Ostetricians are recommending that women avoid the antidepressant Paxil if they are pregnant or planning on becoming pregnant, due to a potential heightened risk for birth defects.
The American College of Obstetricians and Gynecologists (ACOG) also cautioned that treatment with other antidepressants should be considered on a case-by-case basis.
ACOG's Committee on Obstetric Practice "recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible," read the statement, which is in the December issue of Obstetrics & Gynecology.
In 2005 the FDA issued a warning about possible birth defects associated with Paxil when the drug is taken during the first trimester of pregnancy. In December of 2005, the FDA told GlaxoSmithKline to reclassify the drug from a Category C to D (a stronger warning) for pregnant women. Category D means studies in pregnant women have demonstrated a risk to the fetus.
SSRIs, the category of antidepressants which includes Paxil as well as Celexa, Prozac and Zoloft, may cause newborns to have withdrawal symptoms.
The FDA site has more, here.
Thursday, November 30, 2006
Wednesday, November 29, 2006
Katrina II: Judge Slams Bush Admin, Orders Resumption of Payments
The Bush administration must resume housing payments for thousands of people displaced by Hurricane Katrina.
U.S. District Judge Richard J. Leon's ripped the Federal Emergency Management Agency for illegally cutting housing funding and subjecting storm victims to a convoluted application process he called "Kafkaesque."
In the Washington case, Leon said FEMA mishandled the transition from a short-term housing program to a longer-term program this spring and summer.
Until FEMA explains itself and allows victims to appeal, Leon said the government must keep making housing payments.
"It is unfortunate, if not incredible, that FEMA and its counsel could not devise a sufficient notice system to spare these beleaguered evacuees the added burden of federal litigation to vindicate their constitutional rights," Leon wrote in his ruling.
You can find the Memorandum Opinion here.
U.S. District Judge Richard J. Leon's ripped the Federal Emergency Management Agency for illegally cutting housing funding and subjecting storm victims to a convoluted application process he called "Kafkaesque."
In the Washington case, Leon said FEMA mishandled the transition from a short-term housing program to a longer-term program this spring and summer.
Until FEMA explains itself and allows victims to appeal, Leon said the government must keep making housing payments.
"It is unfortunate, if not incredible, that FEMA and its counsel could not devise a sufficient notice system to spare these beleaguered evacuees the added burden of federal litigation to vindicate their constitutional rights," Leon wrote in his ruling.
You can find the Memorandum Opinion here.
Katrina News: USDCT Judge Rules Against Insurers
A U.S. federal judge denied Motions to Dismiss claims based on the water damage caused by a canal levee breach. After reading the 85 page opinion, news reports appear to have incorrectly concluded that the Judge "ruled that insurance companies should pay for widespread water damage that ensued in the wake of Katrina."
Judge Stanwood Duval's ruling does put insurers at risk to pay more than the $41 billion they have already paid to storm victims.
Judge Duval's decision centered on the distinction between flooding caused by high winds and heavy rains and flooding caused by human error. Much of the destruction in New Orleans in the wake of Hurricane Katrina in August 2005 was a result of levee failures.
He said the language in the insurance policies on flood coverage was ambiguous because it did not "clearly exclude man-made" flood disasters. Because the insurers had provided the wording for the policies, he said he felt "constrained to interpret it against the insurers." Most of the arguments set forth by the Plaintiffs suggest that 'water intrusion' is different than flooding. The court did an exemplary job of wading through the many definitions of the term "flood," including one that refers to rising and overflowing as opposed to exiting through a breach.
For more go here.
The 85 page PDF ruling can be found here.
The E.D. of LA Court page can be found here.
Judge Stanwood Duval's ruling does put insurers at risk to pay more than the $41 billion they have already paid to storm victims.
Judge Duval's decision centered on the distinction between flooding caused by high winds and heavy rains and flooding caused by human error. Much of the destruction in New Orleans in the wake of Hurricane Katrina in August 2005 was a result of levee failures.
He said the language in the insurance policies on flood coverage was ambiguous because it did not "clearly exclude man-made" flood disasters. Because the insurers had provided the wording for the policies, he said he felt "constrained to interpret it against the insurers." Most of the arguments set forth by the Plaintiffs suggest that 'water intrusion' is different than flooding. The court did an exemplary job of wading through the many definitions of the term "flood," including one that refers to rising and overflowing as opposed to exiting through a breach.
For more go here.
The 85 page PDF ruling can be found here.
The E.D. of LA Court page can be found here.
Tuesday, November 28, 2006
Idiot Congressman Calls Miami A "3rd World Country"
Republican Congressman Tom Tancredo a so called "leader" of the anti-illegal immigration faction in the U.S. House, spent a recent weekend at The Breakers in Palm Beach. In case you are not familiar with the Breakers, it is perhaps one of the finest old line AAA Five Diamond Hotels in the United States. It is truly a magnificent palatial resort:
Of course, why a politician whose salary is paid for by taxpaying folks like me is staying at a Resort like that is the subject of another blog entry BUT he had this to say about Miami:
Miami, he told a conservative online news site, ``has become a Third World country.'' Source.
''Look at what has happened to Miami,'' the WorldNetDaily quotes Tancredo as saying in an interview. ``It has become a Third World country. You just pick it up and take it and move it someplace. You would never know you're in the United States of America. You would certainly say you're in a Third World country.''
There is no objective definition of Third World or "Third World country" but the use of the term remains common. The term Third World is also disliked as it may imply the false notion that those countries are not a part of the global economic system, according to Wiki.
Tancredo is too dumb to realize that the French demographer Alfred Sauvy coined the expression ("tiers monde" in French) in 1952 by analogy with the "third estate," the commoners of France before and during the French Revolution-as opposed to priests and nobles, comprising the first and second estates respectively. Like the third estate, wrote Sauvy, the third world is nothing, and it "wants to be something." The term therefore implies that the third world is exploited, marked by poverty and high birth rates. The third estate is marked by shantytowns with pockets of rich elite.
