Saturday, January 21, 2006

FDA Preemption and Retroactivity

On an earlier post, DW asked about retroactive effects of the rulemaking.

A relevant excerpt:

Preempt_1

So the FDA thinks this is already the law -- no surprise given the amicus briefs mentioned.  So to some extent, this is a lot of hullabaloo (gosh, I like getting to use that word!) over something that's not really that big a deal.  But it's a nice explicit and non-case-specific articulation of their view.  Indeed, Dan Troy, former counsel at FDA (now at Sidley Austin Brown & Wood) made that position fairly clear, as I recall, at a DRI Drug & Medical Device conference I attended several years ago, and my sense is that the position has stayed consistent throughout the current administration.

So I think the answer is that if the FDA is right, it's not really even a question of retroactivity -- it's been that way all along, just that nobody really knew it.  The fact that the position has generally been unsuccessful in the past may suggest that it won't be in the future, but who knows?

January 21, 2006 | Permalink | Comments (0) | TrackBack (0)

Factual Causation Beyond DES

I'm a little puzzled about how I missed it last fall, but the Wisconsin Supreme Court extended "risk contribution" [big PDF] beyond the DES context, permitting plaintiffs injured by lead paint pigment to sue even without proof of the specific manufacturer of a generic product.  The opinion has the usual justifications -- who's better able to internalize costs, who's more culpable, etc.  Other than a case or two in the blood factor litigation, it's the only recent case I'm aware of -- though since I missed this one for half a year, maybe there are others out there.

In any event, I'll certainly be incorporating it into my factual causation discussions.

January 21, 2006 | Permalink | Comments (0) | TrackBack (0)

Friday, January 20, 2006

Potentially Interesting MDLs

The next hearing of the Judicial Panel on Multidistrict Litigation is coming up next week in sunny Orlando.  Some interesting proposed torts-related MDL matters from the schedule [PDF] for oral argument:

Ephedra (defendants' opposition to transfer of a pile of cases)
Lipitor marketing and sales practices (plaintiffs' motion to centralize)
Teflon (plaintiffs' motion to centralize)
Celexa and Lexapro (defendants' motion to centralize)
Honda Oil Filter (defendants' motion to centralize)
Grand Theft Auto, Second Try (first try was denied, plaintiffs' motion to centralize)
Canon Digital Camera (defendant's motion to centralize)
Ortho Evra (plaintiff's motion to centralize)

A bunch of oppositions to transfer are set for consideration without oral argument.

January 20, 2006 | Permalink | Comments (0) | TrackBack (0)

NYT Intervenes in Guidant Suit; Other Guidant Stuff

The New York Times won access yesterday to documents in the products litigation regarding Guidant's defibrillators.  According to reports describing the ruling, the documents may reveal a decision to sell off inventory even after a problem was identified.  [Update: The Times story has more, including a mention that still more documents may be coming; Guidant obtained a stay of part of the order pending appeal.]

It's just based on a hunch from watching a bunch of mass tort litigation, but it seems that reporters are getting more involved in document discovery issues -- specifically the proper scope of confidentiality designations -- than they ever were before.  At least occasionally, none of the actual direct participants in litigation are seeking to unseal or dedesignate documents, but media outlets intervene as here.  Along with the flip side, in which litigants seek to explore whether medical journals are intentionally affecting litigation, the lines seems to be getting fuzzier. 

Good or bad?  Dunno.  My next article is related to litigation-driven scholarship and discovery into peer review (as part of a broader exploration of law and science), so at the least, it gives me interesting things to think about.

As an aside, Guidant has been getting a ton of attention for the bidding war between Boston Scientific and Johnson & Johnson.  Based on that, one might think that the pending litigation regarding Guidant's defibrillators was a non-issue, or at least an insignificant issue, and it's struck me that most of the reports about the ever-escalating bidding war don't even mention the potential exposure. Here's how Guidant described the litigation status relevant to its defibrillator and pacemaker products (including both civil and criminal contexts) in its latest 10-Q (from November):

Approximately forty-five product liability class action lawsuits and approximately fifty individual lawsuits have been filed in various state and federal jurisdictions against the Company following the Company’s recent implantable defibrillator and pacemaker systems field actions. The majority of these cases are pending in federal court. In late September 2005, the Judicial Panel on Multi-District Litigation conducted a hearing to determine the sole issue of the location for consolidating the federal cases in front of one judge. To date, no decision has been made. An additional six lawsuits have been filed in Canada. The complaints in these product liability lawsuits generally allege strict liability, negligence, warranty and other common law and/or statutory claims. The majority of claimants alleges no physical injury, but is suing for medical monitoring and anxiety. The complaints generally seek class certification, monetary damages and injunctive relief.

