FDA's Inspection Report Regarding Tylenol Recall

The FDA report - not good. In its report, the FDA said McNeil did not initiate "corrective and prevention action" after it had received 46 consumer complaints from June 2009 to April 2010 regarding foreign materials and black or dark specks in its drugs.

The agency cited the facility for not following quality controls and for not maintaining adequate lab facilities for the testing and approval of components and drug products. Source.

OBSERVATION 2:

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

OBSERVATION 5

Written production and process control procedures are not followed in the execution of production and process control function.

Read the rest here

Do ED drugs cause hearing loss?

A new US study attempts to suggest that men who take Pfizer's Viagra (sildenafil) or similar drugs for erectile dysfunction may double their chances of hearing impairment, adding to a Food and Drug Administration warning from 2007 about this side effect.

High doses of Viagra have been shown to damage hearing in mice, but until now only a few anecdotal cases had been described in humans.

The study, based on a national sample of American men over 40, found that slightly more than one in six of those who did not take Viagra-like drugs -- for instance, Eli Lilly's Cialis -- were deaf or hard of hearing.

Source here.

Oil Spill/Georgia: Submitting a Claim under the Oil Pollution Act

Image by zphone via Flickr

Federal law allows people to make a claim now under the Oil Pollution Act. What are the particulars?

What Claims May Be Submitted?

Claims can be submitted for a number of problems associated with either the oil spill or even the substantial threat of discharge of oil. Possible claims include

* Removal Costs
* Real or Personal Property Damage
* Loss Profits and Earning Capacity
* Loss of Government Revenue
* Costs of Increased Public Services
* Natural Resource Damage


These are just some of the ways individuals may be able to be compensated for this disaster as a variety of other reasons do exist.

Who Can Make a Claim for Damage from the Oil Spill?
A claimant could be

* An individual
* A corporation, partnership, or association
* States, municipalities, and political subdivisions of States.



Do You Qualify to Submit an Oil Spill Claim?

To qualify to submit an Oil Spill claim, these factors are to be met

* The incident/events surrounding the spill must have occurred on or after August 18, 1990. EVEN THE THREAT OF THE SPILL GIVES YOU A RIGHT TO FILE A CLAIM.
* The incident involved discharge, or substantial threat of discharge, or oil.
* The discharge or substantial threat of a discharge was into or upon the navigable water or the U.S. and its shorelines



What is the Claim Format for an Oil Spill Claim under OPA?

There is no required format for an Oil Spill Claim under the Oil Protection Act. However, you must support your claim with evidence, information, and documentation. Claims must be made in writing, and must follow include the following information:

* Type and amount of damages for each type of claim
* Total amount claimed
* Your full name, street and mailing address, and telephone numbers for your home and business
* Time, date and geographic location of the oil spill, identification of the navigable water impacted; and an explanation of how the oil impacted the water
* Identify the vessel, facility, or person causing or suspected of causing the spill, if possible, and include an explanation of why you suspect the vessel, facility, or person to have cause the spill.
* A general description of the impact of the spill, including the removal costs or damages claimed by category
* Explanation of how the damage happened, the location, and the date and time (this may/may not be the same as the location, date, or time of the spill)
* Descriptions of actions taken to minimize or avoid damages
* Costs of assessing the damage
* Name, street and mailing address, and telephone numbers of any witnesses and a brief description of what the witness knows
* Copies of any written communications and content of any verbal communications with the RP, including any claims submitted to the RP
* Information on any attempts to submit claims to the person or company responsible for the oil pollution
* Any compensation you have received for removal costs or damages from the spill
* Statement that no action has been taken in court or, if action has been taken, the status of the pending court case
* Certification statement of the accuracy of the claim to the best of your knowledge and belief
* Your signature and, if applicable, your legal representative's signature.

Talk to us if you are considering making a claim.

Sales of counterfeit drugs on the rise

Image via Wikipedia

Manufacturing and sale of counterfeit drugs is on the increase in both rich as well as poor countries with majority of the unwary people buying these drugs over the internet.

Margaret Hamburg, head of the US FDA (Food and Drug Administration) stated that substandard and fake versions of medicines “put people at risk of harm from medical products that may contain too much, too little, or the wrong active ingredient and/or contain toxic ingredients.”

More here.

US FDA warns St. Jude on Heart Device Claims

Device maker St Jude Medical Inc made improper claims about two heart devices, U.S. regulators said in a letter to the company.

The Food and Drug Administration, in an April 23 letter, objected to statements made on a company website about the Epicor LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device.

More here.

Skin-lightening creams poisonous in more than one way

Some creams promising to lighten skin, eliminate age spots and zap freckles contain high levels of mercury, a toxic metal that can cause severe health problems, a Chicago Tribune investigation has found.

The newspaper sent 50 skin-lightening creams to a certified lab for testing, most of them bought in Chicago stores and a few ordered online. Six were found to contain amounts of mercury banned by federal law.

Of those, five had more than 6,000 parts per million — enough to potentially cause kidney damage over time, according to a medical expert.

The Food and Drug Administration banned mercury in skin-bleaching or lightening products in 1990, but the agency rarely tests the products to see if consumers are at risk. The Chicago Tribune's tests — among only a handful ever conducted — show that tainted products are still readily available.

