News Tagged ‘FDA

Pain pump manufacturer enjoys gains despite mounting lawsuits

Postoperative pain delivery system developer and marketer I-Flow Corporation may be facing lawsuits for needlessly injuring patients by instructing physicians to use their products incorrectly, but the company doesn’t seem to be suffering. The company recently announced that total revenue for the first quarter of 2009 has skyrocketed by 9 percent over the first quarter of 2008 – an increase of about $2.5 million, according to OC Metro.

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Athlete’s hopes of playing pro ball dashed by shoulder pain pump

Mathew McKeown, 23, of Blue Ash, Ohio, dreamed of playing pro ball. He was an all-city football player in high school and earned a scholarship to play for Miami. Making it to the NFL was just a matter of time.

But during a game in October 2006, McKeown’s left shoulder was injured while trying to recover a fumble. Doctors implanted the catheter of a On-Q PainBuster pain pump manufactured by I-Flow into his shoulder joint. For up to 72 hours, medication gradually dripped into his shoulder and slowly began eating away at the cartilage.

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FDA told pain pump manufacturers ‘no,’ but they refused to listen

Manufacturers of pain pumps were denied approval by the Food and Drug Administration (FDA) to use the devices in a different manner than what had been previously approved by the FDA for shoulder surgery. But that didn’t stop the manufacturers from advising physicians to use the devices improperly. That improper use has lead to a painful and debilitating condition in many patients.

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More lawsuits filed as link made between pain pumps, chondrolysis

There are approximately 140 lawsuits against manufacturers of pain pumps currently pending in state and federal courts throughout the country filed on behalf of patients who had used pain pump devices following shoulder repair surgery that were unreasonably and dangerously defective and caused serious pain and disability. The number of lawsuits has jumped considerably since the summer of 2008, says Frank Woodson, shareholder with Beasley Allen Law Firm.

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Pain pump manufacturer’s bad advice leads to ‘tragedy’

Surgeons who perform authroscopic surgery to repair shoulder injuries in patients often use pain pumps to help alleviate pain for up to 72 hours following surgery. The pain pumps are devices that hold pain medication that is gradually released into the shoulder area through a catheter implanted in the surgical site. Once all the pain medication has been released into the joint, the catheter is removed by the patient. When used properly, the process offers a beneficial alternative to oral or intravenous painkillers. And most patients can expect a good recovery after physical therapy.

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Pain pump manufacturers named in lawsuit

A lawsuit filed filed against AstraZeneca Pharmaceuticals and Stryker Corp. claims the companies distributed defective pain pumps even after learning the pumps had destroyed shoulder cartilage and the FDA had repeatedly rejected the products, according to Courthouse News Service. The lawsuit also names Hospira Inc. and Abbott Labs, saying the two companies encouraged the pain pump manufacturers to use their anesthetic drugs in conjunction with the pumps even though the medications had not been properly tested.

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The pump that doesn’t ease the pain

Through arthroscopic shoulder surgery, patients hope for better use of their shoulder and to put an end to their . The expectations of the surgery include alleviating patients’ shoulder problems, and for their post-surgical pain to be eased through pain pumps. While the problems initially might have been alleviated through surgery, it was the pump to ease the pain after the surgery that brought the patients back with more pain and suffering than before.

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