Thursday, July 29, 2010

Burgeoning Scandal? Insurance for the Department of Veterans Affairs and Payments to Deceased Veterans

Get ready to get angry when you read this. How this happens to the family of those who made the ultimate sacrifice for our country. From the St. Pete Times:

Prudential handles life insurance for the Department of Veterans Affairs, sent a letter about  a deceased's $400,000 policy. And something that looked like a checkbook. The letter told Lohman that the full amount of her payout would be placed in a convenient interest-bearing account, allowing her time to decide how to use the benefit. "You can hold the money in the account for safekeeping for as long as you like," the letter said.

In small print, in a disclaimer Lohman said she didn't notice, Prudential disclosed that what it called its Alliance Account was not guaranteed by the Federal Deposit Insurance Corp.
Lohman, 52, left the money untouched for six months after her son's August 2008 death. As time went on she tried to use one of the "checks" to buy a bed, and the salesman rejected it. That happened again this year when she went to a Target to purchase a camera.

Lohman says she believed her son's life insurance funds were in a bank insured by the FDIC. That money — like $28 billion in 1 million death-benefit accounts managed by insurers — wasn't sitting in a bank. It was being held in Prudential's general corporate account, earning investment income for the insurer.

More ...

'Millions of bereaved Americans have unwittingly been placed in the same position by their insurance companies. The practice of issuing what they call "checkbooks" to survivors, instead of paying them lump sums, extends well beyond the military. In the past decade, these so-called retained-asset accounts have become standard operating procedure in an industry that touches virtually every American: There are more than 300 million active life insurance policies in the United States, and the industry holds $4.6 trillion in assets, according to the American Council of Life Insurers. '

Insurance companies — in addition to holding onto the money of survivors, paying them uncompetitive interest rates and giving them misleading guarantees — may be violating a federal bank law.

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Thursday, July 22, 2010

Georgia Lawyer and Oil Spill Claims:Deepwater Study

Deepwater Horizon Blowout, Gulf of Mexico - Lo...Image by SkyTruth via Flickr
Just issued this week. Some important statements, some obvious:

One that  should come as no surprise: “This disaster was preventable had existing progressive guidelines and practices been followed. This catastrophic failure appears to have resulted from multiple violations of the laws of public resource development, and its proper regulatory oversight.”

The first DHSG progress report identified seven elements responsible for this disaster:

• Improper cement design (segmented discontinuous cement sheath).

• Flawed Quality Assurance and Quality Control (QA / QC) – no cement bond logs in critical sections of the well, ineffective oversight of operations.
• Bad decision making – removing the pressure barrier – displacing the drilling mud with sea water 8,000 feet below the drill deck.
• Loss of situational awareness – early warning signs not properly detected, analyzed or corrected (repeated major gas kicks, lost drilling tools, including evidence of damaged parts of the Blowout Preventer) during drilling and/or cementing, lost circulation, changes in mud volume and drill string weight).
• Improper operating procedures – premature off-loading of the drilling mud (weight material not available at critical time).
• Flawed design and maintenance of the final lines of defense – including the Blowout Preventers (BOPs) blind shear rams, hydraulic lines, and triggering equipment – and the Emergency Shutdown and Disconnect (ESD) systems.

And more:

In the case of the Deepwater Horizon’s BOPs, the first few days following the incident are very revealing and symptomatic of BP’s failed Safety Management System (SMS). The initial response by engineers was focused on trying to fully engage the rig’s single functional blind shear ram using Remote Operated Vehicles (ROVs). However, it did not work and, in fact, the BP engineers reportedly did not even have accurate information about how the BOPs had been previously modified and wasted precious time trying to activate the BOPs.

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Georgia Avandia Lawyer and Avandia Clinical Trial News for July 22, 2010

Image representing GlaxoSmithKline as depicted...Image via CrunchBase
The FDA has ordered drug maker GlaxoSmithKline to stop enrolling new patients in a  clinical trial of its d diabetes drug, Avandia.

