From various sources including the internet, newspapers, and fellow attorneys:
Judge Higbee in a New Jersey State Court action granted a Merck Motion for Summary Judgment in a case where a Texas man claimed that the drug caused stomach pain and internal bleeding. The Plaintiff was Edgar Lee Boyd.
Judge Higbee's Order said in part: "Plaintiff has not presented sufficient evidence that defendant's failure to warn was the proximate cause of his gastrointestinal injuries." She also wrote that "No reasonable jury could find that a different warning regarding gastrointestinal risks would have made a difference."
My comment: She is right in my opinion. The bigger question here is why was the case filed when the injury is stomach pain and internal bleeding? Perhaps it was because the Statute of Limitations was a concern? Did counsel hold the case too long? Why was this case ever filed?
Tuesday, January 31, 2006
Monday, January 30, 2006
Enron Trial Blog
http://blogs.chron.com/enrontrialwatch/ Is the blog where they claim you can find daily updates.
Let's see what happens to these [alleged] crooks.
Let's see what happens to these [alleged] crooks.
Warfarin (Drug used to Reduce Clotting) Warning
The long-term use of warfarin a drug often prescribed to reduce blood clot risk, now allegedly may increase the risk of fractures associated with osteoporosis, a bone-thinning condition that usually increased with age.
For more information, go here.
For more information, go here.
Informal Gag Order in MDL Court?
Late last week, the attorneys in the next trial before Judge Fallon met regarding the 2/6/06 trial. During the first go 'round in the case set to be retried - during deliberations - the New England Journal of Medicine published an editorial saying that a study which has been a major focus of both federal and state trials had downplayed the drug's possible dangers.
What is the informal Order? It may be more of an 'understanding' that Fallon wants comments limited. Why? Perhaps because of the problems in the case? Stay tuned.
What is the informal Order? It may be more of an 'understanding' that Fallon wants comments limited. Why? Perhaps because of the problems in the case? Stay tuned.
Thursday, January 26, 2006
MDL for Ortho Evra Birth Control Patch?
Yesterday in Orlando Judges heard argument regarding an MDL for Ortho Evra. Johnson and Johnson appears to agree to an MDL, but the location may be the issue. Several Plaintiffs' attorneys asked that the MDL be sent to New Jersey.
The FDA on November 10, 2005 informed the public that an updated new label for the patch was to include information its use of higher levels of estrogen.
Females who use Ortho Evra are exposed to 60 percent more estrogen than those who use the pill, according to the FDA.
The FDA received 21 reports of blood clots and other serious injury allegedly linked to use of the patch. The patch has been linked to the deaths of at least seventeen young American women over the past two years.
The FDA on November 10, 2005 informed the public that an updated new label for the patch was to include information its use of higher levels of estrogen.
Females who use Ortho Evra are exposed to 60 percent more estrogen than those who use the pill, according to the FDA.
The FDA received 21 reports of blood clots and other serious injury allegedly linked to use of the patch. The patch has been linked to the deaths of at least seventeen young American women over the past two years.
Elidel & Protopic (Eczema Drugs) Black Box Warnings Added
The Federal Drug Administration (FDA) announced updated labeling for two topical eczema drugs, Protopic Ointment (tacrolimus) and Elidel Cream (pimecrolimus), each made by Novartis.
There will be a black box warning about a possible cancer risk. The boxed warning lets healthcare professionals know that the long term safety of the drugs is yet to be established. What is new? The updated label will say that each drug is to be used as secondary treatment used only after other prescription topical medicines have been tried.
The possible cancer link was first broached in a February 2005 FDA meeting.
For more information, check out the FDA information by going here.
There will be a black box warning about a possible cancer risk. The boxed warning lets healthcare professionals know that the long term safety of the drugs is yet to be established. What is new? The updated label will say that each drug is to be used as secondary treatment used only after other prescription topical medicines have been tried.
The possible cancer link was first broached in a February 2005 FDA meeting.
For more information, check out the FDA information by going here.
Trasylol (A Drug given before bypass surgery) Warnings Issued
From various sources, including Yahoo, the WSJ and newspapers all over the country:
Trasylol - a drug made by Bayer - that has been provided to heart surgery patients so as to limit or even prevent blood loss doubles kidney failure and stroke risks according to the NEJM.
The drug also increases the chance of heart failure or heart attack by 55 percent.
The drug study involved more than 4,000 patients who were facing heart surgery at 69 medical centers around the world.
Trasylol - a drug made by Bayer - that has been provided to heart surgery patients so as to limit or even prevent blood loss doubles kidney failure and stroke risks according to the NEJM.
The drug also increases the chance of heart failure or heart attack by 55 percent.
The drug study involved more than 4,000 patients who were facing heart surgery at 69 medical centers around the world.
Monday, January 23, 2006
I'm riding in a Mardi Gras Parade - You Can Too*
* Provided that you are a trial attorney, and pony up a little $$$.
