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Johnson & Johnson Recalls Lonsys Pain Drug Device

Oct 16, 2008 | Parker Waichman LLP

Johnson & Johnson just issued a recall in Europe for its Lonsys pain treatment device, which is used in hospitals.  This recent recall is only serving to add to mounting concerns about Johnson & Johnson’s ability to develop profitable new products.

Johnson & Johnson, which is located in New Brunswick, New Jersy, recalled all of its 13,000 Lonsys pain treatment devices it had sold in the United Kingdom, Germany, and several other European countries.  The recalls were initiated since the start of the year following a routine safety check that revealed a defect in one lot, a company spokeswoman reported on Wednesday.  Spokeswoman Gloria Vanderham said the recall was”voluntary and precautionary” and initiated while Johnson & Johnson works to determine the cause of the defect.  Vanderham claims that Johnson & Johnson is not aware of any injuries as a result of the device’s defect.

The Lonsys is a small device that is attached to a hospital patient's upper arm or chest to deliver the pain medication fenanyl to patients experiencing post-surgical pain.  The Lonsys uses a low-intensity electrical field to deliver the drug.  When it was first implemented, Lonsys was seen as innovative in the field of pain relief and was also seen as bonus in Johnson & Johnson's acquisition of the specialty-drug maker Alza Corporation back in 2001.

Lonsys was marketed as a replacement for the popular Duragesic pain patch, which is another fentanyl-based pain product that lost its patent protection in 2005.  Most recently, this past February, Johnson & Johnson recalled a version of the Duragesic patch over manufacturing issues.  Apparently, the Duragesic patch could lead to patients receiving too much or too little medicine.  Also, Johnson & Johnson is currently facing lawsuits that allege injury from the Duragesic patch.

In addition to its problems with the Duragesic patch and the current Lonsys recall, Johnson & Johnson has had its share of other challenges, specifically with Lonsys.  For instance, although the U.S. Food and Drug Administration (FDA) approved Lonsys in 2004, it has not yet provided final clearance for sales of Lonsys in the United States.  Vanderham said Johnson & Johnson is working to answer the FDA's open questions.

Leerink Swann analyst, Rick Wise, estimated that sales of Lonsys next year would amount to only about $100 million and some analysts are concerned that Lonsys's issues might portend larger questions over the strength of Johnson & Johnson's array of new products, which the company is relying on to increase its dwindling pharmaceuticals business.  "Can we really rely on their pharma pipeline, however good it looks on paper, to deliver the goods in the future?” asked Wise of Johnson & Johnson.  Johnson & Johnson shares fell 3.5% to $60.54 in the midst of the historic stock market downturn this week.

Vanderham said Johnson & Johnson sent a letter to doctors, pharmacists, and hospitals in Europe notifying them of the recall.  Vanderham added that Johnson & Johnson does plan to reintroduce the Lonsys device once it determines the cause of the defect and fixes it.


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