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.
Tagged as:
allergies,
emergency medicine,
overwarning,
pharmaceuticals
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.
Tagged as:
Alabama,
pharmaceuticals,
preemption
“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)
Tagged as:
illegal drugs,
Nevada,
pharmaceuticals
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.
Tagged as:
competition through regulation,
hospitals,
lobbyists,
pharmaceuticals
- “On Average, Physicians Spend Nearly 11 Percent Of Their 40-Year Careers With An Open, Unresolved Malpractice Claim” [Health Affairs via Pauline Chen, NY Times]
- SCOTUS lets stand Feds’ “accept Medicare or lose your Social Security” edict [Ilya Shapiro, Cato]
- Robot surgery: from the Google ads, you might think lawyers are circling [Climateer via Tyler Cowen]
- New York mandates more aggressive anti-sepsis measures in hospitals, and White Coat thinks it won’t end well [EP Monthly]
- Shortages of generic FDA-regulated sterile injectables begin to take deadly toll [AP/Worcester Telegram, earlier]
- Continuing the discussion of electronic medical records from a few days back: as medico-legal documents, EMRs are under pressure to be something other than candid and spontaneous [Kaus] While other patients wait for critical care, ER docs and nurses enter mandatory data fields for whether the infant is a smoker or the flu victim is a fall risk [White Coat]
- Obamacare part-time-work fiasco “only starting to become news when it hits university professors” [Coyote, David Henderson, earlier]
Tagged as:
emergency medicine,
hospitals,
medical malpractice,
Medicare,
ObamaCare,
pharmaceuticals
- The late John O’Quinn was an Overlawyered regular: “Ex-clients’ complaint vs silicosis lawyers is catalog of misconduct” [Alison Frankel, Reuters; Ted Frank, Point of Law]
- “How Lawsuits Killed an American Icon” [Rocky Flick, CEO, on closure of Blitz gas can plant in Oklahoma; U.S. Chamber's Faces of Lawsuit Abuse, auto-plays video; earlier here, here, here]
- “Angelos seeks to revive more than 13,000 asbestos cases” [Baltimore Sun] Virginia is latest state to wrestle with asbestos causation standard [David Oliver] Asbestos forum-shopping alive and well in Madison County, Ill., with record-breaking 1,563 cases filed last year [Chamber-backed Madison County Record]
- More on why Toyota settled dubious acceleration case [Michael Krauss, earlier]
- Alabama rules brand-name drug manufacturer can be held liable for generic version’s lack of a warning [Weeks v. Wyeth; Meghan McCaffrey, Weil Gotshal Product Liability Monitor; Morrison Foerster client alert; Michael Krauss] Standards of causation in pharmaceutical cases haven’t been loosened as far as in asbestos [Beck, Drug & Device Law]
- From Judge Gladys Kessler, another sweeping ruling against tobacco companies [Brian Wolfman, CL&P]
- In the coming era of driverless cars, better to empower a robotic “intersection controller,” or rely on intelligence distributed among the individual vehicles? [Mickey Kaus, Jack Baruth/Truth About Cars, E.W. Niedermeyer first, second]
Tagged as:
Alabama,
asbestos,
John O'Quinn,
pharmaceuticals,
silicosis,
tobacco,
Toyota,
traffic laws,
Virginia
“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]
Tagged as:
hospitals,
Michael Bloomberg,
pharmaceuticals
- “Blaming doctors for prescription drug abuse” [White Coat] Judge rules victim of pharmacy robbery can proceed with suit against doctor who prescribed painkillers [NYLJ]
- Louisiana Gov. Jindal’s proposal for letting contraceptives be sold over counter has good libertarian pedigree [David Henderson, Jonathan Adler] More: Ramesh Ponnuru.
