May 6, 2006
Rule 702 and Pre-Rule 702 Rulings
BadScience.net on Mercury Fillings
A pointed look at press coverage of fears about mercury fillings in the UK. I saw a story or two about the results of the first controlled study (which found no ill effects from mercury in dental fillings), in contrast to Goldacre, but certainly not much.
He's also got an interesting take on early coverage of a forthcoming study about "electrosensitivity."
May 5, 2006
S. 22: "Medical Care Access Protection Act of 2006"
The text of the Senate bill is now available.
What it does, in short and occasionally oversimplified form:
- Imposes a statute of limitations of either three years after "manifestation of injury" or one year after either actual or constructive discovery of the injury, whichever is first (with exceptions for fraud, intentional concealment, or Bad Things left in the plaintiff's body;
- Explicitly requires Rule 11 sanctions in med mal cases to include attorney fees;
- Caps noneconomic damages at $250K per provider and institution (edit: with a $250K limit on damages versus providers no matter how many and $500K versus institutions no matter how many), and overall to $750K (not $500K, as I previously had it) (and bars the jury from being informed of the caps);
- Requires proof by clear and convincing evidence (using enumerated factors and  a showing of either malice or something like reckless indifference)) to obtain punitive damages, and caps them at double compensatories or $250K, whichever is greater;
- Requires (for judgments over $50K) structured payouts (edit: to be available on request);
- Eliminates joint & several liability;
- Eliminates the collateral source rule;
- Limits contingent fee percentages on a sliding scale, starting with a maximum of 40 percent and ending at 15% for any damages over $600,000;
- Limits expert witnesses to (more or less) physicians in the same specialty;
- Immunizes in products suits physicians prescribing FDA-approved drugs for approved indications (note that this will, if adopted, make many more pharma suits removable and will probably result in many more sales reps and other random nondiverse parties being added to avoid diversity); and
- Attempts to avoid or mitigate obvious federalism concerns by disavowing preemptive effects in certain categories.
This was a quickly-done list; corrections and additions are welcome. (Some from the comments are reflected above.)
Rhode Island Proposals
Rhode Island (which my daughter informs me is not an island after all) has a fairly broad tort reform measure under consideration. It would:
Places a two-year statute of limitations on filing a medical malpractice claim. The current statute of limitations is three years.
Requires a timely disclosure of expert testimony.
Caps non-economic damages at $250,000 and also the amount of attorneys' fees that can be collected.
Requires timely disclosure of expert witnesses.
Establishes a pre-trial screening mechanism at the outset of the claim to determine if the case has merit to go forward.
Changes the rules on prejudgment interest to discourage plaintiffs from waiting for years before filing a claim.
May 4, 2006
Texas as Reform Model
That's what Newt Gingrich and Dallas surgeon John Gill say in today's WSJ, citing to the state's caps on noneconomic damages, spread-out payments on large awards, and "Good Samaritan" protections. (The actual piece costs money; this Law Blog piece summarizes it.)
physicians are returning to the state, particularly in underserved specialties and counties. Insurance premiums to protect against frivolous lawsuits have declined dramatically, with the state’s largest carrier reporting declines up to 22% and other carriers reducing premiums by an average of 13%. The number of lawsuits filed against doctors has been cut almost in half.
Some questions (real questions - I'd love to know the answers):
- What is the basis for "physicians are returning to the state, particularly in underserved specialties and counties"? Is there a basis for tying this to Texas's legislative changes?
- Do insurers really separately insure "frivolous lawsuits"? Have only frivolous suits been reduced?
- Is it an unmitigated good to report that "the number of lawsuits filed against doctors has been cut almost in half"?
More Bausch & Lomb Recalls to Come?
Apparently a B of A analyst thinks so because non-Moisture Loc products are apparently also being linked to infections. Think lawyers are paying attention? Check out the ads at the bottom of the linked page:
May 3, 2006
Compensation for Injured Clinical Trial Participants
This NEJM piece (free full text) has more, arising out of, among other things, the TGN1412 debacle. The lack of uniformity of insurance and compensation infrastructure is surprising to me. The conclusion:
Although the ethical arguments for compensating injured research subjects are compelling, the practical details are complicated — particularly the determination of the extent and duration of coverage and the assignment of the responsibility for paying compensation. However, the actuarial expense of covering direct medical costs may be relatively low, because serious injuries are unusual. In the United States, national leadership — from the clinical-trials industry, academic medical centers, and the federal government — will be needed to catalyze major change.
A Right To Unapproved Drugs?
