Wednesday, July 29, 2015

Meet Dylann Roof’s Defender | The Marshall Project

David Bruck - an exemplary lawyer. -gwc

Meet Dylann Roof’s Defender | The Marshall Project

Representing an avowed racist, a champion of racial justice.

Officials in Washington and South Carolina are still figuring out who will try Dylann Roof first for the Charleston church shooting on June 17. Local prosecutors quickly brought capital murder charges against the self-proclaimed white supremacist, and the Justice Department announced last week that it would bring a broad capital case against Roof centered around the Matthew Shepard and James Byrd, Jr. Hate Crimes Prevention Act, the federal hate crime law.

The South Carolina case likely will go to trial first — the feds typically defer to local prosecutors except when terror-related charges are involved (and, pointedly, none were brought against Roof). But with this case, the federal trial judge and the first-chair federal defense attorney have already been determined. David Bruck, a 66-year-old, Canadian-born capital expert, who graduated from the University of South Carolina law school, will return to the Palmetto State to tackle yet another challenging assignment representing a high-profile defendant.

Monday, July 27, 2015

Green group sues ConocoPhillips, CNOOC over China oil spill - report | Reuters

Green group sues ConocoPhillips, CNOOC over China oil spill - report | Reuters

A maritime court in the coastal city of Qingdao has said it will hear a landmark case brought by a nonprofit organisation against U.S. oil giant ConocoPhillips and China's CNOOC Ltd, the official China Daily reported.

The China Biodiversity Conservation and Green Development Foundation will not claim compensation, but is calling for the two firms to accept responsibility for damage caused by the 2011 oil spill in northeast China, the paper reported.

The case will be the first public interest litigation brought by a nonprofit organisation over marine environmental pollution, it said.

ConocoPhillips and CNOOC have been embroiled in a series of legal claims following oil spills in 2011 in Bohai Bay that polluted over 6,200 square km of water.

In December last year, a group of 21 Chinese firms launched a claim against the two firms for more than 141 million yuan ($22.7 million) in compensation for losses connected to the impact of the spill on their sea cucumber farms.

China's State Oceanic Administration in April 2012 ordered the two companies to pay 1.683 billion yuan in compensation for damage to the region's marine ecology, as well as to fund environmental protection efforts in the Bohai Sea.

The oil firms also reached an agreement with the Ministry of Agriculture in January 2012 to pay 1 billion yuan to settle compensation claims stemming from oil spills in north China's Bohai Bay.

Thursday, July 23, 2015

Judge Barbier establishes Common benefit fee committee and guidelines in BP Spill

Judge Barbier Establishes Common Benefit Fee Committee and Issues Guidelines in BP Spill Economic and Medical Compensation Case

(Appointment of Common Benefit Fee and Cost Committee and
Guidelines for Common Benefit Attorneys’ Fees and Costs Reimbursement)
[“Initial Fee Order”]
Even though a formal petition for an award of common benefit attorneys’ fees and reimbursement of costs (“Aggregate Fee and Cost Petition”) likely will not be filed in this litigation until 2016 or later, it is important at this time to begin the process of creating a structure, establishing guidelines, and setting a timetable for the eventual presentation to the Court of an Aggregate Fee and Cost Petition and a subsequent recommendation regarding allocation of the Aggregate Common Benefit Fee and Costs Award among eligible Fee Applicants “Allocation Recommendation”).
BP has agreed to pay up to $600 million in common benefit attorneys’ fees, costs, and expenses, as awarded by the Court.1 Under the Fee Agreement, “[a]ny common benefit Class Counsel fees and costs awarded by the Court will not be deducted from Class Members’ recoveries, but will be paid by BP in addition to other class benefits.” In re OIL SPILL by the OIL RIG “DEEPWATER HORIZON” in the Gulf of Mexico, on April 20, 2010, 295 F.R.D. 112, 126 (E.D. La. 2013), appeal dism’d in part, No. 13-30221 (5th Cir. Feb. 11, 2014). 

