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Williams, Love, O'Leary and Powers Alleges That I-Flow Continues to Mislead Injured Athletes on the Safety of Its Pain Pump
PORTLAND, Ore. --(Business Wire)--
Attorneys representing hundreds of athletes injured by an I-Flow (NYSE:KMB) pain pump say that the company allegedly continues to mislead the public about what it knew while it conducted off-label marketing of its pain pump. Attorneys with Williams, Love, O'Leary and Powers claim I-Flow marketed its pain pump to orthopedic physicians treating hundreds of athletes with shoulder joint injuries.
"I-Flow knew it did not have a single safety study or the approval of the U.S. Food & Drug Administration (FDA) behind its pain pump for use in orthopedic joint surgery, yet still aggressively marketed its On-Q Pain Buster pump to treat injured athletes after shoulder joint surgeries," said Mike Williams, a leading attorney with the Portland-based Williams, Love, O'Leary and Powers, P.C., law firm. "Kimberly-Clark, the new owner of I-Flow, is now trying to lay blame on the orthopedic surgeons it failed to warn, but actually marketed the product to. I-Flow deliberately misled its own sales staff and the medical community about the safety of its product."
In fact, the FDA issued a video news alert on its website this month, once again warning the medical community that pain pumps are not approved for use in shoulder joint surgeries.
An Oregon jury last month awarded a $5.5 million verdict to Matthew Beale, a Portland father of four, for the injuries he sustained after his doctor prescribed the use of an I-Flow pain pump. Williams' firm worked closely with attorney John Coletti, of Paulson Coletti Trial Attorneys, P.C., on the case. The Portland attorneys work closely with an Alabama-based firm Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. to represent clients injured by I-Flow's pain pump across the country.
Beale's shoulder was destroyed when a doctor prescribed the use of an I-Flow pain pump after his surgery to repair a minor shoulder injury from a casual football game with co-workers. The use of a pain pump after shoulder joint surgeries has been proven to cause lifelong, crippling injuries that kill cells in the shoulder joints that replace cartilage, according to attorneys who represent I-Flow victims. Many prominent surgeons testified at Beale's trial that it was now generally accepted in the orthopedic community that pain pumps were the cause of the chondrolysis epidemic. Kimberly-Clark refuses to recognize this consensus of medical opinion, Williams said.
Injured athletes ultimately face complete shoulder-joint replacement surgeries that leave them with crippling injuries and chronic pain. The New York Times reported last month that the medical community has scrutinized the use of pain pumps for shoulder surgeries in the wake of an FDA warning issued in November 2009. It warned orthopedic physicians about the pain pump and numerous reports that connect the I-Flow pump to crippling, lifelong shoulder problems related to its use in shoulder joint surgeries.
"Kimberly-Clark on behalf of its new subsidiary, I-Flow, released a media statement last month designed to mislead the public about what it knew and didn't know about its pain pump in the interest of building a bigger market share around pain pumps instead of patient safety," said Williams. "The evidence around pain pumps and shoulder joint surgeries is clear. Pain pumps create lifelong, crippling injuries to patients who are prescribed them. Athletes who were treated with pain pumps following arthroscopic shoulder surgery before 2008 should be examined by their doctors."
Attorneys representing athletes against I-Flow say the company had tried to get approval for the use of pain pumps in orthopedic shoulder surgeries three times, but the FDA rejected the request each time because the company failed to conduct a single safety study that ensured the product was safe, court documents show. However, I-Flow released a media statement last week saying its pain pump was cleared by clinical studies that did not include shoulder joint studies. The statement failed to reveal that the company repeatedly sought FDA approval for the pain pump with zero studies verifying its safety for the specific use of orthopedic surgeries involving shoulder joints. Court documents show that I-Flow attempted to deceive business partners like Don Joy that the product was in fact approved for orthopedic shoulder joint surgeries when it was not.
Documents which the Beale jury did NOT get to see reveal that I-Flow's distribution partner for pain pumps actually interviewed the FDA reviewers to find out why they had repeatedly rejected orthopedic joint surgery as an approved indication. They learned that the FDA had specific concerns about injuries to joints if the pain drugs were infused for days into the small tight space of the shoulder joint. They also learned that no pain pump had ever been tested or approved for such an indication.
"Kimberly-Clark and I-Flow continue to sidestep any responsibility for marketing this product to orthopedic doctors even after learning that leading surgeons suspected the pumps were the cause of the new epidemic of shoulder chondrolysis in young athletes that started showing up in 2003-2004. The company failed to test the pump for use in shoulder joints, and failed to warn doctors that its product was never tested or approved by the FDA to be used in shoulder joint surgeries for injured athletes," said Williams. "These cases underscore the need to have the civil justice tort systems scrutinize how big medical device companies like I-Flow blatantly ignore the FDA rulings on these products."
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