"I'd been on the patches since around 2001 with no side effects," says Vicki. "At first the dosage they prescribed was the lowest microgram but it wasn't working so my pain management specialist in Lexington upped it to the therapeutic level of 75 micrograms per hour, and it was working great.
On July 26, 2006, I was in my office and suddenly felt something running down my arm. I looked up to see if the ceiling was leaking but it wasn't. The liquid was coming from under the patch. Normally I put on a Johnson & Johnson waterproof wound care overlay because I found the patch adhesive wasn't sticky enough. But here was the gel leaking right through the patch and the overlay and we'd just put it on that day."
Fentanyl gel is an opiate 80 times more potent than morphine, and direct exposure can cause serious harm and overdose.
"My doctor instructed me to take the patch off immediately," says Vicki, "wash the skin and to go to Emergency to have my blood pressured checked. I was feeling okay, though, just a little difficult breathing, so I didn't go."The following morning, Vicki showed clears signs of a Fentanyl overdose: extreme sleepiness, dizziness, stumbling and shortness of breath.
Rushed to the hospital, she was immediately put on an IV drip but mistakenly administered twice the prescribed dose of Narcan, an antagonist narcotic used to counter overdoses from narcotic medications. When given intravenously, Narcan speeds up the effect of withdrawal. "It takes you through withdrawal in about 30 seconds and I went into a seizure," says Vicki. "It was the most horrible thing you can imagine.
Fortunately I was on a gurney because I lost consciousness.
"Right away, they gave me some Ativan to calm me down. My husband said he kept his face close to my mouth to make sure I was still breathing."
Vicki was released from hospital later that day and was assured it was safe to reapply a new Duragesic patch at home, but she insisted on a new batch from her doctor. It was then that Duragesic manufacturers began a series of correspondences that raised Vicki's hope for amends but would ultimately lead nowhere.
Duragesic is manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica, both subsidiaries of Johnson & Johnson.
The first to contact Vicki was Johnson & Johnson. "I got note from them saying 'thank you for bringing this situation to our attention...' and that they would report it to their Research & Development department," says Vicki. "Then came Ortho-McNeil-Janssen's scientific affairs person who asked me to send them everything I had. It's a good thing I'd had the foresight to go back to the hospital the very next day and obtain all my records."
"And it went on and on. Janssen insisted I take the original box and the patch back to a pharmacist including the case and control numbers but I wasn't going to give up the box. It was the only evidence I had. I even got a call from a woman at J&J in Britain long afterwards."
Still optimistic, Vicki was expecting some measure of compensation as had been the case when J&J reimbursed her during a voluntary recall of the patches in 2004. "But I got more requests to sign off on forms and for more information, right up to October 2007, sixteen months after the leak. My own letters for a refund, on the other hand, came back with the general message--sorry you're on your own, you have to pay.
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I only wanted to be made whole; to be repaid the $800 I'd paid out of pocket for the doctor's mistake of twice the dose of Narcan. That, plus a letter admitting their wrongdoing." Vicki's claims have never been resolved.
Johnson & Johnson have recalled the pain patches due to various manufacturing problems in 1994, 1996 and specifically in 2004 on the patches supplying 75 micrograms per hour of Fentanyl gel. The most recent, in February 2008, concerned the 25 microgram patch. "At some point," says a partner at MacDonald, Rothweiler & Eisenberg in Boston, "the FDA is going to have to say five strikes and you're out."
As of November 2007 there are some 72 lawsuits pending against Johnson & Johnson.