On Friday, an Oregon state court jury determined that I-Flow Corporation (through Kimberly Clark, its parent company as of late last year) owes Matthew and Krista Beale $5.5 million for defects associated with their On-Q pain pump. The pain pump is a device used after surgery to continuously administer anesthetic (usually bupivacaine or ropivacaine-type drugs) for a few days. I-Flow heavily marketed the drug for use in the shoulder joint after arthroscopic shoulder surgeries (SLAP tear repairs, rotator cuff tears, etc…), despite numerous rejections by the FDA for that indication, because of a lack of safety information. The anesthetic used in these pumps is toxic to cartilage cells, and exposure of even one day can completely destroy the shoulder cartilage, which cannot regrow or heal itself.
Like so many other patients who received the pain pump, Mr. Beale will have to endure at least one shoulder reconstruction surgeries, potentially permanent loss of mobility, and likely constant pain in his shoulder. Mr. Beale is a 38-year old father of four. The verdict was $4.225 million to Mr. Beale, and $1.275 million to Mrs. Beale.
This is simply the first of many plaintiffs’ verdicts. There are numerous pain pump manufacturers, including Stryker, Breg and McKinley Medical. There are very few things that can cause this type of injury, making the pump an easy suspect to rule in.
Furthermore, the regulatory behavior of the device manufacturers clearly indicates that they did not have the right to market the pumps for this off-label use. However, they ignored the risks and promoted the pump directly to orthopedic surgeons, who relied on the manufacturers for their expertise.
See other Drug Recall Lawyer Blog posts on pain pumps.