March 4, 2006
Post-Approval Studies: Still Waiting...
According to the NYT:
When it approves new drugs for sale, the Food and Drug Administration often requires their manufacturers to study whether they are working as intended and whether they have unwanted side effects. But the agency reported Friday that two-thirds of the studies had not even been started.
Hundreds of studies have been pending for years, the F.D.A. said, with one dating to 1955. In many cases, pharmaceutical makers promised to undertake the studies as a way to speed their drugs' approval.
I'd hate to be defense counsel when one of those promised studies dealt with the adverse event alleged.
March 3, 2006
Who is in Clinical Trials?; Also Really Obvious Conclusions
A critical part of most pharmaceutical litigation is the clinical trial information. The selection criteria of the investigators are often a focus, with parties contending that those criteria either do or do not fairly reflect the likely patient population or do or do not provide data that will reveal likely adverse events.
Another factor in trials, though, is the self-selection process -- i.e., which people who would be eligible under the selection criteria to participate actually do so. A new study provides some interesting information about what barriers come into play in cancer studies:
The following issues were identified most often by patients as barriers to participation in a clinical trial:
• fear that their quality of life might be reduced
• reluctance to accept the chance that they might get a placebo
• concern about potential side effects
• concern that treatments under study in the trial are not their best option
These do not obviously lend themselves -- at least to me -- to an argument that the people who do end up signing up for clinical trials (under three percent of cancer patients, according to the report) are not more or less representative of the full group, but these sorts of barriers to volunteering could be interesting to explore, especially if there are differences between the sample group and the general population that would not be captured in screening for selection criteria.
In other recently-publicized federal press releases that could reasonably be identified as coming from the Bureau of Really Obvious Things (with apologies to The Onion for stealing the concept):
Preemption Junction, What's Your Function?
An interesting fight over preemption is developing in connection with a derailment and chemical spill in Minot, ND, and the effect of a federal court's decision in one case on a state case.
Canadian Pacific Railway is appealing a decision by a Minneapolis judge not to dismiss lawsuits filed over a derailment and chemical spill at Minot four years ago.
The railroad is citing a Feb. 14 ruling by U.S. District Judge James Rosenbaum, who threw out a claim against BNSF Railway in an October 2003 Perham, Minn., derailment that damaged a privately owned warehouse.
Rosenbaum said the railroad was immune from legal action under pre-emption, a legal premise by which some businesses under federal regulation are exempt from lawsuits.
Judge Tony Leung in Hennepin County District Court in Minneapolis [who is handling the Minot case] late last year cited a federal magistrate who said there is no intent in the federal laws to pre-empt personal injury claims stemming from a railroad's actions.
Canadian Pacific wants Leung's decision reversed, based on Rosenbaum's ruling.
* * *
Fargo attorney Mike Miller, who is representing hundreds of plaintiffs, said the railroad is "just leaving no rock unturned to try to avoid the responsibility of paying for the damages and injuries caused to the Minot people."
"The Federal Railroad Safety Act is a law that's designed to make the railroad safer, not to allow them to use it somehow as a shield against liability and a means of avoiding responsibility," Miller said.
Of course, the railroad would presumably contend that those goals are not necessarily in conflict. The case also has some interesting negligence per se issues.
[Update: The BNSF opinion is available here: Download BNSF.pdf [PDF].]
[I don't think there's any real need for a disclosure, but I clerked for Judge Rosenbaum.]
March 2, 2006
MDLs -- The Next Hearing
Here's the order [PDF]. Torts-related ones I noticed with oral argument:
- Profiler Products Liability (Not sure what this is. The defendant D-M-E makes molds.)
- iPod Nano Products Liability (presumably the scratching)
- In re Air Crash Near Canandaigua, New York, on September 16, 2002
- In re Bisphosphonate Drugs Products Liability Litigation (osteoporosis treatment)
There are piles of no-oral-argument oppositions to transfers in a Superstar All-Time Greatest Hottest Hits of Products Liability (asbestos, Phen-Fen, Vioxx, and so on), but frankly they're not that interesting.
(Oh, by the way, it's on March 30 in Las Vegas. Tough gig.)
A relatively new paper on SSRN:
Vidmar, Neil J., MacKillop, Kara and Lee, Paul, Million Dollar Medical Malpractice Cases in Florida: Post-Verdicts and Pre-Suit Settlements, Vanderbilt Law Review, forthcoming. Available at SSRN: http://ssrn.com/abstract=880736
From the abstract:
The present article extends that research [on a closed claim database] much further by comparing two sets of cases in which the payment to the claimant equaled or exceed $1 million. The first group involves cases that were tried to juries.We systematically compare the verdict with the amount the insurer actually paid. We also go a step further and examine the nature of the injury, including the medical treatment sought and the alleged cause of the injury.
The second part of the article examines a group of cases that were settled without a lawsuit. One of the most interesting findings from our earlier article is that, of claims resulting in payments of $1 million or more, fully 10.1 percent were paid without pleadings of any kind. In contrast only 7.5% of paid claims over $1 million followed a jury trial. Thus, while jury trials loom large in the public debate, the truly invisible cases - invisible in the sense that they evade the formal court system - constitute an even larger source of payments. We ask about the nature of pre-suit cases and compare them to the cases that went to trial and resulted in a plaintiff verdict.