Treasurer Kennedy on the BP settlement | WBRZ News 2 Louisiana : Baton Rouge, LA |

Louisiana Treasurer Kennedy on the BP settlement | WBRZ News 2 Louisiana : Baton Rouge, LA |

BATON ROUGE- Just a few weeks ago, state officials announced Louisiana would be getting $6.8 billion from the lawsuit with BP over the 2010 oil spill. This morning, Treasurer John Kennedy stopped by 2une In to break down what this money means for the state.
Five billion dollars of the settlement is for natural resource damage, $1 billion is for state economic damages and $787 million is for Clean Water Act penalties.
The money will be paid out over fifteen years, with the first check coming sometime in January.
Kennedy says he's happy the state settled, but there are a few things we need to look out for.
"We have to keep people from stealing the money," said Kennedy. "You're going to have all kinds of consultants coming out of the woodwork that want to study the problem, write papers and hold conferences, but we have to tell them ‘no.'"
Kennedy also stressed the importance of a plan to make sure the state gets all of the money it's owed. Since the settlement is being paid out over time, there's no guarantee that the company will be able to pay the entire amount when the time comes.
The final thing Kennedy expressed was just how important this money is to Louisiana and the gulf coast.
"The state makes its living off the wetlands," said Kennedy. Let's spend this money to restore our wetlands and to rehabilitate the gulf, let's not waste it."

Sunday, July 19, 2015

Memphis seeks removal of heroic statue of slave trader, Confederate General Forest

In 1905 - one of the darkest post Civil War periods for African Americans - the white citizens of Memphis created a park, re-interred the remains, and commissioned a heroic statute of the slave trader and Confederate general Nathan Forrest.  In 2013 Tennessee created a law prohibiting changes in historical monuments.  Now the City Council of Memphis has asked the Historical Commission for permission to remove Forest's remains and the statue.  Seems only fair.  But isn't the statue important historical evidence of the deeply racist history of Tennessee?
The National Civil Rights Museum at the Lorraine Motel in Memphis marks the spot where Rev. Martin Luther King was murdered.  But that is a Black initiative.  What Tennessee needs - and America needs - is for white people to acknowledge the African American experience and practice humility.  - gwc
A Confederate General’s Final Stand Divides Memphis - The New York Times
by Emily Yellin
MEMPHIS — What people see when they look up at the towering statue of Nathan Bedford Forrest in a park near downtown Memphis usually depends on their deepest beliefs, their memories, their loyalties and maybe even their DNA.
Many see a Memphis slave trader, the original grand wizard of theKu Klux Klan and a war criminal who led a gruesome Confederate massacre of surrendered black and white Union troops at nearby Fort Pillow in 1864.
Others see a gallant but misunderstood Civil War general, a military genius and a hero who made a speech calling for racial reconciliation in 1875. And some passers-by have little or no idea who the guy on the horse is, and do not much care.

But this month, the Memphis City Council voted unanimously to begin an intricate process of removing the brass statue from the park — along with the remains of Forrest and his wife, encased since 1905 in its marble base. This effort joins a national wave of casting off Confederate icons since the massacre last month at a church in Charleston, S.C.

Friday, July 17, 2015

The F.D.A.’s Medical Device Problem - The New York Times

The F.D.A.’s Medical Device Problem - The New York Times

THE Food and Drug Administration has been regulating the approval of medical devices since 1976, but its regulatory oversight has not kept pace with the increasing complexity of this technology. Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials). And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).
As a result, there have been many warnings about, and recalls and withdrawals of, medical devices that were found to be dangerous only after they were on the market. (In 2009, for example, the Sprint Fidelis defibrillator, which by that time had been implanted in hundreds of thousands of heart patients, was recalled because it frequently malfunctioned, harming many patients and leading to numerous deaths.) And because the F.D.A.’s oversight of medical devices once they are on the market is also weak, it is very likely that many malfunctions and other problems remain undetected.
Incredibly, legislation that the House of Representatives passed last week would severely weaken, not strengthen, the F.D.A.’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not.
The legislation, disingenuously titled the 21st Century Cures Act, would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). In other words, anecdotal evidence, rather than the scientific studies, could be used to approve devices.

Audio NEJM Interview: Dr. Rita Redberg on the approval process for medical devices in the United States and in Europe.

Dr. Rita Redberg is a professor of medicine at the University of California, San Francisco, and the editor of the Archives of Internal Medicine. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. S. Basu and J.C. Hassenplug. Patient Access to Medical Devices - A Comparison of U.S. and European Review Processes. N Engl J Med 2012;367:485-8.

