Posts Tagged ‘FDA’

February 19 roundup

  • 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

  • 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]

Richard Epstein on Wyeth v. Levine

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.

July 31 roundup

  • 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]

Is patent gridlock keeping drugs off the market?

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

  • 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]

FDA overwarning

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.