- FDA vs. antiemetics: “How Long Before Zofran Gets Black Boxed?” [White Coat]
- ObamaCare vulnerable to an Origination Clause challenge? [Sandefur vs. Taranto, via Randy Barnett]
- “When a child drinks cologne, by all means, sue the doctor… ” [NJLRA]
- U.S. v. Caronia: does First Amendment protect promotion of off-label drug use? [Richard Epstein/Hoover, PoL, WSJ Law Blog, D&DL, Shackford]
- Ideas from John Goodman on med-mal reform [Psychology Today]
Tagged as:
FDA,
medical malpractice,
ObamaCare,
pharmaceuticals
- Community college restructures staff to avoid ObamaCare employee mandate [Daniel Luzer, Washington Monthly] New pressure toward part-time employment is a big story [Coyote] But do regulations allow shift to part-time workers as a way of evading 50-employee rule, as seemingly contemplated in above post? [Gunn Chamberlain, P.A.] Why some workers might prefer being dropped from their employer’s health plan if higher pay results [Thom Lambert]
- Eleventh Circuit: hospital can be sued for not providing sign-language interpreter for emergency department visitors [Disabilities Law/Bagenstos]
- Proposition: “Off-label use can be, in many circumstances, the standard of care.” [Drug and Device Law] On Ben Goldacre’s new book “Bad Pharma” [Tyler Cowen]
- Overnight solution to med-mal crisis? Perhaps standard for lawyers’ malpractice should automatically fluctuate to reflect that for doctors [Ted Frank, Point of Law]
- Criminalizing the professions [White Coat]
- Drug shortages persist [ACSH, earlier here, here, etc.] What the FDA could do to speed antibiotic approval [Yevgeniy Feyman, Medical Progress Today, earlier]
- Clearer line-drawing between pharmacy and mass drug-compounding needed after tainted-steroid debacle [Scott Gottlieb/Sheldon Bradshaw, WSJ, earlier] With compounding pharmacy doubtfully able to pay claims, “You’re going to get people suing everyone.” [Boston Globe, David Oliver]
Tagged as:
FDA,
hospitals,
legal malpractice,
medical malpractice,
ObamaCare,
pharmaceuticals
- False medical reports lead to echo-mill conviction [Drug and Device Law]
- Leads for sale in mass tort cases: Actos $450, Yaz $400, Yazmin $400, Ocella $425 [Ron Miller]
- Ninth Circuit: securities suit vs. pharmaceutical company can’t piggyback on allegations of flawed clinical trials [The Recorder]
- Dubious management idea: subordinate policy/legislative advocacy to corporate social responsibility (CSR) department [Susan Crowley/PharmExec]
- “Former Glaxo VP: ‘The Criminalization of the Practice of Law Is Here’” [WSJ interview with Lauren Stevens]
- Given the state’s legal climate, does it really make sense for a big pharmco to retain its headquarters in Pennsylvania? [Ted Frank] Sounds rather appetizing actually: defendant J&J said to have run into Louisiana home cooking [Eric Alexander, D&D Law]
- On the life-threatening shortages of sterile injectables [earlier here, etc.] here’s the official line of Margaret Hamburg’s FDA, as dutifully transcribed by the Times: if “nearly a third of the industry’s manufacturing capacity is off line because of quality issues,” it’s because that capacity had been operating in an recklessly unsafe manner, and it in no way reflects on the FDA’s stringent new GMP regulations on manufacturing processes, with which drug makers could easily comply were they not so inured to putting up with weevils, rust and urine on the production line. Note however this significant bit: “The shutdowns have contributed to a shortage of critical drugs, and [loosely state-regulated] compounding pharmacies have stepped into the gap as medical professionals scramble for alternative sources. But several serious health scares have been traced to compounding pharmacies in recent years,” including a deadly new meningitis outbreak. [Katie Thomas, NYT]
Tagged as:
FDA,
Pennsylvania,
pharmaceuticals
- “In light of drug safety concerns, the FDA has made it difficult for companies to get new antibiotics approved.” Might this possibly tie in with the article’s theme that the economics of antibiotic research has turned sharply unfavorable despite a dire perceived need for new compounds? [WaPo; background, Avik Roy, Forbes; Josh Bloom, NY Post, on the coming gonorrhea epidemic]
