Wisconsin Court Rules In Favor of Medtronic In Product Liability Case

The Wisconsin Supreme Court, following a U.S. Supreme Court decision, has ruled patients cannot sue the maker of a potentially unsafe medical device approved for sale by the FDA.

A suit was brought against Minneapolis-based Medtronic, Inc. by a man who had his defibrillator surgically removed after the company warned its battery could fail. The defibrillator was implanted in 2004 to try to prevent his heart from stopping.

The next year, Medtronic warned the devices’ batteries might fail in 1 out of 10,000 patients. The company knew of the problem more than two years earlier but kept selling the defective defibrillator, according to the Minneapolis Star Tribune. The FDA did not order a recall nor did it withdraw its 2002 approval.

The Wisconsin decision was not unanimous. Two of the justices warned, “the decision leaves Wisconsin residents at the mercy of the U.S. Food and Drug Administration, […]

Attack of the Killer Tomatoes

Salmonella outbreak causes restaurants to stop serving tomatoes

When I pulled up to my favorite restaurant last night, I noticed a sign on the door, “We, like many other restaurants, will not be serving fresh tomatoes due to the salmonella outbreak.” Now, I have heard about the outbreak in the news but hadn’t realized its scope until I got my favorite entrée sans tomatoes.

Since mid-April, there have been nearly 150 cases of salmonellosis, a rare type of Salmonella Saintpaul poisoning, linked to raw red plum, red Roma and/or round red tomatoes (according to the FDA, grape and cherry tomatoes as well as those still attached to the vine are still safe to eat). At least 23 have been hospitalized and illnesses have been reported across 17 states, making this the biggest food scare since the tainted spinach fiasco of ’06. The source of the tomato contamination has yet to be identified. […]

FDA’s Brain Drain

According to an article from the Associated Press, when Big Pharma has a job opening – the first place they look is the FDA.

The former stewards of public health are extremely valuable to drug companies, because of their crucial experience. But what is good for Big Pharma is not always good for America.

With the FDA coming under fire just about every week now and paychecks that pale in comparison to what the world’s largest drug-makers can provide, some of the agency’s top scientists are leaving for greener pastures.

The problem? The FDA is already stretched thin with the departure of many Baby-Boomers and increased competition for science graduates. Now that other top-level personnel are jumping ship to Big Pharma, the FDA is left with a leaner, less experienced and less-confident staff, and tasking them with keeping America safe. The scenario has been dubbed the “FDA brain drain.” […]