After receiving complaints about the product, orthopedic manufacturer DePuy has issued a recall of its ASR hip implants. This hip system has a shockingly high rate of failure, and many of the victims of these failures have had to undergo a second, painful surgery to remove and replace the defective hip.
Due to a fairly high percentage (12-13%) of five year revision or secondary hip surgeries DePuy Orthopaedics, Inc. reported based on this year's data from the National Joint Registry (NJR) of England and Wales, the manufacturer announced this week it is voluntarily pulling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System from the marketplace. DePuy has notified the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally of the voluntary recall.
The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices preferred by surgeons for young patients who may benefit from the stability of the device, thus limiting the chance of repeated dislocation. The DePuy ASR™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASR™ XL Acetabular System was first launched in 2004 and has been available worldwide.
The risk for revision was highest with women utilizing ASR head sizes below 50 mm in diameter.
As the numbers suggest, most ASR hip replacement surgeries are successful. However, Depuy is strongly suggesting patients utilizing an ASR device immediately see their implant surgeons for a full evaluation of performance.
Tuesday, August 31, 2010
Prempro Case on Breast Cancer Settles Before Retrial
From Bloomberg:
Pfizer agreed to settle an Arkansas woman’s claims that the company’s Prempro menopause drug caused her breast cancer this week.
There was to be a retrial on October 1st of Donna Scroggin’s claims that the company should pay as punishment for the damage that Prempro, a hormone-replacement medicine, caused. An appeals court overturned a $27.1 million punitive award last year and ordered a new trial on damages.
The company agreed to settle Scroggin’s case, U.S. District Judge William Wilson said in an Aug. 19 court filing.
En Espanol:
Pfizer acordó resolver las demandas de una mujer de Arkansas que las drogas de la empresa la menopausia Prempro le causó el cáncer de mama esta semana.
No iba a haber un nuevo juicio el 1 de octubre de reclamaciones Donna Scroggin de que la empresa debe pagar como castigo por el daño que Prempro, un medicamento de reemplazo hormonal, causado. Un tribunal de apelaciones anuló un laudo 27,100,000 dólar punitiva del año pasado y ordenó un nuevo juicio por daños y perjuicios.
La empresa de acuerdo para resolver el caso de Scroggin, EE.UU. El juez de distrito William Wilson dijo en una presentación 19 de agosto la corte
Pfizer agreed to settle an Arkansas woman’s claims that the company’s Prempro menopause drug caused her breast cancer this week.
There was to be a retrial on October 1st of Donna Scroggin’s claims that the company should pay as punishment for the damage that Prempro, a hormone-replacement medicine, caused. An appeals court overturned a $27.1 million punitive award last year and ordered a new trial on damages.
The company agreed to settle Scroggin’s case, U.S. District Judge William Wilson said in an Aug. 19 court filing.
En Espanol:
Pfizer acordó resolver las demandas de una mujer de Arkansas que las drogas de la empresa la menopausia Prempro le causó el cáncer de mama esta semana.
No iba a haber un nuevo juicio el 1 de octubre de reclamaciones Donna Scroggin de que la empresa debe pagar como castigo por el daño que Prempro, un medicamento de reemplazo hormonal, causado. Un tribunal de apelaciones anuló un laudo 27,100,000 dólar punitiva del año pasado y ordenó un nuevo juicio por daños y perjuicios.
La empresa de acuerdo para resolver el caso de Scroggin, EE.UU. El juez de distrito William Wilson dijo en una presentación 19 de agosto la corte
Thursday, August 26, 2010
Georgia/Florida News: Actos Diabetes Drug and Cardio Risks?
There have been several reports suggesting that the cardiovascular risks of the two drugs are allegedly about the same.
Both drugs are members of the family known as thizolidinediones, which decrease the insulin resistance of body tissues and modify the production of cholesterol. They are considered among the most powerful drugs for treating Type 2 diabetes but have been plagued by reports of side effects. A 2007 study of more than 200,000 Medicare patients suggested that Avandia, known generically as rosiglitazone, increased the risk of heart attack, cardiovascular disease, stroke and death by 30% to 40% compared with metformin and other, older diabetes drugs. That study also suggested that the increased risk was not observed with Actos, known generically as pioglitazone.
Source.
I am Hispanic, so I'm going to also start writing periodically in Spanish as well. Here's my first attempt:
Ha habido varios reportes que sugieren que los riesgos cardiovasculares de las dos drogas son supuestamente acerca de lo mismo.
Ambas drogas son miembros de la familia conocida como thizolidinediones, que disminuye la resistencia de insulina de tejidos de cuerpo y modifica la producción de colesterol. Son considerados entre las drogas más poderosas para de tipo tratar 2 diabetes pero han sido plagados por reportes de efectos secundario. Un 2007 estudio de más de 200.000 pacientes de Medicare sugirió que Avandia, conocido genéricamente como rosiglitazone, aumentó el riesgo de infarto, la enfermedad cardiovascular, el golpe y la muerte por 30% a 40% comparado con metformin y con otro, las drogas más viejas de la diabetes. Ese estudio también sugirió que el riesgo aumentado no fue observado con Actos, conocido genéricamente como pioglitazone.