The Abigail Alliance for Better Access to Developmental Drugs (“the Alliance”) seeks to enjoin the Food and Drug Administration (“FDA”) from continuing to enforce a policy barring the sale of new drugs that the FDA has determined, after Phase I trials on human beings, are sufficiently safe for expanded human testing (hereafter “post-Phase I investigational new drugs”). More specifically, the Alliance seeks access to potentially life-saving post-Phase I investigational new drugs on behalf of mentally competent, terminally ill adult patients who have no alternative governmentapproved treatment options (hereafter “terminally ill patients”). The Alliance contends that the FDA’s policy violates the substantive due process rights to privacy, liberty, and life of its terminally ill members. The complaint presents the question of whether the Due Process Clause protects the right of terminally ill patients to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational new drugs that the FDA has yet to approve for commercial marketing but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing on a substantial number of human beings.
Upon applying the Supreme Court’s test for addressing substantive due process claims set forth in Washington v. Glucksberg, 521 U.S. 702, 710 (1997), we hold that the district court erred in dismissing the Alliance’s complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. First, the right at issue, carefully described, is the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor’s advice, even where that medication carries risks for the patient. Second, we find, upon examining “our Nation’s history, legal traditions, and practices,” Glucksberg, 521 U.S. at 710, that the government has not blocked access to new drugs throughout the greater part of our Nation’s history. Only in recent years has the government injected itself into consideration of the effectiveness of new drugs. Third, Supreme Court precedent on liberty indicates that the right claimed by the Alliance can be inferred from the Court’s conclusion in Cruzan v. Director, Missouri Department of Health, 497 U.S. 261, 278 (1990), that an individual has a due process right to refuse lifesustaining medical treatment, id. at 279. Here, the claim implicates a similar right — the right to access potentially lifesustaining medication where there are no alternative government-approved treatment options. In both instances, the key is the patient’s right to make the decision about her life free from government interference.
Update: Still haven't read all of it, but enough of the conclusion to observe that the main conclusion is that the district court is to evaluate the FDA's conduct under the "narrowly tailored" test. A commenter suggests that this is a fairly limited ruling; since I don't know that much about how the compassionate use process is today, it's hard for me to evaluate.
May 2, 2006
Humanizing Tort Reform: The Astroturf Edition
A few months back, I had a series of posts about humanizing the teaching of Torts, in part by emphasizing to students that the cases involve actual people. In the comments, Ted Frank suggested that the negative impact of tort litigation on society, too, should be made clear - humanizing tort reform, if you will. (See here, here, here, here, here, here, and here for I believe the whole series.)
The American Justice Partnership, a group created by the National Association of Manufacturers (in conjunction with "the American Tort Reform Association, Washington Legal Foundation, Manhattan Institute, Center for Individual Freedom, American Legislative Exchange Council, Council of State Chambers, and a number of state manufacturing associations and chambers of commerce") apparently has the same idea.
For more than 40 years, plaintiff lawyers have spent tens of millions of dollars to convince the American public that they are using the civil justice system to protect average citizens. In fact, many plaintiff lawyers have manipulated the courts so that they stand to gain millions -- and even billions -- in legal fees at the expense of their clients, consumers, patients, employees, average investors, small business owners, corporations assaulted by frivolous and unwarranted lawsuits, and our state and national economies.
The American Justice Partnership is collecting examples of lawsuit abuse so that we and our partner organizations can bring more examples to the attention of government and the media about ways that consumers and companies are being victimized.
The survey is administered (based on the contact e-mail address) by Emerging Trends Consulting Group, which "helps chief legal officers and law department management teams to develop and implement transformative strategies to generate better legal, financial and reputation outcomes." Their client list includes "Sears, DuPont, Baxter International, Viacom, Prudential Financial, Pitney Bowes, McDonald’s Corporation, Manulife Financial, The New York Stock Exchange, International Paper, The Hartford, Lucent Technologies, Tyco International, Shell Oil Company, Schering-Plough, DaimlerChrysler and Wal-Mart Stores, Inc., among others." The group lists a wide range of "legal reform partners and resources." AJP's domain names are registered to Agincourt Corporation, an entity related to Emerging Trends. (Note that I don't think there's anything particularly nefarious here -- I just found the links interesting and thought I'd share.)
Update: In the comments, Ted points out, correctly, that AJP is pretty up-front about what it is -- i.e., not a grassroots group. The "Astroturf" in the title is a reference to the NAM blog post which, in my view, should have noted that AJP is an affiliate of NAM itself. It's not hard to find that out, but it's even easier to say up-front. I should have been clearer about the reference, in any event.
