Saturday, August 12, 2006
It's always an exciting day in TortsProf Towers when the JPML releases the new hearing order [PDF] and so, despite the fact that it's 77 and sunny outside, and I should be getting ready for the little party we're having, I'm instead poring over the order for the September hearing in Santa Ana, which is, incidentally, installing new synthetic turf and a new marquee at the Santa Ana Stadium. Go, Santa Ana!
(There is, I'm sure, no truth to the rumor that the location for the hearing was selected because the panel was hoping to see some of the filming of the new season of The O.C.)
Anyway. On with the show. (The MDL show, not The O.C.) Matters of interest that will have oral argument:
MDL-1796 -- In re Department of Veterans Affairs (VA) Data Theft Litigation
MDL-1795 -- In re Insurance Industry Discriminatory Sales Practices Litigation
Wow, pretty weak docket. Maybe they really are going to see if they can find out what happense to those wacky OC kids Ryan and Marissa. Bunch of torts stuff on the non-oral-argument docket - asbestos, MTBE, Zyprexa, Ephedra, Vioxx, Bextra, Celebrex, Guidant defebrillators, Medtronic defibrilators, human tissue, Seroquel. (Man, imagine how a Google AdSense banner would be flashing if we used their advertising.)
Thursday, August 10, 2006
Arkansas looks to be the next state in which "I'm Sorry" legislation will get introduced.
In the same story, the first mandated data on malpractice insurance rates shows a slowdown in the increase of rates, but also stops well short of crediting the state's 2003 damage caps, citing also to factors like increased competition and carry over from past rate hikes. (Plus, it's only one year.)
Wednesday, August 9, 2006
[1.] My first proposed change to the drug-approval process relates to the current lack of long-term safety data. . . .
To encourage the generation of such data, an extended period of exclusivity should be offered to drug manufacturers after the completion of FDA-mandated studies that demonstrate a drug's long-term safety.
[2.] My second proposed change to the drug-approval process relates to . . . unmet phase 4 commitments. I propose that we provide incentives for the completion of these commitments by offering only a limited, shorter period of exclusivity with accelerated approvals. I also suggest that we allow the normal period of extended exclusivity to be restored when the mandated phase 4 studies are completed and yield data that confirm the drug's efficacy and safety.
[3.] To encourage the development of drugs with high commercial risk to prevent chronic diseases, we need to develop a strategy that will convert the approval of such drugs on the basis of apparently beneficial changes on a relevant surrogate, imaging, or biologic marker to the demonstration of benefit on a clinically meaningful end point (e.g., prevention of cognitive deterioration in patients at risk for Alzheimer's disease or avoidance of the need for hip replacement in patients with early osteoarthritis).
When too much time is required to demonstrate a clinically meaningful benefit in a preapproval study, initial FDA approval could be given on the basis of a change in the end point of an imaging or biologic marker. However, that initial approval would provide only a limited period of exclusivity during which the sponsor would have to demonstrate that patients also benefited with respect to a clinically meaningful end point (i.e., meaningful improvement in function or a reduction in morbidity or mortality). The timely provision of such data would result in an extension of the period of exclusivity. . . .
[4.] Our current drug-approval system does not adequately reward the development of the most beneficial drugs. Manufacturers of drugs that are not demonstrably different from many others on the market are offered extended periods of exclusivity, although the risk involved in this drug development is relatively low. . . .
Once an area was designated as being high need and high risk, an extended (i.e., longer than current) period of exclusivity would be available to manufacturers of successfully developed drugs in this area, and the extended exclusivity would increase the value of these drugs.
Manufacturers of late drugs in a class, sometimes called "me too" drugs, would be given a shorter period of exclusivity unless or until they demonstrate that their drugs had some meaningful advantage (such as increased efficacy or improved safety) over other drugs in their class.
