Yaz Recall? Yes there was one

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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

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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

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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

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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

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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.

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

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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