Both drugs are members of the family known as thizolidinediones, which decrease the insulin resistance of body tissues and modify the production of cholesterol. They are considered among the most powerful drugs for treating Type 2 diabetes but have been plagued by reports of side effects. A 2007 study of more than 200,000 Medicare patients suggested that Avandia, known generically as rosiglitazone, increased the risk of heart attack, cardiovascular disease, stroke and death by 30% to 40% compared with metformin and other, older diabetes drugs. That study also suggested that the increased risk was not observed with Actos, known generically as pioglitazone.
Source.
I am Hispanic, so I'm going to also start writing periodically in Spanish as well. Here's my first attempt:
Ha habido varios reportes que sugieren que los riesgos cardiovasculares de las dos drogas son supuestamente acerca de lo mismo.
Ambas drogas son miembros de la familia conocida como thizolidinediones, que disminuye la resistencia de insulina de tejidos de cuerpo y modifica la producción de colesterol. Son considerados entre las drogas más poderosas para de tipo tratar 2 diabetes pero han sido plagados por reportes de efectos secundario. Un 2007 estudio de más de 200.000 pacientes de Medicare sugirió que Avandia, conocido genéricamente como rosiglitazone, aumentó el riesgo de infarto, la enfermedad cardiovascular, el golpe y la muerte por 30% a 40% comparado con metformin y con otro, las drogas más viejas de la diabetes. Ese estudio también sugirió que el riesgo aumentado no fue observado con Actos, conocido genéricamente como pioglitazone.
Tuesday, August 24, 2010
LNG Tankers on Savannah Roadways: A Dangerous and Lethal Mix
Recently a Liquid Natural Gas producer suggested it should be allowed to deliver LNG from Savannah, GA throughout the south, to include Atlanta.
From Savannahnow.com:
A new proposal from the operator of Elba Island, one of the largest importers of liquefied natural gas or LNG in the country, would have some of that natural gas stay in its liquid state and make the journey out of Elba by tanker truck. The proposed route takes 13,000- gallon double-walled tanker trucks south on the Truman Parkway and then across DeRenne Avenue to I-516. Southeast LNG wants to start its trucking operation in late 2012 with 8-10 trucks a day and ramp up to 58 trucks a day over the ensuing decade.
Both the idea of additional traffic and the transport of hazardous material on DeRenne worry some who live along the already beleaguered corridor.
The Danger?
What is the danger? Outside of normal wrecks, tankers are prone to rollovers.
LNG tankers make perfect terrorist bombs. In Savannah these trucks will pass right by Hunter Army Airfield. It is a military airfield and subordinate installation to Fort Stewart.
Hunter features a runway that is 11,375 feet (3,468 m) long and an aircraft parking area that is more than 350 acres (1.4 km²). The runway and apron, combined with the 72,000 sq ft (6,689 m²) Arrival/Departure Airfield Control Group (A/DACG) Facility and nearby railhead, allow the 3rd Infantry Division from nearby Fort Stewart to efficiently deploy soldiers and cargo worldwide. NASA identified Hunter as an alternate landing site for the Space Shuttle orbiters.
In 1944 a LNG explosion leveled one square mile of Cleveland, known as the Cleveland Disaster. The very first commercial LNG facility built in the United States in 1941, caused a major industrial accident known as the "The Cleveland Disaster." According to the U.S. Bureau of Mines report, LNG holding tanks failed and released their contents into the streets and sewers and their vaporous cloud ignited and fire engulfed the nearby residents and commercial establishments.
The Fiery Inferno Devastated One Square Mile Of Cleveland, Ohio. Liquefied Natural Gas Destroyed 79 Homes, 2 Factories, 217 Cars,7 Trailers, Left 680 Homeless,Injured 225 and Killed 131.
In 2004, a blast at Algerian liquefied natural gas plant killed 27 people.
In Savannah, they propose 58 trucks a day passing local retail stores, businesses with thousands of jobs and homes and families.
Each truck tanker will have 13,000 gallons of Liquid Natural Gas which in a wreck, if released, may convert from liquid to vapor and expand to 600 times to about 8 million gallons of gas....
This would will produce about a 5,000 degree fire.
Simply stated, this is a bad idea. Time to kill the proposal now.
From Savannahnow.com:
A new proposal from the operator of Elba Island, one of the largest importers of liquefied natural gas or LNG in the country, would have some of that natural gas stay in its liquid state and make the journey out of Elba by tanker truck. The proposed route takes 13,000- gallon double-walled tanker trucks south on the Truman Parkway and then across DeRenne Avenue to I-516. Southeast LNG wants to start its trucking operation in late 2012 with 8-10 trucks a day and ramp up to 58 trucks a day over the ensuing decade.
Both the idea of additional traffic and the transport of hazardous material on DeRenne worry some who live along the already beleaguered corridor.
