Medical Malpractice Suit Filed Over Delivery-Decapitation Death

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Posted on 15th January 2013 by gjohnson in Uncategorized

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Here’s a nightmare out of a horror movie for you: A Missouri couple are suing an obstetrician who they allege decapitated their baby during a botched birth, according to Courthouse News Service.

http://www.courthousenews.com/2012/10/02/50841.htm

The malpractice lawsuit was filed in St. Louis County Circuit Court by Arteisha Betts and Travis Ammonette against defendants including Dr. Gilbert Webb. The hospital where the incident took place, St. John’s Mercy Medical Center, was not named as a defendant in the litigation.

The suit charges that in March 2011 Betts came to the hospital when she started having preterm contractions. Although one doctor two weeks prior had said that Betts would need a cesarean section because of the baby’s large girth, Webb still insisted that Betts have a vaginal birth, Courthouse News reported.

But the baby, Kaden Travis Ammonette, got stuck in the mother’s birth canal. When Webb was trying to dislodge the baby, the doctor allegedly applied too much pressure and separated the infant’s head from its cervical spine.

In this gruesome scene, the lawsuit says that blood from the baby’s neck shot all over the hospital floor, in front of the parents. To top that horror off, Webb allegedly then pushed the baby’s head and body back into the birth canal and said that a cesarean was necessary, according to Courthouse News. She as wheeled to an operating room.

Even before the mother Betts was given an anesthetic, the suit charges, Webb cut into her abdomen to make the incision for the procedure.

Courthouse News quoted from the lawsuit, saying, “During the course of the cesarean section, defendant Webb surgically and completely removed decedent Kaden Travis Ammonette’s head from his neck and torso.”

I have to ask you: Should there be a cap on any jury awards in that case?

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.

 

N.J. Patients File 15 Lawsuits Over Meningitis Outbreak

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Posted on 24th November 2012 by gjohnson in Uncategorized

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The lawsuits have started flying from the lethal fungal meningitis outbreak that reached across the nation, killing 34 people and sickening countless others.

In New Jersey alone, 15 suits have been filed by patients who developed meningitis or were exposed to it after receiving shots of a tainted steroid produced by New England Compounding Center (NECC) in Massachusetts, according to The Record of North Jersey.

http://www.northjersey.com/news/health/15_meningitis_lawsuits_filed_in_NJ_over_tainted_steroid_outbreak.html

The litigation has been filed in Superior Court in Cumberland County, and names NECC as a defendant, along with assorted doctors and medical facilities that administered the steroid, which is used to quell pain.

The patients who have sued include Jose Ramos, 35, of Millville, N.J., according to The Record. He had his steroid injection in August, and came down with headaches, a stiff neck and “visual disturbances,” the paper reported. According to his suit, Ramos will now have to continue taking anti-fungal medication and have blood tests to check his liver.

The contaminated steroid was recalled, and NECC was closed down. Inspections by the Food and Drug Administration found fungus that could be seen with the eye in vials of medication, The Record reported.

So far 34 people have died and nearly 500 have come down with meningitis in a 19 states, according to The Record. In New Jersey 33 patients have been diagnosed with fungal meningitis, and no one had died.

NECC attorneys maintain that the lawsuits should be heard in federal, not state, court. And The Record reported that several of the cases have already been transferred to U.S. District Court in the Garden State.

PeaPod Travel Tents Recalled For Suffocation, Entrapment Risk

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Posted on 16th November 2012 by gjohnson in Uncategorized

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After the death of a baby, KidCo Inc. Friday voluntarily recalled roughly 220,000 PeaPod and PeaPod Plus Travel Beds. The recall was announced by both the Libertyville, Ill., company and the U.S. Consumer Product Safety Commission (CPSC).

http://www.cpsc.gov/cpscpub/prerel/prhtml13/13043.html

There have been several incidents involving the tents. The CPSC said that a 5-month-old boy who died in December 2011 in New York City was found with his face pressed against the side wall of the tent. The cause of death was not determined.

In addition, CPSC said that it is is aware of six reports, and that Health Canada has had three reports, of children who became entrapped or experienced physical distress in the product.

“Two of the six reports included infants who were found crying underneath of the mattress that had not been inserted into the zippered pocket on the bottom of the tent,” the CPSC said in a press release.

The KidCo PeaPod Travel Beds and PeaPod Plus Travel Beds are small, portable sleep tents for infants to three years and older, depending on the model.

“The tents have a zippered side for putting in and taking out the child and have an inflatable air mattress that fits into a zippered pocket underneath the floor of the tent, the CPSC said. “The tents fold into a compact round shape and come with a fabric bag for storage and transport.”

What is apparently happening is that infants and young children can roll off the edge of the air mattress, become trapped between the mattress and the fabric sides of the tent, and suffocate, according to the CPSC.

Manufactured in China, the travel tents were sold at independent juvenile specialty stores nationwide and online at Amazon.com from January 2005 through the present for between $70 and $100.

Consumers should immediately stop using the tents and contact KidCo to get a free repair kit. The kits will vary depending on the model and will be shipped to consumers starting in December.

Consumers should contact KidCo toll-free at (855) 847-8600 between 8:30 a.m. and 5 p.m. CT Monday through Friday or visit the company’s website at www.kidco.com to receive the kit.

The CPSC is still interested in receiving incident or injury reports that are either directly related to this product recall or involve a different hazard with the same product. They should go to SaferProducts.gov.

