Current Events

The Food and Drug Administration has publicly released a huge amount of data on drug side effects that it hopes will lead to new applications and research.

Under its open FDA project, the agency has released more than 3 million reports on adverse drug events and medication errors recorded between 2004 and 2013. These kinds of reports were only available before through lengthy Freedom of Information Act requests.

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Medtronic Inc. (MDT), one of the world’s largest medical-device makers, was sued by Humana Inc. for allegedly marketing its Infuse bone-graft product for uses that weren’t approved by regulators and duping the insurer into covering those claims.

Medtronic paid doctors hundreds of millions of dollars to tout the safety and effectiveness of the Infuse product for a variety of spinal surgeries even though the U.S. Food and Drug Administration had limited its use to lower-back procedures, Humana said in a complaint filed May 30 in federal court in Tennessee.

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The Food and Drug Administration has finalized a guidance (PDF) that will help drug and biologics manufacturers bring products that treat unmet needs to the market faster than the usual approval pathways currently make possible.

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The Food and Drug Administration made good Thursday on a vow to heighten its oversight of sunlamps used in tanning salons, saying additional warnings are needed to educate consumers about the cancer risks involved.

The agency is reclassifying the devices from “low risk” to “moderate risk,” a designation that will require manufacturers to demonstrate to regulators that their products meet certain standards before they are allowed to market them.

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A Fresenius solution used in hemodialysis machines has been recalled because of concerns over bacteria contamination following a patient death.

The U.S. Food and Drug Administration issued a notice this week of the recall, saying it had received one report of death and two reports of injury that may be related to use of Fresenius NaturaLyte Liquid Bicarbonarte Concentrate. Lab testing identified Halmonas, a bacteria typically found in water with high salt concentration, in the product during its shelf life, the FDA said.

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WASHINGTON — President Obama on Thursday will seek to elevate a national conversation about the dangers of sports-related concussions, especially among children and other young athletes, by pushing for more medical research and more money spent on public awareness campaigns.

The president will host a daylong summit at the White House that will include researchers, professional athletes, parents, coaches, league officials and sportscasters. Officials said the goal was to use the power of the presidency to accelerate progress on one of the most serious health issues to confront sports in a decade.

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The German drug maker Boehringer Ingelheim has agreed to pay $650 million to settle thousands of lawsuits involving its blood thinner Pradaxa,the company said Wednesday.

The settlement will most likely resolve most of the 4,000 cases in state and federal courts filed by patients and their families who claimed that Boehringer failed to properly warn them that the drug, which is used to prevent blood clots, caused serious and sometimes fatal bleeding that could not easily be reversed. The first case was set to go to trial in September.

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U.S. regulators are investigating potential flaws in at least 2 million General Motors Co. (GM) vehicles that remain on the road, underlining the potential for still more recalls on top of this year’s already-record tally.

The largest U.S. automaker may continue to recall vehicles into the middle of the summer months, Brian Johnson, a Barclays analyst, wrote last week after meeting with a top GM executive. The company didn’t dispute Johnson’s characterization.

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BEN WHEELER, Tex. — For most of the last decade, Candice Anderson has carried unspeakable guilt over the death of her boyfriend. He was killed in 2004 in a car accident here, and she was at the wheel. At one point, Ms. Anderson, who had a trace of Xanax in her blood, even faced a manslaughter charge. She was 21.

All these years, Ms. Anderson — now engaged and a mother — has been a devoted visitor to his grave. She tidies it every season, sweeping away leaves and setting down blue daisies with gold glitter for his birthday, miniature lit trees for Christmas, stones with etched sayings for the anniversary of their accident.

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Research has confirmed that 440,000 people die every year because of preventable medical errors. That is equivalent to almost the entire population of Atlanta, Georgia, dying from a medical error each year. Preventable medical errors are the third leading cause of death in the United States and cost our country tens of billions of dollars a year.

Despite this serious epidemic, corporate front groups are working hard in the U.S. Congress and state legislatures throughout the country to limit accountability and access to the civil justice system when patients are harmed or killed by medical negligence.

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As Memorial Day passes and we honor the great sacrifice of the men and women of our armed forces who protect our life ,liberty and pursuit of happiness we face the grim reality of Corporate America which day after day needlessly endangers the safety of consumers. GM and other car makers place safety at the very bottom of their priorities. How many lives and injuries are enough sacrifice before this Corporate misconduct stops? GM seeks to hide behind the bankruptcy laws to avoid responsibility for deaths and injuries that occurred before the bankruptcy. The faulty ignition switch which was the source of the defect in their cars was known and ignored by GM's corporate managers and engineers for years. GM chose recklessness over safety and gambled like Russian roulette with the lives and safety of its consumers. Now 10 years later after public disclosure of this corporate fraud GM seeks recalls of millions of cars that have safety defects. When will the public finally wake up and demand that GM and others be held criminally and civilly responsible for this carnage. A 35 million dollar fine by the DOT is nothing but a parking ticket. Enough is truly enough. Please send your comments.