The Company has received three requests for information in the form of Civil Investigative Demands (CID) from the attorneys general of Arizona, Oregon and Illinois. These attorneys general advise that approximately thirty-one other states and the District of Columbia are cooperating in these CID demands. The CIDs pertain to whether the Company violated any applicable state laws in connection with certain of its implantable defibrillators. The Company is cooperating with these investigations.
On November 2, 2005, the Attorney General of the State of New York filed a civil complaint against Guidant pursuant the New York’s Consumer Protection Law (N.Y. Executive Law § 63(12)). In the complaint, the Attorney General alleges that Guidant concealed from physicians and patients a design flaw in its PRIZM 1861 defibrillator from approximately February of 2002 until May 23, 2005. The complaint further alleges that due to Guidant’s concealment of this information, the Company has engaged in repeated and persistent fraudulent conduct in violation of New York Executive Law § 63(12). With respect to damages, the Attorney General is seeking permanent injunctive relief, restitution for patients in whom a PRIZM 1861 defibrillator manufactured before April 2002 was implanted, disgorgement of profits, and all other proper relief. Guidant plans to vigorously defend itself in this lawsuit.

The absolute numbers of suits are relatively small and maybe they'll stay that way.  And clearly J&J and Boston Scientific are sophisticated players with plenty of familiarity with the unpredictability of tort litigation.  So maybe it all makes sense after all...but it's still a bit surprising not to have that potential exposure mentioned more often.

January 20, 2006 | Permalink | Comments (0) | TrackBack (0)

Thursday, January 19, 2006

More Thoughts on the FDA Preemption

This WSJ Law Blog entry is interesting, if for no other reason as a reminder of what is certainly true: even if the FDA's position prevails (hardly a certainty), there remain a number of suits available to bring in drug cases.  Preemption would, indeed, make the doorway narrower, but not shut it entirely.

Preemption would also increase efforts to show fraud on the FDA or the equivalent, as a way to get around the preemption in the first place.  In many pharma claims, in many jurisdictions, there may be enough evidence that a sympathetic judge might decide that preemption didn't apply, or at least to allow the jury to consider the fraud on the FDA claim.

Update: The NYT article does a decent job of summarizing the rest of the rule.  In short form, it seeks to improve the accessibility of the package insert to physicians, with a "Highlights" section and the like.  It does not impose any similar additions to the patient PI.

January 19, 2006 | Permalink | Comments (0) | TrackBack (0)

FDA Rulemaking

The Products Liability Prof blog has noted the new FDA rulemaking reiterating/declaring the agency's current view that state law labeling claims are generally preempted.  A couple of document pointers may be helpful:

The relevant part of the rule starts on page 38 of this document [PDF]. 

Or, if you'd rather just see the most relevant 9 pages instead of all 100, I've excerpted them in this document [also PDF, but only 1.9 MB instead of 9.7].

ATLA's press release on the topic is available here.

[Disclosure: In practice I did pharmaceutical tort defense and continue as a consultant in ongoing litigation.]

January 19, 2006 | Permalink | Comments (3) | TrackBack (0)

Wednesday, January 18, 2006

Real-Life Documents, Installment 1

Since this blog is largely directed at torts profs (though the rest of y'all are welcome, too), I'm going to periodically share documents I've found useful in teaching.  Here's the first installment.

One of my interests is, oddly enough, amusement park safety (see my other site for much more about that).  I occasionally make FOIA requests of the CPSC and other federal and state agencies, sometimes for things that relate to my scholarship -- see this article, forthcoming in Capital University Law Review, for one example -- but often for more general background.

A recent acquisition is the report of the CPSC's investigation into a carnival ride called the Sizzler that fell apart in Shrewsbury, Massachusetts, in 2004, killing one patron and seriously injuring another.  I've found that very few if any law students have seen CPSC reports or anything of the kind, and that it can be valuable to spend a little time walking through such documents to give a sense of what one might find in discovery.

Similarly, I have about a dozen documents from the state investigation and civil litigation that resulted from a death of a patron on the Superman: Ride of Steel coaster at Six Flags New England (which happens to be five minutes or so from the law school).  Last year, the facts and documents from that case provided something of a storyline for the entire course -- the lawsuit even included intentional claims.

Other torts profs: what do you use along these lines?  Torts students: what do you wish your profs used?  Lawyers: what do you wish your profs used?  Use the comments field or send me a note.