The clinical trial, called TIDE, was mandated by the FDA to assess safety risks of the drug, which is prescribed to treat type-2 diabetes.

The FDA said the action does not mean the drug will be removed from the market. But the agency is demanding that GlaxoSmithKline update physicians and ethics oversight boards involved in the trial regarding all new safety information about the drug.

We are investigating claims regarding Avandia. 
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Tuesday, July 20, 2010

Restore the Gulf - Watch the Video, sign the Petition

I did. It's ours, mine, yours. My kids. My as yet unborn grandkids: 

Arava Gets a Blackbox Warning

The FDA has added a blackbox warning about severe liver injury to the package label for Arava-- a disease-modifying anti-rheumatic drug used to treat RA The decision to add to the warning was based on the FDA's review of adverse event reports. The reports identified 49 cases of severe liver injury, including 14 cases of fatal liver failure, that occurred between August 2002 and May 2009.
Patients at greatest risk for liver injury were identified as those taking other drugs known to cause liver injury and patients with pre-existing liver disease. The additional information being added to the Boxed Warning for Arava recommends that:
  • Patients with pre-existing liver disease should not receive Arava.
  • Patients with elevated liver enzymes (ALT greater than two times the upper limit of normal) should not receive Arava.
  • Caution should be used in patients who take other drugs that can cause liver injury.
  • Liver enzymes should be monitored at least monthly for 3 months after starting Arava and after that, at least quarterly.
  • If ALT level rises to greater than two times the upper limit of normal while a patient is on Arava, the drug should be stopped, cholestyramine washout begun to speed removal of Arava from the body, and follow-up liver function tests conducted weekly until ALT returns to normal.
 The FDA site informs:
  • Be aware that cases of severe liver injury have been reported in people taking leflunomide.   
  • Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
  • Talk to your healthcare professional about any concerns you have with this medication. 
  • Report any side effects with leflunomide to FDA’s MedWatch program using the information at the bottom of the page in the “Contact Us” box.

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    Study: Zinc-based Nose Spray/Loss of Smell Linked

    CHICAGO - JUNE 17:  Boxes of Zicam cold remedy...Image by Getty Images via @daylife

    A researcher who has taken the position that the sprays were harmful says he has scientific evidence to back up the claim. Courts, however, have yet to be convinced.

    Last summer, the FDA warned consumers to stop using three zinc-containing Zicam products: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs for kids. The federal regulators cited 130 reports of loss of sense of smell among users of the products.

    The analysis included 25 patients treated at the University of California, San Diego Nasal Dysfunction Clinic, which Terrence Davidson directs, who experienced loss of smell after using zinc nasal sprays or swabs to prevent or treat colds. Along with colleague Wendy M. Smith, MD, Davidson applied the nine-point Bradford Hill causation environmental exposure statistical measure to assess the probability that the cold-remedy use caused the loss of sense of smell.

    Upper respiratory infections and nasal and sinus disease are major causes of both temporary and permanent loss of smell and diminished sense of smell.

    In nearly a dozen cases, however, Courts have found little scientific evidence to support the claim that zinc-containing Zicam nasal products caused loss of smell. Daubert based decisions have resulted in claims not making it to a jury. Davidson himself was rejected as an expert witness when the judge ruled his opinions on specific causation to be “seriously flawed.”

    Here's an excerpt from the opinion:

    Rose v. Matrixx Initiatives, Inc., No. 07-2404-JPM/tmp, 2009 WL 902311 (W.D. Tenn. Mar. 31, 2009)
    In Rose and Evans (discussed below) Plaintiffs alleged that Defendants' product, Zicam, caused anosmia (loss of smell). Id. at *4. In support of general and specific causation, Plaintiffs in Rose offered the expert testimony of Dr. Terence M. Davidson, a nasal health expert. Id. at *5. In excluding both the general and specific causation opinions of Dr. Davidson, Judge Jon Phipps McCalla noted:

    Dr. Davidson's opinions on specific causation are seriously flawed as the uncontradicted evidence demonstrates that Rose did not spray the Zicam into her right nostril and thus the Zicam could not have been the cause of her bilateral smell loss. . . .
    Dr. Davidson's belief that Rose must have sprayed the Zicam into both nostrils and must have simply forgotten what had happened is not supported by any evidence in the record. 
     Id. at *16.


