Yourlawyer.com (Diseases News) http://www.yourlawyer.com/practice_area/diseases Tue, 18 Jun 2013 17:38:03 -0400 pixel-app en Massachusetts Girl Awarded $63M for Side Effects Injuries Caused by Motrin http://www.yourlawyer.com/articles/read/19199 Wed, 20 Feb 2013 00:00:00 -0500 http://www.yourlawyer.com/articles/read/19199 A Boston jury has awarded a state teen and her parents $63 million for the life-threatening side effects she suffered after taking Children’s Motrin several years ago.

According to an AP and CBS report, Samantha Reckis was diagnosed with toxic epidermal necrolysis (TEN) and lost 90 percent of her skin, was blinded, and suffered life-threatening internal injuries after she took over-the-counter Children’s Motrin when she was 7 years old. TEN is the most severe form of Stevens-Johnson Syndrome (SJS), marked by inflammation of the mucous membranes in the body and severe skin reactions akin to burns.

The parents of Reckis filed a lawsuit against the makers of Motrin, healthcare giant Johnson & Johnson, claiming the company failed to warn about the risks associated with taking its over-the-counter medication, particularly of SJS and TEN. Following a recent five-week trial in Boston, the girl was awarded $50 million in compensatory damages for the injuries she endured and another $13 million was split between her parents.

Reckis had taken Motrin without incident in the past, according to details from the trial as provided by the report. It was around Thanksgiving in 2003 (when Reckis was about 7 years old) when her grandparents gave her Children’s Motrin to allay a fever that the young girl began to develop severe reactions after taking the medicine.

The girl began to develop severe rashes and “burns” on her skin and she was taken for emergency care as the inflammation had spread to her mucous membranes, including eyes, ears, nose, throat, and full respiratory system. As the condition worsened, Reckis had lost most of her skin and was facing life-threatening injuries. She also went blind. Pressure on her brain had built to a point that an emergency surgery in which doctors had to drill through her skull to relieve it was performed. She suffered only minor brain injuries as a result, mostly losing short-term memory.

SJS and TEN are rare side effects associated with taking some drugs, one of them being non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (the Active Ingredient in Motrin products). The Reckis’ claimed when they filed a lawsuit in 2007 against Johnson & Johnson that the company had failed to warn of the dangers associated with these side effects.

The company denied the claim that it failed to warn of these side effects, saying that per-label use of the drug is a proven effective way reducing the symptoms of headache and fever. Clearly, the jury in her case felt otherwise and awarded her this sum in damages.

Reckis is now 16 and an honors student but “must work twice as hard” as others in her class to maintain that level of academic success, caused by the injuries she suffered nearly a decade ago. In a statement to CBS News in Boston, her parents leveled sharp criticism of the drug company: “Drug companies like Johnson & Johnson can no longer hide behind an approval by the overworked FDA as an excuse not to warn consumers about known, devastating drug reactions like SJS and TEN. Parents like us have a right to know. It was an historic day for consumer safety.”

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FCC proposes updates to cell phone radiation standards http://www.yourlawyer.com/articles/read/18849 Mon, 18 Jun 2012 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18849 Federal officials are debating a proposal to revisit the issue of radiation emitted by cell phones and the dangers they pose to consumers.

According to a Reuters report, Federal Communications Commission Chairman Julius Genachowski has proposed a formal inquiry into the dangers posed by cell phones to consumers, specifically the amount of radiation they emit. For the formal inquiry to move forward, it must be approved by a majority of the five-person panel of FCC commissioners.

The FCC first set radiation emission standards for cellular devices in 1996, when only a limited number of Americans owned a cell phone. Since then, use of these devices has grown to almost uncontrollable levels and nearly 5 billion phones and other devices are in use today worldwide. This includes phones used by children.

The proposal from Genachowski concerns the testing standards the FCC uses to determine how much radiation is emitted from cell phones and wireless devices and whether current laws are too relaxed or too strict on the amount of radiation emitted from them. And unlike other organizations around the world which believe that radiation from cell phones can lead to health problems like tumor and cancer growth, domestic health and communications officials do not believe there is a connection.

Last year, the World Health Organization ruled that radiation from cell phones is a possible carcinogen and that more research was needed before determining that it is a likely cause of cancer. This opinion joins a growing concern that cell phones and the increasingly frequent use of them are affecting human health, specifically the growth of brain tumors and the development of glioma and meningioma. 

