Pharmacy behind outbreak chose to do nothing about mold and bacteria

Almost all of us hate to clean. But almost none of us are involved in the critical process of making preservative-free medications to be injected directly into your spinal tissue, providing an easy pathway to meningitis formation.

The FDA says that among the information its investigation have found so far are internal NECC compounding pharmacy reports showing that staffers there had documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile and free of contamination. Injectable steroid medications from the NECC (New England Compounding Center) have been linked to the fungal meningitis outbreak that so far has killed 25 people and sickened 338 at last count. The count keeps going up every day.

Your Health is at Risk. Contact the Texas Drug Injury Lawyers at Denena & Points to Report Exposure to Contaminated Medication

The Texas Drug Injury Lawyers at Denena & Points have been following the progress of the troubling fungal meningitis outbreak throughout the United States. And we want to ensure that patients at risk from the contaminated medications report any symptoms of meningitis right away and get help immediately.

Fungal meningitis can be treated with courses of anti-fungal medications. Patients’ chances of surviving infection are higher the sooner they begin their courses of treatment. Contact your physician right away if you’re experiencing any symptoms after receiving a shot of NECC-made drugs. And make sure that your exposure gets reported to the FDA. Call us toll free at 877-307-9500 or reach our Texas drug injury lawyers online through our “Get Help Now” form.

The NECC Compounding Pharmacy knew of Contamination in its Facility and Chose not to Act to Clean It

The FDA says that even when the mold, fungus, and bacterial contamination at the NECC in Framingham, MA exceeded the company’s own safety levels, there’s no indication that the pharmacy’s staffers investigated or corrected the problems. NECC records reveal four-dozen reports of potential contamination at the pharmacy dating back just to January of this year: not even a full 12 months. These NECC reports came to light in the FDA investigation.

Continued in Part 2.

Important Health Alert on the U.S. Fungal Meningitis Outbreak

Contact the Houston Drug Injury Attorneys at Denena & Points Immediately if You have Information Related to a Fungal Meningitis Infection in Texas Caused by Contaminated Drugs

It’s vital that the FDA be kept update on any new infections and the possible source of the contaminated drug. The FDA attempted to compile a list of facilities that received the contaminated drugs, but admitted that list was inaccurate. Your information could help.

As part of the efforts of the Houston Drug Injury Attorneys at Denena & Points to ensure that victims of tainted medications receive the help and information they need as soon as possible, we are requesting those with important information about actual fungal meningitis infections in Texas to contact us. You can reach us anytime toll free at 877-307-9500 or online by filling out the contact form on our web page. We thank you for your assistance in helping us to gather important current information that we hope can help potential victims of the meningitis outbreak in Texas.

The FDA Posted and then Removed Lists Related to the Meningitis Outbreak due to Inaccuracies

The fungal meningitis outbreak linked to contaminated drugs from the New England Compounding Center (NECC) has now infected approximately 300 people and killed more than 20. On Monday, the FDA had put up a 28-page list on its website that purported to list the names and locations of the medical facilities that had purchased the potentially dangerous, contaminated drugs from the NECC.

If you’ve been relying on this list to determine whether you are safe from danger of infection, don’t. The FDA had already taken the list down on the same day that it was posted, citing technical problems with the list and incorrect data.

The FDA also removed a 261-page list that purported to identify specific NECC drugs that went to the medical centers on the 28-page list. (Source: Terri Gruca, kvue.com, 10/22/12) By clicking here you can access a previously posted 71-page list of all NECC products manufactured since January 2012. That list, however, does not identify facilities that received the drugs.

Current Health Advice for Patients Potentially Affected by the Contaminated Drugs:

If you received an injection of an NECC steroid or another NECC product on or after May 21, 2012, remain vigilant for symptoms of infection and for further information updates regarding the contaminated drugs from the NECC. Contact your physician f you are concerned about your risk of infection.

The FDA says that there is less risk if you received your medication BEFORE May 21, 2012 and that you likely only need to contact your healthcare provider if you are experiencing the symptoms of infection.

