Monday, March 31, 2008
The Chronicle of Higher Education has a story (link will explode in five days), quoting me, about Pfizer's efforts to obtain discovery into the peer review process. It is a better story than most, in my view, in terms of recognizing the potentially overblown (but not baseless) predictions of doom raised by journal editors. As the story notes, but just to be sure it's clear, I have done work for pharma companies, though not Pfizer.
Eric Posner, on the new Slate law blog, has more on Scalia's criticism of press coverage, finding that, indeed, some coverage of the Riegel preemption ruling suggested that the Court just decided it liked the FDA, and that tort suits were thus preempted -- rather than engaging in a textual analysis, etc. Of course, as Posner points out, how one does that textual analysis is often (always?) affected by one's other inclinations, so some of the discussion (particularly that of the NYT's editorial) is not as unfair as Scalia suggests.
Saturday, March 29, 2008
Joseph King (Tennessee) has published an interesting article: The Common Knowledge Exception to the Expert Testimony Requirement for Establishing the Standard of Care in Medical Malpractice, 59 Ala. L. Rev. 51 (2008). In the piece, King wrestles with one of tort law's great shortcomings, uncertainty, in the context of the common knowledge exception.
Pursuant to the exception, a plaintiff does not need to use an expert to establish the standard of care in a med mal case if the subject matter of the allegedly unreasonable conduct is within the common knowledge of people without medical training. Although King supports the doctrine in theory, he argues that its application has been so unpredictable as to arouse rule-of-law concerns. The challenge is to provide sufficient guidance to judges, lawyers, and litigants while retaining enough flexibility to cover an array of factual scenarios.
King's solution is to construct two alternative preconditions, the presence of one or the other being necessary, but not sufficient, for a court to invoke the common knowledge exception:
Either the specific conduct that allegedly constituted negligence was of such a nature that not only could an unlicensed layperson legally perform it without violating or offending applicable medical or health care licensure statutes or duly authorized regulations governing the practice of the health care professions, but also that such an unlicensed layperson would ordinarily be deemed competent and foreseeably expected to routinely perform such conduct; or, the specific decision making by the health care provider that allegedly constituted negligent conduct that caused the injury did not involve the exercise of uniquely professional medical skills, a deliberate balancing of medical risks and benefits, or the exercise of therapeutic judgment.
Friday, March 28, 2008
That's the view in this op/ed piece in today's Concord Monitor. On the one hand, the author, Christopher J. Seufert, is a trial lawyer. He has a financial stake in the argument, and one should take the opinion with a grain of salt. On the other hand, he does support his argument with some empirical data. Does he prove his point?
Keith Hylton has posted on SSRN The Economic Theory of Nuisance Law and Implications for Environmental Regulation. Here's the abstract:
I explore the economic structure of nuisance law as a mechanism for regulating environmental interferences and propose a modernized enforcement regime. The modern regime would retain public enforcement primarily in identifying environmental harms and as a backstop for private enforcement.
Thursday, March 27, 2008
My colleague Barbara Noah has helped put together this event:
On April 1st, 2008, Professor Tom Baker, Connecticut Mutual Professor of Law and Director of the Insurance Law Center at the University of Connecticut, will present "Confronting the Medical Malpractice Myth", an overview of his well-received book on the same subject. (See Tom Baker, The Medical Malpractice Myth, University of Chicago Press, 2005 (ISBN: 0-226-03648-0]). The event will be hosted by the student Health Law Association at Western New England College School of Law.
Quite a number of people were injured on the Son of Beast roller coaster at Paramount's Kings Island in Ohio in 2006 when a timber in the support structure broke. The ride went through extensive reworkings, including the complete removal of the loop (it had previously been the only extant wooden roller coaster in the world with a loop) and major structural changes. In addition, many, if not all, of the riders filed suit for their injuries. Now we know how much, in rough terms, all of that cost.
At least that's how much the park had been awarded in a lower court ruling in its suit against the ride designer's insurer. But the intermediate appellate court reversed, ruling that the kind of damages at issue were not covered.
That's probably about how much the park spent on the coaster when it was initially built.
Wednesday, March 26, 2008
In this week's Writ Column on FindLaw, Tony Sebok analyzes an interesting dram shop case in New Jersey: Bauer v. Nesbitt. As Sebok explains, Bauer involved several young men who were drinking at the C View Inn in Cape May, NJ. One young man, James Hamby, was visibly intoxicated. He left with his friend Frederick Nesbitt, who was not visibly intoxicated and - to the restaurant's knowledge - had been drinking soda all evening. Nesbitt crashed his car, killing Hamby. Hamby's estate sued Nesbitt and the C View Inn under New Jersey's Dram Shop Law. The trial court dismissed the suit against the C View Inn, but in a recent opinion, the appellate court reversed.
