Texas IDs first fungal meningitis case from NECC tainted steroid shot

In a deadly outbreak that has killed 15 and spread to at least 13 U.S. states and 200 patients, the State of Texas has identified its first fungal meningitis case from the NECC tainted steroid shots. The infected patient is a woman in Central Texas. (Source: click2houston.com, 10/12/12)

Texas health officials had already announced that the Dallas Back Pain Management clinic and the Harris Methodist Southlake Hospital had received some of the contaminated steroid vials from the NECC (New England Compounding Center). The steroid drug was found contaminated with two strains of fungus. The injectable steroid drug is used to mitigate lower back pain.

The fungus can be difficult to detect and meningitis from the contamination can take weeks to present symptoms after the steroid injection. Meningitis is an inflammation of the brain and central nervous system tissue resulting from infection. Reaction to the fungus can also lead to clotting in the blood vessels, resulting in stroke.

U.S. health officials have announced that as many as 14,000 patients might have been exposed to the fungus. This is up from an earlier estimate of around 13,000. Because of the long period between injection of the steroid drug and the presentation of meningitis symptoms, the numbers of infected patients are expected to continue to grow over coming weeks.

Contact a Houston steroid drug injury attorney if tainted drugs have harmed you

If you or your loved one received a tainted steroid injection for lower back pain and experienced pain, inflammation, stroke, or other side effects and symptoms, you might need to discuss the matter with and experienced Houston steroid drug injury attorney. At Denena & Points, we will meet with you for a free, no obligation, and completely confidential legal consultation.

We could examine whether you or your loved one have a potentially valid legal claim for financial compensation against the manufacturer of the tainted drug. Contact us toll free or online to schedule your free consultation. We take our cases on a contingency fee basis, so there’s no charge for attorneys’ fees unless we win your case for you.

Dallas compounding pharmacy’s super-strength meds behind 3 deaths

A Dallas compounding pharmacy called Apothécure mixed and sold a medication that was 640 times the normal strength for the gout drug and shipped it to Portland, WA. 3 people died from taking the super-strength medication. Federal investigators quickly found the common thread behind the three victims’ sudden deaths: a Dallas compounding pharmacy called Apothécure.

This past April, the owner of Apothécure, Gary Osborn, pleaded guilty in relation to the three deaths from the super-strength gout drug. You might be surprised, but the charge was only a misdemeanor. It involved the mislabeling of the drug. Mislabeling of drugs is a federal offense, so the FDA did have authority to step in on this instance. (Source: David Schechter, WFAA.com, 10/9/12)

About Compounding Pharmacies in the United States

Around 7,500 compounding pharmacies exist in the United States. That’s up from just about 5,000 only three years ago. The industry has burgeoned due to needs for unavailable and custom-mixed medications partially created by drug shortages caused by high-profile medication recalls.

Most of these compounding pharmacies are small, locally owned “mom and pop” type businesses. Compounding is actually a centuries-old pharmaceutical tradition. Since 1950 though, it has been a specialized industry in the United States.

Technically, compounding pharmacies don’t “manufacture” new or novel drugs. They custom-mix drugs from manufactured brand drugs and bulk ingredients to create tailor-made medications in specific dosages, with new flavors, without allergens, or to re-create drugs that brand manufacturers have taken off the market due to lack of profitability, often once the patent has expired. Compounding pharmacies aren’t supposed to widely “market” their creations either.

The Current Lack of Adequate Oversight of Compounding Pharmacies

Because the compounding pharmacies supposedly do not manufacture new or novel drugs, they aren’t subject to FDA regulation and their compounded drugs don’t require FDA approval. State pharmacy and health boards oversee the compounding pharmacies and their activities. These 50 state boards simply don’t have the budget, manpower, or in-depth knowledge required to adequately oversee the 7,500 compounding pharmacies operating in the United States today.

So sometimes things slip through the cracks. An injectable steroid drug intended to mediate lower back pain, for instance, gets contaminated with fungus that leads to deadly meningitis. Or a drug gets mixed at 640 times the usual strength and deadens the pain of patients who take it, permanently.