The Danger?
What is the danger? Outside of normal wrecks, tankers are prone to rollovers.
LNG tankers make perfect terrorist bombs. In Savannah these trucks will pass right by Hunter Army Airfield. It is a military airfield and subordinate installation to Fort Stewart.
Hunter features a runway that is 11,375 feet (3,468 m) long and an aircraft parking area that is more than 350 acres (1.4 km²). The runway and apron, combined with the 72,000 sq ft (6,689 m²) Arrival/Departure Airfield Control Group (A/DACG) Facility and nearby railhead, allow the 3rd Infantry Division from nearby Fort Stewart to efficiently deploy soldiers and cargo worldwide. NASA identified Hunter as an alternate landing site for the Space Shuttle orbiters.
In 1944 a LNG explosion leveled one square mile of Cleveland, known as the Cleveland Disaster. The very first commercial LNG facility built in the United States in 1941, caused a major industrial accident known as the "The Cleveland Disaster." According to the U.S. Bureau of Mines report, LNG holding tanks failed and released their contents into the streets and sewers and their vaporous cloud ignited and fire engulfed the nearby residents and commercial establishments.
The Fiery Inferno Devastated One Square Mile Of Cleveland, Ohio. Liquefied Natural Gas Destroyed 79 Homes, 2 Factories, 217 Cars,7 Trailers, Left 680 Homeless,Injured 225 and Killed 131.
In 2004, a blast at Algerian liquefied natural gas plant killed 27 people.
In Savannah, they propose 58 trucks a day passing local retail stores, businesses with thousands of jobs and homes and families.
Each truck tanker will have 13,000 gallons of Liquid Natural Gas which in a wreck, if released, may convert from liquid to vapor and expand to 600 times to about 8 million gallons of gas....
This would will produce about a 5,000 degree fire.
Simply stated, this is a bad idea. Time to kill the proposal now.
Guest Post from Trucking Attorney Joe Fried
Image by ER24 EMS (Pty) Ltd. via Flickr - Joe Fried and his firm are to me the consummate trucking lawyers. He's accomplished and to be blunt, knows his stuff. Here's a guest post from Joe:
I recently was asked to do a presentation to a bunch of lawyers and police officers on the current state of technology with tractor trailer black boxes. So, I had to brush up to make sure my information was current. I thought this may be useful to some of you who handle tractor trailer cases.
Most large truck engines have an engine control module (ECM), sometimes called a black box or an Electronic Data Recorder (EDR), that is responsible for monitoring and controlling important engine and vehicle parameters, such as speed, throttle, and braking. You can download this information from the truck engine, but what exactly you should expect to get depends very much on the manufacture of the engine and the date of manufacture.
In this post, I present you with what you can expect from a Caterpillar engine. If you would like to know what to expect from other manufacturers (Detroit Diesel, Mack, Cummins, International), shoot me an e-mail at joe@thetruckingattorneys.com (Put “ECM paper” in the subject box) and I will get you a copy of the entire paper. The powerpoint slides I used in my presentation is available at Slideshare.com.
Here is the skinny on the Caterpillar black box ECM:
Used in many Peterbilt, Kenworth and International tractors.
Caterpillar engine ECMs have been able to record sudden decelerations (“quick stops”) since 1995, but the factory default was set to not record any such data. Some customers change this threshold but not many. For these engines, there is no way to determine with the data will be recorded without downloading the box.
Starting in 2007 the engines started being shipped with “quick stop” function set to “on.” This was the result of new environmental standards. The quick stop record contains 45 seconds of data before the threshold is met and 15 seconds of data after the threshold is reached.
The Quick Stop Record contains:
· Wheel speed (mph)
· Engine load (percent)
· Service brake status (on/off)
· Clutch status (on/off)
· Cruise control status (on/off)
· Other parameters defined by end-user
Caterpillar engine ECMs will also record a report called a “snap shot” if the engine senses a critical fault in the engine such as dangerously low oil pressure. When triggered the ECM will capture about 9 seconds leading up to the fault and 3 seconds after the fault is triggered. This can be useful in timing a collision, but it is not nearly as helpful as a DDEC.
Avandia Georgia/Florida: TIDE Letter
Excerpt from the Tide Trial letter:
Last week we infonned you of the United States Food and Drug Administration's (FDA)
decision to place a partial clinical hold on the TIDE trial (i.e. to continue following randomized
participants but to not randomize new participants). In the letter we also infonned you that you
would receive a summary of the infonnation that was presented at the FDA Advisory Committee
Meeting on July 13 and 14,2010. As requested by the FDA, this summary document was written
by the Sponsor, GlaxoSmithKline. It has now been completed and includes the questions that
the panel voted on and the tally of the votes. It is attached to this email.