Regulators in California have proposed mandating that radiation emission levels from cell phones be clearly labeled on packaging for these products to give consumers more information on the dangers they possibly face from using them. These efforts have largely been blocked by the wireless industry which firmly believes their products do not pose a health risk to the public. 

A spokesperson for the FCC told Reuters the proposed review of the agency's standards is likely necessary because American standards "are the most conservative in the world" and they haven't been addressed in more than 15 years. 

Since that time, there have been numerous studies conducted on the safety of cell phones and the dangers posed by the radiation they emit through their radiofrequency. This form of radiation is different from the rays emitted from medical imaging tests like X-rays and CT scans but some studies believe these rays can alter brain activity.

Specifically in the FCC proposal is to update the standards regarding children and their exposure to the radiation from cell phones. 

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Breast Cancer Risk May Rise with Recent Depo-Provera Use http://www.yourlawyer.com/articles/read/18759 Thu, 05 Apr 2012 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18759 Depo-Provera (depo-medroxyprogesterone acetate, or DMPA) an injectable contraceptive used by about 1.2 million U.S. women, may increase the risk of invasive breast cancer in young women.  Depo-Provera is a progestin-only birth control method, and is made with the same type of progestin found in Prempro, a hormone replacement therapy medication that has been associated with breast cancer in post-menopausal women. 

Few studies have been done to assess the potential of Depo-Provera to cause breast cancer in young women.  However, some international studies have produced mixed findings.  To add to knowledge about this possible risk, researchers at the Fred Hutchinson Cancer Center compared data on 1,028 Seattle-area women ages 20 to 44 who had been diagnosed with breast cancer to 919 age-matched controls who did not have a history of breast cancer. About 10 percent of subjects in the study reported using Depo-Provera.

Recent use of Depo-Provera (within five years) for 12 months or longer was associated with a 2.2-fold increased risk of invasive breast cancer, the study found. Women who used DMPA for less than a year or who had stopped using it more than a year earlier did not have an increased risk of breast cancer.  The risk began to lessen in the months after a woman stopped using Depo-Provera.

“While DMPA is widely used by women throughout the world, there are limited data on the association between DMPA and breast cancer incidence,” Christopher I. Li, M.D., PhD., a member of the Hutchinson Center’s Public Health Sciences Division, said in a press release. “Our study adds to the body of knowledge from international studies conducted in a diverse group of countries – Kenya, New Zealand, Thailand, Mexico and Costa Rica – which have shown that one of the risks associated with DMPA use may be an increased risk of breast cancer."

 

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3 Moms File Lexapro Birth Defect Lawsuits http://www.yourlawyer.com/articles/read/18704 Mon, 27 Feb 2012 00:00:00 -0500 http://www.yourlawyer.com/articles/read/18704 The makers of Lexapro have been named in three lawsuits alleging the drug caused birth defects when taken by pregnant women.  The plaintiffs in the lawsuits are mothers, all of whom took Lexapro while pregnant and gave birth to a child with a congenital defect.

The lawsuits, which were filed in Missouri's St. Louis County Circuit Court earlier this month, assert that the birth defects may have occurred because of the increased levels of serotonin that Lexapro promotes. The plaintiffs, Kimberlee Fisher, Kristy Hernandez and Leah Scott, each allege that they were unaware of Lexapro's risks when they used the drug because Forest Laboratories and Forest Pharmaceutical negligently failed to fully disclose the results of tests it had conducted and failed to warn the medical community that Lexapro could cross the placental barrier. They each state that they would not have taken Lexapro during their pregnancy had they been warned about the drug's risks.

Fisher's daughter, Isabella, was born on Nov. 23, 2009, and diagnosed with spina bifida.  Kayla Hernandez had a club foot when she was born on Aug. 6, 2010 while Damian Guidry had a bilateral cleft lip and palette upon his birth Dec. 28, 2007, the suits state.

A growing umber of studies have linked Lexapro other selective serotonin reuptake inhibitor (SSRI) antidepressant use in pregnancy with serious birth defects, including persistent pulmonary hypertension in newborns (PPHN), heart defects, lung defects, abdominal defects, cranial defects and other malformations.  

GlaxoSmithKline, the maker of Paxil, has been named in more than 800 lawsuits alleging that SSRI caused birth defects, while Pfizer faces more than 50 birth defect lawsuits over its SSRI, Zoloft.



