Tuesday, April 14, 2015
Richard Epstein & Ryan Abbott have posted to SSRN FDA Involvement in Off-Label Use: Debate between Richard Epstein and Ryan Abbott. The abstract provides:
Before a drug can be sold legally in the United States, the Food and Drug Administration (FDA) must approve it as safe and effective for a particular indication or use — the use then appears on the drug's label. Federal law, however, allows doctors to prescribe drugs that the FDA has approved for one indication for any other indication, even though the FDA never evaluated the safety or efficacy of the drug for that use.
Off-label prescribing is an integral part of modern-day medicine. Patients may benefit when they receive drugs or devices in contexts not approved by the FDA. In fact, in some instances an off-label use may be the standard of care for a particular health problem. However, off-label prescribing can also harm patients, especially when an off-label use lacks a solid evidentiary basis.
For this reason, the FDA forbids drug companies from promoting their own products for off-label use, except for certain activities such as disseminating research literature and sponsoring educational programs. In recent years, civil and criminal actions against drug companies for illegal promotion for off-label use have proliferated, leading to many large settlements. For example, in July 2012, GlaxoSmithKline pled guilty and paid $3 billion to resolve criminal and civil liability arising from the company's unlawful prescription drug promotion, failure to report safety data, and false price reporting practices.
As a result of this recent litigation, many have questioned the FDA's current role in regulation of off-label use and whether more or less intervention is needed. This debate sought to address these very issues.
Wednesday, March 18, 2015
On March 6th, Sharon McQuown addressed the ABA's Health Law Section on emerging issues in health care law and discussed the impact of EHR (electronic health records) on med mal litigation. Specifically, she discussed how the design of EHR could have helped avoid the misdiagnosis of Ebola in a Texas hospital. Shortly after the patient died, the hospital instituted EHR changes, including:
- Adding a new tool in the EHR requiring a "hard stop confirmation" by the physician that he/she had been told that the patient had recently been to a country of concern
- Creating a more robust screen that draws attention to travel with a red box on top and specific identification of countries traveled
- Adding a banner alert screen if a patient is flagged for infectious disease with an alert of steps to be immediately taken
- Changing the discharge process so that discharge papers could no longer be printed early or if anything was unresolved in the document.
Fierce EMR has the story.
Monday, September 2, 2013
David Weinstein and Christoper Torres (Greenberg Traurig) have written an article surveying the use of Lone Pine orders, a case management tool used in mass tort cases. In the article, "[t]he authors have compiled a table of decisions or orders issued in 83 cases, (see pages 4 through 7), which are categorized by case name, basic case type, jurisdiction, whether a Lone Pine order was entered, and, if so, whether it was enforced."
A copy of the article can be downloaded here.
Wednesday, May 8, 2013
A team of doctors has published a study by this name in the Journal for Healthcare Quality. The absract provides:
Catastrophic medical malpractice payouts, $1 million or greater, greatly influence physicians’ practice, hospital policy, and discussions of healthcare reform. However, little is known about the specific characteristics and overall cost burden of these payouts. We reviewed all paid malpractice claims nationwide using the National Practitioner Data Bank over a 7-year period (2004–2010) and used multivariate regression to identify risk factors for catastrophic and increased overall payouts. Claims with catastrophic payouts represented 7.9% (6,130/77,621) of all paid claims. Factors most associated with catastrophic payouts were patient age less than 1 year; quadriplegia, brain damage, or lifelong care; and anesthesia allegation group. Compared with court judgments, settlement was associated with decreased odds of a catastrophic payout (odds ratio, 0.31; 95% confidence interval [CI], 0.22–0.42) and lower estimated average payouts ($124,863; 95% CI, $101,509–144,992). A physician's years in practice and previous paid claims history had no effect on the odds of a catastrophic payout. Catastrophic payouts averaged $1.4 billion per year or 0.05% of the National Health Expenditures. Preventing catastrophic malpractice payouts should be only one aspect of comprehensive patient safety and quality improvement strategies. Future studies should evaluate the benefits of targeted interventions based on specific patient safety event characteristics.
Friday, April 12, 2013
By a 27-12 vote, the Florida Senate passed SB 1792, requiring an expert against a defendant doctor to be in the same specialty as the defendant, not just the same field. The bill now goes to the Florida House. The Jacksonville Business Journal has the story.
