The case for DES in STEMI patients | theheart.org

The case for DES in STEMI patients | theheart.org:

New York, NY - Newer-generation drug-eluting stents, particularly the everolimus-eluting stent (Xience V, Abbot; Promus, Boston Scientific), significantly reduce the risk of target vessel revascularization (TVR) in patients with ST-segment-elevation MI (STEMI) without increasing the risk of adverse safety outcomes, including rates of stent thrombosis, when compared with bare-metal stents [1].These are the principal findings of a new meta-analysis of 28 randomized, controlled clinical trials involving more than 34 000 patient-years of follow-up.Published online August 6, 2013 in Circulation: Cardiovascular Interventions, the analysis showed that compared with the sirolimus-eluting stent (Cypher, Cordis), the paclitaxel-eluting stent (Taxus, Boston Scientific), and bare-metal stents, the use of an everolimus-eluting stent reduced the relative risk of stent thrombosis 62%, 61%, and 58%, 

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Generic drug mfrs should have same safety warning duty as brand name patentees - New England Journal of Medicine

On Access and Accountability - Two Supreme Court Rulings on Generic Drugs
by Marcia Boumil, J.D., LL, and Gregory Curfman, MD
New England Journal of Medicine, August 7, 2013

Generic drug manufacturers are not free to add safety warnings without FDA permission, the United States Supreme Court held in Mutual Pharmaceutical v. Bartlett. In a 5-4 decision over Sonia Sotomayor's vigorous dissent the Court dismissed the judgment in favor of a woman blinded by a drug which now carries a warning about the danger.

Tufts medical school professor Marcia Boumil and Dr. Gregory Curfman, executive editor of the New England Journal of Medicine criticize the Bartlett ruling but report that the FDA has announced a proposed rule that would "create parity" between brand-name drug patent holders and generic manufacturers.  That is the FDA plans to change its regulations to impose on generics the same duty to upgrade warnings as do new drug manufacturers still protected by patent. They write:

The Bartlett ruling, however, leaves generics  companies unaccountable to consumers — but it has apparently  prompted the FDA to consider  revising its own labeling rule.  Days after the Court’s decision,  the agency released a proposed  revision that would “create parity” in the ability of brand-name  and generic drug companies to  control their labels’ contents. If  the proposed rule is adopted, it  may increase the cost of generic  drugs, since companies will be  accountable for their labels’  contents and so will have to invest more heavily in their own  safety studies. If the Bartlett ruling stands, the cost of generic  drugs may be reduced, since  companies won’t be liable for  most of the harm caused by  their products. Since nearly four  of five prescriptions are now  filled with generic drugs, the  impact of these decisions on this  already large and growing industry can be expected to be substantial.

BP seeks to stop payouts to claims administrator | The Trinidad Guardian Newspaper

BP seeks to stop payouts to claims administrator | The Trinidad Guardian Newspaper:

NEW ORLEANS—BP is balking at paying more than US$130 million in fees for the court-supervised administrator of its multibillion dollar settlement with Gulf Coast businesses and residents after the 2010 Gulf oil spill. A federal magistrate has scheduled a hearing today for BP to show why it shouldn’t be ordered to fund claims administrator Patrick Juneau’s proposed third-quarter budget.
In a letter Monday, a BP claims official said the company cannot determine if Juneau’s budget request is reasonable without more documentation. The official also claimed the settlement programme has been plagued by poor productivity and excessive costs. Separately, BP has asked a judge to suspend all settlement payments while former FBI Director Louis Freeh investigates alleged fraud in the programme.
BP Plc said Monday it has discovered new evidence of fraud and conflicts of interest in the programme that is paying billions of dollars to businesses and residents who claimed they were harmed by the 2010 Gulf of Mexico oil spill. The oil company made the disclosure in a filing with the US District Court in New Orleans as part of a renewed effort to suspend the payouts until Freeh, the court-appointed monitor, finishes investigating the payout programme.
BP said it learned within the last week that two lawyers reviewing appeals of disputed claims were partners at law firms representing claimants before the Court Supervised Settlement Programme (CSSP), and thus had apparent conflicts of interest. It also said it learned through its fraud hotline of allegations that a worker at a Mobile, Alabama spill claims centre helped people submit fraudulent claims in exchange for a share of the settlement amounts. BP said the CSSP suspended two employees in connection with this matter.
“BP should not have to face the substantial risk of irreparable harm from improper payments,” the company said. Temporarily halting payments until Freeh finishes his report is “modest relief” that will at most “slightly delay” payouts, which have been running at US$93 million a week, it added. Juneau, the Louisiana lawyer who administers the payout programme, previously announced an internal probe of allegations that a former worker in the payout programme referred claimants to lawyers in exchange for a share of payments

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HarrisMartin - Article - N.J. Court Wants Proposed Jury Instructions, Questionnaire 2 Weeks Before Oct. 21 DePuy Hip Trial

HarrisMartin - Article - N.J. Court Wants Proposed Jury Instructions, Questionnaire 2 Weeks Before Oct. 21 DePuy Hip Trial:

N.J. Court Wants Proposed Jury Instructions, Questionnaire 2 Weeks Before Oct. 21 DePuy Hip Trial

August 5, 2013

HACKENSACK, N.J. — New Jersey Superior Court Judge Brian R. Marinotti has ordered counsel for parties in the state’s first scheduled DePuy ASR hip implant trial to submit proposed jury questionnaires, verdict forms and jury instructions by Oct. 7.

