The Chicago-based company said in a regulatory filing that the financial watchdog sent it a subpoena in March 2012 "related to the company’s accounting treatment, financial reporting and disclosures relating to the remediation and recall of the company’s Colleague and Syndeo infusion pumps," according to the filing. "The company is fully cooperating with this investigation."
In May 2010, the FDA made Baxter yank the Colleague line, accusing it of a "long-standing" failure to correct problems with the pumps, and ordered the company to provide refunds to customers or to replace the pumps at no cost.
Problems with infusion pumps in general prompted the FDA to look at stricter regulation of the devices, which are designed to deliver medications, including insulin for diabetes, at a controlled pace. The agency issued nearly 20 recalls over 5 years and said it received more than 56,000 complaints associated with the use of the pumps, scores of which resulted in serious injuries and 500 deaths.
Family members of Junior Seau, the retired football player who took his life last week, are considering donating his brain to a research facility studying athletes’ brains for signs of traumatic injury. Read more
GOP hopeful Mitt Romney’s health care plan to stifle Medicaid spending would take the wind out of policies he helped put in place as governor of Massachusetts, analysts say. Read more
Massachusetts launches a new health care initiative designed to rein in health care spending by tying spending growth rates to economic output. Read more
New guidelines published by the American Heart Assn. and the American Stroke Assn. call for "aggressive" aneurysm care at high-volume centers. Read more
A New Jersey law limits liability for lay people using automated external defibrillators, as well as the companies who make the devices. Read more
A team of researchers at UCLA design an online "video game" through which users can learn, with high rates of accuracy, to look for signs of disease by looking at images of red blood cells. Read more