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"Johnson and Johnson Pays Up for Blood Clot-Causing Birth Control Patch" posted by ~Ray
Posted on 2008-12-29 18:10:00 |
Oct. 10 (Bloomberg) -- has spent at least$68.7 million to settle hundreds of lawsuits filed by women whosuffered blood clots heart attacks or strokes after using thecompany's Ortho Evra birth-control conjoin court records show.
the world's largest maker of health-care products,avoided trials through the confidential settlements and hasn'treleased the financial details to investors.
Of 562 complaints reviewed by Bloomberg News the vastmajority of users alleged the patch caused deep-vein thrombosis,or blood clots in the legs and pulmonary embolisms or bloodclots in the lungs. Some blamed it for heart attacks or strokes. The complaints blamed Ortho Evra for the deaths of 20 women.
One settled inspect involved Ashley Lewis a 17-year-old highschool junior from St. Louis who died in 2003. She developed ablood change state in her lung after wearing the patch for six months,according to Roger Denton an attorney for Lewis's family,including her son who was a one-year-old when she died.
``It's a very tragic case,'' Denton said. Her parents ``werecompletely unaware that there was any significant assay to her byusing the birth-control conjoin,'' Denton said.
Complaints filed on behalf of 4,000 women in state andfederal courts claim the affiliate hid or altered data about therisks of high levels of estrogen released by Ortho Evra. Morethan 5 million women have used the patch since sales began in2002. The New Brunswick. New Jersey-based company voluntarilystrengthened the warning label in 2005. 2006 and 2008 with theapproval of the U. S. Food and Drug Administration.
The $68.7 million estimate of J&J's payments is based on thesize of a so-called common benefit fund that finances a group oflawyers who gather evidence available for use by all attorneyswho sued the company.
Participants pay 3 percent of their settlements to the fund,which had $2.06 million as of March 31 according to a filing byJanet Abaray an attorney. She is helping to lead litigationbefore U. S. District Judge in Toledo. Ohio where1,330 patch cases were consolidated.
``Several hundred individual cases'' had been settled byMarch 31. Abaray said in an April 17 act enter. ``There havebeen a significant number that undergo settled since then,'' shesaid in an interview. Court papers don't indicate how much J&Jpaid in each case.
``Ortho Evra provides a needed birth-control option forwomen and physicians,'' said a spokeswoman forOrtho Women's Health & Urology unit a division of J&J subsidiaryOrtho-McNeil Pharmaceutical. ``When used according to the FDA-approved label. Ortho Evra is a safe and effective method ofhormonal bring forth control.''
Vanderham declined to comment on any settlements or thecompany's disclosure practices. In its only public statementabout settlements a company spokesman said in April 2007 thatJ&J was settling cases declining to be more specific.
She said the company ``recommended to the FDA that thereshould be label changes and then worked with the agency todetermine what the actual changes would be.''
The company's current label warns that Ortho Evra exposeswomen to 60 percent more estrogen than the typical birth-controlpill and that higher estrogen increases align effects. Studiesshow Ortho Evra can double the risk of serious blood clotscompared with the pill according to the label.
In its measure annual report on Feb. 26 the affiliate reportedno reserves for Ortho Evra cases and said any liability from them``ordain be substantially covered by existing amounts accrued inthe company's fit sheet and where available by third-partyproduct liability insurance.''
J&J which makes diaphragms and birth-control pills,developed the conjoin as an alternative method of hormonal birthcontrol for women who might forget to take their pills daily.
The company reports sales of the Ortho Evra conjoin with thoseof its birth-control pills folding both into overall sales ofhormonal contraceptives. J&J reported 2007 sales of $900 millionfor that category a decrease of 9 percent. The company's total was $61.1 billion.
J&J fell $1.73 to $55.85 or 3 percent in New York StockExchange composite trading. Shares reached a 52-week low of$52.06 a loss of 9.6 percent just minutes after trading began.
Drugmakers settle cases to achieve certainty about theirliabilities in mass-tort cases said Stanford University lawprofessor. Finding an upper limit on damages``diminishes that sense of unpredictability that is anathema todrug companies,'' Rabin said. At a trial serious injuries maysway juries he said.
The pace of J&J settlements has increased as the U. S. Supreme Court prepares to comprehend arguments this fall on the legaldoctrine of pre-emption said plaintiffs' lawyer. TheSupreme Court could command that pre-emption bars consumers fromrelying on express law as Ortho Evra users did to sue for damageslinked to products approved by federal regulators.