The Symptoms of a Meningitis Infection Include:

• Headache,
• Fever,
• Stiff neck,
• Nausea and vomiting,
• Sensitivity to light (photophobia), and
• Altered mental status.

Patients who received NECC steroid injections other parts of the body, who received cardioplegic solutions made by the NECC, and who received NECC eye medications should also be particularly alert for symptoms that might include:

• Fever,
• Swelling,
• Redness,
• Warmth at an injection site,
• Increasing pain,
• Changes in your vision,
• Discharge from the eye,
• Chest pain,

Drainage from the surgical site that could indicate an infection in the chest.

Don’t take chances. Contact your healthcare provider immediately if you are experiencing the symptoms of a possible infection related to contaminated drugs from the NECC.

Houston Drug Injury Attorneys Urge Stronger FDA Drug Making Oversight

As of last count, the fatal fungal meningitis outbreak linked to the NECC (New England Compounding Center) compounding pharmacy had killed 23 and sickened more than 280 patients in 16 U.S. states. More than 14,000 patients might be at risk, and the outbreak is still in its early stages. The fatal fungal meningitis can takes weeks to show symptoms in the body.

Contact the Houston Drug Injury Attorneys at Denena & Points if You’ve Received a Contaminated Steroid Injection

If you or a loved one has been affected by the contaminated drugs from the NECC or you have become ill, we request that you contact us to report it. In our ongoing efforts to enhance drug safety efforts, we are seeking people who received the recalled drugs so that the FDA has an accurate count of how many people have been affected. Fill out our “Get Help Now” form online or call us toll free at 877-307-9500 to reach us.

Stronger Oversight of Drug Imports and Manufacturing by the U.S. FDA is Needed to Keep U.S. Patients Safe from Harm

Currently, the medications you take are a product of a vast and largely unregulated global network of raw materials suppliers, brokers, re-sellers, chemical producers, manufacturers, and distributors. Several countries might have been involved in the production of the pharmaceuticals that you take you for your illness. But the FDA will only have oversight authority over some of them.

Even those companies over which the FDA has authority might never have been inspected or might have been inspected only once in more than 10 years. Observation has shown that where companies can escape sound oversight, they will sometimes take chances with people’s safety.

Authorities aren’t saying yet how the fungal contaminants came to be in the recalled NECC drugs that have killed more than 20 people so far. Investigators may not know that answer yet. But patients have apparently been sickened not just by the injectable steroid, but also by a cardioplegic medication from NECC.

Some of the Dangerous Safety Gaps in Current Regulatory Oversight:

• The U.S. FDA may not enter foreign facilities unannounced to inspect them. (It can enter U.S. facilities unannounced to inspect.)
• U.S. regulations mandate that the FDA inspect U.S. pharmaceutical facilities every two years. No similar requirement exists regarding foreign facilities and up to 2/3 of them have never been inspected by the FDA.
• Companies that don’t export their products directly to the United States don’t have to register with the FDA even though their products might enter the U.S. market through a third party (such as when a registered exporter includes ingredients from a non-registered company in its drug).
• FDA oversight of drug ingredients only applies to the manufacturing process and not to other production steps like collecting and extracting source materials.
• FDA oversight applies to ACTIVE ingredients. The inactive ingredients (excipients like flavoring, fillers, and preservatives) that might make up the bulk volume of your drug are only evaluated during the FDA approval process for a new drug. So if a new supplier begins to supply excipients and it is less careful than the one involved at the approval stage, your drug might suffer contamination.
• There is no national track and trace program for prescription drugs to prevent substandard or counterfeit drugs from reaching patients or to notify patients who might have come into contact with contaminated drugs (NECC steroid injections for instance). Medical facilities all over the United States are jumping through hoops now trying to figure out who might have received possibly contaminated NECC products. It’s a slow process without a track and trace program, and only time will tell if the health industry reaches all infected patients in time.
• The FDA cannot recall unsafe drugs on its own authority. It must rely on manufacturers and distributors to make voluntary recalls of the products. (Source: Detroit Free Press, 10/21/12)

As you might perceive, many safety gaps still exist in the U.S. regulatory process that oversees drug safety. Your health is at risk. So is mine. So the Houston drug injury attorneys at Denena & Points join other concerned parties in urging stronger FDA oversight of the drug manufacturing and supply process.

