Vioxx: Merck is not Required to Refund the State of Louisiana

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From Bloomberg:

Managers of Louisiana’s state-sponsored health programs had no power under state law to halt reimbursements for Vioxx prescriptions, even had they known that Merck misled them about the drug’s heart-attack risk, U.S. District Judge Eldon Fallon in New Orleans ruled .  This is the first of about a dozen state litigation matters on the same issue to go to trial.

Lousiana “did not carry its burden that, had the state possessed different clinical information about Vioxx, it would have sought to restrict Vioxx Medicaid reimbursements entirely,” wrote Fallon.

Source.

Georgia: More Informaiton About Avandia and the upcoming FDA meeting

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The new analyses of Avandia's  seem to be all the talk surrounding the drug and the upcoming FDA hearing. Each study however, is not based on clinical trials in which researchers randomly give patients one treatment or another and compare the results after a set period of time, but of a review of information. Two of the studies show that Avandia is bad for people's hearts, and one of them doesn’t.

• One revisited an original analysis conducted back in 2007, adding new data from studies completed in the last three years. The increase in heart attack risk compared to placebo shrinks from 43% to 28%, compared to placebo. The increase in cardiac death is no longer even close to statistically significant. According to the analysis, 37 patients would have to be treated with Avandia for one year to be harmed.

David Graham, an FDA drug safety researcher published a study comparing Avandia to its main competitor, Actos, in a quarter of a million Medicare patients. Graham found no statistically significant increase in the risk of heart attack for patients on Avandia. But those taking Avandia were more likely to have strokes, develop heart failure, or die.

Researchers for the National Institutes of Health presented results from a clinical trial not specifically designed to evaluate Avandia by itself. They found no increase in the risk of heart attack or cardiovascular death for patients on Avandia. In fact, the patients taking the drug had fewer heart attacks or cardiac deaths, though that result wasn't statistically significant.

So what does this mean for the FDA as well as the drug? There were lessons from the FDA's request to withdraw Bextra several years ago, and to me the political pressure will be perhaps to issue warnings - leaving uncertainty with consumers across the US who will read more and more about the risks of Avandia. Certainly the FDA has to know that a recall of this blockbuster drug will have long reaching legal ramifications and likely bring a deluge of ore more lawsuits alleging injury.

What will happen? Stay tuned. 

Will ADHD Drugs Get A Stronger Warning?

A study will be released in August by the FDA regarding concerns about the potential for increased risk of heart attack, stroke or other cardiovascular problems when the drugs are used by children and adults.

ADHD is a behavioural disorder that can have a significant impact on social performance and functioning.

According to the FDA, the most commonly prescribed paediatric include Adderall, Concerta and Strattera.

Attention-Deficit Hyperactivity Disorder (ADHD or AD/HD) is neurobehavioral disorder. It is primarily characterized by "the co-existence of attentional problems and hyperactivity, with each behavior occurring infrequently alone" and symptoms starting before seven years of age.

Source.

Study: Is Crestor Helpful for Healthy Folks?

 From the Archives of Internal Medicine, a recent report that concludes:

Conclusion  The results of the Jupiter trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors.

Here's the abstract:

Background  Among the recently reported cholesterol-lowering drug trials, the JUPITER (Justification for the Use of Statins in Primary Prevention) trial is unique: it reports a substantial decrease in the risk of cardiovascular diseases among patients without coronary heart disease and with normal or low cholesterol levels.


Methods  Careful review of both results and methods used in the trial and comparison with expected data.


Results  The trial was flawed. It was discontinued (according to prespecified rules) after fewer than 2 years of follow-up, with no differences between the 2 groups on the most objective criteria. Clinical data showed a major discrepancy between significant reduction of nonfatal stroke and myocardial infarction but no effect on mortality from stroke and myocardial infarction. Cardiovascular mortality was surprisingly low compared with total mortality—between 5% and 18%—whereas the expected rate would have been close to 40%. Finally, there was a very low case-fatality rate of myocardial infarction, far from the expected number of close to 50%. The possibility that bias entered the trial is particularly concerning because of the strong commercial interest in the study

Source.

Avandia Reporting Risk ahead of Study

A new study led by a federal drug safety expert ties the controversial diabetes drug Avandia to a higher risk of heart problems, strokes and deaths in older adults, and says it is more dangerous than a rival drug, Actos.

The study, involved a Medicare records review, and is released about two weeks before there is an FDA  hearing on Avandia's safety.


The study involved 227,571 Medicare patients, average age 74, who started on Actos or Avandia from July 2006 through June 2009 and were followed for three years on average

Source. 

