Helmets don't prevent concussions - new study

Fooball helmets don't protect - new study - LA Times

By Melissa Healy

February 17, 2014, 4:45 p.m.

Here's a novel idea, given that American parents send almost 4 million of their children out to play tackle football every year, despite mounting concerns about youth concussions: Maybe the helmets their kids wear should be tested and ranked on how well they prevent concussion.
A study to be presented at a meeting of the American Academy of Neurology attempts to do exactly that, comparing 10 of the most widely used football helmets in drop tests designed to measure the kinds of forces that are most likely to result in concussion.
The latest research finds that football helmets, which have been designed largely to prevent skull fractures and brain contusions, aren't all that effective against concussion, which happens when the brain bounces and twists around inside the skull.
"All of them were terrible," said Dr. Francis X. Conidi, who is to present the new research before the American Academy of Neurology's annual meeting April 26-May 3. Conidi, a Florida neurologist who is vice chair of the American Academy of Neurology's sports neurology section, says the helmets' poor showing underscores the importance of emphasizing safety in football culture: Coaches should be teaching football players tackling techniques that limit concussion risk; they should encourage younger football players to follow the example of older ones and strengthen their neck and shoulder muscles; and  officials at all levels of play should be enforcing rules against head-first contact, Conidi said.

http://www.latimes.com/science/sciencenow/la-sci-sn-football-helmets-concussion-20140217,0,1291164.story#ixzz2tgd2IvxF

Laches: Scholars’ Supreme Court Amicus Brief in Support of Neither Party: Petrella v. Metro-Goldwyn-Mayer by Douglas Laycock, Mark P. Gergen, Doug Rendleman :: SSRN

Four scholars of remedies and tort of unquestionable authority have stepped into a copyright case for two reasons: 1) to urge the Supreme Court to recognize the importance of the equitable concept of laches and its applicability to statutory claims; 2) to encourage the court to repair the error of its 2006 decision in eBay v. MercExhange which confused the four part test for issuance of a preliminary injunction ( probable success on the merits, irreparable injury, balance of hardships, and the public interest.)  There is no such test for a permanent injunction which issues only when and to the extent that a party has proven its case. The Supreme Court in eBay:

(1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction

For starters factors 1 and 2 are not separate.  Factor 2) is the definition of 1).  The public interest is not a requirement - just a factor to be considered where appropriate.  And the embrace of a rigid "test" which is contrary to the historic thrust of equity jurisprudence: its flexibility.  - GWC

Scholars’ Supreme Court Amicus Brief in Support of Neither Party: Petrella v. Metro-Goldwyn-Mayer by Douglas Laycock, Mark P. Gergen, Doug Rendleman :: SSRN:

Abstract

The appeal to the Supreme Court in Petrella v. Metro-Goldwyn-Mayer deals with the equitable defense of plaintiff’s laches before suing for copyright infringement. Laches is unreasonable and prejudicial delay. MGM allegedly violated plaintiff’s copyright repeatedly over a period of many years; the statute of limitations has not run on the most recent violations. Plaintiff argues that laches should never apply to a cause of action with a statute of limitations. Defendant argues that laches should bar all relief if defendant relied on plaintiff’s failure to sue earlier, without having to match defendant’s reliance to the remedies plaintiff seeks. 
This scholars’ amicus brief, which supports neither party, argues against all-or-nothing solutions. In particular, the brief says that laches should be available as needed to protect defendant’s reliance, but that defendant should have to show how particular remedies would unfairly override particular reliance interests. Plaintiff also argues that laches should be unavailable because it would be a ground for refusing an injunction that was not mentioned in eBay v. MercExchange. The scholars’ brief takes this occasion to point out several unintended untoward consequences of the four-part test in eBay.

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FDA Advisory Panels Against CV Safety Claim for Naproxen

FDA Advisory Panels Against CV Safety Claim for Naproxen: "SILVER SPRING, MD — In a two-day meeting of the Food and Drug Administration (FDA) Arthritis Advisory Committee (AAC) and Drug Safety and Risk Management (DSARM) Advisory Committee, just nine panel members said they believed naproxen has a lower risk of cardiovascular thrombotic events than other available nonsteroidal anti-inflammatory drugs (NSAIDs).

In contrast, 16 of the advisory panel members felt the data were insufficient to say naproxen was safer than other NSAIDs."



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Settlement in NuvaRing and the demise of product liability law in New Jersey

Updated 2/22/2014

In a landmark 1984 decision Feldman v. Lederle Laboratories the New Jersey Supreme Court affirmed a fundamental proposition:  "drug manufacturers have a duty to warn of dangers of which they know or should have known on the basis of reasonably obtainable or available knowledge."

