Friday, February 28, 2014

The Courts and Public Health: Caught in a Pincer Movement by Peter D. Jacobson, Wendy E. Parmet :: SSRN

Faced with a conservative judiciary the FDA
has given up its plan for images like this on cigaret packs.
Conservative originalism is hostile to regulation and national authority (unlike the historical Federalists who favored national authority but settled low to get a slavery-reserving compromise in 1787)  It embraces an expansive first amendment when that appears to serve the acquisition or preservation of property which Burkeans see as the foundation of liberty.  One result of their ascendancy in the federal judiciary: the FDA has withdrawn its proposed graphic warnings on cigarette packs. - GWC

The Courts and Public Health: Caught in a Pincer Movement by Peter D. Jacobson, Wendy E. Parmet :: SSRN:

Public health practitioners are familiar with the general outlines of legal authority and with judicial standards for reviewing public health regulations. What may not be as familiar are three emerging judicial doctrines that pose considerable risks to public health initiatives. 
We explain the contentious series of judicial rulings that now place health departments’ broad grant of authority in jeopardy. One doctrine invokes the First Amendment to limit regulatory authority. The second involves the Supreme Court’s reinterpretation of federalism to limit both federal and state public health interventions. The third redefines the standard of evidence required to support regulations. 
Together, these judicial trends create a pincer movement that places substantial new burdens on the ability of health departments to protect health.
Accepted Paper Series 

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Thursday, February 27, 2014

Why The Transvaginal Mesh Litigation Won't Become A "Black Hole" Like Asbestos | Litigation & Trial Lawyer Blog

A plaintiffs' lawyer's perspective: move cases to trial.  Resolve cases claim by claim.  But how? "... the solution for the transvaginal mesh conundrum is to hold consolidated trials, and that’s what’s finally going to move the litigation closer to a resolution." - gwc

h/t Torts Prof Blog

Why The Transvaginal Mesh Litigation Won't Become A "Black Hole" Like Asbestos | Litigation & Trial Lawyer Blog:

by Max Kennerly - Beasley Law Firm

"The transvaginal mesh litigation has for some time been the largest medical mass tort ever, at least as measured by filings in the federal multi-district litigation (MDL), which is currently being handled in the Southern District of West Virginia. There are over 42,000 cases in the MDL — more than the combined total of cases ever filed in the Prempro MDL (9,761), the Yasmin and Yaz MDL (11,423), the Vioxx MDL (10,319), and the DePuy ASR Hip Implant MDL (8,900). (See this chart under “Total Actions.”) Add to that the over 6,000 mesh cases pending in New Jersey state court, and numerous cases filed in other state courts, and there are nearly 50,000 transvaginal mesh claims pending in courts across the country against six different manufacturers.


So what are the courts supposed to do with that many cases?"


There’s plenty of useful lessons there for current and future MDL courts. I was elated to see Judge Robreno address head-on the disturbingly common view that an MDL judge is somehow personally responsible for resolving the whole litigation through summary judgment or a handful of bellwethers: “As a matter of judicial culture, remanding cases [to local District Courts for trial] is viewed as an acknowledgment that the MDL judge has failed to resolve the case, by adjudication or settlement, during the MDL process.” As Judge Robreno rightly notes, “That view, together with the business model of aggregation and consolidation of cases for settlement, interfered with the litigation of individual cases in the MDL court,” and thus he concludes: “The objectives of the MDL process are best served by a commitment of the MDL courts to address pretrial issues, but promptly remand cases to the transferor court once the goal of addressing pretrial issues has been achieved.”

Hallelujah! If judges want to resolve mass torts cases, they need to keep an eye on discovery disputes, finish discovery, then move them all along to trial. But the devil is in the details — how do we get 50,000 transvaginal mesh cases to trial? And do we really want to hold 50,000 separate transvaginal mesh trials — e.g., do we really need to hold, in each case, two weeks of the same general liability testimony before we get to the specifics for each plaintiff?

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FDA Opens Review of Rules for Over-the-Counter Drugs, Including Acetaminophen - ProPublica

FDA Opens Review of Rules for Over-the-Counter Drugs, Including Acetaminophen - ProPublica:

