Another Tylenol Recall for J&J Due to Sickening Odor

McNeil Consumer Healthcare, one of the Johnson & Johnson Family of Companies, has issued a recall of Tylenol 8HR caplets due to consumer complaints of a musty smell, the same smell that triggered recalls of other products during the past year.

This is the sixth time that McNeil issued a recall due to an off odor of their products. Consumers have reported health effects such as gastrointestinal events including nausea, stomach pain, vomiting or diarrhea from this odor in the past.

The initial odor problem was revealed when McNeil recalled certain lots of 100ct Tylenol Arthritis Pain with EZ-Open Cap in November 2009 due to a musty smell that made consumers sick, and expanded that recall in December of 2009 to include all lots of the product.

After an investigation of the odor, McNeil found that trace amounts of a chemical called 2,4,6-tribromoanisole (TBA) caused the problem, created by the breakdown of a chemical used to treat build wood pallets that transport and store product packaging materials.

In January 2010, the drug maker expanded the recall again to include various Children’s Motrin, Children’s Tylenol, Benadryl, Extra Strength Tylenol, Motrin, Regular Strength Tylenol, Rolaids, Simply Sleep, St. Joseph Aspirin, Tylenol 8-hour, Tylenol Arthritis and Tylenol PM.

In June 2010, McNeil added lots of Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels because the company inadvertently omitted the products from the January recall list.

In July 2010, the recall expanded to include 21 additional lots of Tylenol, Motrin and Benadryl products.

For a complete list of all recalled products, visit http://www.mcneilproductrecall.com/

Today’s recall involves:

TYLENOL 8 HOUR CAPLET - 50 COUNT
NDC Code # 50580-297-50
UPC # 3 0045-0297-51 8
LOT # BCM155

“This voluntary action is being taken as a precaution and the risk of adverse medical events is remote,” McNeil said in a release. “To date, observed events reported to McNeil for this lot were temporary and non-serious.”

Consumers should stop using the recalled product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036. Consumers can receive either a refund for the average retail price of the product or a product coupon.

Consumers who have medical concerns or questions should contact their healthcare provider and report any adverse reactions to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm or by Fax: 1-800-FDA-0178.

Recall of Frozen Vegetables because they may contain Glass Fragments

The Pictsweet Company, located in Bells, TN, has recalled certain lots of frozen peas, peas and carrots, and mixed vegetables because the company has learned that they may contain glass fragments and cause injury to consumers if eaten.

Consumers may have purchased the affected products at Kroger grocery stores located in , Greater Louisville (including Indiana), Lexington, and Nashville, TN, Greater Memphis, TN, Arkansas, Mississippi and Western Kentucky, North Carolina, Virginia, Eastern WV, Eastern Kentucky, SE Ohio, Georgia, South Carolina, Alabama and Knoxville, Tennessee. Or Walmart stores nationwide.

Pictsweet products affected by this recall:

• Kroger 12 ounce Green Peas (UPC 11110 89736) - Production Codes of 1440BU, 1440BV, 1440BW, and 1600BD
• Kroger 12 ounce Peas and Carrots (UPC 11110 89741) - Production Codes of 1960BD and 1960BE
• Great Value 12 ounce Steamable Sweet Peas (UPC 78742 08369) - Best by Dates of July 20, 2012;  July 21, 2012
• Great Value 12 ounce Steamable Mixed Vegetables (UPC 78742 08026) - Best by Date of July 15, 2012

“No injuries have been reported to date,” a Pictsweet press release said. “While no injuries have been reported, Pictsweet is advising the public that product from these packages indicated above should not be consumed. Consumers who have purchased the above product should return them to the place of purchase for a full refund.”

Consumers who have purchased the above product should return them to the place of purchase for a full refund. Consumers with questions may contact The Pictsweet Company at 1-800-367-7412, extension 417.

NFL Quarterback John Elway Victim of Ponzi Scheme

John Elway, former NFL quarterback for the Denver Broncos, has lost millions of dollars in an investment that turned out to be a Ponzi scheme.

Elway and his business partner Mitch Pierce invested $15 million in March 2010 with hedge fund manager Sean Mueller in what the Denver District Attorney Mitch Morrissey alleges was a classic Ponzi scheme, reports the Wall Street Journal.

According to court documents, Sean Mueller faces charges of securities fraud in which he made untrue statements or omissions, two counts of theft, and racketeering in violation of the Colorado Organized Crime Control Act.

Since 2000, Mueller allegedly created hedge funds and offered investors limited partnerships in his funds. He then conducted day trading in the funds to generate returns for the investors. By April 2010, there were about 65 investors in these hedge funds, who had invested approximately $71 million. However, between 2008 and 2009, Mueller suffered massive losses in his day trading accounts. By April 2010, Mueller had less than 9.5 million in cash and investments and liabilities to hedge fund investors of about $45 million.

