New England Compounding Center Fungal Outbreak Update

As of October 16, 2012, the CDC is now reporting 233 cases of meningitis and 15 deaths associated with New England Compounding Center's methylprednisolone acetate steroid injection. Tennessee remains the hardest hit state, but the numbers are climbing in Michigan,Virginia, and Indiana. In addition to the Aspergillus fungus, the Exserohilum fungus has also been identified as the causal organism in many cases.

Now the FDA is investigating reports of fungal infections associated with some of NECC's other products. One patient has developed meningitis symptoms after receiving a back injection with a different steroid, triamcinolone acetone. Two heart transplant patients have suffered fungal infections after receiving cardioplegic solution from NECC during open heart surgery. The FDA is also concerned about NECC products used during eye surgery, and is investigating NECC's ophthalmic drugs.

If you or a loved one has been injured as a result of receiving a contaminated pharmaceutical product, contact the attorneys at Schlichter, Bogard & Denton for a free evaluation.

13,000 may be at risk for contracting meningitis from contaminated steroid injections.

The Centers for Disease Control and Prevention (CDC) has reported an outbreak of fungal meningitis in patients who have received epidural steroid injections. So far, 105 cases of meningitis have been identified and eight people have died. Several people have suffered strokes related to the meningitis. Thousands more may be affected, as 13,000 patients may have received the recalled product.

The meningitis outbreak has been linked to three contaminated lots of a steroid injection called Preservative-Free Methylprednisolone Acetate. Methylprednisolone Acetate is an injectable steroid medication generally given in hospital or outpatient settings. It is used to relieve chronic back pain and inflammation.

The contaminated steroids are manufactured by the New England Compounding Center (NECC), a pharmacy located in Framingham, Massachusetts. Outbreaks have occurred across  the country, as the contaminated steroid injections were distributed in 23 states, including California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, and West Virginia. A list of the clinics, hospitals, and healthcare facilities that have received the recalled Methylprednisolone Acetate PF is available on the CDC's website, http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html , and is also provided below.

Meningitis is a serious infection which causes an inflammation of the protective membranes that surround the brain and spinal cord. Usually, meningitis is caused by a bacteria or a virus. This meningitis outbreak initially baffled doctors when affected patients did not respond to antibiotics that are usually used to treat meningitis. The antibiotics failed because this meningitis outbreak is caused by Aspergillus, a fungus, and not a bacteria.
Fungal meningitis is very rare, and usually only occurs in patients who have compromised immune systems. However, this outbreak has occurred in otherwise healthy patients. Doctors soon realized that these patients shared a commonality--- they had recently received epidural steroid injections. The infections were then traced to the steroids, which were contaminated with Aspergillus.

Unlike more common cases of meningitis, this meningitis is not contagious. However, if you have recently received a spinal steroid injection and are suffering meningitis symptoms, the CDC recommends that you seek medical care quickly. Symptoms include headache, fever, nausea, stiff neck, confusion, dizziness, and aversion to bright lights.

If you or a loved one has been injured as a result of receiving a contaminated steroid injection, contact the pharmaceutical attorneys at Schlichter, Bogard & Denton for a free evaluation of your potential claim. 

