Current Events

Medtronic Inc. (MDT)’s SynchroMed infusion pumps were found to have four flaws that have led to 14 patient deaths, spurring U.S. regulators to issue their most serious recall on the implantable device used to deliver pain and other medications.

Medtronic, the world’s largest heart device maker, notified customers in early June about the flaws that may interfere with the safe and reliable delivery of medications using the SynchroMed Implantable Infusion System, the Minneapolis-based company said in a statement. Each flaw specified in the notifications was deemed a Class 1 recall by the U.S. Food and Drug Administration, denoting potential life-threatening issues.

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In the wake of Monday's Supreme Court decision that blocked the ability of patients to sue generic drugmakers for design flaws in their medicine because it would conflict with Food and Drug Administration rules, members of Congress and consumer groups renewed their plea to the FDA to change those rules. A link to Tuesday's Inquirer story is here.

Three senators and four representatives - all Democrats - sent a letter to FDA Commissioner Margaret Hamburg, urging her to make the changes happen so that patients who think they are harmed can seek redress in state courts.

Karen Bartlett was the plaintiff in the case that was decided Monday. The New Hampshire woman took a generic painkiller made by Philadelphia's Mutual Pharmaceutical Co., which is now part of Sun Pharmaceutical Industries, Ltd. Her adverse reaction included terrible skin reactions, near blindness, 12 operations and the need for a medically-induced coma.

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WASHINGTON - First Karen Bartlett lost more than 60% of her skin, suffered lung and esophageal damage and became legally blind after taking a generic painkiller. Now the Supreme Court has stripped her of a $21 million state court award.

In another example of its well-documented pro-business tilt, the high court ruled Monday that the generic drug maker wasn't liable for the painkiller's content or warning label because it must mimic the brand-name drug in both instances.

Not that the justices didn't sympathize with Bartlett's plight. The 5-4 decision, written by Justice Samuel Alito, said the case "arises out of tragic circumstances" and spread blame at the feet of doctors, Congress and the Food and Drug Administration.

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The Food and Drug Administration is charged with protecting the public health, but some of its recent actions raise serious questions about drug safety.

One puzzle is its shifting stance on the diabetes drug rosiglitazone (Avandia). Several years ago, Avandia was marketed aggressively and widely prescribed. In its heyday, it earned more than $3 billion a year, making it the most successful diabetes drug of all time. Then cardiologist Steve Nissen, M.D., published an article in the New England Journal of Medicine (June 14, 2007) revealing a 43 percent increased risk of heart attack among patients taking Avandia.

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WASHINGTON - The Food and Drug Administration is tightening standards for a wide range of medical devices – from fetal monitors used in hospitals to pacemakers implanted in people – because of escalating concerns that the gadgets are vulnerable to cybersecurity breaches that could harm patients.

Increasingly, officials said, computer viruses and other malware are infecting equipment such as hospital computers used to view X-rays and CT scans as well as devices in cardiac catheterization labs. The security breaches cause the equipment to slow down or shut off entirely, complicating patient care. As more devices operate on computer systems that are connected to each other, the hospital network and the Internet, the potential for problems rises dramatically, they said.

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The ongoing outbreak of hepatitis A linked to a frozen berry mix sold at Costco is now known to have sickened 119 people in the western United States, according to an update from the Centers for Disease Control and Prevention.

Of these victims, 53 have been hospitalized as a result of their infections. CDC last reported 50 hospitalizations and 113 cases, meaning that 3 of the 6 newly reported cases were hospitalizations.

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WellPoint Inc. (WLP) agreed to pay $6 million to settle a 2008 lawsuit by the city of Los Angeles, which alleged the insurer used illegal rescission methods when individual policyholders filed a claim.

WellPoint denies wrongdoing and has changed its rescission practices, including using a third-party, independent review process, City Attorney Carmen Trutanich said today in a statement. Kristin Binns, a spokeswoman for Indianapolis-based WellPoint, declined to comment further on the settlement.

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SILVER SPRING, Md. - Bottles supposed to contain generic low-dose aspirin were accidentally filled with acetaminophen tablets and have been recalled by their manufacturer, the FDA said.

One lot of Rugby Laboratories 81-mg enteric coated aspirin, manufactured by Advance Pharmaceuticals, has been recalled after a consumer discovered that a bottle actually contained 500-mg acetaminophen tablets, according to the FDA.

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WASHINGTON, D.C. (WUSA) - You've heard about people who can hack into your computer.  But what about hacking into devices that are in our bodies, like a pacemaker?  

The threat is real enough that last week the FDA issued a security warning to all medical device manufacturers.  

In an episode of Showtime's Homeland, a terrorist hacks into the Vice President's pacemaker.  It's fiction, but the plot line was based on some very real research at the University of Michigan.

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A tense standoff between Chrysler and federal regulators over the safety of millions of Jeep sport utility vehicles was resolved in one last high-level phone call.

The call took place Monday between Sergio Marchionne, Chrysler’s chief executive, and David Strickland, head of the National Highway Traffic Safety Administration, according to a person with knowledge of the call who spoke on condition of anonymity because the conversation was private.

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A nationwide outbreak of hepatitis A linked to frozen berries has sickened 118 people in eight states, sending 47 to the hospital, the Centers for Disease Control and Prevention reported Tuesday.

Although the berries were recalled June 3, people are still getting sick. A report in The Oregonian newspaper found that a restaurant in Ashland, Ore., was still serving smoothies made with the recalled berries last Wednesday.

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