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French-Made Silicone Breast Implant at Center of Cancer Scare http://www.yourlawyer.com/articles/read/18656 Thu, 22 Dec 2011 00:00:00 -0500 http://www.yourlawyer.com/articles/read/18656 Fears that a recalled silicone breast implant could cause a rare form of cancer are spreading around the world.   According to a report in The New York Times, regulator in at least a half dozen countries are trying to ease fears among women who have received silicone breast implants made by Poly Implant Prosthese (PIP), a now-defunct French company.

The fears are most acute in France, where 30,000 women received PIP silicone breast implants before they were pulled from the market last year.  The company faces a criminal probe there for using industrial silicone, rather than medical-grade material, in the implants.   French regulators have received about 1,000 reports of PIP silicone breast implants rupturing.  But most worrisome, at least 8 cases of a rare cancer called anaplastic large cell lymphoma (ALCL), including one death, have been reported in French women who received the implants.

So far, investigators haven't been able to prove the implants caused the cancer.  Nevertheless, the French health ministry said yesterday it would recommend that the government there cover the cost of removal in women who received PIP silicone breast implants for reconstructive surgery.

Alexandra Blachere, the leader of a French PIP implant patient group, told Reuters that en from Italy and Spain had been in touch with her with worries about their implants, and she'd seen reports of problems in other countries, including in Venezuela and Brazil.

"It's not just France that's concerned. We're looking at 300,000 to 400,000 potential victims in the world," Blachere said.

According to CNN, PIP never sought approval from the U.S.  Food & Drug Administration (FDA) to sell the silicone breast implants in the U.S., so they were never available to women here.  In March 2000, the FDA decided not to approve saline PIP implants for sale here.

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No Conclusion From FDA on Possible SSRI Antidepressant, PPHN Link http://www.yourlawyer.com/articles/read/18647 Wed, 14 Dec 2011 00:00:00 -0500 http://www.yourlawyer.com/articles/read/18647 The U.S. Food & Drug Administration (FDA) still can't answer the question of whether taking selective serotonin reuptake inhibitor (SSRI) antidepressants  during pregnancy may increase the risk that a baby will be born with pulmonary hypertension of the newborn (PPHN).  In a Drug Safety Communication issued yesterday, the agency said studies on the possible connection between SSRIs and PPHN are conflicting, making it too soon to draw any conclusions about the risk.

The FDA reviewed a total of five studies as part of its SSRI - PPHN safety review.  Two indicated an increased risk.   The first, published in 2006 in the New England Journal of Medicine, reported a six-fold increase in PPHN among newborn babies whose mothers were exposed to an SSRI after 20 weeks of gestation.   The 2008 study in the journal Pharmacoepidemiol Drug Safety found a statistically significant association between SSRI use and PPHN, though the majority of exposures occurring during the first trimester of pregnancy. However, three additional studies reviewed by the FDA did not report a higher risk of PPHN among children born to mothers who used SSRI antidepressants.

"At present, FDA does not find sufficient evidence to conclude that SSRI use in pregnancy causes PPHN, and therefore recommends that health care providers treat depression during pregnancy as clinically appropriate. FDA will update the SSRI labels as any new data regarding SSRI use and PPHN become available," the FDA statement said.

For now, the FDA said it is updating the SSRI drug labels to reflect the new data and the conflicting results.  The agency advised doctors and patients to weigh the possible risk of PPHN against risks associated with under-treatment or no treatment of depression during pregnancy when deciding whether or not use of an SSRI is warranted during pregnancy.

SSRI antidepressants are the most commonly prescribed drug to treat depression in pregnant women.  But as the FDA points out, there are no adequate and well-controlled studies of SSRIs in pregnant women.



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SSRI Antidepressants Cause Autism Traits in Study Rats http://www.yourlawyer.com/articles/read/18599 Tue, 25 Oct 2011 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18599 Another study has found a possible link between autism and pre-natal exposure to selective serotonin reuptake inhibitor (SSRI) antidepressants.   The study, published in the Proceedings of the National Academy of Sciences and involved rats, found that those exposed to the SSRI antidepressant, Celexa, were more likely to exhibit traits of autism spectrum disorders (ASD).

The animals in the study were given Celexa after birth, and at key stages of brain development.  The rats were administered Celexa following birth because they are earlier stage of brain development compared to humans (equivalent to the end of the sixth month of fetal development in humans).

Among other things, the rats treated with Celexa showed abnormal responses to changes in their environment, were uninterested in play when young and displayed poor social behaviors as adults.  In humans, such traits are associated with ASD.

The study also found that autism-like behaviors occurred more often in the treated male rats than in treated females. Similarly, ASD is diagnosed more often in males.