Call our Houston Injury Attorneys if Your Child is Injured in Day Care

The Legal Liability of Day Care Child Care Providers

Today’s news carried a headline regarding a Harris County day care provider that broke the leg of a two-month-old boy on just the second day he was left in her care. Doctors that treated the child said that the injury was consistent with the application of excessive force to the child’s body. The day care provider, Susan Denise O’Dell, was arrested and charged with felony injury to a child. (Source: khou.com, 10/22/12)

Another headline today mentioned the murder charges for another Houston area day care provider. That caregiver abandoned the children in her care to go shopping and left something on a stove that caught fire and then set fire to the home. Four children died in the fire and several more were severely injured.

Another recent headline covered a reckless driver who crashed his vehicle into a day care center, collapsing the facility. Fortunately the accident occurred in the wee hours of the morning and no children were present at the time.

If you’re a parent or guardian who must leave your child in another’s care while you go to work or school, you might be deeply concerned about what could happen to your child while they are not under your supervision.

The Legal Duty of a Day Care Provider in Caring for Your Child

Childcare providers have the legal duty to act with reasonable care with regard to the children left in their care. Their position as caregivers to the children while the parents are at work creates a special relationship of dependency and reliance. When a day care worker is negligent and fails to provide reasonable care and a child is injured, the childcare provider has breached his or her legal duty of care.

A negligent day care provider in such an instance might face criminal charges. And you might be eligible to sue them in civil court for monetary compensation for your child’s injuries. A monetary settlement can never fully repay you or your child for the suffering and injuries a negligent worker’s behavior caused to your family. But if the day care provider was not properly licensed and insured, you might have difficulty obtaining any relief for your child’s injuries at all.

Check the Licensing Status and Insurance Coverage of a Day Care Facility before You Leave Your Child There

When you must leave your child in another’s care at a day care facility, you want to make sure that the day care provider is properly licensed and carries liability insurance in case your child receives an injury in their care. Depending upon the circumstances of the injury, your own insurance might not want to pay, but will look to the day care provider for payment. If the day care facility will be transporting your child in a vehicle at any time, make sure that they have proper driver’s licenses and vehicle insurance coverage for injuries.

Contact the Houston Injury Attorneys at Denena & Points if Your Child has been Injured in a Negligent or Unlicensed Day Care Facility

We believe children should not have to suffer risks of injury or harm because of careless or unlicensed, fly-by-night caregivers. One act of negligence can change a child’s future.

The concerned Houston injury attorneys at Denena & Points make it their mission to help those who children have been injured by others’ negligence. With over 14 years of experience in complex injury litigation, we have the knowledge, skill, and professional dedication you need to hold accountable those whose negligence has harmed your child.

Call us toll free at 877-307-9500 right away or fill out our “Get Help Now” online contact form to schedule your free, no obligation legal consultation. We will help you understand your eligibility for full financial compensation for your child’s harm. Let us help you get your child’s future back on track after a needless injury.

U.S. Politicians Beginning to Call for Changes in Drugmaker Regulation

Continued from Part 1.

On the Regulate the Compounding Pharmacies Better Bandwagon:

U.S. Representative Edward Markey. He sent a letter to U.S. prosecutors asking them to investigate whether the NECC might have been producing medication containing controlled substances in violation of U.S. laws. Our Texas drug injury lawyers note that many medications, particularly pain drugs, contain controlled substances like cocaine and morphine. That’s what makes these drugs effective against pain and controlled substances generally so popular. But you probably already knew that.