Source here.

Georgia Avandia: Lawsuits settled

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GlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company’s Avandia diabetes drug causes heart attacks and strokes in some users.

Avandia has been in the spotlight recently, following reports from various studies linking the drug to cardiovascular complications. The FDA estimates that Avandia treatment caused at least 83,000 heart attacks from 1999 to 2007, and clinical studies have shown that Avandia increases the risk of heart attack by 43 percent and can double the risk of heart failure after only one year of treatment.

At least 13,000 Avandia lawsuits have been filed nationwide, with plaintiffs accusing GlaxoSmithKline of failing to adequately warn patients about the serious risks of heart attack, stroke, heart failure, bone fractures, vision loss, and death associated with the medication.


Source here.

FDA: Don't Swallow Benadryl Skin Gel For Goodness' Sake!

The FDA is warning consumers not to swallow Benadryl Extra Strength Itch Stopping Gel. The gel is designed for topical use on skin. Despite the gel's goopy consistency and squeeze bottle, it appears that multiple consumers have taken it by mouth and been poisoned by the active ingredient, diphenhydramine.

The problem seems to be that the Benadryl brand is also used on liquid allergy products meant to be swallowed, confusing a few consumers.

Perhaps the use of the word "dummy" on the product?

http://calorielab.com/labnotes/20100512/fda-benadryl-gel-warning/

Requip and Mirapex: Compulsive Behavior Link

Parkinson's drugs can triple the odds that people develop impulse control problems such as gambling, binge eating, shopping sprees and compulsive sexual behaviors.


"For some time now we've suspected there might be an association between exposure to dopamine agonists and the development of impulse control problems in patients," said Dr. Daniel Weintraub of the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, whose study appears in the Archives of Neurology. Source.


Context An association between dopamine-replacement therapies and impulse control disorders (ICDs) in Parkinson disease (PD) has been suggested in preliminary studies.

Objectives To ascertain point prevalence estimates of 4 ICDs in PD and examine their associations with dopamine-replacement therapies and other clinical characteristics.

Design Cross-sectional study using an a priori established sampling procedure for subject recruitment and raters blinded to PD medication status.

Patients Three thousand ninety patients with treated idiopathic PD receiving routine clinical care at 46 movement disorder centers in the United States and Canada.

Main Outcome Measures The Massachusetts Gambling Screen score for current problem/pathological gambling, the Minnesota Impulsive Disorders Interview score for compulsive sexual behavior and buying, and Diagnostic and Statistical Manual of Mental Disorders research criteria for binge-eating disorder.

Results An ICD was identified in 13.6% of patients (gambling in 5.0%, compulsive sexual behavior in 3.5%, compulsive buying in 5.7%, and binge-eating disorder in 4.3%), and 3.9% had 2 or more ICDs. Impulse control disorders were more common in patients treated with a dopamine agonist than in patients not taking a dopamine agonist (17.1% vs 6.9%; odds ratio [OR], 2.72; 95% confidence interval [CI], 2.08-3.54; P < .001). Impulse control disorder frequency was similar for pramipexole and ropinirole (17.7% vs 15.5%; OR, 1.22; 95% CI, 0.94-1.57; P = .14). Additional variables independently associated with ICDs were levodopa use, living in the United States, younger age, being unmarried, current cigarette smoking, and a family history of gambling problems. Conclusions Dopamine agonist treatment in PD is associated with 2- to 3.5-fold increased odds of having an ICD. This association represents a drug class relationship across ICDs. The association of other demographic and clinical variables with ICDs suggests a complex relationship that requires additional investigation to optimize prevention and treatment strategies. Source here.

Georgia/Gulf Coast Oil Spill: Deepwater Horizon Well Failed Key Test

Image by SkyTruth via Flickr

From the WSJ and Reuters:

The chairman of a congressional subcommittee said on Wednesday it uncovered significant problems with the device that was supposed to cut the oil flow after BP's (BP.L) oil rig exploded, creating a massive unchecked spill.

Representative Bart Stupak, head of the House Subcommittee on Oversight and Investigations, said the rig's underwater blowout preventer had a leak in its hydraulic system and the device was not powerful enough to cut through joints to seal the drill pipe.

He said the panel also discovered the blowout preventer had been modified, which made it difficult to operate after the accident. Stupak also said the device's emergency backup controls may have failed because the explosion that destroyed the rig also disabled communications, preventing workers from sending signals to the underwater device

Recent Florida Supreme Court Decision on Bad Faith

The Perera decision:

An employer's liability insurer's actions neither caused the damages claimed by an insured nor resulted in exposure of the insured to liability in excess of the policy limits of three policies issued to the insured, the Florida Supreme Court held May 6, answering a rephrased certified question from the 11th Circuit U.S. Court of Appeals in the negative in finding that a cause of action for third-party bad faith against the insurer cannot be maintained (Source)

BP wants oil spill lawsuits centralized in Houston

Image by DavidErickson via Flickr

BP wants more than 70 lawsuits over the Gulf oil spill consolidated before a federal judge in Houston.

The oil giant is asking the U.S. Judicial Panel on Multidistrict Litigation to have U.S. District Judge Lynn Hughes to hear pretrial matters for all the cases.