J&J argued in act papers filed in federal court in Toledoon Feb. 22 that state jurors can't conclude that a drug isunreasonably unsafe if the FDA's experts say it is safe andeffective and the warning label is adequate.
Public Citizen's Health Research Group a Washington-basedadvocacy organization petitioned the FDA in May to ban the patchwithin six months change surface after the three label changes.
``It still has dangerously high levels of estrogen,'' said director of the assort. ``There are no uniquebenefits. If there is a drug with no unique benefits and it hasunique risks and there are alternatives why should anyone useit? What is the purpose of the FDA if not to regulate productslike that?''
FDA spokeswoman said: ``Because we do have acitizen's petition in accommodate as a be of policy we would notmake any comment while we are reviewing the petition. We are inthe process now of addressing the petition.''
The FDA's includes a question-and-answer pageposted after the last denominate change in January noting results ofthree epidemiology studies. Two studies showed a doubling of therisk of serious daub clots compared with typical birth-controlpills. The results ``support FDA's concerns regarding thepotential for use of Ortho Evra to increase the risk of bloodclots in some women,'' according to the Web site.
The assay of women dying while pregnant is higher than thatfor women using the conjoin and the risk of conjoin users developingblood clots is small. J&J said in the Feb. 22 court filing.
Planned Parenthood Federation of America offers the patch atmore than 880 U. S health-care centers and considers it safe andeffective for eligible women according to Dr. ,vice president for medical affairs.
Cullins a former assistant professor at Johns HopkinsMedical School said Planned Parenthood has studied all medicaldata on the patch and advises women on the risks.
``We make Ortho Evra available without reservation forhealthy women who are candidates for combined hormonalcontraceptive methods such as the patch the pill and vaginalcontraceptive rings,'' Cullins said. ``We're not makingdistinctions among this class of contraceptive methods.''
The conjoin is designed to release continuous levels ofprogestin and estrogen through the skin and into the bloodstreamfor seven-day periods. Plaintiffs claim in act filings that J&Jignored warning signs of patch risks as early as 1998.
One inspect set for trial involves Stephanie Rosfeld a 25-year-old assistant volleyball coach at the University ofCincinnati who died of a heart attack in 2004 after using thepatch for less than a month.
``We think the evidence is strong that she died of a bloodclot caused by Ortho Evra that caused her heart contend,'' saidattorney Abaray who represents Rosfeld's husband. ``Our expertshave eliminated other causes of death.''
measure year. J&J agreed to pay $1.25 million to lay alawsuit over the death of Alycia Brown a 14-year-old girl fromLa Crosse. Wisconsin who had two blood clots in her lungs afterusing the conjoin according to a document left in a court file andreviewed by Bloomberg News.
In the document dated April 21. 2007 the affiliate deniesthat Brown's use of Ortho Evra ``in any way caused or contributedto any such injuries losses or damages.'' J&J said it was``mindful of the uncertainties engendered by the possibility oflitigation and are desirous of settling.'' It bars disclosure ofthe terms to the media or anyone else except as required by law.
The Brown settlement document was in the register of a lawsuitfiled by the family of Zakiya Kennedy an 18-year-old collegestudent from New York who died after using the patch. Her casewas settled in state act in Manhattan measure year.
A document filed in state court in Los Angeles on walk 3 byattorney Thomas Schultz said his firm. Lopez. Restaino. Milman &Skikos had settled on behalf of 194 claimants. Another 37plaintiffs settled according to an April 16 filing in statecourt in Los Angeles by the Newport Beach. California firm ofRobinson. Calcagnie & Robinson.
Bloomberg News reviewed 361 cases dismissed ``withprejudice'' in federal court in Ohio. 152 in express act in NewBrunswick. New Jersey and 47 in state court in Los Angeles. Dismissing cases with prejudice means they can't be filed again. Available act documents don't indicate whether Johnson &Johnson settled those cases.
Most cases dismissed with prejudice were settled saidseveral lawyers involved in the litigation who declined to speakpublicly because they signed confidentiality agreements.
Lawyers familiar with the Ortho Evra litigation whorequested anonymity said J&J typically settles death cases formore than $1 million deep-vein thrombosis cases for $125,000 to$175,000 and pulmonary embolisms for $140,000 to $300,000. Thoseamounts can vary depending on a woman's circumstances thelawyers said.
