The plaintiff's suffering with chondrolysis was never in dispute. Health Law Week of February 11 notes that in November 2004 Rodriguez underwent a shoulder procedure at Vanderbilt Medical Center in Nashville. Following the procedure, the plaintiff's surgeon elected to use a shoulder pain pump to control Rodriquez's pain post-operatively.
Pain pumps with regard to the shoulder have been under a cloud of controversy over the last few years. Various manufacturers of pain pumps sought and received approval by the US Food and Drug Administration (FDA) for the use of a pain pump to deliver pain medication to the tissue surrounding an injured (and corrected) shoulder. However, approval was never granted for delivery of pain medication directly to the shoulder joint itself.
Doctors have the authority to use medications and devices off-label for indications not necessarily carrying FDA approval. However, surgeons have said they were unaware of the implications of feeding pain medication directly to the shoulder joint, and allege that some manufacturers actually encouraged them to do so.
The use of a shoulder pain pump to deliver pain medication directly to the shoulder joint has been found to break down the shoulder cartilage—which does not regenerate—causing incapacitation and pain from a condition known as chondrolysis. Many patients have required additional surgeries and some have faced total shoulder replacement.
In the Rodriguez case, it was duly shown in 2008 during a follow-up procedure to his original shoulder pain surgery—four years after the initial surgery—that the cartilage in the plaintiff's shoulder had been compromised.
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However, the US District Court for the Middle District of Tennessee ruled that the plaintiff's strict liability claim had failed. The Court could find nothing in the record to indicate that the defendant was not actually aware of the risk of chondrolysis stemming from use of the shoulder pain pump at the time of the plaintiff's 2004 surgery, Health Law Week reports.
The Court also found little evidence to support an allegation that the defendant had "constructive knowledge" of the risk and, thus, could not have warned against it.
It is not known if the pain pump surgery plaintiff will appeal.
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