January 18, 2006 | Permalink | Comments (0) | TrackBack (0)

Post-Katrina Litigation

USA Today has an interesting piece on lawyering post-Katrina in New Orleans and surrounding areas.  Point Of Law focuses on the sheer number of lawsuits.  The more interesting part to me (and one PoL does mention) is this:

The change in New Orleans' population likely will bring about another change in juries: They are likely to be whiter and wealthier than pre-Katrina juries. Before the storm, New Orleans' population was 68% black, the U.S. Census says, and more than 30% lived in households in which the income was below the federal poverty line, about $19,300 for a family of four.

Conventional wisdom (which I neither endorse or refute, simply observe) says the pre-Katrina demographics were plaintiff-friendly.  Current indications are that many of the first residents to return to New Orleans are wealthier professionals, possibly with a higher proportion of whites.  The impact on jury trials there -- and, not incidentally, on Houston where many Katrina refugees moved -- will be interesting to watch.

January 18, 2006 | Permalink | Comments (0) | TrackBack (0)

The Shrimp, Continued

In case you're desperate for more shrimp-injury-related news, thank heavens for the New York Post.

This Newsday piece provides a bit more substance, including a note that the decedent's physicians were unable to pinpoint the source of the infection that caused his death.

January 18, 2006 | Permalink | Comments (0) | TrackBack (0)

2005's Top Verdicts

Lawyers Weekly has posted the ten biggest verdicts of 2005.  As usual with such things, they should be taken with a recognition that many (most?) will not be recovered in the full verdict amount due to damage caps, high/low agreements, etc.  Notable, but not surprising to anyone who's paid much attention, is the piece's observation of how central e-mail has become, especially on the punitive damages side.

The WSJ law blog has a useful version of the list with links to stories on each one.

By my count, about six of the cases are what I would consider classic (if, in some cases, unusual) tort or products cases.  (I didn't count the fraud case.)

Update: See this entry for a verdict that LW missed.

January 18, 2006 | Permalink | Comments (0) | TrackBack (0)

Tuesday, January 17, 2006

Beware the Shrimp

Many readers have already seen the story (Overlawyered has discussed it several times), but just in case: the trial brought by a widow of a patron against Benihana has begun, and, as usual, you can count on the New York Post to provide measured coverage.  (Follow the link above, as well as this story from the first day of trial.)

The plaintiff, who is seeking $10 million, contends that the chef was a "klutz" who continued to throw food around the table after being asked to stop, and that eventually, the decedent was struck by a shrimp that he attempted to duck.  That blow caused an injury that eventually required surgery, which resulted in an infection, which resulted in the death of Jerry Colaitis, a wealthy fur seller.  The defense has pointed out that it would be an odd thing for a tips-dependent chef to repeatedly ignore the patrons' requests that he stop chucking shrimp around.

Interestingly, given the usual evidentiary rules about subsequent remedial measures, testimony apparently indicated that the shrimp- (or, for the allergic, chicken- or vegetable-) tossing ended after the incident. I suppose the defense may have decided to show its concern for safety by allowing the evidence in.

Testimony also included the tidbit that the practice was inspired by a Jackie Chan movie, Mr. Nice Guy, that I somehow missed.  As usual, I am strangely drawn to the IMDB descriptions of Chan movies: "A Chinese chef accidentally gets involved with a news reporter who filmed a drug bust that went awry and is now being chased by gangs who are trying to get the video tape."

January 17, 2006 | Permalink | Comments (0) | TrackBack (0)

Wrongful Death Damages and Sorrow

The single best event I attended at AALS in DC (besides, of course, the Texas party) was by Andrew McClurg at Florida International.  He presented his article Dead Sorrow: A Story About Loss and a New Theory of Wrongful Death Damages, 85 B.U.L.Rev. 1 (2005), in a session on compensation.

The article is fascinating and moving -- yes, I did just describe a law review article as moving.  He provides a wrenching account of the sudden death of his fiance Kody Logan, exploring his grief and the grief of her family in coping with the (tortious) car accident that took her life.  He also discusses his challenges in advising her family: "How do you explain to a mother who has just lost her only daughter that the value of her life under the law is literally zero?"  (Page 6.)

Ultimately, McClurg concludes that wrongful death suits fail to account for two important aspects of a death: the value of the decedent's life itself and the grief suffered by her survivors.  To deal with this failure, he proposes "damages for the lost value of life" that would

be used for the exclusive purpose of establishing a lasting memorial to the decedent.  Such a solution would promote both the economic deterrence and corrective justice models of tort law and serve, albeit indirectly, to compensate the decedent by continuing his or her memory and place in this earthly world.  Additionally, the memorial established with the lost life damages would, at no additional cost, provide a proven grief-healing instrument for all persons who mourn the decedent's passing.  Finally, because it is recommended that memorials created with lost life damages be required to serve a utilitarian function, another unique aspect of the proposal is that it would allocate tort damages in ways that benefit society in addition to tort victims, enhancing the net social benefit of the tort system.