Why I'm not Real Happy about the potential $20B Claims Funds to be handled by Kennth Feinberg

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There are continuing discussions about the soon to be administered $20 Billion fund from BP through Kenneth Feinberg's process: 

Feinberg plan to set a cutoff date for filing emergency claims which would be submitted at least two months after the spill finally ends. From there, expect a  formal settlement process. Claimants are not being required to sign any waivers during the emergency claims process, but might very well will have to agree not to sue BP in the future when they apply or a final settlement.    He was quoted as saying "At some point I will offer the claimant a lump sum for all future losses and giving a release that they will no longer sue BP in connection with the spill. If they don't like it they can reject the lump sum. "  

What concerns me is the continuing commentary by Feinberg - an 'impartial' administrator who has not opened claim one - that somehow lawyers want "40%" of anything. He's using that figure as a 2 by 4 in advance. I know of more than a dozen firms that are handling BP/OPA claims for free. Others are charging only 10%.

Does Feinberg expect that a person without a lawyer may conclude: 1.  If the settlement is sufficient, or
2.  What the risks are, or will they be significant if an amount is turned down, or 3.  How to determine the value of future claims?

If  a claimant does not know how to find environmental or business valuation experts,  what then?

I'm all for a discussion of what is right and wrong. I'm all for reasonable charges being discussed across the board - accountants, environmental engineers, experts on remediation, business valuation experts - all of whom have much to gain in the claims process.

FDA: Airline Food May pose Health Risks

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At first I laughed when I read the headline, thinking- airline food not healthy? What's next, FDA declares smoking is bad for you? Then I read more ...

 FDA inspectors have found that a large number of catering facilities that supply airlines with food are suspected of violating sanitation regulations. This follows kitchen inspections last year and earlier thius year.
Inspections were carried out at three of the largest airline catering facilities in the world: Gate Gourmet, LSG Sky Chefs and Flying Food Group.

Between them, the three caterers have over 90 kitchens and they prepare at least 100 million airline meals every year to the US trade, as well as foreigh airlines serving from US airports. All the biggest and best known US airlines are included, such as United, US Airways, Delat, American and Continental.
Among the problems reported that could put passengers at risk was food stored at incorrect temperatures, equipment that was not properly cleaned and workers practicing poor unhygiene methods.

If you can stomach more bad news on this, go to the source. 

Dulera Approved with a Black Box Warning

FDA approved Merck's Dulera, a combination inhaler, for asthma patients 12 years and older.

Dulera consists of an inhaled corticosteroid and a long-acting beta agonist, and shares an active ingredient with Merck's Asmanex and Nasonex (mometasone furoate), and Foradil (formoterol fumarate). Dulera carries FDA's most severe safety warning, the black box label, which in this case warns patients about the potential for asthma-related death associated with long-acting beta agonists, or LABAs.

Source. 

Georgians who owns a Condo or Home on the Gulf and the Oil Spill: An -Insurance Covered event?

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The man made calamity that is the BP oil spill will cause extensive property damage and business interruption losses to businesses all along the Gulf Coast vacation homes and condominiums in Florida, and many types of  businesses around the Gulf.

There are also businesses away from the coastline,that might suffer business income losses. Where we go (Seagrove Beach), there is a direct financial hit being felt in towns like Defuniak Springs, Florida, as well as towns filled with hardworking folks -Florala, Flomaton, Chipley.  Gas stations like the Tom Thumb on 30-A in Seagrove seems bustling - are other service stations doing the same?

I spoke with an inn owner east of Destin who had massive losses for June, and July looked even worse.



While home and condo owners and other businesses are looking first at responsible parties to cover their losses, lawsuits against BP, Transocean and others could stretch out over a decade - or more.

So, now what? Folks should start thinking now about their own insurance coverage.

Affected business owners may want to look at their insurance policies, checking to see if  business interruption coverage is included. In our experience most business property policies have "BI".

BI coverage is designed to protect businesses from losses stemming from unavoidable interruptions in their daily operations. BI coverage may apply in a variety of circumstances, such as a forced shutdown, a downturn in business due to the damage from the oil spill, or a substantial impairment in access to products, services, or a premise.

The Business Owner's Policy (BOP) is an "off the shelf," cookie cutter policy written by the Insurance Services Office (ISO) with standard language. Most small businesses purchase BOPs.

The most important section of an insurance policy is the "Declarations" page, which defines, very specifically: Who is insured? What property is covered? In what amount is the coverage? What are the deductibles and co-pays? Are there any special exclusions or endorsements to the policy? This helps an owner figure out if he or she has the basis for a claim and provides a road map to the policy coverages. 