The remarks drew an instant rebuke from Miami Republican Rep. Ileana Ros-Lehtinen, who called Tancredo ''flat out wrong'' and extended an invitation for him to come and judge the city for himself.
Tancredo didn't visit Miami on his trip. Nice of him to trash the city without visiting it, eh?
Nevermind that Miami is home to many thousands of Cubans who arrived in the United States legally. Or that the GOP has a near stranglehold on Cuban votes and most hispanic voters there. Or that Miami is no different than NYC in the 40s and 50s, with enclaves like Little Italy. Tom should know about NYC, since he is the grandson of Italian immigrants who, like Cubans, settled in ethnic enclaves across the United States.
Make no mistake: Trancedo is a rascist.He has received thousands of dollars from individuals linked to white supremacy (Link). He has insulted generations of Hisnapic immigrants who are the stalwarts of the Miami economy. I will take a wild guess that he has never been to Marrakech or Kabul. Open sewers, rampant and unchecked disease.
I was raised in South Florida. While certainly there are many hispanics, you are just as likely to hear German, Italian, and French at shops and on the beach. I challenge him to take a trip to the Miami area and see where the conditions are rough. You know what you will find? Poor whites. Members of many minorities living day to day. But, had he done his research, he would know that. He'd know that the area around the Orange Bowl - a dump of a stadium - is in poor shape, and is according to several census sites, majority white.
That's not enough for this POS ... Tommy goes on to say: "While a recent documentary comparison of Miami-Dade County to Baghdad was a bit of an overstatement no one can argue that it is not one of America's most dangerous areas." Well Tom, not quite ... according to this site, Safest and Most Dangerous U.S. Cities, 2005. D.C. - Tom's 2nd hometown - is there. Miami is not in the Top 25, but Baltimore is. Tom, your rascist notions are wrong. This guy votes on balancing a budget?
But hey, Tommy knows that a Third World Country like Miami has hosted a Super Bowl, has the reigning NBA Champs, hosts international banking, and has one of the USA's busiest ports. Or that those living below the poverty line in Miami-Dade total 18% compared to 15% in Denver.
Tommy boy, if you want to run for President you just crapped on a big segment of your voters. At the conservative seminar/vaction you attended apparently there was no discussion of hispanics deserting the GOP in droves this past election because of spliiter issues like immigration. Your hate rhetoric won't fly - Comprende?
Of course, why a politician whose salary is paid for by taxpaying folks like me is staying at a Resort like that is the subject of another blog entry BUT he had this to say about Miami:
Miami, he told a conservative online news site, ``has become a Third World country.'' Source.
''Look at what has happened to Miami,'' the WorldNetDaily quotes Tancredo as saying in an interview. ``It has become a Third World country. You just pick it up and take it and move it someplace. You would never know you're in the United States of America. You would certainly say you're in a Third World country.''
There is no objective definition of Third World or "Third World country" but the use of the term remains common. The term Third World is also disliked as it may imply the false notion that those countries are not a part of the global economic system, according to Wiki.
Tancredo is too dumb to realize that the French demographer Alfred Sauvy coined the expression ("tiers monde" in French) in 1952 by analogy with the "third estate," the commoners of France before and during the French Revolution-as opposed to priests and nobles, comprising the first and second estates respectively. Like the third estate, wrote Sauvy, the third world is nothing, and it "wants to be something." The term therefore implies that the third world is exploited, marked by poverty and high birth rates. The third estate is marked by shantytowns with pockets of rich elite.
The remarks drew an instant rebuke from Miami Republican Rep. Ileana Ros-Lehtinen, who called Tancredo ''flat out wrong'' and extended an invitation for him to come and judge the city for himself.
Tancredo didn't visit Miami on his trip. Nice of him to trash the city without visiting it, eh?
Nevermind that Miami is home to many thousands of Cubans who arrived in the United States legally. Or that the GOP has a near stranglehold on Cuban votes and most hispanic voters there. Or that Miami is no different than NYC in the 40s and 50s, with enclaves like Little Italy. Tom should know about NYC, since he is the grandson of Italian immigrants who, like Cubans, settled in ethnic enclaves across the United States.
Make no mistake: Trancedo is a rascist.He has received thousands of dollars from individuals linked to white supremacy (Link). He has insulted generations of Hisnapic immigrants who are the stalwarts of the Miami economy. I will take a wild guess that he has never been to Marrakech or Kabul. Open sewers, rampant and unchecked disease.
I was raised in South Florida. While certainly there are many hispanics, you are just as likely to hear German, Italian, and French at shops and on the beach. I challenge him to take a trip to the Miami area and see where the conditions are rough. You know what you will find? Poor whites. Members of many minorities living day to day. But, had he done his research, he would know that. He'd know that the area around the Orange Bowl - a dump of a stadium - is in poor shape, and is according to several census sites, majority white.
That's not enough for this POS ... Tommy goes on to say: "While a recent documentary comparison of Miami-Dade County to Baghdad was a bit of an overstatement no one can argue that it is not one of America's most dangerous areas." Well Tom, not quite ... according to this site, Safest and Most Dangerous U.S. Cities, 2005. D.C. - Tom's 2nd hometown - is there. Miami is not in the Top 25, but Baltimore is. Tom, your rascist notions are wrong. This guy votes on balancing a budget?
But hey, Tommy knows that a Third World Country like Miami has hosted a Super Bowl, has the reigning NBA Champs, hosts international banking, and has one of the USA's busiest ports. Or that those living below the poverty line in Miami-Dade total 18% compared to 15% in Denver.
Tommy boy, if you want to run for President you just crapped on a big segment of your voters. At the conservative seminar/vaction you attended apparently there was no discussion of hispanics deserting the GOP in droves this past election because of spliiter issues like immigration. Your hate rhetoric won't fly - Comprende?
New Blog: Science and Technical Evidence & News
Worth a look: Science Evidence.
