A product liability plaintiff who claims that his shoulder cartilage was destroyed by anesthetic medication injected by an I-Flow pain pump cannot seek punitive damages, a federal judge in Minnesota ruled Tuesday.
“Plaintiff’s counsel in this case obviously had a wealth of information available through what has now been years of discovery from Defendants’ files to try to make out a prima facie case of entitlement to punitive damages by showing that Defendants knew or had reason to know that there was a high probability that the I-Flow pain pump would injure Plaintiff. Plaintiff has failed to do so,” wrote U.S. Magistrate Judge Jeffrey J. Keyes in Healey v. I-Flow Corporation.
The plaintiff, Joseph L. Healey III, is a resident of Virginia. He had shoulder surgeries in October 2002, and May 2004. According to Healey, his doctors implanted I-Flow Pain Buster pain pumps in his shoulder joints following the surgeries to administer pain killers. Healey alleged that the continuous injection of anesthetic medication into the shoulder joint destroyed his shoulder cartilage. The debilitating condition is generally known as glenohumeral chondrolysis.
In December 2009, Healey sued I-Flow and its distributor, DJO, LLC, for negligence and civil conspiracy. The complaint filed in the U.S. District Court for the District of Minnesota alleged that the defendants never performed safety testing for the use of the pain pump to inject anesthetic medication into the joint space – the “intra-articular site” – and that the FDA three times turned down I-Flow’s applications for clearance to market the pumps for orthopedic or intra-articular uses because of the lack of safety data.
According to Healey’s complaint, even though the defendants had not established the safety of the use of the I-Flow pain pump in orthopedic surgery in an intra-articular space and had not obtained FDA clearance to market it for that use, “Defendants engaged in a lucrative and long-standing nationwide campaign to do precisely what the FDA had told Defendants they could not do: Promote their pain pumps to orthopedic surgeons for intra-articular uses, which Defendants successfully did with nary a word to anyone about the untested, uncleared, and literally experimental nature of their product for shoulder stabilization procedures.”
Healey further alleged that, had I-Flow done a meaningful review of the medical literature, the medical device manufacturer “would have learned that continuously exposing articular cartilage to anesthetics, or even to normal saline, can have a toxic effect on cartilage cells.”
Healey alleged that I-Flow did learn about an association between pain pumps and chondrolysis in 2005 or early 2006, but did nothing about it until January 2007, when it added a warning about chondrolysis to the pain pump’s directions.
Last November, Healey filed a motion to amend his complaint to add a claim for punitive damages. Judge Keyes’ decision this week denied that motion.
As a threshold issue, the judge concluded that, because there was no real conflict between Minnesota and Virginia law on this issue, Minnesota’s law on punitive damages applied. Thus, Healey had the heavy burden of showing by clear and convincing evidence that I-Flow and DJO acted with “deliberate disregard for the rights or safety of others.”
In attempting to make a case for punitive damages, Healey made much out of the fact that the FDA in 1998 failed to clear the I-Flow pain pump for the expanded indication of use for the intra-articular site as requested by the medical device manufacturer.
According to Healey, the FDA’s failure to approve the pain pump for such a use placed I-Flow on notice that its product was unsafe for that purpose.
But Keyes concluded that Healey was reading too much into the FDA’s actions:
There is nothing in the evidence submitted by Plaintiff to show that the FDA ever concluded that use of the PainBuster® in the intra-articular joint space after orthopedic surgery was not safe and effective. At most, the FDA was simply saying that its previous §510(k) clearance for the I-Flow pain pump did not encompass the indication for use in the intra-articular site and thus it would require “additional information … to determine the safety and effectiveness of the device with this use”; I-Flow had not submitted such information. Significantly, the FDA did not require any contraindication labeling to warn surgeons about using the pain pump in the intra-articular space.
The judge likewise concluded that Healey failed to show that I-Flow knew or should have known about the risk of chondrolysis from the medical literature available at the time of the plaintiff’s surgeries in 2002 and 2004.
Keyes noted that none of the thirteen articles cited by Healey’s expert described any studies linking the use of a pain pump to slowly infuse an anesthetic into the joint space to chondrolysis. The judge said:
This lack of any association between pain pumps and chondrolysis is also illustrated by the fact that from the mid-1990’s to 2004, when Plaintiff’s second surgery was performed, surgeons chose pain pump infusion systems to treat pain management after joint surgery in hundreds of thousands of cases. Yet Plaintiff submits no evidence that a physician ever raised any issue about the use of I-Flow’s—or any other manufacturer’s—pain pumps causing the destruction of a patient’s cartilage resulting in glenohumeral chondrolysis during this time frame.
The judge also noted that it was not until November 2009 that the FDA required pain pump manufacturers to update their product labels to warn about the risk of chondrolysis.
In denying Healey’s motion to add a claim for punitive damages, the judge concluded that none of his evidence “constitutes clear and convincing evidence that the Defendants knew, or had a reason to know, that use of the I-Flow pain pump in orthopedic surgery would result in a high probability that Plaintiff would suffer devastating cartilage destruction as a result of the post-operative pain management.”
– Pat Murphy