Another article from the New York Times. Many physician joke that the health section is the only medical journal they read. Most of the time, it’s only a joke.
The article discusses a case of a family winning a case against Johnson and Johnson for the tune of $772,500 after the patient had an unexpected death thought to be due to overdose/defect of a duragesic (fentanyl) patch. I’m not sure if the patches were actually defected, and I certainly agree that the death of a such a young woman is indeed tragic. It’s not clear if the jury knew if the defect existed or not as well. It is also not clear if the patient died due to intentional (but misguided) overuse.
My concerns regard the reverberations of this case. According to the article:
“Johnson & Johnson, based in New Brunswick, N.J., added warnings to the patch’s label last July, saying doctors should not prescribe them for patients who cannot tolerate similar drugs or who might be prone to abusing them.The patches, introduced in 1990, release the opiate fentanyl through the skin. Researchers say fentanyl can cause addiction or death in some users.”
Vague terminology like “some” and “might” are entirely unhelpful guidelines.
The medical field tends to undertreat pain, and duragesic patches have done wonders toward relieving pain to thousands if not millions of patients in the US suffering from intractable pain. However, the “guidelines” put out by Johnson and Johnson are just broad statements designed to protect themselves from lawsuits and push the liability onto the physicians that prescribe them. If JNJ seriously thought that fentanyl patches are dangerous to an undefinable segment of the pain-suffering population, perhaps they should pull the product entirely. Of course, they don’t do anything such as that.
This practice is all too common, and physicians have found themselves in a bind as pharmaceuticals create unhelpful guidelines without the best interest of the patient in mind. Many medications are used routinely as “off-label,” and are considered standard of care and best practice. The problem is that a drug only can become FDA approved for that indication if the company applies for it. At times one will find a disconnect where the medical research clearly shows the benefit of the drug and the company simply does not apply to get the medication “officially approved” for that reason.
In the end, it is because of these kinds of lawsuits that JNJ has to charge so much money for their drugs to cover their costs. It is because of these lawsuits that they make statements to push away liability. It is because of these lawsuits that doctors pay high malpractice premiums and eventually leave practice. It is because of these lawsuits that the United States is spending 16% of it’s GDP on healthcare, even as over 40 million people don’t have health insurance.
Time to get off the Saturday morning soapbox….