According to the site:
Science Evidence is devoted to the latest news in scientific evidence in United States courts and news relevant to litigation, including case reports and scientific research articles that bear on legal issues.
Cliff Hutchinson is an engineer, registered patent attorney, and trial lawyer, with over 26 years experience in litigation in state and federal courts and before arbitral tribunals. His practice focuses on complex commercial litigation involving technical issues, such as intellectual property disputes, toxic torts, oil and gas, and contract disputes in other technology industries. He has litigated in trial courts in numerous states and has appeared before state appellate courts and before federal circuit courts in the First and Fifth Circuits and the United States Supreme Court.
According to the site:
Science Evidence is devoted to the latest news in scientific evidence in United States courts and news relevant to litigation, including case reports and scientific research articles that bear on legal issues.
Cliff Hutchinson is an engineer, registered patent attorney, and trial lawyer, with over 26 years experience in litigation in state and federal courts and before arbitral tribunals. His practice focuses on complex commercial litigation involving technical issues, such as intellectual property disputes, toxic torts, oil and gas, and contract disputes in other technology industries. He has litigated in trial courts in numerous states and has appeared before state appellate courts and before federal circuit courts in the First and Fifth Circuits and the United States Supreme Court.
FDA Issues Methadone Warning
People treating with methadone have died or suffered life-threatening side effects according to the FDA.
Overdoses of the increasingly popular narcotic can cause slow or shallow breathing and dangerous changes in heartbeat that patients might not feel.
In 2003, methadone was listed as a cause of 2,452 unintentional poisoning deaths in the United States, up from 623 in 1999, according to the National Center for Health Statistics.
According to most reports, prescribing methadone is complex. Methadone should only be prescribed for patients with moderate to severe pain when their pain is not improved with other non-narcotic pain relievers.
For more go here. You can find the FDA Advisory here.
Overdoses of the increasingly popular narcotic can cause slow or shallow breathing and dangerous changes in heartbeat that patients might not feel.
In 2003, methadone was listed as a cause of 2,452 unintentional poisoning deaths in the United States, up from 623 in 1999, according to the National Center for Health Statistics.
According to most reports, prescribing methadone is complex. Methadone should only be prescribed for patients with moderate to severe pain when their pain is not improved with other non-narcotic pain relievers.
For more go here. You can find the FDA Advisory here.
Merck's Arcoxia (Cox 2 ) Facing Hurdles
Merck has reported that Arcoxia - a not yet approved drug - had the same cardiovascular risks as diclofenac according to studies involving more than 30,000 arthritis patients.
Diclofenac is a nonsteroidal anti-inflammatory drug, or NSAID, the same class that includes naproxen and ibuprofen.
The fuss over Arcoxia started months ago, before Merck released the results of the study known as MEDAL. Critics hammered Merck, suggesting that the company should not have used diclofenac in the studay as it may have a higher cardiovascular risk than naproxen.
You can read more by going here.
Diclofenac is a nonsteroidal anti-inflammatory drug, or NSAID, the same class that includes naproxen and ibuprofen.
The fuss over Arcoxia started months ago, before Merck released the results of the study known as MEDAL. Critics hammered Merck, suggesting that the company should not have used diclofenac in the studay as it may have a higher cardiovascular risk than naproxen.
You can read more by going here.
Monday, November 27, 2006
Thanks - A Georgia Lawyer Blog's #1 Most Popular
This week, at least. Just goes to show if you look long enough, somewhere a law blog search engine may put your blog at the top.
Justia's Blawg Search is making a run to become the de facto search engine for law blogs, and this week in the section for Injury and Accident Law Blawgs somehow this one made it to the top. At least for now, and this week. That, and $5 will buy you a Venti-Over-The-Top Coffee at a certain coffee house.
I like the ease of use of the site as well as the new format over at Blawg.
Justia's Blawg Search is making a run to become the de facto search engine for law blogs, and this week in the section for Injury and Accident Law Blawgs somehow this one made it to the top. At least for now, and this week. That, and $5 will buy you a Venti-Over-The-Top Coffee at a certain coffee house.
I like the ease of use of the site as well as the new format over at Blawg.
Georgia's Former Governor Launches Consumer Site
Pretty impressive. Governor Roy Barnes of Georgia who also happens to be a Plaintiff's lawyer has a new website, myconsumerrights.com.
The site went online last week, and more importantly garnered news that many can only hope for, in that the Atlanta Journal Constitution ran a page one Metro section story on it.
According to the report, the site provides information on everything from credit cards and auto accidents to predatory lending and financing a car. The paper also noted that you can click on the "Ask Roy" link to go directly to Barnes' e-mail address.
You can't buy advertising like that. It's a site worth a look.
The site went online last week, and more importantly garnered news that many can only hope for, in that the Atlanta Journal Constitution ran a page one Metro section story on it.
According to the report, the site provides information on everything from credit cards and auto accidents to predatory lending and financing a car. The paper also noted that you can click on the "Ask Roy" link to go directly to Barnes' e-mail address.
You can't buy advertising like that. It's a site worth a look.
Actiq (Cancer Drug): Rampant Off Label Use?
According to the CT A.G.'s Office, Cephalon may have been a little too aggressive in trying to expand sales of Actiq. Actiq is a lollipop-administered drug approved only to treat cancer pain.
According to reports, doctors ranging from neurologists to anesthesiologists have prescribed the drug for a range of pain conditions including migraines.
What is notable is this comment in an article found online: The use of Actiq for cancer patients may be less than 20 percent of total sales, and many of the sales are based on prescriptions from anesthesiologists, rehabilitation specialists and others. Source here.
According to reports, doctors ranging from neurologists to anesthesiologists have prescribed the drug for a range of pain conditions including migraines.
What is notable is this comment in an article found online: The use of Actiq for cancer patients may be less than 20 percent of total sales, and many of the sales are based on prescriptions from anesthesiologists, rehabilitation specialists and others. Source here.
