Wednesday, May 31, 2006
This article contains a sentence I never thought I'd see:
The research, conducted by New York City's Beth Israel Medical Center with the National Institute of Media and the Family, shows surgeons who played Super Monkey Ball for 20 minutes before surgical tests were faster and more accurate than those who didn't.
Can't wait for a suit asserting that the standard of care for surgeons includes a warmup with XBox.
Aramark is challenging on appeal the award of over $100 million in damages ($65 million in punitive damages) in an alcohol-liability case in New Jersey arising from a drunk driving accident causing the paralysis of a young girl.
Aramark disputes various evidentiary and jury instruction rulings as well as asserting that punitives are unavailable under the New Jersey alcohol liability statute (which is silent as to punitives).
The plaintiffs successfully argued that a culture of intoxication was present:
During the four-week trial, Mazie presented evidence that Aramark vendors repeatedly violated rules against selling more than two beers to a single fan at a time. Lanzaro was called to the witness stand and testified he drank the equivalent of 16 twelve-ounce beers on Oct. 24. 1999, most of them at the stadium, and was slurring his speech when he tipped a vendor at halftime to buy six beers at once.
After leaving Giants Stadium, Lanzaro crashed into the Vernis' car as they returned home from a pumpkin-picking trip. Lanzaro's blood-alcohol level was measured at 0.266 percent, more than 2 1/2 times what was then the legal limit of 0.1 percent. He is serving a five-year prison term.
Aramark disputed the relevance of the "culture" evidence as well as asserting several other arguments:
As part of its appeal, Aramark also argued that the trial judge erred by dismissing claims of liability against the Giants, the National Football League and the New Jersey Sports and Exposition Authority, which had settled with the Vernis for about $700,000. Aramark argued that the jury should have been able to consider whether those defendants were partly responsible for the accident.
Aramark's attorneys also argued that the jury should have considered the potential liability of other parties: Antonia Verni's father, who did not put Antonia in a child car seat before the accident; a friend of Lanzaro who drank with him before the game and was in the car with him at the time of the crash; and a local strip club that the pair patronized shortly before the car crash.
Anthony Sebok wrote a piece about the case back in 2003, concluding that the plaintiffs' case was "dicey," based on the idea that the liability statute was aimed more at corner bars than a stadium.
The Post has a piece about the Court granting cert. in Williams v. Philip Morris, noting, among other things, that it's really the first chance we'll have to see Justices Alito and Roberts dealing with torts issues, which were not a major part of their confirmation hearings.
Tuesday, May 30, 2006
According to an editorial in the NYT, a recent proposed shift in defining hypertension was funded by -- and perhaps pushed by -- drug companies standing to increase sales via a larger number of patients being diagnosed with hypertension. The editorial notes that the new definition (which looks at other risk factors in shifting people who would now be pre-hypertensive into the hypertensive category) has some merit and defenders, but focuses on the funding as a concern.
The Post has a closely-related piece about Restless Leg Syndrome, a bona fide but previously-little-known syndrome that has become much better-known via direct-to-consumer advertising via GSK (the first drugmaker to gain an RLS indication). The basic issue, policy-wise:
The debate has focused attention on what some have dubbed "disease-mongering" -- taking something that is within normal bounds and labeling it a disease needing pharmaceutical treatment.
"We're increasingly turning normal people into patients," said Lisa M. Schwartz of Dartmouth Medical School.
Shy people have "social phobia," requiring psychotropic drugs. High-strung boys have attention deficit disorder and need amphetamines. Baby boomers with slightly elevated blood pressure have "pre-hypertension" and line up for beta blockers. A few nights of restlessness calls for sleeping pills.
"The ordinary experiences of life become a diagnosis, which makes healthy people feel like they're sick," Schwartz said.
On the issue of DTC advertising:
"The argument the pharmaceutical industry is always making is that this is patient education -- that this is an under-diagnosed condition and 'we're just trying to raise awareness,' " said Michael Wilkes of the University of California at Davis. "If you're talking about something like hepatitis C or measles, that might be true. But if you're talking about toenail fungus or baldness or restless leg syndrome, I just don't buy it."
[Hypertension story via Greedy Trial Lawyer. Disclosure: I perform litigation consulting for a couple of drug companies.]