I'm a member of the Southern Trial Lawyers Association, and each year the STLA seminar is held in New Orleans. I was going to pass on this one. I love the city and hated to go back in its current condition. After much cajoling, I am going - and the cool thing is that if you attend, you can ride in with the Krewe of Tucks on February 25, 2006. You find info on the Krewe here. I plan to "throw" till my AC joint needs surgical repair. I've never done that before, so it will be an item I get to cross off of my life list.
I have been trying to figure out if there is an etiquette to the throwing, and thanks to a poster on one of many sites I have visited, I have to say this covers it:
I throw to anyone in a wheelchair
I throw to and thank every policeman I can for protecting us and doing their often thankless job.
I always throw to anyone with a smile who looks me in the eye
I try to hit all of the creative signs
I throw footballs and frisbees to the "bored" 13-17 year old boys who stand in the back, got dragged by parents to parade, and really want to be there, but it is not cool to stand in front and yell - they have a blast chasing the deep throws.....love those ellipese.....dont you....?
I throw to the kids on ladders and seniors in lawn chairs
I look for people who don't have their hands up, make eye contact and throw to them.
I look for people who aren't thrown to usually
I look for mothers and their babies
I throw to people in windows and on porches along the route.
I'm a member of the Southern Trial Lawyers Association, and each year the STLA seminar is held in New Orleans. I was going to pass on this one. I love the city and hated to go back in its current condition. After much cajoling, I am going - and the cool thing is that if you attend, you can ride in with the Krewe of Tucks on February 25, 2006. You find info on the Krewe here. I plan to "throw" till my AC joint needs surgical repair. I've never done that before, so it will be an item I get to cross off of my life list.
I have been trying to figure out if there is an etiquette to the throwing, and thanks to a poster on one of many sites I have visited, I have to say this covers it:
I throw to anyone in a wheelchair
I throw to and thank every policeman I can for protecting us and doing their often thankless job.
I always throw to anyone with a smile who looks me in the eye
I try to hit all of the creative signs
I throw footballs and frisbees to the "bored" 13-17 year old boys who stand in the back, got dragged by parents to parade, and really want to be there, but it is not cool to stand in front and yell - they have a blast chasing the deep throws.....love those ellipese.....dont you....?
I throw to the kids on ladders and seniors in lawn chairs
I look for people who don't have their hands up, make eye contact and throw to them.
I look for people who aren't thrown to usually
I look for mothers and their babies
I throw to people in windows and on porches along the route.
Georgia Lawyer Ad Uses The Word "Shit" Live on the Air
Well, sort of - A radio ad read "live" in English had a Spanish word for that term used by the reader of the ad ... .
Once again I launch a tirade/rant about lawyers who buy live spots on radio. Don't do it.
I have written on here several times about how an attorney should never pay for a "live" spot on radio, a spot that is typically a lead in to traffic, news, or headlines. If the short (10 or 15 seconds) spot is recorded, the attorney has total control over content, language and words used, and inflection.
While on the road late last week, and again today, an attorney decided to pay a station for a spot that was run live. What did I hear? A fill in host on drive time A.M. station said this" "Well, looks like this [traffic] report is brought to you by [Georgia] Lawyer [XX XX] ... "if your car is a piece of CACA," call [XX XX] and he'll sue the pants off the guy that sold it to you ... " Surely the host ad libbed.
Niiiice. I am sure the attorney wanted that said. I'm Hispanic and growing up in my house, using the word "caca" meant shit. This city has many hispanic residents and I can bet some were as taken aback as I was in hearing "shit" used live on the air. Now some may use that word as a children's word for "poop" but ...
Not certain if perhaps that was something unique to our family, on Google I found this as to "caca":
[M]eans `shit' in various European languages (particularly Romance languages; sometimes, given the form, a children's word). Go here.
So now a lawyer's message is: Call me if your car is a piece of shit, and I will sue the bastards. I am pretty certain that is NOT the message he sought to convey.
Once again I launch a tirade/rant about lawyers who buy live spots on radio. Don't do it.
I have written on here several times about how an attorney should never pay for a "live" spot on radio, a spot that is typically a lead in to traffic, news, or headlines. If the short (10 or 15 seconds) spot is recorded, the attorney has total control over content, language and words used, and inflection.
While on the road late last week, and again today, an attorney decided to pay a station for a spot that was run live. What did I hear? A fill in host on drive time A.M. station said this" "Well, looks like this [traffic] report is brought to you by [Georgia] Lawyer [XX XX] ... "if your car is a piece of CACA," call [XX XX] and he'll sue the pants off the guy that sold it to you ... " Surely the host ad libbed.
Niiiice. I am sure the attorney wanted that said. I'm Hispanic and growing up in my house, using the word "caca" meant shit. This city has many hispanic residents and I can bet some were as taken aback as I was in hearing "shit" used live on the air. Now some may use that word as a children's word for "poop" but ...
Not certain if perhaps that was something unique to our family, on Google I found this as to "caca":
[M]eans `shit' in various European languages (particularly Romance languages; sometimes, given the form, a children's word). Go here.
So now a lawyer's message is: Call me if your car is a piece of shit, and I will sue the bastards. I am pretty certain that is NOT the message he sought to convey.
