Consumer Lawyers

Archive for November, 2012|Monthly archive page

11/29/12: Steroid Meningitis Recall News: Litigation Update

In Uncategorized on November 29, 2012 at 10:05 pm

Evidence of a deadly fungus that has sickened thousands and killed hundreds of patients may still exist inside the New England Compounding Center and should  be collected now, say  attorneys who represents a man who has filed a lawsuit against the Center.

“We should to be allowed inside the NECC business office to gather valuable evidence and information by mid-December,” says Mark Zamora, the lawyer for the Plaintiff in the case pending in United States District Court in Boston.

Attorney Mark Zamora,  along with Janet, Jenner & Suggs, represent C. Green who claims he received one or more steroid injections formulated by NECC and now suffers from serious side effects.  Green’s 22-page complaint filed  in  Superior Court of Middlesex County, MA, describes “greenish black foreign matter” and “white filamentous material” discovered by government inspectors when they examined NECC’s products.

The Centers for Disease Control and Prevention said at least 36 people in 19 states are dead and 474 more have been sickened or are seriously ills after receiving injections possibly contaminated with the fungus that causes fungal meningitis.

On Wednesday, U.S. District Court Judge F. Dennis Saylor IV ordered owners of the NECC a to preserve all physical and electronic evidence related to its operations, including personal phone and email records. The Court ruled on Motions filed by Zamora and co counsel Kim Dougherty.

Judge Saylor has temporarily consolidated 12 local lawsuits against the NECC, including the Green suit so that pre-trial proceedings may move forward.

“The NECC’s blatant disregard for even the most basic sterility obligations, its wanton disregard for the limited scope of its licenses, its conscious disregard for safety standards, its deplorable facility conditions where mold and bacteria festered, and blatant contempt for prior complaints, adverse events, and inspection findings, all lead to a national epidemic of fungal meningitis,” according to Green’s complaint.

FDA Closes Peanut Plant Tied to Massive Recalls

In Food Recalls on November 28, 2012 at 10:34 pm

The shutdown of the Sunland Inc. plant in Portales, N.M., was the first of its kind under the 2011 Food Safety Modernization Act, the FDA noted. Forty-one people in 20 states have been sickened by Sunland products tainted with the strain salmonella Bredeney, the agency added.

The FDA issued a scathing report about the salmonella outbreak and Sunland’s culpability, including a finding that Sunland detected salmonella in nut butter samples over a 30-month period ending in September 2012 but still distributed some of the products.

Among the agency’s other discoveries:

  • FDA inspections in September and October 2012 revealed salmonella on plant surfaces, in 13 nut butter samples and in a sample of raw peanuts.
  • Equipment, containers and utensils used to hold and store food were improperly handled.
  • Employees wiped gloved hands on their street clothes and failed to wash their hands or change gloves.
  • The plant lacked hand-washing sinks in the production and packaging areas.
  • Employees placed bare hands on finished peanuts.
  • The same bags were used to hold raw and roasted peanuts.
  • Raw in-shell peanuts were stored in uncovered trailers open to birds and rain.

http://www.dogchannel.com/dog-news/2012/11/27/fda-closes-peanut-plant-tied-to-dog-recalls.aspx

Ranbaxy recalls generic Lipitor doses

In FDA REcalls on November 28, 2012 at 10:32 pm

Ranbaxy Pharmaceuticals Inc. has recalled dozens of lots of its generic version of cholesterol drug Lipitor because some may contain tiny glass particles, the latest in a string of manufacturing deficiencies that once led U.S. regulators to bar imports of the Indian company’s medicines.

Ranbaxy, a subsidiary of Ranbaxy Laboratories Ltd., India’s biggest drugmaker, is operating under increased scrutiny from the U.S. Food and Drug Administration because of quality lapses at multiple Ranbaxy factories over the past several years. The FDA also has alleged the company lied about test results for more than two dozen of its generic drugs several years ago.

On Friday, Ranbaxy posted a notice on its U.S. website, saying it’s recalling 10-, 20- and 40-milligram doses of tablets of atorvastatin calcium. That’s generic Lipitor, the cholesterol fighter that reigned for years as the world’s top-selling drug.

The recall includes 41 lots of the drug, nearly all with 90 pills per bottle, but three lots contain 500 pills per bottle. It’s unclear how many bottles are in each lot, but medicine batches typically contain many thousands of pills. The 80-milligram strength tablets are not affected.

Ranbaxy spokesman Chuck Caprariello did not answer questions or provide any additional information beyond the statement on the company’s website.

“Ranbaxy is proactively recalling the drug product lots out of an abundance of caution,” the website statement read. “This recall is being conducted with the full knowledge of the U.S. FDA.”

Class I recall for HeartSine public-access defibrillator

In FDA REcalls on November 20, 2012 at 5:01 pm

The FDA has issued a highest-level class I recall [1] for some Samaritan model 300/300p public-access defibrillators (HeartSine Technologies) following release of the company’s “global-correction” letter in September that described the problem and its recommended fixes [2].

The defibrillators are at risk of premature battery depletion from intermittently turning on and off. “In addition and separately,” the company says, a glitch in the battery-management software could cause the unit to turn itself off. Either problem could keep it from delivering therapy when needed, the company states.

The recall applies to 300/300p units with serial numbers from 0400000501 to 0700032917, 08A00035000 to 10A0070753, and 10C00200000 to 10C00210106, manufactured from August 2004 through December 2010 with a seven-year warrantee.

 

http://www.theheart.org/article/1477523.do

Stryker Issues Class I Recall for Neptune Devices After Death

In Uncategorized on November 18, 2012 at 6:48 pm

Stryker stopped selling three versions of its Neptune Waste Management System after two people were harmed, one fatally, using the devices that were sold without formal clearance by U.S. regulators.

Stryker initiated a Class 1 recall, the most serious device withdrawal, on June 5 after two reports of serious injury from the products used to collect fluid waste during surgery, the Kalamazoo, Michigan-based company said today in a statement. In one instance, a patient’s passive chest drainage tube was hooked to the Neptune 2 System, a high-vacuum, high-flow device. The patient died, Stryker said.

 

http://www.bloomberg.com/news/2012-09-25/stryker-recalls-neptune-devices-after-death-reported.html

FDA Issues Class I Recall of Surgical Staplers

In Product Recalls on November 18, 2012 at 6:44 pm

A Class I recall is issued by the FDA when a drug or medical device  poses a threat of death or serious injury to patients.

Johnson & Johnson’s Ethicon Endo-Surgery unit recalled more than 157,000 of the surgical stapler devices and accessories used in the surgical treatment of prolapse and hemorrhoids.

The staplers were recalled due to the difficulty of firing the device, which may result in an incomplete firing stroke of the stapler and incomplete staple formation. The problem can cause severe pain, rectal wall damage, bleeding, sphincter dysfunction, sepsis, and occlusion of the rectal canal, reports the FDA.

The inability of these staplers to complete the firing stroke can also lead to poor staple formation causing separation of the rectal wall staple line along with bleeding.

The devices under recall are the Proximate PPH hemorrhoidal circular stapler and accessories, the Proximate HCS hemorrhoidal circular stapler and accessories, and the Transtar circular stapler procedure set, according to the FDA. The lots affected by the recall were manufactured and distributed from April 2011 to July 2012.