Potential class-action lawsuits have been filed in every Gulf Coast state. Plaintiffs include commercial fishermen, business interests, property owners and others.

For more go here.

Yaz Recall? Yes there was one

Image via CrunchBase

Good work by Jim Edwards:

The FDA did issue a recall for Yaz back in November 2009. The reason: Bayer had reported the product was “within specification” when in fact it wasn’t — the company had taken a number of measures and averaged them together to get the number it needed.

It involved specifications for the dosage of drospirenone in the pill, which is the new ingredient that the lawsuits allege is more dangerous than the traditional recipe.


From the FDA site:

PRODUCT
1) YAZ (Drospirenone & Ethinyl Estradiol); Rx only; 3.0 mg drospirenone &0.02 mg ethinyl estradiol; 3 x 28 tablets- blister packages 24 active and 4 placebo, NDC 50419-405-03. Recall # D-046-2010;

2) Ocella (drospirenone and ethinyl estradiol tablets) 3 mg/0.3 mg, Rx only;This package contains one blister of 28 tablets: 21 yellow tablets, containing 3 mg of drospirenone and 0.3 mg of ethinyl estradiol; and seven white inert tablets', NDC 0555-9131-767. Recall # D-047-2010
CODE
1) Lot 91605A, Exp 12/2013;
2) Lot number 84080A, Exp 12/2011; lot number 84081A, Exp. 12.2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer HealthCare Pharmaceuticals, Inc., Wayne, NJ, by letters on November 6, 2009.
Manufacturer: Schering Gmbh Und Co. Produktio, Weimar, Germany. Firm initiated recall is ongoing.
REASON
CGMP Deviations:Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification.
VOLUME OF PRODUCT IN COMMERCE
1) 32,856 boxes (3 blister packages/box);
2) 122,208 boxes (3 blister packages/box)

Source: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm192035.htm

Tylenol Recall Update

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Food and Drug Administration inspectors found in April that McNeil Consumer Healthcare, which has voluntarily recalled certain lots of its children's and infants' Tylenol products, knowingly used bacteria-contaminated materials to make them, a report posted Tuesday by the agency says.

Though the known risk to consumers "is remote," the FDA's Deborah Autor said, "we have theoretical concerns" about the safety of the recalled products.

Link here

FDA monitoring oil spill impact on seafood industry

The Food and Drug Administration (FDA) has said it is working with the National Oceanic and Atmospheric Administration (NOAA) and other agencies to monitor the safety of seafood from the Gulf of Mexico following the recent oil spill.

The FDA has said the public should not be concerned about seafood safety at this time. Last week, Louisiana authorities opened some of the state’s shrimping zones ahead of the regular season to allow harvesting of shrimp before the oil spill reached the area. However, some of those zones have since been closed. Molluscan shellfish beds in some areas have also been closed, the FDA said.

Executive director of the Louisiana Seafood Board Ewell Smith said in a statement: “We support NOAA’s precautionary closure of the affected area so that the American consumer has confidence that the seafood they eat is safe. It is also very important to underscore the fact that this closure is only the affected area of the Gulf of Mexico, not the entire Gulf. The state waters of Louisiana west of the Mississippi River are still open and the seafood coming from that area is safe. That portion of waters represents about 77 percent of Louisiana seafood production of a 2.4 billion dollar economic impact to the state

Gulf oil Spill Events, May 9, 2010

Image by nasa1fan/MSFC via Flickr

Not good this weekend:

In Louisiana, truckloads of sand were being delivered and put in sandbags to be dropped by National Guard helicopters along Fourchon Beach, which is southwest of New Orleans. It's one of the few beaches along the Louisiana coast, with about two miles of public sand and another seven miles that is privately owned.

Officials declared a state of emergency and closed the beach until further notice.

Oil estimate now greater: It has been pouring into the Gulf from a blown-out undersea well at about 210,000 gallons per day.

Booms have been put out to protect estuaries, marshlands and coastlines, from west of the Mississippi River to points as far east as Panama City, Fla.

Source.

Fosamax: Defense Verdict for Merck

A federal jury in New York decided that a woman who claimed she was harmed by Merck & Co's osteoporosis drug Fosamax did not suffer from a serious jaw condition linked to the medicine.

The plaintiff, Louise Maley, an Indiana woman who used Fosamax for nearly eight years, claimed that she suffered osteonecrosis of the jaw -- a form of bone death associated with Fosamax and similar drugs -- and dental problems as a result of long-term use of the medicine.

The New York jury deliberated for only about half an hour before returning unanimous verdict in Merck's favor by finding that the plaintiff did not suffer from osteonecrosis of the jaw as of March 31 2004.

The plaintiff had multiple medical conditions that cause people to develop the jaw and dental problems she claims she has, regardless of whether they were taking Fosamax," Merck attorney Christy Jones said in a statement.

One of the Plaintiff's lawyers was tim O'Brien, who is no 0-2 in these cases, with the first case resulting in a mistrial.

Source.

Drugmakers found liable in hepatitis case

Image via CrunchBase

Two drug companies must pay more than $5 million after a jury found them liable in the first civil trial stemming from Southern Nevada's hepatitis C outbreak.

After deliberating for three days, the jury ruled that Teva Parenteral Medicine and Baxter Healthcare Services, which made and sold the sedative propofol, failed to label drug vials with appropriate warnings and should not have provided large vials of the anesthetic to endoscopy centers.