Friday, January 20, 2006
FDA tries to Limit Drug Lawsuits in State Courts
From everywhere:
People who believe they were injured by drugs approved by the Food and Drug Administration should not be allowed to sue drug companies in state courts the FDA said.
The FDA's claim of "federal preemption" was included as a preamble to guidelines designed to make drug labeling information more accessible and readable for doctors and consumers. Agency officials said that though the preemption policy does not have the weight of law or formal regulation, they hope state judges will accept their position.
The new labeling rules now make drugmakers highlight the most important advisory information in the "package insert" or each drug. The FDA was told by drug company execs and later convinced that they deserved more broadly stated FDA support because the new labeling would make them more vulnerable to lawsuits. Obviously, attorneys and also state lawmakes said it's a bad idea.
There have already been court decisions regarding the FDA and preemption. On Minnesota, James Rosenbaum overturned FDA-supported pre-emption arguments in a 2005.
In McKay v. Pfizer, the Court addressed Pfizer's alleged failure to warn about the suicide risk on the label of its antidepressant, Zoloft.
The Court rejected the re-emption defense in cases involving wrongful deaths due to manufacturers' failure to warn about lethal drug side-effects, such as suicide linked to their drugs.
The Court actually called the pre-emption argument made by the FDA "perverse."
The Judge wrote that State consumer-protection law compliments sytem.
More later.
People who believe they were injured by drugs approved by the Food and Drug Administration should not be allowed to sue drug companies in state courts the FDA said.
The FDA's claim of "federal preemption" was included as a preamble to guidelines designed to make drug labeling information more accessible and readable for doctors and consumers. Agency officials said that though the preemption policy does not have the weight of law or formal regulation, they hope state judges will accept their position.
The new labeling rules now make drugmakers highlight the most important advisory information in the "package insert" or each drug. The FDA was told by drug company execs and later convinced that they deserved more broadly stated FDA support because the new labeling would make them more vulnerable to lawsuits. Obviously, attorneys and also state lawmakes said it's a bad idea.
There have already been court decisions regarding the FDA and preemption. On Minnesota, James Rosenbaum overturned FDA-supported pre-emption arguments in a 2005.
In McKay v. Pfizer, the Court addressed Pfizer's alleged failure to warn about the suicide risk on the label of its antidepressant, Zoloft.
The Court rejected the re-emption defense in cases involving wrongful deaths due to manufacturers' failure to warn about lethal drug side-effects, such as suicide linked to their drugs.
The Court actually called the pre-emption argument made by the FDA "perverse."
The Judge wrote that State consumer-protection law compliments sytem.
More later.
Thursday, January 19, 2006
NE Journal of Medicine Authors to be deposed in Vioxx litigation
Two editors of the New England Journal of Medicine will give deposition testimony week by the company's lawyers. The depositions will be held next Tuesday and Wednesday.
After the NEJM's editorial was reported the attorneys for Merck subpoenaed multiple NEJM editors and sought information on its peer reviewers. The editors subpoenaed include editor in chief Dr. Jeffrey M. Drazen and executive editor Dr. Gregory D. Curfman.
Judge Eldon Fallon of New Orleans of the MDL this week ruled that Merck can depose Curfman but not Drazen. Merkc asked for additonal information but Fallon said no - Merck's sought to get information on the identities of many of the journal's peer reviewers.
My comment: The testimony won't help Merck, and while it helps for Merck to assess how damagaing it may be should any of the information reach a jury, the PR damage that will be wrought will be signficicant for the days after the deposition transcripts are released.
After the NEJM's editorial was reported the attorneys for Merck subpoenaed multiple NEJM editors and sought information on its peer reviewers. The editors subpoenaed include editor in chief Dr. Jeffrey M. Drazen and executive editor Dr. Gregory D. Curfman.
Judge Eldon Fallon of New Orleans of the MDL this week ruled that Merck can depose Curfman but not Drazen. Merkc asked for additonal information but Fallon said no - Merck's sought to get information on the identities of many of the journal's peer reviewers.
My comment: The testimony won't help Merck, and while it helps for Merck to assess how damagaing it may be should any of the information reach a jury, the PR damage that will be wrought will be signficicant for the days after the deposition transcripts are released.
Tuesday, January 17, 2006
Vioxx: Lining up the trials before Judge Fallon
After the Irvin case is heard in early February of 2006, the next cases involve:
New Orleans resident Ellis Diaz, whose claim is considered a medium-term use case. The trial is set for March 13, 2006.
In April, Judge Fallon will hear a Vioxx case involving long-term use, the claim of Charles Borowicz. Counsel agreed that Borowicz' case will be refiled as a federal case and heard in April in New Orleans.
New Orleans resident Ellis Diaz, whose claim is considered a medium-term use case. The trial is set for March 13, 2006.
In April, Judge Fallon will hear a Vioxx case involving long-term use, the claim of Charles Borowicz. Counsel agreed that Borowicz' case will be refiled as a federal case and heard in April in New Orleans.
