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FDA

Jacob Sullum on the FDA’s threat to ban caffeinated alcoholic drinks [Reason “Hit and Run”. Earlier here, here, here, etc.

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November 16 roundup

by Walter Olson on November 16, 2009

  • German law firm demands that Wikipedia remove true information about now-paroled murderers [EFF] More: Eugene Volokh.
  • “Class Actions: Some Plaintiffs’ Lawyers Fed Up, Too?” [California Civil Justice]
  • Drop that Irish coffee and back away: “F.D.A. Says It May Ban Alcoholic Drinks With Caffeine” [NYT]
  • Profile of L.A. tort lawyers Walter Lack and Thomas Girardi, now in hot water following Nicaraguan banana-pesticide scandal [The Recorder; my earlier outing on "Erin Brockovich" case]
  • Federalist Society panel on federalism and preemption [BLT]
  • Confidence in the courts? PriceWaterhouseCoopers would rather face Satyam securities fraud lawsuits in India than in U.S. [Hartley]
  • Allegation: Scruggs continuing to wheel and deal behind bars [Freeland]
  • Not much that will be new to longtime readers here: “Ten ridiculous lawsuits against Big Business” [Biz Insider] P.S.: Legal Blog Watch had more lists back in June.

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November 12 roundup

by Walter Olson on November 12, 2009

  • Judge cites Oregon elder abuse act in barring animal rights activists from harassing elderly furrier [Zick, Prawfsblawg]
  • After fraud accusations against Fort Lauderdale lawyer Scott Rothstein, politicos race to return his many donations [NYT, AmLaw Daily,
    DBR and more, Ashby Jones/WSJ Law Blog and more (Ponzi investments could exceed $1 billion, per FBI)]
  • Ontario court ruling may invite U.S. class action lawyers to take on more projects in Canada [Kevin LaCroix]
  • “Mississippi Cardiologist Won’t Go to Prison for Online Dating” [Balko, Freeland]
  • Manuscript in the mail: “Kings of Tort”, Alan Lange/Tom Dawson book on Dickie Scruggs and Paul Minor scandals, which now has its own website and will go on sale Dec. 2;
  • A “cultural institution destroyed” in Louisiana: more on proposed FDA ban on raw oysters [NYT, earlier]
  • Update on Google Books settlement [Sag, ConcurOp]
  • Mark Steyn on the Zack Christie case and other annals of knives-in-schools zero-tolerance [NRO, Steyn Online via Skenazy]

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FDA vs. fresh oysters

by Walter Olson on October 28, 2009

Remember how the food safety crackdown was going to be a win-win affair for all of us, with only the sinister interests of Big Food having anything real to lose? New Orleans Times-Picayune:

In an effort to reduce cases of a rare, but potentially fatal, bacterial illness contracted from raw oysters, the FDA announced new rules this month that will require any oyster served from April through October to undergo a sterilization process before it can be sold in restaurants or on the market.

The rule will essentially eliminate raw oysters — at least as Louisianans know them — from restaurant menus for seven months of the year. Even oysters that will eventually be cooked during those months would have to go through the same cleansing process before being added to any dish, a move some say would undermine the culinary integrity of some of New Orleans’ most famous delicacies. …

C.J. Casamento, the owner of Casamento’s restaurant on Magazine Street, said many chefs have tried the sterilized oysters in the past but have stopped because the flavor isn’t the same. … “If they try to implement this, it will destroy all the raw oyster restaurants in the city.”

Another restaurant owner, Tommy Cvitanovich of Drago’s, called the rules “ludicrous”, pointing out that they will also require sterilization of oysters destined for cooked use in gumbos, broils and po’ boys. Processor Mike Voisin compared the new guidelines to a “nuclear bomb” on the oyster business. And Louisiana state health officials, as well as fisheries officials, have assailed the new rules as going too far.

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More easily said than done, it seems. [Daniel Compton, CEI "Open Market"]

P.S. While on the subject of food politics, here from Marion Nestle is one of our favorite typos ever: “Richard Blumenthal, the Connecticult Attorney General.” [emphasis added]

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October 12 roundup

by Walter Olson on October 12, 2009

  • Speech-curbing proposals continue to get polite academic reception: NYU’s Jeremy Waldron, big advocate of laws to curb “hate speech”, delivered Holmes Lectures at Harvard this past week [HLS, schedule]
  • Lawsuit over collectible baseball hit into stands by Phillies’ Ryan Howard, his 200th career homer [Howard Wasserman, PrawfsBlawg; NJLRA]
  • Orchid-importer prosecution a poster case for the evils of overcriminalization? Maybe not [Ken at Popehat]
  • Texas State Fair and city of Dallas don’t have to allow evangelist to distribute religious tracts inside the fair, judge rules after three years [Dallas Observer blog]
  • Drug maker: FDA’s curbs on truthful promotion of off-label uses impair our First Amendment speech rights [Beck and Herrmann and more, Point of Law and more]
  • Did plaintiff Eolas Technologies go to unusual lengths to ensure Eastern District of Texas venue for its patent litigation? [Joe Mullin, IP Law and Business via Alison Frankel, AmLaw]
  • Update: “Lesbian Denied Infertility Treatment Settles Lawsuit” [San Diego 6, earlier]
  • Even in the Ninth Circuit, “psychological injury resulting from a legitimate personnel action” is not compensable [Volokh]

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Funny how Philip Morris, the biggest tobacco company, is the bill’s “most important ally“. [CEI "Open Market"] More: Jacob Sullum, Reason “Hit and Run”, Jonathan Adler, Volokh (”the bill represents the marriage of big government and big business”).