(Page 9, footnotes omitted.)

I've assigned the article as part of my survival/wrongful death section in my evening Torts class (which is full year) and expect to add it to my syllabus in the future.  My hope is that it brings a reminder of the realities that the tort system seeks to deal with to a section of the course that can sometimes be rather technical.

The article is not online so far as I can tell, but is of course available via Westlaw and Lexis.

January 17, 2006 | Permalink | Comments (0) | TrackBack (0)

FDA Attempts to Preempt By Rule

Our neighbors here on the network at the Products Liability Profs Blog have a pointer for the FDA's attempt to preempt labeling claims via language in the preamble of a new rule.  As they note, this is part of an ongoing FDA effort to assert more exclusive control over pharmaceutical regulation.

January 17, 2006 | Permalink | Comments (0) | TrackBack (0)

Monday, January 16, 2006

Subsequent Remedial Apologies?

Vermont is discussing various tort reform measures, mostly in the context of medical malpractice.  The linked-to story is interesting for a number of reasons, including the fact that the commission set up by the legislature -- made up of plaintiffs' lawyers, physicians, medical industry representatives, insurance representatives, and so on -- is (surprise!) not agreeing on much.

What caught my eye, though, was this proposal:

The [Vermont] Medical Society is backing a range of reforms, including a "safe apology'' system under which doctors and hospitals can acknowledge errors without having that acknowledgment used against them in court . . . .

This is evidently not a completely new proposal, though it's new to me (this Tennessean story indicates that Colorado has a so-called "I'm sorry" law).  The idea, presumably, is the research and other writing that indicates that apologies can deter litigation or at least reduce animus and, presumably, settlement costs.

Edit: My colleague Barbara Noah suggests I link to the work of Jonathan Cohen at the University of Florida College of Law.  Good idea.  He's done a lot of work on apology.

January 16, 2006 | Permalink | Comments (0) | TrackBack (0)

CAFA's Impact

The Class Action Fairness Act was adopted nearly a year ago (at the time, I wrote about it on my other site, masstort.org).  Wondering about its impact so far?

One terrific resource on it is the CAFA law blog published by McGlinchey Stafford, which identifies itself as a defense and commercial law firm specializing in class action and other mass litigation defense.  The blog provides coverage of (so far as I can tell) every court decision discussing CAFA and a fairly detailed summary.

Many of the cases thus far have focused on whether the Act applies to a particular action at all.  A handful, such as the current top story, involve more substantive issues, like the scope of discovery available on the CAFA-related issues (size of class, size of aggregate claims, etc.).

I assume there are a number of other CAFA sites out there.  If you have a favorite, let me know (you can also use the comments field).

January 16, 2006 | Permalink | Comments (0) | TrackBack (0)

Alito and Torts

The National Association of Manufacturers endorsed Samuel Alito's nomination to the Supreme Court.  Their judicial criteria are available on their website and their blog includes quite a bit on the nomination, including statements from various of Alito's former clerks.  The criteria are, at most, general, and would seem likely to permit an endorsement or nonendorsement of just about any nominee.

ATLA does not appear to have taken a position on the nomination, though I may be missing it somewhere on its website.

(Disclosure: I signed the law profs' letter [PDF] opposing Judge Alito's nomination, though not generally for torts-related reasons.)

January 16, 2006 | Permalink | Comments (0) | TrackBack (0)

Trial Lawyers "Infiltrating" Texas Republicans

A new group in Texas claims that trial lawyers are trying to take over the Republican party in that state.  Janelle Shepard, executive director of Texans For Texas, which has launched a "Shark Watch" initiative:

I saw all this infiltration and influence by the trial lawyer culture, which is not compatible with the basic conservative agenda, so there's not really a way for conservatives to support what the plaintiffs/class action/trial lawyers are trying to do.

The group's report and other materials can be seen at the Texas Shark Watch website.

Among the attorneys contributing money to Republicans, and hence giving her organization concern, are Mark Lanier (who obtained the $250+ million Vioxx verdict [to be reduced by Texas's caps]), John O'Quinn (who made a lot in tobacco litigation), and Baron & Budd (which made its fortune in asbestos litigation).

As the San Antonio Express-News story linked to indicates, the Republican party dominates Texas politics.

January 16, 2006 | Permalink | Comments (0) | TrackBack (1)

Sunday, January 15, 2006

The Complicated World of Tort Reform

One of my first steps on taking on this blog was to set up a Google News search for "Tort Reform."  Today's top three responses seem particularly telling:


Tortreformsearch_2

January 15, 2006 | Permalink | Comments (0) | TrackBack (0)