Now that deaths from compounding pharmacy errors have captured headlines nationwide, consumers and lawmakers are starting to take notice and ask questions about the massive gap in regulatory authority that leaves the industry prone to such errors. Whether questions will lead to action is another matter.

Contact Texas Drug Injury Lawyers Denena & Points – Always Free Legal Consultations

The Texas drug injury lawyers at Denena & Points help victims injured by tainted, mislabeled, or defective medications to win proper financial compensation for their injuries and suffering. Our lawyers’ experience, knowledge, and dedication make our team among the highest rated in Houston.

If you or your loved one has been serious injured by a defective drug in Texas, you should contact the Texas drug injury lawyers at Denena & Points. Schedule your free legal consultation. Our Texas board Certified personal injury lawyers possess a degree of success, dedication, trail experience, and personal injury knowledge above the range of the ordinary personal injury firm.

We have the skill and many years of experience to successfully represent you in your personal injury or wrongful death claim in Texas. Your initial consultation is free and without obligation. And if you do decide to pursue your drug injury claim with us, we generally take your case on a contingency fee basis. So you won’t pay any attorney’s fees unless we win your case for you. You have nothing to lose. Call us toll free at 877-307-9500 or online and schedule your free initial consultation today.

Toll from deadly U.S. fungal meningitis outbreak continues to grow

Texas drug defect lawyers note that the death toll from the fungal meningitis outbreak linked to steroid shots for lower back pain currently stands at 7 victims according to the U.S. CDC. And the number of identified meningitis cases rose to 91 on Sunday from 69 on Saturday. The number of cases has risen even further today to 105.

The deadly outbreak is widespread in the U.S. and still growing

Cases of the rare form of meningitis have now been identified in 11 states. The steroid medication linked to the fungal meningitis outbreak was distributed to 76 medical facilities in 23 states, including Texas.

The New England Compounding Center (NECC) in Framingham, MA that manufactured the steroid has made the unusual move of surrendering its license and recalling all of its products from the market pending the outcome of federal and state investigations into the outbreak and its causes.

What caused the deadly outbreak?

Patients came down with the deadly fungal meningitis after receiving steroid shots in their spines for lower back pain. The formal name of the steroid is methylprednisolone acetate. Our Texas drug defect lawyers mention that the steroid was manufactured in a preservative-free form.

The federal investigation into the steroid contamination linked to NECC has been going on since last Monday. Investigators found fungal contamination in sealed vials of the steroid. Reportedly, there are two forms of fungus involved in the contamination, one of which is commonly found in leaf mold and can spread through the air.

Thousands still at risk of infection: federal health officials urge extreme caution

The U.S. FDA, involved in the ongoing investigation of the NECC steroid fungal meningitis outbreak, has said that hundreds of patients could have been injected with the contaminated steroid and other NECC products. The rare form of meningitis can take weeks to show symptoms.

Federal authorities are urging anyone injected with steroids for lower back pain to find out if they might have been injected with the contaminated steroid. You can find information on accessing a list of the facilities that received the NECC steroid, as well as a full list of recalled NECC products, by clicking here.

The rare form of deadly fungal meningitis can be treated with a course of anti-fungal medications. The Texas drug defect lawyers at Denena & Points emphasize that a patient’s chances of surviving the infection are greater the sooner they begin treatment.

Continue to part 2 to learn about the weak oversight of compounding pharmacies like NECC.

Thousands at risk of deadly meningitis: identified US cases up to 105

Continued from part 3.

Texas drug defect lawyers report that on Monday, health officials announced that the number of those known to have the deadly fungal meningitis linked to steroid injections in the spine had risen to 105 from 91 on Sunday. And approximately 13,000 have received shots of the steroid linked to the fungal contamination. Thousands are still at risk. Symptoms of the illness can take weeks to manifest themselves after injection.

The fungal form of meningitis can be treated by an intravenous anti-fungal medication that requires hospitalization. The course of therapy can be prolonged, up to months. But the earlier therapy is administered after infection, the better results could be for patients. The U.S. CDC specifically said that the earlier a patient receives treatment, the more likely that patient is to survive.