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The Food and Drug Administration wants to protect you, whether you’d like it to or not. Don Surber: “Next they will tell me that Lucky Charms are not magically delicious, but rather manufactured like any other cereal.”

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Wyeth v. Levine

by Ted Frank on March 4, 2009

After the Wyeth v. Levine argument, I worried that the Supreme Court might decide the case on such narrow grounds that it would do little good to confront the problem of trial-lawyer abuse. I now see I wasn’t nearly pessimistic enough.

We can put the nail in the coffin in the idea that this is a pro-business Supreme Court: the 6-3 Wyeth v. Levine decision is the worst anti-business decision since United States v. Von’s Grocery, 384 U.S. 270 (1966). Justice Thomas’s confused concurring opinion is especially disappointing, as it declares an abdication of the Supreme Court’s appropriate structural role to prevent individual states from expropriating the gains from interstate commerce.

Sell your pharmaceutical stocks now, because the Supreme Court just declared it open season on productive business. One should now fear the coming decision in the as-yet-to-be-briefed Clearinghouse v. Cuomo, and the effect that is going to have on an already battered banking economy, as well.

Beck and Herrmann have first thoughts, but are likely to be relatively quiet thereafter.

Update, as Walter points out in the comments, see also Andrew Grossman’s post at Point of Law, and the earlier coverage at that site by numerous authors, dating back to when the case first began making headlines.

Contrary to the suggestion of Justice Thomas, Dan Fisher, this is not a “victory for federalism” by any stretch of the imagination: federalism is a two-way street, and permitting states to impair interstate commerce through a litigation tax upsets the federalist structure of the Constitution. See, e.g., Epstein and Greve.

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February 19 roundup

by Walter Olson on February 19, 2009

  • Surprising origins of federal corruption probe that tripped up Luzerne County, Pa. judges who were getting kickbacks on juvenile detention referrals: insurers had noted local pattern of high car-crash arbitration sums and sniffed collusion between judges and plaintiff’s counsel [Wilkes-Barre Times Leader, Legal Intelligencer] Court administrator pleads to theft [Times Leader] Judge Ciavarella had secret probation parole program [PAHomepage]
  • We get accolades: “Overlawyered.com has a new look. Great new format, same good stuff,” writes ex-securities lawyer Christopher Fountain, whose real estate blog I’m always recommending to people even if they live nowhere near his turf of Greenwich, Ct. [For What It's Worth]
  • “Fla. Jury Awards $8M to Family of Dead Smoker in Philip Morris Case” [ABA Journal; for more on the complicated background of the Engle case, which renders Florida a unique environment for tobacco litigation, start here]
  • Scott Greenfield vs. Ann Bartow vs. Marc Randazza on the AutoAdmit online-bathroom-scrawl litigation, all in turn playing off a David Margolick piece in Portfolio;
  • Eric Turkewitz continues his investigations of online solicitation by lawyers following the Buffalo crash of Continental Flight #3407 [NY Personal Injury Law Blog, Mon. and Tues. posts; earlier]
  • One vital element of trial management: keep track of how many jurors there are [Anne Reed, Deliberations]
  • Public Citizen vs. public health: Sidney Wolfe may succeed in getting the FDA to ban Darvon, and the bone marrow transplant nurse isn’t happy about that [Dr. Wes, KevinMD, more on Wolfe here]
  • “Baseball Star’s [uninfected] Ex Seeks $15M for Fear of AIDS” [OnPoint News, WaPo, New York Mets star Roberto Alomar]

January 29 roundup

by Walter Olson on January 29, 2009

  • Free class-action swag if you bought department store cosmetics between 1994 and 2003; not that they’re giving away the very best stuff or anything [Tompkins/Poynter, California Civil Justice, WSJ Law Blog, settlement site] We’ve been covering the story for quite some time;
  • Law school “can be a financial disaster” for unwary students [Law and More] Law schools not immune from economic downturn [Above the Law]
  • Bruce Bawer on Dutch prosecution of Islam-criticizer Geert Wilders [City Journal]
  • More on possible passenger suits after the miracle Hudson-landing USAir Flight #1549 [USA Today, earlier] Update: NY Post, NY Mag.
  • Bad news for patients and other living things: Sidney Wolfe of Public Citizen somehow got named to a key FDA panel during the late Bush administration [Point of Law, Postrel, Bernstein/Volokh, Hooper & Henderson/Forbes]
  • “Friends weren’t really trying to reach me!” class action against Reunion.com encounters another setback [Spam Notes]
  • Stand and deliver it back: “Minnesota: $2.6 Million in Red Light Camera Tickets Refunded” [The Newspaper]
  • Gary, Indiana’s is the last standing of what were once thirty “gun sales = nuisance” suits filed by cities; now Indiana high court says it can go to trial [Point of Law]

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The Chicago lawprof discusses the pending Supreme Court case on implied pre-emption:

…it is folly to act as if the private lawsuits attacking FDA warnings just backstop a porous and lax FDA. Often those lawsuits add an unwanted deterrent against the sale of desperately needed drugs. That risk is multiplied by hyperventilated state tort law that, in many instances, is lopsidedly pro-plaintiff.