FACILITIES THAT RECEIVED RECALLED CONTAMINATED STEROIDS

FACILITY	CITY	STATE
CYPRESS SURGERY CENTER DBA	VISALIA	CA
ENCINO OUTPATIENT SURGICENTER	ENCINO	CA
UKIAH VALLEY MEDICAL CENTER	UKIAH	CA
UNIVERSAL PAIN MANAGEMENAT	PALMDALE	CA
INTERVENTIONAL SPINE AND SPORTS MED	MIDDLEBURY	CT
FLORIDA PAIN CLINIC	OCALA	FL
INTERVENTIONAL REHAB CENTER	PENSACOLA	FL
MARION PAIN MANAGEMENT CENTER	OCALA	FL
NORTH COUNTY SURGICENTER	PALM BEACH GARDENS	FL
ORLANDO CENTER FOR OUTPATIENT SURGERY	ORLANDO	FL
PAIN CONSULTANTS OF WEST FLORIDA	PENSACOLA	FL
SURGERY CENTER OF OCALA	OCALA	FL
SURGICAL PARK CENTER	MIAMI	FL
FORSYTH STREET AMBULATORY SURG. CTR.	MACON	GA
PAIN SPECIALISTS OF IDAHO	IDAHO FALLS	ID
WALTER KNOX MEMORIAL HOSPITAL	EMMETT	ID
APAC CENTERS FOR PAIN MANAGEMENT	WESTCHESTER	IL
APAC CENTERS FOR PAIN MANAGEMENT-	CHICAGO	IL
THOREK MEMORIAL HOSPITAL	CHICAGO	IL
AMBULATORY CARE CENTER LLC	EVANSVILLE	IN
FORT WAYNE PHYSICAL MEDICINE	FORT WAYNE	IN
OSMC OUTPATIENT SURGERY CENTER	ELKHART	IN
SOUTH BEND CLINIC	SOUTH BEND	IN
UNION HOSPITAL--	TERRE HAUTE	IN
WELLSPRING	COLUMBUS	IN
BALTIMORE PAIN MANAGEMENT	BALTIMORE	MD
BERLIN INTERVENTIONAL PAIN MANAGEMENT	BERLIN	MD
BOX HILL SURGERY CENTER	ABINGDON	MD
GREENSPRING SURGERY CENTER	BALTIMORE	MD
HARFORD COUNTY ASC, LLC	EDGEWOOD	MD
PAIN MEDICINE SPECIALISTS	TOWSON	MD
SURGCENTER OF BEL AIR	BEL AIR	MD
MICHIGAN NEUROSURGICAL INST.	GRAND BLANC	MI
MICHIGAN PAIN SPECIALISTS	BRIGHTON	MI
NEUROMUSCULAR & REHABILITATION	TRAVERSE CITY	MI
SOUTHEAST MICHIGAN SURGICAL HOSPITAL	WARREN	MI
MAPS-EDINA MEDICAL PAIN CLINIC	MINNEAPOLIS	MN
MAPS-MEDICAL ADVANCED PAIN	FRIDLEY	MN
MEDICAL ADVANCED PAIN SPECIALISTS*	SHAKOPEE	MN
MEDICAL ADVANCED PAIN SPECIALISTS.	MAPLE GROVE	MN
MINNESOTA SURGERY CENTER	EDINA	MN
MINNESOTA SURGERY CENTER-	MAPLE GROVE	MN
HIGH POINT SURGERY	HIGH POINT	NC
NORTH CAROLINA ORTHOPAEDIC CLINIC	DURHAM	NC
SURGERY CENTER OF WILSON	WILSON	NC
DR. O'CONNELL'S PAIN CARE CTR	MERRIMACK	NH
DR. O'CONNELL'S PAINCARE CENTERS, INC	SOMERSWORTH	NH
CENTRAL JERSEY ORTHOPEDICS SPECIALISTS PC	SOUTH PLAINFIELD	NJ
EDISON SURGICAL CENTER	EDISON	NJ
IF PAIN ASSOCIATES / ISAIAH FLORENCE	TEANECK	NJ
PREMIER ORTHOPEDICS SURG. ASSOC., LLC	VINELAND	NJ
Comprehensive Pain Management	SPARTA	NJ
SOUTH JERSEY HEALTH CARE	ELMER	NJ
SOUTH JERSEY HEALTHCARE	VINELAND	NJ
SAHARA SURGERY CENTER	LAS VEGAS	NV
BUTANI, SUNIL H. PHYSICIAN PC	MINEOLA	NY
OBOSA MEDICAL SERVICES	MOUNT VERNON	NY
ROCHESTER BRAIN AND SPINE	ROCHESTER	NY
BKC PAIN SPECIALISTS,LLC	MARION	OH
CINCINNATI PAIN MANAGEMENT	CINCINNATI	OH
MARION PAIN CLINIC	MARION	OH
ORTHO-SPINE REHAB. CENTER, INC.	DUBLIN	OH
ALLEGHENY PAIN MANAGEMENT	ALTOONA	PA
SOUTH HILLS PAIN & REHAB ASSOC.	JEFFERSON HILLS	PA
NEW ENGLAND ANESTHESIOLOGY (NEA)	WARWICK	RI
OCEAN STATE PAIN MANAGEMENT	WOONSOCKET	RI
OCEAN STATE PAIN MANAGEMENT-	EAST GREENWICH	RI
INTERVENE MD	MOUNT PLEASANT	SC
PCA PAIN CARE CENTER-	OAK RIDGE	TN
SPECIALTY SURGERY CENTER	CROSSVILLE	TN
ST. THOMAS OUTPATIENT NEUROSURGIACL	NASHVILLE	TN
DALLAS BACK PAIN MANAGEMENT	DALLAS	TX
HARRIS METHODIST SOUTHLAKE CENTER	SOUTHLAKE	TX
INSIGHT IMAGING-ROANOKE	ROANOKE	VA
NEW RIVER VALLEY SURGERY CENTER	CHRISTIANSBURG	VA
PARS INTERVENTIONAL PAIN	PARKERSBURG	WV

