The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.
The consumer group, Public Citizen, filed a petition with the Food and Drug Administration to have Avandia taken off the market.
"The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities," Public Citizen said in its petition. "Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure.
Links: Here and here.
Friday, October 31, 2008
Friday, October 24, 2008
Fen Phen Verdict - Primary Pulmonary Hypertension
From Bloomberg.com:
A recent verdict regarding Wyeth's Pondimin drug resulted in a decision that the cause of Gloria Stribling's primary pulmonary hypertension was caused by Fen Phen. The trial loss was Wyeth's first in four years in a case involving the often-fatal illness.
Wyeth sought to resolve most fen-phen users' claims through a $3.75 billion national settlement program. The accord didn't cover people stricken with the fatal lung disease.
For more, go here.
A recent verdict regarding Wyeth's Pondimin drug resulted in a decision that the cause of Gloria Stribling's primary pulmonary hypertension was caused by Fen Phen. The trial loss was Wyeth's first in four years in a case involving the often-fatal illness.
Wyeth sought to resolve most fen-phen users' claims through a $3.75 billion national settlement program. The accord didn't cover people stricken with the fatal lung disease.
For more, go here.
1 Million Cribs Recalled
The recall announced by the U.S. Consumer Product Safety Commission involved older cribs that are no longer on the market but are often reused by families or sold at resale shops and online at sites such as Craigslist. The recall covered cribs sold in the U.S. from 1995 to 2007 by Delta Enterprise, the largest distributor of cribs in the world.
Delta is recalling all cribs with the “Crib Trigger Lock with Safety Peg” drop side hardware design. When the safety pegs are missing from the lower track, the crib locks can disengage and detach if lowered below the peg hole, creating a hazardous gap which can lead to entrapment and suffocation.
The model numbers for the recalled Delta cribs with the "Crib Trigger Lock with Safety Peg" drop side hardware are: 4320, 4340, 4500, 4520, 4530, 4532, 4540, 4542, 4550, 4551, 4580, 4600, 4620, 4624 (production dates 01/06 through 11/07), 4640, 4660, 4720, 4735, 4742, 4750 (production dates 01/95 through 12/00), 4760, 4770, 4780, 4790, 4820, 4840, 4850, 4860, 4880, 4890, 4892, 4900, 4910, 4920, 4925-2, 4925-6, 4930, 4940, 4943, 4944, 4947, 4948, 4949, 4950, 4958, 4963, 4968, 4969, and 4980.
The recalled cribs have date codes ranging from 1995 though December 2005; one model (4624) was made in 2007. The model numbers are located on the top of the mattress support board. The cribs, made in Taiwan and Indonesia, were sold at major retailers, including WalMart, Kmart, and Target.com from January 1995 through September 2007 for about $100 and may also have been sold secondhand.
Go to the Delta site for more.
http://www.cribrecallcenter.com/
Delta is recalling all cribs with the “Crib Trigger Lock with Safety Peg” drop side hardware design. When the safety pegs are missing from the lower track, the crib locks can disengage and detach if lowered below the peg hole, creating a hazardous gap which can lead to entrapment and suffocation.
The model numbers for the recalled Delta cribs with the "Crib Trigger Lock with Safety Peg" drop side hardware are: 4320, 4340, 4500, 4520, 4530, 4532, 4540, 4542, 4550, 4551, 4580, 4600, 4620, 4624 (production dates 01/06 through 11/07), 4640, 4660, 4720, 4735, 4742, 4750 (production dates 01/95 through 12/00), 4760, 4770, 4780, 4790, 4820, 4840, 4850, 4860, 4880, 4890, 4892, 4900, 4910, 4920, 4925-2, 4925-6, 4930, 4940, 4943, 4944, 4947, 4948, 4949, 4950, 4958, 4963, 4968, 4969, and 4980.
The recalled cribs have date codes ranging from 1995 though December 2005; one model (4624) was made in 2007. The model numbers are located on the top of the mattress support board. The cribs, made in Taiwan and Indonesia, were sold at major retailers, including WalMart, Kmart, and Target.com from January 1995 through September 2007 for about $100 and may also have been sold secondhand.
Go to the Delta site for more.
http://www.cribrecallcenter.com/
Thursday, October 23, 2008
Total Body Formula Litigation: MDL is in AL
In the Total Body Formula lawsuits, the MDL for all of the litigation, including the Total Body Class Action, will be Birmingham, Alabama. Judge Proctor drew the cases.