Best Headline Today
(I have to note that I was much more amused when I thought it said "Self-Hating Latte Cans Bring Out Lawyers." One can only imagine what a self-hating latte can would be -- perhaps its labeling would say "C'mon, it's just coffee and hot milk in a can, and you're paying three bucks for it?! I'm not worth it, you pretentious-yet-oddly-downmarket consumer.")
Anyway, it's an interesting story about Wolfgang Puck's line of self-heating lattes-in-cans being withdrawn due to utterly predictable (to the non-self-heating-latte-specialist, anyway) Bad Things(tm) -- exploding cans, leaking chemicals, etc.
The story also contains a stunning blast of obviousness at the end:
But one beverage industry expert says that self-heating coffee was never going to be a booming business. "This package was an interesting novelty, but was never going to be a big idea," said John Sicher, publisher of Beverage Digest. "It's not exactly hard to find a hot cup of coffee in America."
(Via WSJ LawBlog.)
Peer Review & Fraud
The NYT has a useful overview of recent discredited scientific research and a look at the realities of the peer review process.
Because findings published in peer-reviewed journals affect patient care, public policy and the authors' academic promotions, journal editors contend that new scientific information should be published in a peer-reviewed journal before it is presented to doctors and the public.
That message, however, has created a widespread misimpression that passing peer review is the scientific equivalent of the Good Housekeeping seal of approval.
Virtually every major scientific and medical journal has been humbled recently by publishing findings that are later discredited. The flurry of episodes has led many people to ask why authors, editors and independent expert reviewers all failed to detect the problems before publication.
Worth a read.
Warning: Do Not Use or Sell These Products. Ever.
I was certainly aware of the generally negative take on trampolines, but wasn't aware of the fact that "the American Academy of Pediatrics recommends that trampolines never be used at home, school or on outdoor playgrounds." Wow. Well, that leaves, I guess, indoor playgrounds.
Also of interest: United Nuclear Scientific Equipment & Supplies asserts that the CPSC is trying to bar it from selling all sorts of chemicals that can be used in explosives but also in various legal uses. United Nuclear (who might want to consider a new name if they're really trying to improve their public perception) is seeking financial contributions to fight the requested injunction.
(both via Consumerist.)
May 1, 2006
Bush on Malpractice
From Point of Law (which has a longer quote), the president at a speech this afternoon:
Our fifth policy to confront high cost health care and to make sure private medicine is central in the United States is to confront the glut of frivolous lawsuits that are driving good doctors out of practice and driving up the cost of health care. (Applause.)
* * *
The total cost of defensive medicine to our society is estimated at $60 billion to $100 billion a year, and that includes $28 billion billed directly to the American taxpayers through increased costs of Medicare, Medicaid, Veterans Affairs, and other federal health programs. The costs of frivolous litigation are more than financial; they hurt patients all across America.
* * *
This is a national issue that requires a national response. The House of Representatives have [sic] passed a good bill. The Senate has done nothing on medical liability reform. For the sake of affordable and accessible health care, we need medical liability reform this year. (Applause.)
Update: The full transcript is available on the WH website.
You can also see Bush's State of the Union reference to med mal and blogs' discussions of it...
April 30, 2006
Tort Filing Trends
Point of Law notes that federal non-asbestos products filings are rising (from around 6,000 in 1995 to around 29,000 in 2005) as a response to claims that tort claims more generally are falling. Of course, tort law is largely a state matter (with diversity cases and, now, CAFA moving many cases to the federal courts).
So what do we know about state filings?
While it's not as specific as the federal data are (PoL cites non-asbestos products cases, which I agree represent a useful metric - probably more useful than just tort cases), we can also look at some state data.
In 29 states, there were just shy of 571,000 tort cases in 1994 and just over 542,000 in 2003; given population trends, that is clearly a drop. That said, the NCSC does not appear to provide a way to break it down further into, for example, non-asbestos products cases, so I'm not sure at this point what smaller trends it may reflect.
[Update: Ted has updated the PoL post to acknowledge the state law role in tort litigations, so some of the above doesn't make sense.]
Doctors and Lawyers and Evidence, Oh My!
An interesting discussion of evidence in medical malpractice cases.
(Why, yes, I am avoiding working on writing exams.)
Money-Grubbing Everyone, Redux
The NLJ has another overview of the battling money-being-placed-in-various-places tort reform ads.
(See this entry for my earlier note on it.)
FDA & Politics
LAT has a story about the FDA, simultaneously showing an agency in disarray and continuing with its daily business. Plan B's approval (or lack thereof) is identified as the wrench in the works, causing (and along with) the lack of a confirmed director. It's worth a read.
(Blogging may be a little slow while I work on drafting exams.)