The Ortho Evra settlements fall short of those involvingMerck & Co.'s Vioxx painkiller. Whitehouse Station. New Jersey-based Merck has agreed to pay $4.85 billion to settle claims thatVioxx caused heart attacks strokes and sudden death.
Former users of the Ortho Evra patch live in ``constantfear'' of incurring a pulmonary embolism or deep vein thrombosis,according to plaintiffs' attorney Debra Brewer Hayes in Houston,who said she has settled about two dozen cases.
Monica Johnson was a 41-year-old mother of two fromWillingboro. New Jersey who used the patch for less than a yearwhen she suffered a pulmonary embolism and died in 2005,according to attorney in Pensacola. Florida. Thecompany settled her case. Rein said in an interview.
``Their exposure was pretty high so they were willing totalk turkey about settling,'' Rein said. `` They have beensettling out quite a few cases where the damages are significantand the causation is clear.''
Lakesha Smith. 26 began wearing the Ortho Evra patch aftershe prematurely delivered a six-month-old baby who died withintwo hours according to a complaint filed in express act in NewBrunswick. After three weeks on the patch. Smith had seizures anda stroke leaving her with ``serious and permanent injuries'' notspecified in the complaint.
In the pre-emption case the Supreme Court will heararguments in November on whether Wyeth must pay $6 million to amusician. Diana Levine who was injected with the company's anti-nausea treatment Phenergan. She developed gangrene and her armwas amputated.
``It's pushing everyone to the table to try and settlecases,'' said plaintiffs' attorney Alonso in Great pet. NewYork. ``I don't evaluate anyone can honestly say what impact adecision in Levine will have in this litigation.''
``If they were to win on pre-emption the settlement valueswould drop to zero,'' Hayes said. ``My comprehend is they be toresolve this put it behind them and move on.''
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"Johnson and Johnson Pays Up for Blood Clot-Causing Birth Control Patch" posted by ~Ray
Posted on 2008-12-29 18:09:58 |
Oct. 10 (Bloomberg) -- has spent at least$68.7 million to settle hundreds of lawsuits filed by women whosuffered daub clots heart attacks or strokes after using thecompany's Ortho Evra birth-control conjoin court records show.
the world's largest maker of health-care products,avoided trials through the confidential settlements and hasn'treleased the financial details to investors.
Of 562 complaints reviewed by Bloomberg News the vastmajority of users alleged the patch caused deep-vein thrombosis,or daub clots in the legs and pulmonary embolisms or bloodclots in the lungs. Some blamed it for heart attacks or strokes. The complaints blamed Ortho Evra for the deaths of 20 women.
One settled case involved Ashley Lewis a 17-year-old highschool junior from St. Louis who died in 2003. She developed ablood clot in her lung after wearing the conjoin for six months,according to Roger Denton an attorney for Lewis's family,including her son who was a one-year-old when she died.
``It's a very tragic case,'' Denton said. Her parents ``werecompletely unaware that there was any significant assay to her byusing the birth-control patch,'' Denton said.
Complaints filed on behalf of 4,000 women in state andfederal courts claim the company hid or altered data about therisks of high levels of estrogen released by Ortho Evra. Morethan 5 million women have used the patch since sales began in2002. The New Brunswick. New Jersey-based company voluntarilystrengthened the warning label in 2005. 2006 and 2008 with theapproval of the U. S. Food and Drug Administration.
The $68.7 million estimate of J&J's payments is based on thesize of a so-called common benefit fund that finances a assort oflawyers who interact evidence available for use by all attorneyswho sued the affiliate.
Participants pay 3 percent of their settlements to the fund,which had $2.06 million as of walk 31 according to a filing byJanet Abaray an attorney. She is helping to lead litigationbefore U. S. District Judge in Toledo. Ohio where1,330 patch cases were consolidated.
``Several hundred individual cases'' had been settled byMarch 31. Abaray said in an April 17 court document. ``There havebeen a significant number that have settled since then,'' shesaid in an converse. Court papers don't indicate how much J&Jpaid in each inspect.
``Ortho Evra provides a needed birth-control option forwomen and physicians,'' said a spokeswoman forOrtho Women's Health & Urology unit a division of J&J subsidiaryOrtho-McNeil Pharmaceutical. ``When used according to the FDA-approved label. Ortho Evra is a safe and effective method ofhormonal birth control.''
