Nurse Medical Malpractice Responsible for CP
Lest we forget that in modern medical care, nurses play larger roles in the delivery of babies, an Illinois nurse who ignored signs of fetal distress broadcast by a fetal monitor was slapped with an $11.4 million dollar verdict. In today’s Cerebral Palsy Law Blog, it was reported that the nurse’s negligence caused the infant to suffer brain damage that manifested itself as cerebral palsy. The award addressed pain and suffering, and loss of earning capacity.
Sowing the Seeds of Doubt in New Cancer Therapy
UPDATE: Several posts ago, I discussed anti-consumerist legal trends that would ultimately hurt patients in this country. The U.S. Supreme Court decision in Reigel v. Medtronic had allowed for the manufacturers of FDA-approved medical devices to escape state court lawsuits through federal preemption of such patients’ claims. And, as noted in the earlier post, FDA trials are not necessarily the meticulous process that patients have a right to expect.
In an article by Reed Abelson in today’s New York Times, we learn of yet another medical device that skipped through FDA trials, and is now being used to treat breast cancer, even though there is no proof yet that it is even medically effective. The treatment, MammoSite brachytherapy, consists of the insertion of radioactive “seeds” into the breasts of women diagnosed with breast cancer. The seeds irradiate the cancerous tissue, and hopefully eradicate the malignancy. It is an alternative to more traditional forms of radiation therapy, and in theory, has some advantages over it. But it is virtually an experimental treatment, because so few long-term studies of its effectiveness have been performed. In fact, the approval was based on a study consisting of 25 women that lasted only six years. But standards of success in preventing cancer recurrence are measured in intervals of five to ten years or more, as Ms. Abelson points out.
In the fast-track review conducted by the FDA, it is supposed to determine whether the product presents any undue safety risks. But how can the FDA have responsibly concluded that the seeds are safe, based on the minimal, and short lived trial that it conducted?
Unfortunately, what the patients who are trying this treatment may not realize is that, thanks to the Reigel decision, they will have no recourse in state courts if and when a deficiency in the MammaSite delivery of radiation causes them harm, or simply fails to do what standard radiation therapy does. And the cynic in me was jolted by Ms. Abelson’s report that critics of the new treatment contend that its popularity may be a result of the high reimbursements paid to physicians by insurers. So it seems that MammmoSite and the physicians who recommend utilizing it are making money, and the FDA is largely immune from liability if things go wrong, while most patients continue to believe that if the FDA approved it, it is certainly effective, and undoubtedly safe. There is something wrong with this picture.
Benefits of Electronic Health Records Clear to British Physicians
In my August 1, 2008 post, I spoke about the benefits of a national health registry, and questioned why it had not been implemented in the United States. I also touched on an additional concern: how the passing of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) had resulted in making it more difficult to obtain patient’s medical records.
Because so many medical errors happen because of a lack of information about a patient’s medical history, it is crucial for a physician to have immediate and unfettered access to a patient’s prior records of care. The physician ought to know: the medications the patient is taking; the medications he/she is allergic to; the patient’s chronic conditions, if any (high blood pressure, heart disease, diabetes). And that’s just for starters.
Our healthcare system, however, has not moved quickly enough to take advantage of the technology that would enable such access, which would, in turn, save lives and prevent unnecessary illness. England, however, is another story.
British physicians Matthew J. Armstrong and Caroline Booth wrote, in the October 23, 2008 issue of The New England Journal of Medicine, that “electronic health records have been widely adopted by primary care and hospital trusts of the National Health Service in the United Kingdom. York Hospital is now using electronic resources to improve communication among health care providers by implementing a prompt (<24 hours), accurate, electronic summary of each patient’s hospital discharge.”
The British primary care physicians are now able to have immediate records informing them of their patient’s diagnosis, status of their medications, and recommendations for follow-up treatment. They appreciate the fact that they can read the computerized records (as opposed to the old and problematic handwritten format), and they appreciate how it improves communication between hospital physicians and primary care physicians.
We could, and should, incorporate such communication into our healthcare system. The cost in upgraded technology is surely less than the cost to our patient population if we continue to sit on our hands.