As the use of SSRI antidepressants has increased among pregnant women, so has the incidence of autism and ASD.  The number of pregnant women taking SSRIs has grown from about .5 percent in 1985 when the first one came on the market to nearly 10 percent today.  At the same time, autism has also become more prevalent.  1996, the rate of incidence was less than 1 in 1,000 births and by 2007 it reached about 1 in 200.

"The diagnosis has widened with the awareness that it's a spectrum disorder that encompasses a whole range of communication problems, but that doesn't account for all the increase by any means," Dr. Ian Paul, University of Mississippi Medical Center (UMCC)  professor of psychiatry and human behavior, said in a press release detailing the new study's findings.

The latest researched comes on the heels of an epidemiologic study in humans, published in July in the Archives of General Psychiatry. That investigation found that children of mothers who took SSRIs during the year prior to giving birth ran twice the normal risk of developing autism.


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Zoloft Lawsuit Filed Over Baby's Anencephaly http://www.yourlawyer.com/articles/read/18585 Tue, 18 Oct 2011 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18585 The parents of a little boy who died from the birth defect, anencephaly, have filed suit against Pfizer Inc., claiming the antidepressant, Zoloft, caused the disorder.   According to a report from Courthouse News Service, Susan and James Hodge allege Pfizer knew of birth defect risks associated with Zoloft but did nothing to alter the drug's prescribing information. 

Zoloft belongs to a class of antidepressants known as selective serotonin inhibitors, or SSRIs.  Other SSRIs include Prozac, Paxil, Celexa, Lexapro and others.   In 2006, the U.S. Food & Drug Administration (FDA) asked the manufacturers of several SSRI antidepressants to add information to their labels describing the potential risk of persistent pulmonary hypertension of the newborn (PPHN) after a study in the New England Journal of Medicine (NEJM) found a six-fold increased risk of the disorder among infants born to mothers who took an antidepressant in the last trimester of pregnancy.

A 2007 study published in the Harvard School of Public Health  that drew on data from the Centers for Disease Control's National Birth Defects study also found that anencephaly was one of three neural tube defects most often associated with a mother's use of an SSRI antidepressant.

According to the Hodge's lawsuit, before taking Zoloft, Susan “relied upon the fact that congenital birth defects ... were not listed or emphasized on the Zoloft monograph and/or drug information as a basis to believe that Zoloft was safe for use during her pregnancy."

The Hodges’ son, Dillon, was born on October 1, 2009 with anencephaly, a birth defect "generally described as the absence of a large part of the brain and skull," according to their complaint.    Anencephaly is always fatal, and Dillon died the day after his birth.

"During the entire time Zoloft has been on the market in the United States, FDA regulations have required Pfizer to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and Zoloft," the complaint states. "The regulations specifically state that a casual link need not have been proven to issue the new warnings. Further, the regulations explicitly allowed Pfizer to issue such a warning without prior FDA approval."

"Thus, prior to the mother plaintiff's pregnancy, Pfizer had the knowledge, the means, and the duty to provide the medical community and the consuming public with a stronger warning regarding the association between Zoloft and congenital birth defects," it continues.

The Hodges seek punitive damages for product liability, negligence, fraud, breach of warranty, unjust enrichment, false advertising and wrongful death, according to Court House News.

The Hodges filed their lawsuit in Cuyahoga Court of Common Pleas in Ohio.


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British Report Finds Metal-on-Metal Hip Implants Failing Faster http://www.yourlawyer.com/articles/read/18558 Fri, 16 Sep 2011 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18558 A new report from the United Kingdom finds that premature failures of DePuy Orthopaedic’s ASR hip implant, as well as other metal-on-metal hip implants, are increasing.  The report focuses on U.K recipients of all-metal hip implants, but according to The New York Times, its findings do not bode well for U.S. hip implant recipients, as some 500,000 are estimated to have received all-metal devices In fact, about 40,000 of the 90,000 ASR hip implants sold worldwide prior to  its August 2010 recall were used in this country.

The report draws data from National Joint Registry for England and Wales.  According to a statement issued from the registry, while all of the non-metal prostheses types reported a less than 1 percent increase in revision rates, the metal-on-metal group climbed 4.11 percent.  The registry also found that women were experiencing the highest rates of metal-on-metal hip implant failure. At five years, revision rates for a 60-69-year old female were 7.34 percent for traditional hip replacement with metal-on-metal devices. Meanwhile, the same statistics for men with all-metal devices came in 5.48 percent the report said.