(”Wyeth v. Levine Could Endanger Your Health”, Forbes, Nov. 11). Much more on the debate at Point of Law here, here, here, etc.

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July 31 roundup

by Walter Olson on July 31, 2008

  • Raft-flip mishap at Riviera Beach, Fla. water park: family’s collective weight far exceeded posted limit on warning signs, they’re mulling suit [Palm Beach Post]
  • New Rigsby/Katrina depositions include sensational new allegations of Scruggs misconduct as well as touches of pathos [Point of Law]
  • “Al Gore Places Infant Son In Rocket To Escape Dying Planet” [The Onion]
  • So much coverage of Hasbro vs. Scrabulous but so little solid reportage by which readers might judge strength of copyright infringement claims [Obbie]
  • City of Seattle spokesman says police actions in shootout with gunman might have “saved countless other lives”, which hasn’t saved city from being sued by injured bystander [Seattle Times]
  • First the vaccine-autism scare, now this? “Mercury militia” crows after FDA agrees to move forward with statement on possible risks of dental amalgam, but maybe there’s not a whole lot for them to chew on [Harriet Hall, Science-Based Medicine]
  • Of lurid allegations in paralegal Angela Robinson’s suit against Texas plaintiff potentate Richard Laminack, the most printable are the ones about chiseling fen-phen clients and not paying overtime [American Lawyer; Laminack response]
  • U.K. attorney suing former bosses for £19 million: that wasn’t me at the interview, that was my alternative personality [Times Online]
  • Allegation: Foxwoods croupier thought he could mutter lewd comments in Spanish about Anglo female patrons, but guess what, one was entirely fluent [NY Post]
  • “Richard Branson claims to own all uses of ‘Virgin’” [three years ago on Overlawyered]

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Readers know I’m sympathetic to the idea of patent reform, but I have to agree with Derek Lowe’s skepticism as he tears a hole in the Michael Heller story told to the WSJ Law Blog about an alleged Alzheimer’s drug that will “earn billions” but can’t be tested because of patent gridlock.  A must read as he eviscerates the law and science behind that statement, and read the follow-up as well.  As Lowe points out,

the safe harbor provisions of the 1984 Hatch-Waxman Act, as reaffirmed in the 2005 Merck v. Integra decision by the Supreme Court [protects] from infringement [claims] in the use of a patented compound for purposes of submitting regulatory filings. And the language of the ruling makes it look like it’s intended to cover all sorts of patented technologies as well.

July 6 roundup

by Ted Frank on July 6, 2008

  • Beck and Herrmann fisk a NEJM anti-preemption editorial. [Beck/Herrmann; NEJM]
  • Lessons of the Grasso case. [Hodak]
  • You think BigLaw has it bad? Plaintiffs’ attorney who invented the benefit-of-the-bargain theory for pharmaceutical class actions where no one has suffered any cognizable injury, has made his firm tens of millions, but still hasn’t made partner. “Zigler said he never meets most of the people he represents in these high-profile cases.” [St.L. Post-Dispatch; related analysis from Beck/Herrmann]
  • Speaking of harmless lawsuits, “an atrocity in Arkansas,” as Arkansas Supreme Court ignores basic principles of due process and civil procedure to certify an extortionate pre-CAFA class action from MIller County. [Hmm, that's Beck/Herrmann again; General Motors v. Bryant; related from Greve]
  • Speedo competitor: unfair competition to say your innovative swimsuit has an advantage just because 38 out of the last 42 world records (as of June 30) were broken in the suit. [Am Law Daily]
  • Background on bogus shower curtain scare story (earlier). [NYT; related AEI event]
  • EMTALA-orama: don’t discuss payment in the emergency room if you don’t want to get sued. [ER Stories]

I’m quoted by Amanda Erickson in today’s Chicago Tribune:

[click to continue…]

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FDA overwarning

by Ted Frank on February 25, 2008

One of the justifications for FDA preemption is the fear of overwarning; warning overload can be counterproductive, causing people to ignore important warnings. Thus, failure-to-warn litigation impedes safety. See “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” 71 Fed. Reg. 3922 (Jan. 24, 2006); Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2004).

Further evidence comes from a CNNMoney.com report (Aaron Smith, “Consumers tune out FDA warnings”, Feb. 25) suggesting that the FDA’s post-Vioxx caution has already caused the agency to be at the point of diminishing returns, as it is averaging 50% more safety alerts a year for 2005-2007 than it did in 2004, the year Vioxx was withdrawn from the market.

I discussed overwarning in other contexts on Overlawyered in Sep. 2006.