The Transfer Order may be found here. (PDF Alert)
Expect an initial hearing in Birmingham soon.
The Transfer Order may be found here. (PDF Alert)
Expect an initial hearing in Birmingham soon.
New Blog: Georgia Justice Blog
You may find it here. http://georgiajustice.blogspot.com/
What is it? It's the blog from the Georgia Trial Lawyers Assoc. The most recent post starts with a recap of this:
A Great Escape and a Great Man
The Georgia Trial Lawyers Association honors Judge Anthony A. Alaimo
Atlanta, GA—Hailed as what will be the largest gathering of judges and attorneys in the history of the state of Georgia, the Georgia Trial Lawyers Association [GTLA] is hosting The Height of Excellence—an event honoring excellence in Georgia’s judiciary and where Judge Anthony A. Alaimo, a Senior United States District Court Judge of the Southern District of Georgia, will be the first recipient of the inaugural Anthony A. Alaimo Award for Judicial Excellence.
“It is very appropriate that the first award given by the members of GTLA for judicial excellence carries the name of Judge Anthony A. Alaimo and that he will be the very first recipient,” said GTLA President Fred Orr. “Judge Alaimo, at age 88, remains one of the hardest working judges in the entire country. He is among the most beloved and respected judges of the federal judiciary. He is a true American Hero.” More on their site.
It's worth reading, and worth adding to a blogroll.
What is it? It's the blog from the Georgia Trial Lawyers Assoc. The most recent post starts with a recap of this:
A Great Escape and a Great Man
The Georgia Trial Lawyers Association honors Judge Anthony A. Alaimo
Atlanta, GA—Hailed as what will be the largest gathering of judges and attorneys in the history of the state of Georgia, the Georgia Trial Lawyers Association [GTLA] is hosting The Height of Excellence—an event honoring excellence in Georgia’s judiciary and where Judge Anthony A. Alaimo, a Senior United States District Court Judge of the Southern District of Georgia, will be the first recipient of the inaugural Anthony A. Alaimo Award for Judicial Excellence.
“It is very appropriate that the first award given by the members of GTLA for judicial excellence carries the name of Judge Anthony A. Alaimo and that he will be the very first recipient,” said GTLA President Fred Orr. “Judge Alaimo, at age 88, remains one of the hardest working judges in the entire country. He is among the most beloved and respected judges of the federal judiciary. He is a true American Hero.” More on their site.
It's worth reading, and worth adding to a blogroll.
Tuesday, October 21, 2008
Pfizer Settles Bextra and Celebrex
From various sources:
Pfizer has announced that is has offered a total of $894 million to settle heart attacks, strokes, and other damages caused by its painkillers Bextra and Celebrex.
According to Pfizer, the settlement ends about 90 percent of the 7,000 personal injury lawsuits brought by those who were allegedly hurt by the painkillers.
The proposed settlement also would ends lawsuits filed by insurers and patients looking for reimbursement for the money they spent on Bextra and Celebrex, as well as claims by state attorneys general over Pfizer’s improper promotion of Bextra.
The AP link is here.
Pfizer has announced that is has offered a total of $894 million to settle heart attacks, strokes, and other damages caused by its painkillers Bextra and Celebrex.
According to Pfizer, the settlement ends about 90 percent of the 7,000 personal injury lawsuits brought by those who were allegedly hurt by the painkillers.
The proposed settlement also would ends lawsuits filed by insurers and patients looking for reimbursement for the money they spent on Bextra and Celebrex, as well as claims by state attorneys general over Pfizer’s improper promotion of Bextra.
The AP link is here.
FDA Regulators Missing Deadlines
From Reuters:
Several U.S. deadlines for reviewing new drugs have come and gone without a decision from the FDA. Here is a partial list:
Prasugrel, a blood thinner from Eli Lilly and Daiichi Sankyo. A decision was due Sept. 26. The application remains pending.
Promacta, a drug for a clotting disorder. The deadline was Sept. 19. No decision has been made.
For more go here.
Several U.S. deadlines for reviewing new drugs have come and gone without a decision from the FDA. Here is a partial list:
Prasugrel, a blood thinner from Eli Lilly and Daiichi Sankyo. A decision was due Sept. 26. The application remains pending.
Promacta, a drug for a clotting disorder. The deadline was Sept. 19. No decision has been made.
For more go here.