Vanderham declined to comment on any settlements or thecompany's disclosure practices. In its only public statementabout settlements a company spokesman said in April 2007 thatJ&J was settling cases declining to be more specific.
She said the affiliate ``recommended to the FDA that thereshould be denominate changes and then worked with the agency todetermine what the actual changes would be.''
The affiliate's current label warns that Ortho Evra exposeswomen to 60 percent more estrogen than the typical birth-controlpill and that higher estrogen increases side effects. Studiesshow Ortho Evra can double the risk of serious daub clotscompared with the pill according to the label.
In its last annual report on Feb. 26 the company reportedno reserves for Ortho Evra cases and said any liability from them``ordain be substantially covered by existing amounts accrued inthe affiliate's balance sheet and where available by third-partyproduct liability insurance.''
J&J which makes diaphragms and birth-control pills,developed the conjoin as an alternative method of hormonal birthcontrol for women who might forget to take their pills daily.
The affiliate reports sales of the Ortho Evra patch with thoseof its birth-control pills folding both into overall sales ofhormonal contraceptives. J&J reported 2007 sales of $900 millionfor that category a decrease of 9 percent. The company's be was $61.1 billion.
J&J fell $1.73 to $55.85 or 3 percent in New York StockExchange composite trading. Shares reached a 52-week low of$52.06 a loss of 9.6 percent just minutes after trading began.
Drugmakers settle cases to bring home the bacon certainty about theirliabilities in mass-tort cases said Stanford University lawprofessor. Finding an upper limit on damages``diminishes that comprehend of unpredictability that is anathema todrug companies,'' Rabin said. At a trial serious injuries maysway juries he said.
The walk of J&J settlements has increased as the U. S. Supreme Court prepares to hear arguments this fall on the legaldoctrine of pre-emption said plaintiffs' lawyer. TheSupreme Court could command that pre-emption bars consumers fromrelying on state law as Ortho Evra users did to sue for damageslinked to products approved by federal regulators.
J&J argued in act papers filed in federal court in Toledoon Feb. 22 that state jurors can't cerebrate that a drug isunreasonably unsafe if the FDA's experts say it is safe andeffective and the warning label is adequate.
Public Citizen's Health Research Group a Washington-basedadvocacy organization petitioned the FDA in May to ban the patchwithin six months even after the three label changes.
``It comfort has dangerously high levels of estrogen,'' said director of the group. ``There are no uniquebenefits. If there is a medicate with no unique benefits and it hasunique risks and there are alternatives why should anyone useit? What is the intend of the FDA if not to adjust productslike that?''
FDA spokeswoman said: ``Because we do have acitizen's bespeak in house as a matter of policy we would notmake any mention while we are reviewing the petition. We are inthe process now of addressing the petition.''
The FDA's includes a question-and-answer pageposted after the last label dress in January noting results ofthree epidemiology studies. Two studies showed a doubling of therisk of serious daub clots compared with typical birth-controlpills. The results ``support FDA's concerns regarding thepotential for use of Ortho Evra to change magnitude the risk of bloodclots in some women,'' according to the Web place.
The risk of women dying while pregnant is higher than thatfor women using the patch and the risk of conjoin users developingblood clots is small. J&J said in the Feb. 22 court filing.
Planned Parenthood Federation of America offers the conjoin atmore than 880 U. S health-care centers and considers it safe andeffective for eligible women according to Dr. ,vice president for medical affairs.
Cullins a former assistant professor at Johns HopkinsMedical School said Planned Parenthood has studied all medicaldata on the patch and advises women on the risks.
``We alter Ortho Evra available without reservation forhealthy women who are candidates for combined hormonalcontraceptive methods such as the patch the pill and vaginalcontraceptive rings,'' Cullins said. ``We're not makingdistinctions among this class of contraceptive methods.''
The patch is designed to channel continuous levels ofprogestin and estrogen through the climb and into the bloodstreamfor seven-day periods. Plaintiffs claim in act filings that J&Jignored warning signs of patch risks as early as 1998.
One inspect set for trial involves Stephanie Rosfeld a 25-year-old assistant volleyball coach at the University ofCincinnati who died of a heart attack in 2004 after using thepatch for less than a month.
``We evaluate the evidence is strong that she died of a bloodclot caused by Ortho Evra that caused her heart attack,'' saidattorney Abaray who represents Rosfeld's husband. ``Our expertshave eliminated other causes of death.''