Wednesday, July 15, 2015

Paul Lioy, Scientist Who Analyzed 9/11 Dust and Its Health Effects, Dies at 68 - The New York Times

A hero of public health has died. - gwc

Paul Lioy, Scientist Who Analyzed 9/11 Dust and Its Health Effects, Dies at 68 - The New York Times

by Margalit Fox

Paul J. Lioy, an environmental scientist widely known for his analysis of the dust spawned by the Sept. 11 attacks on the World Trade Center and for his studies of its health effects over time, died on Wednesday after collapsing at Newark Liberty International Airport. He was 68.
The cause had not been determined, his wife, Jean Lioy, said.
Dr. Lioy (pronounced LEE-oy) was an internationally renowned authority on exposure science, a field concerned chiefly with pollutants and toxins that straddles environmental science and occupational health. He was the author of “Dust: The Inside Story of Its Role in the September 11th Aftermath,” a book for a general readership published in 2010.
At his death he was a professor of environmental and occupational health of the Rutgers University School of Public Health, in Piscataway, N.J., as well as the department’s deputy director for government relations.
From his home in Cranford, N.J., Dr. Lioy could see the plumes of dust that rose from the ruins of the trade center towers on Sept. 11, 2001. A million tons of dust would rain down on Lower Manhattan.
Dr. Paul Lioy.CreditNick Romanenko/Rutgers, The State University of New Jersey
Once his initial horror at the spectacle subsided, the scientist in him began to wonder just what was in that dust.
“It was unprecedented in terms of the complex characteristics of the materials released,” Dr. Lioy toldThe Asbury Park Press in 2011.
He was one of the first scientists to gather samples from the scene, arriving to find a fluffy gray dust so profuse, The New York Times reported, that he and his colleagues simply scooped it from the windshields of nearby cars and secured it in Teflon bags.
“It had a weird texture and color to it,” Dr. Lioy told The Times in 2005.
The samples were dispatched for laboratory analysis. The results indicated the presence of elements that included chromium, aluminum, barium, titanium, mercury and lead; jet-fuel components; cellulose from paper and cotton; particles of wood, plastic, glass, asbestos and concrete; and organic matter that Professor Lioy, with circumspection and great tenderness, described as containing “everything we hold dear.”
The findings allayed a potential health concern — asbestos-related illnesses — while illuminating an actual one: the persistent cough and other respiratory symptoms developed by some police officers, firefighters, construction workers and residents.
“In the first 48 hours, the government was concerned about asbestos being the primary threat,” Dr. Lioy explained a decade after the attacks in an interview on the Rutgers website. “But it was not. Asbestos exposure is a long-term problem. Once the ‘World Trade Center cough’ started appearing, we realized it wasn’t caused by asbestos.”
Dr. Lioy's book about Sept. 11 residue.
Three things, he continued, caused the cough.
“First, cement dust was very alkaline — the pH was above 10,” he said. “That irritated the linings of the lungs. Second, glass fibers got stuck in people’s upper airways, like wooden logs in a narrow stream. That trapped the cement particles and enhanced the irritation. And there were very coarse particles that comprised the vast quantity of the dust mass.”
Paul James Lioy was born on May 27, 1947, in Passaic, N.J. He earned a bachelor’s degree in physics from Montclair State College, as it was then known, followed by a master’s degree in the field from Auburn University in Alabama and master’s and doctoral degrees in environmental science from Rutgers.

Tuesday, July 14, 2015

FDA strengthens warning that NSAIDs increase heart attack and stroke risk - Harvard Health Blog - Harvard Health Publications

It remains the case that Naproxen (Aleve) is probably safer than the other NSAIDS. That evidence, of course, was the basis for the plaintiffs verdicts against Merck in the Vioxx cases. - gwc

FDA strengthens warning that NSAIDs increase heart attack and stroke risk - Harvard Health Blog - Harvard Health Publications

