The three plaintiffs in the cases, Christina McClellan, Danny Arvidson and Juan A. Huerta, all reportedly underwent arthroscopic shoulder surgery, according to the LexisNexis legal database.
After the procedures, surgeons installed a PainBuster pump to continuously deliver local anesthetic drugs to the operative site in their shoulders for pain relief.
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The three sued the maker of the shoulder pain pumps, I-Flow Corp. and their distributor DJO LLC, for allegedly marketing the pain pumps for post-operative use for those who underwent shoulder surgery, even though the FDA had rejected the device maker's request to approve the pumps for such uses.
Both companies countered that the FDA had approved the shoulder pain pumps for orthopedic surgery, and that claims against them are barred by the learned intermediary doctrine, in part because they were unaware of the damage that could potentially be caused by the devices at the time of the defendants' surgeries.
The federal jury sided with the defendants, saying that the plaintiffs did not prove that the pump was defective due to inadequate warnings.