A decade letter the New Jersey Product Liability Act addressed the problem of how to determine if that standard had been met.  The PLA provides that warnings that comply with FDA  requirements are entitled to a presumption of reasonableness.  In Perez v. Wyeth Laboratories (1999) the Court recognized a duty owing directly to the public by drug manufacturers who advertise directly to the public.  Justice Daniel O'Hern (who thought the new Product Liability Restatement was calculated to weaken consumer protection) sought  to emphasize the consumer protectiveness of New Jersey product liability law which had been the standard bearer since 1960's Henningsen v. Bloomfield Motors.   The Act, in O'Hern's view had essentially codified New Jersey strict product liability law without emasculating the courts ability to adapt to changed conditions - sch as the explosion of direct-to-consumer advertising and the demise of the "father knows best" model of health care delivery.  But O'Hern offered the prediction that cases that "[f]or all practical purposes, absent deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, compliance with FDA standards should be virtually dispositive of such claims. By definition, the advertising will have been "fairly balanced.""  

The natural reading of New Jersey strict product liability law is that liability flowed from  "deliberate concealment OR non-disclosure of after-acquired knowledge" that rendered the drug "not reasonably safe".  But the lack of an adjective before "non-disclosure" was a chink in the armor that emboldened drug company lawyers to argue that the  "Perez exception" was limited to "deliberate" concealment or intentional "non-disclosure of after acquired knowledge".  Thus was read into O'Hern's dicta a regulatory compliance defense.  Even actual knowledge of danger no longer triggered a duty to warn in this new defense perspective.  Feldman, they would effectively argue, had been silently overruled by Perez.  A plaintiff must now show fraud or other aggravated conduct.

The proofs in the Vioxx case McDarby v. Merck  (2008) revealed a company that systematically downplayed risks in order to maximize sales.  "Substantial evidence" overcame the statutory presumption, the court held in an opinion by Judge Edith Payne.  That became "the McDarby exception".  Paired with the "Perez exception" to the default immunity rule in the next assault on the Lederle  the duty to inform was eviscerated by trial judge (and former med-mal defense attorney) Jami Happas in  Bailey v. Wyeth  an estrogen therapy drug case decided in 2008.   Gone was the focus on whether the product - a carcinogenic hormone - was "reasonably safe".  The focus was now on the  company's conduct toward the FDA.  Only "intentional misconduct" could overcome the statutory presumption, Happas held.  Affirming in a 2011 summary opinion penned by Edith Payne the Appellate Division embraced the Happas opinion and ordered it to be published - entrenching it as binding appellate precedent. 
The state's Supreme Court denied cert.  Thus does a proud tradition die - without serious - or any - discussion of the consequences of such a decision.  Happas embedded  the idea of a "super-presumption" in the law of a state which used to embrace strict liability.  Styled as an evidentiary ruling it is really a rule of substantive law  which shields pharma from liability for negligent failure to inform patients of newly recognized risks.  The statutory presumption was thus converted into a full-throated regulatory compliance defense - the Pharmaceutical Research and Manufacturers Association's holy grail.  The real battle is moved to the FDA - a quasi-captive agency whose limitations were demonstrated in the Institute of Medicine's report The Future of Drug Safety.   In Kendall v. Hoffman-La Roche, Inc., 209 N.J. 173(2012) the high court had rather casually embraced the "super-presumption" phrase that was the industry by-word

New Jersey plaintiffs' weakened position was demonstrated in the Nuvaring litigation.  There  Bailey compelled a grant of summary judgment dismissing the New Jersey plaintiffs while those of other states citizens survived.  Brian Martinotti, the Superior Court Judge who was managing the cases in New Jersey where Merck is headquartered, methodically reviewed the aw in the states of the "bellwether plaintiffs. .  His opinion exposed weaknesses in proofs - such as doctors who did not say that they would not have prescribed  the contraceptive device if they had known of the vascular risks.  But most importantly Martinotti was bound by the industry-protective  "super presumption" of adequacy of FDA approved warnings which had wiped out not only strict product liability but even negligent failure to warn as causes of action against FDA-regulated drug makers.

The New Jersey Supreme Court - long a beacon of product liability law has rather become a slough of despond.  The super-presumption eviscerates not only New Jersey's history of strict product liability, but erases even negligence liability.  With Chris Christie at the helm in New Jersey and three more Supreme Court vacancies on his plate the pilgrim's progress in New Jersey is likely to be stalled for a generation. - GWC

Nod Given To $100M Settlement of NuvaRing Litigation Against Merck | New Jersey Law Journal:

A New Jersey state judge on Friday signed off conditionally on a settlement that requires Merck & Co. to pay $100 million to settle mass litigation over its allegedly unsafe NuvaRing birth-control device.Superior Court Judge Brian Martinotti made the approval contingent on achieving a 95 percent participation rate by plaintiffs in about 3,800 filed and pending matters in New Jersey and Missouri federal courts.U.S. Judge Rodney Sippel in St. Louis also approved the deal on Friday.The product, a contraceptive vaginal ring that releases hormones, went on the market in 2001 after Organon—a Dutch company with its U.S. headquarters in Roseland—in 2001 obtained Food and Drug Administration approval.The company was acquired in 2007 by Schering-Plough Corp., which two years later was acquired by Merck.