- Congress considers restoring asthma inhaler access [Angela Logomasini/CEI, earlier]
- Righteous Derek Lowe rant on pharmaceutical innovation [vs. British Medical Journal; Pipeline/Corante]
- Things the New York Times left out of its FDA spygate coverage [Jon Entine, Forbes]
- Bill signed by President last month includes provisions attempting to address drug manufacturing shortages [Abnormal Use, earlier] Lawsuit against drug maker for withdrawing drug from market fails [Beck, Drug and Device Law]
- Regulation-by-litigation striking out in drug pricing cases? [Cruz-Alvarez & Sherr, WLF]
- The Seroquel black box warns of what, exactly, now? [White Coat]
Tagged as:
pharmaceuticals
- Town of Gold Bar, Wash. (pop. 2,100) brought to brink of bankruptcy by multiple lawsuits following political feuds; “We are going broke winning lawsuits,” says mayor [Monroe Monitor via ABA Journal]
- “No one in Youngstown Ohio has a Swiss bank account…except maybe that big new Swiss employer in town?” [Matt Welch, earlier] William McGurn: FATCA and the IRS’s reach abroad [WSJ via TaxProf, earlier here, here] Politicians and lawyers demand “improvements” to IRS bounty-paid-informant program, but what if anything they improve may depend on your point of view [TaxProf, earlier]
- A human rights professor endorses a new model of residential facility that comes with names like “Freedom Place.” But what’s that on the door — could it be a lock to prevent escape? [Maggie McNeill] Romney spokesman says he’ll smite smut, Gov. Gary Johnson takes a more libertarian view [Daily Caller]
- New Mark Herrmann book on in-house lawyering [Victoria Pynchon, Scott Greenfield, Paul Karlsgodt]
- Mortgage eminent-domain seizure plan raises serious constitutional concerns [Andrew Grossman, earlier here, here]
- Central casting? Send over one “business basher,” please: Sidney Wolfe says $3 billion Glaxo settlement too lenient [CL&P, earlier]
- Ted Frank pre-vets the possibilities for Romney VP [PoL] Romney’s law and legal policy team [Brian Baxter, AmLaw Daily]
Tagged as:
eminent domain,
international human rights,
lawyers,
legal blogs,
Mitt Romney,
mortgages,
pharmaceuticals,
Switzerland,
taxes,
Ted Frank,
Washington state
- 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]
Tagged as:
emergency medicine,
expert witnesses,
FDA,
HIPAA,
John Roberts,
medical apology,
ObamaCare,
pharmaceuticals,
Supreme Court,
United Kingdom,
Vioxx
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.
Tagged as:
failure to warn,
pharmaceuticals,
preemption,
Wyeth
- Government’s hospital care guidelines may be fueling dangerous overuse of antibiotics [White Coat] FDA says fewer drugs are in shortage [Reuters, earlier here, etc.]
- “Post-tort-reform Texas doctor supply” [Ted Frank/PoL and commenters] “Change in Procedures Lets Medical Malpractice [Insurance] Industry Thrive” [PC 360]
- Forcing companies to make politicized disclosures to customers implicates First Amendment [Hans Bader on HHS "must credit ObamaCare" reg]
- Iqbal and Twombly SCOTUS decisions on pleading have helped protect pharmaceutical defendants from flimsily based suits [James Beck, who has changed law firms to Reed Smith]
- How accurate is hospital data coding? Ask thousands of pregnant British men [Nigel Hawkes via Flowing Data]
- Class-action-fed boom in Medicaid dentistry + “let’s put docs in schools” idea = scope for horrific abuse, no matter how it’s financed [Bloomberg via Jesse Walker]
- Suits blaming obstetricians for cerebral palsy rack up $78 million win in Philadelphia, $74 million in California [Legal Intelligencer, Cal Coast News]
- Ninth Circuit: on reflection, let’s not seize control of VA mental health programs [AP, earlier here, etc.]
Tagged as:
hospitals,
medical malpractice,
medical malpractice insurance,
Ninth Circuit,
ObamaCare,
pharmaceuticals,
pleading,
psychiatry,
Texas