When investigators reviewed Mueller’s bank accounts, they found that he used investor funds to live an extravagant lifestyle, including the purchase and maintenance of three luxurious homes, several expensive cars, personal expenses and memberships at exclusive country clubs.

Investigators allege that Mueller knowingly used new investor funds to pay returns and disbursements to existing investors in true Ponzi fashion. He failed to deposit investor funds into brokerage accounts as promised.

Mueller allegedly duped his own accountants by providing fictitious brokerage statements showing the hedge funds were solvent to hide his scheme. He also knowingly provided investors with fictitious monthly account statements reflecting positive returns. He caused investors to receive fictitious IRS K-1 schedules that reflected positive yearly investment returns in the funds for which they paid taxes when in actuality they suffered investment losses.

The Ponzi scheme was finally exposed when police responded to a call on April 22, 2010 and found Mueller threatening to commit suicide by jumping off a parking garage.

Mueller sent an email to employees and investors that day apologizing for the losses stating, “Nobody here or anywhere else had any idea what was happening. I think you can redo the taxes and recover a good amount of money.”

“I always thought I could make it back but that’s not going to happen,” he said.

Court papers filed for Elway and Pierce by lawyer Stephen Dietrich say their investment was to remain separate from other investor’s funds and held in trust until they could chose conservative investments, not Mueller’s hedge funds. They want to recover their losses ahead of other investors and have filed court documents requesting a declaratory judgment. The two had invested with Mueller in the past.

GM recalls 322,409 Chevy Impalas because the Seatbelts may Not Work in a Crash

General Motors Corp. announced today that the company is recalling 322,409 model year 2009-2010 Chevrolet Impala passenger vehicles because the seat belt could fail to restrain the occupant in a crash situation due to improper anchoring.

In a letter to the National Highway Traffic Safety Administration (NHTSA), General Motors reported that an assembly error led to the improper securing of the front safety belt webbing to the lap belt anchor pretensioner mounted to the side of the seat nearest the door.

“Vehicles with this condition may have an anchor that can separate in a crash, and therefore may not meet the anchor strength requirements of the U.S. and Canadian Motor Vehicle Safety Standard that covers seat belt assembly anchorages,” General Motors said in a news release.

The company discovered the defective seat belts after investigating incidences of seat belt separation during warranty repairs. By June 2009, GM had received nine reports of the defect and as of August 2010 there were 32 more reports of seat belt anchors either twisted or partially installed and separated.

“There are no reports of injuries or fatalities where the belts were reported to have the condition,” GM’s letter to the NHTSA said.

Under the recall, GM dealers will inspect and the seat belts for proper installation and reinstall them if necessary free of charge. Owners can contact Chevrolet at 1-800-630-2438 or visit the owner center at www.gmownercenter.com.

Is your cordless drill a fire hazard? 455,000 Ryobi drills recalled

The U.S. Consumer Product Safety Commission (CPSC) and Ryobi Technologies Inc. announced today the recall of 455,000 Ryobi Cordless Drills because of reports of burn injuries and damage to homes and vehicles from fires caused by a switch on the drill that can overheat.

According to the CPSC release, consumers have filed 47 reports with the manufacturer of the drills overheating, smoking, melting or catching fire, including 12 reports of property damage to homes or vehicles. Two of the incidents involved minor burns from touching an overheated switch.

The product affected by this recall Ryobi Model HP 1802M Cordless Power Drill powered by an 18-volt rechargeable NiCad battery. The drill is blue and black in color with "Ryobi" appearing in red and white on the left side. Consumers can find the model number on a white label on the right side of the drill. Home Depot sold this drill from January 2001 to July 2003 for about $100.

Consumers should stop using the recalled Ryobi Cordless Drill immediately and contact Ryobi Customer Service at (800) 597-9624.

FDA says Osteoporosis Drug Labels Must Warn Patients of Risk of Leg Fractures

The U.S. Food and Drug Administration (FDA) announced today that the agency is requiring the labels of bisphosphonate osteoporosis drugs Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia and Reclast (and their generic products) to include a warning about increased risk of fracture of the thigh bone.

Doctors prescribe these bisphosphonates for the prevention or slowing of bone loss, or osteoporosis, in postmenopausal women. Prescriptions for bisphosphonates in the U.S. number more than 5 million yearly.

Patients taking bisphosphonates have reported leg fractures including atypical subtrochanteric femur fractures, fractures in the bone just below the hip joint, and diaphyseal femur fractures in the long part of the thigh bone. Patients who suffered fractures also reported hip or thigh pain in the months preceding the fracture. The FDA says that it is unclear whether bisphosphonates are the cause. However, patients taking the osteoporosis drugs are the predominant the victims of unusual femur fractures. These atypical fractures may be related to long-term term bisphosphonate use.

