Thursday, August 24, 2006
Wednesday, August 23, 2006
I just realized I hadn't even linked to the D.C. Circuit case about tax consequences of non-physical injury damage recoveries. It's a big deal and better covered by Paul Caron than I could possibly hope to. Here is his first post, and here is today's, linking to coverage elsewhere.
(Or can two count as "galore"?)
Couple of interesting recent products cases.
In the first [PDF], the Michigan Supreme Court held (over two dissenting votes) that a hair oil manufacturer was not liable for failing to warn about the risk of organ failure from ingestion of the hair oil, concluding that the fact that ingestion raised a material risk was obvious to a reasonably prudent user. The purchaser's eleven-month-old child ingested the product and died of organ failure about a month later. The product carried warnings against spraying it near flame, but did not have any warnings about ingestion or about keeping it away from children.
Of note, the court concludes that the user need not understand the specific risks -- only that there are material risks associated with the conduct (here ingestion). The dissent focuses on this, asserting that the majority has let the defendant off the hook based on the notion that knowing one risk is equivalent to knowing all risks. The opening to the dissent:
Michigan consumers beware: If you know or should know that there is any material risk from using or accidentally misusing the product you buy, then the manufacturer of that product now has no duty to warn you of any risk at all, even when the potential harm you knew of is not the harm you ultimately suffer. Stated differently, if you know or should know that if, for example, you accidentally drink or inhale a product, you may become ill, then you are charged with knowing that if you accidentally drink or inhale that product, you could die. And the manufacturer need not warn you of either of those risks—illness or death. According to the majority, the obviousness of any material risk, such as that of illness, is identical to and has the same effect on your behavior as the obviousness of all risks, including death.
In another case, Judge Kennedy of the District Court for the District of Columbia dismissed [PDF] a putative class action against various dairy and retail defendants, contending that milk producers should have warned against gastrointestinal symptoms from lactose intolerance. The plaintiffs contended that, though lactose intolerance is common, it is frequently unknown by those who suffer from it:
Notwithstanding the vast number of people allegedly afflicted with lactose intolerance, plaintiffs insist that the extent to which people suffer from this condition has been minimized by the milk industry and “the government’s marketing efforts.” Id. ¶ 6. Plaintiffs maintain that defendants, with the aid of the government, have propagated the myth that milk is a necessary part of a healthy diet while simultaneously stifling information about the incidence of lactose intolerance.
The plaintiffs sought warnings such as these:
WARNING—IF YOU EXPERIENCE DIARRHEA OR STOMACH CRAMPS AFTER CONSUMING MILK, YOU MAY BE LACTOSE INTOLERANT. CHECK WITH YOUR PHYSICIAN.
WARNING—LACTOSE INTOLERANT INDIVIDUALS MAY EXPERIENCE BLOATING, DIARRHEA, OR OTHER GASTROINTESTINAL DISCOMFORT FROM CONSUMING MILK. CHECK WITH YOUR PHYSICIAN.
The court dismissed the case based on preemption, noting that labeling of food is within the realm of agencies, and citing the experience with olestra:
In 1996, FDA approved olestra as a food additive. Food Additives Permitted for Direct 7 Addition to Food for Human Consumption; Olestra, 61 Fed. Reg. 3118 (Jan. 30, 1996). As part of this approval process, FDA determined that there was “a reasonable certainty of no harm” with respect to olestra consumption. Id. The determination was made notwithstanding the possibility that olestra consumption could cause “a broad range of GI [gastrointestinal] symptoms, including loose stools, cramping and bloating, fecal urgency, oil-in-the toilet, and anal leakage.” Food Additives Permitted for Direct Addition to Food for Human Consumption; Olestra, 68 Fed. Reg. 46,403, 46,408 (Aug. 5, 2003). FDA “appli[ed] the statutory standard of ‘safe,’ [and] concluded that none of these effects is harmful to health.” Id. Given this conclusion, the court sees no reason why the symptoms of lactose intolerance—very similar to those exhibited by olestra consumption—should raise any safety concerns. Consequently, the court finds that there is no basis upon which to invoke the safety exception to the FDCA preemption clause. The court concludes, therefore, that plaintiffs’ complaint must be dismissed in light of the express preemption clause in the FDCA.
The court also concluded that there was no duty to warn under Restatement provisions, noting that there is no duty to warn about common and well-known allergies.
Tuesday, August 22, 2006
FDA and MIT announced a collaboration, building on systems designed to anticipate infectious disease spreads, to predict problems with prescription medications:
The current system relies on the largely manual assessment of reports voluntarily submitted to the FDA, sometimes months or years after an event has occurred. As a result, potential problems typically are underreported, said Dr. Scott Gottlieb, the FDA‘s deputy commissioner for scientific and medical affairs.
The system would build on methods developed to identify infectious disease outbreaks, detect bioterrorism attacks and model the spread of bird flu, he said.
Monday, August 21, 2006
A mostly anecdotal but interesting article in the Ft. Worth Star-Telegram, looking back at the effects of Texas's 2003 Medical Malpractice and Tort Reform Act. Some pull quotes:
"Clearly the legislation has had the result intended. The number of filings in medical malpractice is down significantly," said [Cantey & Hanger managing partner] Rogers, who's also seen the effect from his position as a board member of Baylor All Saints Medical Center at Fort Worth. "I would say the number of lawyers [at Cantey & Hanger] doing medical malpractice defense has been reduced by two-thirds."
* * *
The number of medical malpractice suits filed in Tarrant County and other Texas metropolitan areas has plunged since Sept. 1, 2003, when the law went into effect. The measure also bolstered defenses in civil suits involving a personal injury, such cases of product liability or the release of hazardous materials, and those cases also are down, although not as sharply.
* * *
For 27 years, Fort Worth plaintiffs' lawyer Steven Laird filed malpractice suits full time. But "no one does principally medical malpractice work anymore," he said. "Now my practice consists of other types of serious injury and wrongful death."
The evidence behind those comments is on file at the Tarrant County Courthouse.
In 2001, there were 158 medical malpractice lawsuits filed locally. The next year there were 166. But in early 2003, plaintiff attorneys blitzed the courthouse to file 337 malpractice suits, all but 20 of those before the new law took effect.
The number of new suits in 2004 fell to 55, and last year 60 were filed, about a 60 percent decline from 2001-02, according to the Tarrant County district clerk's office. In the first six months of 2006, 38 malpractice suits were filed.