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| Shapiro, Washburn & Sharp

I am on a mission to use my forum as an editor on three Injuryboard regional injury law blogs to educate consumer/patients, doctors, pharmacists and medical providers about the extreme risk of accidental overdose deaths associated with the prescription of Fentanyl pain patches, also known as Duragesic pain patches. Fentanyl patches are often being prescribed to patients who can instead be prescribed a safer alternative pain medication, and my argument is that the medical community is unaware of the epidemic of accidental overdose deaths nationwide. Does the FDA realize the truth about how many accidental fentanyl overdose deaths are really occurring nationwide?

Our firm has been investigating two accidental fentanyl patch overdose deaths in North Carolina alone, and what about the other 49 states? Based on my research of lawsuits against the manufacturers of this drug, I have officially associated with James Orr, a Texas lawyer with the firm of Heygood, Orr, Reyes, Pearson & Bartolomei, to investigate a wrongful death because of fentanyl toxicity/accidental overdose, involving one of our law firm’s North Carolina client’s. I consider James Orr to be one of the foremost authorities on the dangers of fentanyl pain patches, because of at least two prior successful wrongful death trials he has participated in, representing the families of those killed by this exceedingly dangerous pain patch medication. Fentanyl toxicity death is turning up with frightening frequency. And as the public learned in the Firestone tire defect/safety cases, and many other public health & safety scenarios, who usually exposes dangerous health and safety problems first? Yes, the injury lawyers through the civil justice system. I asked Jim Orr if I could interview him for our Injuryboard injury law blog network and our interview follows:

Shapiro: Jim: Thank you for agreeing to this interview about what I consider to be the epidemic of nationwide sudden deaths/accidental overdoses of persons who were lawfully prescribed Fentanyl or Duragesic pain patches.

My first question is this–why is the fentanyl patch so dangerous in the hands of consumer/patients in your view?

Orr: It is the most potent narcotic there is. It is 100 times stronger than morphine. Everyone’s skin absorbs fentanyl at different rates, as much as a 10 fold difference. Typically, if a person is starting to suffer from fentanyl poisoning, they don’t get sick, they just get sleepy. If they lay down, they never wake up. Also, even if you do recognize that you may be in trouble, if you take off the patch, it does not help. The fentanyl enters the skin from the patch into what is called the "skin depot" and it takes as much as 18 hours for that fentanyl to subsequently enter the blood stream. Thus, if you take off the patch, it is too late as the fatal dose may already be in the "skin depot." This is why a leak can be so dangerous. If you have a leak, the skin depot can fill up real fast and then kill you hours later.

Shapiro: How many trials have gone to verdict that you participated in the trial as a trial attorney?

Orr: The first case was the Hendelson case which was tried in federal court in West Palm Beach Florida in June of 2007. Hendelson involved a father that lost his 28 year old son due to a defective fentanyl patch. The result of the case was a $5.5 million verdict for our client. The second case was the DiCosolo case which was tried in state court in Chicago in November of 2008, just a couple of months ago. DiCosolo involved the death of a 38 year old wife and mother of 3 children due to a defective fentanyl patch. The result was a $16.5 million verdict for our clients.

Shapiro: Is it true that Johnson and Johnson and one or more of its subsidiaries have earned well over $1 billion in distributing transdermal Fentanyl patches?

Orr: Yes, their sales from just the brand name Duragesic are as follows:

2003 1.63 Billion

2004 2.08 Billion

2005 1.58 Billion

2006 1.29 Billion

2007 1.16 Billion

Shapiro: When the food and drug administration first approved Fentanyl patches for patient use, wasn’t it limited to only terminal cancer patient pain cases? How did it get expanded?

Orr: No. It was originally approved in 1990 for “management of chronic pain in patients requiring opioid analgesia.” However, its use initially was primarily for cancer patients. Now, due to J&J’s marketing claims such as “Duragesic stops the pain, not the patient” and “Life uninterrupted”, it is being handed out for all kinds of pain. In fact, J&J subsidiaries have recently been found guilty by a West Virginia court of willfully publishing misleading promotional materials relating to Duragesic and were fined heavily for doing so.

Shapiro: What have some of the drug manufacturer corporate representatives stated was the need for the widespread prescription of Fentanyl patches in their defense of this product?

Orr: J&J claims that fentanyl is a potent drug and that it carries with it a risk. In fact, they have filed a pleading in a case asserting that Duragesic is unavoidably unsafe. They claim that they have not encouraged its use in situations in which it is not indicated. Unfortunately for J&J, they don’t sufficiently warn about the risk they themselves claim fentanyl patches present.

Shapiro: Are you advocating removal of Fentanyl medication from the hospital operating rooms setting, or just removing it from the hands of patients and why?

Orr: I would advocate that leaking patches getting out of the plant and sold to the public be eliminated. In terms of patches that are manufactured properly, I would advocate that doctors and patients be warned that the proper use of fentanyl patches carries with it a risk of death and that in fact many patients have died. I would advocate stronger warnings in the black box regarding use of fentanyl patches at the same time with other sedating medications. I would advocate that these warnings not only be included in the package insert, but that they be prominently displayed in any promotional materials regarding fentanyl patches.

Shapiro: What types of product defects have you proven have gone wrong with Fentanyl patches?

Orr: Manufacturing defects, i.e., that the patches have failed to perform as intended; marketing defects, i.e., the warnings were inadequate

design defect, i.e., safer alternative design existed.

Shapiro: What is your opinion about what the FDA should do to control the fentanyl patch prescription death overdose epidemic in the United States?

Orr: Require drastic changes in both the package insert, the patient information insert and J&J’s promotional materials. Also, in my view, the prescribing of this medication in a patch form should be limited to anesthesiology, pain medicine and oncology physicians.

Shapiro: Thanks so much for explaining some of these details. If this article can prevent one doctor from prescribing these fentanyl patches where it is unnecessary, or help build a groundswell to convince the FDA that the present warnings are totally inadequate, we accomplished something here. Also, I plan to send this interview to every physician or pharmacist I know to get the truth out there about this fentanyl patch accidental overdose epidemic.

Shapiro, Cooper Lewis & Appleton personal injury law firm is based in Virginia, with offices in northeast NC and Virginia Beach (VA), practicing primarily in the southeastern U.S. and handles only injury law, including car, truck, railroad, and medical negligence cases and more. The firm’s website is:, the firm edits three injury law blogs: Virginia Beach Injuryboard & Norfolk Injuryboard, as well as the Northeast North Carolina Injuryboard and also hosts a video library covering many FAQ’s on personal injury subjects.

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