Local health officials said the outbreak was caused by nurse anesthetists reusing vials among patients after the vials had become contaminated by the nurses reusing syringes on the same patient.

Source here

Will US Vehicles Get A Black Box?

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Following Toyota's recall of its faulty models, which heavily affected the American market, the US government is considering plans to introduce black box recorders to all new cars and lorries.

The US House of Representatives' Energy and Commerce Committee has put forward a draft legislation that would see black boxes - similar to those on aeroplanes - being used to determine the cause of accidents.

Releasing the draft, Energy and Commerce chairman Henry Waxman said that it is aimed at improving vehicle safety and strengthening the National Highway Traffic Safety Administration (NHTSA) ability to more effectively investigate complicated safety problems.

The draft also suggests the removal of a limit on the civil penalty a manufacturer could face over a fault and to enable the NHTSA to order an immediate recall in the case of any safety issue.

Source here.

Plavix News from Europe

Several European countries have recalled batches of generic heart drug Plavix made at a factory in India.

Plavix, or clopidogrel, is sold as a brand by Sanofi-Aventis and Bristol-Myers Squibb and is the world's second biggest-selling medicine, with worldwide sales of more than $9 billion a year.

The medicine is off patent in some European markets.

Source here.

FDA: New Sunscreen Rating

Image by Felipe Skroski via Flickr

The FDA 4-Star Rating System:

The FDA plans to implement include a four-star rating system for UVA protection that would be based on both in vitro and in vivo tests and incorporate a measurement of photostability.

Manufacturers would be required to include the four-star rating on their sunscreen labels and would face new restrictions in what they can and cannot say on labels. For instance, the proposed guidelines would prohibit claims such as "chemical-free," "waterproof," "helps prevent skin damage," or any SPF designation greater than 50.

SPF would no longer stand for "Sun Protection Factor" but, rather, "Sunburn Protection Factor" to clarify its use as a measurement of only UVB, the rays responsible for sunburns but not the premature signs of aging or skin cancer, which is mostly attributed to UVA.

Source here.

FDA Report Re: Tylenol Plant

Image by Getty Images via Daylife

U.S. inspectors found thick dust and contaminated ingredients at the Johnson & Johnson plant that produces Children's Tylenol and dozens of other products that were recalled last week.

A Food and Drug Administration report released on Tuesday said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products recalled last Friday.

Inspectors also found raw ingredients contaminated by an unspecified bacteria, a lack of quality control procedures and poor handling of complaints, according to the report dated April 30.

Read more: http://www.nationalpost.com/life/health/story.html?id=ffb68e67-cc42-47a4-a289-b4f9b6f6b4a1#ixzz0n3UlgO60

Georgia: Oil Spill Litigation and a Recent Consent Order

On Sunday, the U.S. District Court Eastern District issued a ruling that Louisiana fishermen were not bound by language in work agreements signed to participate in cleanup and mitigation efforts organized by BP. The consent agreement applies these same protections to any U.S. citizen, according to my friend, lawyer Rick Kuykendall, (205) 252-6127.

div style="width:477px" id="__ss_3965092">Alabama Lawyer Oil Spill Lawsuit

View more documents from R.K..

May 2, 2010 Oil Spill Info: A Must Read Blog Entry

Image by Chris Denbow via Flickr

From: http://blog.nature.org/2010/05/bill-finch-nature-conservancy-oil-spill-alabama-oyster/

BAYOU LA BATRE, ALABAMA, May 2, 2010 — On Saturday morning, barges decked with giant coils of fluorescent yellow and orange booms designed to contain the coming oil spill here bobbed among fading shrimp boats on the Bayou (which is what the Alabama coastal community is called here).

Everyone who comes to the Bayou makes a living off the waters of the Gulf of Mexico. There is no living here without it.


There must be 30 miles of these floating vinyl tubes stacked up at multiple deployment areas all along the Alabama coast. All morning, tugs and a flotilla of smaller boats let off steam, ready to get the goods on the water before high winds drive the slick ashore.

Jeff Dequattro, the Nature Conservancy’s oyster restoration project manager here in Alabama, had pulled off something like a miracle, collecting 3,500 feet of boom and pallets of absorbent material from two or three different states in 24 hours. Just enough, maybe, to intercept the first swells of oil before they coat our newly established oyster reef around Coffee Island. The boom is on board, but the anchors are still in transit — to the wrong destination, we suddenly learn. Jeff rushes off to intercept. We wait as the wind blows harder.

Read the rest at the link above

Alabama: Oil Spill - BP Officials meet residents of Bayou La Batre

It was a packed house at the community center in Bayou La Batre. With no air conditioning it was also a sweaty, hothouse. Officials from BP, the Coast Guard and others tried to update an uncomfortable crowd on the oil spill. At times the meeting was tense. One man grabbed the microphone and called it BP propaganda. A BP spokesman updated the room on what they're doing to contain the spill and offered numbers for people to file claims with the company. Bayou La Batre Mayor Stan Wright urged fishermen not to sign anything with the company if they do get a settlement.

People left the meeting with some contact sheets, but many wanted more.