DePuy's ASR hip implant, which was recalled last year because of an unexpectedly high number of early failures, was associated with the highest rate of early failure.  According to The New York Times, the British Registry is following 2,100 ASR patients who received the implant in traditional hip replacement surgery, which is how the devices were used in the U.S. The registry found that 29 percent of those who received the implant six years ago experienced failure, while 17 percent who received the ASR five years ago had failures. A hip implant should last for 15 years.

It is believed all-metal hip implants can shed dangerous amounts of cobalt and chromium through wear, leading to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems.    In May, the U.S. Food & Drug Administration (FDA) asked DePuy and 20 other manufacturers of metal-on-metal hip implants to conduct safety studies aimed at determining how often they fail prematurely, and if these devices are shedding dangerous amounts of metallic debris in patients. However, it will likely be years before those studies are completed.

In August, the Times reported that since January, the FDA received around 5,000 adverse event reports related to all-metal hip replacements, more than it received in the previous four years combined.

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Autism Linked to Use of SSRI Antidepressants Before or During Pregnancy http://www.yourlawyer.com/articles/read/18551 Tue, 13 Sep 2011 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18551 A study published earlier this summer in the Archives of General Psychiatry has given women taking selective serotonin reuptake inhibitor (SSRIs) antidepressants another reason to speak with their doctor before becoming pregnant.  The study found that mothers treated with SSRI drugs, such as drugs Prozac, Luvox, Paxil, Celexa and Zoloft, either before or during the pregnancy face a slightly higher risk of having a child with autism spectrum disorder (ASD).

Many studies in the past have found an association between SSRI antidepressants and birth defects, including heart problems and neural tube defects.  In fact, the U.S. Food & Drug Administration (FDA) has placed most SSRIs in Pregnancy Category C, a classification that means they have been linked with birth defects in animal studies, but have not been proved safe or unsafe in humans because few studies have been conducted.  However, Paxil has been placed in Category D, meaning that studies have shown it to pose a risk to a developing fetus, but in some cases its benefits may outweigh its risks.

This latest study compared both pharmaceutical records and medical records of 289 mother-child pairs where the child had been an ASD diagnosis to more than 1,500 pairs where there was no such diagnosis.  According to Environmental Health News, the researchers - a team from Kaiser Permanente in Northern California - determined which mothers had taken an SSRI, paying special attention to when the prescription was issued relative to their pregnancy.  The researchers also accounted for maternal psychiatric illnesses, such as depression, as well as the severity of such illnesses.

The researchers found that children born to mothers who took an SSRI in the year before pregnancy faced a two-fold increased risk of being diagnosed with ASD.  The risk jumped to nearly four-field if an expectant mother took an SSRI antidepressant in the first trimester of pregnancy.

The study is important because it provides the first look at the relationship between SSRI use and autism risk, Environmental Health News said.

 

 

 

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Study Backs Use of Rotarix, Despite Bowel Risk http://www.yourlawyer.com/articles/read/18419 Fri, 17 Jun 2011 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18419 A new study has found a slight risk of a serious bowl disorder associated with GlaxoSmithKline's rotavirus vaccine, Rotarix.  Still, authors of the Rotarix study, which was published in the New England Journal of Medicine (NEJM), say the benefits of the vaccine far exceed its risks.

The study confirms that the risk of the bowel disorder - intussusception - was not limited to the RotaShield vaccine, which was pulled from the U.S. market in 1999.  According to the Food & Drug Administration (FDA), that vaccine caused intussusception in 1 in 10,000 babies who got it. 

According to the Mayo Clinic, intussusception is a condition in which either the colon or small intestine slides into another part of the intestine.  This creates a blockage that cuts off the blood supply to the part of the intestine that's affected. The disorder can be fatal, but can often be successfully treated with prompt attention.

The NEJM Rotarix study was conducted by researchers at the U.S. Centers for Disease Control, as well as health agencies in Brazil in Mexico.  The study looked at children in those two Latin American countries, and found that between 1 in 51,000 and 1 in 68,000 vaccinated babies given Rotarix will develop intussusception.  The researchers noted an increased risk of intussusception 1 to 7 days after the first dose among infants in Mexico vaccinated with Rotarix.  There was no significant risk after the first dose in children in Brazil, but some increased risk 1 to 7 days after vaccination.

According to the study authors, data from both countries indicate that about 80,000 hospitalizations and 1,300 deaths are prevented in the two countries every year by vaccinating babies against rotavirus. 

