Weight-Loss Drugs and Risk of Liver Failure

There is a potential, rare occurrence of liver failure in people who take the weight-loss medications Xenical or Alli, according to the Food and Drug Administration (FDA).

FDA has identified and reviewed 12 cases of severe liver injury reported in people taking Xenical and one case reported with the use of Alli. In some of these cases, other factors or drugs may have contributed to the development of severe liver injury.

The active ingredient in both of these drugs is orlistat. Xenical(orlistat 120 mg) is a prescription product. Alli (orlistat 60 mg) is sold over-the-counter without a prescription.

A cause-and-effect relationship of severe liver injury with orlistat use has not been established; however, because of the seriousness of this possible side effect, FDA has revised the drug labels for Xenical and Alli to include new safety information about the rare occurrence of severe liver injury.

Contact your health care professional immediately if you experience itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.

For more information please call 1 877 MESSALAW.

Tylenol recall: Serious side effects investigated

The Food and Drug Administration is looking into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson, according to a source close to a Congressional investigation.

Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.

The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" - and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.

Adverse event reports are consumer complaints of a serious side effect associated with the use of a medical product, according to the FDA. Adverse events could include death, hospitalization, disability and other health complications.

Following the most recent recall, Johnson & Johnson has suspended production at McNeil's facility in Fort Washington, Penn., that manufactured the children's drugs.

McNeil has maintained that its recall of the children's drugs was not "undertaken on the basis of adverse medical events" but as a precautionary measure.

For more information, please call 1 877 MESSALAW.

Messa & Associates, P.C. Superlawyers 2010

Miley Cyrus Jewelry Pulled After Toxic Metal Report

Miley Cyrus’ brand of jewelry is being yanked from the shelves at Walmart following a report that the jewelry contains high levels of a toxic metal.

The move is in response to a newly released nationwide test performed for the Associated Press, in which several items from the Miley Cyrus jewelry line -- sold exclusively at Walmart -- contained an unsafe level of cadmium ... which can be very dangerous if ingested.

The AP notes that the items are not known to be dangerous if simply worn -- but experts fear that the cadmium can enter a person's system if the jewelry is "sucked, bitten or swallowed." According to the report, long-term exposure to cadmium can lead to bone softening, kidney failure and other conditions.

The AP says Walmart became aware the jewelry contained cadmium back in February, but continued selling the products anyway -- until now.

Walmart has released a statement, saying the jewelry was "designed for and marketed to older audiences" and was "not intended for children." The company also says they will no longer sell the jewelry "while we investigate its compliance with our children's jewelry standard."

For more information please call 1 877 MESSALAW.

900,000 Dangerous General Electric Coffee Makers Recalled

Walmart is recalling about 900,000 coffee makers sold under the General Electric brand after receiving more than 80 reports of the machines overheating, smoking, melting, burning and catching fire, the U.S. Consumer Product Safety Commission said.

At least 83 consumers reported the problems to the CPSC said, including three who suffered burns. One coffee maker caused a "significant" kitchen fire, the CPSC said, while others damaged cabinets and counter-tops.

The 12-cup programmable digital coffee makers imported from China were sold in white or black. On the base is the "GE" logo. On the bottom is the model number. The models being recalled are169164 (black) and 169165 (white).

The coffee makers were only sold at Walmart stores and were available from March 2008 until January 2010. The price was about $30.

If you have one of the machines, the CPSC urges you to stop using it immediately. You can bring it to any Walmart and a full refund.

For more information please call 1 877 MESSALAW.

Recall: 1.8 million toy dart gun sets

Family Dollar Stores is recalling 1.8 million toy dart gun sets following reports of two boys choking to death on the darts.

The two boys who died were a 9-year-old from Chicago and a 10-year-old from Milwaukee. The Chinese-made toys were imported by Henry Gordy International Inc. of Plainfield, N.J., which has refused to recall the darts, the CPSC said. The dart sets were sold exclusively at the CPSC said.

While some companies will drag out a recall and be less than eager participants, it is unusual for a company to refuse to work with the CPSC to get the product out of homes.

Family Dollar said it would refund anyone who purchased the toys, which were sold between September 2005 through January 2009 for about $1.50. Family Dollar sold the "Auto Fire" toy dart target sets between September 2005 and January 2009.

The toy guns that fire the suction cup darts are either orange and yellow or blue and yellow. The sets come with eight orange darts and a small dartboard.

If you have one of the sets in your home take it away from children and throw it away or bring it to a Family Dollar store for a full refund.

Step2 recalls 2.5 million ride-on toys

Step2 Co. is recalling 2.5 million Push Around and Whisper Ride model ride-on toys because they pose a serious injury risk to young children.

