patients who, in September 2008, was unwittingly and without her informed consent enrolled in the experimental research project at Pomona Hospital.
April Cabana, 35, of Alta Loma, is one of at least 17 patients who randomly received this unapproved, off-label experimental procedure. Letters addressed to Ms. Cabana’s surgeon marked “HIGHLY CONFIDENTIAL” from two doctors on the Institutional Review Board overseeing the experiment asked for a progress report on the 17 patients who had received the medical procedure as part of a “research project and randomization.” The letters were dated February 4, 2009, and February 4, 2010. It appears the alleged experiments took place at Pomona Hospital between 2006 and 2011, with the majority of the experimental procedures occurring after 2009, according to evidence obtained by Baum Hedlund.
Ms. Cabana sustained serious injuries as a result of unwanted and excessive bone growth that developed as a result of her experimental OP-1 Putty surgery. These injuries included the development and migration of unwanted bone growth onto her nerve channels, which compressed her nerves, and required a second unsuccessful operation to remove the extra growth. Ms. Cabana has never recovered from her experimental surgery (or from the second failed remedial surgery) and she is now permanently disabled.
The number and identity of other Pomona Hospital patients who may have sustained injuries as a result of this experiment is unknown, however, even those who were not injured may have a claim against Pomona Hospital because the hospital failed to obtain their informed consent.
Mr. Esfandiari has alerted the Office of Research Protections of the Department of Health and Human Services about Pomona Valley Hospital’s violations and has asked that an immediate investigation be commenced and that the agency inform the 16 other research subjects that they were unwitting participants in an experimental research project.
According to Mr. Esfandiari, “The recent revelation regarding the secret and non-consensual ‘research project’ at Pomona Hospital is disturbing and demonstrates a total disregard of the free-will, safety and well being of patients. Turning ordinary patients into unwitting test-subjects is not only morally and ethically reprehensible but is also a violation of state and federal law and a breach of the basic tenets of medicine.”
Background Information
Ms. Cabana went to Pomona Hospital to undergo a routine surgical operation in 2008. Instead of receiving conventional surgery, Ms. Cabana was enrolled, without her consent, in a “research project” taking place at the hospital. Instead of receiving conventional surgical techniques, she was implanted with OP-1 Putty, a humanitarian device that had not been approved as effective by the FDA. The device was used in an unapproved experimental manner (i.e., by mixing it with another Stryker device called Calstrux) whose safety and efficacy had never been tested nor approved.
After the trial Court ordered Pomona Hospital to produce the Institutional Review Board (IRB) records, Pomona appealed the decision to the Court of Appeal of the State of California, Second Appellate District. Ms. Cabana’s attorneys filed a response on Ms. Cabana’s behalf on June 29, 2012 (2nd Civil no. B241684). A hearing is scheduled for Tuesday, September 11 at 11:00 a.m.
During a federal criminal trial conducted against Stryker in January of this year, Stryker agreed to plead guilty and paid a $15 million fine for misbranding and promoting its OP-1 Putty bone growth mixture to surgeons for illegal off-label/non-approved uses. The U.S. also charged Stryker Biotech with conspiring to defraud surgeons into combining the company’s OP-1 Putty with another Stryker product called Calstrux. The combined use of OP-1 Putty and Calstrux has never been formally tested nor has it ever been approved by the FDA. The unapproved mixed use of OP-1 Putty and Calstrux caused serious side effects in some patients, including but not limited to, the migration, and unwanted bone growth, onto nerve channels. The U.S. Attorney prosecuting the case stated at the beginning of the trial, “That mixture was never studied clinically. They did not know if it worked. They did not know if it was safe, and they marketed it to doctors anyway.”
Definitions
- OP-1 Putty is a surgical putty used to promote bone growth in certain spinal fusions.
- Calstrux is a bone void filler for surgically created bone defects or bone defects resulting from traumatic injury.
The mixed use of these two products (Calstrux and OP-l) has not been approved by the FDA and, according to Ms. Cabana’s complaint, defendant Stryker knew, or should have known, that mixed use of these two products was ineffective and could lead to unwanted bone growth.
Read the complaint against Stryker, Medtronic, and Pomona Hospital here.
About Baum Hedlund Aristei & Goldman
Baum Hedlund is a preeminent plaintiff firm that handles serious personal injury and wrongful death lawsuits across the nation. Over the past 20 years, the firm has represented thousands of patients in pharmaceutical product liability cases against major pharmaceutical manufacturers. Baum Hedlund has offices in Los Angeles, Philadelphia, and Washington, D.C.
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