The "off the shelf" language usually looks like this: "We will pay for the actual loss of ‘Business Income’ you sustain due to the necessary suspension of ‘operations’ during the ‘period of restoration’… The suspension must be caused by direct physical loss or damage to property at the ‘described premises’…." In order to understand the coverage that a policy offers, you have to understand the terms used in defining the coverage.

Business Income: Business income is specifically defined in the policy as net income that would have been earned AND continuing normal operating expenses that would have been incurred. Payroll may be treated separately depending upon the policy coverage.

There may be other coverage, such as Civil Authority coverage:

• Interruption by Civil Authority.  Losses caused by orders of city or governmental authority which prohibits access to your premises due to direct physical loss to the property are covered under some policies. There may be a time limitation of the period of indemnity of one, two or three weeks.

  There are other types of coverage which may apply to some policy holders.

• Extra Expenses. Extra expenses are those cost that a business operator incurs as a result of a covered period to avoid or minimize his or her business income loss. These extra expenses are covered to the extent that they reduce the amount of the loss of the insured. 
• Extended Period: Some policies provide for an extended coverage period to allow a business to return to normal operations. This period is usually limited, and is in addition to the period of restoration.

What makes sense to do right now: The list may be long, but looking at it makes sense.

• Locate all of your insurance policies
  
• Read each one -- Liability, D&O or first-party property insurance. Then, read them again
  
• As you read keep in mind that that property damage, business income, contingent business income and extra expense coverage may be available under your policy - but you need to read it for yourself.
  
• In some jurisdiction, an argument may be made that coverage may be available even without direct physical loss or damage
  
• If you think there is coverage, it's time to consider if the next step is giving notice to all levels of coverage
  
• Consider whether insurance coverage may be available under other insurance policies.

1. 
   
   Now's the time to looks over what you have - what you paid for - to see if your risk is covered. If you need help, call us.

Kellogg's Recalls Some Cereals

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Looks like the culprit related to cereal products packaged in white foil bags that have an off -flavor and smell coming from the bag.

• 
  Only products with the letters "KN" following the Better If Used Before Date are included in the recall.
  
  Kellogg's® Apple Jacks®UPC 3800039136
  17 ounce package with Better if Used Before Dates between APR 10 2011 and JUN 22 2011
  UPC 3800039132 3
  8.7 ounce packages with Better if Used Before Dates between JUN 03 2011 and JUN 22 2011
  Kellogg's® Corn Pops®UPC 3800039109
  12.5 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  UPC 3800039111
  17.2 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  UPC 3800039116
  9.2 ounce packages with Better if Used Before Dates between APR 05 2011 and JUN 22 2011
  Kellogg's® Froot Loops®
  UPC 3800039118
  12.2 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  UPC 3800039120
  17 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  UPC 3800039125
  8.7 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  Kellogg's®Honey Smacks®
  UPC 3800039103
  15.3 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  
  
  Again, only products with the letters "KN" following the Better If Used Before Date are included in the recall.
  
  Sourcce:  http://consumeralert.kelloggs.com/consumeralert.aspx?id=3870
  

Crib Recall

There has been a recall of 2 million drop-side cribs for deadly hazards.

The moveable sides that raise and lower on such cribs make it easier to whisk away crying babies without straining parents' backs. But the sides repeatedly malfunctioned in ways that were hard to spot, leading to horrific scenes in nurseries around the nation.

When the sides separate from the crib, babies' bodies can slip into the resulting gap. Their heads get trapped, and they hang to death or suffocate. At least 32 children died when their drop-side cribs malfunctioned, and the U.S. Consumer Product Safety Commission said another 14 babies' deaths may be linked to drop sides.

According to the AP, the recalled cribs include:

• "50,000 Jenny Lind drop-side cribs distributed by Evenflo Inc.
• 747,000 Delta drop-side cribs. Delta is also urging parents to check all fixed and drop-side cribs that use wooden stabilizer bars to support the mattress. The company says the bars can be installed upside down, causing the mattress platform to collapse. CPSC spokesman Scott Wolfson said Delta "was not cooperative with providing the full number of units involved in the mattress support assembly problem."
• 306,000 Bonavita, Babi Italia and ISSI drop-side cribs manufactured by LaJobi Inc.
• 130,000 Jardine drop-side cribs imported by Toys R Us.
• 156,000 Million Dollar Baby drop-side cribs.
Story continues below
• 50,000 Simmons drop-side cribs.
• 40,000 to 50,000 Child Craft brand stationary-side cribs and an unknown number of Child Craft brand drop-sides. Child Craft ceased operations last summer and sold its name to Foundations Worldwide Inc., which did not manufacture or sell any of the recalled cribs but will offer rebates for some of them.

