Trying to order medications for a heart attack victim using electronic medical records, White Coat is frustrated to run into screen after screen preventing him from completing the order without addressing unlikely allergy issues (and thus protecting the hospital from liability):
For those of you who don’t know what alarm fatigue is, think of a car alarm. The first time you hear it going off, you run to your window to see who’s breaking into a car. Maybe you run to the window the second time and the third time, too. By the tenth time the alarm goes off, you’re thinking that the alarm is broken and someone needs to get that fixed. After about thirty false alarms, you’re feeling like going out there and busting up the car yourself – especially if the car alarm wakes you when you’re asleep.
It’s a concept with many applications beyond the emergency room setting, too, product warnings being just the start.
P.S. Dr. Westby Fisher has some related thoughts about the limits of trying to engineer physician responsibility through electronic records design.
A WSJ editorial and news coverage have called attention to a case from the Alabama high court holding Pfizer liable for a drug it didn’t produce, namely a generic knockoff of its acid reflux drug Reglan. Michael Greve agrees that it’s daffy to allow such suits, but traces the problem to the U.S. Supreme Court’s popular (at least with the media) 2009 decision in Wyeth v. Levine, okaying state tort actions over federally approved labels — and cautions that any victories for regulated business on the issue of federal-state preemption tend to be temporary at best. More: Coyote, FedSocBlog.
“A bill that would allow patients addicted to prescription drugs to sue the doctors who prescribed the medication — and the drug’s makers — was met with stiff opposition Wednesday in a Nevada legislative hearing.” Sen. Tick Segerblom (D-Las Vegas), who introduced SB 75, defended the measure: “They know the person can get addicted to the drug so they should pay for the process of them getting off it.” [AP; related effort to use drug-dealer-liability laws] (& White Coat)
Compounding pharmacies, which mix medications to order, are a corner of the drug business that has been much less heavily regulated than mass-manufacturing drug companies. As a result, the compounders began expanding their market presence as against the mass manufacturers, and even get into mass manufacturing methods themselves. The process accelerated in the past few years after tightened FDA control of conventional makers’ production practices (under GMP, or Good Manufacturing Practice, regulation) began to result in widespread production-line suspensions; for hospitals and other users, the availability of compounded alternatives is often the only fallback in the face of shortages.
Unfortunately, poor quality control at some compounders resulted in a series of fiascos culminating in a meningitis outbreak. Now the Washington Post reports that major drug companies are seizing the chance to hobble their competition by pressing for maximally burdensome regulation of compounders, including the addition of regulations unrelated to safety, such as rules aimed at restricting the compounding of formulas that imitate the action of patented products. Hospitals, which sometimes engage in compounding themselves to obtain medication for their patients, say overregulation could worsen the problem of drug shortages. [Kimberly Kindy and Lena Sun, Washington Post] Earlier on drug shortages here, here, etc.
“So we now have a politician directly dictating medical policy to doctors at city hospitals.” [Radley Balko]
P.S. In the mayor’s view, just as you can’t make an omelet without breaking eggs, so you can’t fight painkiller abuse without overriding doctors’ judgment: “so you didn’t get enough painkillers and you did have to suffer a little bit…. there’s nothing perfect.” [Colin Campbell, Politicker]
New Jersey: “Harding Pharmacy, others agreed to pay $4.1M to a man who swallowed stolen Xanax in 2007 and suffered serious injuries. A state court ruled Wednesday that the wholesale distributor, Kinray Inc., was not liable for injuries.” [James Kleimann, Ridgewood Patch, October, earlier here and here]
Perhaps there should be a warning label on pharmaceutical warning labels, since they can induce many of the side-effect symptoms they warn against [Maggie Koerth-Baker, BoingBoing]
- How’d we get shortages of hospital and community sterile injectables? Check out the role of FDA Good Manufacturing Practice (GMP) regs, warning letters, and resulting plant closures [Tabarrok, with comments controversy; earlier here, here, here, etc.]
- California orthopedist sues, wins damages against medical society that took action against him based on his testimony for plaintiff in liability case [American Medical News; earlier here, etc.]
- Can’t have that: medical apology should be opposed because it “can create an emotional connection with an injured patient that makes the patient less likely to ask for compensation.” [Gabriel Teninbaum (Suffolk Law), Boston Globe]
- Feds’ war on painkillers is bad news for legit patients and docs [Reuters, Mike Riggs/Reason]
- New federal pilot project in Buffalo will provide concierge-style home care to emergency-department frequent fliers. Spot the unintended consequence [White Coat]
- Dastardly drug companies? Deconstructing Glaxo SmithKline’s $3 billion settlement [Greg Conko, MPT] More: Beck, Drug and Device Law, on suits over “what are mostly medically valid and beneficial off-label uses”. Paging Ted Frank: “HIPAA’s Vioxx toll” thesis may depend on whether one accepts that the premised Vioxx toll has been established [Stewart Baker, Ted's recent post]
- U.K.: “Lawyers seizing lion’s share of payouts in NHS negligence cases” [Telegraph]
- Silver linings in SCOTUS ObamaCare ruling? [Jonathan Adler and Nathaniel Stewart] “DNC Scientists Disprove Existence of Roberts’ Taxon” [Iowahawk humor] Did Ginsburg hint at the court’s direction on the HHS contraception mandate? [Ed Morrissey, Hot Air]
[cross-posted at Cato at Liberty]
The media and legal academy largely applauded the Supreme Court’s 2009 ruling on preemption, but Michael Greve deems its outcome “irresponsible and not even minimally rational”:
Under the Federal Food Drug and Cosmetics Act (FDCA), drugs sold in the United States require an FDA-approved label—the elaborate, incomprehensible (to laymen) sheets you find inside every package. Every sentence is dictated by FDA requirements, down to the font and letter size. Violations of these requirements, and the sale of drugs without the label or a different label, are subject to very severe penalties. The statutory scheme operates to the explicit exclusion of any state regulatory (administrative) scheme. What Wyeth asks us to believe is that state juries may nonetheless hold drug manufacturers liable, for accidents caused by use in direct contravention of the federal label, on the grounds that the federally required label was inadequate. Meticulous compliance with federal requirements doesn’t preempt “failure to warn” liability under state common law.
Following the rules in Florida: a 17-year-old high school student “very nearly died because the school nurse refused to let him use his inhaler because his mother didn’t sign a form.” [Isa-Lee Wolf, Yahoo via Free-Range Kids]