In March, the FDA issued a notice that it was investigating the potential risk of atypical bone fractures and working with the American Society of Bone and Mineral Research.

In addition to the new labeling requirements, the drug manufacturer must give patients taking bisphosphonates a medication guide that warns of the risks of leg fractures, describes the symptoms of atypical femur fracture and recommends that patients notify their healthcare professional if they develop symptoms.

The FDA recommends that if you currently take a bisphosphonate, you should:

• Continue to take your medication unless you are told to stop by your healthcare professional.
• Talk to your healthcare professional if you develop new hip or thigh pain (commonly described as dull or aching pain), or have any concerns with your medications.
• Report any side effects with your bisphosphonate medication to FDA’s MedWatch program

This notice does not affect bisphosphonate drugs that only are used to treat Paget’s disease or high blood calcium levels due to cancer (i.e., Didronel, Zometa, Skelid, and their generic products).

A study released in September 2010 found that people who take bisphosphonates such as Actonel, Boniva and Fosamax for more than five years might have double the risk of developing cancer of the esophagus.

Supreme Court to decide if people injured by childhood vaccines can sue the drug maker

The Justices of the Supreme Court heard arguments today in a case regarding whether a person who develops injuries from a childhood vaccination can file a lawsuit against the vaccine maker if that drug company could have offered a safer vaccine.

In 1986, the U.S. government enacted the National Childhood Vaccine Injury Compensation Act in an effort to encourage pharmaceutical companies to continue the manufacture of vaccines and ensure an adequate supply of them by reducing the financial liability of the drug companies from vaccine injury claims. Congress felt that substantial awards in vaccine injury lawsuits could deter pharmaceutical companies from developing and manufacturing vaccines.

Under this law, those injured or killed by certain vaccines, or their guardian, must first file injury claims through the National Vaccine Injury Compensation Program (VICP), called vaccine court, instead of suing the vaccine maker.

Health and Human Services and the Department of Justice review VICP vaccine injury claims and file a combined report with the U.S. Court of Federal Claims. A special master, a lawyer appointed by the judges of the Court, then decides if the claim will be paid and the amount. The injured party may accept or reject the award from the special master and can the appeal the decision to a judge of the Court by the petitioner or HHS, then to the U.S. Court of Appeals for the Federal Circuit, and finally, to the U.S. Supreme Court.

Compensation the injured person may receive from the VICP program is restricted to a reasonable amount for medical care, lost earnings, reasonable attorneys’ fees and legal costs, and up to $250,000 for pain and suffering compensation. Wrongful death claims are restricted to reasonable attorneys’ fees and legal costs plus $250,000.

Awards are paid from a compensation trust fund funded by a .75-cent excise tax on every vaccine purchase.

There are currently more than 5,000 vaccine injury claims before the VICP vaccine court.

According to the Washington Post, the parents of Hannah Bruesewitz and their attorney David C. Frederick filed the case Bruesewitz v. Wyeth (09-152), because their infant daughter developed seizures and will require life-long care after receiving the Tri-Immunol diphtheria-pertussis-tetanus vaccine made by Wyeth Inc., which is now part of Pfizer Inc.. They allege their daughter’s injury was avoidable because Wyeth owned another vaccine for the same diseases that had fewer side effects but the company and U.S. Food and Drug Administration failed to encourage approval of this potentially safer vaccine.

The Bruesesitzes had first filed a claim with the VICP that the special master denied. They then filed a personal injury tort lawsuit in the court of Pennsylvania. However, the court would not allow the lawsuit to proceed because federal law prohibits lawsuits for defective vaccines.

The Justices of the Supreme Court must now interpret just what Congress meant when it passed this law as it does not specifically exempt vaccine makers from all injury lawsuits. The court must decide whether those injured by vaccines have the legal right to sue the manufacturers if a safer vaccine was available.

"The language that they used is certainly, to say the least, confusing," said Justice Ruth Bader Ginsburg.

"What is the motivation for the manufacturer to either continue the testing of their product and voluntarily stopping it if a better design has been found by someone else, or even an inducement for them to find a better design if a competitor comes around?" Justice Sonia Sotomayor asked during today’s argument. "Because I don’t see why they should stop until they have caused as many injuries as they need to before the FDA says stop."

OSHA Fines NY Paper Mill after Worker Crushed to Death

Norampac Industries Inc. has received citations and a $70,000 fine from the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) after the death of a worker at its Niagara Falls, NY paper mill.