Step2 disclosed 28 reports of the buggy's handle detaching, the U.S. Consumer Product Safety Commission (CPSC) said in a statement. The cause of the detachment is linked to a pin attached to the handle, which loosens too easily.

To date, 26 people have reported minor scraps and scratches, and two customers reported seeking medical attention, according to the CPSC.

The Streetsboro, Ohio-based Step2 manufactures children's toys and home & Garden products, including play kitchens, playhouses, wagons, and swing sets.

The recall covers two Step2 buggy model types, which are listed on the company's Website at www.step2.com.

The affected toys, which were made in the United States, were sold at retail and specialty stores between August 1999 and March 2010, at prices ranging from $29 to $59.

Step2 urged consumers to stop using the recalled buggies immediately.

The company advised those customers who own buggies that have a pin with a yellow knob attached to the base of the handle to contact the company for a free repair kit.

HEPATITIS C LAWSUIT: Jury awards Las Vegas couple a record $500 million award

Jury awards a Las Vegas couple $500 million in punitive damages after the husband contracted hepatitis C during a colonoscopy procedure.

The couple had sued the Teva Parenteral Medicine and Baxter Healthcare Services on several product liability claims related to propofol, a popular anesthetic that was used at the Endoscopy Center when he was infected with hepatitis C in 2006.

In 2008, two Las Vegas endoscopy clinics notified over 50,000 patients about possible exposure to hepatitis, HIV and other blood-borne diseases because of unsafe injection practices at the clinic. Hundreds of patients have filed lawsuits as a result of the outbreak.

Officials blamed the local outbreak on nurse anesthetists reusing single-dose drug vials between patients after the vials had become contaminated by the nurses reusing syringes on the same patient.

The couple’s lawyer said the companies knew of the temptation to reuse the large 50 milliliter vials of propofol, which contained four to five times the amount needed for a typical 10-minute colonoscopy.
Teva wrote to the U.S. Food and Drug Administration in 2000 to get approval to make 10 milliliter vials of propofol. The report acknowledged that some medical workers were reusing the larger vials among patients to avoid throwing away unused anesthetic.

The smaller vials would improve patient safety undergoing endoscopic procedures because there would be less leftover anesthetic to tempt medical workers to reuse the vials, the report stated.

Teva made the 10 milliliter vials until 2007, when it stopped production in part because the smaller vials (10 millimeter) cost more to make than the larger vials (50 millimeter).

The jury found both drug companies liable for failure to warn and for breach of warranty. They awarded more than $5 million in compensatory damages. They also agreed that punitive damages were warranted; ultimately deciding during deliberations, that Teva Parenteral Medicines should pay $356 million and Baxter Healthcare Corp. should pay $144 million.

Hepatitis C can lead to liver disease, including cirrhosis or liver cancer. The husband’s hepatitis was controlled after weeks of treatment similar to chemotherapy, which made the virus inactive. He said the treatments, which were grueling, reduced his stamina and have caused lingering joint pain.

The couple’s lawyer said the drug companies knew about 148 cases of hepatitis linked to propofol before he underwent the colonoscopy and didn’t do anything to warn medical professionals.

If you have had a colonoscopy or an endoscopy procedure, or another procedure where you believe you have received the drug propofol or  have been recently diagnosed with HIV or Hepatitis C following a medical procedure, please contact 1 877 MESSALAW for a free consultation.

Bacteria Identified in Tylenol Recall

The Food and Drug Administration confirmed Wednesday that the bacteria found at the Johnson & Johnson plant that produced the recalled children's medicines was Burkholderia cepacia, a bacteria often resistant to common antibiotics.

The company said that although the bacteria was found on some drums used by its vendor to transport the raw materials, those contaminated drums never reached the Fort-Washington, PA-plant that made the recalled drugs.

According to the Centers for Disease Control and Prevention (CDC), B. cepacia is the name for a group of bacteria that can be found in soil and water. 

The CDC said B. cepacia poses little medical risk to healthy people. However, those with certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. 

The CDC also said that transmission of B. cepacia from contaminated medicines and devices has been reported in the past and that the bacteria has caused infections in hospitalized patients.

An FDA official said, "To the agency's knowledge, no bacterially contaminated components were used in the manufacture of any of the recently recalled McNeill products. Also, testing done to date has not found bacteria in finished products." 

"Still, the FDA felt there was the potential for contamination and that a recall of all of these products was prudent to protect the public health. Once again we advise that consumers not use these McNeil products at this time."

McNeil recalled some 50 children's versions of the non-prescription drugs on Saturday for quality concerns, including "tiny particles" in some of the products that the company said may be solidified product ingredients or manufacturing residue such as tiny metal parts.

The FDA said the recall affects some 1,500 "lots" of the drugs which were distributed both in the United States and internationally.

