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Troubling News Emerges from 2013’s West Fertilizer Plant Explosion

Although it has been over a year since the explosion at the West Fertilizer Company killed 15, new reports on the tragedy are still surfacing.

In the first official public health report, county officials have indicated that injuries were more severe than previously known. The report also suggests that many injuries may have been missed in the initial chaos following the explosion.

This new report, issued by the Waco-McLennan County Public Health District, finds that more than one in five of those injured by the explosion experienced traumatic brain injury (TBI) or concussion.

The report also states “some injuries, particularly ear injuries as well as traumatic brain injury, may not have been identified at the time of medical treatment immediately after the explosion,” indicating that many of the injured may have left the hospital without proper treatment or instructions.

Ear injuries affected more than 10 percent of the injured.

Reese Dunklin of the Dallas Morning News has been reporting on a second issue: the latest moves by the Texas Department of State Health Services to keep basic information about chemical storage facilities away from the public.

In early July, the office of the Texas Attorney General informed reporters at the Dallas Morning News that the Department of State Health Services would no longer release information about chemical inventories to the public.

In a letter, the Attorney General stated that the decision was based on Texas Homeland Security statutes. Several federal agencies have spoken out against the withholding of information about potential chemical hazards.

In April of 2014, the U.S. Chemical Safety Board concluded that a lack of community awareness of the chemical hazard at the West facility contributed to the disaster. No emergency response plan was in place at the time of the explosion. 

In the last few weeks, a new federal task force has publicly called for increased release of information about large chemical inventories. Such information would make it possible for local citizens and businesses to make effective emergency response plans based on real knowledge of the risks that surround them.

Faulty Defibrillator Wires Are Once Again Being Recalled

St. Jude’s ultra-thin defibrillator wires are part of a new recall for heart patients.

On January 13, St. Jude Medical Inc. issued a recall of the wire that is used to secure a device designed to close an opening which can occur in the heart between the two upper chambers. According to the recall, the wire has the potential to fracture, according to the U.S. Food and Drug Administration.

The Amplatzer TorqVue FX Delivery System has been in use since 2012; the product has been recalled by medical device manufacturer due to its potential for fracture when used in some implant practices and to repair some cardiac anatomies. All batches of the device have been recalled after a number of the wires fractured during surgery. While there have not yet been any reported deaths or serious injuries associated with the product, physicians have been advised to stop using the product and remove it from surgical inventory. Physicians have been advised to use a previous version of the same system which has a somewhat different design. The devices are considered a Class I recall; the patients who received the device are in danger of being seriously injured or killed if it fails.

This is the latest recall in the wake of a larger St. Jude’s recall in 2010, when the manufacturer’s Riata defibrillators were taken off the marker after they were found to have insulation capable of eroding. Almost 80,000 heart patients in the U.S. still have the implant in a blood vessel which leads to the heart.

Extracting defibrillator leads is a risky surgery; it is estimated that many patients with the Riata leads will continue to live with them rather than risk the surgery. Reportedly, two patients have died and one was seriously injured during surgery to remove faulty Riata leads. St. Jude Medical Inc. manufactures and distributes a wide variety of medical devices, implanted defibrillators and pacemakers. In 2012, the company recalled two other similar wires, QuickFlex and QuickSite.

The FDA has ordered St. Jude to conduct a three-year study in which to learn about the risk of insulation failure. The Riata was noted for its ultra-thin wires and was popular with surgeons, but a recent study has shown that 15 percent of patients who received the Riata defibrillator lead later experienced an “insulation breach” or “insulation abrasion,” where the defoliator wires protruded from the cable’s coating. In late 2011, the FDA issued a Class 1 recall for Riata leads when it was found that they were failing at a high rate.

If you have any concerns about your pacemaker or defibrillator or any surgical implants you have received, speak with a Waxahachie personal attorney at Hale Law Firm.

John Hale is a Waxahachie personal injury attorney and Ellis County personal injury lawyer helping injury victims near Dallas Texas. Learn more at http://www.hale911.com/

NECC Employees Subpoenaed, NECC Blames Cleaners For Fungal Meningitis

Employees of the New England Compounding Center are expected to soon begin testifying about the role that pharmacy played in the fungal meningitis outbreak. A federal grand jury in Boston has issued subpoenas as part of an investigation into potential criminal charges.

Boston prosecutors may be looking to charge NECC with several crimes, including fraud, violating the FDA act by selling tainted medication, and defrauding Medicare and Medicaid. NECC’s managing pharmacist, Barry Cadden, previously invoked his Fifth Amendment right during questioning by Congress in late 2012.

There are now 70 lawsuits against NECC, and dozens more are winding their way through the system, with an estimated 400 cases against the compounding company. NECC has asked that all the fungal meningitis lawsuits be consolidated before Boston’s U.S. District Judge Dennis Saylor.

Judge Saylor granted a request for a temporary consolidation of one dozen fungal meningitis lawsuits, and advised NECC to preserve all evidence now that the company’s offices and laboratories are shut down.

To date, more than 650 people have been sickened by the tainted steroid shots which inadvertently contained a rare form of fungal meningitis. The lawsuits filed are alleging that NECC produced a defective and dangerous product due to negligent practices and conditions. At least 40 people have died.