Source.http://www.huffingtonpost.com/2010/06/24/crib-recall-2010-evenflo_n_624845.html

Georgia Oil Spill Update -The BP Oil Spill $20B Fund

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Lots of questions about the $20B fund that will have $5B in it when claims begin to be analyzed later this summer: Attorney Kenneth Feinberg has been assigned the responsibilities of overseeing the $20 million fund that oil giant is likely to pay as compensation to the victims of the oil spill disaster off the gulf coast

What is an escrow fund?

The money is put into an escrow account to ensure that an amount  will handle oil spill claims. BP does not have access to the money once it has been released the US Government.

Where does the $20 billion go?

The escrow fund  will be handled by an Independent Claims Facility (ICF), designed for claims of individuals and businesses who have been harmed by the oil spill. The Fund will be used to pay claims decided by the Independent Claims Facility. Expect natural resource damage costs and state and local response costs to be pulled from the Fund.






Is the $20 billion accessible now?

Not by any stretch. BP  must pay $5 billion per year over the course of four years at a minimum. The company will make initial payments into the escrow fund of $3 billion this summer and $2 billion in the fall, followed by $1.25 billion per quarter until the $20 billion figure is reached.

Does the Fund limit BP's liability?

It does not. If paid claims are more than the commitment, BP is on the hook 


How does a claimant receive money from the fund?

No specifics yet. The claims process will be hands off for BP. Claims denials are reviewed by a three-judge panel. BP can only appeal claims exceeding $500,000.


Expect more details in July. 

No more Candy Cigarettes

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Candy cigarettes have officially been banned by the Food and Drug Administration.

The ban is a part of the Family Smoking Prevention and Control Act. Officials have been arguing for years to eliminate candy cigarettes because of the likelihood that children would eventually move on to the real thing.

A recent poll revealed that 22 percent of current or one-time smokers ate candy cigarettes during their childhood. On the contrary, just 14 percent of non-smokers used the fake cigarettes.

Georgia and Oil Spill Claims, June 24, 2010

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As folks begin to try to grasp the quagmire of a claim involving the gulf oil spill man made calamity, some quick information from various publications about making a claim:

 
Mitigation


When making a claim under the Oil Pollution Act, there is no required format for OSLTF claims. You must, however, support your claim with evidence, information, and documentation.


The Coast Guard considers that each claimant has a responsibility to make reasonable efforts to mitigate—that is, to avoid or minimize—the losses from an oil spill incident. Additional expenses related to avoiding or minimizing losses by a claimant can be included in the claim as additional expenses. The claimed amount of a direct loss will be adjusted for extra expenses and/or income related to avoidance/minimization efforts.

Know that you can make a claim for Property Damage. This means damages for injury to, or economic losses resulting from destruction of property.

You Must Provide Information Showing:

Your ownership or leasehold interest in the property

That property was injured or destroyed

Value of property both before and after injury

Cost of repair or replacement of the property

If you lost money, show:

The property was not usable because of the oil spill

The value of your property before and after the spill

Don't expect this list to change much when the $20 B fund is set up by August.

Georgia and Trucking: New Hours of Service Rules - Less Fatigued Drivers?

Daily driving time under a new Hours of Service rule should be reduced by 27 percent, a document filed by a group of safety advocates.  Sourcewww.regulations.gov
 

The document, filed by Henry Jasny on behalf of the Truck Safety Coalition, Public Citizen and Advocates for Highway and Auto Safety, was posted last week on the www.regulations.gov and is one of over 300 documents related to the new rule.

Under the heading Daily Shift Drive Time Maximum, the document reads: “[There should be] No more than eight consecutive hours of driving per shift, based on extensive research findings that show dramatic increase in relative risk of crashes after eight consecutive hours of driving.” 

The document lists basic safety parameters for a new rule:

• 24 hour-circadian schedule

• Lower daily driving and work time limits

• Lower weekly driving and work time maximums

• Increased daily off-duty time, including in sleeper berths

• Increased end-of-week rest time

• Recognition of safety hazards of night-time driving, and

• Universal electronic on-board recorder (EOBR) equipment. 

 

The coalition said it wants to see a maximum of 40 driving hours in a seven-day period and a maximum of 60 hours of work time in a seven-day period.

Paxil Claims Settle

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GlaxoSmithKline has agreed to settle almost 200 cases in which plaintiffs allege the use of the antidepressant Paxil caused birth defects.There has been just one trial so far. In Philadelphia a a jury awarded $2.5 million.