Health officials expand warnings to receiving spinal steroid injections between July 1 and September 28 of their risk

Our Texas drug defect lawyers caution that infected patients have taken up to a month after injection to show symptoms of the deadly fungal meningitis. Your symptoms might include nausea, fever, headache, stiffness of the neck, confusion, dizziness, discomfort from bright lights, trouble walking, falling, worsening back pain, and neurological deficits consistent with small deep brain strokes.

At least 23 U.S. states and 76 medical facilities received the tainted steroid

The 23 states known to have received the tainted steroid medication are: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia. A report our Texas drug defect lawyers noticed today indicated that Alaska had also received some of the medication but it appeared that it had not been used in that state.

Health officials from the U.S. CDC warn that: “All patients who may have received these medications need to be tracked down immediately. Patients can find the names of the clinics that used these medications on the CDC website…. It is possible that if patients with infection are identified soon and put on appropriate anti-fungal therapy, lives may be saved.” A link to the CDC website listing of the 76 medical facilities known to have received the contaminated steroid is linked to this post.

Contact your physician immediately if you might be infected and contact us if you need help obtaining fair compensation after receiving a contaminated drug

Our Texas drug defect lawyers urge you to use an abundance of caution if you have received a steroid injection in your spine since July 1st. Check the CDC list to see if the medical facility where you received your injection received the tainted steroid. Contact your physician immediately about your risk for fungal meningitis. The physician may ask you to be tested to see if you have contracted the infection. Remember, for infected patients, the sooner they seek treatment, the better their chances are of overcoming and surviving the meningitis.

Any form of meningitis can be deadly. If you or a family member has become ill from a contaminated drug, you may face expensive, long-term therapies. Your needless exposure to disease could leave you heavily burdened by these expenses you never expected and for which you’re not prepared. A contaminated drug can have widespread effects on your life and the lives of your family members.

Our Texas drug defect lawyers understand the difficulties and trauma you face. We are always available for a free, private consultation to discuss your illness or injury. Just call or contact us online. We could answer your urgent questions about what to do to protect your rights, help point you at medical treatment f you need assistance, and counsel you regarding your eligibility and potential for a full financial recovery for the harm you’ve suffered. Let us help. We’ve already helped many others make their recoveries over more than 14 years. Contact us today for your free case evaluation consultation.

Beware: deadly fungal meningitis from steroid shot spreading in U.S.

Continued from part 2 of our Texas drug defect attorneys’ series on the deadly outbreak

NECC, source of contaminated steroid, has been investigated before for violations

Texas drug defect attorneys note that The Boston Globe has been reporting on some of the past lapses at the NECC (New England Compounding Company). Tainted tinctures from the NECC of a steroid injected into the lower back for pain have been fingered as the source of the outbreak of the deadly fungal meningitis that has killed at least 7 people so far.

Both state and federal authorities have already investigated the NECC several times for previous lapses. In some cases, the lapse involves overstepping the proper role of a compounding pharmacy and actually “manufacturing” and marketing new drugs. In other cases, the investigations involved lapses in sterile procedures during production of drugs.

For example, one complaint against the NECC this year involved the potency of a “triple strength” eye medication. That complaint remains under investigation. Our Texas drug defect attorneys point out that three complaints from 2002 and 2003 involved the company’s preparation of methylprednisolone acetate, the tainted steroid at issue in the current deadly outbreak of a rare form of meningitis.

A 2004 inspection at the NECC found a number of problems at the Framingham, MA facility. The problems were detailed in a warning letter issued to the NECC by authorities in 2006.

Just how serious is a fungal meningitis infection?

Meningitis is a very serious, potentially fatal, inflammation of the protective membranes that cover your brain and spinal cord. The most common forms involve viral or bacterial infection. The current outbreak, however, has been linked to a much more rare form of fungal meningitis. The Texas drug defect attorneys at Denena & Points emphasize that the fungal form of meningitis, unlike the viral and bacterial forms, is not contagious.