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    Monday, July 19, 2010

    Georgia law: Apportionment Statute Ruling from Ct of Appeals

    A recent ruling has far reaching effects in Georgia litigation.   The case is CAVALIER CONVENIENCE, INC.,
    v. SARVIS,A10A0538, A10A0539.

    The issue presented in these appeals is whether, under recently amended OCGA § 51-12-33, a trier of fact is required to apportion its award of damages among multiple liable defendants when the plaintiff bears no fault.

    The Court held: "It is clear from that subsection's plain language that the legislature did not intend for apportionment to be limited to those cases wherein the plaintiff was to some degree at fault."

     The Court went on to hold that:

    In accordance with the legislature's unambiguous language in OCGA § 51-12-33 (b), we hold that where damages are to be awarded in an action brought against more than one person for injury to person or property — whether or not such damages must be reduced pursuant to OCGA § 51-12-33 (a) — the trier of fact "shall . . . apportion its award of damages among the persons who are liable according to the percentage of fault of each person."[ 15 ] Had the legislature intended for subsection (b) of OCGA § 51-12-33 to be triggered only upon a reduction of damages pursuant to subsection (a) of that Code section, it could have so stated; but it did not impose any such prerequisite.

    Find it here. 
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    Diovan, Avapro and Cozaar (and other) get FDA Review

    Just a short time after a meta-analysis suggested angiotensin receptor blockers (ARBs) for hypertension may increase cancer risk, the FDA has said it will conduct a safety review.

    The agency emphasized that patients now receiving these agents may stay on them and that physicians could write new prescriptions.

    The studies included data on four of the seven available ARB agents -- losartan (Cozaar), candesartan (Atacand), telmisartan (Micardis), and valsartan (Diovan). The other three ARBs now on the market are irbesartan (Avapro), olmesartan (Benicar), and eprosartan (Teveten).

    Another 12 products contain one of these agents in combination with other antihypertensives, most commonly a hydrochlorothiazide, according to the FDA.


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    Sunday, July 18, 2010

    Oil Spill and the Gulf (Florida)

    I have spent about 10 days in the Florida panhandle with family and friends. The photo above if from the Sandestin area, where folks still flock despite all of doomsday talk of the spill across the USA.

    I will tell you that folks are waking up to the nightmare every day. It's quite a sight to see on the beaches- volunteers and workers walking in Seagrove Beach, empty (thank goodness) bags to pick up tar balls. For most of the time, nothing on the beach but perhaps sun tan oil. That, plus an endless stream of 4 wheel vehicles of workers looking for something to do.

    Keep the gulf in your prayers.  

    FDA and bazter Pump Recall

    Image representing Baxter International as dep...Image via CrunchBase
    The FDA has issued specific instructions to Baxter Healthcare for how to handle the recall of thousands of Colleague Volumetric Infusion Pumps.

    The orders require Baxter to ship replacements or issue refunds for affected products and continue to provide batteries, spare parts, and service for devices held by customers with certificates of medical necessity.
    Additionally, Baxter must maintain service of pumps held by customers with the certificate for 24 months following today's order or until the customer has made use of a replacement product.
    The recall was issued in early May, when the FDA required Baxter to recall and destroy the fluid delivery pumps. The announcement came after the agency said in April it received 56,000 adverse event reports -- including 500 deaths -- related to infusion pump use from all manufacturers from 2005 to 2009.

    More here. 
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    Florida/Georgia Avandia News: Restrict, but don't Recall Avandia

    Avandia survives another round of FDA meetings. An FDA panel  panel took six votes on a variety of issues, but its most important came near the end of the meeting when asked what the FDA should do. Sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings.

    Avandia, which was once the biggest-selling diabetes medicine in the world, saw its sales abruptly decline in 2007 after a study by Dr. Steven Nissen, a Cleveland Clinic cardiologist, found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.