The jury awarded only compensatory damages and no punitive damages. But GSK then decided to settle Kilker v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline along with another 190 cases, according to an order signed by Philadelphia Common Pleas Judge Sandra Mazer Moss last week.The cases have settled for confidential amounts, according to the lawyer who litigates the cases.


Up to another 100 cases, including cases that have not yet been filed, have settled.

Source

Georgia: Avandia Study

Good find by Pharmalot:

A new study that compares Aandia with Actos found an increased risk of various cardiovascular problems with Avandia, but the studay that hasn’t raised as many concerns.

The authors looked at records of 227,571 Medicare patients with an average age of 74.4 years who were followed for up to three years after starting either of the two pills. What was found? Avandia increased the risk of stroke by 27 percent; heart failure by 25 percent; death by 13 percent; acute myocardial infarction or death by 11 percent; AMI, stroke, or death by 14 percent and AMI, stroke, heart failure or death by 17 percent.

The drug's maker has said about the study:   “it is unclear whether this study has been peer reviewed, and until then, it would be premature to comment. However, it is important to note that there are inherent limitations with retrospective observational studies…Randomized clinical trials remain the gold standard…Results from six randomized clinical trials…show that Avandia does not increase the overall risk of heart attack, stroke or death."

Source here. 

J&J Hit With More Recalls

McNeil Consumer Healthcare has added five more product lots to its recall list.

The latest includes four lots of Benedryl Allergy Ultratab tablets sold in the United States and one lot of Extra Strength Tylenol rapid-release gels, sold in the United States, Trinidad, Tobago, Bermuda, and Puerto Rico.

This recall is a follow-up to the company's January 15 recall, from which these products were inadvertently omitted.

The January 15 recall was initiated in response to consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the presence of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.

From the FDA site:

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW).

This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.

BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.

Pfizer pulls Mylotarg

Pfizer has agreed to pull a leukemia drug off the market after a follow-up study showed it failed to slow the disease.

The Food and Drug Administration cleared the drug Mylotarg in 2000 under its accelerated approval program, which grants speedy access to drugs that show early promise. The drug was cleared for patients older than 60 with relapsed acute myeloid leukemia, a bone marrow cancer.

A follow-up study was stopped  after researchers reported more deaths among patients taking Mylotarg plus chemotherapy, compared with chemotherapy alone. The study was intended to show that adding Mylotarg to chemotherapy increased lifespan, which it failed to do.

Mylotarg carries a warning label about a sometimes fatal liver condition called veno-occlusive disease. The FDA said the rate of reports of the disease associated with the drug increased during its time on the market.
The drug will not be available to new patients, according to the FDA statement.
Pfizer said in a statement that patients currently taking the drug can continue taking it if their doctors approve.

Source. 

FDA Warns Drug Makers On Misleading Promotional Efforts

The FDA  sent letters to several companies requesting that they stop distributing misleading promotional materials for their drugs.

The letters were sent in recent weeks to several companies and posted on the FDA's website this week.

The FDA said a 60-second television advertisement for Sepracor's Lunesta sleep aid makes "unsubstantiated superiority claims" in violation of federal law. A voice-over in the ad says viewers who have trouble sleeping even after taking a sleep aid should ask their doctors about switching to Lunesta because Lunesta is "different." The ad says Lunesta "keys into receptors that support sleep."

The FDA said this language misleadingly implies that Lunesta is clinically superior to other insomnia medications, and that Lunesta might work where others fail. The agency says it isn't aware of any evidence to support these claims. Also, the agency said the claim about how Lunesta works is misleading because there's still some uncertainty about the drug's mechanism of action.

Source.

Prempro Litigation

Pfizer is set to defend itself in Texas trial over the company's hormone-replacement drugs after a court overseeing lawsuits over the medicines sent 200 cases back to their home courts.


A judge in Galveston, Texas, set a 2011 trial date for Karen Zahn’s claims against Pfizer’s Wyeth unit. Zahn says in her suit that the Prempro menopause drug helped cause her breast cancer. There are more than 8,000 lawsuits over the medicine consolidated in federal court in Arkansas to be returned for trial.

More than 6 million women took the menopause drugs to treat symptoms such as hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, topped $2 billion before the Women’s Health Initiative study concluded they posed an increased breast-cancer risk.

Source. 

Depomed recalls 52 lots of diabetes drug

Drug developer Depomed Inc  said it will recall 52 lots of its diabetes drug Glumetza due to the presence of traces of a certain chemical in the tablet's 500 mg bottle.


The recall followed an investigation of a single product complaint of a smell and taste consistent with the chemical, the company said in a regulatory filing.