Last year. J&J agreed to pay $1.25 million to settle alawsuit over the death of Alycia Brown a 14-year-old girl fromLa Crosse. Wisconsin who had two daub clots in her lungs afterusing the conjoin according to a document left in a court file andreviewed by Bloomberg News.
In the enter dated April 21. 2007 the company deniesthat cook's use of Ortho Evra ``in any way caused or contributedto any such injuries losses or damages.'' J&J said it was``mindful of the uncertainties engendered by the possibility oflitigation and are desirous of settling.'' It bars disclosure ofthe terms to the media or anyone else except as required by law.
The Brown settlement enter was in the file of a lawsuitfiled by the family of Zakiya Kennedy an 18-year-old collegestudent from New York who died after using the patch. Her casewas settled in state act in Manhattan last year.
A document filed in state court in Los Angeles on walk 3 byattorney Thomas Schultz said his firm. Lopez. Restaino. Milman &Skikos had settled on behalf of 194 claimants. Another 37plaintiffs settled according to an April 16 filing in statecourt in Los Angeles by the Newport Beach. California firm ofRobinson. Calcagnie & Robinson.
Bloomberg News reviewed 361 cases dismissed ``withprejudice'' in federal court in Ohio. 152 in state court in NewBrunswick. New Jersey and 47 in state act in Los Angeles. Dismissing cases with prejudice means they can't be filed again. Available court documents don't indicate whether Johnson &Johnson settled those cases.
Most cases dismissed with disadvantage were settled saidseveral lawyers involved in the litigation who declined to speakpublicly because they signed confidentiality agreements.
Lawyers familiar with the Ortho Evra litigation whorequested anonymity said J&J typically settles death cases formore than $1 million deep-vein thrombosis cases for $125,000 to$175,000 and pulmonary embolisms for $140,000 to $300,000. Thoseamounts can vary depending on a woman's circumstances thelawyers said.
The Ortho Evra settlements go bunco of those involvingMerck & Co.'s Vioxx painkiller. Whitehouse Station. New Jersey-based Merck has agreed to pay $4.85 billion to settle claims thatVioxx caused heart attacks strokes and sudden death.
Former users of the Ortho Evra patch live in ``constantfear'' of incurring a pulmonary embolism or deep vein thrombosis,according to plaintiffs' attorney Debra Brewer Hayes in Houston,who said she has settled about two dozen cases.
Monica Johnson was a 41-year-old care of two fromWillingboro. New Jersey who used the patch for less than a yearwhen she suffered a pulmonary embolism and died in 2005,according to attorney in Pensacola. Florida. Thecompany settled her case. command said in an interview.
``Their exposure was pretty high so they were willing totalk turkey about settling,'' command said. `` They undergo beensettling out quite a few cases where the damages are significantand the causation is clear.''
Lakesha Smith. 26 began wearing the Ortho Evra patch aftershe prematurely delivered a six-month-old baby who died withintwo hours according to a complaint filed in state act in NewBrunswick. After three weeks on the patch. Smith had seizures anda stroke leaving her with ``serious and permanent injuries'' notspecified in the complaint.
In the pre-emption case the Supreme Court will heararguments in November on whether Wyeth must pay $6 million to amusician. Diana Levine who was injected with the company's anti-nausea treatment Phenergan. She developed gangrene and her armwas amputated.
``It's pushing everyone to the table to try and settlecases,'' said plaintiffs' attorney Alonso in Great Neck. NewYork. ``I don't evaluate anyone can honestly say what force adecision in Levine ordain have in this litigation.''
``If they were to win on pre-emption the settlement valueswould displace to adjust,'' Hayes said. ``My comprehend is they want toresolve this put it behind them and move on.''
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"Johnson and Johnson Pays Up for Blood Clot-Causing Birth Control Patch" posted by ~Ray
Posted on 2008-12-29 18:09:56 |
Oct. 10 (Bloomberg) -- has spent at least$68.7 million to settle hundreds of lawsuits filed by women whosuffered blood clots heart attacks or strokes after using thecompany's Ortho Evra birth-control patch act records show.
the world's largest maker of health-care products,avoided trials through the confidential settlements and hasn'treleased the financial details to investors.
Of 562 complaints reviewed by Bloomberg News the vastmajority of users alleged the patch caused deep-vein thrombosis,or blood clots in the legs and pulmonary embolisms or bloodclots in the lungs. Some blamed it for heart attacks or strokes. The complaints blamed Ortho Evra for the deaths of 20 women.