As mentioned in last week's note and as requested by the FDA, please send this document to
your local ethics committees as soon as possible for their infonnation, together with the short
cover note that you may want to modify to accompany the document. As you will recall, last
week we provided participant infonnation letters that describe the FDA meeting. However, if
you or your ethics committee feel that the current consent fonn should be modified for the
current participants, please do so. Finally, if applicable for your site, your local sponsor team will
submit this letter to the central ethics committee on your behalf. It will also provide a copy of
the document to the regulatory agency in your country according to local requirements.
As noted last week, the TIDE leadership remain committed to the relevance and appropriateness
of this trial regardless of the current controversy. We will certainly continue to keep you
infonned of any new developments. In the meantime, it remains important that the interests and
the autonomy of the study participants be paramount and that any questions that they may have
should be openly addressed.
This is the letter that went with the Glaxo letter to others.
http://www.markzamora.com/AvandiaFLA/index.html
Last week we infonned you of the United States Food and Drug Administration's (FDA)
decision to place a partial clinical hold on the TIDE trial (i.e. to continue following randomized
participants but to not randomize new participants). In the letter we also infonned you that you
would receive a summary of the infonnation that was presented at the FDA Advisory Committee
Meeting on July 13 and 14,2010. As requested by the FDA, this summary document was written
by the Sponsor, GlaxoSmithKline. It has now been completed and includes the questions that
the panel voted on and the tally of the votes. It is attached to this email.
As mentioned in last week's note and as requested by the FDA, please send this document to
your local ethics committees as soon as possible for their infonnation, together with the short
cover note that you may want to modify to accompany the document. As you will recall, last
week we provided participant infonnation letters that describe the FDA meeting. However, if
you or your ethics committee feel that the current consent fonn should be modified for the
current participants, please do so. Finally, if applicable for your site, your local sponsor team will
submit this letter to the central ethics committee on your behalf. It will also provide a copy of
the document to the regulatory agency in your country according to local requirements.
As noted last week, the TIDE leadership remain committed to the relevance and appropriateness
of this trial regardless of the current controversy. We will certainly continue to keep you
infonned of any new developments. In the meantime, it remains important that the interests and
the autonomy of the study participants be paramount and that any questions that they may have
should be openly addressed.
This is the letter that went with the Glaxo letter to others.
http://www.markzamora.com/AvandiaFLA/index.html
Florida Bar: Proposed Rule on Lien Outsourcing
There has been some concern and questions regarding the outsourcing of lien resolution and the ability to pass along those costs to the client. There were also questions regarding cases where another lawyer handles a lien resolution issue on a reverse contingency and how fees could be charged. The bar formed a committee to look at these issues after an ethics opinion request. The committee has issued a new proposed rule (please see below) that would allow for a lawyer to outsource if it is disclosed in the initial fee contract. The costs come out of the client's recovery, not the lawyer's contingent fee. The new rule is not final until approved by the Florida Supreme Court and may be tweaked by the bar through its internal review process in between now and when the Supreme Court reviews it.
Proposed New Rule language:
(E) The lawyer shall include in the contract an explanation of the scope of any subrogation or lien resolution services the lawyer will undertake at the conclusion of the primary matter. The lawyer may not charge additional fees for handling lien resolution services if those additional fees, when combined with the lawyer's fees for handling the primary claim would exceed the contingent fee schedule set forth in this subdivision. If extraordinary subrogation or lien resolution services are handled by others outside the primary lawyer's firm who will charge additional attorney's fees or costs to the client, these services shall only be provided after obtaining the client's informed written consent to the additional fees or costs. Any additional fees or costs charged by the other lawyer involved in the subrogation or lien resolution services must separately comply with the provisions of Rules 4-1.5(a) through 4-1.5(e), and if the fees are contingent on the outcome of the lien resolution, the lien or subrogation resolution fees on their own must also comply with Rule 4-1.5(f).
New Comment language:
Rule 4-1.5(f)(4)(E) addresses the resolution of medical liens and subrogation claims that are directly related to the underlying personal injury or wrongful death case in which the lawyer represents a client. This subdivision requires that the lawyer undertaking the personal injury or wrongful death case set forth in the lawyer's fee contract with the client whether the lawyer will undertake the resolution of any medical liens or subrogation claims related to the personal injury or wrongful death case as part of the lawyer's services in that case. Extraordinary subrogation or lien resolution services are those that are beyond simple negotiation by the original lawyer. As part of every personal injury and wrongful death case, the lawyer handling the matter has an obligation under his contingent fee contract to ascertain the existence of any medical liens and subrogation claims, advise the client of their existence, make reasonable efforts to negotiate liens that are negotiable, and disburse the amounts to lien holders and subrogation claimants as agreed by both the client and the third party and under the trust accounting rules set forth in chapter 5 of these rules.