AEDs -- those defibrillators that you're seeing more and more often, and, if you're like me, think, "Do I really want that guy working at the One Potato Two trying that thing out on me?" -- are becoming more and more common. Today, in a JAMA piece (subscription only, see this Washington Post piece for a good overview), researchers indicate some concerns about the devices' reliability -- but emphasize that the risk/benefit ratio is still good. From the Post story:
Harvard Medical School researchers found that over the past decade, one in five automated external defibrillators were recalled because of the potential for malfunction, and devices that failed were associated with 370 deaths.
Nevertheless, the devices have saved tens of thousands of lives, and the benefits outweigh the risk of malfunctions, said study author Dr. William Maisel.
"The number of malfunctions may be alarming to some, but you have to take it in the context of the large number of patients saved by these devices," he said.
Any time you get frustrated by the constant recalls of toys featuring lead ("Lead paint - tasty but deadly!"), just be glad that the folks at Worth1000 don't get to design them. I particularly like "Baby's First Lighter."
Tuesday, August 8, 2006
No, the Steelers' QB is not suing anyone over his serious motorcycle crash. But Gregg Easterbrook (of the Broookings Institution, Atlantic Monthly, and, for these purposes, ESPN.com) has some interesting comments about the bike Roethlisberger was riding:
Roethlisberger was straddling . . . a Suzuki Hayabusa, advertised by the manufacturer as "the fastest production bike on the planet." The Hayabusa has a 160-horsepower engine, same as the new Ford Fusion sedan. But the motorcycle weighs 478 pounds, while a Fusion tips the scales at 3,101 pounds. This means a Hayabusa throbs with seven times the horsepower-to-weight ratio of a modern car. Another vehicle with a 160-horsepower engine is the Cessna 172 Skyhawk, with a maximum takeoff weight of 2,450 pounds. Roethlisberger's bike had five times the power-to-weight ratio of an airplane, and minimum-weight criteria dominate aircraft design. [Other "look at how crazy fast it is" materials omitted.]
Like all max-performance bikes, the Hayabusa is basically a big engine with two wheels and a seat. There are no safety mechanisms: no roll bars, no shoulder harness, no impact-absorbing beams, no air bags, not even bumpers. Acceleration of max-performance motorcycles is wildly disproportionate to driving needs. The only real use of the acceleration ability is road rage -- to drag-race from stoplights, cut others off in traffic, speed like mad. Perhaps you've been on a highway when a couple colorful high-performance bikes have roared past you at far over the speed limit. The people on the bikes may be morons, which is their problem. But their antisocial behavior is your problem, since vehicles moving significantly faster than the speed of traffic are a leading cause of accidents.
This column isn't much of a fan of the tort bar, yet wonders why litigators have not put the Hayabusa and similar overpowered bikes out of business. High-performance street motorcycles are socially irresponsible, and designed without regard for the safety of riders. Roethlisberger and others who buy high-performance bikes don't wish anyone harm, they're just looking for an ego rocket. But harm is what they cause, and legislatures should intervene. The Constitution says you've got a right to own a gun and to read a newspaper; firearms and materials related to First Amendment political, artistic and religious expression are the only categories of purchases with specific constitutional protection. Race a mega-motorcycle on a private track? Sure. But public roads are subject to public regulation. Our nation's laws do not confer any "right" to operate on public roads a high-horsepower bike, anymore than there's a "right" to drive a bulldozer down the middle of an interstate. It is past time the high-horsepower motorcycle was regulated off the roads. The intended use of these bikes is lawbreaking!
Easterbrook continues discussing the new Revolution football helmet.
A useful set of reflections by Rick Lempert on the use and misuse of empirical work in legal scholarship, posted as his first in a series of guest posts on the Empirical Legal Studies blog. He touches briefly on litigant-funded research, among other things.
Monday, August 7, 2006
Most of the attention goes to the criminal aspects, but many of the laws changing the situations in which people can legally use force also create civil immunity -- though horror stories notwithstanding, the frequency of burlgars suing homeowners is rather low. The NYT has more.
The Miami Herald today has an interview with Lewis S. "Mike" Edison, the new president of ATLA/AAJ, covering, among other things, the group's efforts to improve the image of trial lawyers, various specific proposals to change tort law, and the tension, or lack thereof, between him and his wife and daughter, both physicians.