“You know I just think there's so many questions they don't have answers for all of them yet, they seem to be doing the best they can with what they have to work with,” says charter and commercial fisherman Skipper Thiery. Most people wanted some idea of how the oil spill was going to affect them and their way of life--something we won't really know until the oil gets here.

From another source:

On Saturday afternoon May 1, as the oil spill continued to work its way onto the northern Gulf Coast, BP held what it had said would be a public information meeting in the south Alabama fishing town of Bayou La Batre. Those in attendance included town leaders, fishermen, local business owners and townspeople, all of whom are certain to be economically damaged by the oil slick now bearing down on the coastline. However, BP converted the public meeting into a public relations and litigation ploy. BP told the fishermen, business owners and local officials present that it will be unnecessary for them to hire their own legal counsel, that if they call a BP 1-800 telephone number and claim total damages for themselves and their businesses of less than $5,000 dollars, then BP would pay a claim of less than $5,000 but the damaged individuals and businesses in Bayou La Batre will be required to sign BP paperwork. If the claim against BP is more than $5,000, BP told the audience they would be required to deal directly with BP's legal department.



Local town leaders took the microphone from the BP representative, and told the townspeople present not to sign BP’s paperwork.


It is astonishing that BP, with its hordes of high-priced lawyers, would tell innocent victims not to obtain legal help for themselves, and that BP would try to lure these victims into dealing directly with BP's legal department.

GA: Texting and Cell Phone Bans made into Law

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* HB 23, sponsored by Rep. Matt Ramsey (R-Peachtree City), which would ban Class D drivers -- mostly teenagers -- from talking on cellphones while driving.

* SB 360, which would ban texting by all drivers. Sponsored by Sen. Jack Murphy (R-Cumming), the bill will be known as the Caleb Sorohan Act, named after a Morgan County teenager who died while texting and driving.

Medications for Children Recalled

McNeil Consumer Healthcare, based in Fort Washington, Pa., issued the voluntary recall late Friday in the United States and 11 other countries after consulting with the FDA. The recall involves children's versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl, because they don't meet quality standards.

The FDA said it was reviewing procedures at McNeil, which appears to be the sole source of the problems. "We are following through with the facility to make certain that everything has been checked," said FDA spokeswoman Elaine Gansz Bobo.

According to McNeil and the FDA, some of the products recalled may have a higher concentration of active ingredient than is specified on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet internal testing requirements.

The FDA called the potential for serious medical problems "remote," but it advised consumers to stop using the medicine as a precaution. It said a health care professional should be consulted if a child has recently taken any of the recalled products and is exhibiting unexpected symptoms.

http://www.ajc.com/business/fda-investigating-recall-of-510464.html

Gul Oil Spill Lawsuits/State Actions: Florida, Alabama, LA, Miss and TX get together

The top law enforcement executives for five states will meet to talk about legal options for dealing with the effects of a massive oil spill threatening their Gulf of Mexico shores.

The attorneys general from Alabama, Florida, Mississippi, Louisiana and Texas will meet Sunday in Mobile, Ala.

A statement said the meeting will discuss legal options, strategies, and preparations for the spill that erupted after a drill rig exploded April 20.

Asked if the states may file lawsuits against oil company BP PLC and other firms, a spokeswoman for Florida Attorney General Bill McCollum said he is looking at all possibilities.

Lawyers for private plaintiffs including fishermen have filed at least 26 potential class action lawsuits so far for damages from the spill.

Florida Attorney General and the Gulf Oil Spill 4/30/10

Attorney General Issues Statement on Oil Spill Approaching Florida's Coastline

TALLAHASSEE, FL -- Attorney General Bill McCollum today issued the following statement on the British Petroleum oil spill approaching Florida’s coastline:

"The British Petroleum oil spill in the Gulf of Mexico presents a clear and present danger to our coastline, our environment, and our economy. With the damaged well leaking as much as 200,000 gallons a day, we must move as rapidly as possible to protect our shores.

“On Sunday, at the invitation of Alabama Attorney General Troy King, I will join the Attorneys General from Alabama, Louisiana, Texas and Mississippi in Mobile, Alabama to discuss the shared impacts to the Southeast United States and explore legal options. Currently, my office is also working with the Florida Department of Environmental Protection and other state and federal agencies to ensure we do everything possible to protect our delicate coastal ecosystems and recoup costs to taxpayers.

“This mishap is an unfortunate example of why drilling threatens our state’s most precious resources – our pristine beaches, our vast wetlands, and countless other environmental treasures. Until technology advances, we must continue to be extraordinarily cautious with our consideration of any proposal that would further jeopardize our beaches and our environment for future generations.”

Gulf Oil Spill and the Law: Fishermen wait for spill effects

From: http://neworleanscitybusiness.com/blog/2010/04/29/fishermen-lawyers-wait-for-oil-spill-effects/

Shrimp fishermen in south Louisiana have traded in their fishing gear for garbage bags and anything else they can use to collect as much of the crude oil now leaking at about 200,000 gallons per day from a collapsed BP rig and posing an increasing threat to their livelihood.

“We’re trying to save our industry at this point,” said Kim Chauvin, fourth generation co-owner of Mariah Jade Shrimp Co. south of Houma.