A lawyer is not obligated to file or defend a separate lawsuit to resolve medical liens or subrogation claims as part of the lawyer's original agreement to represent the client in the personal injury or wrongful death matter, unless the lawyer makes a specific agreement to do so. Additionally, some liens or claims are so complex that they cannot be resolved through standard negotiation that is normally undertaken by the lawyer handling the personal injury or wrongful death case. In such cases, the client's best interests may best be served by having the lien and/or subrogation matters resolved by another with significant experience in this field. Therefore, a lawyer may indicate in the lawyer's initial fee contract that the lawyer will not undertake any resolution of medical liens or subrogation claims beyond the identification, negotiation, and disbursement described above. In such circumstances, or when reasonable efforts to negotiate such liens or claims fail, the lawyer may, with the client's informed consent, either refer the client to a third party or hire a third party on behalf of the client to handle the medical lien and/or subrogation claim resolution who may charge an additional fee or cost to the client. If a lawyer provides the additional services, that lawyer's contract with the client must separate comply with all provisions of rule 4-1.5.
The original lawyer handling the personal injury matter should not make an agreement to divide fees with the third party to whom the lawyer refers the additional lien and/or subrogation resolution services, as the division of fees would result in an excessive fee to the original lawyer and would likely exceed the contingent fee schedule. If the additional services are to be provided by another, the lawyer should first determine whether the services constitute the practice of law and, if so, should not refer those services to a nonlawyer or someone not authorized to provide the services. A lawyer's duties when a third party claims an interest in funds held by the lawyer are addressed in rule 5-1.1(f) and comment.
Rule 4-1.5(f)(4)(F) discusses a lawyer's obligations in a personal injury or wrongful death case in which an estate must be opened or a guardianship must be established. In a wrongful death case, often an estate must be opened to appoint a personal representative who will act on behalf of the estate of the decedent. In personal injury cases in which minors are involved, or in which a person is under a disability and cannot adequately act on his or her own behalf, often a guardianship must be established. The probate and guardianship matters are separate legal matters in which a separate reasonable fee may be charged. The probate and guardianship matters are not considered part of the personal injury or wrongful death matter for which the lawyer is subject to the contingent fee schedule set forth in this rule. Likewise, ancillary services such as estate planning, bankruptcy, financial planning, public benefit planning, tax planning, real estate transactions, and Medicare set-asides are not considered part of the personal injury or wrongful death matter for which the lawyer is subject to the contingent fee schedule set forth in this rule.
Proposed New Rule language:
(E) The lawyer shall include in the contract an explanation of the scope of any subrogation or lien resolution services the lawyer will undertake at the conclusion of the primary matter. The lawyer may not charge additional fees for handling lien resolution services if those additional fees, when combined with the lawyer's fees for handling the primary claim would exceed the contingent fee schedule set forth in this subdivision. If extraordinary subrogation or lien resolution services are handled by others outside the primary lawyer's firm who will charge additional attorney's fees or costs to the client, these services shall only be provided after obtaining the client's informed written consent to the additional fees or costs. Any additional fees or costs charged by the other lawyer involved in the subrogation or lien resolution services must separately comply with the provisions of Rules 4-1.5(a) through 4-1.5(e), and if the fees are contingent on the outcome of the lien resolution, the lien or subrogation resolution fees on their own must also comply with Rule 4-1.5(f).
New Comment language:
Rule 4-1.5(f)(4)(E) addresses the resolution of medical liens and subrogation claims that are directly related to the underlying personal injury or wrongful death case in which the lawyer represents a client. This subdivision requires that the lawyer undertaking the personal injury or wrongful death case set forth in the lawyer's fee contract with the client whether the lawyer will undertake the resolution of any medical liens or subrogation claims related to the personal injury or wrongful death case as part of the lawyer's services in that case. Extraordinary subrogation or lien resolution services are those that are beyond simple negotiation by the original lawyer. As part of every personal injury and wrongful death case, the lawyer handling the matter has an obligation under his contingent fee contract to ascertain the existence of any medical liens and subrogation claims, advise the client of their existence, make reasonable efforts to negotiate liens that are negotiable, and disburse the amounts to lien holders and subrogation claimants as agreed by both the client and the third party and under the trust accounting rules set forth in chapter 5 of these rules.
A lawyer is not obligated to file or defend a separate lawsuit to resolve medical liens or subrogation claims as part of the lawyer's original agreement to represent the client in the personal injury or wrongful death matter, unless the lawyer makes a specific agreement to do so. Additionally, some liens or claims are so complex that they cannot be resolved through standard negotiation that is normally undertaken by the lawyer handling the personal injury or wrongful death case. In such cases, the client's best interests may best be served by having the lien and/or subrogation matters resolved by another with significant experience in this field. Therefore, a lawyer may indicate in the lawyer's initial fee contract that the lawyer will not undertake any resolution of medical liens or subrogation claims beyond the identification, negotiation, and disbursement described above. In such circumstances, or when reasonable efforts to negotiate such liens or claims fail, the lawyer may, with the client's informed consent, either refer the client to a third party or hire a third party on behalf of the client to handle the medical lien and/or subrogation claim resolution who may charge an additional fee or cost to the client. If a lawyer provides the additional services, that lawyer's contract with the client must separate comply with all provisions of rule 4-1.5.