The device allegedly causes blood clots in some women, leading to increased risk of potentially fatal health problems like heart attack, stroke, pulmonary embolism and myocardial infarction.In August 2008, federal lawsuits filed in New Jersey, Missouri and Georgia were centralized for multidistrict litigation in the Eastern District of Missouri. The New Jersey state court cases were centralized before Martinotti the following March.

Read more: http://www.njlawjournal.com/id=1202642104645/Nod-Given-To-%24100M-Settlement-of-NuvaRing-Litigation-Against-Merck#ixzz2svhYcP63



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U.S. Sailors Sick From Fukushima Radiation File New Suit Against Tokyo Electric Power | EcoWatch

The USS Ronald Reagan

U.S. Sailors Sick From Fukushima Radiation File New Suit Against Tokyo Electric Power | EcoWatch:

by Harvey Wasserman

 "Citing a wide range of ailments from leukemia to blindness to birth defects, 79 American veterans of 2011’s earthquake/tsunami relief Operation Tomadachi (“Friendship”) have filed a new $1 billion class action lawsuit against Tokyo Electric Power.

The suit includes an infant born with a genetic condition to a sailor who served on the USS Ronald Reagan as radiation poured over it during the Fukushima melt-downs, and an American teenager living near the stricken site. It has also been left open for “up to 70,000 U.S. citizens [who were] potentially affected by the radiation and will be able to join the class action suit.”"

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Drug Safety Podcasts > FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products

An unusual initiative by the FDA to reassess drug safety based on published studies about approved drugs - not about unapproved testosterone supplements.

And the podcast format is an innovation - probably works best for people with long commutes to work.  - GWC

Drug Safety Podcasts > FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products:

Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug Information.  On January 31, 2014, FDA announced that it is investigating the risk of stroke, heart attack, and death in men taking FDA approved testosterone products.   We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.   We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.

At this time, FDA has not concluded that FDA approved testosterone treatment increases the risk of stroke, heart attack, or death.   Health care professionals should consider whether the benefits of FDA approved testosterone treatment is likely to exceed the potential risks of treatment.   The prescribing information in the drug labels of FDA-approved testosterone products should be followed. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.  Example conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.  Other examples include problems with the hypothalamus and pituitary that control the testicles’ production of testosterone. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.

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Statistically Insignificant Deaths: Disclosing Drug Harms to Investors (and Patients) Under Sec Rule 10b-5 by George A. Mocsary :: SSRN

I'm in favor of disclosure of drug adverse effects, as Fordham Law grad and now law professor George Mocsary lucidly argues. He argues that the statistical significance standard for disclosure by drug companies of adverse effect reports deprives investors - and patients and doctors - of relevant information.  A further problem is that drug companies don't have very good information- because they generally have no duty to actively study what happens to patients who actually use the drug.  The dangers of Vioxx which figures in Mocsary's analysis were largely the product of studies intended by Merck to expand approved uses.  Neither the FDA nor any recognized common law duty compelled Merck to systematically monitor Vioxx actual health effects on the arthritic patients who took the massively promoted pain-reliever. I urged recognition of an affirmative duty to monitor drug use in a 2007 article Punctuated Equilibrium.  
Mocsary's article nicely ties together the interests of investors, patients, and physicians, demonstrating that while evidence against the "null hypothesis" that a drug does not cause harm may not be judged 'statistically significant" it may nonetheless be relevant to prudential considerations by consumers and investors.  - GWC

Statistically Insignificant Deaths: Disclosing Drug Harms to Investors (and Patients) Under Sec Rule 10b-5 by George A. Mocsary :: SSRN:

This Article, using statistical tools and theory in conjunction with more standard legal approaches, argues that pharmaceutical manufacturers should disclose all cases of illness or injury associated with their products because this data is material to patients and their doctors, and therefore to Securities and Exchange Commission Rule 10b-5’s “reasonable investor.” Patient and investor interests complement each other in this context, so each will benefit from disclosures that interest the other. Because individuals process more information than traditional statistical tests convey, they act reasonably in expanding their treatment and investment criteria beyond statistical data. Moreover, two sets of expert intermediaries—doctors and professional investors—will be involved. Their expertise will contribute to a more accurate assessment of the risks that adverse-event reports may suggest a drug presents, and of the significance of these risks to shareholders.

