The Tennessee Valley Authority (TVA) said residents in the area of last week’s fly ash spill near Kingston, TN should not drink water from private wells and springs.  However state and federal officials still insist that that municipal water supplies are safe.

According to a NewsChannel5 report, the U.S. Environmental Protection Agency (EPA) detected high levels of arsenic and heavy metals in the Clinch and Emory rivers near an area where the sludge spill occurred.  TVA spokesman Jim Allen told the Associated Press that there are four private drinking water wells in the area affected by the spill and the agency should have tests from them this week. (more…)

Sterility problems have prompted Stryker Corp. to issue a Class I recall of its Custom-made Cranial Implant Kits. The Stryker cranial implant kit recall has been deemed a Class I recall by the Food & Drug Administration (FDA_.  Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death, the agency said.

According to the FDA, the Cranial Implant Kits are used to correct defects in the jaw and face, or cranium and face. In a press release, Stryker said it issued the recall  after determining that the sterilization validation of the product was not performed according to appropriate standards. Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly, Stryker said.

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The group Greenpeace is calling for a criminal investigation into  the Tennessee Valley Authority (TVA) fly ash spill that occurred earlier this week.  Meanwhile,  the TVA has tripled its original estimate of the the mount of  potentially toxic fly ash that was released from a retention pond at its Kingston Fossil Plant in Roane County, TN when a dam burst there early Monday morning.

Greenpeace is just the latest environmental group to sound off over the TVA fly ash spill.  “Every facility like this is supposed to have a spill contingency plan to prevent this kind of disaster,” Rick Hind, Greenpeace Legislative Director said in a press release. “The authorities need to get to the bottom of what went wrong and hold the responsible parties accountable.”  Similar spills have resulted in felony charges, the release noted. (more…)

At least 38 people were injured when a Continental Airlines plane with 115 people aboard veered off a runway, broke apart and burst into flames Saturday night in Denver.  While five people were hospitalized because of the plane crash. there were no deaths reported.

Investigators still don’t know why the Boeing 737 skidded off the runway as it attempted to take off around 6:18 MT Saturday night. According to CNN, the National Transportation Safety Board (NTSB)  had recovered the plane’s data and voice recorders, which were sent to Washington, DC for review.  Investigators will interview crew members, review crew training and evaluate several factors, including the weather at the time of the crash and structure of the plane, CNN said. (more…)

Sun Med of Largo, FL has issued a Class I recall for its Greenline/D MacIntosh No. 3 Laryngoscope Blades.  The laryngoscope blades were recalled because a piece of the acrylic light tube that runs along the laryngoscope blade may break off during procedures. The Food & Drug Administration (FDA) issues Class I recalls when there is a reasonable probability that the use of a device will cause adverse health consequences or death.

According to the FDA recall notice, the blades are part of a medical device (laryngoscope) used to view the vocal cords and other structures when opening a patient’s airway.  The FDA said that Sun Med has sent a notice to their distributors requesting that the defective laryngoscope blades be returned.  Customers with questions may contact Sun Med at 1-727-530-7099. (more…)

Because of a legal concept called “fraudulent conveyance”, investors who got out early might still suffer losses as a result of the  Bernard Madoff investment fraud.

Fraudulent conveyance is the illegal transfer of property to another party in order to defer, hinder or defraud creditors. According to Reuters, because of fraudulent conveyance, investors who took their money out of Madoff’s funds before the fraud was discovered might have to return their profits to help offset losses incurred by others who stayed in.   Basically, those “profits” were just an illusion, because Madoff was simply using funds from new investors to pay off old ones. (more…)

The Food & Drug Administration (FDA)  wants the makers of new diabetes drugs to make sure they don’t increase heart risks before they are approved. To that end, agency announced new testing standards for diabetes drugs currently in development.

The FDA has provided written notice of the new recommendations to more than 100 manufacturers who have submitted investigational new drug applications for type 2 diabetes treatment.  The new standards mean that it could take longer for drug makers to bring these new medications to market. (more…)

Federal regulators failed to act on “credible and specific allegations” regarding Bernard Madoff’s investment activities Securities and Exchange Commission (SEC) head Chistopher Cox said yesterday.  Cox’s frank admission came as he was announcing an internal probe of the SEC’s oversight of Madoff’s allegedly fraudulent investment business.

As the details of the Bernard Madoff scandal have unfolded, it has become increasingly apparent that the SEC failed in its oversight of Madoff’s business.  The agency had apparently received various tips over the years that questioned Madoff’s activities. The SEC conducted routine examinations of the company in 1999, 2004, and 2005, as well as investigation that ended in 2007.  However, only the 2005 examination found “minor problems”. (more…)

The Food & Drug Administration (FDA) has decided to order the makers of epilepsy drugs to include suicide warnings on their labels. In addition to the suicide warning, the FDA is also requiring the drugs’ manufacturers to submit f a Risk Evaluation and Mitigation Strategy for each medication , including a Medication Guide for patients.

The FDA said its actions were based on the agency’s review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo, the agency said. (more…)

In the wake of Bernard Madoff’s arrest for securities fraud, the Securities and Exchange Commission (SEC) is facing criticism for ignoring warning signs about his investment-advisory business. Meanwhile, as federal officials and others investigate the regulatory failure that allowed Madoff’s alleged fraud to occur,  investors are left to trying to asses the extent of their losses.

Those investors did receive a small bit of good news yesterday.  According to the Associate Press, a federal judge signed an order allowing clients of  Madoff’s private investment business to seek relief under a federal statute created to rescue cheated investors.  The order was signed after the Securities Investor Protection Corporation (SIPC) asked that steps be taken to protect investors in the scheme, the Associated Press said. (more…)