Senator Richard Blumenthal, a Democrat from Connecticut, who is also calling for a criminal investigation of the company. We note that the NECC resides in Massachusetts rather than his own state of Connecticut. Does he want to scrutinize the activities of Connecticut compounding pharmacies as well? Our Texas drug injury lawyers suspect that the NECC’s mass-production and mass-marketing activities are not an isolated incident in light of current drug shortages and patients; clamoring for magic drugs to solve all their problems.

The U.S. House Energy and Commerce Committee: the Committee has widened its own investigation into the outbreak to look at the role health regulators played in monitoring the NECC. The Committee is also asking the Massachusetts pharmacy board to reveal what it knew about irregularities at the NECC.

As our Texas drug injury lawyers pointed out in a previous article, the FDA and state officials have investigated the NECC before for irregularities, including a previous drug contamination incident and a previous improper marketing incident. We also note that such state pharmacy boards are understaffed, under funded, and faced with the daunting task of keeping tabs on about 7,500 compounding pharmacies nationwide. And so long as health officials present drugs as the magic solutions to all your ills, there will be myriad opportunities for pharmaceutical companies both small and large to profit from your pain with little risk to themselves.

Contact a Texas Drug Injury Lawyer if You’ve Suffered because of a Defective Drug

If you or your loved one received a medication in the last two months that came from the NECC, you might want to discuss the matter with a Texas drug injury lawyer. At Denena & Points, we will meet with you for a FREE, completely confidential legal consultation when you need our help. We will discuss whether you or your loved one are eligible to make a valid claim for financial compensation against the manufacturer of the defective drug that harmed you. To reach us, call our Texas Board Certified personal injury lawyers at 877-307-9500 or use our convenient online contact features.

If a defective drug has harmed you, you have legal rights to compensation. The law firm of Denena & Points knows how to deal with big manufacturers like the NECC and other drug makers. We have more than 14 years of experience helping injured victims like you to recover the financial compensation they need to move on with their lives after the injury.

Read the information on our website to get the free information that will help you answer your pressing questions about your injury. Then contact our offices for your free, no obligation legal consultation.

Politicians alarmed over deadly meningitis outbreak in U.S. states

The count of infected patients has been going up daily. And yesterday’s headlines screeched that the drug recall related to the fungal meningitis outbreak could rival the Tylenol scare of the 1980s. The Dallas County HHS (Health and Human Services) Director, Zach Thompson, was quoted in Dallas media as saying we’re “talking about probably the largest recall we have seen in recent times in the United States.” (Source: DFW CBS 11, 10/16/12)

This large recall is the approximately 70 pages long list of recalled drugs manufactured by the NECC (New England Compounding Center), the company that made the contaminated medications linked with the deadly meningitis outbreak in the United States.

Originally, it was an injectable steroid medication used to mitigate lower back pain that was linked to the outbreak. But federal health officials have since become aware of a cardiac medication and another epidural medication that appear contaminated with fungus.

Federal Agents Raid the NECC Compounding Pharmacy; Better Late than Never

Yesterday, federal agents raided the Framingham, MA home of the NECC compounding pharmacy that has been fingered as the source of the deadly meningitis outbreak. Agents confiscated medications and records and sealed off the manufacturing facility with yellow police tape. (Source: Erin Smith, Boston Herald, 10/16/12)

Federal and state officials are investigating the NECC not just to determine the source of the fungal contamination, but because the compounding pharmacy was mass-producing (or “manufacturing” which it cannot legally do) tens of thousands of doses of drugs and soliciting physicians to distribute them, without requiring patient prescriptions for each dose as is legally required. Compounding pharmacies like the NECC play a very limited role in the pharmaceutical world, legally supplying only custom-mixed prescriptions filled for individual patients and their unique drug needs.

Our Texas drug injury lawyers find it difficult to believe that politicians and state and federal officials were unaware that compounding pharmacies had begun to exceed this role in order to take advantage of mass drug shortages produced by other drug recalls, among other things. In any case, the deadly fungal meningitis outbreak has finally raised some questions among politicians (it’s an election year, after all) and drug regulators about how compounding pharmacies operate.

Continued in Part 2.