While environmentalists and ecologists struggle to predict the coastal impact of the slick, which has already come aground on the Mississippi Delta, Chauvin is optimistic that the central and western parts of the state will not be affected.

“There’s no need for alarm in the central and western parts of the state,” she said.


In New Orleans, a team of lawyers from throughout the Gulf Coast has been assembled to prosecute claims for affected commercial fisherman. With the oil just now reaching land, the attorneys said that there is still no way of knowing what kind of monetary impact the oil leak could have on fisherman. But in any case, they’re taking “pre-emptive action.”



On Wednesday, the state Department of Wildlife and Fisheries opened up an area to shrimp harvesting a couple weeks early in anticipation of damage from the oil slick.

“In consideration of the potential threat to these resources… this special season should provide fisherman with added economic opportunity through harvest and sale of over-wintering white shrimp,” the release says.

The LDWF has been trying to figure put what kind of economic impact the oil leak could have on the state’s seafood industry. It has begun gathering the dockside value of commercial seafood landings with a focus on the the Mississippi Delta area and parts east.

“We identified an area likely to suffer because of the spill,” said Jack Isaacs, an economist with the LDWF.

From 2007 to 2009, the average annual value of shrimp caught in the Lake Pontchartrain Basin was $9.24 million or 7.1 percent of the state’s total commercial seafood landings. In the Mississippi Delta, there was nearly $7.41 million worth of shrimp caught yearly, or 5.68 percent of the state’s total.

There is a total yearly dockside commercial value of seafood at $44.8 million in the Lake Pontchartrain Basin and $8.7 million in the Mississippi Delta, and the values do not include any additional value added by wholesalers, processors, packers, distributors, retailers or restaurants, Isaacs said.

Perhaps more worrisome for the seafood industry is the vulnerability of oysters. State research shows that 78 percent of oysters harvested from public reefs in Louisiana are in the Lake Pontchartrain Basin, representing $11.7 million in value. Another 45 percent of oyster coming from private leases in the state are in that same basin, totaling $12.7 million in value.

“The good thing for shrimp and fish is that they can swim away as the slick of oil approaches them,” said Cliff Hall, co-owner of seafood distributor New Orleans Fish House. “Oysters, unfortunately, will not be so lucky, as they are connected to the reefs and cannot move.”

Like Chauvin, Hall is anxiously hoping that winds keep the slick to the east of the Mississippi River delta.

“While it’s not good for the east side of the river, the positive part of this is it’s not affecting west side of river,” Hall said. “We’ll continue to draw from those resources for our restaurants.”•

Alabama/Georgia/Florida Oil Spill Damage Information

Image by NASA Goddard Photo and Video via Flickr

I grew up in Florida, and consider the Gulf Coast South my home - from the Bayous of LA, to favorite places like Fairhope, to Seagrove Beach - all in the path of a man made disaster that may be worse than any hurricane.

How to help:

For folks in Mississippi: Please call 1.866.448.5816. If you want to register your desire to help and receive updates, visit Volunteer Mississippi.

www.mcvs.org/

If you're in Louisiana: To report oiled or injured wildlife, please call 1-866-557-1401.For spill claims: 1-800-440-0858.

For Community and Volunteer Information, please call 1-866-448-5816

Also worth a look is: www.emergency.louisiana.gov.

For Alabama citizens: The Alabama Coastal Foundation at 251-990-6002; the Mobile Bay National Estuary Program at 251-431-6409; or Mobile Baykeeper at 251-433-4229.

For the Coast of Florida: Go to www.volunteerfloridadisaster.org/

Gulf Oil Spill Lawyer Information

From my friend Rick Kuykendall, whose home is in South Alabama:

Rick is a key founder of a litigation team of Gulf state lawyers that is one of the first to file for damages arising out of the growing oil spill disaster in the Gulf of Mexico. This suit seeks damages for fishing and other industries as well as property owners impacted by the spill and are the first of many actions to be filed by the group.

Kuykendall has extensive experience litigating environmental damage cases, and has extensive experience litigating against the oil industry. In 2009, he was co-lead counsel against Constellation Energy in an action that resulted in pollution abatement and damages to citizens whose water had been contaminated by chemicals. In major cases against Weyerhauser Paper, Shell, Exxon, Hoechst Celanese, Conoco and others, Kuykendall has demonstrated a no nonsense approach.

" We are witnessing the beginning of what may very well become the largest environmental disaster in the history of the United States. The source of the spill is still spewing upwards of 50 million gallons of oil a day into the spawning grounds of shrimp, snapper and oysters in areas of the Gulf waters. If the spill isn't contained, it will soon threaten critical gulf beaches and marshlands. The impact on individuals and small businesses still recovering from a series of hurricanes is incalculable. The oil industry, like the financial industry, asked the citizens that populate the Gulf coast to trust them with our most valuable resource and they breached that trust. They must be held accountable and I, along with the group of dedicated environmental lawyers, have the skills and resources to do just that. While we all pray for a good ending, the courthouse doors of the Gulf Coast must be opened to protect our citizens and ecosystems."Said Kuykendall.

Kuykendall’s commitment to environmental concerns is evident. He was appointed by the governor of Alabama to a select Commission on the Environment, is an Honorary Member of the Board of Directors of Mobile Bay Keepers and Co-Founder of the Pensacola River Keepers. Combining his concern for the environment with his legal expertise and resources Kuykendall has successfully brought polluters to justice.

