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White House reform director served on boards w/questionable behavior

White House health reform director Nancy-Ann DeParle is in a tight spot. A new investigative report has concluded that DeParle earned more than $6 million serving on the boards of major healthcare... Read more...

Decision makes it harder to sue device makers

A new Supreme Court opinion has come down this week that should make it harder for patients to seek damages for harm caused by FDA-approved medical devices. The ruling held that federal law doesn't... Read more...

Researcher settles price disclosure case with Guidant

Not-for-profit market research firm ECRI Institute has settled a legal dispute with Boston Scientific over whether it could publish pricing information on the devicemaker's products. ECRI had been... Read more...

ALSO NOTED: MA doc wrote fake prescriptions; J&J sues Guidant for $5.5B; and much more...

> A Massachusetts doctor is facing charges for writing fake prescriptions for painkillers. Report

> Brentwood, TN-based Community Health Systems has abandoned a deal to purchase Ohio-based system Forum Health. Report

> Johnson & Johnson is suing device maker Guidant for $5.5 billion. …

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Patients face defibrillator recalls

A group of already-vulnerable patients are facing yet another trauma as a wave of implantable heart device recalls hits the market. According Newsday, the FDA has targeted more than 300,000 such devices within the past 18 months alone, the majority of which came from Boston Scientific's Guidant. In some cases, it won't be necessary for doctors to remove the device, but others must go through additional surgery and risk to get the implant out of their body. Generally speaking, …

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Boston Scientific announces recall, shares drop

Boston Scientific said it will recall one of its pacemaker models after an FDA report released last week suggested many of the units will eventually malfunction. The device maker's shares fell seven percent on the news Monday and are down midday Tuesday. CEO Jim Tobin said in a conference call that it may take 18 months to two years to correct problems with the pacemakers and defibrillator lines the company acquired in the Guidant deal this year. He also hinted the recall may not be the …

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FDA report pains Boston Scientific

An internal FDA estimate of the dangers posed by a Boston Scientific pacemaker suggests that they may be far higher than earlier estimates had suggested. In the report, agency experts argue that the odds of the Contak Renewal short circuiting may be ten times higher than than its maker previously admitted. Boston Scientific acquired the pacemaker when it bought Guidant in a $27-billion deal. The news comes a day after The Wall Street Journal published a front-page piece …

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Guidant warning letter drafted in 2005

The New York Times reports that Guidant officials prepared a letter to doctors warning of serious quality control issues with some of its implanted devices long before the company admitted problems, but never sent it. Earlier this week, a Texas court made public a number of company documents, including the letter, which was dated January 2005. The development appears to suggest that liability for Guidant--and new owner Boston Scientific--over the recall of the Contak …

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HRS addresses device safety issues

The annual meeting of the Heart Rhythm Society in Boston was dominated by talk of how best to reassure patients after the recent recalls of implantable cardiac devices. Attending electrophysiologists say the safety problems reported by Guidant and Medtronic have led to "near panic" among patients. Several panels discussed ways in which doctors can dissuade patients from having surgery to replace potentially defective devices in light of studies which show the procedure can pose more risks …

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ALSO NOTED: Boston Scientific in wireless trial; Hospital infection rates in Phila. raise questions; and much more...

> Hospital acquired infection rates are at record lows in Philadelphia. Observers say the rates are suspiciously low. Article

> Meditech says it has signed its first customer in Australia. Article

> RFID tags are turning up everywhere. The Financial Times reports that RFID is being used to reunite lost pets with …

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