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.”
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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