Wednesday, October 15, 2008
FOIAs Reveal How Bush Administration Made Complete Immunity for Negligent Corporations a Top Priority
From the AAJ:
"In a stealth effort coordinated at the highest levels of the Bush administration, multiple federal agencies were repeatedly ordered to usurp state law and undermine consumer protections, according to documents obtained through repeated FOIA requests by the American Association for Justice (AAJ). The documents released today detail how helping corporations escape accountability for dangerous products has been the administration’s top priority.
“This is the real Bush legacy,” said AAJ President Les Weisbrod. “In effect the Bush administration made the safety of Americans secondary to corporate profits.”
The FOIA documents detail a Bush regulatory strategy called preemption. In short, the Bush administration has decided that federal rules should usurp – or preempt – the rights of states to protect their citizens with stricter safety standards. In turn, consumers can no longer use the state protections when harmed by negligence or misconduct, giving total immunity to corporations instead.
AAJ has tracked how the administration’s first attempts to preempt states rights utilized friend-of-the-court briefs on behalf of corporations in civil justice cases. After only mixed success, the administration then shifted strategies, targeting instead regulatory agencies in charge of product safety oversight. Beginning in 2005, carbon copy statements claiming that federal agency rules preempt state law began surfacing in the “preambles” of regulation issued by the federal government, and in some cases in the body of the final rules themselves. Because the courts have not yet conclusively determined whether preambles carry the full weight of law, corporations have a new legal theory on which they can argue in product liability cases.
“Unelected federal regulators are now claiming that states can’t protect their own citizens with stronger consumer protections,” Weisbrod added. In an upcoming Supreme Court case, 47 state attorneys general filed a brief arguing the FDA is breaking with historical precedent. In fact, in their brief they urge the U.S. Supreme Court to uphold a Vermont Supreme Court ruling that state law forces a drug manufacturer to pay $6.8 million to a Diana Levine, whose arm had to be amputated after she was injected with an improperly-labeled Wyeth drug.
Since 2005, seven federal agencies have issued over 60 proposed or final rules with preemption language in the preamble. During the past year, AAJ submitted numerous FOIA requests that prove the Office of Management and Budget (OMB) had direct involvement in the placement of the “complete immunity” preemption language. In an earlier request, OMB responded that there were no documents. However, emails recently obtained from the individual agencies prove that OMB did indeed discuss preemption with agencies, and in some instances OMB officials wrote the language.
Given this discrepancy, AAJ submitted an expanded request for OMB documents. On September 26, 2008, OMB responded it had identified 146 documents, but refused to release any of them, saying that “the disclosure of these documents would not be in the public interest.”
In piecing together the emails from the FOIAs, AAJ uncovered the cozy relationship between federal officials and the industries they regulate. For example, the pharmaceutical industry intensified its efforts to influence the FDA in the months leading up to the physician labeling rule’s release on January 24, 2006. Much of the lobbying efforts were aimed at Sheldon Bradshaw, who had succeeded Daniel Troy as FDA chief counsel in April 2005.
AAJ obtained emails that list attendees of a meeting between Bradshaw and the Pharmaceutical Research and Manufacturers of America (PhRMA) revealing the FDA chief counsel met with legal representatives from Pfizer, Wyeth, Eli Lilly, Berlex, Organon, Abbott Laboratories, Takeda, Sanofi-Aventis, Serono, AstraZeneca, Cephalon, Millenium, Eisai, Amgen, Astellas, GlaxoSmithKline, Bristol Myers Squibb, Johnson & Johnson, Novartis, Merck, and 3M.
Less than six months after this meeting, the agency would release its final physician labeling rule with complete immunity preemption language in the preamble, a complete about-face from the language in the proposed rule that specifically said the agency did not intend to preempt state law with the rule.
“Big business lobbyists have been on a crusade to destroy state consumer protection laws, and further stack the deck against American consumers,” said Weisbrod."
"In a stealth effort coordinated at the highest levels of the Bush administration, multiple federal agencies were repeatedly ordered to usurp state law and undermine consumer protections, according to documents obtained through repeated FOIA requests by the American Association for Justice (AAJ). The documents released today detail how helping corporations escape accountability for dangerous products has been the administration’s top priority.
“This is the real Bush legacy,” said AAJ President Les Weisbrod. “In effect the Bush administration made the safety of Americans secondary to corporate profits.”