    Many of the same experts who decided to keep the drug on the market in 2007 voted Wednesday that it should be withdrawn or restricted. Those restrictions could mean that patients would have to apply for special permission to use the drug.

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    Zelnorm: Claims Settle

    Logo of the U.S. Food and Drug Administration ...Image via Wikipedia
    Novartis looks like it will settle 124 lawsuits brought by people who claimed their use of the gastrointestinal drug Zelnorm caused heart-related injuries.

    Novartis had suspended U.S. sales of Zelnorm in 2007 at the request of the U.S. Food and Drug Administration because a safety analysis found it increased the risk of heart attack, stroke and chest pain, compared with placebo.

    Zelnorm, which first went on sale in 2001, was approved to treat irritable bowel syndrome with constipation. It had sales of $561 million in 2006, the last full year before its withdrawal.
    The withdrawal sparked a number of lawsuits. Novartis said in its earnings release it's a defendant in about 135 cases brought in U.S. and Canadian courts.
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    Monday, July 12, 2010

    Avandia: FDA Reviewers Suggest the Drug's Withdrawal

    Avandia should be pulled from the market because of the "serious" cardiovascular risk the diabetes drug poses, which exceeds that of competitor pioglitazone (Actos), FDA staff reviewers again recommended.Rosiglitazone is no more effective at improving glycemic control in type 2 diabetes than pioglitazone and provides no known unique health benefits, and while both drugs increase the risk of congestive heart failure, rosiglitazone's effect is "substantially greater," FDA reviewers wrote in a massive briefing document released Friday

    In the FDA reviewers' analysis, the hazard ratios with rosiglitazone versus placebo were:
    • 1.42 for MI (95% lower confidence limit 0.93, 95% upper confidence limit 2.16)
    • 0.96 for strokes (95% LCL 0.60, 95% UCL 1.54)
    • 0.95 for cardiovascular death (95% LCL 0.57, 95% UCL 1.60)
    • 1.13 for major adverse cardiovascular events (95% LCL 0.85, 95% UCL 1.50)
     More here.
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    Thursday, July 01, 2010

    SCOTUS: Case versus Pfizer involving Non Citizens may Proceed

    The US Supreme Court declined to take up a case examining whether drug giant Pfizer could be sued in an American court for allegedly conducting nonconsensual drug tests on 200 Nigerian children in 1996. The action allows the case to move toward a trial.

    The suit was filed under the Alien Tort Statute (ATS), which empowers federal judges to hear civil lawsuits filed by non-US citizens for violations of the “law of nations.”

    Lawyers for Pfizer denied that the Nigeria experiments were conducted without the consent and knowledge of the children and their guardians. In addition, the lawyers argued that the children’s case should be thrown out of court because the alleged drug experiments are not the precise type of international law violation covered under the ATS.

    What made the high court appeal potentially significant is that the Supreme Court has declared that foreign plaintiffs may rely on the ATS to file lawsuits, but only in a few limited circumstances. The high court has not yet identified precisely which few cases may be brought and which may not. Pfizer v. Abdullahi (09-34) offered an opportunity for the justices to offer guidance and clarification.


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    Effient on the FDA Radar

    The logo of Eli Lilly and Company.Image via Wikipedia
    The FDA launched probes into possible risks from an Eli Lilly and Co (LLY.N) bloodthinner, a Sanofi-Aventis heart drug and other medicines.

    The FDA released its quarterly list of early investigations into health problems reported with various drugs on Wednesday.

    On the list, the agency said it was probing cases of thrombotic thrombocytopenic purpura (TTP) in patients treated with Effient, a blood thinner from Lilly and Daiichi Sankyo. TTP is a rare but potentially fatal blood disorder.

    Effient's makers have seen one, or "possibly two," reports of TTP with the drug since its approval a year ago, Lilly spokeswoman Tammy Hull said. No cases were recorded in clinical trials, she said.

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    Spill: Florida Projections

    Here's an illustration of the spill projection for Florida's west coast: