bad medical devices blog

An inspector general with the Health and Human Services Department told Congress that unspecified medical device makers have been paying off doctors for financial gain.
The companies control about 75 percent of the hip and knee replacement parts market and have spent in excess of $800 million in royalties and fees in four years to influence […]

The FDA and medical device manufacturer Synthes are meeting the wrath of Senate Finance Committee member Charles Grassley over financial conflicts of interest in getting artificial spinal replacement Prodisc pushed through clinical trials for approval in 2006.
Lumbar disk replacement Prodisc was developed by US-based Spine Solutions, a start-up company funded by New York investment firm […]

Lawyers for medical device maker Medtronic Inc. have been fined $10 million for their conduct in a patent infringement case, the Minneapolis-St. Paul Business Journal reports.
A U.S. District Court Judge says lawyers for Medtronic – from the New York firm Dewey & LeBouef – “elected to proceed with a defense that threatened to mislead and […]

Embattled medical device maker Medtronic Inc. says a proposed Sunshine Act that would require full disclosure of payments and communication between device makers and physicians, should include all device makers, not just the large ones.
Reuters reports the Sunshine Act would require disclosure of payments made to physicians that helped medical device makers with an annual […]

Democrats on Capitol Hill are aiming to overturn a Supreme Court ruling last week preventing people from suing medical device makers whose products have undergone a federal premarket approval process.
Members of the House and Senate are drafting legislation that would return some protection to patients who were injured by medical device malfunction or device maker […]

The troubled medical device firm Medtronic isn’t exactly pinching pennies after releasing its third-quarter 2007 earnings, maybe just pinching hundred dollar bills.
Medtronic reported a net income of $77 million for the quarter, down considerably from the income in the third quarter 2006, $710 million, according to Forbes. The numbers are down considerably for the year […]

The Supreme Court ruled in favor of medical device makers on Wednesday, saying they are immune from personal injury lawsuits if its device was approved by the Food and Drug Administration.
Justices ruled 8-to-1 in favor of the decision, thought of as a victory for the Bush Administration, that long sought to pre-empt state laws on […]

The Food and Drug Administration recently sent a letter to physicians warning of unretrieved device fragments.
Earlier this month we reported on this blog about the nearly 1,000 incidents a year when a medical device, or at least part of one, is left inside a patient’s body. Patients are often not aware of this medical gaffe, […]

It seems the only good news Stryker Corp. can report is about its earnings. Those of us not benefiting from the company’s recently announced 2007 net income of $1.01 billion tend to hear the other side of the controversial medical device maker.
But according to headlines since New Year’s Day, Stryker cut corners on the way […]

The Food and Drug Administration has issued a draft of rules drug and medical device makers can follow if they wish to disseminate information on their products for non-FDA approved use.
Prior to September 2006, these companies could do this under the umbrella of the FDA Modernization Act. At that time, however, the Act expired and […]