That was one of several deadlines included in a July 26 pre-trial order in a case scheduled for trial beginning Oct. 21 in the Bergen County Superior Court, where the New Jersey ASR Hip cases are coordinated before Judge Martinotti.

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State Oceanic Administration sued over oil production in spill-hit Bohai Bay | South China Morning Post

State Oceanic Administration sued over oil production in spill-hit Bohai Bay | South China Morning Post:

China’s State Oceanic Administration (SOA) is being sued for allowing US oil major ConocoPhillips to resume production after spills off northern China in 2011, state media reported on Monday.

The Global Times newspaper, affiliated with the ruling Communist Party, said the SOA confirmed it was being pursued for administrative misconduct.

The action is being mounted by the All-China Environment Federation, which describes itself on its website as a non-profit civil society organisation supported by the government.

It is rare for a Chinese official agency to face court action from another government-backed entity.

The spills in June 2011 at the offshore Penglai field, jointly developed by ConocoPhillips and state-owned China National Offshore Oil Corporation, allowed more than 3,000 barrels of oil and oil-based mud – used as a lubricant in drilling – to vent into Bohai Bay.

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Warnings on helmets? Adequate? Effective?

by Ken Belson
Even by the alarmist standards of many product warnings, the labels on the backs of the football helmets are bracingly blunt: “No helmet system can protect you from serious brain and/or neck injuries including paralysis or death. To avoid these risks, do not engage in the sport of football....”

SAC Capital Advisors - a criminal enterprise?

When tort remedies are inadequate the case for criminal prosecution grows stronger. Such appears to be the case for SAC Capital Advisors - the hedge fund owned by founder Steven A. Cohen. The Securities and Exchange Commission took the unusual step of obtaining an indictment of the company itself, while filing an administrative complaint under the Investment Advisers Act charging Cohen as manager with civil liability for overseeing the enterprise and failing to stop specified insider trades.

The wire fraud act 18 USC 1343 was called "our stradivarius" by Jed Rakoff, reflecting on his years as a federal prosecutor. It reaches "[w]hoever, having devised or intending to devise any scheme or artifice to defraud..." obtains money by false pretenses, etc. A corporation is a "whoever". Innocent investors and stockholders may suffer greatly from an ill conceived prosecution under such a broad criminal statute.

The indictment describes an enterprise with a corrupt culture, led by a principal shareholder who sought and obtained portfolio managers and research analysts with "an edge" over competitors, instructed to find "high conviction" investment opportunities.

A jury will have to decide whether these structures and incidents so characterize the enterprise - SAC Capital Advisors, etc. that the entity is guilty beyond reasonable doubt. The fact that a criminal enterprise is a large one is an aggravating not a mitigating factor. In this case, reportedly, little remains of stockholders beyond Steven A. Cohen himself. If the allegations are true those defrauded by SAC are legion.

Former Goldman Trader Is Found Liable in Mortgage Deal - NYTimes.com

Fabrice Fabre - who lamentably described himself as the Fabulous Fab in a now notorious email - has been found liable by a jury in an enforcement action by the S.E.C.  The case arises from the famed %500 million deal in which John Paulson bet against derivative securities while ACA management bet they bonds would perform.  Tourre was the Goldman Sachs broker who knew but did not disclose that Paulson was taking the short side, misleading investors with cagey formulations, while marveling at his own cleverness. Background information including the complaint can be found on this blog HERE (I have not however updated that page for since 2012) - GWC
Former Goldman Trader Is Found Liable in Mortgage Deal - NYTimes.com:

In finding Mr. Tourre liable for civil fraud, the jury concluded that he made a material — or important — misstatement to investors and failed to correct it. The S.E.C. had to prove its case by a preponderance of the evidence, a lower standard than criminal cases.

In deliberating the S.E.C.’s most serious claims, the jury was instructed to weigh whether Mr. Tourre intended to defraud investors, or at least acted recklessly. The lesser charges required only that Mr. Tourre acted negligently.

In 2010, the S.E.C. had also charged Goldman with fraud. Not long after the case was announced, the bank settled for $550 million, a record fine at the time.

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OTHERWISE: Legal Ethics Forum: Sixth Circuit: it was unreasonable for Cooley applicants to believe Cooley's "objectively untrue" statements

OTHERWISE: Legal Ethics Forum: Sixth Circuit: it was unreasonable for Cooley applicants to believe Cooley's "objectively untrue" statements:

Caveat emptor for law students?


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Approaching Georges Harbor, Muscongus Bay, Maine
VIDEO by Milton Mejia