FDA Warning Re: Dietary Supplements
The U.S. Food and Drug Administration (FDA) has warned consumers to avoid to products that marketed as dietary supplements. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill and Herbathin Dietary Supplement may contain several active ingredients, including controlled substances, found in prescription drugs that could lead to serious side effects or injury.
The supplements are made in Brazil by Fitoterapicos (also spelled Fytoterapicos) and Phytotherm Sim. The information indicates that may contain chlordiazepoxide HCl (the active ingredient in Librium) and fluoxetine HCl (the active ingredient in Prozac). Chlordiazepoxide HCl (Librium) is used to relieve anxiety and to control the symptoms of alcohol withdrawal. It may be habit forming, and can cause drowsiness and dizziness and impair the ability to drive. Fluoxetine HCl (Prozac) is an anti-depressant medication used to treat obsessive-compulsive disorder, panic disorder, and bulimia.
For more information, go here (most of which was used in this post).
The supplements are made in Brazil by Fitoterapicos (also spelled Fytoterapicos) and Phytotherm Sim. The information indicates that may contain chlordiazepoxide HCl (the active ingredient in Librium) and fluoxetine HCl (the active ingredient in Prozac). Chlordiazepoxide HCl (Librium) is used to relieve anxiety and to control the symptoms of alcohol withdrawal. It may be habit forming, and can cause drowsiness and dizziness and impair the ability to drive. Fluoxetine HCl (Prozac) is an anti-depressant medication used to treat obsessive-compulsive disorder, panic disorder, and bulimia.
For more information, go here (most of which was used in this post).
Monday, January 16, 2006
An Invitation to Trial Attorneys in the South
More precisely, 13 states - AL, GA, FL, NC, SC, VA, TN, KY, AR, MS, WVA, LA and TX ...
If you're a Trial Attorney who does not defend insurance companies, there is a seminar and Trial Lawyer Association that has a worthwhile seminar each February. It's the Southern Trial Lawyers Association, whose website can be found here.
STLA's Mission: The essential mission of the Southern Trial Lawyers Association is as simple as it is straightforward: To promote fellowship, learning, and networking among trial lawyers throughout the 13 southern states. We do not engage in political activity or fundraising of any kind, leaving those worthwhile activities to the state trial lawyer associations and to ATLA.
The Conference: The annual conference takes place in New Orleans the weekend preceding Mardi Gras day (Fat Tuesday). February 22 through 26, 2006 in New Orleans. The food is wonderful. The music and sights are excellent. On Saturday Night STLA has a party with live music and a Hotel balcony over looking, Endymnion, the best parade Mardi Gras has to offer.
The speakers: You can find more information here (in PDF Format) - trial attorneys with proven results on the agenda.
If you'd like to know more, email me.
Why New Orleans? That is where the STLA had its roots. I know that some of you may have questions about the city and how it is holding up. I will report back the first week of February, on the scene from the Vioxx Trial.
If you're a Trial Attorney who does not defend insurance companies, there is a seminar and Trial Lawyer Association that has a worthwhile seminar each February. It's the Southern Trial Lawyers Association, whose website can be found here.
STLA's Mission: The essential mission of the Southern Trial Lawyers Association is as simple as it is straightforward: To promote fellowship, learning, and networking among trial lawyers throughout the 13 southern states. We do not engage in political activity or fundraising of any kind, leaving those worthwhile activities to the state trial lawyer associations and to ATLA.
The Conference: The annual conference takes place in New Orleans the weekend preceding Mardi Gras day (Fat Tuesday). February 22 through 26, 2006 in New Orleans. The food is wonderful. The music and sights are excellent. On Saturday Night STLA has a party with live music and a Hotel balcony over looking, Endymnion, the best parade Mardi Gras has to offer.
The speakers: You can find more information here (in PDF Format) - trial attorneys with proven results on the agenda.
If you'd like to know more, email me.
Why New Orleans? That is where the STLA had its roots. I know that some of you may have questions about the city and how it is holding up. I will report back the first week of February, on the scene from the Vioxx Trial.
Saturday, January 14, 2006
More bad news for Serevent?
From various sources, including Reuters:
Serevent, a widely prescribed inhaled asthma treatment, may pose a special risk to blacks.
Newly released details from a safety trial that was stopped early reveal that respiratory-related deaths or life-threatening events occurred four times as often among blacks who took Serevent than among blacks who did not take the drug.
There was no significant difference in deaths or serious adverse outcomes among whites who did and did not take the asthma drug, which is manufactured by GlaxoSmithKline, a WebMD sponsor.
The findings, first reported to the U.S. Food and Drug Administration in 2003, led the regulatory agency to require a black-box warning on the labeling for Serevent and the similar GlaxoSmithKline asthma drug Advair.
The warning notes that use of the drug in the study led to a "small but significant increase in asthma-related deaths." A separate box also states, "Data from this study further suggests that the risk might be greater in African-American patients."
Thirteen deaths occurred among 13,176 study participants treated with Serevent for 28 weeks, compared with three deaths among 13, 179 participants who did not take the drug.