Vioxx Class Action Cert. Denied: The Right Decision
The federal judge overseeing the lawsuits filed against Merck & Co. over Vioxx
has ruled that the cases cannot be compiled into a class-action suit.
Judge Fallon ruled the cases had unique injuries and many different ingestion periods and should not be combined.
For more go here.
It's the right decision. With so many different types of claimed injuries, together with different dosages and length of ingestion, this should come as no surprise to anyone other than the attorneys that sought class action status.
has ruled that the cases cannot be compiled into a class-action suit.
Judge Fallon ruled the cases had unique injuries and many different ingestion periods and should not be combined.
For more go here.
It's the right decision. With so many different types of claimed injuries, together with different dosages and length of ingestion, this should come as no surprise to anyone other than the attorneys that sought class action status.
Tuesday, November 21, 2006
A New Law Blog Search Engine
Justia has up and running a "Blawg Search" site which you can find here.
There are 844 Blawgs in 45 categories according to the site, with more being added each day. Eyeing the catergoies it looks like Intellectual Property Law has the most blogs within it(80), with Law Professors (71) and Tech (59) 2nd and 3rd. Blawg.org lists nearly 1500.
To pick a nit, it looks like there is are separate categories for "Carolina" and "South" which probably means South Carolina, which probably means Dave Swanner's site. Alas, his site is not in the section titled "Injury and Accident Law" where it should be. Let's see how long it takes to fix that.
There are 844 Blawgs in 45 categories according to the site, with more being added each day. Eyeing the catergoies it looks like Intellectual Property Law has the most blogs within it(80), with Law Professors (71) and Tech (59) 2nd and 3rd. Blawg.org lists nearly 1500.
To pick a nit, it looks like there is are separate categories for "Carolina" and "South" which probably means South Carolina, which probably means Dave Swanner's site. Alas, his site is not in the section titled "Injury and Accident Law" where it should be. Let's see how long it takes to fix that.
EPO -The Scourge of Cycling- Linked to Heart Risks?
An anti-anemia drug used by chronic kidney disease sufferers may pose health problems accordnig to a recent study. You can find the abstract of the study in the NEJM.
Scientists found aggressive efforts to boost red blood cell production with erythropoietin (EPO) may increase the risk of heart failure in one study and could increase the need for dialysis according to another study.
EPO is sold under the names Eprex, NeoRecormon, and Aranesp. It is an artificial hormone that allows the blood to carry more oxygen, thus boosting endurance. It has been favored by endurance athletes and has saturated such sports as professional cycling and cross-country skiing.
First introduced into the world of cycling in the late 1980s, EPO gained notoriety during the 1998 Tour de France. Beginning with EPO and other doping drugs discovered by border police in the car of a masseuse for one of the cycling teams, the scandal progressed to riders being detained and questioned, with several admitting to taking doping drugs.
Now, the Harvard Medical School said patients who were treated aggressively were nearly 50% more likely to experience heart problems than patients in the low-hemoglobin group. Harvard's Medical School also published a report on EPO and blood doping.
For more information, go here.
Scientists found aggressive efforts to boost red blood cell production with erythropoietin (EPO) may increase the risk of heart failure in one study and could increase the need for dialysis according to another study.
EPO is sold under the names Eprex, NeoRecormon, and Aranesp. It is an artificial hormone that allows the blood to carry more oxygen, thus boosting endurance. It has been favored by endurance athletes and has saturated such sports as professional cycling and cross-country skiing.
First introduced into the world of cycling in the late 1980s, EPO gained notoriety during the 1998 Tour de France. Beginning with EPO and other doping drugs discovered by border police in the car of a masseuse for one of the cycling teams, the scandal progressed to riders being detained and questioned, with several admitting to taking doping drugs.
Now, the Harvard Medical School said patients who were treated aggressively were nearly 50% more likely to experience heart problems than patients in the low-hemoglobin group. Harvard's Medical School also published a report on EPO and blood doping.
For more information, go here.
Aspirin: Good News
I actually look for good news regarding pharmaceuticals and meds, and here is a bit of news that may help:
An aspirin a day may help keep head and neck cancers away, a new long-term study suggests. What is key is not the amount of aspirin ingested but the length of time that people were taking it that mattered.
According to the study, taking aspirin for under 10 years did not have a significant effect, [but] taking it 10 years or more was associated with a 30 percent reduction in cancer.
You can find the results in the study in the easy to find Archives of Otolaryngology.
The study involved 529 patients with head and neck cancer and another 529 without the malignancy. Participants were matched for age, sex and smoking status. They were also asked about their use of aspirin over the preceding decades.
Anyone who wants to take aspirin as a cancer preventive should first consult their physician. You should always talk to a physician before taking anything chronically.
An aspirin a day may help keep head and neck cancers away, a new long-term study suggests. What is key is not the amount of aspirin ingested but the length of time that people were taking it that mattered.
According to the study, taking aspirin for under 10 years did not have a significant effect, [but] taking it 10 years or more was associated with a 30 percent reduction in cancer.
You can find the results in the study in the easy to find Archives of Otolaryngology.
The study involved 529 patients with head and neck cancer and another 529 without the malignancy. Participants were matched for age, sex and smoking status. They were also asked about their use of aspirin over the preceding decades.
Anyone who wants to take aspirin as a cancer preventive should first consult their physician. You should always talk to a physician before taking anything chronically.
Monday, November 20, 2006
Military Jets Buzz The Swamp
Not law related, but worth a look. I attended the Gators game versus South
Carolina. At halftime two jets flew over the stadium, at no more than 1000 feet.
Catch them streaking across the stadium right at the 25 second mark.
I think 90,000 people soiled themselves.
Carolina. At halftime two jets flew over the stadium, at no more than 1000 feet.
Catch them streaking across the stadium right at the 25 second mark.
I think 90,000 people soiled themselves.
Big Pharma Courting Dems
From MSNBC:
After spending $10 million on G.O.P. incumbent candidates ahead of this year's mid-term elections, with Democrats getting about $4.5 million, Big Pharma can expect a somewhat hostile reception on Capitol Hill after the Democrats begin running the show in 2007.
