Perspective: “Black Box” drugs raise red flags
By Charles A. Pilcher MD FACEP
“Black Box Drugs” are those that require the strongest available warning used by the FDA for an approved drug, because they carry “a significant risk of serious or even life-threatening adverse effects.” The warning is placed at the top of the PDR and “package insert” description of the drug and highlighted with a “black box,” thus the name. The warnings are are impossible to miss if one looks up the drug description in the PDR. The drugs CAN be used, and still are, sometimes with disastrous consequences. More ->
Uterine morcellator recalled due to cancer concern
Retrospective evidence published in JAMA shows that uterine morcellation, a laparoscopic procedure that can essentially allow a hysterectomy to be “done through a straw,” adds a remote but measurable risk (27 of 10,000 patients were found to have unsuspected sarcoma) that unknown cancer cells in the removed tissue can create metastases in a small number of patients. Based on the findings, Johnson and Johnson asked all hospitals on July 30, 2014, to cease using their device. The FDA is doing further review.
Missed x-ray? Here’s a must read
Radiologists occasionally miss a finding on an x-ray, CT scan or other diagnostic test. Often it’s “no harm, no foul.” But sometimes the result means disaster for the patient, the ordering physician, the radiologist and others. For those cases that come to litigation, this article by Durand et al. in the Journal of the American College of Radiology is a superb summary on the biases that defense and plaintiff experts may bring to the courtroom. Expert Witness Blinding Strategies to Mitigate Bias in Radiology Malpractice Cases: A Comprehensive Review of the Literature
Strokes: Chiropractic neck manipulation a likely contributor
The American Heart Association published a “Scientific Statement” in its journal Stroke in early August stating that neck manipulation and adjustments may be associated with an increased risk of stroke, resulting from a cervical (carotid or vertebral) artery dissection. The article seems to stop short of stating a causative role, but is definitely of interest to to anyone who has experienced such an unfortunate outcome.
“We can’t prove any one made a mistake, so it must be the “team’s” fault”
The Washington State Supreme Court on September 16 will hear Grove v. PeaceHealth, in which the plaintiff claims the health care “team” failed to meet the standard of care, even though no single individual could be found negligent. The WSMA and others are urging the Court to uphold current Washington state medical negligence law that requires plaintiffs to prove that an individual physician has acted negligently.
Brand name drug manufacturers liable for patient warnings on generic knockoffs
The Alabama Supreme Court ruled on August 15, 2014, that the makers of name brand drugs may be held liable for injuries patients receive while taking generic forms of the same medicines, which the companies may not even have made. The majority in the 5-4 opinion said this would apply narrowly to the heavily regulated pharmaceutical industry, and if the maker of the generic drug only copied warnings written by the brand-name manufacturer, a practice permitted by the U.S. Food and Drug Administration. The Business Council of Alabama noted that 98 courts around the country already have rejected the Alabama Supreme Court’s legal theory, while 3 courts have agreed.
Facebook, Twitter, et al. can help, harm malpractice cases
Defense attorney John E. Hall says that social media “can be used to take the pulse of the parties, to discover public information… and to explore themes for trials.” In a July article in Internal Medicine News, Alicia Gallegos reports how the use of social media by both physicians and patients can affect a medical malpractice case. For example, a Facebook or Twitter account might reveal information that contradicts a patient’s alleged leg injury when she discusses her recent 5K race online. Or, says Adam Davis, another defense attorney, a surgeon’s late night posts may reveal sleep deprivation in the hours before performing a major operation. “Once that information is out there in a public forum, it’s fair game,” says Mr. Davis. He also adds that changing any posted material during a malpractice case would not look good for a defendant physician.
“Everyone who comes to see me has already had a bad medical outcome. The last thing they need from me is a bad legal outcome.”
WFN, Plaintiff Attorney