Seven of the 13 deaths in the Serevent arm of the study involved blacks, even though blacks made up just 18% of the total study population.
Serevent, a widely prescribed inhaled asthma treatment, may pose a special risk to blacks.
Newly released details from a safety trial that was stopped early reveal that respiratory-related deaths or life-threatening events occurred four times as often among blacks who took Serevent than among blacks who did not take the drug.
There was no significant difference in deaths or serious adverse outcomes among whites who did and did not take the asthma drug, which is manufactured by GlaxoSmithKline, a WebMD sponsor.
The findings, first reported to the U.S. Food and Drug Administration in 2003, led the regulatory agency to require a black-box warning on the labeling for Serevent and the similar GlaxoSmithKline asthma drug Advair.
The warning notes that use of the drug in the study led to a "small but significant increase in asthma-related deaths." A separate box also states, "Data from this study further suggests that the risk might be greater in African-American patients."
Thirteen deaths occurred among 13,176 study participants treated with Serevent for 28 weeks, compared with three deaths among 13, 179 participants who did not take the drug.
Seven of the 13 deaths in the Serevent arm of the study involved blacks, even though blacks made up just 18% of the total study population.
I'll be on the air this weekend - FL Radio
I am a guest of attorney Eddie Farah on his show, "The Consumer Law Hour" on WVOJ. You can find the station at wokv.com. The show begins at 1PM and is archived.
Farah's show is the #1 rated weekend show in Jacksonville, Florida.
Farah's show is the #1 rated weekend show in Jacksonville, Florida.
Thursday, January 12, 2006
Merck Press Release on Vioxx Trial - Garza
Says in part:
"There is no reliable scientific evidence that VIOXX caused Mr. Garza's heart attack," said Ted Mayer of Hughes Hubbard & Reed, outside counsel for Merck. "At the time of Mr. Garza's heart attack, he exhibited numerous major risk factors for coronary artery disease. His autopsy report lists acute myocardial infarction as the cause of his death and notes evidence of severe atherosclerotic disease in all of Mr. Garza's coronary arteries. We are confident that any fair jury will find that VIOXX had nothing to do with the unfortunate passing of Mr. Garza since there is no reliable scientific evidence that short-term use of VIOXX increases cardiovascular risk."
want to read more? Go here.
"There is no reliable scientific evidence that VIOXX caused Mr. Garza's heart attack," said Ted Mayer of Hughes Hubbard & Reed, outside counsel for Merck. "At the time of Mr. Garza's heart attack, he exhibited numerous major risk factors for coronary artery disease. His autopsy report lists acute myocardial infarction as the cause of his death and notes evidence of severe atherosclerotic disease in all of Mr. Garza's coronary arteries. We are confident that any fair jury will find that VIOXX had nothing to do with the unfortunate passing of Mr. Garza since there is no reliable scientific evidence that short-term use of VIOXX increases cardiovascular risk."
want to read more? Go here.
Why is the Garza Vioxx case being tried to jury????
The next case to be tried on Vioxx is the Garza case, a Texas State Court case. Earlier this week I noted that the case involved a gentleman who was 71 years of age when he took Vioxx, took the drug for a month or so, then had a heart attack and died.
The first issue to me is that this gentleman took the drug for one month. Vioxx admits that after eighteen months of ingestion risks of an adverse event may increase. I can't belive that the firm handling the case has this as its best case.
Today we know this:
Leonel Garza Sr., died of a heart attack on April 21, 2001.
Merck in a Press Release (found all over the Net)said, "Approximately one month before his death, Mr. Garza was given a one-week supply of Vioxx 25 milligram samples for arm pain," Merck said in a release.
Merck also tells any who will listen that Garza had a 23-year history of cardiovascular disease and had suffered a prior heart attack (But they didn't say when).
So why is this case the third case in line? If this is true, and there surely will be more facts before it plays out to a jury ... expect a W for Merck?
The first issue to me is that this gentleman took the drug for one month. Vioxx admits that after eighteen months of ingestion risks of an adverse event may increase. I can't belive that the firm handling the case has this as its best case.
Today we know this:
Leonel Garza Sr., died of a heart attack on April 21, 2001.
Merck in a Press Release (found all over the Net)said, "Approximately one month before his death, Mr. Garza was given a one-week supply of Vioxx 25 milligram samples for arm pain," Merck said in a release.
Merck also tells any who will listen that Garza had a 23-year history of cardiovascular disease and had suffered a prior heart attack (But they didn't say when).
So why is this case the third case in line? If this is true, and there surely will be more facts before it plays out to a jury ... expect a W for Merck?
Tuesday, January 10, 2006
ADHD Drugs: Storm brewing? FDA involvement?
There have been reports of deaths, strokes, heart attacks and hypertension in children and adults who take drugs to treat ADHD disorders, and this has led to our trusted government's desire to dig deeper.
The FDA's reps have said it had received reports of "adverse events" -- including deaths -- when the drugs are used.
