According to the texts of a series of lawsuits currently active and under litigation, the US Food and Drug Administration (FDA) approved the use of pain pumps—devices that feed medication through a catheter directly to the source of pain— for the delivery of pain medication to the soft tissue around the shoulder joint. However, the FDA indicated that the product should not be used directly on the shoulder joint itself.
The lawsuits allege that shoulder pain pump manufacturers continued to circumvent the FDA's ruling by promoting the use of shoulder pain pumps to mitigate pain directly in the shoulder. Many former pain pump users claim the companies were negligent in designing, researching and selling pain pumps that they should have known were dangerous. The legal filings include claims of fraud, breach of warranty and products liability against the defendant manufacturers.
Various plaintiffs have alleged that the pain pumps cause postarthroscopic glenohumeral chondrolysis (PAGCL), the progressive breakdown of cartilage in the glenohumeral joint connecting the arm to the shoulder. Without the cartilage, bones grind together and cause excruciating pain. PAGCL was first widely identified in 2004, with subsequent studies establishing a link between shoulder pain pumps and PAGCL.
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Five lawsuits have been recently filed in Los Angeles County Superior Court. Defendants include Stryker Corp., I-Flow Inc., Moog Inc., Sgarlato R.P. Inc., Breg Inc. and Linvatec Corp. Other companies facing lawsuits include DJO Inc. and some leading pharmaceutical companies: AstraZeneca, Abbott Laboratories, APP Pharmaceuticals and Hospira Worldwide.
(source: PR Newswire November 11, 2009)
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