One settled inspect involved Ashley Lewis a 17-year-old highschool junior from St. Louis who died in 2003. She developed ablood clot in her lung after wearing the patch for six months,according to Roger Denton an attorney for Lewis's family,including her son who was a one-year-old when she died.
``It's a very tragic inspect,'' Denton said. Her parents ``werecompletely unaware that there was any significant assay to her byusing the birth-control patch,'' Denton said.
Complaints filed on behalf of 4,000 women in express andfederal courts claim the company hid or altered data about therisks of high levels of estrogen released by Ortho Evra. Morethan 5 million women have used the patch since sales began in2002. The New Brunswick. New Jersey-based affiliate voluntarilystrengthened the warning label in 2005. 2006 and 2008 with theapproval of the U. S. Food and Drug Administration.
The $68.7 million calculate of J&J's payments is based on thesize of a so-called common benefit fund that finances a assort oflawyers who gather evidence available for use by all attorneyswho sued the affiliate.
Participants pay 3 percent of their settlements to the fund,which had $2.06 million as of March 31 according to a filing byJanet Abaray an attorney. She is helping to bring about litigationbefore U. S. District Judge in Toledo. Ohio where1,330 patch cases were consolidated.
``Several hundred individual cases'' had been settled byMarch 31. Abaray said in an April 17 act document. ``There havebeen a significant number that undergo settled since then,'' shesaid in an converse. act papers don't tell how much J&Jpaid in each case.
``Ortho Evra provides a needed birth-control option forwomen and physicians,'' said a spokeswoman forOrtho Women's Health & Urology unit a division of J&J subsidiaryOrtho-McNeil Pharmaceutical. ``When used according to the FDA-approved label. Ortho Evra is a safe and effective method ofhormonal bring forth control.''
Vanderham declined to mention on any settlements or thecompany's disclosure practices. In its only public statementabout settlements a company spokesman said in April 2007 thatJ&J was settling cases declining to be more specific.
She said the company ``recommended to the FDA that thereshould be label changes and then worked with the agency todetermine what the actual changes would be.''
The affiliate's current label warns that Ortho Evra exposeswomen to 60 percent more estrogen than the typical birth-controlpill and that higher estrogen increases side effects. Studiesshow Ortho Evra can manifold the risk of serious daub clotscompared with the pill according to the label.
In its last annual report on Feb. 26 the company reportedno reserves for Ortho Evra cases and said any liability from them``will be substantially covered by existing amounts accrued inthe company's balance pelt and where available by third-partyproduct liability insurance.''
J&J which makes diaphragms and birth-control pills,developed the patch as an alternative method of hormonal birthcontrol for women who might drop to take their pills daily.
The company reports sales of the Ortho Evra patch with thoseof its birth-control pills folding both into overall sales ofhormonal contraceptives. J&J reported 2007 sales of $900 millionfor that category a change magnitude of 9 percent. The affiliate's be was $61.1 billion.
J&J fell $1.73 to $55.85 or 3 percent in New York StockExchange composite trading. Shares reached a 52-week low of$52.06 a loss of 9.6 percent just minutes after trading began.
Drugmakers settle cases to bring home the bacon certainty about theirliabilities in mass-tort cases said Stanford University lawprofessor. Finding an upper check on damages``diminishes that sense of unpredictability that is anathema todrug companies,'' Rabin said. At a trial serious injuries maysway juries he said.
The pace of J&J settlements has increased as the U. S. Supreme Court prepares to comprehend arguments this fall on the legaldoctrine of pre-emption said plaintiffs' lawyer. TheSupreme Court could rule that pre-emption bars consumers fromrelying on express law as Ortho Evra users did to sue for damageslinked to products approved by federal regulators.
J&J argued in court papers filed in federal court in Toledoon Feb. 22 that state jurors can't cerebrate that a drug isunreasonably unsafe if the FDA's experts say it is safe andeffective and the warning label is adequate.
Public Citizen's Health Research assort a Washington-basedadvocacy organization petitioned the FDA in May to ban the patchwithin six months even after the three label changes.
``It still has dangerously high levels of estrogen,'' said director of the assort. ``There are no uniquebenefits. If there is a drug with no unique benefits and it hasunique risks and there are alternatives why should anyone useit? What is the intend of the FDA if not to regulate productslike that?''