Health Canada pulled Adderall XR for six months in 2005 after they received reports of 20 sudden deaths and 12 strokes in adults and children using the drug. A number of the cases involved children with structural heart defects. (Health Canada site, here)
Now the FDA wants its Drug Safety and Risk Management advisory committee to look at how it may study cardiovascular risks of the drugs. Longer-term use of ADHD drugs provide little information on those risks that may exist.
Dr. Peter Gross is a committee chairman who has been quoted as comparing this potential problem to the issues revolving around Cox-2 painkillers like Vioxx and Bextra pulled from the market because of evidence they can raise the risk of a heart attack or stroke. The committee is to meet Feb. 9 and 10 in Gaithersburg, Md. (See various reports, including Yahoo reports and Reuters).
The FDA web site doesn't list the drugs by name. Popular ADHD drugs include Adderall XR and Ritalin.
My comment: I found this on the Reuters site to counter the concerns:
Drugs to treat attention deficit hyperactivity disorder (ADHD) are generally safe, some doctors said on Thursday after U.S. health officials announced a meeting to discuss possible heart risks.
"It's not a big deal for patients without a cardiac history," Dr. Adelaide Robb, a psychiatrist at Children's National Medical Center in Washington, told Reuters.
Stay tuned.
The FDA's reps have said it had received reports of "adverse events" -- including deaths -- when the drugs are used.
Health Canada pulled Adderall XR for six months in 2005 after they received reports of 20 sudden deaths and 12 strokes in adults and children using the drug. A number of the cases involved children with structural heart defects. (Health Canada site, here)
Now the FDA wants its Drug Safety and Risk Management advisory committee to look at how it may study cardiovascular risks of the drugs. Longer-term use of ADHD drugs provide little information on those risks that may exist.
Dr. Peter Gross is a committee chairman who has been quoted as comparing this potential problem to the issues revolving around Cox-2 painkillers like Vioxx and Bextra pulled from the market because of evidence they can raise the risk of a heart attack or stroke. The committee is to meet Feb. 9 and 10 in Gaithersburg, Md. (See various reports, including Yahoo reports and Reuters).
The FDA web site doesn't list the drugs by name. Popular ADHD drugs include Adderall XR and Ritalin.
My comment: I found this on the Reuters site to counter the concerns:
Drugs to treat attention deficit hyperactivity disorder (ADHD) are generally safe, some doctors said on Thursday after U.S. health officials announced a meeting to discuss possible heart risks.
"It's not a big deal for patients without a cardiac history," Dr. Adelaide Robb, a psychiatrist at Children's National Medical Center in Washington, told Reuters.
Stay tuned.
Avandia (diabetes drug) Warning Regarding Eye Swelling
There has been a warning from U.S. regulators diabetes drug Avandia to a few instance of swelling in the back of the eye as of last week.
The FDA issued a notice last week after GSK said it had received "very rare" reports of the swelling (macular oedema).
The warning also applies to Avandamet, a combination product (with the same active ingredient).
- From the FDA web site.
The FDA issued a notice last week after GSK said it had received "very rare" reports of the swelling (macular oedema).
The warning also applies to Avandamet, a combination product (with the same active ingredient).
- From the FDA web site.
Monday, January 09, 2006
Disclaimer
1. Disclaimer
The hiring of a lawyer is an important decision that should not be based solely upon advertisements. This blog site is not intended to be an advertisement or solicitation. Material contained is for general information only and does not constitute legal advice or solicitation of legal services. Transmission of information from this site is not intended to create, and its receipt does not constitute, an attorney-client relationship between me and the reader. In the event that any information on this Web site does not conform fully with regulations in any jurisdiction, this law firm will not accept representation based on that information.
The hiring of a lawyer is an important decision that should not be based solely upon advertisements. This blog site is not intended to be an advertisement or solicitation. Material contained is for general information only and does not constitute legal advice or solicitation of legal services. Transmission of information from this site is not intended to create, and its receipt does not constitute, an attorney-client relationship between me and the reader. In the event that any information on this Web site does not conform fully with regulations in any jurisdiction, this law firm will not accept representation based on that information.
Friday, January 06, 2006
Vioxx: MDL Judge Fallon Frustrated
This week Judge Fallon has commented that he may stop (before he has even begun in earnest) trying any cases in New Orleans. During this week's monthly hearing Fallon
said he may ``shut down'' the consolidation if all the cases are being tried in state court before we get one tried in federal court.'
Fallon had said before Katrina struck that he wanted to try some Vioxx claims before starting settlement talks. By my count, at least six Vioxx suits are set for trial in state courts in New Jersey, Texas, Florida and California.
How to try them? The Judge commented from the bench that witnesses could not be located, lawyers were not available, and records and doctors could not be located. That is to say nothing of seating a jury in NOLA.
What will happen? IMHO they either get sent back to the state where the suit was filed (and tried in USDCT there), the MDL is moved permanently elsewhere, it is kept there but Judge Fallon sits by designation in other states (not likely), or the MDL is dismantled (not likely). Would the PSC and Merck Counsel agree to some sort of abeyance? With the two (2) year anniversary of the market withdrawal coming up, the closer that date is, the better idea Merck will have (in 2 year SOL states) how many claims are out there. My best guess is that the another trial will be held in NOLA but it may have to be set closer to late summer.
