Torts Blog: FDA addresses issues related to sleeping pills

Torts Blog: FDA addresses issues related to sleeping pills:

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Conoco Phillips looks to resume drilling in north China's Bohai Bay

BEIJING, Jan. 10 (Xinhua) -- China's State Oceanic Administration (SOA) on Thursdayset out how it will mete out strict environmental protection measures in Bohai Seaareas as part of the country's attempt to curb ocean pollution.

These measures, including strictly limiting commercial exploitation in the sea andcarrying out oceanic restoration projects, will help accelerate the recovery of BohaiBay, which was seriously dirtied by oil spilled from a subsidiary of the United States-based oil company ConocoPhillips in 2011, according to the SOA.

"Environmental pressure from the ocean pollution hasn't been relieved much, which inthe long run will shake the foundation for stable economic and social development incoastal regions," said the SOA head Liu Cigui.

Liu said the SOA will work out a sound oceanic ecological appraisal systemnationwide and actively promote compensation for damage to oceanic zoology.

The administration will also slash the amount of pollutants allowed to enter the ocean,and improve the environmental assessment system regarding oceanic engineeringprojects.

Legal Ethics Forum: Heather Baxter, "Too Many Clients, Too Little Time: How States are Forcing Public Defenders to Violate Their Ethical Obligations"

Heather Baxter

I have been banging this drum slowly for a while now.  I keep hoping that something will give in this the fiftieth anniversary year of Gideon v. Wainwright.  The public defense system of Pennsylvania is a gross failure, and New York's is an admitted failure.  Now Nova Southeastern law prof Heather Baxter surveys the broad scope of the problem and its impact on the ability of public defenders to meet their ethical obligation to provide competent and effective defense. Unfortunately it's like the weather: everyone talks about it, no one does anything about it. - GWC
Legal Ethics Forum: Heather Baxter, "Too Many Clients, Too Little Time: How States are Forcing Public Defenders to Violate Their Ethical Obligations":

"Budget cuts have had a devastating effect on public defenders and their ability to effectively represent indigent clients, mostly in the form of increasing caseloads. Much has been written about the effect these excessive caseloads have had on indigent defendants’ right to counsel. This article, instead, focuses on how excessive caseloads are placing public defenders in ethical dilemmas. Public defenders are bound by the Model Rules of Professional Conduct, but these high caseloads are making it increasingly difficult for them to meet these required ethical standards. Specifically, it is more challenging for an attorney to represent indigent clients diligently and competently when dealing with caseload numbers well beyond the recommended levels. The author discusses why the solutions being offered by the American Bar Association‘s Formal Opinion 06-441 are not tenable and concludes that true reform in indigent defense is the only way to alleviate the excessive caseloads."

still unheard

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Ninth Circuit Allows Failure to Warn Medical Device Case to Proceed

Sheila Scheuerman at TortsProf Blog reports: "Muddling the preemption waters, the Ninth Circuit has ruled that a plaintiff can bring a state law failure to warn claim against a medical device manufacturer.  The court found the claim was not preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act."
The Ninth  Circuit, in a unanimous en banc decision Stengel v. Medtronic, reverses the panel and trial judge below who had dismissed the action as preempted by the 1976 Medical Device Amendments to the Food Drug & Cosmetic Act.  In an amended complaint Richard Stengel alleged that "Medtronic had violated a state-law duty of care by failing to report known risks associated with use of its medical device to the Food and Drug Administration" The decision allows Stengel to proceed with his 

"proposed new claim under Arizona law, insofar as the state-law duty parallels a federal-law duty under the MDA, is not preempted. Arizona state law has long been concerned with the protection of consumers from harm caused by manufacturers’ unreasonable behavior. Plaintiffs’ claim is brought under settled Arizona law that protects the safety and health of Arizona citizens by imposing a general duty of reasonable care on product manufacturers. “‘The whole  modern  law  of  negligence,  with its many developments, enforces the duty of fellow-citizens to observe in varying circumstances an appropriate measure of prudence to avoid causing harm to one another.’” 

The Circuit Court was constrained by the deplorable decision of the United States Supreme Court in Riegel v. Medtronic which barred design defect claims against manufacturers of Class III medical devices.  Thus victims of unreasonably dangerous products like Medtronic's implanted intrathecal spinal pain pump are limited to manufacturing defects and - now thanks to the 9th Circuit - at least one type of state law claim for failure to warn the FDA of product dangers.  As the concurring opinion points out Stengel faces a formidable obstacle in proving causal relationship.  He must show that had Medtronic submitted information to the FDA that his doctors would not have inserted the Medtronic pain pump which left Stengel paraplegic.  The decision does not recognize a duty to warn the patient directly.

The 9th Circuit opinion is consistent with what I have called the duty of product stewardship, and the Institute of Medicine in its 2006 report The Future of Drug Safety called a "life-cycle approach" to drug safety.  The heart of the approach is that a product manufacturer has an affirmative duty to monitor how its product actually performs after marketing permission is granted by the FDA.

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River Pollution Compensation conundrum | chinadaily.com.cn

Hazmat workers remove contaminated river ice

The recent chemical spill into the Zuozhang River, Shanxi Province (northwest) has focused attention on environmental pollution, China Daily reports. - GWC
Compensation conundrum |Cover Story |chinadaily.com.cn:

Some Changzhi residents told China Daily that contaminated water from the aniline spill has flowed into their fallowfarmland, and they expressed concerns that the toxic chemical would affect the spring harvest. If that proves to be thecase, they will ask for compensation from the plant or the local government.

