Posted On: March 30, 2012

FDA Wants to Investigate "Inhalable Caffeine" Further

1152203_27222868_03312012.jpgA new product, described as “inhalable” or “breathable” caffeine, has drawn the attention of the U.S. Food and Drug Administration (FDA) due to questions about its safety and suitability for the marketplace. This is due partly to recent incidents involving injuries and deaths allegedly caused by high-caffeine energy drinks, as well as the mixture of caffeine-containing energy drinks with alcohol. The apparent popularity of these products among college students and other young people is also a cause for concern.

“Breathable caffeine,” currently marketed as the AeroShot, reportedly contains 100 milligrams of caffeine in a single “shot.” This is roughly the same amount of caffeine contained in a large cup of coffee. The device resembles an asthma inhaler. The owners of the company that produces the AeroShot state in interviews that the product is not intended for anyone under the age of 18, nor should it be mixed with alcohol.

The FDA’s concerns primarily involve the labeling of the product in regards to whether consumers should inhale, drink, or eat it. In a letter sent to the company on March 5, the FDA notes that product labels and the website prominently describe the product as “breathable.” At the same time, other statements and materials describe it as “ingestible,” and refer to it as a “dietary supplement.” FDA regulations require clear labeling of a product as either “breathable” or “ingestible.” A “breathable” product cannot be described as a “dietary supplement.”

The FDA also expresses concerns about consumer safety in the absence of clear instructions about inhalation versus ingestion. If the product is intended for inhalation, ingestion could be dangerous, and vice versa. Very little research exists on the safety of inhaled caffeine products, which also worries the FDA.

Finally, the FDA notes concerns about the intended age of the product’s consumers and warnings about its use in combination with alcohol. While the company states that no one under 18 should use the product, some materials allegedly state the minimum age as 12. Marketing materials describe using the product when, for example, “study[ing] in the library,” an activity the FDA notes is most common among children and young adults. Publicity around the product featured on its website describes its use with alcohol as a “party drug.” This, according to the FDA, contradicts the company’s message that it should not be mixed with alcohol.

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Posted On: March 22, 2012

NHTSA Delays Decision on Backup Cameras in Cars

712987_19601479_03222012.jpgThe National Highway Transportation Safety Administration (NHTSA), an office within the U.S. Department of Transportation, has delayed a final rule regarding rear visibility requirements in cars. This is the second delay of the rule since the agency began working on it. The purpose of the rule would be to prevent “backover” accidents due to a driver’s inability to see people or objects behind the vehicle. The Secretary of Transportation has said that they expect to have final standards ready by the end of 2012.

The rule is required by the Cameron Gulbransen Kids Transportation Safety Act of 2007, passed by the U.S. Congress in early 2008. This law addresses several child safety concerns, including the risk to children of vehicles moving in reverse where the driver cannot see the child. It is named for a two year-old child who died when his father accidentally backed his car over him in their driveway. According to the NHTSA, 292 deaths and 18,000 injuries result each year from “blind zones” behind vehicles. The majority of the fatalities involve light vehicles, meaning those weighing 10,000 pounds or less. Those most vulnerable to these kinds of accidents are children and the elderly. In addition to addressing visibility issues, the law requires rules for auto-reverse in power windows and transmission systems that prevent cars from easily shifting out of “park.”

The proposed rule would require additional mirrors or even camera devices to enable drivers to see the area behind the vehicle while driving in reverse. In December 2010, the NHTSA announced that it expected to require new passenger cars, minivans, pickup trucks, and other vehicles to have “rear mounted video cameras and in-vehicle displays” to allow an expanded field of vision for drivers.

The New York Times reportedly found that backup cameras are already standard issue in forty-five percent of new vehicles, and that they are available as an option in twenty-three percent. For all other vehicles, owners would have to purchase cameras. The NHTSA reportedly estimates that, for vehicles without an embedded navigational screen, the cost to a vehicle owner would be between $159 and $203, and between $58 and $88 for cars with a screen already installed. The total annual cost for the country would be between $1.9 and $2.7 billion.

Secretary of Transportation Ray LaHood announced in February that the NHTSA would need to do further research before formally issuing the new rules. The rule has also proven to be controversial politically, considering the large price tag attached to it. The controversy persists even though it was actually President Bush who signed it into law in 2008. Bloomberg Businessweek says that it is among the five most expensive regulations still pending in the Obama administration, and it is one of many facing delays.