Merck should want them in one place, but given the strategy so far, the company may wish to have them splintered off, and it will result the death of the company by a thousand cuts.
said he may ``shut down'' the consolidation if all the cases are being tried in state court before we get one tried in federal court.'
Fallon had said before Katrina struck that he wanted to try some Vioxx claims before starting settlement talks. By my count, at least six Vioxx suits are set for trial in state courts in New Jersey, Texas, Florida and California.
How to try them? The Judge commented from the bench that witnesses could not be located, lawyers were not available, and records and doctors could not be located. That is to say nothing of seating a jury in NOLA.
What will happen? IMHO they either get sent back to the state where the suit was filed (and tried in USDCT there), the MDL is moved permanently elsewhere, it is kept there but Judge Fallon sits by designation in other states (not likely), or the MDL is dismantled (not likely). Would the PSC and Merck Counsel agree to some sort of abeyance? With the two (2) year anniversary of the market withdrawal coming up, the closer that date is, the better idea Merck will have (in 2 year SOL states) how many claims are out there. My best guess is that the another trial will be held in NOLA but it may have to be set closer to late summer.
Merck should want them in one place, but given the strategy so far, the company may wish to have them splintered off, and it will result the death of the company by a thousand cuts.
Resolutions Part II: It's BLOG not BLAWG (a jargon rant)
I have firmly resolved from the top down in my office to rid it of jargon.
First to go: Blawg. No more emails or comments with it spelled that way. There are enough problems explanining what a web log is to someone over 40 as it is. No need to make it worse. It goes in the bin along with "scaleability" and other tech jarson insider foolishness. Speak english to me.
Second to go: Use of throw away words in pleadings. In Georgia it is common to begin a Complaint this way: "COMES NOW the Plaintiff and for his Complaint prays as follows against the stated Defendant" ... We use "Plaintiff sues Defendant and alleges ... ."
Third to go: "Please do not hesitate to contact the undersigned at your earliest convenience." I have never used it, but team members here let it creep in to form letters they write. We're not paid by the word, and last I checked plain ol' English works just fine - "Call me if you have any questions."
Fourth to go: No more mini Miranda warnings at the bottom of all of emails. You know, the one that mentions that the email is confidential and that you are to destroy it, or send it back, or print it and mail it back at my expense, or print it and make a paper airplane out of it. There's a toggle bar on the email, use it! I asked a friend if he was going to dinner, and in the midst of 1 and 2 word emails, there was the confidential language.
First to go: Blawg. No more emails or comments with it spelled that way. There are enough problems explanining what a web log is to someone over 40 as it is. No need to make it worse. It goes in the bin along with "scaleability" and other tech jarson insider foolishness. Speak english to me.
Second to go: Use of throw away words in pleadings. In Georgia it is common to begin a Complaint this way: "COMES NOW the Plaintiff and for his Complaint prays as follows against the stated Defendant" ... We use "Plaintiff sues Defendant and alleges ... ."
Third to go: "Please do not hesitate to contact the undersigned at your earliest convenience." I have never used it, but team members here let it creep in to form letters they write. We're not paid by the word, and last I checked plain ol' English works just fine - "Call me if you have any questions."
Fourth to go: No more mini Miranda warnings at the bottom of all of emails. You know, the one that mentions that the email is confidential and that you are to destroy it, or send it back, or print it and mail it back at my expense, or print it and make a paper airplane out of it. There's a toggle bar on the email, use it! I asked a friend if he was going to dinner, and in the midst of 1 and 2 word emails, there was the confidential language.
Thursday, January 05, 2006
2006 Resolutions?
I always make them both as to personal and as to business. Here is my business list, are any of these yours?
1. Revisit office form letters: Our office handles a number of cases where certain letters are simply not redone each case. It's worth it to review the key ones although I have undertaken reviewing nearly all of them. In particular, my letter of representation (LOR) is worth a second look, and I have had to unfortunately make one change - I have added a line that states "Unless or until you have received from this office a written notice that the Firm is no longer working for [client name], do not contact [client name] under any circumstances. Also, our letter to a health insurance company regarding any claim of reimbursement can evolve considering the litigation surrounding this issue.
2.Analyze your tech needs and wants: After more years than I care to admit, I finally was able to decide on a flat screen monitor. I added another product to carry (Sidekick II). We are considering scanning all documents and attaching them to the current database and moving quickly to paperless.
With technology changing, it simply does not make sense to sit back and not analyze. Another attorney, a sole practitioner in his 50's who is on the same floor as our offices visited me yesterday and asked me to convert a Word document to Wordperfect 4.0. Now realize that the product in use by attorneys is WP 12, and that it likely means his software if probably ten or more years old ... . Why not upgrade?
