I-Flow Pain Pump Lawsuit Cross-Claim Filed Against Doctor for “Off-Label” Use

In a shoulder chondrolysis lawsuit brought against I-Flow Corporation, the pain pump manufacturer has filed a cross-claim against a doctor for using their device “off-label,” even though the company has been accused of promoted their pain pumps for such use.

The parents of Lucas Frietsch, a teenager who suffered permanent shoulder damage after an I-Flow pain pump was implanted following arthroscopic shoulder surgery, originally brought the product liability lawsuit against I-Flow, alleging that the company failed to adequately test their device or warn physicians about the risk that the pain pump may destroy shoulder cartilage.

The complaint also alleges that I-Flow encouraged doctors to the shoulder pain pump for uses that had not been approved as safe and effective.

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The plaintiff’s orthopedist, Dr. Bruce Holladay, used an I-Flow pain pump to deliver the pain medications marcaine and epinephrine following shoulder surgery in 2007. As a result, the family alleges that the teen developed permanent destruction of his shoulder cartilage, known as chondrolysis.

Earlier this month, I-Flow filed a cross-claim against Dr. Holladay, alleging that the doctor should not have used the pain pump in this manner.

I-Flow and other pain pump manufacturers face hundreds of similar pain pump lawsuits from patients who say they have suffered shoulder damage as a result of the off-label use of the pumps. The U.S. Department of Justice is also investigating I-Flow for allegedly illegally marketing its pain pumps, for uses that were never approved by the FDA.

In November 2009, the FDA required manufacturers of the pumps and the local anesthetics used with the devices to add new warnings about the risk of chondrolysis from should pain pumps. The warnings were designed to alert healthcare professionals that the use of pain pumps following shoulder surgery to infuse medication directly into the joint increases the risk of chondrolysis, particularly involving the shoulder.

Chondrolysis is a painful and debilitating loss of cartilage that can cause decreased range of motion, pain, popping and grinding of the joint, which often leads to the need for a total joint replacement. 

In addition to the I-Flow pumps, other pain pumps from different manufacturers, including Stryker, Breg, DePuy, Inc. and Smith & Nephew, Inc., have also been linked to cartilage damage when used after arthroscopic shoulder surgery.

According to allegations contained in the Frietsch complaint, I-Flow and other manufacturers have known that direct infusion of pain medication into the shoulder joints may cause chondrolysis, but continued to encourage orthopedic surgeons to use them in this manner and provide inadequate warnings.


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