At least two forms of fungus have so far been found in patients that have contracted the rare form of fungal meningitis. The two fungi, Aspergillus and Exserobilium, can be found in back yards. The latter form causes leaf spots, but also can cause sinus and skin infections in humans. Aspergillus can cause lung infections in those with HIV, cancer, and compromised immune systems.

Fungus can grow in drugs that are not stored properly and can contaminate the drugs through air contact. Our Texas drug defect attorneys caution that the NECC steroids at the source of the deadly fungal meningitis outbreak was prepared without preservatives that might usually tend to destroy the fungi.

What NECC products might contain the deadly fungal contamination?

In the interests of caution, health officials are telling health providers and patients to avoid all products manufactured by the NECC, particularly those 35 products that can be injected into the spine. These products include epidurals used to block the pain of childbirth, and surgical and saline solutions. Three steroids, betamethasone, dexamethasone, and traimcinolone, as well as the anesthetics lidocaine and bupivicaine, and the blood pressure drug clonidine are of particular concern.

Continue to part 4 to learn what to do if you might be affected by the tainted medication.

Deadly fungal meningitis outbreak linked to MA compounding pharmacy

Texas drug defect attorneys: continued from part 1

What does a compounding pharmacy do?

The growing outbreak of a rare, but deadly, form of meningitis has been linked by investigators to contamination of a steroid manufactured by the New England Compounding Center (NECC). The Texas drug defect attorneys at Denena & Points clarify that the NECC is one of many compounding pharmacies nationwide that takes manufactured drugs and re-mixes them into other, individualized prescription forms.

Compounding pharmacies, for instance, might change the dosage of a drug, remove an allergen to which some patients are sensitive, add a flavoring to make a medicine more palatable, change a drug from a pill form to a liquid, or add a bulk ingredient to a manufactured medication.

Compounding pharmacy drugs are exempt from FDA approval and safety oversight

Patients might not realize that almost 10% of prescription drugs used in the United States come out of the compounding pharmacies. Our Texas drug defect attorneys point out that drugs mixed by these compounding pharmacies are not required to undergo the FDA pre-market approval process. Instead, compounding pharmacies are licensed and overseen by the individual U.S. states’ pharmacy boards.

Drug manufacturers in the United States, including compounding pharmacies, often rely heavily on foreign labor imported under U.S. visa programs such as the H-1B visa. And a visa website indicates that NECC apparently had at least two labor certifications (the certification underlying permanent foreign residence green card applications) approved around 2004.

While the risks posed to patients by drugs manufactured by compounding pharmacies and not receiving FDA approval have been known for some while, shortages of needed drugs have led physicians to seek alternatives. One of the best alternatives to ensure availability of required drugs has been use of the state-licensed compounding pharmacies.

Our Texas drug defect attorneys understand that nationwide, many drugs are back-ordered or out of stock. So hospitals, clinics, and doctors have been looking to the compounding pharmacies to fill the gap. Compounding pharmacies have also been a good source for custom-made medications that “name” manufacturers have discontinued due to lack of profitability. Currently, the U.S. has about 7,500 compounding pharmacies. This number is up substantially just since 2009, when there were only about 5,000 in operation.

Because compounding pharmacies do not manufacture “new” drugs, but only derivative or re-mixed drugs, they are exempt from FDA oversight. They operate under state pharmacy board oversight only. And the state boards do not generally have the budget, personnel, in-depth knowledge, or time to rigorously supervise the companies’ production processes. The FDA only steps in if there’s a problem with a compounding pharmacy or its products.

Federal investigators only step in when a dangerous problem occurs with compounded drugs

Of course, now there’s a BIG problem with NECC and its steroid product that has been found with fungal contamination. And the FDA has been busy for a week investigating the cause of the contamination and resulting outbreak of deadly fungal meningitis.

U.S. health inspectors began their inspection of the NECC plant in Framingham, MA this past Monday and found contamination in sealed vials of the steroid. After federal investigators tested one of the sealed vials, they found the contaminant to be fungus. Investigators have since determined that two types of fungus might be involved in the outbreak. Our Texas drug defect attorneys note that the federal investigation of NECC, its operations, and the outbreak is still in process.

Continue to part 3 to learn about NECC’s record of violations.