GOP Billy Tauzin left Congress in 2005 to work as a lobbyist for PhRMA.
Soon-to-be Speaker Nancy Pelosi, said Tauzin sold seniors down the river for two million dollars, the sum Tauzin was reportedly paid to join the association he runs.
A PhRMA rep now says, "There will be a renewed emphasis on making new friends and reaching out to Democrats, and especially pro-business Democrats." Source here.
My prediction: A waterfall of money will change the minds of key Dems. No surprise there.
After spending $10 million on G.O.P. incumbent candidates ahead of this year's mid-term elections, with Democrats getting about $4.5 million, Big Pharma can expect a somewhat hostile reception on Capitol Hill after the Democrats begin running the show in 2007.
GOP Billy Tauzin left Congress in 2005 to work as a lobbyist for PhRMA.
Soon-to-be Speaker Nancy Pelosi, said Tauzin sold seniors down the river for two million dollars, the sum Tauzin was reportedly paid to join the association he runs.
A PhRMA rep now says, "There will be a renewed emphasis on making new friends and reaching out to Democrats, and especially pro-business Democrats." Source here.
My prediction: A waterfall of money will change the minds of key Dems. No surprise there.
Hemophilia Drug Causing Problems in Vets?
There are reports that a blood-coagulating drug used primarily to treat rare forms of hemophilia has been used on wounded American troops in Iraq, even though it can cause clots that lead to heart attacks and strokes.
The drug is known as Recombinant Activated Factor VII. The FDA has approved in the United States for treating forms of hemophilia that affect fewer than 3,000 Americans.
te Army medical command considers it a medical breakthrough that gives front-line physicians a way to control deadly bleeding. Physicians in Iraq have injected it into more than 1,000 patients, according to the Baltimore Sun.
For more go here.
The drug is known as Recombinant Activated Factor VII. The FDA has approved in the United States for treating forms of hemophilia that affect fewer than 3,000 Americans.
te Army medical command considers it a medical breakthrough that gives front-line physicians a way to control deadly bleeding. Physicians in Iraq have injected it into more than 1,000 patients, according to the Baltimore Sun.
For more go here.
Will Congress Give FDA Firepower?
From several sites:
Last week the U.S. Senate took testimony regarding a bill that gives a bit of oomph to the FDA.
The new bill includes a temporary ban on consumer advertising of newly approved drug. The FDA had issued a report that informed that that it simply cannot track the safety of new drugs, nor respond quickly to problems.
The bill would require pharmaceutical companies to devise safety plans for new drugs. It calls for more disclosure of the results of drug trials in human subjects. It also would give the FDA the authority to require companies to carry out safety studies of drugs once they are on the market.
Source here.
Last week the U.S. Senate took testimony regarding a bill that gives a bit of oomph to the FDA.
The new bill includes a temporary ban on consumer advertising of newly approved drug. The FDA had issued a report that informed that that it simply cannot track the safety of new drugs, nor respond quickly to problems.
The bill would require pharmaceutical companies to devise safety plans for new drugs. It calls for more disclosure of the results of drug trials in human subjects. It also would give the FDA the authority to require companies to carry out safety studies of drugs once they are on the market.
Source here.
Thursday, November 16, 2006
"Trial Lawyers" In the GOP ?
The RNC Chairman is now Mel Martinez, a former trial attorney from Florida. He made his bones in Florida working personal injury cases, and now leads the cause for the recently thumped GOP. My guess is his Hispanic heritage was a key factor, since Hispanics deserted the GOP in droves earlier this month in the mid term elections. "Although between 40 and 44 percent of Latinos voted for President Bush in 2004, almost 70 percent of Hispanic voters cast their lot for Democrats last week, according to exit polls." Source here.
In Florida, a trial attorney is now Lt. Governor. He was a member of one of the state's most aggressive trial lawyer firms, Morgan & Morgan. A good background article on him can be found here.
How will a Hispanic Trial Attorney accept the personal debasing that is such a part of the hysterial dialogue on immigration while working the byways of the USA? Will the medical malpractice mess of laws in Florida be revisited? Kottkamp himself had a brush with death that may have changed him, and it turned into a malpractice claim.
The article notes that he was a plaintiff in an October 2005 lawsuit alleging that improper maintenance of the hospital's roof allowed mold to infiltrate the room where he had surgery. That event almost killed him.
Perhaps each will be able to avoid the demonizing that goes on in the litigation arena. Perhaps each will be able to fight the splitting that goes on at the highest levels of the GOP. Time will tell.
In Florida, a trial attorney is now Lt. Governor. He was a member of one of the state's most aggressive trial lawyer firms, Morgan & Morgan. A good background article on him can be found here.
How will a Hispanic Trial Attorney accept the personal debasing that is such a part of the hysterial dialogue on immigration while working the byways of the USA? Will the medical malpractice mess of laws in Florida be revisited? Kottkamp himself had a brush with death that may have changed him, and it turned into a malpractice claim.
The article notes that he was a plaintiff in an October 2005 lawsuit alleging that improper maintenance of the hospital's roof allowed mold to infiltrate the room where he had surgery. That event almost killed him.
Perhaps each will be able to avoid the demonizing that goes on in the litigation arena. Perhaps each will be able to fight the splitting that goes on at the highest levels of the GOP. Time will tell.
Vioxx: Another Verdict in Favor of Merck
A federal jury on Wednesday cleared Merck in the July 2003 heart attack suffered by a Utah man who took Vioxx for 10 1/2 months.
Charles Mason blamed the drug for the heart attack which he suffered in July 2003. He had taken Vioxx after years of taking other anti-inflammatory drugs because of back pain.
Defense counsel: Beck said he and co-counsel Tarek Ismail made several points during trial. The attorneys focused on Mason's admission under cross-exam that he stopped taking Vioxx four days before the heart attack. The other was that film taken during the operation to open his blocked artery showed that the blockage was almost all plaque, rather than a big blood clot.
