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I-Flow Loses in Oregon
In what may be the first of such decisions, a jury in Oregon decided on January 22 that I-Flow Corporation must pay nearly $5.5 million to a shoulder pain pump patient. The patient claimed that I-Flow, the manufacturer of the pump, did not warn doctors that using pumps to inject medication directly into the shoulder joint might cause PAGCL (postarthroscopic glenohumeral chondrolysis).
There are, reportedly, another 150 such cases working their way through the courts.
A federal judge in Florida dismissed a similar case against Orthofix subsidiary BREG Inc., last June, citing a lack of scientific evidence that the pumps cause PAGCL.
The FDA has only cleared the pumps to be used in the muscle tissue surrounding the joint. In November 2009, the FDA issued a warning about such use and ordered labeling changes by the manufacturers. Beside I-Flow and BREG, other manufacturers named in suits across the country reportedly include: Stryker, AstraZeneca, Smith & Nephew, DePuy, and DJO, Inc.
I-Flow reportedly changed its labeling in late 2006 after reports began surfacing that the pumps may be associated with PAGCL. There is still no clear evidence that the application of medication directly to the joint causes the cartilage to degenerate.
I-Flow, the largest manufacturer of should pain pumps, reported in November that it has been named as a defendant in 191 cases involving 412 patients. AstraZeneca is a defendant in 68 active cases.
Constance R. Chu, M.D., an orthopedic surgeon and associate professor at the University of Pittsburgh who studies cartilage regeneration, was quoted in a New York Times story on January 26 that, "There's no study that I'm aware of that shows a direct cause [between the pumps and PAGCL]." Chu has completed several laboratory studies on the affect of local anesthetic on cartilage cells, which she says provide important information, "but it's a huge leap to say this is what's going on in the patient."
Most of the other cases are in the discovery stage.