Archive for the ‘Defective Products’ Category

Contaminated Heparin - An Intentional Act?

Wednesday, April 30th, 2008

An article in the New York Times outlines how LeRoy Hubley lost his wife and son from an allergic reaction to contaminated heparin.  The FDA believes the contamination was deliberate but they have been prevented from inspecting the Chinese plants that made the drug.So far, 81 deaths have been linked to a contaminant in the blood thinner, Heparin.  Dr. Janet Woodcock, director of the FDA said a third of the material in some batches of Heparin was the contaminant.  David Strunce, the CEO of Scientific Protein Laboratories, the company that supplied the Heparin said it was an “insidious act that seems to us an intentional act upstream in the supply chain.”

Additional Patient Deaths May Be Linked To Tainted Heparin

Sunday, March 2nd, 2008

The FDA reports additional patient deaths are possibly linked to the blood thinner heparin so the company is mounting a recall of all of the drug.  

Baxter International Inc. will recall the remaining lots of single and multi-dose injection and it will recall HEP-LOCK products.

Last month, Baxter recalled nine lots of heparin multi-dose after the drug’s use was linked to four deaths and hundreds of mysterious allergic reactions.

Most of those adverse events were attributed to the multi-dose vial of heparin.

Now 17 other deaths are being investigated because of a link to heparin, although the FDA reminds reporters that those patients were already very sick so a definitive cause-effect at this time has not been established.

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Bacteria-Tainted Syringes Causing Serious Injury To Patients

Monday, January 28th, 2008

More lawsuits have been filed over bacteria-tainted syringes.  Sierra Pre-Filled of Angier, North Carolina makes the syringes, filled with heparin or saline are used to flush IV or catheter lines.  In December, bacteria-contaminated pre-filled syringes sickened 20 outpatients of Rush University Medical Center in Chicago.  14 of those patients required hospitalization from five to nine days.   All already have compromised immune systems from cancer and other ailments and many were undergoing chemotherapy. Quick investigative work linked the syringes to the bacteria, Serratia marcescens.  On December 20, 2007, the FDA announced AM2 PAT, Inc., initiated a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H.  Then the FDA in January expanded the recall to include all lots and sizes the company makes of heparin and saline pre-filled syringes after finding they too were contaminated with Serratia marcescens. The heparin IV flush syringe contamination was later confirmed by the CDC after checking several unopened syringes of this product.                

FDA Approves New Ortho Evra Birth Control Patch Labeling

Monday, January 21st, 2008

The FDA recently approved additional changes to the label of the Ortho Evra birth control patch to include results from a new epidemiology study that suggests that users of the patch are at higher risk for developing serious blood clots than those taking birth control pills. These dangerous blood clots are known as venous thromboembolism (VTE), which can lead to pulmonary embolism. The findings support earlier studies further reinforcing elevated risks of VTE associated with the patch.

The Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson, the makers of the patch, conducted the study that prompted the labeling changes. In September of 2006 the FDA advised the label of Ortho Evra to warn an elevated risk of VTE based on two studies.

Jury Award For Construction Worker Injured By Nail Gun

Tuesday, December 11th, 2007

A construction worker who was severely injured when a nail from a nail gun became embedded in his head was awarded $3.4 million from a Hartford, Connecticut jury.

Jerry Crutchfield, 51, of Hartford had sued toolmaker Stanley Works and Home Depot, which sold the nail gun, claiming they were partly liable for the injuries he sustained Feb. 3, 2003.

The jury stated that Crutchfield was 55% liable for his injuries because he was the one to fire the nail gun into metal instead of a wood surface. This action caused the nail to backfire at him. But nevertheless, the jury ordered Stanley Works and Home Depot to pay $3.4 million for their percentage of the liability. The two companies have not decided if they will appeal the verdict yet.

The assistant general counsel for Stanley disagrees with the verdict. He stated that the nail gun met industry standards and is used every day without injuries. Also, the case for the nail gun warns consumers to follow all instructions.

Crutchfield was doing carpentry in a church when the incident occurred. The 3 in. nail went through his cheek and into his brain, which has partially paralyzed him and causes him to have seizures.