An editorial accompanying the study notes that researchers in Australia have reported a small intussusception risk with a Merck vaccine called RotaTeq.  

"The vaccines’ pluses so outnumber the minuses that it’s almost immaterial to talk about the minuses,” Greenberg said. “In places like the United States or Western Europe, the new vaccines substantially reduce hospitalizations and morbidity,” Harry Greenberg, MD, author of the editorial writes. "They save hospital costs, plus the cost of work lost to parents who have to bring their child to the doctor or have the child hospitalized.”

Greenberg goes on to write that the research suggests that natural rotavirus infection itself probably causes intussusception at some low frequency.

In March 2010, use of Rotarix was temporarily suspended by the FDA after it was found to contain a pig virus called porcine circovirus 1, or PCV1. But in May of that year, the agency recommended that physicians resume using Rotarix and continue using Merck's RotaTeq, citing their "strong safety records."


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Citing Muscle Risks, FDA Restricts Highest Zocor Dose http://www.yourlawyer.com/articles/read/18402 Thu, 09 Jun 2011 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18402 Patients taking the statin Zocor (simvastatin) should not be given the highest 80 mg dose in their first year of treatment, according to the U.S. Food & Drug Administration (FDA).  The agency's review of a clinical trial, as well as an analysis of its adverse even reports prove that such patients face the highest risk of suffering myopathy (severe muscle injury), including it's most severe form, rhabdomyolysis.

Zocor 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury, the FDA said. The FDA also said health care professionals should switch such patients to another statin if they find that taking 40 mg of simvastatin isn't meeting their LDL cholesterol goal, rather than raising the simvastatin dose to 80 mg.

The agency also revised the labels for generic forms of simvastatin, Vytorin and Simcor. In addition, the FDA has revised the labeling of simvastatin products to include new dosing recommendations when these drugs are used with certain medications that interact to increase the level of simvastatin in the body, which can increase the risk for myopathy.

Muscle injury is a known side effect of statins, and drugs in this class already bear a warning to this effect.   But evidence reviewed by the FDA indicates the risk is higher among patients treated with high dose Zocor during their first 12 months of therapy. That evidence included Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) revealed 52 cases of myopathy occurring in the group of patients treated with 80 mg simvastatin versus one in the group treated with 20 mg.   Twenty-two patients in the 80-mg group developed rhabdomyolysis, while none in the 20-mg group developed the disorder.

The risks for myopathy and rhabdomyolysis with the 80 mg dose were highest in the first 12 months of treatment, 5 per 1000 person-years and 2 per 1000 person-years, respectively.   The risk for myopathy decreased to 1 per 1000 person-years after one year, while the risk for rhabdomyolysis fell to 0.4 per 1000 person-years, the agency said.

According to a report in The New York Times, the FDA's decision to restrict high-dose Zocor is viewed by many as long-overdue.

“Most experts in the field have known for many years that these high doses of Zocor were not safe compared with the other statins," said Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen pointed out that two other statins - Lipitor and Crestor - are more potent and can accomplish the same cholesterol targets at lower doses, the Times said.

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Exposure to Pesticide Ziram Associated with Higher Risk of Parkinson's Disease http://www.yourlawyer.com/articles/read/18386 Tue, 31 May 2011 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18386 A group of UCLA researchers who were the first scientist to link exposure to the pesticides maneb and paraquat to Parkinson's disease have now connected a third – ziram - to the neurological disorder.  The same team also found that combined exposure to ziram, maneb and paraquat near any workplace - farm or nonfarm - increased the risk of Parkinson's disease threefold.

Parkinson’s disease, a brain disorder common after the age of 50, leads to shaking and difficulty with walking, movement and coordination. The disease has been reported to occur at high rates among farmers and in rural populations, contributing to the hypothesis that agricultural pesticides may be partially responsible.

The UCLA researchers first discovered the connection between maneb and paraquat and Parkinson's disease in a study published in 2009.  That study found that the risk for Parkinson's disease for people who lived near farm fields that were sprayed with the two pesticides increased by 75 percent.

For this study, the same group of researchers evaluated 703 people, including 362 with Parkinson’s, who lived in California’s heavily agricultural Central Valley from 1974 to 1999. They found that that the combined exposure to ziram, maneb and paraquat near any workplace increased the risk of Parkinson's disease (PD) threefold, while combined exposure to ziram and paraquat alone was associated with an 80 percent increase in risk.