Our approach to malpractice litigation issues in this paper involves qualitative as well as quantitative analyses. The qualitative analyses place a concrete face on the nature of the issues and the injuries experienced by patients involved in malpractice claims.
March 1, 2006
...And the Ball Goes Back Over the Net
“This is clearly a case where Americans for Insurance Reform decided they wanted to declare that there were no longer any problems getting medical malpractice insurance, and then they manipulated numbers to support their agenda,” said Ken A. Crerar, president of The Council of Insurance Agents & Brokers.
The press release goes on to say that AIR (nice acronym, by the way) misinterpreted data in the CIAB (less impressive acronym) reports -- for example (as Ted Frank noted in the comments on my earlier post), AIR took 63% of insurers increasing rates as constituting a 63% rate increase. Oops.
It does not seem quite accurate to state that AIR didn't take into account tort reform at all, since they do include a section going through a handful of states with or without recent caps and argued that the presence or absence of caps didn't affect insurance rates. That said, it's certainly not an in-depth look.
No Punitives for Lead Paint Makers in Rhode Island
The Judge ruled yesterday. Next is the evaluation of how much the abatement (required based on the underlying nuisance finding) will cost.
February 28, 2006
Punitives Arguments in Rhode Island
The lead paint manufacturers, not surprisingly, say they shouldn't be imposed, citing the enormous expenses they will incur in dealing with the public nuisance verdict. Additionally:
They said the companies' behavior could not be compared to criminal conduct since they were making a selling a legal product that was in high demand among consumers and government agencies alike. Lead-based paint was banned in the United States in 1978 after studies showed that the substance could cause severe health problems to children exposed to it.
The state is presenting arguments today.
Still More Med Mal Insurance Conclusions
It's beginning (or continuing) to feel a bit like a tennis match. Today we've got a study saying that the medical malpractice insurance crisis is over, and tying that to stabilization of insurance investments rather than tort reform or anything similar.
Americans for Insurance Reform (AIR) released a new study today confirming the wholesale decline of medical malpractice insurance rates nationwide. The AIR study also shows that this phenomenon is occurring whether or not states enacted restrictions on patients’ legal rights, such as “caps” on compensation. The medical malpractice insurance “crisis” is over, according to the study.
AIR’s study is based on the most recent Council of Insurance Agents and Brokers survey of market conditions, showing that the average rate hike for doctors over the past six months has been 0 percent. This is following similar results for the last quarter of 2004, which saw rates rising only 3 percent at the end of that year. By comparison, rates jumped 63 percent during the same quarter of 2002.
* * *
According to Joanne Doroshow, AIR spokesperson and Executive Director of the Center for Justice & Democracy, “Consumer rights organizations have long maintained that the ‘crisis’ of skyrocketing insurance rates for doctors and other policyholders would end when the insurance investment cycle stabilized, and that this would occur whether or not so-called tort ‘reform’ laws were enacted. Insurance industry data now unmistakably confirms this prediction.”
The full report is available here [PDF].
February 27, 2006
McDonald's Gluten Complaint
I tracked down the complaint filed by Dale & Pakenas against McDonald's based on the previously undisclosed gluten; you can download it here [PDF]. Of note, the suit is a class action, and not one limited to people with celiac disease (which the named plaintiff has):
(You can mentally insert the "[sic]" after the "it's.")
Update: While looking around a bit for a copy of the complaint, I noticed that in Cook County, Illinois alone, three class suits have been filed over the Frey book. I note, happily, that the named plaintiff in the McDonald's suit is not also the named plaintiff in the Frey suit:
Lead Paint and Punitive Damages
The Rhode Island punitives argument will be today. With most of the relevant conduct a long time ago (like many toxic tort cases), it's going to be challenging proof, I imagine, and hard to connect up the damages sought with anything that resembles the current defendants. Such an old case puts into question the value of punishment (though the deterrent effect presumably has as much force as it ever does). Much like the asbestos litigation, it's a good example (as was the underlying trial), too, of the difficulties of putting on an old case.
How Broad a Net for Adverse Events?
An FDA advisory panel earlier this month recommended a black box warning for ADHD drugs like Ritalin based on cardiovascular risks.
Much like the concerns about SSRIs and suicidal thoughts, however, a number of people argue that these drugs increase risks of violence among those taking them. From MediaMonitors.net, for example:
The numbers cited by the Food and Drug Administration (FDA) for possible attention deficit drug-related deaths and injuries represent a gross understatement of statistics. The truth is that these drugs are responsible for and [sic] endless stream of deaths and injuries all over the country.
* * *
For instance, on November 20, 1986, after being on Ritalin since the third grade, fourteen-year-old Rod Mathews lured a classmate, Shawn Ouillette, into a wooded area near his home in Canton, Massachusetts, under the pretense of a plan to build a snow fort, and beat him to death with a baseball bat.
Now, this seems like a bit of a cheap shot at the FDA report, which was presumably prepared specifically about CV risks. And it is difficult to attribute causation in any of the cases cited in the article (and there are a number) -- what else happened between third grade and 1986 in Mathews's life? (The article notes that he had no history of violence, but that's hardly enough to connect up -- no history of violence before third grade is not unique, even, I reckon, among murderers.)
Even with all of that, it's an interesting question -- if these were submitted to the drugmakers and FDA in the MedWatch system, how were they evaluated by their various recipients? How should they be evaluated? Is there a structure for monitoring third-party risks?