J&J, Novartis Recall Pain Patches Over Possible Leak
By Jef Feeley and Elizabeth Lopatto

Feb. 12 (Bloomberg) -- Johnson & Johnson and Novartis AG's Sandoz unit recalled some patches containing the painkiller fentanyl, saying manufacturing defects may cause leaks that can lead to fatal overdoses.

The Duragesic patches, made by Johnson & Johnson's Alza Corp., may have a cut along the drug reservoir, exposing users directly to the fentanyl gel inside, the New Brunswick, New Jersey-based company said in a statement. It's the fifth recall of some version of the patches since 1994.

``Perhaps the time has come for the FDA to order Johnson & Johnson to pull all versions of this product off the shelves,'' said Alex MacDonald, a lawyer who represents the families of former patch users. Juries have found defective patches caused the deaths of two users since lawsuits over the products began going to trial in 2006.

Today's recall covers patches in the U.S. and Canada that release 25 micrograms of fentanyl in an hour, Johnson & Johnson said. The expiration dates are on or before December 2009. Duragesic patches generated $1.16 billion in global sales last year, making them Johnson & Johnson's eighth-biggest selling product, spokesman Greg Panico said.

Sandoz distributes the patches. Mylan Inc., based in Canonsburg, Pennsylvania, began selling a lower-cost copy of the Duragesic patch in 2005, and was joined by other companies including Watson Pharmaceuticals Inc.

Safety Warning

The U.S. Food and Drug Administration issued a safety warning in December over the patches, saying improper use can cause breathing difficulties and death. That followed a July 2005 alert put out by the FDA after 120 patients taking the drug died. Johnson & Johnson said in November that it faced 72 lawsuits over the patches.

``The FDA continues to engage with the company in its voluntary recall and is investigating the situation,'' FDA spokeswoman Susan Cruzan said in an e-mail.

Johnson & Johnson rose $1.09, or 1.8 percent, to $62.97 in New York Stock Exchange composite trading today. The shares have fallen 5.6 percent this year.

The recall ``is small enough that I doubt this will impact the bottom line,'' said Jon Fisher, a portfolio manager at Fifth Third Asset Management in Minneapolis. The fund held 3.1 million shares of Johnson & Johnson as of September, according to data compiled by Bloomberg.

Fentanyl is mostly used to treat cancer pain, according to the FDA, and doctors say it's a stronger painkiller than morphine. Duragesic patches contain fentanyl in a pouch between two membranes. In January, Johnson & Johnson received returned patches that had cut edges, prompting the company to notify the FDA, Panico said.

`Small Percentage'

``Patches that have this defect were not in place properly when they were cut,'' Panico said in an interview. The 25- microgram patches ``account for small percentage of sales,'' since Johnson & Johnson sells higher-dose versions, he said.

Different manufacturing problems caused Johnson & Johnson to recall versions of the patches in 1994 and 1996, Panico said. A 2004 recall covered patches supplying 75 micrograms of the drug.

``At some point, the FDA is going to have to say five strikes and you're out,'' said MacDonald, a partner at MacDonald, Rothweiler & Eisenberg in Boston.

Reports of leaking patches have prompted the families of some users who died to seek millions of dollars in damages from Johnson & Johnson.

Juries in Texas and Florida concluded that defective patches caused the deaths of Michaelynn Thompson and Adam Hendelson. A Texas state court jury awarded Thompson's family more than $772,000 in damages, and a federal jury in Florida ordered the company to pay Hendelson's family $5.5 million.

Texas Settlement

Johnson & Johnson appealed in the Thompson case, Tommy Fibich, a Houston lawyer who represents the dead woman's family, said in a December interview. The company agreed in July to pay $2.5 million to resolve the Hendelson family's claims.

Today's recall shows ``why we have been filing these suits,'' said Ed Angwin, a Birmingham, Alabama-based lawyer for former patch users who was involved in the Hendelson case.

``Their manufacturing facility is still not able to produce patches that aren't defective,'' Angwin said. ``The public needs to be aware of this continuing problem.''