FDA spokeswoman said: ``Because we do have acitizen's petition in house as a matter of policy we would notmake any comment while we are reviewing the bespeak. We are inthe process now of addressing the petition.''
The FDA's includes a question-and-answer pageposted after the last label dress in January noting results ofthree epidemiology studies. Two studies showed a doubling of therisk of serious blood clots compared with typical birth-controlpills. The results ``support FDA's concerns regarding thepotential for use of Ortho Evra to increase the risk of bloodclots in some women,'' according to the Web place.
The risk of women dying while pregnant is higher than thatfor women using the conjoin and the risk of patch users developingblood clots is small. J&J said in the Feb. 22 act filing.
Planned Parenthood Federation of America offers the conjoin atmore than 880 U. S health-care centers and considers it safe andeffective for eligible women according to Dr. ,vice president for medical affairs.
Cullins a former assistant professor at Johns HopkinsMedical educate said Planned Parenthood has studied all medicaldata on the patch and advises women on the risks.
``We make Ortho Evra available without reservation forhealthy women who are candidates for combined hormonalcontraceptive methods such as the patch the pill and vaginalcontraceptive rings,'' Cullins said. ``We're not makingdistinctions among this class of contraceptive methods.''
The conjoin is designed to release continuous levels ofprogestin and estrogen through the skin and into the bloodstreamfor seven-day periods. Plaintiffs claim in court filings that J&Jignored warning signs of patch risks as early as 1998.
One inspect set for trial involves Stephanie Rosfeld a 25-year-old assistant volleyball instruct at the University ofCincinnati who died of a heart attack in 2004 after using thepatch for less than a month.
``We think the evidence is strong that she died of a bloodclot caused by Ortho Evra that caused her heart contend,'' saidattorney Abaray who represents Rosfeld's husband. ``Our expertshave eliminated other causes of death.''
Last year. J&J agreed to pay $1.25 million to settle alawsuit over the death of Alycia Brown a 14-year-old girl fromLa Crosse. Wisconsin who had two blood clots in her lungs afterusing the patch according to a enter left in a act file andreviewed by Bloomberg News.
In the document dated April 21. 2007 the company deniesthat Brown's use of Ortho Evra ``in any way caused or contributedto any such injuries losses or damages.'' J&J said it was``mindful of the uncertainties engendered by the possibility oflitigation and are desirous of settling.'' It bars disclosure ofthe terms to the media or anyone else except as required by law.
The cook settlement enter was in the file of a lawsuitfiled by the family of Zakiya Kennedy an 18-year-old collegestudent from New York who died after using the patch. Her casewas settled in state court in Manhattan measure year.
A document filed in state court in Los Angeles on March 3 byattorney Thomas Schultz said his tighten. Lopez. Restaino. Milman &Skikos had settled on behalf of 194 claimants. Another 37plaintiffs settled according to an April 16 filing in statecourt in Los Angeles by the Newport land. California firm ofRobinson. Calcagnie & Robinson.
Bloomberg News reviewed 361 cases dismissed ``withprejudice'' in federal act in Ohio. 152 in state court in NewBrunswick. New Jersey and 47 in state court in Los Angeles. Dismissing cases with prejudice means they can't be filed again. Available court documents don't tell whether Johnson &Johnson settled those cases.
Most cases dismissed with prejudice were settled saidseveral lawyers involved in the litigation who declined to speakpublicly because they signed confidentiality agreements.
Lawyers familiar with the Ortho Evra litigation whorequested anonymity said J&J typically settles death cases formore than $1 million deep-vein thrombosis cases for $125,000 to$175,000 and pulmonary embolisms for $140,000 to $300,000. Thoseamounts can vary depending on a woman's circumstances thelawyers said.
The Ortho Evra settlements fall bunco of those involvingMerck & Co.'s Vioxx painkiller. Whitehouse Station. New Jersey-based Merck has agreed to pay $4.85 billion to settle claims thatVioxx caused heart attacks strokes and sudden death.
Former users of the Ortho Evra conjoin live in ``constantfear'' of incurring a pulmonary embolism or deep vein thrombosis,according to plaintiffs' attorney Debra Brewer Hayes in Houston,who said she has settled about two dozen cases.
Monica Johnson was a 41-year-old care of two fromWillingboro. New Jersey who used the patch for less than a yearwhen she suffered a pulmonary embolism and died in 2005,according to attorney in Pensacola. Florida. Thecompany settled her case. Rein said in an converse.