Gregory Curfman, MDEditor in Chief, Harvard Health Publications
Back in 2005, the FDA warned that taking nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen increased the risk of having a heart attack or stroke. Last week it took the unusual step of further strengthening this warning. This was done on the advice of an expert panel that reviewed new information about NSAIDs and their risks. Because NSAIDs are widely used, it’s important to be aware of downsides of taking an NSAID and to take steps to limit the risk.
Many people take NSAIDs to relieve mild to moderate pain. These medications may be particularly effective in conditions in which pain results primarily from inflammation, such as arthritis or athletic injury. Examples of commonly used over-the-counter NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve); celecoxib (Celebrex), diclofenac (Cataflam, Voltaren) are prescription NSAIDs. Aspirin is also an NSAID, but it does not pose a risk of heart attack or stroke and is not covered by this new warning.
For more than 15 years, experts have known that NSAIDs increase the risk of heart attack and stroke. They may also elevate blood pressure and cause heart failure. The risk of heart attack and stroke achieved special notoriety with rofecoxib (Vioxx), a type of NSAID called a COX-2 inhibitor. It caused as many as 140,000 heart attacks in the U.S. during the five years it was on the market (Vioxx was removed from the market in 2004). The regrettable experience with Vioxx raised awareness about the cardiovascular risk of NSAIDs, and led to further studies showing that the risk is not limited to Vioxx but is associated with all NSAIDs.
The new warnings from the FDA point out:
  • Heart attack and stroke risk increase even with short-term use, and the risk may begin within a few weeks of starting to take an NSAID.
  • The risk increases with higher doses of NSAIDs taken for longer periods of time.
  • The risk is greatest for people who already have heart disease, though even people without heart disease may be at risk.
  • Previous studies have suggested that naproxen may be safer than other types of NSDAIDs, but the new evidence reviewed by the expert panel isn’t solid enough to determine that for certain.

Wicker: BP Settlement Adds Certainty to Oil Spill Recovery |

Wicker: BP Settlement Adds Certainty to Oil Spill Recovery |

The 2010 Deepwater Horizon disaster in the Gulf of Mexico was the worst oil spill in U.S. history. Five years later the legal claims against BP have made history, too, with the nation’s largest-ever environmental settlement.

The news is a major milestone for Mississippi. For the past five years, Gulf Coast states and the Department of Justice have sought compensation for the spill’s extensive environmental and economic damage. Earlier this month, they reached an agreement with BP over the remaining penalties that the oil company owes. The agreement includes the final figure for BP’s Clean Water Act fines – a critical piece of the RESTORE Act.
Reaping the Benefits of RESTORE
Giving states the authority and flexibility to prioritize their most urgent recovery projects after the oil spill is something I championed as a coauthor of the RESTORE Act. The law, passed by Congress in 2012, directs 80 percent of Clean Water Act fines to affected Gulf Coast states. Typically, the U.S. Treasury would reserve these fines for the cleanup of future oil spills. RESTORE ensures that the funds will go where they are needed most.
RESTORE also recognizes that recovery efforts should be comprehensive, allowing Gulf states to pursue both economic and environmental initiatives. It established the Gulf Coast Ecosystem Restoration Council to facilitate partnerships between states and the federal government, promoting the strategic collaboration we need to make the Coast whole again.
The recent court agreement puts Clean Water Act fines at $5.5 billion, giving states more certainty about available resources and the viability of their long-term restoration plans. Mississippi is set to receive $582 million, in addition to the $106 million in early RESTORE payments. These funds can be directed to environmental, economic, and research projects. RESTORE funds will also be used for Research Centers of Excellence in each Gulf state.
Closing a Difficult Chapter
Overall, Mississippi is expected to receive an additional $1.5 billion over the next 17 years, putting its total compensation at nearly $2.2 billion. Among these payments is $750 million in economic damages, which the state legislature will determine how to allocate.
As Mississippians well know, the consequences of the spill were felt far and wide, not only jeopardizing the health of marine ecosystems but also residents’ livelihoods. Misperceptions of tainted seafood and polluted beaches severely damaged tourism and small businesses. Although the full extent of the harm may not be known for years, the settlement helps close a difficult chapter and promises to strengthen our recovery efforts in substantial ways.
Restoring a U.S. Treasure
It is important to build on the progress we have made. Mississippi’s early restoration projects have focused on replenishing oyster harvests and reef habitats as well as advancing infrastructure improvements for recreational use. Funding through the National Fish and Wildlife Foundation has addressed critical conservation needs and invasive species management. Meanwhile, tourism, the seafood industry, and energy exploration are showing signs of rebound, helping restore a way of life for our coastal communities.
Continued cooperation, transparency, and accountability will be necessary as Mississippi puts its portion of the BP settlement money to good use. We have an opportunity to make the Coast better than ever. Vibrant fisheries, energy resources, and recreational fun make the Gulf one of America’s greatest treasures. Its success is a win for the entire nation.