The chemical compound, 2,4,6-tribromoanisole (TBA), can cause temporary, non-serious gastrointestinal upset when present in amounts detectable by smell, the company said.

The recall does not impact the 1,000 mg formulation, which currently constitutes about 40 percent of total Glumetza net product sales, Depomed said.

Source/

FL Court: Commercial Fishermen Have Causes of Actions Based on Pollutants' Release

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A recent Florida Supreme Court decision is especially timely given the man made catastrophe in the Gulf. The Court answered two certified questions:



    DOES FLORIDA RECOGNIZE A COMMON LAW THEORY UNDER WHICH COMMERCIAL FISHERMEN CAN RECOVER FOR ECONOMIC LOSSES PROXIMATELY CAUSED BY THE NEGLIGENT RELEASE OF POLLUTANTS DESPITE THE FACT THAT THE FISHERMEN DO NOT OWN ANY PROPERTY DAMAGED BY THE POLLUTION?

    DOES THE PRIVATE CAUSE OF ACTION RECOGNIZED IN SECTION 376.313, FLORIDA STATUTES (2004), PERMIT COMMERCIAL FISHERMEN TO RECOVER DAMAGES FOR THEIR LOSS OF INCOME DESPITE THE FACT THAT THE FISHERMEN DO NOT OWN ANY PROPERTY DAMAGED BY THE POLLUTION?    

As to the first question, here's what the Court held:

"The Legislature has enacted a far-reaching statutory scheme aimed at remedying, preventing, and removing the discharge of pollutants from Florida‟s waters and lands. To effectuate these purposes, the Legislature has provided for private causes of action to any person who can demonstrate damages as defined under the statute. There is nothing in these statutory provisions that would prevent commercial fishermen from bringing an action pursuant to chapter 376."

The Court wrote as to the second question:

'We have plaintiffs who have brought traditional negligence and strict liability claims against a defendant who has polluted Tampa Bay and allegedly caused them injury. Thus, the economic loss rule does not prevent the plaintiffs from bringing this cause.'

The Court went on:

We conclude, as did many of the courts in the cases discussed above, that the defendant owed a duty of care to the commercial fishermen, and that the commercial fishermen have a cause of action sounding in negligence.

In the present case, the duty owed by Mosaic arose out of the nature of Mosaic‟s business and the special interest of the commercial fisherman in the use of the public waters. First, Mosaic‟s activities created an appreciable zone of risk within which Mosaic was obligated to protect those who were exposed to harm.

Mosaic's business involved the storage of pollutants and hazardous contaminants. It was forseeable that, were these materials released into the public waters, they would cause damage to marine and plant life as well as to human activity.

Here, the discharge of the pollutants constituted a tortious invasion that interfered with the special interest of the commercial fishermen to use those public waters to earn their livelihood. We find this breach of duty has given rise to a cause of action sounding in negligence. We note, however, that in order to be entitled to compensation for any loss of profits, the commercial fishermen must prove all of the elements of their causes of action, including damages.

Find the opinion here. http://www.floridasupremecourt.org/decisions/2010/sc08-1920.pdf 

Canadian Version of Chantix Gets a Warning

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A strong public warning was issued Thursday about stop-smoking pill Champix by the drug-maker and federal health officials concerned over mounting reports of mood changes, hostility, suicidal behaviour and serious, sometimes fatal, skin reactions.

Champix, the brand name of varenicline tartrate sold by Pfizer Canada Inc., must now carry a boxed warning, which is reserved for drugs that have been linked to serious safety issues or adverse events. The U.S. Food and Drug Administration has required a similar safety warning on the product since last July.

Health officials say Champix, sold in the U.S. under the name Chantix, has been linked to serious neuropsychiatric symptoms in numerous patients, including depressed mood, agitation, aggression, hostility, thoughts of self-harm or suicide. In the warning issued Thursday, Health Canada and Pfizer also highlighted reports of dizziness, loss of consciousness, seizures and other serious side effects linked to the drug.

Problems were experienced by patients with or without a history of psychiatric disorders. Alcohol intake could increase the risk to patients, Health Canada said.

Source.

FDA: New Warnings for Beta- Agonists (Advair and others)

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The regulatory agency says new warnings are needed on long-acting beta-agonists, including GSK’s Serevent and Advair, because the medication could result in severe asthma symptoms that lead to hospitalizations in children and adults or even result in death.

The FDA believes that when LABAs are used according to the recommendations outlined above and in the approved drug labels, the benefits of LABAs in improving asthma symptoms outweigh their risks of increasing severe asthma exacerbations and deaths from asthma.

