May 26, 2006
Mercury: Bad in Teeth & Vaccines, Not Bad in Herbal Medicines?
From the essential Respectful Insolence, a post about the irony of alternative medicine practitioners defending the (rather high) levels of mercury and other heavy metals in certain Chinese herbal remedies whle simultaneously attacking mercury in dental fillings and (pre-2003) vaccines. A sampling -- though you should just go read all of it:
This is actually not the first time I've heard this sort of excuse from boosters of Chinese and Indian herbal medicines, the claim that, even if there's mercury in them, it's "safe" because it's somehow different, rendered nontoxic by unspecified compounds in the herbal goodness in the remedies (either that, or that the laboratory results come from an evil conspiracy between big pharma, the government, and greedy doctors). Even more ironic, though, this is exactly the explanation as to why the mercury in amalgams is safe (it's bound up with the silver, tin, copper, and zinc in the amalgam). Try explaining that to anti-amalgam alties, and they'll have none of it.
It's worth noting that neither RI nor I are saying that mercury is yummy or good for you or your kids (though the evidence remains iffy to nonexistent on both vaccines and fillings). It's just a goose/gander thing.
[My former firm was and may still be involved in vaccine/thimerosal defense. I was not.]
Federally approved prescription drug labeling has not been considered conclusive on the reasonableness or adequacy of the label for assessing tort liability on the manufacturer because federal regulations in this field set a minimum standard rather than an optimal one. That fundamental statement of black-letter tort law is under attack. The Food and Drug Administration (FDA) has promulgated a regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In the FDA’s 100 year history, it has not taken the position that federal regulations preempt common law tort claims based on prescription drug labeling until now. This Article explains the applicability of preemption doctrine to prescription drug product liability actions, explores the importance of the change in FDA position on that doctrine, and provides direction to courts seeking to discover the boundaries of federal preemption in this critical area.
The article does not yet have a full conclusion, but the start that's there suggests that Professor Davis is not fond of the idea of preemption:
it is clear that no labeling regulation can create the perfect incentive for manufacturers to seek better and more complete information regarding the adverse side effects of the prescriptions we take. In a world where United States patients receive proper medical care from doctors and nurses only 55 percent of the time, pharmaceutical companies are in control of the research conducted on their products pre- and post-marketing, pharmaceutical sales representatives have increasing influence on the drugs that physicians prescribe, and the pharmaceutical industry is the largest lobbying group in the United States, the products liability litigation system is a critical component to create incentives for greater access to risk information to insure the public’s health.
May 25, 2006
I may have linked to it before, but SorryWorks.net is an interesting site. Their mission:
The coalition has three goals: 1) educate all stakeholders in the medical malpractice debate about the Sorry Works! approach to reducing liability costs from medical errors; 2) serve as an organizing force and a central clearinghouse for information, news, ideas, and research on Sorry Works! and related full-disclosure efforts; 3) promote and push for the development of Sorry Works! pilot programs in different states.
From the press release at the group's launch in February 2005:
"Sorry Works! must become the new way of doing business for malpractice insurance companies. The old approach of ostracizing patients after bad outcomes sets doctors up for lawsuits by stoking anger. Sorry Works! is not only the ethical thing to do, it will also improve the bottom line for insurance companies," said Jim Cunningham, medical malpractice insurance broker and Sorry Works! board member.
It Is All Just Too Exciting
Right now -- right now! while you are (or might be) reading this -- lawyers are engaging in oral argument about potential MDLs [PDF], and if that's not enough, it's in Kansas City! And if they finish quickly enough, the lawyers could go see the world's (allegedly) largest shuttlecocks or the Airline History Museum.
Man, it's exciting.
May 24, 2006
Obama, HR Clinton's Bill, Introduced in NEJM
Barack Obama and Hillary Clinton have an editorial (free full text) in the New England Journal of Medicine discussing their new National Medical Error Disclosure and Compensation (MEDiC) Bill.
Our proposed MEDiC program provides grant money and technical assistance to doctors, hospitals, insurers, and health care systems to implement programs for disclosure and compensation. The MEDiC model promotes the confidential disclosure to patients of medical errors in an effort to improve patient-safety systems. At the time of disclosure, compensation for the patient or family would be negotiated, and procedures would be implemented to prevent a recurrence of the problem that led to the patient's injury.
The bill contains protections for apologies by medical professionals and provisions for mediated settlement discussions upon disclosure of medical errors, while maintaining patients' right to counsel.
