Showing posts with label tainted drugs. Show all posts
Showing posts with label tainted drugs. Show all posts

Congressional Hearings into Fungal Meningitis Crisis Reveal Potential Missed Opportunities to Prevent Outbreak

The first Congressional hearings into the fungal meningitis outbreak have already begun.  The House Energy and Commerce Committee has followed the release of a 25 page report on the history of the outbreak that began at the New England Compounding Center (NECC.)  Today's hearings allowed members of Congress to quiz the U.S. Food and Drug Administration (FDA) Chief Margaret Hamburg.

According to the Associated Press (AP,) Representative Cliff Stearns, R-Fla, asked, "After a tragedy like this, the first question we all ask is: could this have been prevented? After an examination of the documents provided by the Massachusetts Board of Pharmacy and the FDA — the answer here appears to be yes."

Missed Opportunities- the Anatomy of a Crisis

Representatives of the House presented a timeline in the hearings focusing on a history of both FDA and Massachusetts Board of Pharmacy inspections over sterility issues.  According to the report, the the Massachusetts Board of Pharmacy investigated 12 separate complaints dating back to the NECC's establishment.  The FDA, in contrast, reportedly investigated 3 separate times since 2002 for sterility issues.

Said the Chair of the House Energy and Commerce Committee, Rep. Fred Upton, R-Mich, "I was stunned and angered to learn that an inspection of the NECC by the FDA and the Mass Board over 10 years ago identified contamination in the very same drug at issue in the current outbreak."

According to the report and the current Congressional hearings, the NECC had a history of troubles with contaminations and sending medication without a prescription.

In her prepared speech to the House Energy and Commerce Committee, the AP reported Chief Hamburg called for laws to further define the jurisdiction over these nontraditional pharmacies.

Are Consumers Still At Risk?

After an estimated 14,000  people received the tainted steroid shots, according to the AP.  An estimated 440 consumers developed nonfatal fungal meningitis and another 32 people died from the infection. 

Early reports were that if consumers passed a month incubation period without symptoms, they could be free from worry over contracting fungal meningitis.  However, recent increases in cases reported have caused regulators to reconsider whether or not that window was truly over.  Consumers who feel ill are encouraged to seek the help of a physician.

Symptoms to be aware of:

  • Fever
  • Headache
  • Stiff neck
  • Nausea and vomiting
  • Photophobia (sensitivity to light)
  • Altered mental status
If you experience the above symptoms, contact your doctor today.  You may also want to contact a skilled product liability attorney to discuss the legal remedies available to you.


Fungal Meningitis Cases Continue to Spread

If you've been following the fungal meningitis cases, you might be surprised to learn the numbers have jumped dramatically.  The Center for Disease Control (CDC) has updated the infection count to 354 cases and 25 deaths in 19 states.

As you may recall, the fungal meningitis outbreak began in a compound pharmacy with tainted steroids.  A common injection for pain management, this steroid spread the infection rather quickly.  Thousands of these steroids were shipped out, but the CDC believes they caught it early enough to prevent massive damages across the United States.

Fungal meningitis is especially frightening because its initial onset mirrors cold symptoms.  Since it's fall, many people are feeling the body aches and pains associated with fevers and sinus pressure.  However, as 25 people found out, if you wait too late, you may die.  The danger with fungal meningitis is that it gets worse.  What starts out feeling like a cold can progress to tissue death, gangrene, organ failure, and death.  This is a very serious illness that requires immediate medical attention.

The updated numbers are the result of intense effort on the part of the CDC and the FDA to inform the general public of the extreme dangers associated with the tainted steroids. Those who caught the disease in time lived.  If you have suffered from fungal meningitis as the result of this compounding pharmacy's tainted steroids, you could be entitled to compensation.  You should consult a skilled attorney today.  We will be happy to speak to you about your rights.  We accept cases nation wide.

THE FUNGAL MENINGITIS DEATH TOLL CONTINUES TO RISE


The death toll in the fungal meningitis outbreak continues to rise as of today.  The death toll now stands at 11 patients with 191 now ill.  Federal regulators estimate that between May 21 and September 25, approximately 13,000 people may have received the tainted steroid methylprednisolone acetate from the New England Compounding Center (NECC). 

Following the initial outbreak, the NECC recalled every one of its products and voluntarily surrendered its license to operate.  While federal regulators continue to investigate, the death toll continues to rise. Doctors and administrators are busy contacting thousands of patients to request that they come in to test for symptoms of the non- contagious fungal meningitis. Because the incubation period lasts from 2 days to a month, patients could have fungal meningitis without being aware of it. Patients who have received these steroid injections are encouraged to contact their health care provider today for an evaluation.

What Caused the Outbreak?

To date, federal investigators have found at least one tainted vial of fungus at the NECC’s facility.  According to the Food and Drug Administration (FDA), compounding pharmacies such as the NECC are required to abide by the strict guidelines required of pharmaceutical manufacturers.  However, these pharmacies are allowed to run virtually unchecked because of a legal loophole.  You see, compounding pharmacies are in the business of tailoring available medications to patient needs.  Therefore, using available approved medications, the NECC was able to change medications to suit the needs of the patient.  For example, if an elderly patient could not swallow a pill, the medication could be turned into syrup to swallow.  Provided these pharmacies used products already approved, they fly relatively below the radar.  That is, until a potentially deadly outbreak occurs.  Who’s to blame?

If You Have Been Injured
If you have beeninjured in this recent outbreak of fungal meningitis, it is important that you seek IMMEDIATE medical help to preserve your life.  You may also want to contact one of our experienced attorneys to explore your legal options.

 

CDC AND FDA REPORT FUNGAL MENINGITIS OUTBREAK


This morning the internet is abuzz about fungal meningitis.  Last week, complaints to the FDA and the CDC began to pour in from medical facilities across the nation.  This rare but life threatening outbreak has already claimed 91 victims and 7 deaths in 9 states.  As federal investigators continue their investigation, these numbers are likely to rise again.

Federal investigators tracked the outbreak to the New England Compounding Center (NECC), which distributed tainted steroidinjections.  These steroids, named Methylprednisolone Acetate, were tainted with a fungus which caused many patients to develop this rare and potentially deadly disorder. Approximately 76 centers in 23 states received these tainted medications and are now on high alert for patients who may have developed fungal meningitis. 

A facility investigation has revealed foreign substances in unopened vials.  When tested, the CDC claims these substances were fungus.  In response, the NECC has issued a voluntary recall of its products and has voluntarily surrendered its license to operate.  As investigations continue and the death count rises, the nation is on high alert.

If you or a loved one has received steroid injections between July 1 and September, you should immediately get checked by your doctor.  Fungal meningitis has a 1 to 4 week incubation period, after which you may experience mild symptoms which will rapidly deteriorate.

These symptoms include:

·         Headache

·         Confusion or altered state

·         Vomiting

·         Sensitivity to light and sound

·         Low blood pressure

These symptoms could rapidly deteriorate into the following:

·         Lack of blood flow to the organs

·         Gangrene

·         Excessive blood clotting

·         Death

Fungal meningitis is a serious health emergency and needs to be treated as such.  If you have any of these symptoms and have recently received medication from the NECC or have recently received steroid injections, you should get tested immediately.  Your life could literally be on the line.  

If you or a loved one has in fact been injured by receivingtainted steroids, you could be entitled to compensation.  You should consult an experienced and trusted attorney.