The Eighth Circuit Court of Appeals has affirmed a summary judgment in favor of Stryker Corp. in relation to a lawsuit filed because of damage caused to a patient’s shoulder following the implant of a post-surgery pain pump.
The device was designed and marketed as a way to help alleviate patient pain following surgical procedures by injecting a set dosage of drugs (here, bupivacaine) at various intervals directly at the surgical site. However, in this case, Mack, et al. v. Stryker Corp., et al.,, and several others, the pain pumps ended up reportedly causing more harm than good.
Defective medical device attorneys know this is not the first time Stryker has come under fire for its products. Its knee replacement devices were the subject of a Class 1 recall by the U.S. Food & Drug Administration in April last year. These products have also been the subject of extensive litigation.
The pain pump issues have been raised more recently, though the injury in this case occurred in 2002. The summary judgment, and the appellate court’s affirmation of that decision, was based on the fact that the medical community in 2002 was unaware that the pain pumps could cause joint damage. There was no existing literature at the time linking the two. That didn’t occur until at least 2007. It was not reasonably foreseeable, the court indicated, that the manufacturer should have known or had a duty to warn patients of possible joint problems its product might cause.
According to the plaintiff, she underwent surgery to treat persistent pain in her shoulder. Following the initial procedure, the surgeon implanted one of Stryker’s pain pumps into the patient to help with pain management post-surgery. The implant was there for a total of two days.
Following the surgery, the patient continued to experience intensifying pain in her shoulder. She started additional therapy and treatment, and by 2004, she was diagnosed with a condition known as chondrolysis. This is an ailment caused by the rapid deterioration of cartilage between joints. It’s extremely painful and, we now know, precipitated in some cases by the use of these pumps.
The plaintiff in this case had to undergo multiple surgeries to combat the effects of the chondrolysis.
In 2010, the filed a lawsuit against the manufacturer based on several theories, including strict product liability based on design defect and failure to warn, as well as negligence. Her husband also brought a claim for loss of consortium.
The appellate court’s refusal to grant the plaintiff the chance to move forward on this case is disappointing. It’s unclear exactly how the ruling will affect similarly-situated cases. For example, Huggins v. Stryker is very similar, also filed in Minnesota and alleging injury stemming from a procedure in 2002. He too claims that the implanted pain pump caused him to later develop chondrolysis. However in that case, the district court refused to grant a summary judgment to Stryker. That case is set for trial in 2015.
It seems in future cases involving this product, it will be important to establish what the medical community knew of the dangers this device posed, and when they knew it.
The Ferraro Law Firm handles medical malpractice claims as a result of defective medical products or dangerous pharmaceuticals. Call 1-800-275-3332 for a free and confidential consultation. Offices in Miami and Washington, D.C.
Mack, et al. v. Stryker Corp., et al., May 12, 2014, U.S. Court of Appeals for the Eighth Circuit
More Blog Entries:
FDA: Recalled Knee Replacement Devices Cause Serious Health Problems, April 13, 2014, Florida Defective Medical Device Lawyer Blog