4-Year-Old Can Be Sued, Judge Rules in Bike Case - NYTimes.com

The age of reason?

4-Year-Old Can Be Sued, Judge Rules in Bike Case - NYTimes.com
HERE is the opinion.

Firms Knew of Cement Flaws Before Spill, Panel Says - NYTimes.com

The National Commission on the BP DEEPWATER HORIZON OIL SPILL
AND OFFSHORE DRILLING has issued its first report.  The Times ahs the story:


WASHINGTON — Halliburton knew weeks before the fatal explosion of the Macondo well in the Gulf of Mexico that the cement mixture they planned to use to seal the bottom of the well was unstable but still went ahead with the job, the presidential commission investigating the accident said on Thursday....

Firms Knew of Cement Flaws Before Spill, Panel Says - NYTimes.com

UPDATE: and Halliburton's reply

Dollars For Docs: Drug Co. Flattery Wins Docs, Influences Prescriptions : NPR

Dollars For Docs: Drug Co. Flattery Wins Docs, Influences Prescriptions : NPR


NPR partnered with proPublica - a public interest organization. here is their Dollars for Docs site.

District Judge Denies DADT Stay Sought by U.S.

Jurist reports that Judge Virginia Philips denied the government's motion for a stay of her injunciton forbidding enforcement of the Don't Ask Don't Tell policy enacted by Congress, according to this report on Jurist.


Reports later today are that the 9th Circuit stayed the injunction while it considers the merits:

This court has received appellant's emergency motion to stay the district court's October 12, 2010 order pending appeal. The order is stayed temporarily in order to provide this court with an opportunity to consider fully the issues presented. Appellee may file an opposition to the motion for a stay pending appeal by October 25, 2010. To expedite consideration of the motion, no reply shall be filed.

It is hard to see how the Circuit could do otherwise.  Compliance with the order would create a complicated situation in which some open homosexuals have been admitted to the military - at risk that the policy will survive, despite the hopes of plaintiffs, Judge Philips, and the Obama administration.  


The Department of Justice filed the appeal and sought a stay saying that though it opposes the DADT policy and seeks its repeal longstanding policy is that the government defends any statute which is susceptible of reasonable defense.  A decision voiding a statute which plainly expresses a plicy declared by Congress is such a law. (See DOJ brief on DADT page)

Editorial - The Court’s Pre-emption Test - NYTimes.com

In the Supreme Court last week, oral arguments in a case called Bruesewitz v. Wyeth turned on the meaning of the word “unavoidable,” but the real issue was something much bigger. The case is about whether the family of a girl, who they said was badly injured by a vaccine, can sue the manufacturer in a state court. Or are they barred by a 24-year-old federal law that blocks this sort of lawsuit if “the injury or death resulted from side effects that were unavoidable?” 

That prohibition is called pre-emption, a hot issue in constitutional law because it is at the heart of the balance of power between states and the federal government — the meaning of federalism. At stake is the ability of states to protect their citizens, by regulating health, safety, the environment, and other primary interests and by giving victims of wrongdoing redress in court, as long as a state law doesn’t conflict with a federal law....

Editorial - The Court’s Pre-emption Test - NYTimes.com

When Drugs Cause Problems They Are Supposed to Prevent - NYTimes.com

When new drugs are approved by the FDA they are compared to placebo: i.e. do they do any good? and does the good they appear to do outweigh the toxic side effects? These approvals are all based on quite small samples, and short time frames. Phase IV follows approval. I call it mass marketing: the poorly controlled mass human experiment stage. That may be too kind. Most of the time there is no systematic study of the actual conditions of use, as I discuss in my 2007 article Punctuated Equilibrium, in which I call for recognition of a duty of product stewardship. 


For new drugs - and for old drugs that have been little monitored - that means recognizing their  experimental nature - even after FDA has approved it as "safe and effective".  Their experimental nature  should lead courts to recognize a corresponding duty of product stewardship - a duty of ongoing active study and product development; a duty of the manufacturer to conduct systematic  active post-approval surveillance of the actual use of the product.


The need for such surveillance is highlighted by our experience with drugs like the diabetes drug Avandia - now virtually banned because it increases the risk of heart attack - the principal killer of diabetics.   FDA now permits its use only if every other drug has failed.  The drug's deleterious effects became known not through company study, nor through FDA surveillance, but rather because a prominent cardiologist Steven Nissen in 2007 raised the hue and cry in the pages of the New England Journal of Medicine.