The U.S. Food and Drug Administration has launched a review of the way it ensures the safety and use of over-the-counter drugs taken by hundreds of millions of Americans, opening the door to the most significant reform in four decades.The agency’s announcement follows a ProPublica investigation last fall focusing on acetaminophen, the active ingredient in Tylenol, which is among the drugs that would fall within the review.As we reported, despite more than 40 years of work, the FDA has yet to finalize rules governing the safe use of acetaminophen, hobbled, in part, by the cumbersome and bureaucratic system for regulating non-prescription drugs.Acetaminophen can cause liver damage and death in amounts close to the current recommended daily limit. Our investigation found that about 150 people die each year from accidentally taking too much of the drug. Tens of thousands of others are rushed to the emergency room or hospitalized.FDA officials have complained that the system in place since the early 1970s, known as the monograph process, is too slow to adjust to emerging safety issues.“When we look at how rapidly science now evolves and the impact this has had on the emergence of drug safety issues and on drug development, it is clear to that  a more agile and responsive process” is needed for over-the –counter drugs, the agency said in a response to questions.Our investigation showed that such delays have sometimes carried a high cost. The agency spent at least 15 years arguing with Tylenol’s manufacturer, Johnson and Johnson unit McNeil Consumer Healthcare, on how to improve the safety of pediatric acetaminophen. During that time, some 20 children died after their parents accidentally gave them overdoses of the medicine.In contrast, the prescription drug system allows the agency to make relatively quick changes to warning labels or dosage instructions. For instance, the FDA recentlyannounced that prescription medications containing acetaminophen could contain no more than 325 milligrams of the drug, citing the potential health risk.But consumers can still buy pills with twice that amount of acetaminophen over the counter at drug stores and supermarkets because the monograph system requires lengthy periods of debate and public comment.The FDA announcement reaches far beyond acetaminophen...........
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Tuesday, February 25, 2014

Tylenol use in pregnancy may increase risk of ADHD children - JAMA Pediatrics

A  new study published in JAMA Pediatrics  suggests but does not conclude that women who took Tylenol (acetaminophen) have children with an elevated rate of ADHD.  Remarkably it is the most commonly used drug in pregnancy.  56% of the women in the cohort of 64,000 children and mothers in a Danish national registry.  The discovery of possible new adverse effects highlights the basic fact that mass marketing of drugs is a mass uncontrolled experiment.  It supports the argument I have long made that courts and regulators should impose a duty of active post-aproval surveillance on drug makers. - GWC
Washington (AFP) - Acetaminophen, a common pain reliever considered safe for pregnant women, has been linked for the first time to an increased risk of attention deficit and hyperactivity disorder in children, said a study Monday.
More studies are needed to confirm the findings, but experts said the research points to a new potential cause for the worldwide rise in cases of ADHD, a neuro-behavioral condition which has no known cause and affects as many as five percent of US children.Women who took acetaminophen, also known as paracetamol, while pregnant had a 37 percent higher risk of having a child who would be later given a hospital diagnosis of hyperkinetic disorder, a particularly severe form of ADHD, said the study in February 24 edition of the Journal of the American Medical Association (JAMA) Pediatrics.

Monday, February 24, 2014

Torts Blog: Court of Appeals for the Seventh Circuit decides question left open by the US Supreme Court in 2010: prosecutor should not be immune to civil claims for misconduct during investigation phase of a case

Torts Blog: Court of Appeals for the Seventh Circuit decides question left open by the US Supreme Court in 2010: prosecutor should not be immune to civil claims for misconduct during investigation phase of a case:

by Alberto Bernabe

[I]n an opinion written by the very influential Judge Richard Posner, a split panel of the Court of Appeals for the Seventh Circuit has held that a prosecutor is not entitled to absolute immunity when his wrongful conduct is committed during the investigation of a case which results in a wrongful conviction.  The case is called Fields v. Wharrie and the opinion is available here.
The case is remarkably similar to the one before the Supreme Court back in 2010.  Here a prosecutor fabricated evidence against a defendant during the investigative stage of the case. He then coerced witnesses to give testimony that the prosecutor (as well as the witnesses) knew to be false.  Based on the false evidence, the defendant was convicted of two murders. The defendant eventually was acquitted in a retrial and subsequently received a certificate of innocence from the court in which he had been tried. 

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Collision at home plate rule adopted

The right way - Jackie Robinson steals home
Baseball is trying to reduce the risk of brain injury.  It is a non-contact sport but there are plays: like collisions at home and leaping up against outfield walls that can cause such harm. The new rule will be enforced by instant replay.  The rule is discussed HERE


(1) A runner attempting to score may not deviate from his direct pathway to the plate in order to initiate contact with the catcher (or other player covering home plate). If, in the judgment of the Umpire, a runner attempting to score initiates contact with the catcher (or other player covering home plate) in such a manner, the Umpire shall declare the runner out (even if the player covering home plate loses possession of the ball). In such circumstances, the Umpire shall call the ball dead, and all other base runners shall return to the last base touched at the time of the collision. 