As Sebok notes, the appellate court "held that the risks that the Dram Shop Act was intended to prevent were not just accidents resulting from drunk-driving, but also any accidents that could foreseeably result from intoxication." Sebok argues that the appellate court "created a new duty in Bauer. It essentially held that since Hamby, the passenger, was visibly drunk, the bar had a duty to protect him against his own bad judgment which led him to accept a ride from Nesbitt, the driver. The problem with this logic, however, is that while Nesbitt was too drunk to drive, and Hamby knew it, the staff at the bar did not."
The full column analyzes the underlying rationales of the decision, the precedents cited by the court, and the potential policy implications. Give the column a read!
Today's Wall Street Journal includes an interesting article by Jeanne Whalen comparing the FDA's approval process for new drug applications with the European process:
It is unclear whether getting FDA approval has become tougher than getting approval from its European Union counterpart in London, the European Medicines Agency, known as the EMEA. Current data on the speed of approvals in the regions aren't available. In a study comparing the FDA and EMEA from 2000 to 2005, Tufts University researchers found that mean approval times were similar at the agencies -- about 15.7 months -- but that there was "considerably more variability" in FDA approval times.
Some industry executives theorize that the FDA faces more public and political pressure when considering approvals.
Tuesday, March 25, 2008
As the Philadelphia Legal Intelligencer (via law.com) reports, Philadelphia Common Pleas Judge Mark I. Bernstein has held that Pfizer can be held liable for off-label marketing of the generic version of its epilepsy drug, Neurontin:
The plaintiffs in the class action allege that the drug company defendants conducted a campaign to promote the prescription of its Neurontin drug and its generic equivalent, gabapentin, for a number of medical uses not approved by the FDA, according to court papers.
Philadelphia Common Pleas Judge Mark I. Bernstein let stand the claims of negligent misrepresentation, negligence and intentional misrepresentation in Clark v. Pfizer Inc. regarding the generic gabapentin made by third-party drug manufacturers.
Bernstein said that the legal question presented in Pfizer's and Warner-Lambert's motion for partial summary judgment was whether a drug company, which "negligently or intentionally perpetrates a fraud upon the medical community" by the off-label marketing of its name-brand drug, can be held responsible for money paid to other drug companies that make the generic equivalent of the name-brand drug. Assuming that the plaintiffs can prove their allegations at trial, "under Pennsylvania law, a defendant may be liable for misrepresentation to foreseeable plaintiffs even without any direct relations between the parties," Bernstein said in his March 14 opinion. It was foreseeable that the marketing of Neurontin for off-label use would increase the demand for the generic version of the drug, Bernstein said.
Under the judge's order, the class action against Pfizer will proceed with purchasers of both the brand-name Neurontin as well as purchasers of the generic gabapentin.
MedPage Today reports on a conversation with Neera Tanden, the chief policy director for Senator Hillary Clinton's presidential campaign. The interview included Senator Clinton's position on tort reform:
On tort reform, Clinton and Obama see practically eye to eye. Before they became presidential candidates, the two senators co-authored an article in the New England Journal of Medicine and co-sponsored legislation to fund programs for the disclosure of medical errors and compensation to patients. The bill would have created an office of public safety. Physicians would be given some protection from liability under a system that encourages greater disclosure.
Like Obama, Clinton strongly opposes caps on awards for pain and suffering. "There are instances where injured patients would be disadvantaged by a cap," said Tanden. "Malpractice premiums have gotten out of control and Hillary is focusing on reforming the insurance system so that physicians won't have to pay as much."
McCain, who has voted in favor of caps, says tort reform is a top priority. He favors eliminating liability for physicians who follow clinical guidelines and adhere to patient safety protocols.
Monday, March 24, 2008
The NYT today has a story about a now-fifteen-year-old boy in Fayetteville, Arkansas, who has been subjected to endless and merciless bullying over the years. As the story notes, it's not at all clear why he's been targeted the way he has been; at least one school official seems to think he is inviting it in some way. After several years and what seem to be reasonable efforts to work with the school system, the family has turned to litigation:
The Wolfes are not satisfied. This month they sued one of the bullies “and other John Does,” and are considering another lawsuit against the Fayetteville School District. Their lawyer, D. Westbrook Doss Jr., said there was neither glee nor much monetary reward in suing teenagers, but a point had to be made: schoolchildren deserve to feel safe.
In news that is certain to be central to litigation over the Minnesota bridge collapse, the AP (via the Washington Post) reports that 2003 photos showed bends in gusset plates that are now believed to be among the key failure points in the collapse.
The two photos are believed to have been taken by URS Inc., a San Francisco consulting firm the state hired to examine the bridge from 2003 to 2007.
"URS and the state have both got a lot of explaining to do as far as why (the bending) was not observed, and if it was observed, why that was not immediately investigated," James Schwebel, an attorney representing a group of victims, told the AP on Sunday. "How could it possibly have been missed?"