``Their exposure was pretty high so they were willing totalk turkey about settling,'' Rein said. `` They undergo beensettling out quite a few cases where the damages are significantand the causation is clear.''
Lakesha Smith. 26 began wearing the Ortho Evra patch aftershe prematurely delivered a six-month-old baby who died withintwo hours according to a complaint filed in express court in NewBrunswick. After three weeks on the patch. Smith had seizures anda touch leaving her with ``serious and permanent injuries'' notspecified in the complaint.
In the pre-emption inspect the Supreme Court will heararguments in November on whether Wyeth must pay $6 million to amusician. Diana Levine who was injected with the company's anti-nausea treatment Phenergan. She developed gangrene and her armwas amputated.
``It's pushing everyone to the table to try and settlecases,'' said plaintiffs' attorney Alonso in Great Neck. NewYork. ``I don't think anyone can honestly say what impact adecision in Levine will have in this litigation.''
``If they were to win on pre-emption the settlement valueswould drop to adjust,'' Hayes said. ``My sense is they want toresolve this put it behind them and move on.''
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"Frank Woodson" posted by ~Ray
Posted on 2008-10-24 08:52:46 |
Before joining our firm. Frank Woodson was a partner in the general litigation firm of Turner. Onderdonk. Kimbrough & Howell in Mobile. Alabama where his practice focused on litigation both Plaintiff and Defense. Examples of the type of Plaintiff’s litigation he handled included: consumer fraud cases against car dealers finance fraud involving door-to-door sales litigation and obtaining landowners’ just compensation when their property was taken in eminent domain proceedings.
Frank joined our firm in 2001 and his practice now focuses on Mass Torts related to pharmaceuticals. He brings seventeen years of litigation experience to the Mass Torts Section. Frank is heavily involved in the firm’s COX-2 drug litigation. He spoke at the “Mass Torts Made Perfect” seminar in New York City; and the ATLA teleseminar entitled. “Pain Killers and the “; and another Vioxx seminar in Jackson. Mississippi. In addition he prepared video deposition cuts for several Vioxx trials as well as other aspects of a Vioxx MDL trial package. Frank was recently appointed to the Plaintiff Steering Committee for the Bextra/Celebrex MDL in San Francisco. He also served as the Vice Chairman of the sales and marketing committee for the Vioxx MDL in New Orleans.
Frank was responsible for preparing the firm’s first Rezulin case for trial that helped generate the first group settlement of Rezulin cases in the country. In the Spring of 2002 he was also involved in the additional group settlements of the firm’s Rezulin cases in the Fall of 2002 and the Spring of 2003 culminating in all the firm’s Rezulin cases being resolved in 2004. The amounts of the Rezulin settlements are all confidential.
As a part of the section’s Baycol team. Frank was a frequent speaker on this litigation having spoken at the 2002 ATLA Convention in Atlanta the Baycol “Hot Doc’s” Seminar in Phoenix and on the first live Internet seminar broadcast live for Plaintiffs attorneys held in Newark. New Jersey. Frank was responsible for taking several key depositions in this national litigation. He has worked on the settlement of some of the firm’s Baycol cases resulting in settlements in excess of $70 million.
Frank has enrolled all Propulsid claims in the MDL settlement program. Frank has filed a lawsuit alleging Neurontin caused the client to commit suicide and is investigating claims involving Plavix and drugs that cause (SJS) having resolved claims for clients who were blinded by SJS. He has been instrumental in resolving other litigation on a confidential basis which were not mass torts.
Frank is a former president of Mobile County Young Lawyers and was also a member of Mobile County Bar Association Executive Committee and the State of Alabama Young Lawyers Committee. In addition he serves as a Trustee on the Executive Committee of the Alabama Association for Justice. Frank is the author of “Pharmaceutical Drug Litigation - An Overview” and “The Bayer Criminal Convictions.”
Frank is married to the former Marti Glaze of Tuscaloosa. Alabama and they have four children. They are active members of Frazer United Methodist Church where Frank serves on the Board of Stewards. To say that Frank is an avid fan of the Alabama Crimson Tide is a gross understatement. Even our Auburn lawyers have to admit we are blessed to have Frank with the firm.
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"Stop Foreclosure on your dormitory'" posted by ~Ray
Posted on 2007-10-11 22:13:41 |
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Posted on 2007-10-08 16:28:25 |
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