Biosite and FDA notified healthcare facilities and clinicians of the recall of Biosite® brand Triage Cardiac Panel
Biosite and the Food and Drug Administration have recently notified emergency room and hospital laboratory personnel of a Class 1 recall of the Biosite brand Triage Cardiac Panel. FDA defines a Class 1 recall as “the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death. “
The Biosite ®Triage Cardiac Panel is a test used by hospitals and clinics to assist medical professionals in making the diagnosis of a heart attack. On April 27, 2009, the company sent an urgent recall notice to hospitals and clinics. Facilities were instructed to immediately stop using the tests, and to throw away all packages showing the recalled lot number. Using test kits from the defective lot may lead to false negative results in blood samples containing very low levels of the blood markers used to determine heart damage.
These inaccurate test results can possibly mean that heart attacks, especially in the early stages, were incorrectly diagnosed or missed completely as clinicians relied on incorrect test results as a part of making a correct diagnosis. The defective test kits might not have been sensitive enough to detect low levels of the blood markers to indicate that a person had a heart attack or other damage to the heart muscle.
Testing packets with the recalled lot number were sold to hospitals and clinics from January 24, 2009 through February 17, 2009. If you or a loved one has recently been treated for heart related chest pain or other heart related symptoms, and early signs of a heart attack were missed or incorrectly diagnosed, you may be entitled to compensation.
If you would like to view the complete recall notice, you may do so at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Panel

Coal Power Plants Polluting Water, Causing Serious Health Risks

People who live near coal waste deposit sites may be at risk of suffering damaging health effects. This announcement was made recently by two environmental groups, the Environmental Integrity Project and Earthjustice, in a report which stated that coal waste has polluted water in at least 24 states and at more than 70 sites around the United States.

Coal waste, or coal ash, is a byproduct produced by coal-burning power plants, which constitute the majority of the power plants in the United States. These plants generally store coal waste in ponds or landfills. Often, the waste ponds and landfills have inadequate lining that allows chemicals from the waste to leach into drinking water.

Coal waste contains lead, arsenic, cadmium, cobalt and other harmful metals. These chemicals are known to cause cancer, liver damage, lung disease, gastrointestinal problems, birth defects, and a number of other serious injuries.

The highest risk of coal waste leaching into drinking water is near the sites of older coal waste storage facilities, as these landfills and ponds are more likely to lack liners or to have damaged liners.