The new recommendations in the updated labels state:

* Use of a Long Acting Beta Agonist (LABA) alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.
* LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
* LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
* Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
* Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications.

Source

Georgia: Avandia Case Settles in PA

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GlaxoSmithKline Plc (GSK.L) has settled more lawsuits alleging its Avandia diabetes drug caused heart attacks, heading off the first trial in the United States concerning the medicine.

The company said on Tuesday that terms of the settlement remained confidential. It declined to specify how many claimants were involved.

"We can confirm that the case that was scheduled for the first trial in state court in Philadelphia, for June 1, 2010, has been settled," company spokeswoman Claire Brough said in an emailed statement.

"The next case scheduled for trial is in that court and is scheduled for October 2010. GSK has not settled the multi-district litigation pending in federal court."

The latest move follows reports by plaintiff lawyers last month that about 700 cases had been settled for around $60 million.

Source

FDA Warnings Re: Possibly Tainted IV Drugs

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The FDA has issued an alert to health care professionals against the use of certain IV bags of metronidazole, ondansetron and ciprofloxacin because of potential contamination.

The alert came after floating matter was observed in bags manufactured by Claris Lifesciences Limited. Claris is initiating a recall of all lots of these products, as well as all lots of ciprofloxacin. The products were all manufactured on the same manufacturing line. The FDA is investigating the situation and will notify the public when new information becomes available.

Potentially affected bags are sold under the Claris, Sagent Pharmaceuticals, Pfizer and West-Ward Pharmaceuticals labels, according to an FDA press release.

The affected products include:

* Claris – metronidazole, ciprofloxacin, ondansetron
* Pfizer – metronidazole, ciprofloxacin, ondansetron
* Sagent Pharmaceuticals – metronidazole, ondansetron
* West–Ward Pharmaceuticals – metronidazole, ondansetron

Health care professionals should not use — and should immediately remove from their pharmacy — inventories from any of these products.

FDA officials said that patients who have received these products should be observed for signs and symptoms of illness and treated appropriately.

White matter found in a Claris metronidazole bag was identified as a Cladosporium mold, which can cause infection in susceptible patients. Similar matter found in a Claris ondansetron bag is currently being analyzed. Health officials are not aware of any injuries relating to the contamination.

Source.

Questions and Answers about an Oil Spill Claim

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We've been answering questions by phone and email about what to do and how to make a claim regarding the Oil Spill:

Question: What legal options are available to individuals or businesses that are damaged by the oil spill in the Gulf of Mexico?

Answer: There are two main avenues to recover monetary damages: through traditional state-law causes of action, such as negligence; and through the federal Oil Pollution Act of 1990 (“OPA”). Generally, unless oil physically makes contact with you or property, federal law limits claims for economic damages and requires them to be filed under OPA.

Question: What kind of claims can be made pursuant to OPA?

Answer: Under OPA, claims may be filed for a broad spectrum of economic damages, including lost profits and earning capacity, oil cleanup costs, and damage to property.

Question: What do I have to do to file an OPA claim?

Answer: The filing of an OPA claim is a multi-step process. Prior to filing suit under OPA, the claimant must comply with certain procedural requirements. The claimant must first present his/her/its claim to the responsible party as designated by the federal government, BP in this situation. The responsible party then has ninety (90) days to process the claim and either settle the claim or deny it. If there no settlement by the conclusion of the 90 days, then the claimant has the option to file a lawsuit or to file a claim with the Oil Spill Liability Trust Fund.

Question
If I make a claim pursuant to OPA, does that mean that I am going to receive the full amount of the damages claimed?

Answer
The existence of the OPA does not guarantee that any person can be compensated for all economic losses. There are important risks inherent in the OPA scheme that may prevent a full recovery. Some of these include:

• The value of the claim is initially evaluated by the responsible party, which may undervalue the claim or deny it entirely. BP has promised to pay “legitimate” claims but has not yet given guidelines for what that means. If a lawsuit must be filed, there is a risk that a court would not agree with the valuation and the lawsuit could be partially or completely lost.
• It may take a very long time to resolve the claim, particularly if a lawsuit must be filed and protracted litigation begins. Some claimants are still awaiting full payment from the Exxon Valdez disaster in 1989.
• There is a risk that BP or other responsible parties will run out of money to pay claims, enter bankruptcy, or otherwise be unable to satisfy all damages. If litigation is needed, this risk increases.
• There is a cap on each responsible party’s total liability pursuant to OPA. For BP, the cap is $75 million plus clean-up costs, and there is an as-yet undetermined amount for other parties. These limits apply to the total value of all claims to be paid out by the responsible parties, meaning that, for example, BP’s $75 million might be divided up among all claimants in the Gulf of Mexico (or might be fully disbursed before claims can be filed).