Defense counsel argued that there was no Vioxx in the Plaintiff's system when the heart attack happened. During his closing argument, Beck focused on those four days without Vioxx.
During closing, Merck counsel apparently told jurors that the New Orleans M.D. who had testified he believed Vioxx caused the heart attack also testified that he had never seen that film and was not qualified to evaluate it.
More later.
Charles Mason blamed the drug for the heart attack which he suffered in July 2003. He had taken Vioxx after years of taking other anti-inflammatory drugs because of back pain.
Defense counsel: Beck said he and co-counsel Tarek Ismail made several points during trial. The attorneys focused on Mason's admission under cross-exam that he stopped taking Vioxx four days before the heart attack. The other was that film taken during the operation to open his blocked artery showed that the blockage was almost all plaque, rather than a big blood clot.
Defense counsel argued that there was no Vioxx in the Plaintiff's system when the heart attack happened. During his closing argument, Beck focused on those four days without Vioxx.
During closing, Merck counsel apparently told jurors that the New Orleans M.D. who had testified he believed Vioxx caused the heart attack also testified that he had never seen that film and was not qualified to evaluate it.
More later.
Wednesday, November 15, 2006
Ketek (Antiobitic): Bad News Ahead?
Ketek is a drug that has been approved in 2004 for the treatment of acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. There has been a link to Ketek ib reports of severe liver problems and deaths. As ar result the drug will be subjected to new scrutiny by the FDA.
The FDA will discuss the overall risks and benefits of the antibiotic Ketek during a Dec. 14-15 meeting, according to their site.
The joint panel's two-day review of Ketek could lead to a recommendation that the agency add further warnings to the label of the drug.
Ketek, also called telithromycin, carries a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal, in patients treated with the drug.
For more, go here.
The FDA will discuss the overall risks and benefits of the antibiotic Ketek during a Dec. 14-15 meeting, according to their site.
The joint panel's two-day review of Ketek could lead to a recommendation that the agency add further warnings to the label of the drug.
Ketek, also called telithromycin, carries a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal, in patients treated with the drug.
For more, go here.
Tuesday, November 14, 2006
A New Litigation Blog Worth A Look:
The Texas Litigation Blog.
My good friend Angel Reyes and his law partner Brian Cuban have started it. Not a stuffy blog, it seems to be focusing more on current events as well as law.
My good friend Angel Reyes and his law partner Brian Cuban have started it. Not a stuffy blog, it seems to be focusing more on current events as well as law.
Vioxx By The Numbers
Merck filed papers with the SEC that indicated that as 10/6/06:
There were 23,800 Vioxx lawsuits, with 41,750 individuals, and more than 14,700 claims have been filed under the MDL's "File and Stay" agreement with Merck.
Nearly 7,600 Vioxx claims were filed in or transferred to the MDL in New Orleans;
13,750 Vioxx lawsuits have been filed before Judge Higbee in a NJ State Court;
Merck took a charge of $598 million for Vioxx legal expenses on top of the $685 million it had previously set aside for litigation reserves.
Source here.
There were 23,800 Vioxx lawsuits, with 41,750 individuals, and more than 14,700 claims have been filed under the MDL's "File and Stay" agreement with Merck.
Nearly 7,600 Vioxx claims were filed in or transferred to the MDL in New Orleans;
13,750 Vioxx lawsuits have been filed before Judge Higbee in a NJ State Court;
Merck took a charge of $598 million for Vioxx legal expenses on top of the $685 million it had previously set aside for litigation reserves.
Source here.
Monday, November 13, 2006
A Bad Marketing Idea
I drove back from Florida this past weekend, watching the Gators beat USCe. On the way back to Georgia, I saw a car whiz by ... loaded up with lettering advertising an accountancy office.
The new SUV had Georgia plates; the rear tailgate window had two inch high lettering indicating the website of the business. Below it, the telephone number with an Atlanta area code. On the right side, the same number with the name of the business.
Good enough, you say. Well, not really. I watched as the SUV weaved in and out of traffic. Cut off by my count at least five cars. As the driver passed me then jumped in front of me in order to traverse two lanes to exit the interstate, a cigarette butt went out the window. Then he/she was gone.
About twenty minutes later, going nearly 100 m.p.h., you guessed it - the accountant. Again, swerving across lanes. Amazingly, another butt tossed from the window. As traffic was heavier (construction), the SUV was in view for a while. Cut off an 18 wheeler, with the trucker using his horn.
I can only tell you that I will remember that business, for all of the wrong reasons. How could this person be so stupid?
The new SUV had Georgia plates; the rear tailgate window had two inch high lettering indicating the website of the business. Below it, the telephone number with an Atlanta area code. On the right side, the same number with the name of the business.
Good enough, you say. Well, not really. I watched as the SUV weaved in and out of traffic. Cut off by my count at least five cars. As the driver passed me then jumped in front of me in order to traverse two lanes to exit the interstate, a cigarette butt went out the window. Then he/she was gone.
About twenty minutes later, going nearly 100 m.p.h., you guessed it - the accountant. Again, swerving across lanes. Amazingly, another butt tossed from the window. As traffic was heavier (construction), the SUV was in view for a while. Cut off an 18 wheeler, with the trucker using his horn.
I can only tell you that I will remember that business, for all of the wrong reasons. How could this person be so stupid?
Merck's Vioxx Successor - Arcoxia
Merck sent data on heart risks as to the delayed arthritis drug Arcoxia. Arcoxis is/was to be a potential successor to the withdrawn painkiller Vioxx. The company said it seeks a government OK of Arcoxia in 30-milligram and 60-milligram dosages.
Merck supposedly expects the FDA's Arcoxia to take about six more months.
Arcoxia can be purchased in more than sixty countries but has been under review by the FDA since 2003.
