Amazon, Retailers Agree To Recall 155,000 Nap Nanny Recliners

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Posted on 28th December 2012 by gjohnson in Uncategorized

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Several major retailers, including Amazon.com and Toys “R” Us/Babies “R” Us, are voluntarily recalling 155,000 Nap Nanny recliners after the manufacturer refused to pull the items off the market in the wake of five infant deaths.

The U.S. Consumer Product Safety Commission (CPSC) announced the recall involving the retailers Thursday, saying that they had agreed to participate “because the manufacturer is unable or unwilling to participate in the recall.” The recliners are made by Baby Matters LLC of Berwyn, Pa.

In addition to Amazon.com and Toys “R” Us/Babies “R” Us, Buy Buy Baby and Diapers.com agreed to take part in the recall.

According to The Wall Street Journal, the CPSC this month filed suit against Baby Matters after it could not reach a recall plan with the company.

http://online.wsj.com/article/SB10001424127887323984704578205360137285032.html

The CPSC warned parents and caregivers that the baby recliners contain defects in the design, warnings and instructions that “pose a substantial risk of injury and death to infants.” The recall includes the Nap Nanny Generations One and Two, and the Chill model infant recliners.

In July 2010, CPSC and Baby Matters issued a joint press release that offered a discount coupon to Generation One owners toward the purchase of a newer model Nap Nanny, and improved instructions and warnings to consumers who owned the Generation Two model of Nap Nanny recliners.

“At the time of the 2010 recall, CPSC was aware of one death that had occurred in a Nap Nanny recliner and 22 reports of infants hanging or falling out over the side of the Nap Nanny, even though most of the infants had been placed in the harness,” the agency said in a press release.

“Subsequently, despite the improvements to the warnings and instructions, additional deaths using the Nap Nanny recliners were reported, including one in a Chill model,” the agency said. “Since the 2010 recall, CPSC has received an additional 70 reports of children nearly falling out of the product.”

The Nap Nanny is a portable infant recliner designed for sleeping, resting and playing. The recliner includes a bucket-seat-shaped foam base and a fitted fabric cover with a three-point harness.

Some 5,000 Nap Nanny Generation One and 50,000 Generation Two models were sold between 2009 and early 2012 and have been discontinued. Another 100,000 Chill Models have been sold since January 2011.

The recalled Nap Nanny recliners were sold at toy and children’s retail stores nationwide and online, including at www.napnanny.com. All models were priced around $130.

 

Two Anti-Patient Medical Malpractice Bills Pass In Michigan

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Posted on 26th December 2012 by gjohnson in Uncategorized

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Michigan this month passed two bills reforming medical malpractice rules, and the consumer winds up the loser in that state. Ironically, the legislation was part of a “Patients First Reform Package.”

Senate Bill 1115 limits the amount of malpractice damages that can be awarded to victims, and it passed with a wide margin, namely a 108-2 vote in the state Senate.

Senate Bill 1118 decreases the time limit that a person or family has for suing on someone who is deceased, and also bars prejudgment interest on attorney fees and costs. It flew through the Senate in a 107-3 vote, according to Michigan Live Media Group.

http://www.mlive.com/politics/index.ssf/2012/12/two_medical_malpractice_bills.html

Mag Mutual, a medical professional liability insurer, also issued a press release on the legislation, which benefits its industry.

http://www.sbwire.com/press-releases/senate-makes-crucial-malpractice-ruling-in-michigan-reports-mag-mutual-190687.htm

The two anti-patient bills that passed were criticized by Marc Lipton, the Southfield attorney who is president of the Michigan Association for Justice, a trial lawyers group.

“I’m disappointed that the Legislature spent all this time on bills that were designed to protect insurance companies and ultimately would endanger patients,” Michigan Live Media Group quoted him as saying.

Exactly so.

There were actually four malpractice bills under consideration in Michigan, and only two of them made it to a vote. Of the bills that didn’t make it, one sought to expand the types of health care professionals that can be sued for medical malpractice. The Senate approved it but it never made it to a vote in the Senate.

The other bill, left hanging in committee, mandated that a medical facility and or health care professional couldn’t be sued for malpractice “if the doctor acted with reasonable and good-faith belief that the conduct was well-founded in medicine and the patient’s best interests,” Michigan Live Media Group reported.   





 

 

Painkillers Recalled As Potential Danger To Liver

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Posted on 21st December 2012 by gjohnson in Uncategorized

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Pharmaceutical maker Mylan Inc.  is conducting a voluntary nationwide recall of three lots of the pain killers hydrocodone bitartrate and acetaminophen hydrocodone bitartrate tablets, the Pittsburgh company said in a press release.

http://www.prnewswire.com/news-releases/voluntary-product-recall-initiated-by-qualitest-pharmaceuticals-impacts-three-lots-of-hydrocodone-bitartrate-and-acetaminophen-tablets-usp-10-mg500-mg-repackaged-and-distributed-by-mylan-institutional-184249291.html

The three lots were manufactured by Qualitest Pharmaceuticals, and Mylan Institutional repackaged and distributed the product in unit dose (CD100) under the UDL Laboratories, Inc. (n/k/a Mylan Institutional Inc.) label.