Thursday, April 11, 2013
The Florida Senate is set to vote today on a tort reform package (SB 1792) that would make med mal cases more difficult to pursue. The major provision requires expert witnesses called against a defendant doctor to practice the exact same kind of medicine as the defendant instead of only being in a similar field. An AP story is here.
Thursday, December 8, 2011
In my Torts class, we discuss consent to intentional torts in, among other contexts, sports -- in particular hockey. Given the interesting evident difference between what is technically prohibited and what is generally accepted as part of the game, it's a nice foundation for a conversation. Add to that the New York Times extensively-researched look at hockey through the life, and death, of "enforcer" Derek Boogaard. Certainly worth a read.
Thursday, May 12, 2011
Or so goes the argument at Abnormal Use, addressing a case in which savvy expert selection probably got the plaintiffs past an otherwise-likely summary judgment.
(Incidentally, you should be reading Abnormal Use if you're doing anything connected to products liability.)
Thursday, April 28, 2011
Thursday, February 3, 2011
I've written, both here and in more formal settings, a bit about historians serving as expert witnesses in litigation -- mostly in the setting of toxic torts. This year, I'm starting a long-term project examining the broader role of historians in all sorts of litigation settings. The first step will be an attempt to catalog in wiki form -- as exhaustively as possible -- all of the instances of historians serving as expert witnesses.
The wiki will not immediately be public; I want to get it started and figure out the standardization before opening it up to others. But it will be made public sometime relatively early in the process. I expect it to include both information about experts (and the litigation in which they have participated) and original documents -- expert reports, briefing, judicial orders and opinions, and so on.
And so, I turn to you, our readers. If you have anything relating to historians serving in litigation settings -- in any context -- please send it to me. I'm looking broadly, so if it's someone who is opining in the context of history even though the expert's field is formally something else, send it. I figure more is better than less at this point.
My e-mail is wchilds AT law DOT wnec DOT edu. I thank you in advance for your help.
Thursday, November 18, 2010
LegalNewsline focuses on how toxicogenomics--the study of the relationship among the cell's genome, chemicals in the environment, and disease--will play out in toxic tort litigation, especially on proof of causation. Among other issues, the article discusses whether toxicogenomics will favor plaintiffs or defendants as a class. Andy Klein (Indiana-Indianapolis) and Steve Gold (Rutgers) are quoted.
Thursday, August 12, 2010
As readers may recall, David Egilman was a plaintiffs' expert in the Zyprexa litigation and the courts concluded that he worked with Alaska attorney James Gottstein to make public documents designated as confidential under a protective order. Dr. Egilman settled the potential contempt litigation with a donation to a charity and with an affidavit in which he acknowledged, under oath, violating the protective order, releasing documents selectively, and so on. (The affidavit is here.)
Monday, July 19, 2010
The National Law Journal (via law.com) reports that a federal district court judge has thrown out the plaintiff's causation expert in the "popcorn lung" case. The suit alleged that microwave popcorn caused the plaitniff's bronchiolitis obliterans, also known as "popcorn lung." WIth no causation expert, plaintiff's suit was dismissed.
Thanks to Lisa Smith-Butler for the story.
Sunday, April 25, 2010
Tuesday, March 9, 2010
Jon Wiener of The Nation has an interesting cover story, "Big Tobacco & the Historians: A Tale of Seduction and Intimidation," in last week's issue. It's well worth a read, especially to see the view of the tort system from the academic historian's perspective.
Some quick observations:
- The piece addresses R.J. Reynolds's attempt to subpoena an unpublished work-in-progress by plaintiffs' expert Robert Proctor, describing the effort as "harassment-by-subpoena." The subpoena was ultimately rejected, according to the story, but the story doesn't suggest (at least to me) that the attempt to obtain the material was facially frivolous, dealing as it did with fairly unusual issues of Constitutional dimension. And of course, it seems fair to observe that Proctor's expert work is compensated, pretty well ($40,000 per year over a dozen years), so I expect he's not having to pay for his lawyers out of his academic salary. That's not to say I think litigants should engage in discovery as a way to intimidate witnesses, nor that people should have to pay for lawyers to protect themselves from unwarranted harassment -- just that it's not self-evident that that's what happened here as opposed to discovery.