Merck said its response to approvable letters issued on Arcoxia by the FDA includes results of the "Medal" clinical trial. The trial, begun in 2002, was specifically designed to evaluate Arcoxia's cardiovascular risks.
Merck supposedly expects the FDA's Arcoxia to take about six more months.
Arcoxia can be purchased in more than sixty countries but has been under review by the FDA since 2003.
Merck said its response to approvable letters issued on Arcoxia by the FDA includes results of the "Medal" clinical trial. The trial, begun in 2002, was specifically designed to evaluate Arcoxia's cardiovascular risks.
Thursday, November 09, 2006
Trial Attorney Blog: Podcast
Dave Swanner and I have spent hours working on the Trial Lawyer Resource Center along with many others who are respected within the trial bar.
Mark Wahlstrom from Legal Broadcast Network talked with me about the efforts of the Trial Lawyer Blog. You can find it here.
Mark's blog is found here.
Mark Wahlstrom from Legal Broadcast Network talked with me about the efforts of the Trial Lawyer Blog. You can find it here.
Mark's blog is found here.
Tuesday, November 07, 2006
FDA Pharma Preemption: Recent Court Opinions
The news comes from both sides of the USA when it comes to the FDA Preamble as to preemption and its applicability in drug litigation. One supporter of the FDA's position says, "The FDA's bottom-line concern is that 'state-law attempts to impose additional warnings can lead to labeling that does not accurately portray a product's risks, thereby potentially discouraging safe and effective use of approved drugs." Source here.
First, the cases rejecting preemption - McNellis v. Pfizer Inc., 2006 WL 2819041 (D.N.J. Sept. 29, 2006), and others:
In McNellis the Court did not allow the preemption defense. The Court held that the regulations do not conflict with New Jersey's failure-to-warn laws. Recognizing the preamble as "an official agency statement" that favors pre-emption of conflicting state law claims, the court gave no deference to the FDA's interpretation because the agency's position has not been consistent over time, the regulations allow increased warnings when new risks emerge, and the relevant Act does not contain an express preemption clause.
You can find McNellis here:here (PDF Alert). You can find the Perry brief that was submitted on behalf of the Plaintiff by going here. (PDF)
After McNellis, Perry v. Novartis Pharma. Corp., No. 05-5350 (E.D. Pa. Oct. 16, 2006) was rendered and it also rejected the FDA's argument. The Perry Court found that a state law requirement to provide an additional warning would not create a conflict or make it impossible to comply with state and federal law.
A 2nd Circuit case, Desiano v. Warner-Lambert (2d Cir. Oct. 5, 2006) also did not agree with the FDA's position.
Court Opinion siding with the FDA Preemption argument:
In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, 2006 WL 2374742 (N.D. Cal. Aug. 16, 2006),
In Bextra and Celebrex, the U.S. District Court for the Northern District of California dismissed state law failure-to-warn claims involving a prescription drug because they conflict with the FDA's determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the Food, Drug and Cosmetic Act. The original label for the drug was approved in 1998, was revised in 1999 to add cardiovascular risks, and was later revised in 2005.
In dismissing claims that cardiovascular warnings were not adequate, the Court gave deference to the FDA's interpretation of the reach of the agency's labeling regulations. Note that the Court rules that consumer fraud claims were not deemd preempted.
The Court relied on the Geier decision.
First, the cases rejecting preemption - McNellis v. Pfizer Inc., 2006 WL 2819041 (D.N.J. Sept. 29, 2006), and others:
In McNellis the Court did not allow the preemption defense. The Court held that the regulations do not conflict with New Jersey's failure-to-warn laws. Recognizing the preamble as "an official agency statement" that favors pre-emption of conflicting state law claims, the court gave no deference to the FDA's interpretation because the agency's position has not been consistent over time, the regulations allow increased warnings when new risks emerge, and the relevant Act does not contain an express preemption clause.
You can find McNellis here:
After McNellis, Perry v. Novartis Pharma. Corp., No. 05-5350 (E.D. Pa. Oct. 16, 2006) was rendered and it also rejected the FDA's argument. The Perry Court found that a state law requirement to provide an additional warning would not create a conflict or make it impossible to comply with state and federal law.
A 2nd Circuit case, Desiano v. Warner-Lambert (2d Cir. Oct. 5, 2006) also did not agree with the FDA's position.
Court Opinion siding with the FDA Preemption argument:
In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, 2006 WL 2374742 (N.D. Cal. Aug. 16, 2006),
In Bextra and Celebrex, the U.S. District Court for the Northern District of California dismissed state law failure-to-warn claims involving a prescription drug because they conflict with the FDA's determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the Food, Drug and Cosmetic Act. The original label for the drug was approved in 1998, was revised in 1999 to add cardiovascular risks, and was later revised in 2005.
In dismissing claims that cardiovascular warnings were not adequate, the Court gave deference to the FDA's interpretation of the reach of the agency's labeling regulations. Note that the Court rules that consumer fraud claims were not deemd preempted.
The Court relied on the Geier decision.
Trasylol (Heart Surgery) News: Link To Kidney Failure
Trasylol (Generic: Aprotinin) is produced by Bayer. It is an injectable drug used to prevent excessive blood loss during heart surgery.
According to reports the drug doubles the risk of kidney failure and stroke and increases the risk of heart failure or heart attack by 55%. It is also linked with encephalopathy (degenerative brain diseases). Researchers announced their findings earlier this year, and the study results were published in the New England Journal of Medicine.
In late September of this year, the FDA held a public advisory committee meeting on to address the safety profile for Trasylol.
Also in September, Bayer informed the FDA that it had completed a study on this drug. The early findings from this study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.
October was not kind to Bayer and Trasylol. In October, Bayer suspended two senior employees over the company's failure to provide U.S. regulators with data on its heart-surgery drug Trasylol. Bayer also said it had hired an independent counsel to investigate its actions regarding the disclosure of the preliminary results from the Trasylol study. Source here.
FDA officials apparently contacted Bayer about making changes to the label, and also about developing a possible blood test to screen patients for adverse reactions.
