Current Events

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

Eli Lilly & Co. (LLY)’s injectable form of the antipsychotic Zyprexa is being investigated by U.S. regulators after two patients died three to four days after receiving the drug.

The two patients, given intramuscular injections of Zyprexa Relprevv, were later found to have very high levels of the drug in their systems, which can cause delirium, cardiac arrest and arrhythmias and coma or loss of consciousness, the Food and Drug Administration said in a statement today. The agency isn’t calling the deaths an overdose, and said the patients hadn’t been given an inappropriate amount of the drug.

Click here to read more.

Oregon researchers have found that a manufacturer's studies of a popular spinal fusion product overstated its effectiveness and downplayed harms that include risk of cancer.

Findings by Oregon Health & Science University researchers were designed to settle questions raised over the product Infuse, manufactured by the Minnesota firm Medtronic to promote bone growth. In 2011, a journal associated with a spine surgeons' professional group accused the firm of bankrolling "biased and corrupted" research, and estimated adverse events in as many as 50 percent of patients.

Click here to read more.