This is the first study that provides strong evidence in humans that the combination of the three chemicals confers a greater risk of Parkinson's than exposure to the individual chemicals alone, according to the study authors.

"Our estimates of risk for ambient exposure in the workplaces were actually greater than for exposure at residences,"  Dr. Beate Ritz, senior author and a professor of epidemiology at the UCLA School of Public Health, said in a UCLA press release.  "And, of course, people who both live and work near these fields experience the greatest PD risk. These workplace results give us independent confirmation of our earlier work that focused only on residences, and of the damage these chemicals are doing."

In animal studies conducted as part of the research, the team found that ziram was especially destructive to neurons that use the transmitter chemical dopamine to send messages.  They die off in regions of the brain that govern motor function, causing symptoms, such a tremor, that are typical in Parkinson's patients.  When ziram was given systemically to rodents, it reproduced many of the features of Parkinson's disease.

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Fewer Kidney Patients Received Gadolinium Agents Following 2006 NSF Alert http://www.yourlawyer.com/articles/read/18225 Thu, 04 Nov 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18225 Fewer kidney patients have received gadolinium contrast dyes during MR studies since the US Food & Drug Administration (FDA) first issued warnings about their association with nephrogenic systemic fibrosis (NSF) in 2006. NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs that can be fatal. Evidence suggests that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes.

Gadolinium contrast dyes are sold under the names Ablavar, Eovist, Magnevist, Multihance, Omniscan, Optimark, and Prohance. In 2007, the FDA mandated that all gadolinium agents sold in the US carry a black box warning – the agency’s strongest safety notice – regarding the risk of NSF. This past September, the FDA ordered the warning be strengthened.  

All gadolinium contrast dye labels will now emphasize the need to screen patients to detect these types of kidney dysfunction before administration, the FDA said. Three of the dyes which the FDA said are associated with a greater risk of NSF compared to the other agents, Bayer Healthcare’s Magnevist, GE Healthcare’s Omniscan, and Covidien’s Optimark, will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease.

According to a new study published in the American Journal of Kidney Diseases, the rate at which patients with kidney disease are exposed to gadolinium agents has dropped significantly since the initial FDA alert was issued. The study looked at patients receiving medical care in the US Department of Veterans Affairs Health Care System. From July 2005 to September 2008, a total of 1,080,536 MR studies were performed. Of these, 406,003 (38 percent) were gadolinium-enhanced MR studies

From the first warning in 2006 through the fourth quarter of 2008, the usage of gadolinium agents in patients undergoing MR studies was essentially unchanged for patients with a glomerular filtrate rate (GFR), a measurement of kidney function, above 60. The rate declined, however, by 71 percent for those with a GFR of 15-30 and 61 percent for patients with a GFR of 15 or less. A GRF under 30 is indicative of kidney failure. Patients with a GFR of 15 or less must undergo dialysis

In addition, the rate declined 81 percent among subjects who had received recent dialysis (98 percent for a subset of patients with acute kidney injury).

Meanwhile, the rate of use of non-gadolinium MR agents increased for all GFR categories, except for patients who had received recent dialysis. The rate rose by 19 percent for patients with a GFR of 15-30 and by 71 percent for those with a GFR of 15 or below.

In addition, it appears that clinicians began screening patients for kidney issues prior to their MR studies after the FDA issued its first gadolinium alert in 2006. During the time frame covered by the study, the proportion of gadolinium enhanced MR studies with serum creatinine measurements – a test used to measure GFR – obtained within one month, three months, and six months prior to the study increased by 99 percent, 59 percent and 41 percent.

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FDA Stregnthens Warnings on Gadolinium MRI Dyes http://www.yourlawyer.com/articles/read/18074 Thu, 09 Sep 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18074 Gadolinium-based contrast dyes will now bear new warnings on their labels regarding their association with nephrogenic systemic fibrosis (NSF), according to the Food & Drug Administration (FDA). Gadolinium-based contrast dyes are intravenous drugs approved by the FDA for use with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) to help detect abnormalities of body organs, blood vessels, and other tissues.

Three of the dyes, Bayer Healthcare’s Magnevist, GE Healthcare’s Omniscan, and Covidien’s Optimark, will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All gadolinium contrast dye labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration, the FDA said.

In a statement, the FDA said these label changes are intended to help ensure these drugs are used appropriately, and that patients at risk for NSF who receive these agents are actively monitored for the development of the disease.