The original lawyer handling the personal injury matter should not make an agreement to divide fees with the third party to whom the lawyer refers the additional lien and/or subrogation resolution services, as the division of fees would result in an excessive fee to the original lawyer and would likely exceed the contingent fee schedule. If the additional services are to be provided by another, the lawyer should first determine whether the services constitute the practice of law and, if so, should not refer those services to a nonlawyer or someone not authorized to provide the services. A lawyer's duties when a third party claims an interest in funds held by the lawyer are addressed in rule 5-1.1(f) and comment.
Rule 4-1.5(f)(4)(F) discusses a lawyer's obligations in a personal injury or wrongful death case in which an estate must be opened or a guardianship must be established. In a wrongful death case, often an estate must be opened to appoint a personal representative who will act on behalf of the estate of the decedent. In personal injury cases in which minors are involved, or in which a person is under a disability and cannot adequately act on his or her own behalf, often a guardianship must be established. The probate and guardianship matters are separate legal matters in which a separate reasonable fee may be charged. The probate and guardianship matters are not considered part of the personal injury or wrongful death matter for which the lawyer is subject to the contingent fee schedule set forth in this rule. Likewise, ancillary services such as estate planning, bankruptcy, financial planning, public benefit planning, tax planning, real estate transactions, and Medicare set-asides are not considered part of the personal injury or wrongful death matter for which the lawyer is subject to the contingent fee schedule set forth in this rule.
Monday, August 23, 2010
Total Body Cleanse Lawsuits
Total Body Cleanse Lawsuit information:
In a filed lawsuit, the Plaintiff claims Jillian Michaels' "Triple Process Total Body Detox & Cleanse" diet supplement contains a "potentially lethal combination of toxic ingredients" ... and it "might kill you."
In the suit, R.D. lays out what she considers to be the risks associated with various ingredients in Jillian's product, including:
-- Irish Moss Powder ... "causes gastrointestinal ulcers" and is "so toxic that it is the gel commonly applied to aircraft wings to dissolve ice"
-- Bearberry ... "known to cause nausea and vomiting"
-- Yarrow ... "a toxic lawn weed that causes dermatitis"
-- Chinese Rhubarb ... "a harsh laxative and dangerous diuretic that can cause sever dehydration and may cause irreversible liver damage"
-- Fenugreek Seed ... "interferes with digestion and causes both diarrhea and gas"
In a filed lawsuit, the Plaintiff claims Jillian Michaels' "Triple Process Total Body Detox & Cleanse" diet supplement contains a "potentially lethal combination of toxic ingredients" ... and it "might kill you."
In the suit, R.D. lays out what she considers to be the risks associated with various ingredients in Jillian's product, including:
-- Irish Moss Powder ... "causes gastrointestinal ulcers" and is "so toxic that it is the gel commonly applied to aircraft wings to dissolve ice"
-- Bearberry ... "known to cause nausea and vomiting"
-- Yarrow ... "a toxic lawn weed that causes dermatitis"
-- Chinese Rhubarb ... "a harsh laxative and dangerous diuretic that can cause sever dehydration and may cause irreversible liver damage"
-- Fenugreek Seed ... "interferes with digestion and causes both diarrhea and gas"
FDA: Rodents at GA warehouse that held jail food
Image via WikipediaAuthorities seized nearly $1 million worth of cookies, crackers and other packaged food that was bound for jails and prisons throughout the Southeast after rodents were found at an unlicensed Georgia warehouse.The Mid-States Services Inc. warehouse shipped to six Georgia facilities, though their names were not immediately released. FDA spokesman Ira Allen would not say which out-of-state facilities received products, citing proprietary protections.
Oscar Garrison, assistant commissioner for consumer protection with the Georgia Department of Agriculture, said the FDA received a complaint about the facility, and officials discovered it didn't have a license.
Georgia law requires a license for facilities that store, sell or manufacturer food.
Source
Painkiller: Stroke Risk?
Image via WikipediaResearchers found that among nearly 38,000 Taiwanese adults who suffered a stroke over one year, the use of a non-steroidal anti-inflammatory drug (NSAID) in the prior month may have elevated their stroke risk.The increases linked to individual NSAIDs were generally modest, the investigators report in the medical journal Stroke. And the findings do not prove that the medications themselves led to some people's strokes.
NSAIDs are a group of painkillers that include over-the-counter medications like aspirin, ibuprofen (Advil, Motrin and other brands) and naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors.
The COX-2 inhibitors were first linked to an increased risk of heart attack and other cardiovascular problems, and two of the drugs -- rofecoxib (Vioxx) and valdecoxib (Bextra) -- were pulled from the market in 2004 and 2005, respectively; a third COX-2 inhibitor, celecoxib (Celebrex) remains on the market.
But subsequent studies also raised concerns about the possible heart risks of some of the older, over-the-counter NSAIDs, including ibuprofen and diclofenac (Voltaren).