The Supreme Court’s reasons for not requiring full disclosure are out of place in the context of adverse-event reporting given Rule 10b-5’s pro-disclosure mandate and the fact that even seemingly singular and unconnected facts can substantially move investors’ and patients’ opinions about a drug’s safety, and thus its maker’s viability. A full-disclosure rule would place the determination of which facts are important into the hands of parties with “skin in the game” rather than regulators or self-interested drug makers.

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Black at Stuyvesant High — One Girl’s Experience - NYTimes.com

Black at Stuyvesant High — One Girl’s Experience - NYTimes.com:

When the bell rings and the school’s 3,295 students spill out of classrooms into the maze of hallways, escalators and stairs like ants in a farm, blacks stand out because they are so rare. Rudi was one of 64 black students four years ago when she entered Stuyvesant, long considered New York City’s flagship public school. She is now one of 40.¶Asians, on the other hand, make up 72.5 percent of Stuyvesant’s student body (they are 13.7 percent of the city’s overall public school population), a staggering increase from 1970, when they were 6 percent of Stuyvesant students, according to state enrollment statistics. Back then, white students made up 79 percent of Stuyvesant’s enrollment; this year, they are 24 percent, and 14.9 percent systemwide.¶Hispanic students are 40.3 percent of the system. Currently, they make up 2.4 percent of Stuyvesant’s enrollment, while blacks, who make up 32 percent of the city’s public school students, are 1.2 percent.¶New York City has eight specialized high schools whose admission is based entirely on the results of an entrance exam, a meritocratic system that does not consider race or ethnicity.

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Hard Times at Howard U. - Charlayne Hunter Gault NYTimes.com

by Charlayne Hunter-Gault

A distinguished Black journalist discusses the ironies of progress in the elimination of de jure segregation - weakening of the historically black colleges and universities which played an important role in the progress of Black Americans. - GWC

Hard Times at Howard U. - NYTimes.com:

Howard is not unique in the constellation of private and public H.B.C.U.’s, or even in the overall higher education community. Earlier this year, Moody’s put out a negative outlook on the entire higher education sector.

But as the saying goes, when white America catches a cold, black America catches pneumonia.

HOWARD, which sits on a sprawling 258-acre campus in Northwest Washington, has educated many of the civil rights leaders who fought to end segregation at white colleges and universities, among them Thurgood Marshall and Vernon Jordan Jr.

As a newly minted lawyer, Mr. Jordan worked on my successful case to desegregate the University of Georgia in 1961. (Now a Howard board member, he declined to be interviewed for this article.) In those days, the State of Georgia went so far as to pay black graduate students to study in other states if no black institution in Georgia offered the courses they wanted to take.

In my case, the University of Georgia had the only journalism school in the South — my dream was to be Brenda Starr, having read the exciting exploits of the comic strip character from an early age. Hamilton Holmes, who was also part of the lawsuit against the State of Georgia, had gone to Morehouse, the men’s H.B.C.U. in Atlanta, for almost two years before our victory. But the University of Georgia had more laboratory facilities than Morehouse, and Hamp, as he was known to his friends, wanted to be a doctor, so he chose Georgia.

The lawsuit made it possible for me and other students to pursue our dreams in places that had always been closed to African-Americans. Little did any of us realize the price many black colleges would pay for equal opportunity.

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How the left’s embrace of busing hurt the cause of integration. - Slate

How the left’s embrace of busing hurt the cause of integration.: Part 1

by Tanner Colby

Today, America’s schools are more racially homogenous than they were 25 years ago. But to say that those schools are “resegregating” is to misstate the facts. They can’t resegregate. They never integrated. We moved a lot of kids around for the sake of making things look good on a spreadsheet, but our communities and social networks remained largely unchanged. The racial balance created by busing was a fiction, and in the absence of those programs we’re just seeing the country for what it has been all along, what it never stopped being: separate and unequal.

So what do we do about it now? Not much—not in terms of education policy, anyway. Some cities still have token integration efforts here and there, but nothing on the scale we had back in the 1970s. Thanks to the legal precedents set in Detroit and Kansas City—and other recent cases in Oklahoma City, Louisville, and Seattle—court-mandated programs aimed at creating racial balance are increasingly a dead letter. Just last week in Little Rock, Ark., the historic flashpoint where National Guardsmen had to escort black students into the segregated Central High School in 1957, the courts decided tothrow in the towel after a nearly 60-year, billion-dollar effort to bring proportional racial balance on the city’s schools. (They’re still 66 percent black—better than many districts but hardly proportional.) 
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