Thursday, July 9, 2015

Pope Francis: Speech at World Meeting of Popular Movements

Pope Francis: Speech at World Meeting of Popular Movements

"Time, my brothers and sisters, seems to be running out; we are not yet tearing one another apart, but we are tearing apart our common home. Today, the scientific community realizes what the poor have long told us: harm, perhaps irreversible harm, is being done to the ecosystem. The earth, entire peoples and individual persons are being brutally punished. And behind all this pain, death and destruction there is the stench of what Basil of Caesarea called “the dung of the devil”. An unfettered pursuit of money rules. The service of the common good is left behind. Once capital becomes an idol and guides people’s decisions, once greed for money presides over the entire socioeconomic system, it ruins society, it condemns and enslaves men and women, it destroys human fraternity, it sets people against one another and, as we clearly see, it even puts at risk our common home."

Clearing Ascertainability Hurdle Yields $30M Accord | New Jersey Law Journal

Clearing Ascertainability Hurdle Yields $30M Accord | New Jersey Law Journal

by Charles Toutant

A $30 million settlement by OSRAM Sylvania Inc. in a class action over automotive replacement headlamps shows the increased efforts class-action attorneys are making to meet the heightened ascertainability standard set by the U.S. Court of Appeals for the Third Circuit.

The first checks to class members were issued this week in the suit, which asserted that Sylvania's top-of-the-line SilverStar headlamps cost much more than standard bulbs but were falsely promoted as providing better visibility. In March, U.S. District Judge Madeline Cox Arleo of the District of New Jersey approved the settlement and a fee award of $10 million, which is to be drawn from the settlement fund. An objector, Clarence Morrison, appealed the judge's approval to the Third Circuit but withdrew his appeal June 3.

But class counsel faced a challenge in counting and identifying class members because Sylvania sells its products to retailers, not to consumers. According to Barry Eichen of Eichen, Crutchlow, Zaslow & McElroy in Edison, that problem made the suit vulnerable to a challenge under the Third Circuit's strict ascertainability standard, most recently expressed in an April decision in Byrd v. Aaron's Inc.

To identify persons who bought the SilverStar headlamps, class counsel served third-party subpoenas on seven retailers that represent the majority of the sales of the products. The retailers resisted production of data about their customers but ultimately agreed to turn over names that were obtained from loyalty-card programs and credit-card transactions, Eichen said. The seven retailers can't be identified because their cooperation was conditioned on confidentiality orders, Eichen said. After spending months obtaining the data and analyzing it, class counsel ended up with a list of nearly 1.7 million names, he said.

Eichen represented the class along with Evan Rosenberg of his firm and John Keefe Jr., Stephen Sullivan Jr. and Paul DiGiorgio of Keefe Bartels in Red Bank.

The settlement will also be distributed through a more traditional claims process, in which the call for class members is published in major publications, in addition to the list of buyers obtained from the retailers, Keefe said.
Read more:

FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

Twenty different non-steroidal anti-inflammatory compounds are on the market.  Many are sold over the counter - e.g. Advil, Motrin, Feldene, Aleve.  Others are by prescription only.  The largest drug product liability settlement - the Vioxx cases against Merck - centered on a debate about the safety of its NSAID rofecoxib marketed as Vioxx compared to Naproxen -marketed as Aleve and Naprosyn.

Evidence developed by Merck showed that the rate of heart attacks was increased five-fold among certain patients taking Vioxx compared to those taken by the control group who took naproxen - a drug with a different biological mechanism.

During the litigation evidence began to emerge that the entire category of drugs presented cardiac risks.  Merck fought to blunt the dramatic evidence that differentiated their drug from others.

Now ten years after its first warnings the FDA has strengthened its class-wide warnings but refuses to distinguish among the various drugs, despite contrary evidence. This sort of debate demonstrates that the marketing consequences of FDA statements are great - and raises the question of what motivates the FDA  Advisory Committees and the agency itself when such prescriptive statements. are made by the federal watchdog.  - gwc

Drug Safety and Availability > FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

July 9, 2015

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on our comprehensive review of new safety information, we are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. We will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs).

