It’s a typical pain pump story—the patient has a minor shoulder injury and gets routine arthroscopic shoulder surgery; the patient recovers from surgery okay and feels better, but then within a year patient’s shoulder starts to really hurt. The patient returns to the doctor and discovers his cartilage is missing. The patient learns that the pain pump used after his surgery was to blame because it pumped anesthetic into his shoulder joint, which killed the cartilage.
In one case filed in the U.S. District Court for the Southern District of Florida, plaintiff Douglas Kilpatrick lost late last month on summary judgment. The defendant, Breg, Inc., argued that Kilpatrick did not prove the pump caused the injury. In its Daubert analysis, the court held that the causal link testified to by Kilpatrick’s expert, Dr. Gary Poehling, was excluded under the reliability prong of Federal Rule of Evidence 702.
The court’s ruling considered the following as deficiencies in Poehling’s testimony:
None of the articles cited by Poehling were based on controlled, randomized epidemiological studies of human beings (though such studies would be unethical in this context);
None of the articles explained the process by which bupivacaine (the anesthetic drug) destroyed cartilage;
None of the articles ultimately concludes that general causation exists—that is, that bupivacaine inserted into the shoulder joint can destroy cartilage;
He did not describe the “background risk” of acquiring chondrolysis (background risk is the risk of losing cartilage absent exposure to the pain pump); and
He relies too much on a temporal argument that the pump must have injured the cartilage because there were no other possible causes.
This boils down to one fundamental problem with Dr. Poehling’s testimony—he relied too much on articles that did not “go the distance.” The main article relied on was the Hansen/Beck article, which did not do a rigorous statistical analysis of the conclusion that 63% of patients who received pain pumps lost cartilage. That was the first article to mention an association between the pumps and cartilage loss, so, unsurprisingly, it was not persuasive to the court. Additionally, Poehling couldn’t explain why 37% of patients did not lose cartilage—in his deposition testimony, he just chalked it up to unknown physical differences.
As for the background risk, many articles describe the causes of chondrolysis—Poehling should have identified each of them and discussed their incidence rate. These risks include specific types of infection, age, thermal energy, and other chemicals—all of which can be excluded in any decent pain pump case.
Finally, the temporal argument is not firmly rooted in scientific methodology.
These cases are challenging in many ways—part of the main problem for Kilpatrick may be that his only causation expert was an orthopedic surgeon—it seems that the court is looking for more on causation. In this vein, a pharmacologist or cell biologist to testify about how cartilage cells react to anesthetic drugs may have given him the extra push he needed. And, there is much more medical literature out there—the expert really needed to do a full review of the literature, and be able to testify about it. It’s a harsh result for Kilpatrick and his lawyers, but these cases are still winnable.
Pain Pump Litigation History
The history of pain pump litigation is rooted in the widespread use of pain pumps in the late 1990s and early 2000s. Pain pumps are medical devices implanted into the body to deliver pain medication directly to the source of pain. The pumps were marketed as a more effective way to manage pain and reduce the risk of adverse side effects associated with other pain medications.
However, as the use of pain pumps increased, so did the number of reports of severe side effects and complications. In many cases, patients experienced pain, swelling, and other symptoms that were worse than the original pain. Some patients also experienced permanent damage to their joints and other tissues, which required additional surgery to repair.
As a result of these and other adverse events, a number of lawsuits were filed against the manufacturers of pain pumps. The lawsuits accused the manufacturers of failing to properly warn patients and physicians of the potential risks associated with the devices, as well as of making false and misleading statements about the safety and efficacy of the pumps. A number of efforts were made to get a pain pump class action lawsuit going. But they never went very far.
Some manufacturers settled these cases out of court and the were some verdicts. But this litigation never really took off.