On May 12, 2010, a worker at the company’s paper mill became caught between a fixed metal barrier and a large paper roll that was moving on a conveyor, crushing the worker to death. The Niagra Gazette identifies the worker as Peter Neville, 40, husband and father of 3 children. After an investigation, OSHA issued Norampac repeat and serious safety violations.

"Our inspection found that the area where the moving paper roll and the barrier intersected lacked guarding to prevent employees from being caught between the two objects," Arthur Dube, OSHA’s area director in Buffalo said in a release. "Proper and effective machine guarding is essential to protecting workers against serious injury or death."

The OSHA inspectors also found Norampac employees working under hazardous conditions, including lack of eye and face protection for workers performing voltage testing on live electrical circuits; unmarked and painted-over electrical disconnects; and not ensuring that confined space entry supervisors could verify that rescue services were available and able to be contacted in the event of a confined space emergency.

OSHA issued two repeat citations with $70,000 in proposed fines for the lack of machine guarding that resulted in Neville ‘s death, and lack of eye and face protection. The repeat citations stem from violations found in 2009 for similar hazards at the company’s Thompson, CT manufacturing plant. The agency also issued two serious citations with $5,000 in fines for the remaining items.

A serious citation is warranted when death or serious physical harm is likely to result from hazards about which the employer knew or should have known.

"One means of eliminating hazards such as these is for employers to establish an illness and injury prevention program in which workers and management jointly work to identify and eliminate hazardous conditions on a continual basis," said Robert Kulick, OSHA’s regional administrator in New York.

Norampac has 15 business days from receipt of its citations and proposed penalties to comply, meet with OSHA or contest the findings before the independent Occupational Safety and Health Review Commission.

Google says cars driving themselves would reduce crashes, but who is liable if they do crash?

Using cameras, radar and lasers, a fleet of Google robot cars have racked up 140,000 miles on California roads and developers believe the vehicles will not only reduce fuel consumption, but also reduce accidents, says an article in The New York Times.

Seven Toyota Prius vehicles make up the Google autonomous fleet. The cars are equipped with a GPS navigation system and database of speed limits. Google has outfitted each car with a rotating sensor on the roof called LIDAR that creates a three-dimensional map by scanning 200+ feet in every direction. Video cameras assist in determining traffic lights and recognizing moving objects, radar sensors in the front and rear help define position of objects.

Google has not left its cars completely unmanned. A licensed driver traveling in car may over ride the computer at any time. However, the company says the cars have driven more than 1,000 miles independently without human intervention.

According to the U.S. Census Bureau statistics of motor vehicle crashes for 2007, 1,711,000 accidents resulted in injury and 37,200 accidents ended in fatalities. More than four million more crashes involved property damage only without injury or death.

The computer system driving a Google car reacts faster than a human reacts and views the roadway in 360-degree perception. It also does not succumb to human factors that can contribute to a crash including distraction, fatigue or intoxication.

The fleet of Google cars has only encountered one accident in all the miles they have traveled, another vehicle rear-ended a Google car while it stopped at a stoplight.

In and out of congested traffic and zooming down the highway, these computer driven cars may be the way of the future. Google is not the only company working on artificial intelligence for consumer automobiles. An Associated Press article reveals that Volkswagen and Intel Corp. are developing similar technology.

The new technology raises some liability questions. In the event of an accident, who is at fault? Is the vehicle owner or human operator in the vehicle liable, perhaps the software company or equipment manufacturer?

Mercedes-Benz Recalls 85,000 Cars Due to Steering Defect

Mercedes-Benz USA LLC, part of Daimler AG, has announced a recall of 85,078 2010 Mercedes Benz C-Class and 2010-2011 Mercedes Benz E-Class vehicles because the power steering system in the subject vehicles may fail due to the loss of power steering fluid.

According to the National Highway Transportation Safety Administration (NHTSA), after vehicle owners complained of reduced power steering and loss of power steering fluid, Mercedes-Benz determined that a connection fitting on the high-pressure power steering line at the connection to the pump did not have sufficient torque applied during the production process. Over time, this could cause a loss of power steering fluid and increase the likelihood of a crash.

A document submitted to the NHTSA by Mercedes-Benz projected that 100% of the 85,078 recalled vehicles contain this defect.

The manufacturer will remedy the defect by having dealers check and retorque the connection free of charge. Dealers will also change the O-ring seal as a precautionary measure in all cases where the connection fitting shows evidence of loosening.

Neither Mercedes-Benz nor the NHTSA reported any crashes attributed to this defect.

Owners may contact Mercedes-Benz at 1-800-367-6372 the National Highway Traffic Safety Administration’s Vehicle Safety Hotline at 1-888-327-4236 (tty 1-800-424-9153), or go to http://www.safercar.gov.