The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, we have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies,1 a large combined analysis of clinical trials, 2 and other scientific publications.1 These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.

Based on our review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:
The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
The risk appears greater at higher doses.
It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
There is an increased risk of heart failure with NSAID use.

We will request similar updates to the existing heart attack and stroke risk information in the Drug Facts labels of OTC non-aspirin NSAIDs.

Tuesday, July 7, 2015

Furl the Confederate Flags - Walker v. Sons of Confederate Veterans -

The public display of the confederate battle flag on public property has a public meaning. It is time to end the use of the confederate battle flag as a public symbol.

On the morning after the Charleston Emanuel A.M.E. Church massacrethe Supreme Curt in Walker v. Texas Division of Sons of Confederate Veterans   held that Texas speaks when it allows a message on a license plate.  And it therefore can pick and choose what is said on them.  Surprisingly Texas did not allow the Confederate battle flag to be portrayed on the vanity plates sought by the Sons of Confederate Veterans.

The lineup was unusual: Justice Clarence Thomas joined the liberals while the other conservatives joined Samuel Alito in dissent. They argued that the more than 350 varieties of vanity plates in Texas, issued for purchase, are not likely to be understood as expressing the view of the State.  Rather the plates are seen as expressions of the vehicle owners.   Basically - it's a money-maker for the State and that settles it.  Thus picking and choosing among acceptable messages impinges the rights of free speech of those who buy the vanity plates.

The dissenters view is plausible.  The degree of control Texas has exercised is minimal.  But sometimes the narrow view is the wrong view.  So it is here.  One may choose to remember ancestors who fought for an unjust cause.  But the
public display of the confederate flag on public property has a public meaning.  The Confederacy was many things but its overwhelming historical importance is that it was a seditious rebellion whose principal object was to preserve chattel slavery.  The modern resurgence of the stars and bars battle flag was contemporaneous with  massive resistance to public school integration, and to the civil rights movement.  Its public meaning is inextricably linked to slavery and the racial segregation that followed and frustrated the implementation of the 14th and 15th Amendments.

The Walker opinion, fortuitously, could not have been more timely.
It is time to end the use of the confederate battle flag as a public symbol.

Withdraw Approval for Seprafilm - Public Citizen to FDA

Image result for seprafilm
Public Citizen to FDA: Withdraw Approval of Seprafilm and Initiate Mandatory Recall

Medical Device Not Shown to Be Safe and Effective; Associated With Patient Death and Injury

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should remove the medical device Seprafilm from the market because it has not been shown to be safe and effective, and has been associated with patient death and severe injury, Public Citizen told the agency in a petition filed today.

Seprafilm – approved by the FDA in August 1996 – is a thin sheet of gel-like material that surgeons use during abdominal and pelvic surgery to prevent internal organs from forming fibrous bands of tissues that can block the intestine and cause other complications following surgery.

The clinical studies the FDA relied on when approving Seprafilm were plagued with problems. A study researcher at one hospital did not follow the study protocol or report all adverse event data and filed incomplete and inaccurate paperwork. There were also high numbers of serious adverse events in patients receiving Seprafilm. At the time of approval, the FDA ordered the product’s manufacturer, Genzyme, to conduct a post-approval safety study to address the agency’s concerns with the initial trials.

Image result for seprafilmYet this postmarket study, when finally completed, used highly questionable forms of analysis and failed to establish that Seprafilm offers any important clinical benefits for patients. More troublingly, evidence from this study, along with reports filed with the FDA over the years, shows that Seprafilm may interfere with wound healing and cause severe reactions – including death – in some patients.

“Seprafilm never should have been approved. There is no evidence that this device achieves any important clinical benefit for patients – but ample evidence showing serious adverse health consequences,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The FDA needs to immediately withdraw the approval of Seprafilm and initiate a mandatory recall of the device.”

Through records in the FDA’s Manufacturer and User Facility Device Experience database, Public Citizen found 21 reports of death in patients in whom Seprafilm was placed during surgery. It is likely that many other deaths have gone unreported. In addition to the death reports, Public Citizen identified a total of 524 reports of adverse events linked to Seprafilm.