Current Events

The Food and Drug Administration on Tuesday released a sharply worded warning letter to St. Jude Medical in which it said it might soon fine or take other actions against the company for failing to address agency concerns about a widely used heart device component.

The component — an electrical wire, or lead, called the Durata — connects an implanted defibrillator to a patient’s heart. In the letter, dated Jan. 10, the agency said that St. Jude had failed to address a variety of concerns about the component arising from an F.D.A. inspection last fall of a company factory in California.

Click here to read more.

The U.S. Food and Drug Administration has sent a warning letter to St. Jude Medical regarding manufacturing processes at a facility in Southern California, St. Jude and the FDA have confirmed.

Until St. Jude corrects the issues that prompted the letter, the FDA will not approve certain types of cardiac rhythm management products from the Little Canada-based medical technology company, the company confirmed Monday. The plant in Sylmar, Calif., is where St. Jude manufactures the Durata defibrillator lead, a wire that connects the defibrillator to the heart.

Click here to read more.

Thousands of individuals could receive new hearings on their disability benefit claims as part of a proposed settlement addressing allegations of hostility and bias against five federal administrative law judges in Queens, New York.

The proposed class action settlement, filed Friday in Brooklyn federal court, aims to resolve a 2011 lawsuit accusing the five administrative law judges, or ALJs, of failing to give fair hearings to disabled individuals who appeared before them.

Click here to read more.

Federal banking regulators are trumpeting an $8.5 billion settlement this week with 10 banks as quick justice for aggrieved homeowners, but the deal is actually a way to quietly paper over a deeply flawed review of foreclosed loans across America, according to current and former regulators and consultants.

To avoid criticism as the review stalled and consultants collected more than $1 billion in fees, the regulators, led by the Office of the Comptroller of the Currency, abandoned the effort after examining a sliver of nearly four million loans in foreclosure, the regulators and consultants said.

Click here to read more.

Businesses and individuals who claim BP's oil spill in the Gulf of Mexico cost them money have been paid more than $1 billion through the company's class-action settlement with a team of private plaintiffs' attorneys, court-supervised claims administrator Patrick Juneau said.

Juneau said the payments reached the $1 billion mark before the end of 2012. He also said 95 percent of claimants who were offered payments decided to accept them.

Click here to read more.

A state law tort claim of failure to warn about risky medical devices is not pre-empted by the federal medical device law — so long as the state law duty of care runs "parallel" to a duty established by the federal law.

That brain-twisting holding Thursday by an en banc panel of the U.S. Court of Appeals for the Ninth Circuit could expose manufacturers of hundreds of high-risk medical devices to hefty state tort damages.

Johnson & Johnson (JNJ) sold a defective vaginal mesh implant after testing it inadequately and failing to warn of all the risks, a lawyer for a South Dakota woman told a jury in the first of 1,800 such lawsuits to go to trial.

Linda Gross, 47, claims that she had 18 operations to repair damage caused by the Gynecare Prolift implanted in her on July 13, 2006, to shore up pelvic muscles. Her lawyer told jurors in Atlantic City, New Jersey, today that her chronic pain and other problems were risks that J&J’s Ethicon unit knew before first selling Prolift in March 2005.

Click here to read more.

Fisher-Price®, in cooperation with the United States Consumer Product Safety Commission, is voluntarily announcing a recall to inspect Fisher-Price Newborn Rock ’n Play Sleepers™. The company says that mold can develop between the removable seat cushion and the hard plastic frame of the sleeper when it remains wet/moist or is infrequently cleaned.

The CPSC advises that mold has been associated with respiratory illnesses and other infections.  Around 800,000 of the infant sleepers are subject to the recall.  Fisher-Price has received 600 reports of mold on the product. Sixteen consumers have reported that their infants have been treated for respiratory issues, coughs and hives after sleeping in the product.

Ten of the nation's largest mortgage servicers have agreed to an $8.5-billion settlement with federal regulators to end a review of foreclosure abuses.

The settlement, announced Monday, involved some of the biggest names in the financial industry, including Bank of America Corp., Wells Fargo & Co., JPMorgan Chase & Co. and Citigroup Inc..

They agreed to pay a total of $3.3 billion to more than 3.8 million borrowers whose homes were in foreclosure in 2009 and 2010, according to the Federal Reserve and the Office of the Comptroller of the Currency. Borrowers could receive as much as $125,000, depending on the type of problems with their foreclosures.

Click here to read more.

After a cautious and rigorous analysis of national malpractice claims, Johns Hopkins patient safety researchers estimate that a surgeon in the United States leaves a foreign object such as a sponge or a towel inside a patient’s body after an operation 39 times a week, performs the wrong procedure on a patient 20 times a week and operates on the wrong body site 20 times a week.

The researchers, reporting online in the journal Surgery, say they estimate that 80,000 of these so-called "never events" occurred in American hospitals between 1990 and 2010 - and believe their estimates are likely on the low side.

Click here to read more.

The driller whose floating Deepwater Horizon oil rig blew out in 2010, causing a massive oil spill, has agreed to settle civil and criminal claims with the federal government for $1.4 billion, the Justice Department announced Thursday.

The Deepwater Horizon exploded, burned and sank in April 2010. Eleven men were killed and millions of gallons of oil flowed into the Gulf of Mexico and fouled the shores of coastal states. The well, known as Macondo, was owned by British oil giant BP, which settled its own criminal charges and some of its civil charges in November for $4.5 billion.

Click here to read more.