Similar was the Vioxx experience - an anti-arthritic drug competitive with Aleve that caused heart attacks and lasted only 5 years before it was withdrawn.  The lessons of that experience and the additional powers given the FDA in 2007 are explored here by Margaraet Gilhooley, a former Associate General Counsel at the FDA. 


Since 2007 the FDA has had the power to require post-approval studies - but it still has been  employed only rarely.  The problem of drug safety is particularly acute when drugs  - like Avandia - have been mass marketed and the problems which they cause or exacerbate are the very conditions they are meant to treat, or those from which their intended target is particularly likely to suffer - even without the drug. 


As the article by Gina Kolata in today's  New York Times points out drugs which are used long-term for chronic conditions present particularly difficult problems because the mass use of the drug makes active surveillance an expensive proposition. And only recently approved drugs are even subject to the review power that the FDA gained in 2007.

News Analysis - When Avandia and Other Drugs Cause Problems They Are Supposed to Prevent - NYTimes.com

Medtronic to Settle Sprint Fidelis Defibrillator Suits - NYTimes.com

8,100 claims settled for $268 million - about $33,000 each - in the tort litigation against Medtronic, manufacturer of the defective Fidelis model electrical leads in their ICD's (Implanted cardiac defibrillators).  13 died, others have had their leads removed after failure - in a precarious operation as the leads are embedded in the arteries serving the heart.  Others have leads that may soon fail.


The settlement is at nuisance value because, following the United States Supreme Court's decision in Riegel v. Medtornic courts have concluded that all claims arising form the defective devices are preempted - and barred by federal law.  The FDA in reviewing new devices does not analyse whether an alternative safer design was practical and feasible.  Yet the the Supreme Court ruled 7-2 that the language of 21 USC 360k barred suits because it forbids states to impose requirements that are "different from or in addition to" those imposed by the FDA.  The only state suits that appear to survive Riegel are "parallel" to, not "in addition" to FDA "requirements".


The latest decision - by the 8th circuit in Bryant v. Medtronic dismissed all claims - even the manufacturing defect claims that seemed to have been spared in Riegel.  The 8th Circuit ruling was celebrated by the drug and medical device industry cheerleaders at Dechert's Drug & Device Law blog, where they have long practiced licking the hand that feeds them.


Fortunately for the plaintiffs they were able to salvage some value because Circuit Judge Melloy dissented.  the plaintiffs should have been given the opportunity - after a partial summary judgment grant - to amend their complaint to more specifically allege that there was a manufacturing defect - a departure from the Premarketing Approval requirements of the FDA.  The complaint lacked specificity about the defect the Circuit court held.  But specification was possible only if the plaintiffs obtained through discovery the FDA's otherwise unavailable manufacturing requirements.  The procedural specificity requirements of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) thus provided another obstacle in the already rocky road faced by plaintiffs.


Judge Melloy explained, in dissent:

[T]he parallel state claim that may escape preclusion under § 360k requires the plaintiffs to prove Medtronic failed to manufacture the Sprint Fidelis Leads in compliance with the requirements set forth in the confidential PMA and supplemental PMAs. To apply Twombly rigidly without permitting discovery as to these documents effectively creates an impossible-to-achieve specificity requirement.The combination of the rigid application of Twombly and the now-articulated parallel claim exception to § 360k preemption have, in these cases, led to the dismissal of over two hundred potentially meritorious lawsuits on a technicality.

The real villain is the Congress - and particularly the Republican minority thanks to the 60 vote cloture requirement.  They have blocked H.R. 1346, which would reverse Riegel.

YouTube - Gulf Coast Claims Facility Likely to Shield Top Defendants Richard Nagareda Interview

YouTube - Gulf Coast Claims Facility Likely to Shield Top Defendants Richard Nagareda Interview: ""

Snyder v. Phelps - the funeral protest case

Snyder v. Phelps is a case with facts so bizarre that they seem to have been the product of a law professor's mind.  As summarized by the trial court and adopted in the 4th Circuit Court of Appeals opinion the Westboro Baptist Church is a bizarre little fundamentalist cult of five or six dozen members almost all of whom are the family of its pastor Fred W. Phelps, Jr.
They are vehemently opposed to homosexuality, adultery, divorce, and abortion which they believe our society sinfully tolerates and God punishes.  To publicize their moral message members traveled from Kansas to Maryland to protest at the funeral of Marine Lance Cpl. Matthew Snyder who had been killed in Iraq.  They stood about 30 feet from the driveway, about  1,000 feet from the church where the funeral was held.