The FOIA documents detail a Bush regulatory strategy called preemption. In short, the Bush administration has decided that federal rules should usurp – or preempt – the rights of states to protect their citizens with stricter safety standards. In turn, consumers can no longer use the state protections when harmed by negligence or misconduct, giving total immunity to corporations instead.
AAJ has tracked how the administration’s first attempts to preempt states rights utilized friend-of-the-court briefs on behalf of corporations in civil justice cases. After only mixed success, the administration then shifted strategies, targeting instead regulatory agencies in charge of product safety oversight. Beginning in 2005, carbon copy statements claiming that federal agency rules preempt state law began surfacing in the “preambles” of regulation issued by the federal government, and in some cases in the body of the final rules themselves. Because the courts have not yet conclusively determined whether preambles carry the full weight of law, corporations have a new legal theory on which they can argue in product liability cases.
“Unelected federal regulators are now claiming that states can’t protect their own citizens with stronger consumer protections,” Weisbrod added. In an upcoming Supreme Court case, 47 state attorneys general filed a brief arguing the FDA is breaking with historical precedent. In fact, in their brief they urge the U.S. Supreme Court to uphold a Vermont Supreme Court ruling that state law forces a drug manufacturer to pay $6.8 million to a Diana Levine, whose arm had to be amputated after she was injected with an improperly-labeled Wyeth drug.
Since 2005, seven federal agencies have issued over 60 proposed or final rules with preemption language in the preamble. During the past year, AAJ submitted numerous FOIA requests that prove the Office of Management and Budget (OMB) had direct involvement in the placement of the “complete immunity” preemption language. In an earlier request, OMB responded that there were no documents. However, emails recently obtained from the individual agencies prove that OMB did indeed discuss preemption with agencies, and in some instances OMB officials wrote the language.
Given this discrepancy, AAJ submitted an expanded request for OMB documents. On September 26, 2008, OMB responded it had identified 146 documents, but refused to release any of them, saying that “the disclosure of these documents would not be in the public interest.”
In piecing together the emails from the FOIAs, AAJ uncovered the cozy relationship between federal officials and the industries they regulate. For example, the pharmaceutical industry intensified its efforts to influence the FDA in the months leading up to the physician labeling rule’s release on January 24, 2006. Much of the lobbying efforts were aimed at Sheldon Bradshaw, who had succeeded Daniel Troy as FDA chief counsel in April 2005.
AAJ obtained emails that list attendees of a meeting between Bradshaw and the Pharmaceutical Research and Manufacturers of America (PhRMA) revealing the FDA chief counsel met with legal representatives from Pfizer, Wyeth, Eli Lilly, Berlex, Organon, Abbott Laboratories, Takeda, Sanofi-Aventis, Serono, AstraZeneca, Cephalon, Millenium, Eisai, Amgen, Astellas, GlaxoSmithKline, Bristol Myers Squibb, Johnson & Johnson, Novartis, Merck, and 3M.
Less than six months after this meeting, the agency would release its final physician labeling rule with complete immunity preemption language in the preamble, a complete about-face from the language in the proposed rule that specifically said the agency did not intend to preempt state law with the rule.
“Big business lobbyists have been on a crusade to destroy state consumer protection laws, and further stack the deck against American consumers,” said Weisbrod."
Tuesday, October 14, 2008
Vioxx Study: Heart Risks Last Nearly One Year
From various sites:
A long-term analysis of people who took the arthritis drug Vioxx confirms it doubles the risk of strokes and heart attacks. The risk seems to decline a year after people stop taking it. And other drugs in the same class of painkillers known as Cox-2 inhibitors may cause similar harm. Link here. The study may be found in the journal known as The Lancet. Vioxx articles are linked here.
A long-term analysis of people who took the arthritis drug Vioxx confirms it doubles the risk of strokes and heart attacks. The risk seems to decline a year after people stop taking it. And other drugs in the same class of painkillers known as Cox-2 inhibitors may cause similar harm. Link here. The study may be found in the journal known as The Lancet. Vioxx articles are linked here.
Wednesday, October 08, 2008
Price Gouging Update: GA does nothing, FL getting results
Just after Hurricanes Gustav and Ike wreaked havoc, I posted on price gouging going on in Florida and Georgia.
It's been about a month. What has happened?
Florida:
A Florida gas station accused of price gouging after Hurricane Ike has agreed to reimburse anyone with a receipt who was overcharged for gasoline, under a settlement with the state attorney general.