In a recent filing in U.S. Bankruptcy Court, Boston, a federal bankruptcy court official stated that “gross mismanagement” by NECC officers led to the fungal meningitis outbreak.

Meanwhile, in early January 2013, attorneys for NECC sent a letter to the janitorial company which provided cleaning services to NECC’s laboratories, demanding that it take legal responsibility for the tainted steroids. UniFirst’s “Uniclean” business provided what NECC’s attorneys characterized as “limited, once-a-month cleaning services” for the compounding company’s cleanroom facilities. UniFirst responded with a statement that the claim was “without merit.”

The cleaning services that were requested by NECC consisted of two UniClean techs cleaning cleanrooms for ninety minutes once a month, using NECC’s own cleansing solutions, UniClean stated. UniClean claims that its services did not have anything to do with NECC’s day-to-day operations, the overall cleanliness of the facilities, or the sterility of the products produced there.

As part of their investigation, inspectors with the CDC and FDA examined other unopened vials manufactured at NECC and found additional bacterial contamination.

John Hale is a Waxahachie personal injury attorney and Ellis County personal injury lawyer helping injury victims near Dallas Texas. Learn more at http://www.hale911.com/

New Safety Recall of More than 200,000 Infant Travel Beds

The Consumer Product Safety Commission just announced a recall of infant beds. Children’s safety equipment manufacturer KidCo Inc. is working with CPSC to recall approximately 220,000 infant travel beds in light of nine reported entrapment incidents and at least one infant death while using the portable sleep tent. It has been determined that a baby might get trapped by rolling into the space between the bed’s air mattress and the tent’s fabric sides, and suffocate.

The Pea Pod Travel Crib includes an air mattress that tucks into a closeable envelope built into the dome tent floor. The domed tent is designed to collapse for travel, but when the inflatable mattress is in the tent floor, as designed, there is a space between the floor and the soft wall where the infant’s head can get lodged. It is believed that a 5-month-old baby boy became trapped in such a manner while napping in late 2011. He had his twin sister were placed the Pea Pod Travel Crib. The sister survived. The baby boy died.

The Pea Pod Travel Crib has been on the market since 2005, and approximately 220,000 have been sold nationwide. This recall is the first for KidCo Inc. The company is offering modification kits to travel crib owners which are designed to strengthen the tent sides, and also includes a replacement mattress that is thinner to remove the risk of suffocation.

The company has stated that they believe the safety kit addresses any safety issues the travel crib may have. However, the safety consumer group Kids in Danger has said that they would rather the company issue refunds so that parents can purchase a different item, one tested for sleep safety. A product must be considered a crib, bassinet or play yard to be tested for sleep safety.

The Pea Pod Travel Crib and the PeaPod Plus Travel Beds were manufactured in China and distributed nationwide in stores and by Amazon.com starting in January 2005.

John Hale is a Waxahachie personal injury attorney and Ellis County personal injury lawyer helping injury victims near Dallas Texas. Learn more at http://www.hale911.com/

Meningitis Outbreak Leads To Examination of Compounding Pharmacies

There are currently at least 184 cases of meningitis in the U.S., including 14 fatalities, confirmed by the Center for Disease Control. The fungal meningitis outbreak started when steroid medication was contaminated with a fungus and the fungus was injected into the bloodstream when the shots were administered to patients. Infection has been recorded in numerous states, including Florida, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Tennessee, Texas and Virginia and numbers are expected to increase: the incubation period can take as long as three months.

According to Dr. Ilisa Bernstein, the acting director of the FDA’s Center for Drug Evaluation and Research Office of Compliance, the FDA is examining the way compounding pharmacies are monitored for safety. A compounding pharmacist customizes medication as needed to fit each individual’s need; if a dosage is too large or needs to be delivered without dyes, for example, the pharmacist can combine medications, or “compound” them. Compounding, or combining different items to make a specialty medication, was the standard way all medications were manufactured until the 1950s, when mass production became the norm.

Pharmacies like The New England Compounding Center may compound medications for specific prescriptions, and are usually supervised by that state’s pharmacy boards. The New England Compounding Center has been in the spotlight previously: the FDA looked at their compounding practices in 2006 and stated that the firm’s actions were inconsistent in its compounding practices and acted more like a drug manufacturer.

While compounding production is legally restricted to individual prescriptions, the pharmacy may have mass produced the compounding production, which is why such a large batch was contaminated. The New England Compounding Center where the medication was compounded has recalled more than 17,000 vials of the injectable steroid treatment used for back and joint pain. The fungi which has tainted the steroid includes Aspergillus fumigatus and Exserohilum, and are often found in grass, leaf mold, grass, and old wood.

At this time, it is believed that as many as 14,000 people received the contaminated steroid injections. Some 90 percent of those individuals have been contacted. Multiple investigations are ongoing and Connecticut’s Sen. Richard Blumenthal of Connecticut has called for a criminal investigation into the company.

Symptoms of meningitis include fever, headache, and nausea. An infection of the membranes which cover the brain and spinal cord, fungal meningitis must be treated in a timely fashion. It is not contagious.

John Hale is a Waxahachie personal injury attorney and Ellis County personal injury lawyer helping injury victims near Dallas Texas. Learn more at http://www.hale911.com/