Articles Posted in Ocala

Whittel & Melton 352-369-5334 – Ocala Meningitis Outbreak Attorneys

The Florida Department of Health has announced three more cases of fungal meningitis in Florida associated with tainted shots of methylprednisolone acetate that was manufactured and distributed by the New England Compounding Center.

One of the patients, a 50-year-old man, resides in Marion County. He received his shot at Marion Pain Management Center in Ocala.

The other two, a 60-year-old man and a 36-year-old woman, are from Escambia County.

These three new cases bring the total number of fungal meningitis cases to 22, including three deaths. All of the deaths occurred in Marion County.

The following lots of contaminated medication made and distributed by the NECC have been recalled:

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012

The Ocala facilities that received and injected patients with the contaminated batches of the above medications include:

FLORIDA PAIN CLINIC – 3241 Southwest 34th Street Ocala, FL 34474
MARION PAIN MANAGEMENT CENTER – 1737 Southeast 28th Loop Ocala, FL 34471
SURGERY CENTER OF OCALA – 3241 Southwest 34th Street Ocala, FL 34474

With the number of fungal meningitis cases in Florida on the rise, it is very important to make sure you are familiar with the symptoms associated with the disease in case you have received an epidural back injection within the last three months. Fungal meningitis results in inflammation of the protective membranes of the brain and spinal cord. Symptoms may include fever, headache, neck stiffness, sensitivity to light, weakness, numbness and pain, redness or swelling of the injection site. According to the CDC, it can anywhere from one to four weeks for symptoms of fungal meningitis to appear in a patient that received an injection of the tainted medication.

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Whittel & Melton 352-369-5334 – Ocala Meningitis Outbreak Attorneys
The Florida Department of Health confirmed Tuesday that a 19th case of fungal meningitis has been linked to contaminated lots of the tainted steroid medication manufactured and distributed by the New England Compounding Center.

The newest case is a 66-year-old Marion County woman who received an injection at the Florida Pain Clinic in Ocala just six weeks ago.

Nearly 300 patients nationwide have contracted fungal meningitis due to methylprednisolone acetate, which is a steroid primarily used for epidural back injections. There have been a total of 23 deaths, three of them in Marion County.

Dr. John Armstrong, the state’s secretary of health, said in a press conference Tuesday that the average incubation period for patients affected by fungal meningitis is 14 days, with a range of seven to 81 days. Nationwide, the average is 22 days with a range of four to 89.

The following lots of tainted medication linked to the fungal meningitis outbreak made and distributed by the NECC have been recalled:

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012

The three facilities in Ocala that administered injections of the possibly contaminated steroid include:

FLORIDA PAIN CLINIC – 3241 Southwest 34th Street Ocala, FL 34474
MARION PAIN MANAGEMENT CENTER – 1737 Southeast 28th Loop Ocala, FL 34471
SURGERY CENTER OF OCALA – 3241 Southwest 34th Street Ocala, FL 34474

Fungal meningitis causes inflammation to the protective membranes of the brain and spinal cord. Symptoms may include fever, headache, neck stiffness, sensitivity to light, weakness, numbness and pain, redness or swelling of the injection site. If you or someone you love has any of the above symptoms and has received an epidural back injection recently, it is extremely important to see a doctor right away. The sooner a patient begins treatment for fungal meningitis, the better their chances are of recovering.

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Whittel & Melton 352-369-5334 – Ocala Meningitis Outbreak Attorneys
As of Friday, four more confirmed cases of fungal meningitis were reported in Florida – three in Marion County. This new outbreak has been linked to contaminated steroids used for back pain distributed by the New England Compounding Center.

Florida’s total count is now at 17, including three deaths. More than 250 people have been sickened by this outbreak nationwide and 21 people have died.

Florida’s newest cases include a 53-year-old woman who received treatment at Pain Consultants of West Florida in Escambia County and three women in Marion County, a 69-year old and a 71-year-old who received at least one injection of the tainted steroid at the Florida Pain Clinic in Ocala and a 73-year-old who was treated at Marion Pain Management Center.