Doctors currently are advised to give a small test dose to patients first, but FDA staff have said the tests do not always work and can also be fatal.
According to reports the drug doubles the risk of kidney failure and stroke and increases the risk of heart failure or heart attack by 55%. It is also linked with encephalopathy (degenerative brain diseases). Researchers announced their findings earlier this year, and the study results were published in the New England Journal of Medicine.
In late September of this year, the FDA held a public advisory committee meeting on to address the safety profile for Trasylol.
Also in September, Bayer informed the FDA that it had completed a study on this drug. The early findings from this study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.
October was not kind to Bayer and Trasylol. In October, Bayer suspended two senior employees over the company's failure to provide U.S. regulators with data on its heart-surgery drug Trasylol. Bayer also said it had hired an independent counsel to investigate its actions regarding the disclosure of the preliminary results from the Trasylol study. Source here.
FDA officials apparently contacted Bayer about making changes to the label, and also about developing a possible blood test to screen patients for adverse reactions.
Doctors currently are advised to give a small test dose to patients first, but FDA staff have said the tests do not always work and can also be fatal.
Election Day: What A Candidate Should Not Do
I have always subscribed to an adage (which some say is a tad corny) coined by Coach Don Shula years ago: "When you win, you can't always tell if you have done too much; when you lose you can always tell you've done too little." I apply it to my work ethic in all aspects of my office: Convincing a potential client to allow my firm to work for her, preparing for a deposition, getting ready for trial. From sports to family.
I have seen many candidates try to do too much in their campaigns, only to end up doing too little.
One candidate for Indiana's Ninth congressional district (source thanks to Crescat Sententia) started a blog in May 7, 2006 with one post, and did too little over the course of his campaign with it. He never paid attention to it after one post. It just sits there on the web, like a business card kept in a wallet. One comment was apparently written by a person named "dick in the dirt."
So future candidates, don't put up a blog and let it wither away. To make matters worse, now it's crosslinked on another blog - comments and all - as an example of not following through.
I have seen many candidates try to do too much in their campaigns, only to end up doing too little.
One candidate for Indiana's Ninth congressional district (source thanks to Crescat Sententia) started a blog in May 7, 2006 with one post, and did too little over the course of his campaign with it. He never paid attention to it after one post. It just sits there on the web, like a business card kept in a wallet. One comment was apparently written by a person named "dick in the dirt."
So future candidates, don't put up a blog and let it wither away. To make matters worse, now it's crosslinked on another blog - comments and all - as an example of not following through.
Monday, November 06, 2006
Ortho Evra (Contraceptive Patch): More Lawsuits Filed
Two lawsuits were filed in San Francisco regardnig the Ortho Evra patch. You can find them listed as Bracken-Hodge v. Ortho-McNeil, 06-457523; and Abel v. Ortho McNeil, 06-457524. In all more than forty women sued the makers of a popular birth-control patch alleging the contraceptive caused serious illnesses and at least one death.
In September, the FDA warned women that their risk of blood clots in the legs and lungs may be higher if they use the Ortho Evra birth-control patch instead of the pill.
The product label was updated to reflect the results of one study that found women using the patch faced twice the risk of clots than did women on the pill. A second study, however, found no difference in risk between the two forms of birth control.
For source go here.
In September, the FDA warned women that their risk of blood clots in the legs and lungs may be higher if they use the Ortho Evra birth-control patch instead of the pill.
The product label was updated to reflect the results of one study that found women using the patch faced twice the risk of clots than did women on the pill. A second study, however, found no difference in risk between the two forms of birth control.
For source go here.
Wednesday, November 01, 2006
Judicial Elections: A Disgrace
I've been in several states where there are hotly contested elections for judge or justice. I can tell you that I am sick of the attacks. Shameful. Disgraceful. An attack on the very fabric of our justice system.
In one Florida community there is an ongoing battle for a County Court position. The jurisdiction of county courts extends to civil disputes involving $15,000 or less.
The majority of non-jury trials in Florida take place before one judge sitting as a judge of the county court. The county courts are sometimes referred to as "the people's courts," probably because a large part of the courts' work involves voluminous citizen disputes, such as traffic offenses, less serious criminal matters (misdemeanors), and relatively small monetary disputes.
In the relatively small potatoes court the level of name calling and sniping literally took my breath away. I witnessed a shouting match between supporters of each candidate. I have heard that one candidate has trashed the moral reputation of one lawyer who dared oppose that candidate. The lawyer caught in the crossfire handles six and seven figure cases so the likelihood that he will ever appear before who gets elected is almost zero.
In Georgia, there is a spot running that has been called the most brutal ad ever produced. The opponent had a staffer tell him not to refer to his opponent as a "one legged Jew."
In Virginia a law student is physically tackled for asking a hard question of a senate candidate.
For shame. No solution in sight. Judicial appointments will not work.
In one Florida community there is an ongoing battle for a County Court position. The jurisdiction of county courts extends to civil disputes involving $15,000 or less.
The majority of non-jury trials in Florida take place before one judge sitting as a judge of the county court. The county courts are sometimes referred to as "the people's courts," probably because a large part of the courts' work involves voluminous citizen disputes, such as traffic offenses, less serious criminal matters (misdemeanors), and relatively small monetary disputes.
In the relatively small potatoes court the level of name calling and sniping literally took my breath away. I witnessed a shouting match between supporters of each candidate. I have heard that one candidate has trashed the moral reputation of one lawyer who dared oppose that candidate. The lawyer caught in the crossfire handles six and seven figure cases so the likelihood that he will ever appear before who gets elected is almost zero.
In Georgia, there is a spot running that has been called the most brutal ad ever produced. The opponent had a staffer tell him not to refer to his opponent as a "one legged Jew."
In Virginia a law student is physically tackled for asking a hard question of a senate candidate.
For shame. No solution in sight. Judicial appointments will not work.
Subscribe to:
Posts (Atom)