Call him at 256-702-5005

Georgia Avandia News: US Senate Reports

Amazing. You just have to read the report released yesterday. From the Senate Report:

Senators "asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. In 2008, FDA officials called the clinical trial, as then-designed, “unethical and exploitative” of patients."

"Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust.",


From Sen. Grassley's letter:

The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.… Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.

Link.

Topamax Maker to Pay $81 Million Fine

The Justice Department announced Thursday that two subsidiaries of the pharmaceutical giant Johnson & Johnson had agreed to pay more than $81 million in a case accusing them of illegally promoting the epilepsy drug Topamax for psychiatric uses. Source.

While the Food and Drug Administration approved Topamax for the treatment of partial onset seizures, Ortho-McNeil Pharmaceutical promoted the drug for unapproved psychiatric uses, the government said

Pain Pump MDL REJECTED

Again.

In re Ambulatory Pain Pump-Chondrolysis Products Liability Litigation, J.P.M.L., MDL No. 2139 (4/14/10).

Injured consumers claim that they developed chondrolysis after a pump used to directly send anesthetic into their shoulder joints following surgery failed.

From the Order:

Although these personal injury actions have some commonality as to whether
shoulder pain pumps and/or the anesthetic drugs used in those pumps cause
glenohumeral chondrolysis, an indeterminate number of different pain pumps made
by different manufacturers are at issue, as are different anesthetic drugs made by
different pharmaceutical companies.

Moreover, not all of the thirteen constituent actions involve pharmaceutical company defendants, and many defendants are sued only in a minority of those actions. The proponents of centralization have not convinced us that the efficiencies that might be gained by centralization would not
be overwhelmed by the multiple individualized issues (including ones of liability and causation) that these actions appear to present. The parties can avail themselves of alternatives to Section 1407 transfer to minimize whatever possibilities there might be of duplicative discovery and/or inconsistent pretrial rulings.

The Court went on to say:

the constituent actions are at widely varying procedural stages. In many, fact
discovery is either over or nearly over. The record shows that expert discovery is underway or has been completed in a number of actions.4 Although movants and other plaintiffs favoring centralization argue that defendants have stymied their efforts to streamline discovery, that argument is undercut by the multiple requests to exclude certain actions on the ground that they are too advanced to warrant inclusion in an MDL. Given all these circumstances, we are still unconvinced
that centralization would serve the convenience of the parties or promote the just and efficient conduct of the litigation, taken as a whole.

Find it here.

PA Medical Malpractice Info

Image by ipeters61 via Flickr

Thanks to the folks at the Torts Prof Blog for this tidbit:


Pennsylvania prepares more detailed med mal filings and verdicts data than most states. 2009 figures were recently released. In 2009, there were 1,533 med mal filings, a 43.9% decline from the "base" years of 2000-2002. In 2003, Pennsylvania enacted two reforms: (1) a certificate of merit requirement and (2) a venue restriction.

Excluding Philly, there were just 4 cases in 2009 with a verdict b/t 1 and 5 M.

South Dakota gets $$$ from AZ

SD's State Attorney General says South Dakota will receive $1.1 million as part of a sweeping settlement with pharmaceutical manufacturer AstraZeneca that resolved allegations of illegal marketing of the company's antipsychotic drug Seroquel.

Source here.

Guidant Plea Deal on Defibs Rejected

Image via Wikipedia

U.S. District Judge Donovan Frank in St. Paul, Minnesota, gave the judicial thumbs down to a plea agreement with prosecutors. He said the company should be placed on probation for failing to disclose defects with its heart devices to regulators. Boston Scientific had agreed to plead guilty to two misdemeanors and pay $296 million to settle a U.S. Justice Department probe.


On February 25, 2010, the United States of America charged Guidant LLC (formerly known as Guidant Corporation and hereinafter referred to as “Guidant”) with two misdemeanor violations of the FDCA pursuant to 21 U.S.C. § 333.

The filing of the Information was pursuant to a plea agreement that was
reached following a lengthy criminal investigation. As described more fully in the plea agreement, Guidant will plead guilty to: (1) making a materially false statement in a required submission to the FDA with regard to the Ventak Prizm 2DR device; and (2) failing to notify the FDA of a “correction” to the Contak Renewal
devices, which the company made to reduce a risk to health caused
by the devices.

Source.

“At a minimum, the public’s interest in accountability would be served by Guidant and Boston Scientific being placed on probation,” Frank said in his 37-page ruling.


Link here.

GA Avandia: TIDE Trial

From: http://www.theheart.org/article/1069095.do

Looks like folks will have to wait until July of 2010 to see if the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial, commissioned by the FDA and pitting rosiglitazone against pioglitazone (Actos, Takeda Pharmaceuticals), will be allowed to continue.

There are concerns about whether or not the informed consent forms are up to snuff:

"If people were to reexamine the informed-consent forms, particularly in light of the data as of 2010, they may have second thoughts about whether they want to continue the trial at their own institution."

More at the link, above.