Fortunately, the cap can be lifted if gross negligence or a violation of an applicable federal regulation can be shown. Also, although this has not yet been confirmed in writing, BP has indicated that it will not assert the cap as a defense to paying its full share of damages. However, these statements are not binding.

• All lawsuits must be filed within three (3) years of the incident.

Question
Is OPA the only basis for recovery of damages caused by the oil spill?

Answer
In the event that oil comes into contact with property, state-law causes of action may assist in recovering damages. These causes of action could apply in addition to damages provided under OPA. Consequently, in addition to the remedies provided under OPA, there may be other ways to recover.

This is a just an overview. Please, use common sense and talk to a lawyer if you feel like one would be able to help.

BP pays out $3 million to Floridians who lost business to spill

From the SPT:

As of Friday, BP had paid out more than $3 million in claims to nearly 4,000 Floridians. BP spokesman Ray Dempsey said the company hasn't turned anyone down so far.

Still, some Floridians say BP has done about as good a job at helping them cope with their financial losses as it has in stopping the oil from flowing.

"On the news, they're talking about how much they're doing for everybody, but they haven't done nothing for us," said Bill McCullers, who owns three commercial fishing boats in Madeira Beach.

Some fishermen say they haven't been able to get anything but a runaround out of BP. Others say they were handed a check for $2,500 or $5,000, but that's not much compared with their expenses.

"That's the expense of going on one fishing trip," said Bob Spaeth, who owns six commercial fishing boats and Madeira Beach Seafood.

Both Florida Chief Financial Officer Alex Sink, a Democrat, and Attorney General Bill McCollum, a Republican, have criticized BP's claims process.

"They're up in the Panhandle issuing checks of $1,000 and $2,000, and you've got charter fishing operations that are experiencing losses of $10,000," Sink said.

No government agency is looking over BP's shoulder, either. Under the law, the U.S. Coast Guard is supposed to review how the company sets up its payment of claims but does not see any of the claims that are filed, a Coast Guard spokesman said.

Source here.

FDA warns of heartburn medication side effects

The FDA is warning doctors and patients that popular heartburn drugs like Nexium and Prilosec may cause bone fractures when used for more than a year.

The FDS said several studies have shown increased risk of hip, wrist and spine fractures in patients using drugs that block stomach acid. The agency said a half-dozen studies tracked fractures in patients older than 50 when the drugs were used between one and 12 years.

The agency says the association between the drugs and bone fractions is still not understood and it plans to investigate further.

The drugs are known as proton pump inhibitors and include both prescription drugs like Nexium and Prevacid as well as Prilosec OTC.




From the FDA site:

Additional Information for Patients and Consumers

* Proton pump inhibitors are effective in treating a variety of gastrointestinal disorders. Do not stop taking your proton pump inhibitor unless told to do so by your healthcare professional.
* Be aware that an increased risk of fractures of the hip, wrist, and spine has been reported in some studies of patients using proton pump inhibitors. The greatest increased risk for these fractures was seen in patients who receive high doses of these medications or use them longer (a year or more).
* Read and follow the directions on the OTC Drug Facts label, when considering use of OTC proton pump inhibitors.
* Be aware that the OTC proton pump inhibitors should only be used as directed for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your healthcare professional. No more than three 14-day treatment courses should be used in one year.
* Talk to your healthcare professional about any concerns you may have about using proton pump inhibitors.
* Report any side effects with proton pump inhibitors to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.

FDA UIpdates Rare Cases of Liver Injury Reported with Use of Xenical, Alli

he U.S. Food and Drug Administration today advised consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli.

The FDA has approved a revised label for the prescription drug Xenical. The agency is working with the manufacturer of Alli on label revisions to reflect this rare occurrence.

Both Xenical and Alli are medications contain the same active ingredient, orlistat. Xenical, available only by prescription, contains 120 milligrams of orlistat. Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. An estimated 40 million people worldwide have taken either Xenical or Alli.

The FDA’s safety information and labeling changes are based on a review of cases of severe liver injury reported in individuals taking orlistat. The agency has identified 13 cases of severe liver injury, 12 of which were reports from outside of the United States. The only U.S. report of severe liver injury involved Alli. At this time, a cause-and-effect relationship of severe liver injury with orlistat use has not been established.

People who take Xenical or Alli should be aware that liver injury with orlistat – while rare – has been reported. Those taking the drug also should be aware of the signs and symptoms of liver injury, which include itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.

Source.