As for the rest of the contention that the discovery process is overly demanding and constitutes harassment of experts, nothing in the story suggests that the depositions, etc., in the tobacco litigation are anything more than what is expected of experts on both sides of every high-stakes case. Especially in mass tort cases, experts end up getting deposed many times, because those factual issues predominate and are specific to the particular plaintiffs. Maybe that's a problem in its own right, but I don't see it as something unique to tobacco litigation or unique to plaintiffs' experts.
- More notably, there is, it seems to me, a bit of a disjunction between the types of historian testimony being offered. (The article notes, with evident disapproval, that there are far more historians testifying for defendants in tobacco litigation than for plaintiffs. I'm not sure numerical equivalence is or should be a goal, but set that aside.)
As a general matter, the defense experts testify, per Wiener, that "'everybody knew' smoking causes cancer. So if you got cancer from smoking, it's your own fault." If there is a factual dispute about the level of knowledge of the risk of cancer at a particular time, that seems to me to be a reasonable situation to use expert testimony, and like a reasonable thing for a historian to do. To the extent that plaintiffs' witnesses rebut that testimony, again, that seems reasonable, and indeed, in at least some cases, that's what Proctor testifies about. So far so good, since the knowledge of a plaintiff of a risk is clearly a relevant factual issue in most smoking cases, and one way to show that is through the general knowledge. (It also presumably goes to the reasonableness of the defendant's conduct in light of the purported knowledge of consumers about risks -- if a knife is obviously sharp, one generally need not tell the buyer that the knife is sharp.)
On the other hand, a mistrial was granted when Proctor started to testify about the history of racism in tobacco marketing, including highly offensive brands -- brands not, so far as I can tell, marketed by any extant company or defendant -- that included racial epithets in their names. The mistrial motion is termed a "tactic practiced by tobacco lawyers," again with evident disapproval. In an Engle progeny case, I cannot imagine the relevance of that testimony, no matter how abhorrent the underlying conduct (again, by entities not in the trial) is. The trials -- again, especially in Engle progeny cases -- are about a single factual dispute between one plaintiff and one defendant. While that history is disturbing and relevant to moral judgments (and perhaps to punitive damages if the defendant in that case marketed those products), I don't see how it would make anything at issue either more or less likely to be true. Unless there is a connection between those brands and the defendants in that case, the mistrial motion seems pretty reasonable.
As with many cases of academics venturing into the world of high-stakes litigation (see also Pathophilia's recent post about my Nebraska Law Review article), much of the story suggests some shock that the litigation world is what it is. And certainly it can be ugly, and perhaps ought to be changed. But that doesn't mean its ugliness is directed specifically at any particular expert, or solely at experts for one side or another. It does suggest that experts should be better educated early on about what is likely to happen in litigation.
Update: The Nation has posted an exchange between Weiner and a reader involved in the issues.
(In case it is of interest, I have never done work for the tobacco industry or tobacco plaintiffs, and have had no private clients of any sort for well over a year. Maybe two.)
Tuesday, February 9, 2010
On last week's roundup, I linked to a Drug & Device Law Blog post on litigation-driven scholarship and peer review. I'd commented on that post, and that triggered a post from Dr. Barbara Martin that might be of interest.
Wednesday, January 20, 2010
Business Week has the details. The plaintiffs (nineteen among thousands of people with related claims) are former pipe workers and they allege that Exxon knew as early as the 1930s that their drilling pipes were contaminated but didn't inform regulatory agencies until 1988.
Exxon asserts that it did nothing wrong and contends that the radiation levels that were there are insufficient to cause harm. The story suggests that the plaintiffs are seeking medical monitoring and punitive damages -- it makes no reference of any current injuries. Three workers who do have cancer settled prior to trial; none of the current plaintiffs have cancer.
The owners of the property where the plaintiffs worked obtained a $1 billion punitive damages award against Exxon in 2001; that amount was reduced to $112 million and paid. In those appeals, a Louisiana appeals court called Exxon's conduct "inexcusable."
Tuesday, March 3, 2009
In a story that touches on both criminal and civil cases (and notes the financial influence of civil cases), The Nation this week gives a preview of the upcoming Massachusetts Supreme Judicial Court's appeal of Paul Shanley, convicted a few years ago in a sex abuse scandal largely on the basis of "recovered memories." The article is critical of the expert testimony and notes that most courts in more recent years have rejected similar evidence.
Thursday, February 12, 2009
Monday, February 9, 2009
It's a lengthy and complicated story, but you might find it interesting: here (Goldacre's Bad Science blog, including a gazillion links to more coverage).