Defective Cardiac Science Corporation Powerheart, CardioVive, Nihon Kohden, and GE Responder External Defibrillators: Updated April 27, 2010

From the FDA site:

Device: Cardiac Science Powerheart, CardioVive, Nihon Kohden (NK) and GE Responder External Defibrillatorsmanufactured between August 2003 and August 2009. These devices are used for emergency treatment of victims with symptoms of sudden cardiac arrest who are unresponsive and not breathing.

Expanded Scope of Recall

Cardiac Science Corporation issued a press release2 (11/13/09) alerting users of its Powerheart, and CardioVive external defibrillators of defective components and reported failures. This update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. Approximately 280,000 Cardiac Science external defibrillators worldwide are potentially affected by this problem.

The updated list of affected models includes:

* Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, and 9390E
* CardioVive 92531, 92532 , and 92533
* Nihon Kohden 9200G, and 9231
* GE Responder 2019198, and 2023440

In addition to failure to deliver needed shocks, other problems with these devices may include:

* Interruption of electrocardiography (ECG) analysis that prevents shock delivery,
* Failure to recognize pad (electrode) placement during use, or
* Interference or background noise that makes the device unable to accurately analyze the heart rhythm and deliver a shock, even if an ECG analysis is successfully conducted.

Improper functioning of the device during a rescue attempt may prevent resuscitation of patients and lead to serious adverse health events or death. The Daily/Weekly/Monthly self-tests performed by the affected devices’ software to ensure proper functioning may not detect defects in certain electronic components that can lead to device failure. Cardiac Science issued a software upgrade for the devices’ self tests on 2/24/10 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects. Normally, users of these devices should always check the status indicator on the front of the external defibrillator and/or audible indicators to see whether the device is rescue-ready (green light is displayed). However, the presence of a green light on the affected devices may not reveal defective or non-working components inside the external defibrillators and give a false sense that they are in proper working order.

Updated Recommendations

FDA recommends that all users of Cardiac Science external defibrillators affected by this recall take the following precautions:

* High Risk and/or Frequent Use Facilities should obtain an alternate external defibrillator or immediately arrange for repairs or replacement of the Cardiac Science external defibrillator. Examples of such facilities include hospitals, ambulances, clinical settings, high-risk patient population facilities, facilities with only one external defibrillator, and emergency transport settings.
* All other users, including Home Users and Public Access Defibrillation Programs, should take the following steps while arranging for repair or replacement of the Cardiac Science external defibrillator.

More here.

Astra Zeneca Pays $520 Million Fine for Seroquel Off Label Marketing

AstraZeneca has finalized its agreement with US federal and state entities, under which it will pay $520 million to resolve allegations that it marketed the anti-psychotic drug Seroquel for off-label uses.

The US contends that the company promoted the drug to doctors who do not typically treat schizophrenia or bipolar disorder, for which the drug is FDA approved. Instead, the drug was marketed to physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons for the treatment of unapproved uses including Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder and depression.

As part of the settlement, AstraZeneca has also entered into a corporate integrity agreement with the US Office of Inspector General of the US Department of Health and Human Services (HHS).

From the DOJ Press Statement:

AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services’ Health Care Fraud Enforcement Action Team (HEAT) announced today. Such unapproved uses are also known as "off-label" uses because they are not included in the drug’s FDA approved product label.

The Wilmington, Del.-based company signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.

Under the terms of the settlement, the federal government will receive $301,907,007 from the civil settlement, and the state Medicaid programs and the District of Columbia will share up to $218,092,993 of the civil settlement, depending on the number of states that participate in the settlement. The allegations were originally brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act and various state False Claims Act statutes.

Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug may not be marketed or promoted for off-label uses.

The FDA originally approved Seroquel in September 1997 for the treatment of manifestations of psychotic disorders. In September 2000, FDA proposed narrowing the approval for Seroquel to the short term treatment of schizophrenia only. In January 2004, the FDA approved Seroquel for short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania). In October 2006, the FDA approved Seroquel for bipolar depression.

SCOTUS and Merck Securities opinion

The U.S. Supreme Court has ruled that a securities fraud lawsuit can proceed against Merck over the pharmaceutical company's disclosures to investors about its withdrawn Vioxx pain drug. Find the opinion here.

A full discussion is on Wiki here.

The justices unanimously upheld a ruling by a U.S. appeals court that allowed the lawsuit seeking billions of dollars in damages to go forward. The appeals court held the claims were not time-barred under the statute of limitations.

The securities fraud lawsuit was unrelated to the $4.85 billion settlement in 2007 between Merck and plaintiffs who filed personal injury lawsuits against the company over Vioxx.

A federal judge initially dismissed the lawsuit and ruled the investors had waited too long, more than two years, to file the lawsuit after the first warnings that Vioxx might be unsafe.

But the appeals court in Philadelphia disagreed and ruled the two-year limitations period does not begin to run until the plaintiffs have actual knowledge the defendant intended to mislead investors.

Source here.

FDA warns TEVA

The Food and Drug Administration said it found "significant" manufacturing violations at Teva Pharmaceutical Industries Ltd. (TEVA) facility that makes the sedative drug propofol.

The agency posted a Dec. 11 warning letter to its Web site on Tuesday. The letter involved violations found during a FDA inspection of an Irvine, Calif. facility last July. Propofol, an injectable drug, is used for general anesthesia or sedation in operating rooms and intensive care units.

Source here.