These latest findings suggest that the "concern may also extend to the risk of stroke,"
Source
Friday, August 20, 2010
Avandia Georgia News
From the NYT:
Federal drug regulators ordered GlaxoSmithKline to send a letter to crucial doctors describing a hearing in July where an expert advisory panel discussed the risks of Avandia, the company’s controversial diabetes medicine.
Doctors who received the letter, dated July 28, are investigators in a study called the Tide trial, which was intended to compare the heart risks of Avandia with those of Actos, a similar drug made by Takeda Pharmaceuticals.
Results of the trial, which was requested by the F.D.A., are not expected for years. The ethics of the Tide trial were a point of contention at the advisory committee hearing, and the F.D.A. ordered GlaxoSmithKline to stop recruiting new patients into the trial, although current patients could continue.
Dr. David Graham, an F.D.A. medical officer, made an impassioned presentation at the advisory hearing arguing that the study should be stopped because thousands of patients in the trial were being exploited. None of these arguments were mentioned in GlaxoSmithKline’s letter.
“This summary is biased, misleading and not truthful,” Dr. Graham said in an interview. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”
http://www.nytimes.com/2010/08/20/health/policy/20fda.html
Federal drug regulators ordered GlaxoSmithKline to send a letter to crucial doctors describing a hearing in July where an expert advisory panel discussed the risks of Avandia, the company’s controversial diabetes medicine.
Doctors who received the letter, dated July 28, are investigators in a study called the Tide trial, which was intended to compare the heart risks of Avandia with those of Actos, a similar drug made by Takeda Pharmaceuticals.
Results of the trial, which was requested by the F.D.A., are not expected for years. The ethics of the Tide trial were a point of contention at the advisory committee hearing, and the F.D.A. ordered GlaxoSmithKline to stop recruiting new patients into the trial, although current patients could continue.
Dr. David Graham, an F.D.A. medical officer, made an impassioned presentation at the advisory hearing arguing that the study should be stopped because thousands of patients in the trial were being exploited. None of these arguments were mentioned in GlaxoSmithKline’s letter.
“This summary is biased, misleading and not truthful,” Dr. Graham said in an interview. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”
http://www.nytimes.com/2010/08/20/health/policy/20fda.html
Georgia: Trasylol Cases Settles
Bayer has agreed to pay at least $60 million to settle about 150 lawsuits over Trasylol, a drug used to control bleeding during heart surgeries.
The settlements, which Bayer announced in court earlier this month, provide an average payout of about $400,000 per patient, said three people familiar with the agreements who weren’t authorized to speak publicly about them. Bayer pulled Trasylol off the market in 2007 after researchers found the medicine posed a higher risk of death than competing drugs.
Bayer halted Trasylol sales after studies linked the product to a 50 percent higher risk of death than rival treatments in patients undergoing heart surgery. Trasylol was approved in the U.S. in 1993 to reduce bleeding and cut the need for transfusions during open-heart surgery.
“After thorough examination of each case, Bayer will, at times, consider the option of settling litigation on a case-by- case basis,” Marcy Funk, a Bayer spokeswoman, said in an e- mailed statement. She declined to comment on the size of the settlements.
Sales of the injectable drug were 230 million euros ($292 million) in 2005, before falling 34 percent the next year after researchers raised safety concerns. Studies in 2006 and 2007 found the drug may cause kidney damage, heart attacks and strokes, according to a February filing with the U.S. Securities and Exchange Commission.
1,600 Suits
Leverkusen, Germany-based Bayer faces at least 1,600 suits alleging the company hid Trasylol’s risks from patients and doctors, according to Bayer’s SEC filing. The vast majority of those cases have been consolidated before a federal judge in Florida, for pre-trial proceedings.
Steven Derringer, one of Bayer’s lawyers, told U.S. District Judge Donald Middlebrooks at a hearing in Palm Beach, Florida, earlier this year the company had devised a “settlement program aimed at resolving not just one or two cases at a time, but to provide an overall framework for resolving the litigation,” according to a court-hearing transcript.
Derringer also told Middlebrooks at the April 12 hearing that the drugmaker had settled a total of 63 cases at that time. The company brought in a mediator to help resolve the cases, according to the transcript.
“We now have a track record, your honor, that shows these cases are being settled, parties can agree on values, and settlements do not depend on trial dates,” Derringer said.
The company had settled “with about 120 plaintiffs as of July 6, 2010,” without making any admission of liability, Funk said in the e-mailed statement.
The settlements, which Bayer announced in court earlier this month, provide an average payout of about $400,000 per patient, said three people familiar with the agreements who weren’t authorized to speak publicly about them. Bayer pulled Trasylol off the market in 2007 after researchers found the medicine posed a higher risk of death than competing drugs.
Bayer halted Trasylol sales after studies linked the product to a 50 percent higher risk of death than rival treatments in patients undergoing heart surgery. Trasylol was approved in the U.S. in 1993 to reduce bleeding and cut the need for transfusions during open-heart surgery.