 

Massachusetts Health Chief Cans Coffey Over Meningitis Outbreak

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Posted on 10th November 2012 by gjohnson in Uncategorized

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This certainly took long enough to happen: The Massachusetts Department of Health has booted James Coffey, the director of its pharmacy board.

http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy/121107-statement-from-lauren-smith.pdf

Coffey’s apparent incompetency may have contributed to a meningitis outbreak that has killed more than 30 people and made hundreds of others ill. Coffey was canned Wednesday for not following up on a complaint from the Colorado Pharmacy Board against the New England Compounding Center (NECC), which is the source of the steroids that were contaminated by a fungus and proved deadly.

Massachusetts Department of Public Health (DPH) Interim Commissioner Dr. Lauren Smith made the announcement Wednesday.

“We have discovered a Colorado Board of Pharmacy complaint against NECC, which was forwarded to James D. Coffey, Director of the Massachusetts Board of Pharmacy, on July 26,” the press release said.

“The information shared by Colorado showed that NECC had distributed manufactured drugs to many hospitals in that state between 2010 and 2012 without patient–specific prescriptions, in violation of NECC’s Colorado and Massachusetts licenses,” the statement said.

“”The Colorado Board of Pharmacy contacted the FDA who confirmed that NECC was not a licensed manufacturer. As seen in the attached documents, this information was provided in detail by Colorado to Mr. Coffey in July, which he then forwarded to Boa rd attorney Susan Manning and Board inspectors.”

“The director of the Board is responsible for ordering investigations,” Smith said in her statement. “Mr. Coffey failed to order an investigation or take any other action on the Colorado complaint. It is incomprehensible that Mr. Coffey and Ms. Manning did not act on the Colorado complaint given NECC’s past, and their responsibility to investigate complaints.”

“Following the outbreak, staff also failed to disclose the existence of Colorado’s complaint to leadership at DPH,” Smith said. “As a result of these findings, we have terminated James Coffey and placed Susan Manning, a member of a bargaining unit, on administrative leave pending the final conclusions of our investigation. We have identified highly qualified individuals to fill these positions and the important work of the agency will continue with even greater resolve at this critical juncture.”

Smith didn’t mince words.

“I find the actions of NECC reprehensible,” she said. “We have the right to expect that all companies producing medication for use in delivering health care to comply with laws designed to protect patient safety. But I also expect the staff charged with oversight to perform their duties to the highest standards. That failed to happen here.”

Summing up, Smith said, “Since starting as interim commissioner, I have promised and delivered swift and decisive actions. This investigation and the Department’s thorough response will not stop until we have a complete understanding of what happened, assign accountability where it is warranted and can be certain the failures that led to this tragedy never happen again.”

Coffey is one of the witnesses who has been called to testify as part of an investigation into the meningitis outbreak. The U.S. House Energy and Commerce Committee has said that the Subcommittee on Oversight and Investigations will convene a hearing next week, on Nov. 14.

http://energycommerce.house.gov/press-release/committee-schedules-hearing-deadly-meningitis-outbreak

One of the other witnesses called to appear was Barry Cadden, Director of Pharmacy and NECC owner. He indicated that he would not appear, and was promptly subpoenaed.

Congress Issues Subpoena, Sets Nov. 14 Hearing On Meningitis Outbreak

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Posted on 7th November 2012 by gjohnson in Uncategorized

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Maybe Washington is going to actually to crack down on compounding pharmacies, the apparent culprits in a fungal meningitis outbreak that has killed more than two dozen people.

Continuing its investigation of the public health tragedy, U.S. House Energy and Commerce Committee leaders this week announced that the Subcommittee on Oversight and Investigations will convene a hearing on Nov. 14.

http://energycommerce.house.gov/press-release/committee-schedules-hearing-deadly-meningitis-outbreak

In its original press release, the subcommittee said it had also invited James Coffey, Director of the Massachusetts Board of Registration in Pharmacy, and Barry Cadden, Director of Pharmacy and owner of the New England Compounding Center (NECC), to appear at the hearing. That is the facility that was the source of a tainted steroid that had caused deaths and sickened hundreds of people.

Although Cadden was invited, he apparently didn’t want to come. So on Tuesday House Energy and Commerce Committee Chairman Fred Upton, after consulting with ranking member Henry Waxman, issued a subpoena for  Cadden to testify at next week’s hearing.

“Through his counsel, Cadden has declined to appear voluntarily,” the committee said in a press release.

http://energycommerce.house.gov/press-release/committee-issues-subpoena-head-facility-linked-meningitis-outbreak

Upton and Waxman also issued a joint statement.

“With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak,” they said. “Since Mr. Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena. We urge Barry Cadden to put the public health first and answer the committee’s questions about the deadly outbreak.”

FDA Commissioner Margaret Hamburg is also scheduled to testify next week. Apparently, she didn’t have to be subpoenaed.

Upton,  Waxman, Subcommittee Chairman Cliff Stearns, and Subcommittee Ranking Member Diana DeGette put out a joint statement Monday.

“Our committee has a long, bipartisan history of conducting drug safety oversight,” they said.

“Since the meningitis outbreak, we have been in close contact with the involved agencies and parties, but many unanswered questions remain. The NECC has a history of problems, some of which were documented in an FDA warning letter in 2006 – we want to know what went wrong at this facility, the views and actions of its regulators, and what steps can be taken to ensure such an outbreak never happens again.”

The FDA has virtually no authority over compounding pharmacies, a situation that several lawmakers want to remedy with new legislation,