Children's Meds Recalled, and other products

A voluntary recall has been issued for dozens of over-the-counter drugs for children, including Tylenol and Motrin, because they don't meet quality standards. The maker of the recalled products said on Monday that they are taking "corrective actions" at its U.S. plant after some 40 children's versions of those drugs were recalled for quality concerns.

McNeil said on Saturday that it took action as a "precautionary measure," saying that some of the products could have problems with their ingredients while others could contain "tiny particles."

On Monday, McNeil elaborated on the nature of the "tiny particles," saying they may be solidified product ingredients or manufacturing residue such as tiny metal parts. McNeil's Pennsylvania plant is the only plant that manufactures Consumer Healthcare liquid pediatric products.

She said the agency decided to push for the recall before releasing all the details of the inspection because of the "vulnerability" of the consumers of these drugs.

"These are over-the-counter drugs and they impact infants and children," she said. "So it was even more important to get the message out that there could be a potential problem."

As of Monday, she said the FDA still maintains its position that the recalled drugs pose a "remote" potential for serious health problems.

Drugs affected include children's versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl. They were made in the United States and distributed to Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago and Kuwait.

GM Recalls 126000 H3 Models

General Motors has just announced a large recall on Hummer H3 models manufactured between 2006 and 2010. The vehicles have defective hood louvers (the slanted openings used for ventilation) that could come loose over time and detach from the vehicle while driving. The tabs that hold the louvers in place have been found to break, causing vibration that can lead to total separation.

The National Highway Transportation Safety Administration is warning H3 owners to be on the lookout for any vibration of the louver assembly, as that may be an indicator that a failure is likely.

A total of 162,000 Hummers are covered under the recall, and General Motors says that technicians will apply an adhesive in order to keep the louvers from coming loose at no cost. Owners may contact Hummer at 800-732-5493 or call 1 877 MESSALAW for more information.

Nissan recalls 134,000 Infiniti G35s for airbag fix

According to the National Highway Traffic Safety Administration, just over 134,000 Infiniti G35 coupes and sedans sold in the mid-2000s are affected by a problem in which wire harnesses for the airbags may wear down to the point of not functioning properly, meaning that the airbags may not deploy in a crash.

Infiniti is recalling 2005-06 model year G35 sedans and 2005-07 model year G35 coupes sold around the world due to the airbag problem.

The automaker has not yet notified the Feds of how the faulty wire harnesses will be fixed, but the official recall is now being announced, just two weeks after the potential problem was reported to NHTSA.

At the time, no crashes or injuries have been reported due to this issue, and Infiniti's parent company, Nissan, is hard at work developing a solution for this potentially dangerous situation.

For more information please contact 1 877 MESSALAW.

Johnson & Johnson recalls 11 kids' drugs in Canada

Eleven formulations of over-the-counter children's cold and allergy medicine are being recalled in Canada as part of a larger worldwide recall for failing to meet quality standards.

McNeil Consumer Healthcare said Saturday that all lots of Children's Motrin and Infant's Motrin liquid suspension products and Children's Tylenol Cough & Runny Nose liquid suspension products are being recalled. No other Canadian product is impacted, the company said in a release.

The company said the recall was issued, in consultation with Health Canada, because "these products may not fully meet the required manufacturing specifications."

In the United States, more than 40 over-the-counter kids medications under the brand names Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl are being recalled by the company, a subsidiary of pharmaceutical and health care giant Johnson & Johnson.

The affected products in Canada are:

• Infant's Motrin Suspension Drops Dye-Free, 30ml (DIN 02238626)

• Infant's Motrin Suspension Drops Dye-Free, 15ml (DIN 02238626)

• Children's Motrin Suspension Dye-Free, 120ml (DIN 02242365)

• Children's Motrin Suspension, 120ml (DIN 02242365)

• Children's Motrin Suspension Grape, 120ml (DIN 02242365)

• Children's Motrin Suspension Grape, 30ml (DIN 02242365)

• Children's Motrin Suspension Bubblegum, 120ml (DIN 02242365)

• Children's Motrin Suspension Tropical Punch, 120ml (DIN 02242365)

• Infant's Motrin Suspension for Fever due to Colds/Flu, 30ml (DIN 02238626)

• Children's Motrin Suspension for Fever due to Colds/Flu, 120ml (DIN 02242365)

• Children's Tylenol Cough & Runny Nose Suspension, 100ml (DIN 02292122)

Company spokeswoman Tina Peyregatt says no illnesses have been reported so far, and stresses no other infant's or children's Tylenol products in Canada are affected, nor are any medicines in tablet form.

"We want to make sure Canadians aren't concerned or panicking" about products that aren't on the recall list, she said, adding she doesn't expect the list to grow.

Customers should stop using the recalled products and contact the company at 1-888-222-6036 or call Messa & Associates, PC at 1 877 MESSALAW for more information.