Showing posts with label recall. Show all posts
Showing posts with label recall. Show all posts

Wednesday, July 15, 2015

Wright's Hip Implant Patient Receives $4.5 Million For Settlement

A California jury has ordered Wright Medical Technology Inc. to pay $4.5 million to Alan Warner, a metal hip implant patient, and his wife after finding that his implant was defective and caused him harm. This was the first trial among 1,200 cases claiming Wright’s hip implants are defective. The jury agreed with the patient’s allegation that the hip implant he received contained a manufacturing defect, and that the implant’s failure injured both him and his wife. Interestingly, the jurors didn’t find that Wright was negligent in designing the Profemur R implant.
The jury didn’t award Mr. Warner any damages for his medical expenses. But they did award him $4 million for his past and future pain and mental suffering. His wife was awarded $500,000 for the losses she’s suffered as the result of his defective hip implant.
The suit was filed in December 2011, alleging that on Oct. 27, 2010, Mr. Warner’s implant failed while he went to the kitchen to get a cup of coffee, throwing him into extreme agony and forcing him to undergo extensive surgery to fix it. Laser guidance marks etched too deeply on the implant allegedly weakened the implant and caused it to fail, according to Mr. Warner. His case is a bit different than most of the others, in that the implant appeared to break in the stem of the implant. Most others appear to have broken in the neck or leeched chromium and cobalt into the bloodstream and hip capsule.
Steven R. Vartazarian, a for Mr. Warner, told jurors during the trial that the hip implant was supposed to last 15 to 20 years, but that this one failed after less than three years. This case is the first of more than 600 lawsuits in coordinated in California state court and about 600 more in federal multidistrict based in Georgia to go before jurors. All of the cases focus on the alleged metal-on-metal failure of Wright’s Profemur hip implants, though the specific types of failure vary. Wright took the position during the trial that the device failed because it was not installed correctly. It was contended by Wright that this allowed slight movements that eventually caused the fracture.

Thursday, February 26, 2015

Heritage Pharmaceuticals Doing The Right Thing--

 

Heritage Pharmaceuticals has initiated a nationwide voluntary

recall of ten lots of colistimethate for injection (150 mg) and

three lots of rifampin for injection (600 mg) because of

concerns over lack of  sterility.

 

Colistimethate is indicated for the treatment of acute or

chronic infections due to sensitive strains of certain gram-

negative bacteria.

 

 Rifampin is indicated for the treatment of all forms of 

tuberculosis.The recalled colistimethate has national drug code

(NDC) 23155-193-31, and the recalled rifampin has NDC

23155-340-31.

Both products are sold in single-vial monocartons in case packs

of ten. The recall (to the user level) stems from observations by

the US Food and Drug Administration (FDA) regarding aseptic

and general manufacturing practices at the manufacturer's site

potentially affecting product sterility, according to a company

news release posted on the FDA website. "Intravenous

administration of nonsterile injection products to a normally

sterile site may result in a site-specific or systemic infection,

which in turn may cause hospitalization, significant morbidity

(permanent organ damage), or fatal outcome. To date, Heritage

 is not aware of any adverse patient events resulting from the

use of the subject product lots," the release says.

 

The recalled products were distributed to hospitals, wholesalers, and distributors nationwide from December 2012 through January 2015 for colistimethate and from October 2014 through January 2015 for rifampin.

Customers are being notified by fax, email, United Parcel Service, and/or certified mail to return all recalled product.

Heritage asks all customers to check their inventory "immediately and to quarantine, discontinue distribution of, and return the recalled lots of product. Customers who may have further distributed these products have been requested to identify their customers and notify them at once of this product recall."

Questions regarding this recall can be directed to the customer call center at (866) 901-1230 Monday through Friday from 9:00 am to 5:00 pm Eastern Standard Time.

Adverse reactions or quality problems experienced with the use of these products should be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch- online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



Saturday, December 27, 2014

GM Chevy Volt Safety Risk for Drivers!


General Motors LLC (GM) is facing a proposed defective

automotive class action lawsuit over an alleged defect in the

steering system of its Chevrolet Volts which causes the steering

wheel to freeze intermittently while driving. 



 Filed in New Jersey federal court, by plaintiffs Christopher Johnson and Tara Follari-Johnson, the lawsuit claims that GM knew, or should have known, about the alleged defect, but continued to sell the cars. The lawsuit further claims that the alleged defect poses a hazardous safety risk to drivers and that even when GM agrees to fix the steering system, it only replaces the allegedly defective steering rack with the same or similarly defective components.

“When class members present to GM’s authorized dealerships complaining of the steering defect, the dealerships recommend repairs such as replacing the steering rack or steering gear assembly,” the plaintiffs said. “However, these repairs only temporarily mask the problem.”

The lawsuit alleges GM is in violation of the New Jersey Consumer Fraud Act and the Magnuson-Moss Warranty Act, and in breach of implied warranty of merchantability and express warranty and common law fraud.

The plaintiffs propose to represent a nationwide class of owners and lessees of 2011-2014 Chevrolet Volt bought or leased new in New Jersey and a subclass of national class members who live in New Jersey. There are at least 100 members of the proposed class, according to the plaintiffs, and their claims are more than $5 million.

Saturday, September 13, 2014

FDA Warns of NuVision Contamination!

Connecticut health care providers are being urged by the FDA to cease using sterile products from NuVision Pharmacy. The FDA discovered poor sterilization practices being used by NuVision Pharmacy during an inspection that took place in April. Due to the findings of the inspection, the FDA has called upon the pharmaceutical manufacturer to issue a recall for all their sterile products that have not yet passed their expiration dates.


The FDA believes the products made by NuVision Pharmacy may be dangerous and defective drugs due to their possible lack of sterility. According to the FDA, if drugs that are marketed as sterile actually contain a microbial contamination, patients who are given the drugs may be at risk of infection, which can be life-threatening in some cases. The drug manufacturer has repeatedly declined to issue a recall for their sterile products.


Since the FDA does not have the authority to demand a recall of products from NuVision Pharmacy, the manufacturer is not required to do so. However, to deal with the issue, the FDA has called upon health care providers to stop using products labeled sterile by the company. So far, NuVision Pharmacy is not aware of any adverse events related to their sterilized products, but they did end up recalling two other drugs earlier in the year due to sterility concerns. Individuals who have been injected with products made by the company should contact their health care provider if they have any concerns.



Wednesday, August 20, 2014

Yet Another Ford Recall!


 

Ford is recalling 83,250 vehicles because a faulty part could cause loss of power or cause the vehicle to roll away if parked. This recall includes the 2012-2014 Ford Edge & Lincoln MKX, also the 2013 and newer Ford Flex & Lincoln MKT, and 2013 and newer Ford Taurus & Lincoln MKS. Due to the faulty installation of a clip in the axle the half shaft can disengage causing a break in the transmission to the wheels, increasing the risk of an accident. The vehicles can also roll out of park if the emergency brake isn’t secured. Repairs will be free if your vehicle is part of this group.

 


In the event that any of these problems should contribute to an accident of any kind, please call Jim Vander Linden, 612-339-6841 to discuss your options to recover any losses you may have endured.