August 2009 Archives

August 28, 2009

Johnson & Johnson Removes Reservoir Duragesic Patch From The Market

Following years of litigation and FDA scrutiny, a subsidiary of Johnson & Johnson, Ortho-McNeil, has removed the reservoir Duragesic fentanyl patch from the market. Duragesic is one of J&J's top-selling drugs with more than $2 billion in sales in 2005 alone. However, the reservoir design can cause leaks which has led to numerous recalls. Fentanyl is 100 times more potent than morphine and therefore a leaking patch can be fatal. PainPatch.jpgOur Fentanyl Patch Litigation Team has successfully prosecuted wrongful death cases throughout the entire United States representing the families whose loved ones have died as a result of leaking Duragesic reservoir patches. The FDA has investigated more than 120 deaths that may have been caused by the dangerous patch. After nineteen years of marketing and selling the reservoir design to the general public, J&J has replaced the reservoir patch design with a "new" design that they allege does not leak. However, Johnson & Johnson's "new design" is not new. Johnson & Johnson has been using the matrix technology in Europe for years. Additionally, generic manufacturers of the fentanyl patch have been using the matrix technology in the United States for years.

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August 11, 2009

CPSC Reminds ATV Riders to Ride Safe this Summer

Since the start of summer the Consumer Products Safety Commission has received numerous reports of injuries involving the popular but unsafe Yamaha Rhino All Terrain Vehicle. The reports name the 450, 660 and 700 models and many appear to involve rollovers at low speeds on level terrain. Nearly 60 fatalities and other serious injuries including head and neck injuries, and injuries to limbs that require amputation have been documented by the CPSC.
Rhino(2).jpg
The CPSC urges all Yamaha owners to install half doors, additional passenger handholds, rear wheel spaces and remove the rear anti-sway bar. Consumers can visit their local dealers to have their vehicles modified free of charge. The CPSC urges that consumers


  • Drive with safety in mind and recommends:

  • Wear their seat belt properly every time,

  • Strap on their helmet every time,

  • Follow on-product warnings,

  • Never remove the half-doors,

  • Never allow a child younger than 16 to drive,

  • Never allow a child to be a passenger if he/she is unable to place both feet on the floorboard with his/her back against the seat, and

  • Only operate off-road--the Rhino is not designed for use on public roads or paved surfaces.


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August 7, 2009

FDA Examining the Safety of the Asthma Medication Xolair

The Food and Drug Administration is investigating the safety of the popular asthma medication Xolair. The five year observational study of the long term effects of the drug have found that patients using the injectable drug may lead to strokes, heart attacks, irregular heartbeats, hypertension and other heart problems.

Xolair is manufactured by Genetech and marketed by Novartis and was approved in 2003 by the FDA for patients with moderate to severe asthma in which inhalable treatments do not work. There is no recall yet on the product and the FDA is telling patients to continue to use the medication. The current observational health study is set to end in 2012 but the FDA is working to conduct a new study that will be better able to evaluate the risks associated with the drug.

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August 5, 2009

Concentrated Acetaminophen Drops Recalled

Brookstone Pharmaceuticals is recalling all lots of Concentrated Acetaminophen Drops in fear of patients overdosing on the drug.

An overdose of Acetaminophen can lead to liver toxicity, kidney damage and blood disorders. The FDA is investigating medication error reports that have lead to deaths and is considering that the concentrated acetaminophen should be removed from the market to lessen consumer confusion. The concentrated Acetaminophen drops contain 80 mg/0.8mL and regular strength Acetaminophen elixir contains 160mg/5mL.

The container that the concentrated drops come in is similar in size to regular strength preparations and the absence of an integrated dosage delivery system is leading to dosage errors and inadvertent overdosing. In efforts to mitigate confusion Brookstone has recalled all lots of its Concentrated Acetaminophen Drops and is requesting that any stores who have the product on its shelf to remove it immediately and return it to Brookstone for a full refund.

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