The contaminated steroids were received from New England Compounding Center. Three lots of the pain medication, primarily used for epidural back injections, were received by six clinics in Florida. More than 1,000 patients were given injections using the contaminated steroids. Last month, these medications were recalled.

According to the Department of Health, NECC relinquished its permit to operate as a pharmacy in Florida. The relinquishment is apparently a form of disciplinary action and means that the company will not be allowed to reapply for a pharmacy permit in the state of Florida.

The recall issued earlier this month includes a dozen of injectable medications produced by the NECC. More than 260 facilities in Florida received some form of medication from NECC.

The federal government has advised all health care facilities that may have used these medications, including eye and heart surgeries, dating back to May 21 should notify patients to be aware of the symptoms associated with fungal meningitis.
At this time, only the contaminated back medication has been linked to the nationwide fungal meningitis outbreak.

Three facilities in Ocala administered injections of the contaminated steroid:

FLORIDA PAIN CLINIC – 3241 Southwest 34th Street Ocala, FL 34474
MARION PAIN MANAGEMENT CENTER – 1737 Southeast 28th Loop Ocala, FL 34471
SURGERY CENTER OF OCALA – 3241 Southwest 34th Street Ocala, FL 34474

The batches of tainted medication linked to the fungal meningitis outbreak made and distributed by the NECC that have been recalled include:

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012

If you or someone you care for received an injection of any of the above contaminated lots of pain medication, consult with your doctor immediately. Fungal meningitis is an infection that causes the protective membranes surrounding the brain and spinal cord to become inflamed. Be aware that symptoms may not present themselves immediately. In fact, it could take up to a month for symptoms to fully develop. The symptoms associated with fungal meningitis include:

• Fever
• Headache
• Nausea and Vomiting
• Neck Stiffness
• Sensitivity to Light
• Confusion
• Difficulty Balancing
• Altered Mental Status

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Whittel & Melton 352-369-5334 – Ocala Meningitis Outbreak Attorneys

The Florida Department of Health reported a third death Wednesday that has been linked to fungal meningitis.

According to Florida Surgeon General and Secretary of Health Dr. John Armstrong, the 78-year-old man died earlier this week. He was the 13th confirmed case of fungal meningitis in the state – 10 in Marion County and three in Escambia County. All three deaths have been in Marion County.

Armstrong believes the man received an injection of the tainted steroid methylprednisolone acetate on Aug. 28 and began reporting symptoms on Oct. 6. He was given an injection of the contaminated pain medication at the Marion Pain Management Center in Ocala.

The average age of affected patients in Florida is 72. The average incubation period from the time of injection to the onset of symptoms is 23 days, according to Armstrong.

The first death was a 70-year-old man who received a shot of the tainted steroid in July at the Marion Pain Clinic before officials were aware of the outbreak. The second death was an 83-year-old man who died last week after receiving an injection of the contaminated steroid at the Marion Pain Management Center in Ocala.

The owner of the Florida Pain Management Clinic is apparently disagreeing that his patient died of fungal meningitis.

The Surgery Center of Ocala also received and injected doses of the possibly tainted medication.

The three clinics administered an estimated 500 shots of the contaminated steroid. Some patients likely received more than one injection.

Eight Florida medical facilities received the contaminated medications. Of those eight facilities, six injected doses into 1,038 patients. Only 11 patients remain on the list to be contacted and notified of the health risks.

The tainted steroid was manufactured by the New England Compounding Center in Massachusetts. Currently, it is believed that as many as 17,000 vials of the steroid were shipped to 23 states and injected into at least 14,000 people.

More than 140 people that received a shot of the contaminated steroid have gone to local hospitals for treatment. Of those, 16 remain hospitalized.

According to the Centers for Disease Control and Prevention, as of now, there are 247 confirmed cases of fungal meningitis in 15 states. The latest death in Ocala brings the total number of deaths to 19 in six states as of Wednesday.

The nationwide fungal meningitis outbreak can be linked back to steroid medications made and distributed by the New England Compounding Center (NECC). The CDC and U.S. Food and Drug Administration have located the states and individual facilities that received shipments of the potentially tainted injections, and urge patients who received injections from May 21 through September 26, 2012 to see their physician immediately.