They carried signs which expressed general messages such as "God Hates the USA," "America is doomed,"

"Pope in hell," and "Fag troops." The signs also carried more specific messages, to wit: "You’re going to hell," "God hates you," "Semper fi fags," and "Thank God for dead soldiers." Phelps testified that it was Defendants’ "duty" to deliver the message "whether they want to hear it or not." Lance Cpl. Snyder’s funeral was thus utilized by Defendants as the vehicle for this message.

Later the group posted video of the protest on a website they maintain - www.godhatesfags.com.


Albert Snyder, father of the soldier, sued the church and several members, including the pastor.  In the diversity action Maryland tort law applied.  Snyder testified to

the severity of his emotional injury, stating that he is often tearful and angry, and that he becomes so sick to his stomach that he actually physically vomits. He testified that Defendants placed a "bug" in his head, such that he is unable to separate thoughts of his son from the [Defendants'] actions: "there are nights that I just, you know, I try to think of my son at times and every time I think of my son or pass his picture hanging on the wall or see the medals hanging on the wall that he received from the [M]arine [C]orps, I see those signs." He testified also that "I want so badly to remember all the good stuff and so far, I remember the good stuff, but it always turns into the bad.

The Phelps were held liable for, inter alia, intentional infliction of emotional distress. As charged to the jury, the elements for this tort are: (1) the Phelps' conduct was intentional or reckless; (2) the conduct was extreme and outrageous; (3) the conduct caused emotional distress to Snyder; and (4) the emotional distress was severe.


The jury awarded $2.9 million in compensatory damages for emotional harm and punitive damages of $8 million (later remitted to $2.1 million).

Phelps appealed.  The 4th Circuit found the signs and the internet posting were protected under the First Amendment guarantee of freedom of speech.  One judge, concurring in the decision, was of the view that the evidence did not support the tort judgment and that the free speech issue need not be decided.  


Snyder petitioned the Supreme Court of the United States which agreed to decide `Does the First Amendment protect protesters at a funeral from liability for intentionally inflicting emotional distress on the family of the deceased?'


According to the attorney for Mr. Snyder "the private, targeted nature of the speech" takes it out of the purview of the First Amendment's free speech guarantees.
The Scotus Blog page is: Snyder v. Phelps

SCOTUS: Court to consider liability for DA’s offices on Brady violations : SCOTUSblog

42 U.S.C. 1983 provides a cause of action for state policies that deny citizens rights under the Constitution and laws. John Thompson alleges that the New Orleans District Attorney's failure to train prosecutors in their obligations under Brady v. Maryland (to provide the defense with all exculpatory material) caused him to be wrongfully convicted of robbery and murder.  He recovered a verdict and an equally divided Fifth Circuit en banc affirmed.

Is this consistent with the common law  principle of absolute prosecutorial immunity from suit extended to claims under 42 USC 1983 as enunciated emphatically in Imbler v. Pachtman (1976)?  Or will it prove to be the vindication of Justice Byron "Whizzer" White who concurred in the result but warned:

I write, however, because I believe that the Court's opinion may be read as extending to a prosecutor an immunity broader than that to which he was entitled at common law; broader than is necessary to decide this case; and broader than is necessary to protect the judicial process. Most seriously, I disagree with any implication that absolute immunity for prosecutors extends to suits based on claims of unconstitutional suppression of evidence, because I believe such a rule would threaten to injure the judicial process and to interfere with Congress' purpose in enacting 42 U.S.C. § 1983, without any support in statutory language or history.

The Thompson case is one in a line of § 1983 cases in which state entities' failure to train  evidences an actionable  "deliberate indifference" to the rights of citizens . In an amicus brief  a group of law school criminal justice and legal ethics centers argues that the prosecutor's duty to disclose exculpatory evidence is so complex  that without training constitutional violations are inevitable, and deliberate indifference can thus be shown.

The case is competently presented by Jessica Fitts, a Harvard law student, writing for ScotusBlog:

Argument preview: Court to consider liability for DA’s offices on Brady violations : SCOTUSblog