Qualitest initiated the recall on Dec. 6 due to the possibility that a small number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients hydrocodone bitartrate and acetaminophen.

http://www.fda.gov/Safety/Recalls/ucm331218.htm

As indicated in Qualitest’s announcement, unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day.

In its press release earlier this month Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary recall of 101 lots of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg.

“It is possible that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of hydrocodone bitartrate and acetaminophen,” Qualitest said. “Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.”

Qualitest warned that bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.

“Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day,” the press release said. “The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.”

The affected lots were distributed between Feb. 20 and Nov. 19 to wholesale distributors and retail pharmacies nationwide.

It’s crucial that consumers do not exceed the maximum daily dose in the prescribing information for this product (no more than six tablets per day) and are fully aware of any other prescription or over-the-counter medications they may be taking that contain acetaminophen. If there is any doubt, a consumer should consult with their health care professional.

“Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants,” the press release said.

No injuries have been reported to date, according to Qualitest.

Consumers who have the affected lots should contact Qualitest at 1-800-444-4011. Consumers who are unsure if they have the affected lot numbers or have any concerns about their product should consult their pharmacy or health care professional.

Pharmacists and wholesalers need to check their inventories for the affected lots, segregate any material from the lots, and contact MedTurn Pharmacies.

 

 

Tainted Lot Of Zicam Nasal Gel Recalled

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Posted on 20th December 2012 by gjohnson in Uncategorized

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The maker of Zicam Extreme Congestion Relief, an over-the-counter nasal gel, is voluntarily recalling one lot of the treatment because one sample of it at a factory was found to have a contaminant.

http://www.fda.gov/Safety/Recalls/ucm332787.htm

In a press release issued by the Food and Drug Administration, Matrixx Initiatives said it was doing the recall after finding a small amount of Burkholderia cepacia in a single sample of the product taken from the affected lot.

“The problem was detected during a routine review at the manufacturing facility,” the press release said. “Tests on additional samples from the same lot have shown no evidence of the organism.”

Burkholderia cepacia doesn’t pose a risk to healthy individuals, according to Matrixx.

“But Burkholderia cepacia in a nasal spray could cause upper airway colonization and secondarily lead to respiratory infections in individuals with a compromised immune system or those with chronic lung conditions, such as cystic fibrosis,” the press release said. “The organism is resistant to many antibiotics and may be difficult to eradicate in this sensitive population if an infection occurs.”

Matrixx hasn’t received any reports of illness.

Zicam Extreme is a non-drip liquid nasal gel used as a nasal decongestant. It is packaged in a half-ounce spray bottle contained in an outer carton, bearing NDC number 62750-005-10.

The affected Zicam Extreme Congestion Relief lot is 2J23, Expiration 09/15. The gel was distributed to retailers nationwide throughout the United States, according to the press release.

Matrixx said that it is notifying its distributors and retail customers by FEDEX letter and by phone and is arranging for return of all recalled products.

Consumers that have the affected lot of Zicam Extreme Congestion Relief nasal gel should stop using the product and contact Matrixx for a full refund.

 

Florida Jury Clears Nurse In Brain Injury Malpractice Case

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Posted on 19th December 2012 by gjohnson in Uncategorized

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It looks like no one is going to be held legally responsible in this sad scenario.

A Florida jury Monday cleared a nurse of any liability in a lawsuit stemming from a case where a child sustained permanent brain injury after coming to an emergency room with flu-like symptoms, according to TCPalm.com.

http://www.tcpalm.com/news/2012/dec/18/jury-finds-irmc-emergency-room-nurse-not-liable/

The $65 million medical malpractice suit was filed in 2009 by the parents of Milan Carvelli, 9, of Vero Beach. Following a three-week trial, the jury found that emergency room nurse Vicki Marchand of Indian River Medical Center “didn’t contribute to the child’s medical problems,” TCPalm reported.

The hospital had already reached a settlement of the suit for what was described as a “small, undisclosed amount of money.”

The suit alleged that the girl was brought to the emergency room on Feb, 4, 2008, vomiting and unnaturally thirsty. She was diagnosed with pediatric diabetic ketoacidosis, according to TCPalm.com. The child’s doctor directed that the child be transferred to a hospital that was equipped to deal with that ailment, but  inclement weather delayed the child’s transfer to Arnold Palmer Hospital in Orland, TCPalm.com reported.

The malpractice suit had alleged that Marchand didn’t realize until it was too late that fluid was building up on the child’s brain, according to TCPalm.com. The girl had to be resuscitated, and had sustained brain injury.  Now she has developmental issues, partial paralysis in her right arm and hand, and has a limp.

The family’s lawyers had sought $65 million in damages, saying that $40 million would cover the girl’s continued medical care, TCPalm.com reported.

The jury thought differently.