In Marion County, three facilities administered injections from the contaminated lots of medication:

FLORIDA PAIN CLINIC – 3241 Southwest 34th Street Ocala, FL 34474
MARION PAIN MANAGEMENT CENTER – 1737 Southeast 28th Loop Ocala, FL 34471
SURGERY CENTER OF OCALA – 3241 Southwest 34th Street Ocala, FL 34474

The following batches of medication made and distributed by the NECC have been recalled:

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012

If you received an injection of the tainted pain medication from a facility in Ocala – which was administered in the spine for back pain, it is vital that you understand the symptoms related to fungal meningitis. Fungal meningitis is not contagious, but can be lethal if left untreated. Symptoms can be slow to develop, but are usually apparent between one to four weeks after the injection. Symptoms include:

• Headache
• Neck Stiffness
• Fever
• Stroke
• Redness or Inflammation at or around the site of the injection
• Sensitivity to light
• Weakness

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Whittel & Melton 352-369-5334 – Ocala Meningitis Outbreak Attorneys

The Florida Department of Health announced Tuesday that 1,038 patients have received at least one shot of contaminated pain medication manufactured and distributed by a New England compounding pharmacy.

The state has apparently notified all but 12 of those patients. The state does know the identity of the remaining 12 patients and is still making efforts to reach them. They could be Florida residents or they could have been visitors to the state that may have received the medication while passing through.

The Secretary of Health Dr. John Armstrong discussed the details of the meningitis outbreak during a 1:30 p.m. press conference.

Earlier in the afternoon, the state announced that there were two more confirmed cases of fungal meningitis related to the contaminated pain medication – one of them in Marion County. This brings the total number of patients affected by the outbreak to 12, including two deaths.

The two newest patients suffering from fungal meningitis received epidural back injections of contaminated lots of methylprednisolone acetate.

The Marion County patient, a 74-year-old woman, received her shot at the Florida Pain Clinic. The other patient, a 79-year-old man, received treatment in Escambia County.
Of the 12 confirmed cases, 10 are in Marion County, which includes both deaths.

The Florida Department of Health is continuing its investigations into the outbreak under the guidance of the Food and Drug Administration and the Centers for Disease Control and Prevention.

Nationwide, 233 cases of fungal meningitis have been linked to the tainted medication, including 15 deaths in 15 states.

As local, state and federal officials sift through the methylprednisolone acetate issue, it appears the problem only continues to grow.

Now the FDA is questioning the sterility of any injectable drugs produced by NECC, which includes drugs used in conjunction with eye surgery and open heart surgery.

The state is now advising health professionals who used any medications produced by NECC after May 21 to contact affected patients as a precautionary measure.
No problems with any other medications have been reported.

On a side note, a second federal lawmaker has asked the Justice Department to look into whether the NECC violated federal laws or regulations.
Rep. Edward Markey, (D-Mass.) has now joined U.S. Sen. Richard Blumenthal, (D-Conn.) in prompting investigations.

Fungal meningitis is generally very rare. Unfortunately, there is no such thing as a mild case of the disease. The steroid, methylprednisolone acetate, has been confirmed to have caused a multistate outbreak of fungal meningitis affecting patients who received tainted batches of this epidural steroid injection to their spines after May 21. The contaminated medication has been traced back to the NECC, a compounding pharmacy based out of Massachusetts. Compounding pharmacies are known for mixing custom medications for numerous medical applications. Unlike drug manufacturers, these facilities are not regulated that closely and their products are not subject to FDA approval.

Fungal meningitis symptoms include the following:

• Neck Stiffness
• Severe Headache
• Fever
• Numbness
• Sensitivity to Light
• Pain, Swelling or Redness at Injection Site
These symptoms can develop over time, and an affected patient may not experience all of these at once. It can take up to a month for a person to experience these symptoms. If you or someone you care for received an epidural steroid injection and begins to experience any of the above symptoms, contact your doctor immediately.