Monday, May 29, 2006
The post's basic concept, based on Gilbert's research indicating that non-disabled people underestimate the happiness of disabled people, is that non-disabled jurors may overcompensate via hedonic damages tort victims who have become disabled.
Sunday, May 28, 2006
The amusement industry happens to be my particular interest (see my other blog, MassTort.org, for more rambling about it), but this story from the Minneapolis Star-Tribune is certainly representative of a more general category of media coverage -- the industry overview after a high-profile accident. The recent mining tragedies triggered a similar series of stories. It's worth a look in that context.
The CPSC has no oversight over fixed-site amusement parks, only over traveling carnivals, and state regulation varies widely, ranging from state inspections of every ride to no state oversight at all (SaferParks.org has a generally accurate overview). In Minnesota, ride safety is left to the parks and their insurers (except, I assume, if a worker is injured, in which case OSHA or the state equivalent could get involved, or if there is a criminal offense). This exchange seems to summarize the ongoing debate about regulation of rides -- but really it could be about regulation of nearly everything:
When there's an accident in a system like Minnesota's, "there's no one there who doesn't have a serious vested financial interest," said Kathy Fackler, who started an advocacy group in La Jolla, Calif., called Saferparks, after her son lost toes on a ride at Disneyland eight years ago.
But that financial interest keeps parks from being reckless about safety, said Tip Harrison, physical plant director at Valleyfair.
The financial incentive argument, of course, has its limitations, especially at the undercapitalized end of the spectrum (typically but not exclusively non-fixed-site entities like traveling carnivals). Valleyfair is owned by Cedar Fair LP, with net revenues over $500 million a year (about to jump dramatically after its purchase of the Paramount Parks chain); there is no shallow pocket problem.
The one thing the story doesn't quite make clear -- and stories rarely do -- is that the proposal to remove the exception for fixed-site parks (sometimes called the "rollercoaster loophole") is not preemptive of state regulation. The CPSC does not have an inspection system, nor does anyone, I think, expect them to create one.
What the CPSC may be good at is serving as an information clearinghouse -- so that if, as in the case of Valleyfair, there's a problem with a particular part on a particular kind of coaster made by a particular manufacturer, the CPSC can facilitate information-sharing among competing chains and independent parks. See these documents relating to a death on a Sizzler ride at a fair in Massachusetts to get a sense of what the CPSC does now in connection with non-fixed-site rides.
Friday, May 26, 2006
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.
Thursday, 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.
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.
Wednesday, May 24, 2006
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.)
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.
Tuesday, May 23, 2006
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.
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.
Monday, May 22, 2006
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.
Saturday, May 20, 2006
Friday, May 19, 2006
Almost a year ago, the California Supreme Court ruled that amusement park rides such as roller coasters trigger the common carrier status under tort law. Not an intuitive outcome, but, as I wrote, it was actually a fairly straightforward outcome given the statute and caselaw (see this entry for my early thoughts on the issue).
There was much gnashing of teeth in the amusement industry, including this:
“It puts roller coasters out of business.” – John Robinson, California Attractions and Parks Association
Not surprisingly, it's done no such thing, and in fact probably has had (and will have) no substantial effect on tort litigation relating to amusement ride injuries or on the building or opening of new rides in the state of California. (Nor, interestingly, did the pending California case make it into any of the amusement companies' SEC filings, so far as I can tell, while I'd imagine the potential of eliminating roller coasters would count as material...)
There's no reason to go through all of the reasons in detail (see this entry for my view at the time). Briefly, though, a good number of states have applied common carrier status to amusement rides for decades, with no discernable impact on parks and rides opening and operating, in addition to the fact that, in general, the incentives are such that -- especially for well-capitalized large parks -- parks already usually comply with the theoretically higher standard of a common carrier.
There's a broader point too, though (and here's where you can tell I'm avoiding grading), and that's about how huge pronouncements like that will often come back to bite you. So -- an invitation: Think back to predictions of doom or disaster from any side of a tort-related issue, check to see if said doom or disaster has come to be, and let me know about them.