Kelly Junior #9, a gas station in Quincy, Fla., will also pay the American Red Cross $2,000 under terms of the agreement and pay the costs of the state's investigation into the price gouging.
The price of unleaded gasoline at Kelly Junior #9, individually owned by S and K of Quincy, Inc., increased twice on September 12, starting at $3.99 and ending at $4.29.
That's one of 4,000 being investigated.
Georgia:
Nearly 150 Georgia gas stations are having to defend why they charged inflated prices after Hurricanes Gustav and Ike made fuel scarce over the past month.
The state has subpoenaed sales records from businesses following complaints from 1,500 customers angry over what they were paying at the pump. State officials received reports of gas as high as $9.99 a gallon for regular unleaded, said Bill Cloud, spokesman for the Governor's Office of Consumer Affairs.
He said his office is still getting a few dozen calls a day about gas prices.
One station in Cobb County was charging $8.82 a gallon, and a Houston County gas station was asking customers to pay $7 per gallon, Cloud said.
Source here.
How many will ultimately be found to have gouged GA consumers? Does it really take a month to figure out that charging $9.99 is gouging?
It's been about a month. What has happened?
Florida:
A Florida gas station accused of price gouging after Hurricane Ike has agreed to reimburse anyone with a receipt who was overcharged for gasoline, under a settlement with the state attorney general.
Kelly Junior #9, a gas station in Quincy, Fla., will also pay the American Red Cross $2,000 under terms of the agreement and pay the costs of the state's investigation into the price gouging.
The price of unleaded gasoline at Kelly Junior #9, individually owned by S and K of Quincy, Inc., increased twice on September 12, starting at $3.99 and ending at $4.29.
That's one of 4,000 being investigated.
Georgia:
Nearly 150 Georgia gas stations are having to defend why they charged inflated prices after Hurricanes Gustav and Ike made fuel scarce over the past month.
The state has subpoenaed sales records from businesses following complaints from 1,500 customers angry over what they were paying at the pump. State officials received reports of gas as high as $9.99 a gallon for regular unleaded, said Bill Cloud, spokesman for the Governor's Office of Consumer Affairs.
He said his office is still getting a few dozen calls a day about gas prices.
One station in Cobb County was charging $8.82 a gallon, and a Houston County gas station was asking customers to pay $7 per gallon, Cloud said.
Source here.
How many will ultimately be found to have gouged GA consumers? Does it really take a month to figure out that charging $9.99 is gouging?
Eli Lilly to pay $62 million in Zyprexa settlement
From Reuters:
Lilly, has settled Zyprexa claims for $62 million. Zyprexa is Lilly's biggest product, with global sales of $4.76 billion in 2007.
The settlement with 32 states and the District of Columbia ends an 18-month investigation of the Indianapolis-based company, which had been accused of promoting the drug for unapproved off-label uses and of playing down side effects such as weight gain, which can increase the risk for diabetes.
Source here.
Lilly, has settled Zyprexa claims for $62 million. Zyprexa is Lilly's biggest product, with global sales of $4.76 billion in 2007.
The settlement with 32 states and the District of Columbia ends an 18-month investigation of the Indianapolis-based company, which had been accused of promoting the drug for unapproved off-label uses and of playing down side effects such as weight gain, which can increase the risk for diabetes.
Source here.
Total Body Formula Lawsuit: State Court Hearing 10/13/08
On Monday October 13, 2008 at 9:00 a.m. in Decatur, GA Judge A. Wong will hold the first hearing on cases involving folks who claim they were injured by a supplement known as Total Body Formula and Total Body Mega Formula.
I and others will attend. Judge Wong will consider a proposed Case Management Order on the currently filed cases.
Stay tuned.
I and others will attend. Judge Wong will consider a proposed Case Management Order on the currently filed cases.
Stay tuned.
Friday, October 03, 2008
Raptiva Brain Link?
From Bloomberg:
A patient taking its drug for chronic psoriasis, Raptiva, has developed a rare brain infection.
The infection, progressive multifocal leukoencephalopathy, or PML, was linked to a 70-year-old who received Raptiva for more than four years.
For more go here.
A patient taking its drug for chronic psoriasis, Raptiva, has developed a rare brain infection.
The infection, progressive multifocal leukoencephalopathy, or PML, was linked to a 70-year-old who received Raptiva for more than four years.
For more go here.
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