SANTA ANA, Calif. (CN) - Astrazeneca Pharmaceuticals and Stryker Corp. distributed defective "pain pumps" despite knowing that they destroyed shoulder cartilage and despite the FDA's repreated rejection of the pumps, a patient claims in Orange County Court, and then Abbott Labs urged use of its anesthetic in the pain pumps without enough testing.
The complaint says both Hospira Inc. and Abbott Labs encouraged the pain-pump makers to use their anesthetic drugs in the pumps without adequate testing.
The personal injury lawsuit concerns "pain pumps" that deliver anesthetics to patients. Until the late 1990s, the pumps delivered small amounts of drugs at "a limited flow rate," the complaint states. "Beginning in the late 1990s, however, the manufacturers increased the anesthetic capacity of the pumps (high volume), and with the knowledge and encouragement of the pain pump manufacturers, surgeons began to insert the catheters directly into the shoulder joint space.
"Continuous injection of these anesthetics into the shoulder can cause serious and permanent damage to the shoulder joint cartilage," plaintiff Bruce Lamarche claims. "The damage occurs when the anesthetic kills the chondrocytes (shoulder cartilage cells) which causes cartilage to degenerate progressively. Patients injured by pain pumps develop a condition called 'chondrolysis,' which is the complete or nearly complete loss of cartilage in the shoulder joint. It is an irreversible, disabling, and extremely painful condition. These patients typically require additional surgeries, including complete shoulder joint replacement. As written in the medical literature, 'the prognosis for these shoulders is grim.'"
Lamarche claims, "The pain pump companies manufactured and marketed these devices without doing a single study to determine the safety of high-volume pain pumps, or what damage could be caused when physicians placed the catheter into the shoulder, much less directly into the shoulder joint space. The manufacturers of the anesthetics, similarly, did nothing to investigate whether the continuous infusion of their drugs into an near shoulder joint spaces was harmful. Instead, they encouraged orthopedic surgeons to use the pumps and anesthetics, in tandem, in an untested and dangerous manner.
"Indeed, the pain pump manufacturers sought approval from the Food and Drug Administration for the placement of the catheter in the shoulder joint space beginning in the late 1990s. For lack of safety information, the FDA rejected their applications multiple times. Yet the manufacturers of the pumps and anesthetics chose not to advise physicians about these dangers, not to advise patients of these risks, and not to tell physicians that their FDA applications were rejected. Instead, they continued to sell and market these pumps with reckless indifference - all to the detriment of thousands of patients generally, and the plaintiff, Bruce Lamarche, in particular."
Lamarche claims that the industry knew by late 2005 or early 2006 of "the toxic effects of commonly used anesthetics on cartilage," and that by then Dr. Charles Beck, an orthopedic surgeon, "was reporting to the scientific community some very disturbing findings. He found a significant number of his shoulder patients developed chondrolysis following placement of a pain pump catheter, and he associated these injuries with the use of pain pumps. Dr. Beck's studied confirmed anecdotal reports of shoulder chondrolysis that had been previously reported to the pain pump manufacturers at least as far back as 2003, if not earlier."
Lamarche demands compensatory damages for fraudulent misrepresentation, negligent misrepresentation, negligence, strict liability, and breach of warranty. He is represented by Mark Robinson Jr. with Robinson, Calcagne & Robinson of Newport Beach.
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