The following products distributed by the NECC have been recalled:

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012

Contaminated medications were received by the following medical facilities in Ocala, Florida:

FLORIDA PAIN CLINIC – 3241 Southwest 34th Street Ocala, FL 34474
MARION PAIN MANAGEMENT CENTER – 1737 Southeast 28th Loop Ocala, FL 34471
SURGERY CENTER OF OCALA – 3241 Southwest 34th Street Ocala, FL 34474

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Whittel & Melton 352-369-5334 – Ocala Meningitis Outbreak Attorneys
As of Thursday, a second Marion County patient’s death has been confirmed a direct result of contaminated steroid injections leading to a fungal meningitis outbreak in Ocala.

The most recent fatality was an 83-year-old man who received shots of the tainted pain medication at the Marion Pain Management Center in Ocala, Florida.

According to the Florida State Surgeon General and Secretary of Health Dr. John Armstrong, the man was being treated at Ocala Regional Medical Center when he died.

This death increases the number of meningitis cases in Marion County from six to seven. The seven cases include the two deceased patients.

The newest patient is a 48-year-old man.

The first fatality was a 70-year-old man who was injected with a lot of the tainted steroid at the Florida Pain Clinic in Ocala.

The state has yet to release either of the deceased men’s names, but did say that both received shots of one of the contaminated lots of New England Compound Center (NECC) methylprednisolone acetate. This medication is used for epidural back injections.

The NECC sent the contaminated lots to a total of eight clinics in Florida, including three in Marion County. In total, up to 14,000 patients might be at risk for contracting fungal meningitis. Tainted medications were sent to 76 clinics in 23 states.

According to the federal Centers for Disease Control, the fungal meningitis outbreak has affected at least 170 patients and caused 14 deaths in 11 states.

As of now, all of Florida’s cases are in Marion County.

Patients in Florida have been administered 775 doses of the tainted shots to their spine areas. All seven cases of fungal meningitis in Ocala have come from this set of patients.

This same steroid was also injected into the joints of another 306 patients throughout the state of Florida. There have been no reported symptoms in these patients that relate to fungal meningitis.

Armstrong claims 95 percent of Florida patients that received potentially contaminated injections have been notified of the recall.

Fungal meningitis is treatable; however the side effects of the medicines used to cure the disease carry more severe side effects than compared to the treatments of the more common bacterial meningitis. Armstrong said the medications can cause injury to the kidney and liver.

All NECC products, including the three contaminated lots of steroids, have been removed from Florida health facilities.

Because of the deadly outbreak, U.S. Sen. Richard Blumenthal, D-Conn., a member of the Senate’s heath oversight committee, has formally requested a criminal probe.
On Thursday, the senator apparently wrote a letter to Attorney General Eric Holder accusing the NECC of committing misconduct, possibly including misrepresentation, fraud and other criminality.

Any patients that received a steroid shot in Ocala should have been contacted by their doctor regarding the meningitis outbreak. Be aware that fungal meningitis symptoms can take up to four weeks to appear. If you received an injection and start to notice symptoms including fever, severe headaches, sensitivity to light, numbness, weakness, neck stiffness and pain, swelling or redness of injection site, contact your physician immediately. Fungal meningitis is not contagious, but it can be difficult to treat, so you must act fast if you notice any of the above warning signs.

Contaminated medications were received by the following medical facilities in Ocala, Florida:

FLORIDA PAIN CLINIC – 3241 Southwest 34th Street Ocala, FL 34474
MARION PAIN MANAGEMENT CENTER – 1737 Southeast 28th Loop Ocala, FL 34471
SURGERY CENTER OF OCALA – 3241 Southwest 34th Street Ocala, FL 34474

The FDA has confirmed that the NECC has voluntarily shut down its facility and recalled all of their products. The possibly contaminated steroid injections were given starting in May and continuing through September. It is suspected that the pain medications were tainted by a lethal fungus found in leaf mold. Fungal meningitis occurs when the protective membranes coating the brain and spinal cord become irritated and swell.

The following products distributed by the NECC have been recalled:

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012

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