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Current Events
Monday, June 24, 2013
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.
Wednesday, June 19, 2013
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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Wednesday, June 19, 2013
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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Wednesday, June 19, 2013
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.
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Wednesday, June 19, 2013
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.
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Wednesday, June 19, 2013
Pharmaceutical companies that pay rivals to keep less-expensive generic versions of best-selling drugs off the market can expect greater federal scrutiny after a Supreme Court ruling on Monday.
In a 5-to-3 vote, the justices effectively said that the Federal Trade Commission can sue pharmaceutical companies for potential antitrust violations, a decision that is likely to increase the number of generic drugs in the marketplace and benefit consumers.
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Monday, June 17, 2013
Townsend Farms, the organic berry and pomegranate-mix manufacturer whose products were recalled due to hepatitis A contamination earlier this month, is facing 2 additional lawsuits from people who allege they fell ill with hepatitis A infections after consuming the company’s berry and pomegranate seed mix.
According to a lawsuit filed Thursday in Maricopa County Superior Court in Arizona, Claudine Rad ate the Townsend Farms organic berry mix multiple times during April and May. She initially fell ill with flu-like symptoms, fatigue and nausea and later became jaundiced—a typical sign of hepatitis A infection.
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Monday, June 17, 2013
WASHINGTON — A surgeon at Chicago's Sacred Heart Hospital cut a hole in Earl Nattee's throat on Jan. 3, the day before he died. It's not clear why.
The medical file contained no explanation of the need for the procedure, called a tracheotomy, according to a state and federal inspection report that quotes Sacred Heart's chief nursing officer as saying it happened "out of the blue." Tracheotomies are typically used to open an air passage directly to the windpipe for patients who can't breathe otherwise.
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Monday, June 17, 2013
General Motors is recalling nearly 200,000 mid-sze SUVs because the master power door and window module in the driver's door can short out and catch fire.
Because the risk is serious enough -- and can happen when the truck is not in use -- GM says owners should park the trucks outdoors until the module is repaired, according to documents posted by the National Highway Traffic Safety Administration.
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Thursday, June 13, 2013
Merck & Co. (MRK), Novo Nordisk A/S (NOVOB) and other makers of popular treatments for diabetes may be asked to collect more data on a potential cancer link even as they try to reassure U.S. regulators this week of the drugs’ safety.
The Food and Drug Administration said it’s considering setting up a study, either through the agency or the companies, that looks deeper into whether medicines for Type 2 diabetes, including Merck’s Januvia and Bristol Myers-Squibb Co.’s Byetta, cause pancreatic cell growth that could turn cancerous. One option is a large clinical trial designed to show patterns of adverse events, said Morgan Liscinsky, an FDA spokeswoman.
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Thursday, June 13, 2013
A Tennessee pharmacy believed to be the source of a second outbreak of fungal infections linked to pain shots was a mess when Food and Drug Administration inspectors went in last month, with stray spiders in a clean room and few written procedures for making sure products were sterile, the FDA says.
The FDA has found fungus and bacteria in at least two vials of steroid distributed by Main Street Pharmacy of Newbern, Tenn. So far, 25 patients in four states have developed abscesses after getting injections of the pharmacy’s product.
Click here to read more.
Alan W. Clark & Associates represent clients throughout Long Island and the New York Metropolitan Area, including New York County, Richmond County, Kings County, Queens County, Bronx County, Nassau County, Suffolk County, and Westchester County.
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