No lawsuit has been filed, but Schwebel said his engineering experts are studying the information.
Attorney Phil Sieff, who represents another group of plaintiffs, said the deformation could have affected how much weight the gusset plate could hold.
Saturday, March 22, 2008
This morning, Walter Olson points his Overlawyered readers to a post and comments on Coyote Blog. The discussion was initiated because of comments by jurors in the Ritter med mal case that they were torn between sympathy for the family and their belief that the doctors were blameless. It's worth a look.
Friday, March 21, 2008
I'm traveling (and writing this in a dark hotel room with the rest of my family asleep, so forgive incoherence), and so haven't been following it all carefully, but In The Pipeline notes, in connection with Pfizer's efforts to take discovery into the peer review process at the NEJM, some developments.
A fair amount of commentary has suggested that Pfizer is purely fishing and/or purely an attempt to scare reviewers off. Perhaps, but it's worth remembering (as I argue here (e-mail me for a final reprint)) that much of what happens in the peer review process can be quite relevant to litigation (tending to lead to admissible evidence) -- and peer reviewers, and journals, are just as much subject to discovery as, say, doctors' records.
This is all the more so if the methodology used in the article is at issue in the litigation, in which case the mere fact of peer review makes testimony based on that methodology more likely to be admitted under Daubert. All of the Daubert factors are fact issues; thus, discovery related to them is appropriate. (If the peer review is done poorly and the peer reviewers' notes indicate that, then that factor should get less weight, for instance.) After losing the first subpoena issued, Pfizer has narrowed its request in a way that suggests to me that they are in fact focused on Daubert issues, as they are just asking for peer reviewers' comments.
All that said, as again I argue, there are in some cases greater risks in connection with peer review discovery than garden-variety third party discovery, and I propose some protections. But I do not think it appropriate to treat the entire neighborhood of peer review as sacrosanct and immune from the same third-party discovery that the rest of us are subject to. The courts are looking at the requests and, probably appropriately, balancing the hassle compared to Pfizer's interests. Maybe these requests should be granted, maybe they shouldn't, but the outrage seems misplaced.
On Wednesday, the Attorney General of Washington, Rob McKenna(R), faulted tort law for siphoning away scarce government resources. He cited the lack of boundaries on claims and Washington's continued use of joint-and-several liability. He also compared Washington's annual tort payments with those of neighboring states (allegedly ten-times as much as Idaho and six-times as much as Oregon). McKenna did not advocate a return to sovereign immunity, but called for limits. He also said he would not propose tort reform again (he last did so in 2006) until it had a reasonable chance of passage. The Washington State Trial Lawyers disputed McKenna's characterization of Washington as overly-friendly to liability. The group noted that Washington is one of only two or three states that allows no wrongful death suit by anyone on behalf of a person who reaches the age of majority and has no children, thus allowing a complete avoidance of responsibility for the death. In addition, Washington is one of the few states that has no punitive damages. The full story is here.
James Gibson (Richmond, Visiting at Virginia) has posted on SSRN Doctrinal Feedback and (Un)Reasonable Care. In this piece, Gibson discusses the relationship between an abstract legal standard (e.g., reasonable care) and the "real world" to which the standard is applied (e.g., medical practice). Here's a taste from the abstract:
For example, suppose a physician provides more-than-reasonable care - extra tests, unneeded procedures, etc. - so as to steer clear of tort liability's considerable gray area. If other physicians follow suit, their precautions slowly but surely become the new legal norm, as the reasonable care standard dutifully absorbs the conduct of those it governs. Instead of discouraging wasteful practices, the law feeds them back into doctrine, making overcompliance into mere compliance and racheting up the standard of care. Overcautious physicians then have to do even more to steer clear of liability, and the cycle begins anew.
Thursday, March 20, 2008
A 60-foot escalator allegedly malfunctioned at Giants Stadium in late December, immediately following the Giants-Patriots game. The Star-Ledger reports that eight people have filed notices to sue the New Jersey Sports and Exposition Authority. Several of the reported claims are serious. The potential overlap between products and premises liability can make these claims doctrinally interesting. Perhaps the potential defendant is taking a cue from the Sorry Works! theory reported by Sheila yesterday:
"While the investigation is ongoing it is inappropriate for us to comment, but the authority management empathizes with those guests of ours who were affected," said John Samerjan, a spokesman for the sports authority, which operates Giants Stadium.
Notice the distinction between an expression of sympathy and an acknowledgment of responsibility.
After passing the Health Committee, the Hawaiian tort reform bill moved to the House floor, where the House agreed by voice vote to send the bill back to committee. The Honolulu Advertiser has more. State KHNL reports that Rep. Josh Green (D-6th) plans to bring tort reform up again next session.