Interesting piece from the American Prospect. While acknowledging that caps and the like can potentially reduce malpractice insurance rates, Ross Eisenbrey (VP of the Economic Policy Institute) says (a) such reductions will have minimal effect on overall cost of healthcare and (b) we should focus more on reducing medical error in the first place. He uses as one example progress in anesthesia, where deaths have been reduced from 1 in 5,000 to 1 in 200,000 to 300,000 in the space of twenty years. In the same time frame, he says, insurance rates for anesthesiologists have fallen by 37%.
Of course, it's possible for malpractice insurance rates to be a small part of health care costs but still to have a substantial effect on the quality of care, simply through the availability of care. Whether that's true or not is a different issue, but saying that a reduction in insurance rates wouldn't make my health insurance cost much less isn't the end of the issue.
Nonetheless, it seems to me that an effort to join reforms of the liability system to improvements in avoiding malpractice in the first place might be more politically appealing -- at least to some -- than either in the abstract.
Thursday, May 18, 2006
The SJC rejected the "personal choice" defense in a tobacco wrongful death suit, saying it can only be used if the cigarettes were used in a really, really "unreasonable" way. (Backwards? One up each nostril? Actually, they do give examples -- see below.)
Massachusetts puts all of strict liability law within the UCC warranty provisions, and doesn't bar recovery due to the plaintiff's negligence unless the use was "unreasonable." This decision affirms that the doctrine applies in the tobacco context, and that there is no reasonable way to use a cigarette, and thus that the "unreasonable" use defense will ordinarily be unavailable. The only times when it might be would be, the court suggests, when the plaintiff has a particular medical condition that, I suppose, makes it really unreasonable to smoke:
We have examined the numerous warranty cases cited to us by the parties in which the Correia defense was invoked and there is none where the defendant conceded that reasonable use of the product was impossible....
Nor do we conclude, in the circumstances of this case, that the plaintiff's stipulation of knowing unreasonable use to be fatal.... On the record before us, the plaintiff's stipulation restates the obvious: that cigarettes cannot be used safely and therefore that cigarette use is unreasonable. The stipulation that the decedent was aware of the well- publicized health risks of cigarettes merely places him in the same position as the ordinary consumer or potential consumer of cigarettes. Without more, it is insufficient to justify dismissal of the defective design warranty claim.
Our conclusion does not, as Philip Morris claims, eviscerate the Correia defense. We agree with the defendant that the "key to the Correia defense is not the care, knowledge, or intent of the manufacturer, but the duty of the user to act reasonably concerning a product known to be defective and dangerous." But where the defendant merchant affirmatively invites the consumer to use a product that cannot safely be used for its ordinary purposes, then public policy demands that the merchant bear the burden of reasonably foreseeable injuries that result from that invitation.... If Philip Morris chooses to market an inherently dangerous product, it is at the very least perverse to allow the company to escape liability by showing only that its product was used for its ordinary purpose.
We agree with Philip Morris, however, that a defendant in a cigarette product liability warranty claim should not be entirely foreclosed from asserting the Correia defense as a matter of law. We are persuaded by Philip Morris's argument that, in certain situations, a consumer's use of cigarettes may be so overwhelmingly unreasonable as to make the imposition of warranty liability on the merchant fundamentally unfair. When a consumer, for example, begins smoking cigarettes knowing that she has a particular medical condition, such as emphysema, that is exacerbated by smoking, the Correia defense may be appropriately invoked. To succeed in interposing the Correia defense in such circumstances, the defendant must demonstrate that the plaintiff knew of her particular medical condition and the risks smoking posed to that specific condition at the time she began smoking. The defendant need not show that the consumer had a medical expert's knowledge of the risk; it is enough for the defendant to demonstrate that the plaintiff knew that smoking would exacerbate her specific illness. Cf. Cigna Ins. Co. v. Oy Saunatec, Ltd., supra at 19 (defendant need not demonstrate that plaintiff had technical knowledge of dangerous and defective condition).
The record before us contains no evidence that the decedent's use of cigarettes was overwhelmingly unreasonable in the manner we have described above. However, the plaintiff brought her summary judgment motion early in the litigation, when neither side had full opportunity for discovery. At that stage, the judge properly denied the motion to strike the Correia defense, but she terminated the case prematurely. We do not foreclose the plaintiff from renewing, at a later time and on a more fully developed record, her motion to preclude the Correia defense.