3.Web presence: I recently visited a website of a firm that had a photo and bio of an attorney that had left the firm more than a year ago. I went to our site and found deficiencies. It's addressed and is also being tweaked. It's the little things that matter - having your Firm name, address, contact email and telephone number on each page; having a decent form to fill out with as few required fields as possible (we deleted the "retype your email" line).
4.Staff issues: Mike Papantonio's well written book, In Search of Atticus Finch (you can buy it here)
mentioned a decent problem solving requirement that we implemented now system wide: If there is an issue or problem facing an office team member, it is required that the team member: 1)reduce the problem to a one sentence issue and 2)not come into my office or another employee's office unless that team member has one suggested solution. It works wonders. It ends the practice of an employee walking in and simply handing off a problem.
That's part of my list - what are you resolving to do?
1. Revisit office form letters: Our office handles a number of cases where certain letters are simply not redone each case. It's worth it to review the key ones although I have undertaken reviewing nearly all of them. In particular, my letter of representation (LOR) is worth a second look, and I have had to unfortunately make one change - I have added a line that states "Unless or until you have received from this office a written notice that the Firm is no longer working for [client name], do not contact [client name] under any circumstances. Also, our letter to a health insurance company regarding any claim of reimbursement can evolve considering the litigation surrounding this issue.
2.Analyze your tech needs and wants: After more years than I care to admit, I finally was able to decide on a flat screen monitor. I added another product to carry (Sidekick II). We are considering scanning all documents and attaching them to the current database and moving quickly to paperless.
With technology changing, it simply does not make sense to sit back and not analyze. Another attorney, a sole practitioner in his 50's who is on the same floor as our offices visited me yesterday and asked me to convert a Word document to Wordperfect 4.0. Now realize that the product in use by attorneys is WP 12, and that it likely means his software if probably ten or more years old ... . Why not upgrade?
3.Web presence: I recently visited a website of a firm that had a photo and bio of an attorney that had left the firm more than a year ago. I went to our site and found deficiencies. It's addressed and is also being tweaked. It's the little things that matter - having your Firm name, address, contact email and telephone number on each page; having a decent form to fill out with as few required fields as possible (we deleted the "retype your email" line).
4.Staff issues: Mike Papantonio's well written book, In Search of Atticus Finch (you can buy it here)
mentioned a decent problem solving requirement that we implemented now system wide: If there is an issue or problem facing an office team member, it is required that the team member: 1)reduce the problem to a one sentence issue and 2)not come into my office or another employee's office unless that team member has one suggested solution. It works wonders. It ends the practice of an employee walking in and simply handing off a problem.
That's part of my list - what are you resolving to do?
Tuesday, January 03, 2006
Georgia has a new Pro Hac Admission Process: $200 per case
Georgia has a new Uniform Rule of Superior Court, Rule 4.4 which has been revised and is now effective.
The rule sets forth a detailed process for applying for and obtaining pro hac vice admission in the State Courts of Georgia. A fee of $200 for each application must be paid to the State Bar of Georgia and the State Bar General Counsel's Office has the authority to object to a lawyer's proposed pro hac vice admission.
Go here for the text of the Rule.
My comment: Looks like the State Bar is trying to centralize and watch out of state lawyers who should likely be licensed here. Florida has been battling this demon as well.
The rule sets forth a detailed process for applying for and obtaining pro hac vice admission in the State Courts of Georgia. A fee of $200 for each application must be paid to the State Bar of Georgia and the State Bar General Counsel's Office has the authority to object to a lawyer's proposed pro hac vice admission.
Go here for the text of the Rule.
My comment: Looks like the State Bar is trying to centralize and watch out of state lawyers who should likely be licensed here. Florida has been battling this demon as well.
Accutane Registry Established
From various sites including the FDA's own:
A national registry began accepting names of Americans who take the anti-acne drug Accutane. This is done as part of a federal effort to limit use of the birth-defect-causing drug by pregnant women.
The Food and Drug Administration has tried to limit the exposure of fetuses to the drug, prescribed to about 100,000 people each month. If a woman uses Accutane during pregnancy or becomes pregnant shortly after taking the drug the baby runs a risk of brain and heart defects or mental defects.
The registry is known as iPledge and can be found at https://www.ipledgeprogram.com/
A national registry began accepting names of Americans who take the anti-acne drug Accutane. This is done as part of a federal effort to limit use of the birth-defect-causing drug by pregnant women.
The Food and Drug Administration has tried to limit the exposure of fetuses to the drug, prescribed to about 100,000 people each month. If a woman uses Accutane during pregnancy or becomes pregnant shortly after taking the drug the baby runs a risk of brain and heart defects or mental defects.
The registry is known as iPledge and can be found at https://www.ipledgeprogram.com/
A Maritime Blog - Worth a Look
Dwayne Clark in Jacksonville, Florida has an interesting blog which can be found here.
It's called Lawboat. It has a good set of links to Maritime subjects including the Coast Guard safety site. Worth a read and it's a good addition to your RSS reader.
Thanks Dwayne!
It's called Lawboat. It has a good set of links to Maritime subjects including the Coast Guard safety site. Worth a read and it's a good addition to your RSS reader.
Thanks Dwayne!
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