At first blush, it's an interesting proposal. I'll try to spend more time discussing it in coming days.
Update: Greedy Trial Lawyer is unimpressed, calling the provision of a confidential disclosure system a "bribe."
(See also my earlier post on medical error reduction as part of reforms.)
Milberg Weiss & Class Actions
Findlaw's Writ has a good piece by Michael Dorf (Columbia) taking off from the Milberg Weiss indictment and providing an overview of class action litigation more generally, discussing what he terms the "love/hate" relationship Americans have with class litigation. He contends that the alleged conduct of Milberg Weiss is more or less unsurprising:
In sum, we have a system of class action litigation rife with principal-agent problems. Ironically, in the corporate context, we employ it as a mechanism for combating rampant principal-agent problems within corporations.
In these circumstances, one can hardly blame the government and the grand jurors in the Milberg, Weiss case for wanting to stop what they saw as an effort to add yet another layer of principal-agent problems.
May 23, 2006
Off-Label Usage Study
Results In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (P<.05), few other drug characteristics predicted off-label prescription.
Conclusions Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.
Case, Meet Foreseeability Requirements
A wongful death suit has been filed after the unfortunate alleged consequences of a paraplegic's pedicure:
[A]fter [Kimberly Kay Jackson's] heel was cut with a pumice stone during a July pedicure, she developed an oozing wound that wouldn't heal despite repeated rounds of antibiotics, relatives said. The 46-year-old died in February of a heart attack triggered by a staph infection, said the family's attorney, Steven C. Laird.
Now, her three teenage children are suing Angel Nails and its owner for unspecified damages. The lawsuit, filed last week, claims the Fort Worth salon did not follow state regulations for disinfecting the whirlpool and instruments.
May 22, 2006
Michigan Taking on Asbestos
Michigan is considering asbestos-specific legislation:
People could not sue unless they have a physical impairment that is substantially attributable to asbestos or silica exposure. Damages for pain and suffering would be limited to $250,000, or three times the amount of economic losses, whichever is greater.
The bill is here. One interesting section, just as an example of what it's about (it's a lengthy bill, and worth looking through):
(2) A person shall not bring or maintain a civil action
alleging an asbestos claim based on a nonmalignant condition unless
the person makes a prima facie showing that the exposed person has
or had a physical impairment resulting from a medical condition to
which exposure to asbestos was a substantial contributing factor. A
prima facie showing required by this subsection includes, at a
minimum, all of the following:
(a) Evidence verifying that a qualified physician has taken a
detailed occupational and exposure history of the exposed person
or, if the exposed person is deceased, from a person who is
knowledgeable about the exposures that form the basis of the
asbestos claim, including both of the following:
(i) The identification of all of the exposed person's principal
places of employment and exposures to airborne contaminants.
(ii) Whether each place of employment involved exposures to
airborne contaminants, including, but not limited to, asbestos
fibers or other disease causing dusts, that can cause pulmonary
impairment and the nature, duration, and level of each exposure.
(b) Evidence verifying that a qualified physician has taken a
detailed medical and smoking history, including a thorough review
of the exposed person's past and present medical problems and the
most probable cause of the problems.
(c) A determination by a qualified physician, on the basis of
a medical examination and pulmonary function testing, that the
exposed person has or had a permanent respiratory impairment rating
of at least class 2 as defined by and evaluated pursuant to the AMA
guides to the evaluation of permanent impairment.
(d) A diagnosis by a qualified physician of asbestosis or
diffuse pleural thickening, based at a minimum on radiological or
pathological evidence of asbestosis or radiological evidence of
diffuse pleural thickening.
(e) A determination by a qualified physician that asbestosis
or diffuse pleural thickening, rather than chronic obstructive
pulmonary disease, is or was a substantial contributing factor to
the exposed person's physical impairment, based at a minimum on a
determination that the exposed person has or had 1 or more of the
(i) Total lung capacity, by plethysmography or timed gas
dilution, below the predicted lower limit of normal.
(ii) FVC below the lower limit of normal and a ratio of FEV1 to
FVC that is equal to or greater than the predicted lower limit of
(iii) A chest x-ray showing small, irregular opacities (s, t)
graded by a certified "B" reader at least 2/1 on the ILO scale.
(f) A conclusion by a qualified physician that the exposed
person's medical findings and impairment were not more probably the
result of causes other than the asbestos exposure revealed by the
exposed person's employment and medical history.