2010

We are honored to announce that the ABA Journal has once again recognized the Drug and Device Blog (that’s us) as one of the top 100 legal blogs of the year. Here’s the announcement.

If we’re judged by the company we keep, we must be doing pretty well, as once again the ABA Journal

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Medtronic wins another PMA-preemption-based dismissal.   The cite:  Walker v. Medtronic, Inc., C.A. No.

2:07-00317, slip op. (S.D.W. Va. Nov. 24, 2010).  The reasoning:  It’s a PMA device (an infusion pump), so there’s preemption.  There was some discovery on FDA compliance.
The opinion is a nice citator.  It’s got footnotes that, while we haven’t compared

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We recently read an article about plaintiff law firm settlement mills. The article — Engstrom, Run of the Mill Justice, 22 Georgetown J. Legal Ethics 1485 (Fall 2009) — presents interesting contrasts and similarities with mass tort litigation. A “settlement mill” is marked by the following characteristics: (1) high volume of cases; (2) high volume of advertising; (3) “entrepreneurial legal practices;” (4) few if any cases go to trial; (5) tiered contingency fees; (6) little case screening and, therefore, lots of low value cases; (7) little attorney-client interaction; (8) incentivized settlements via quotas or rewards; (9) quick resolution of cases – usually within two to eight months of the accident; and (10) rare filing of lawsuits.
Some of that sounds familiar to us and some does not. Of course, the article isn’t about mass torts. Rather, the cases more often than not involve car accidents. The damages arise from medical bills and the dreaded “soft-tissue injuries.” Consequently, the settlements seldom reach five figures.
Engstrom includes case studies of settlement mills. Some of those firms no longer exist. Disbarment isn’t exactly foreign to this milieu. Hegel said that quantitative differences after a point become qualitative. When we learn that a settlement mill lawyer will have 300-400 open files on her desk at any time, we’re talking about something alien to our experience. How does one handle such an enormous case load with skill and diligence? It isn’t pretty. One of the “entrepreneurial” innovations is to allow non-lawyers to handle client-screening (of which there really isn’t any besides verifying the existence of insurance). Amazingly, non-lawyers sometimes even handle the negotiations with claims adjusters. Those “negotiations” might take all of ten minutes to resolve the case. Meanwhile, the client might not see a lawyer until he or she receives the settlement check. Well, to be more precise, they might not see a live lawyer. Many settlement mills simply plant their clients en masse in a conference room where they watch a videotape of a lawyer “explain” the process.Continue Reading Grinding Out Settlements

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Remember those statutes that some New England states adopted over the last few years (no, not those having to do with gay marriage) that prohibited pharmaceutical companies from using pharmacy prescription data – sold by data miners – for commercial purposes?  Well the Second Circuit just declared Vermont’s statute an unconstitutional restriction on commercial speech in IMS Health, Inc. v. Sorrell, Nos. 09-1913-cv(L), 09-2056-cv(CON), slip op. (2d Cir. Nov. 23, 2010).
In doing so, the Second Circuit created a direct circuit split on the issue with the First Circuit, which had earlier affirmed the constitutionality of similar statutes in New Hampshire and Maine. See IMS Health Inc. v. Ayotte, 550 F.3d 42 (1st Cir. 2008) (New Hampshire statute); IMS Health Inc. v. Mills, 616 F.3d 7 (1st Cir. 2010) (Maine statute). This issue could well go to the Supreme Court.
Vermont was quite explicit that its statute was intended to intervene in the informational marketplace in order to put a thumb on the scales against drug company’s marketing of brand name drugs.  It hoped that, by depriving brand name manufacturers of information that helped them identify which doctors were prescribing what drugs, it would make pharmaceutical detailing less effective.  Slip op. at 15-16, 21-22.  Having explicitly stated that the state’s intent to reduce the effectiveness of certain commercial speech, the legislature made it was hard for its lawyers later to attempt to pass off the statute as some sort of regulation of mere “conduct”.  Slip op. at 18-23.  Didn’t work.  The would-be censors couldn’t get their pretexts lined up in a row.
The Sorrell court left open the possibility that the regulation may well regulate non-commercial speech because it found that the restriction couldn’t even survive the intermediate scrutiny to which commercial speech restrictions are judged.  Slip op. at 28.  That would be a very interesting question if the commercial speech ruling was ever reversed, but for now it’s a footnote.Continue Reading Interesting Pharma First Amendment Decision

We have written before about the virtues of Lone Pine orders, which require plaintiffs to produce elementary evidence supporting their claims, usually some prima face evidence of exposure, injury, and causation. These orders provide an excellent tool to eliminate the cases filed in any mass tort by people just hoping to cash in without having

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As defense lawyers at trial, we usually hit the theme of how a corporation is made up of people — folks who live in the neighborhood, who work hard for a living, and who try to do the right thing and make good products. We usually make sure that a corporate representative sits in the

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This just in:  The West Virginia Supreme Court of Appeals today reversed that scary trial court decision that held a drug manufacturer to be bound by, and incapable of disputing, FDA-DDMAC “false and misleading” violation claims in warning letters.  Here’s a copy of the opinion, encaptioned, West Virginia v. Johnson & Johnson, No. 35500,