Many Americans believe spending time in the hospital will relieve health issues that they came in to solve. Most of the time this is the case, but that wasn't the case for 17 patients that were checked into the Pomona Valley Hospital in California. The hospital is in an ongoing medical malpractice case regarding doctors who performed experiments on the patients.
The medical center began conducting secret experiments on patients that entered the hospital in 2008 and didn’t stop for 3 years. Doctors used a medical device to promote bone growth in areas where there was no bone, which has not been approved by the U.S. Food and Drug Administration. Allegations against the hospital include negligence, fraud, breach of express and implied warranty, medical malpractice and strict liability, according to court documents.
April Cabana, a patient that was involved in the procedures alleges her surgeon used a mixture of two products, Calstrux and OP-l, manufactured by a company called Stryker Biotech. The combination of the two products was known to lead to unwanted bone growth. The company used off-label and illegal promotion of the mixture for financial gain.
Cabana, 35, of Alta Loma underwent surgery at the medical center after a car collision four years ago. She noticed a bone growth at the site of her surgery afterwards, which caused excruciating pain because the bone migrated to a nerve channel. Ali H. Mesiwala was the doctor who conducted surgery on Cabana, according to the San Gabriel Valley Tribune.
The doctor is accused with medical negligence. A situation that Cabana thought was isolated was later discovered to be only one of 17. While under oath, hospital officials revealed the product had not been approved for testing, and three letters stated the hospital approved the use of the products and the conducting of experiments. Stryker Biotech, LLC, Stryker Corporation, Medtronic Sofamor Danek USA Inc. and Medtronic Inc. are the medical device manufacturers named in the lawsuit.
The only known patient this far in the case is Cabana. She had to undergo another surgery to remove the “bone of unknown origin” from her lower back, which resulted in further damage and pain to her spine. During her second surgery, the doctor used a device called Infuse Bone Graft manufactured by Medtronic, Inc., which was also promoting its off-label devices illegally. The woman has since had to undergo additional corrective surgeries, which has left her unable to work, unable to be mobile and she has been placed on disability.
The FDA issued a warning against Infuse Bone Graft in July 2008, but a new report says the medical device may cause additional damage. The implant, which was created to release a genetically modified protein into the body, was found to prompt other complications 2 to 14 days after a procedure.
A report from the FDA stated: “These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. Severe dysphagia following cervical spine fusion using rhBMP products has also been reported in the literature.”
Medtronic, Inc. was also reported to have been paying millions of dollars in consulting fees and royalty payments to doctors to conduct studies on the devices. Dr. Kenneth Burkus, who practices in Columbus, Ga., and Dr. Thomas Zdeblick, a professor at the University of Wisconsin were two doctors that allegedly were involved, according to a reports in the New York Times.
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