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Posted On: March 15, 2012

BP Settles Lawsuit Related to 2010 Oil Platform Explosion

Deepwater Horizon offshore drilling unit on fire 2010BP, Transocean, and several other companies have settled lawsuits with some of the individuals injured in the April 2010 explosion in the Gulf of Mexico that killed eleven people and caused one of the worst oil spills in history. The companies have also settled some of the claims pending between the various businesses involved with the drilling operation. Still, the situation is a mess of competing claims and lawsuits that may take years to unravel, as injured plaintiffs seek to separate their claims from several thousand consolidated claims for damages.

The Deepwater Horizon drilling rig, owned by Transocean and operated by BP, was a deep water rig positioned in the Gulf about 48 miles south of the Louisiana coast. It had drilled the deepest oil well in history, at more than 35,000 feet, in late 2009, and at the time of the explosion was drilling in an area called Mississippi Canyon Block 252. The explosion occurred on April 20, 2010, when a blowout, typically the result of a failure in pressure control systems, killed eleven workers on the rig and created a fireball visible for miles. The rig sank, while the well, located over 4,000 feet underwater, continued gushing and caused the massive oil spill.

A crew of 126 people was on the rig at the time, including a visiting group of Transocean and BP executives. Nearly all the survivors suffered injury. The person with the worst injuries, according to Bloomberg, is Buddy Trahan, a Transocean executive who suffered twelve broken bones when the explosion threw him thirty feet through a wall and buried him under rubble. A crew member freed him from the wreckage and found that a door hinge had nearly pierced his carotid artery. Trahan and numerous other individuals sued BP and other companies for negligence. Businesses and individuals affected by the explosion, including fishermen and tour companies, also have claims pending. State and federal governments have claims against various companies for damages and regulatory infractions.

The injury and wrongful death lawsuits have been delayed by disputes between BP, Transocean, and other companies over liability for the explosion itself and various property damage claims. Transocean recovered for the total loss of the rig, but other companies lost equipment as well. BP has made claims against manufacturers whose equipment may have caused or contributed to the explosion. The court consolidated several thousand claims for property damages and other economic injuries with the personal injury claims in order to facilitate pretrial processes. Around twelve personal injury claims are still pending.

One worker injured in the explosion, Oleander Benton, settled her federal lawsuit against BP, Transocean, and others. Benton asked a U.S. district judge in New Orleans to dismiss the suit in February. She had sought $5.5 million in compensation for her injuries, but the exact details of the settlement have not been disclosed.

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Posted On: March 7, 2012

Washington DC Metro Settles Seven of the Nine Wrongful Death Lawsuits Brought Over 2009 Red Line Crash

1106951_17967869_03072012.jpgThe Washington Metropolitan Transit Authority (WMATA) settled seven lawsuits brought by the families of people killed in a 2009 crash on the Red Line. The crash remains the deadliest accident in WMATA’s history. The exact terms of the settlement are confidential. Along with three companies that provide equipment for the train system, WMATA has admitted liability for the crash in a court document filed in mid-February. Four remaining lawsuits, two for wrongful death and two for injuries sustained in the crash, are expected to go to trial.

The crash occurred just after 5:00 p.m. on June 22, 2009. A faulty circuit in the automatic train control system failed to detect a train on the track. It directed Car 1079 into the parked train at full speed. Car 1079 was pushed up onto the other train before coming to rest. Nine passengers died in the crash, and dozens were injured.

An investigation by the National Transportation Safety Board (NTSB) scrutinized WMATA and the Tri-State Oversight Committee, which has responsibility for monitoring safety. The NTSB concluded that the control system’s failure directly caused the crash, and that WMATA had “failed to prioritize safety at all levels.” Multiple WMATA officials left or were reassigned. All trains have been operated manually since the crash, while they develop new safeguards.

Families of each of the nine people who died filed wrongful death lawsuits against WMATA and several of its suppliers. People who were injured in the crash also filed lawsuits to recover for their injuries. The recent settlement news resolves all but four of the lawsuits. The remaining suits are pending in the U.S. District Court for the District of Columbia.

The admissions of liability from WMATA and the other companies will make the trials go more smoothly. In a court filing, they say that they are stipulating to liability in order to “avoid the significant risks and costs” involved with a courtroom fight over the issue. The only issue for trial in the remaining cases, therefore, is the amount of compensatory damages each plaintiff should receive.

The day after the announcement of the settlements and the admission of liability, the judge presiding over the cases issued a gag order preventing the parties from discussing it publicly. A pretrial conference was reportedly scheduled for March 1. At least one of the cases, a wrongful death claim brought by the mother of victim Lavonda King, is scheduled for trial in mid-March.

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