“After thorough examination of each case, Bayer will, at times, consider the option of settling litigation on a case-by- case basis,” Marcy Funk, a Bayer spokeswoman, said in an e- mailed statement. She declined to comment on the size of the settlements.
Sales of the injectable drug were 230 million euros ($292 million) in 2005, before falling 34 percent the next year after researchers raised safety concerns. Studies in 2006 and 2007 found the drug may cause kidney damage, heart attacks and strokes, according to a February filing with the U.S. Securities and Exchange Commission.
1,600 Suits
Leverkusen, Germany-based Bayer faces at least 1,600 suits alleging the company hid Trasylol’s risks from patients and doctors, according to Bayer’s SEC filing. The vast majority of those cases have been consolidated before a federal judge in Florida, for pre-trial proceedings.
Steven Derringer, one of Bayer’s lawyers, told U.S. District Judge Donald Middlebrooks at a hearing in Palm Beach, Florida, earlier this year the company had devised a “settlement program aimed at resolving not just one or two cases at a time, but to provide an overall framework for resolving the litigation,” according to a court-hearing transcript.
Derringer also told Middlebrooks at the April 12 hearing that the drugmaker had settled a total of 63 cases at that time. The company brought in a mediator to help resolve the cases, according to the transcript.
“We now have a track record, your honor, that shows these cases are being settled, parties can agree on values, and settlements do not depend on trial dates,” Derringer said.
The company had settled “with about 120 plaintiffs as of July 6, 2010,” without making any admission of liability, Funk said in the e-mailed statement.
Wednesday, August 11, 2010
FDA warns about IVC Filters
The FDA has warned that inferior vena cava (IVC) filters, devices inserted into a large vein to help prevent potentially deadly blood clots from reaching the lungs, might come apart, shift within the body or perforate the blood vessel.
IVC filter usage has increased rapidly during the past thirty years. In 1979, 2,000 IVC filters were used, while in 2007, almost 167,000 filters were implanted, and the market for IVC filters is only expected to increase, with an estimated 259,000 IVC filters to be deployed in 2012 (Smouse and Johar, Endovascular Today, February 2010).
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of PE has subsided.
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
Diet Drugs to Get FDA Review
An FDA committee will review the safety risk of weight-loss drug Meridia the day before evaluating Arena Pharmaceuticals Inc.'s drug for treating obesity.
The agency had said it planned to review Abbott's Meridia, which has been pulled from the market in Europe on concerns about cardiovascular side effects; however, scheduling the session on Sept. 15, a day before Arena's meeting, sets up a situation similar to last month, when the same panel held a two-day safety review of Avandia before evaluating Qnexa.
The Avandia meeting's focus on safety concerns is thought to have contributed to the Endocrinologic and Metabolic Drugs Advisory Committee ultimately recommending that the FDA reject Vivus's Qnexa because of potential safety issues. The panel cited the lack of long-term safety data on a drug that could be used by millions of Americans for an indefinite period.
The agency had said it planned to review Abbott's Meridia, which has been pulled from the market in Europe on concerns about cardiovascular side effects; however, scheduling the session on Sept. 15, a day before Arena's meeting, sets up a situation similar to last month, when the same panel held a two-day safety review of Avandia before evaluating Qnexa.
The Avandia meeting's focus on safety concerns is thought to have contributed to the Endocrinologic and Metabolic Drugs Advisory Committee ultimately recommending that the FDA reject Vivus's Qnexa because of potential safety issues. The panel cited the lack of long-term safety data on a drug that could be used by millions of Americans for an indefinite period.
Seroquel cases settle
Image via Wikipedia The settlements resulted from a court-ordered mediation. AstraZeneca had previously agreed to pay at least $55 million to resolve more than 5,500 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, people familiar with those settlements said. These earlier agreements are part of the 17,500 settlements, the company said.
Monday, August 09, 2010
Total Body Cleanse Lawsuits
"Biggest Loser" trainer Jillian Michaels sells a diet supplement, the Triple Process Total Body Detox & Cleanse, that "just might kill you," according to a lawsuit. .
It has been claimed that the product Contains a potentially lethal combination of toxic ingredients that can cause ulcers, nausea, vomiting, dehydration, liver damage, and diarrhea the class claims which is not how consumers expect to be 'detoxed and cleansed.'
The claimed dangerous ingredients are:
It has been claimed that the product Contains a potentially lethal combination of toxic ingredients that can cause ulcers, nausea, vomiting, dehydration, liver damage, and diarrhea the class claims which is not how consumers expect to be 'detoxed and cleansed.'
The claimed dangerous ingredients are:
- Irish Moss Powder: "causes gastrointestinal ulcers" and is "so toxic that it is the gel commonly applied to aircraft wings to dissolve ice"
- Bearberry: "known to cause nausea and vomiting"
- Yarrow: "a toxic lawn weed that causes dermatitis"
- Chinese Rhubarb: "a harsh laxative and dangerous diuretic that can cause sever dehydration and may cause irreversible liver damage"
- Fenugreek Seed: "interferes with digestion and causes both diarrhea and gas."
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