Rule 7.13 Comment: The failure by the runner to make an effort to touch the plate, the runner’s lowering of the shoulder, or the runner’s pushing through with his hands, elbows or arms, would support a determination that the runner deviated from the pathway in order to initiate contact with the catcher in violation of Rule 7.13. If the runner slides into the plate in an appropriate manner, he shall not be adjudged to have violated Rule 7.13. A slide shall be deemed appropriate, in the case of a feet first slide, if the runner’s buttocks and legs should hit the ground before contact with the catcher. In the case of a head first slide, a runner shall be deemed to have slid appropriately if his body should hit the ground before contact with the catcher. 

(2) Unless the catcher is in possession of the ball, the catcher cannot block the pathway of the runner as he is attempting to score. If, in the judgment of the Umpire, the catcher without possession of the ball blocks the pathway of the runner, the Umpire shall call or signal the runner safe. Notwithstanding the above, it shall not be considered a violation of this Rule 7.13 if the catcher blocks the pathway of the runner in order to field a throw, and the Umpire determines that the catcher could not have fielded the ball without blocking the pathway of the runner and that contact with the runner was unavoidable.

Frostburg State football player pressured back on field after blows to the head dies - Washington Times

The most intriguing part of the court filings is an affidavit submitted by Dr. Robert Stern. The affidavit was included by the Latecomers to substantiate their position that pre-2004 student athletes have real claims and they are entitled to relief.
As an indictment on the NCAA leadership, Dr. Stern opines:
The NCAA and its leadership has known for two or more decades of the long-term risks associated with concussions and other brain trauma experienced by collegiate and other football players, and that medical intervention, brain trauma prevention strategies, and concussion management, may reduce the risk of subsequent brain disease and injury and related cognitive, mood, and behavioral impairment.
Accordingly, it is clear that the NCAA and its leadership have failed to live up to its founding principles of protecting student athletes for far too long. As you may recall, the NCAA did not take any action on concussions until 2010, and even then, it only issued toothless guidelines that have left member institutions scratching their head. And when it comes to schools egregiously violating NCAA rules, the NCAA does NOTHING. Instead, it spends its resources chasing down sandwich violators and ensuring that its labor force goes unpaid and medically unprotected from the real dangers of concussions. After all, that is the real meaning of modern-day amateurism: grave injustices.

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Saturday, February 22, 2014

F.D.A. Orders 4 Bidi Cigarette Brands Removed From Shelves -

F.D.A. Orders 4 Bidi Cigarette Brands Removed From Shelves -

by Catherine Saint Louis

The Food and Drug Administration on Friday ordered four tobacco products removed from the market, the first time the agency has done so since being given the legal authority in 2009.
“It’s a big deal,” said Matthew L. Myers, the president of the Campaign for Tobacco-Free Kids, an advocacy group. “This is first time the F.D.A. has ever ordered a product to be removed from the market for broad public health concerns.”
“It’s also significant that they did so because the manufacturer was unable or unwilling to provide sufficient evidence that the product didn’t raise new or different concerns for public health,” he added.
Since June 2013, the F.D.A. has rejected 13 new tobacco productsbecause agency scientists believed they posed health risks above and beyond comparable products already on the market.
Agency officials said that four cigarette brands made by Jash International may no longer be domestically sold, distributed or imported. They are Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone. In 30 days, the F.D.A. will begin seizing any goods that remain on shelves.

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A Hot Debate Over E-Cigarettes as a Path to Tobacco, or From It -

Dr. Michael Siegel is an E-Cigaret advocate
A Hot Debate Over E-Cigarettes as a Path to Tobacco, or From It - by Sabrina Tavernese

Dr. Michael Siegel, a hard-charging public health researcher at Boston University, argues that e-cigarettes could be the beginning of the end of smoking in America. He sees them as a disruptive innovation that could make cigarettes obsolete, like the computer did to the typewriter.
But his former teacher and mentor, Stanton A. Glantz, a professor of medicine at the University of California, San Francisco, is convinced that e-cigarettes may erase the hard-won progress achieved over the last half-century in reducing smoking. He predicts that the modern gadgetry will be a glittering gateway to the deadly, old-fashioned habit for children, and that adult smokers will stay hooked longer now that they can get a nicotine fix at their desks.

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Tuesday, February 18, 2014

Helmets don't prevent concussions - new study

Fooball helmets don't protect - new study - LA Times
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.,0,1291164.story#ixzz2tgd2IvxF

Tuesday, February 11, 2014

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:

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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Monday, February 10, 2014

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:

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Sunday, February 9, 2014

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

Now docked in San Diego, the USS Reagan’s on-going safety has become a political hot potato. The $6 billion carrier is at the core of the U.S. Naval presence in the Pacific. Critics say it’s too radioactive to operate or to scrap, and that it should be sunk, as were a number of U.S. ships contaminated by atmospheric Bomb tests in the South Pacific.
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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Thursday, February 6, 2014

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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Tuesday, February 4, 2014

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 -

Black at Stuyvesant High — One Girl’s Experience -

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

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. -

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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