Despite the toxic risks of coal combustion waste, there are no national standards for storing or disposing of it. Some states require companies that produce coal waste to obtain permits and other states monitor water for leached chemicals, however, regulations vary greatly from state to state. Even in states that do regulate coal waste, there is still a risk of leaching from older structures that have damaged liners or lack liners completely. A list of the 100 most polluting coal plants is available here.

In December, 2008, a dam at a coal plant in Harriman, Tennessee collapsed, releasing over one billion gallons of toxic coal waste over 300 acres of land, poisoning water with hazardous chemicals. While the risk of this type of disaster is serious, the risk of leaching from coal waste ponds and landfills is even more alarming, as it occurs constantly and is generally unmonitored.

Contaminated water has also been discovered recently in Crestwood, Illinois and Camp Lejeune, North Carolina, though the contaminated wells in those locations were polluted by sources other than coal waste storage sites.

See the following links for more information:

http://www.thesouthern.com/articles/2009/01/25/front_page/27857494.txt

https://www.istockanalyst.com/article/viewnewspaged/articleid/2980037/pageid/2

Kidney failure associated with bowel cleansing medicines

Did you know that the medications used to cleanse your bowels before having a colonoscopy performed or other surgeries can cause you to go into kidney failure? These medications are known as Oral Sodium Phosphates; some of which are prescription medications and some of which are over-the-counter. The prescription products include Visicol and Osmo Prep and over-the-counter medications inlcude Fleet Phospho-Soda and Fleet Accu-Prep. Recently the FDA has issued black box warnings associated with many of these products. If you have taken one of these medications - Osmoprep, Visicol, Fleet Phosphosoda, or Fleet Accuprep - and have suffered kidney failure following your use of these medications, the attorneys at Schlichter, Bogard & Denton can assist you. For more information about the FDA's action involving these products, click here: http://www.fda.gov/consumer/updates/bowel_cleansers121608.html

Schnucks Olives Recalled for Glass Hazard

Schnucks announced a voluntary recall yesterday on Schnucks brand olives as some of the jars may contain shards of glass.

The recalled olives come in 5.75 ounce jars with the UPC code: 04131819003, and a date of "best by" 02/06/11.

For more information, see http://www.schnucks.com/pressreleases/pressrelease.asp?id=6.

If you or someone you love has been injured by a defective product, you may be entitled to compensation. Contact the expert lawyers at Schlichter, Bogard and Denton for a free consultation.

FDA Urged to Ban Ortho Evra Birth Control Patch

Public Citizen, a nonprofit consumer advocacy program, petitioned the FDA asking that it pull Ortho Evra from the market.

Otho Evra, more commonly known as the “birth control patch” or simply “the patch” is about twice as likely to cause blood clots as the birth control pill. That’s because women who use the patch are exposed to a dose of estrogen that is 60% higher than the dose in the pill.

Public Citizen has a long history of success in helping keep dangerous drugs off the market. To name a few victories:

• 1976: a Public Citizen petition lead an FDA ban of chloroform, a cancer-causing chemical, in cough medicine and toothpaste.
• 1982: Oraflex, an arthritis drug, was taken off the market after Public Citizen exposed that it was causing injuries, including death.
• 1985: Upon urging from Public Citizen, the FDA required a label change for aspirin warning of the link between Reye’s Syndrome and the use of aspirin in children.
• 1986: Public Citizen obtained a court order requiring the FDA to add a warning regarding Toxic Shock Syndrome to tampon labels.
• 1996: Public Citizen won a Supreme Court case, confirming the right of injured people to sue medical device manufacturers.
• 2000: Public Citizen lead efforts to ban Rezulin, a deadly diabetes drug.

To read the petition, click here: http://www.citizen.org/pressroom/release.cfm?ID=2654

If you or someone you love has been hurt by Ortho Evra, you may be entitled to compensation. Contact the expert Ortho Evra attorneys at Schlichter, Bogard and Denton for a free consultation.