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,

 

Bill Looks To Regulate Pharmacies Linked To Meningitis Outbreak

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Posted on 2nd November 2012 by gjohnson in Uncategorized

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It only took 28 deaths, but our astute lawmakers in Washington are drafting legislation that would finally empower the Food and Drug Administration to regulate so-called compounding pharmacies, like the one that produced the batches of tainted steroids linked to a meningitis breakout.

According to The Wall Street Journal Friday, U.S. Rep. Ed Markey, D-Mass., was going to introduce a law mandating that compounding pharmacies, which create customized drugs, meet the same sterility and manufacturing standards as traditional pharmaceutical makers. His bill is being co-sponsored by Reps. Steve Cohen, D-Tenn., and Louise Slaughter, D-New York.

http://online.wsj.com/article/SB10001424052970204707104578093174235021886.html?mod=googlenews_wsj

Rep. Rosa DeLauro, D-Conn., also plans to sponsor similar legislation, The Journal reported. Congress is probing the fatal fungal meningitis outbreak, with a hearing scheduled for after the Presidential Election.

The brouhaha comes in the wake of 28 dying and nearly 400 made ill after receiving contaminated steroid shots, medicine manufactured by the New England Compounding Center (NECC) of Framingham, Mass. The Journal reported that on Thursday, federal health officials announced that two other NECC products had been tested and had bacteria.

Compounding pharmacies have essentially fallen through the cracks when it comes to control and safety, “governed by fragmented regulations for too long, leading to the worst public-health disaster in recent memory,” The Journal quoted Markey as saying.

As the law stands now, states are supposed to regulate compounding pharmacies, but the problem is operations like NECC have grown too large for states to effectively control, according to The Journal. And currently the FDA can inspect compounding pharmacies, but can’t make them to adhere to safe drug-manufacturing standards.

Under Markey’s proposed legislation, the FDA could regulate pharmacies “partially based on their volumes,” according to The Journal. The bill draws a distinction between pharmacies that only make small amounts of drugs for individual patients and those that manufacture large quantities for use across the nation.