Pain Patches Draw Thin Line Between Therapy and Death
Chronic pain – with the agony some people feel, a prescription for a patch that slowly seeps an opioid through the skin makes the doctor seem like an angel. But it some cases, he could be an angel of death.
- Fentanyl pain patches have been recalled a number of times
- The side effects include respiratory failure and death
- Two companies make the patch, which may have a faulty design
On May 4, 2010, Janine Ward, 55, from Hyde Park, Utah, died after multiple surgeries and cancer treatments. Toxicology reports showed a lethal concentration of the pain medication fentanyl in her blood.
Her family filed a wrongful death suit against Alza Corporation, owned by Johnson & Johnson. The family lawyers claimed the faulty design and manufacture of the patch made the drug seep into Ward’s skin too quickly.
Ward’s husband is seeking $300,000 or more in damages. Johnson & Johnson responded to the suit with a statement by William Foster, business unit communication leader, who said of the patch, “Like all prescription medications, it has benefits and risks.”
Feeling No Pain
The pain patch, called Duragesic, contains the drug fentanyl, a synthetic opioid more potent than morphine, and meant for severe pain that can’t be relieved otherwise. Another pharmaceutical empire, Mylan, manufactures a generic version.
Fentanyl molecules bind to the area of the brain that controls pain and emotions. It’s been sold on the black market since the 1970s, causing the same effects as heroin - euphoria, drowsiness, respiratory arrest, nausea, confusion, constipation, sedation, unconsciousness, coma, tolerance, and addiction – but much more potent.
According to government indications, the pain patch Duragesic is only good for opioid tolerant patients who need around-the-clock pain management that can’t be managed any other way. It’s a serious drug that can cause “life-threatening hypoventilation” within three days of first applying the patch.
Naturally, for a medication so dangerous, users and prescribing doctors have to be careful.
“There’s two problems with this patch,” says Tulsa, OK, attorney A. Laurie Koller, who practices complex litigation involving class actions, bad faith, and product liability in three states. “One, when they make it incorrectly and there’s a manufacturing defect. There were a lot of recalls in 2004, 2005 and 2006. Something went wrong in the factory and they knew they had to get it off the market.”
“The other problem is the patch technology itself, delivering or functioning properly,” says the attorney, whose firm Carr & Carr hasn’t opened any Duragesic cases, but accept them. “They made it the way they intended to make it but there’s problems with the technology. We’ve talked to a former medical examiner and a doctor in Alabama. The problem is the patch releasing more than it’s supposed to.”
A Thin Line
“The former medical examiner here said the difference between a therapeutic dose (of fentanyl) and a lethal dose is very little,” says Koller. She’s had to turn down people who died from using two patches at once, or putting a new patch on too soon. She says manufacturers will most often argue the patient abused the medicine.
Cases that can go forward, however, relate to the design of the patch itself. “Some people apply the patch with heat, in a hot tub or with a hot water bottle, and “some people’s skin is more permeable,” Koller says. “That’s where you see people OD’ing on the drug even though they used it properly.”
“There are warnings now that say don’t use heat, don’t do these things. So the manufacturer may say, ‘Well we told them not to do it.’ I think you still may have an argument though, because the technology is not as failsafe as it should be,” she concludes.
There have been medical malpractice cases, resulting in seven-figure awards, arising from doctors’ negligence in selling the patch: a man suffered brain damage from the respiratory failure. The jury decided the doctor incorrectly prescribed to treat post-operative pain, even though it’s contra-indicated by the manufacture.
In another case, a 37-year-old man was found dead by his girlfriend with a patch on his chest. His doctor had prescribed the patch for his back pain, with a dosage three times more than recommended by the manufacturer. The hospital’s review panel agreed that the doctor wasn’t negligent, but a jury decided otherwise.