However, it's difficult for residents to defend their rights as individuals, according to Tian Fengchang, a legal adviser atthe All-China Environment Federation. A lack of legal knowledge prevents many people from asserting their rights andmost are unable to afford the legal fees.

"They either ask for a huge amount in compensation that exceeds the prescribed limit, or don't know their rights," saidTian.

People are often vulnerable when they are up against big business or the government, said Tian, who has paid closeattention to environment compensation claims since 2005. Instead they usually turn to specialist organizations such asAll-China Environment Federation for help.

"These groups are professional and find it easier to attract the government's attention," he said. "Individuals are highlyunlikely to get any response."

He advised the Changzhi residents to collect evidence for use in investigations by taking photos and water samples.However, the compensation procedure could take years, said Tian.

Hu Sanhu, head of the Changzhi Government Information Office, said no schedule has yet been drawn up forcompensation claims, but pledged that experts from the Ministry of Environmental Protection will test the contaminated soil.

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Committee on Sports-Related Concussions in Youth - Institute of Medicine

The Institute of Medicine - a research arm of the National Academy of Sciences - has announced a new study: Committee on Sports-Related Concussions in Youth - Institute of Medicine: "An IOM committee will conduct a study on sports-related concussions in youth, from elementary school through young adulthood, including military personnel and their dependents. The committee will review the available literature on concussions, in the context of developmental neurobiology, in terms of their causes, relationships to hits to the head or body during sports, and the effectiveness of protective devices and equipment. The committee will also review concussion risk factors, screening and diagnosis, treatment and management, and long-term consequences.

Dates and agendas for future open sessions of the committee will be posted on the IOM project's web page. You can sign up for the project list serv.  The Committee on Sports-Related Concussions in Youth's first meeting
was January 7, 2013.
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Gun Violence: Live Harvard School of Public Health Webcast Tomorrow - Robert Wood Johnson Foundation

OTHERWISE: Gun Violence: Live Harvard School of Public Health Webcast Tomorrow - Robert Wood Johnson Foundation:



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USDOJ: Transocean Agrees to Plead Guilty to Environmental Crime and Enter Civil Settlement to Resolve U.S. Clean Water Act Penalty Claims from Deepwater Horizon Incident

USDOJ: Transocean Agrees to Plead Guilty to Environmental Crime and Enter Civil Settlement to Resolve U.S. Clean Water Act Penalty Claims from Deepwater Horizon Incident: "WASHINGTON – Transocean Deepwater Inc. has agreed to plead guilty to violating the Clean Water Act (CWA) and to pay a total of $1.4 billion in civil and criminal fines and penalties, for its conduct in relation to the Deepwater Horizon disaster, the Department of Justice announced today.   The criminal information and a proposed partial civil consent decree to resolve the U.S. government’s civil penalty claims against Transocean Deepwater Inc. and related entities were filed today in U.S. District Court in the Eastern District of Louisiana."



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Social Withdrawal and Violence — Newtown, Connecticut — New England Journal of Medicine

Social Withdrawal and Violence — Newtown, Connecticut — NEJM: by John T. Walkup, M.D., and David H. Rubin, M.D

"In the aftermath of the great tragedy in Newtown, Connecticut, the mental health community is responding to our own and others' desperation to understand why this event occurred and is advocating for strategies that might prevent similar events in the future. Discussion has focused on whether Adam Lanza was mentally ill, the risk of violence among the mentally ill, access to high-quality mental health care, gun control, and the relationship between the media and violence. An important dimension that has been less discussed is the question of social withdrawal and isolation, within and beyond the confines of mental illness. For the withdrawn and isolated and the angry and alienated, there are deep-seated barriers to care, and there may exist a small subgroup that is uniquely vulnerable to the seductive power of violence in our culture."...

The tragedy in Newtown has revived many Americans' passion for gun control and has drawn attention to the media's influence on violent behavior. What is missing from most related discussions is a focus on the seductive, powerful subculture that celebrates and advocates violent and antisocial behavior. Most people are not interested in and do not engage with this subculture, and most who do so are not seduced into action by antisocial themes and violence in films, video games, written materials, or interest groups. However, a very small minority of angry and alienated mentally ill persons may gain a sense of belonging and support from this subculture and may be particularly vulnerable to being seduced into action.

As we launch into relevant policy debates, mental health professionals are best tasked with addressing the problems in our system that make it difficult for individuals and their loved ones to obtain effective, high-quality mental health care early in life. Since most psychiatric disorders begin in childhood or adolescence, more research is needed on the progression of mental health problems from childhood through adolescence and into adulthood. More specifically, research is needed to elucidate the multiple trajectories of the early withdrawn and isolated behavior that is so common in the reported histories of people who perform violent acts. Finally, discussions of gun control and violence in the media need to delve deeper and illuminate the dark subculture of alienation and antisocial violence that may engage and seduce rare individuals into performing extreme acts of violence like the one in Newtown."

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OTHERWISE: Preventing Gun Deaths in Children — New England Journal of Medicine

OTHERWISE: Preventing Gun Deaths in Children — New England Journal of Medicine:
More on the appalling barriers to developing the public health information needed to develop effective strategies to prevent gun deaths and injuries. = GWC

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