In its announcement, the agency said its safety review of the most widely used gadolinium agents determined that Magnevist, Omniscan, and Optimark are associated with a greater risk than other gadolinium contrast dyes for NSF in certain patients with kidney disease.

To further enhance the safe use of the imaging agents, the FDA further recommends that health care professionals:

• Estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function.

• Avoid use of gadolinium contrast agents in patients suspected or known to have impaired drug elimination unless the imaging is essential and not available without contrast.

• Monitor for signs and symptoms of NSF if a gadolinium is administered to a patient with acute kidney injury or chronic, severe kidney disease.

• Administer a gadolinium contrast agent only once during an imaging session.

NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.

While not much is known about the disease, a growing mountain of evidence indicates that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes. Since 2007, all gadolinium agents sold in the U.S. have carried the same black box warning – the FDA’s strongest safety notice – regarding the risk of NSF.

GE Healthcare and the other makers of gadolinium agents are named in approximately 500 lawsuits filed by NSF patients, most of which have been consolidated in the U.S. District Court for the Northern District of Ohio as part of a multidistrict litigation (MDL) before Judge Dan Polster.

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Paper Questions ALS Diagnosis in Athletes, Soldiers http://www.yourlawyer.com/articles/read/18011 Tue, 17 Aug 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18011 A newly-published scientific paper contends that some soldiers and athletes diagnosed with Lou Gehrig’s disease – amyotrophic lateral sclerosis (ALS) – may have actually been victims of concussions and other brain trauma. The paper is to be published tomorrow on the Web site of the Journal of Neuropathology & Experimental Neurology.

The papers findings will be discussed this evening during a segment of the HBO sports program “Real Sports.” The program airs at 10 p.m. EST.

According to the ALS Association Web site, Lou Gehrig’s disease – named for the Yankee slugger believed to have succumbed to ALS in 1941 – is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death.

According to a report in the New York Daily News, ALS is rare, affecting only about 100,000 people. But NFL players have a higher rate of the disease than the general population. Statistically, only about two should have the disease, but the Daily News pointed out that since 1970, 14 NFL players have been diagnosed with ALS.

Players in other sports also have a higher rate of ALS than the population at large, the Daily News said. In Canada, eight Canadian Football League players have been diagnosed with the fatal ailment, and in Italy, more than 40 professional soccer players are victims.

According to an Associated Press report, Dr. Ann McKee, a neurology professor at Boston University and one of the paper’s authors, was able to study the brains and spinal cords of ex-Minnesota Vikings linebacker Wally Hilgenberg, former Southern California linebacker Eric Scoggins, and a boxer whose family asked that his name be kept private. All suffered head injuries in the course of their careers, and all later died of Lou Gehrig’s disease. McKee found toxic proteins in the spinal cords of all three individuals, the Associated Press said.

McKee has studied chronic traumatic encephalopathy (CTE), a disease linked to head injuries that causes cognitive decline, abnormal behavior and dementia. She said the proteins were not found in the spines of athletes with CTE who didn’t have Lou Gehrig’s disease, and they were not found in non-athletes who died of ALS, according to the Associated Press.

According to a report in The New York Times, both Mckee and her colleague, Dr. Robert Stern, said the finding solidifies a long-suspected connection between ALS-like motor disease and head trauma experienced in collision sports and combat.

“People are being misdiagnosed clinically while they’re alive as having A.L.S. when in fact they have a different motor-neuron disease,” Stern said. He added that the new information will lead to a better understanding of the disease and more effective treatments.

The paper does not address the case of Lou Gehrig specifically, but the as the Time’s points out, the baseball legend was the victim of some significant head injuries – including concussions – during his career, and was known for playing through his injuries. For example, during one game in 1934, Gehrig was hit with a pitch just above the right eye and was knocked unconscious for what was described in news reports as five minutes. Despite a headache and a large bump on his head, Gehrig played the next day.

It’s entirely possible, the Times said, that Gehrig did not die from the disease that was named for him. However, it is impossible to know for sure, as his remains were cremated.

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Jury Awards Popcorn Lung Victim $30 Million http://www.yourlawyer.com/articles/read/18012 Tue, 17 Aug 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18012 A man who worked at a Flavorchem Corp. plant in the Chicago area has been awarded $30 million in a Popcorn Lung lawsuit. According to a report in the Joplin Globe, the verdict is the largest rendered to date in a lawsuit involving the chemical diacetyl, an ingredient in butter flavoring.

Popcorn Lung, known formally as Bronchiolitis obliterans, is a potentially life-threatening, irreversible ailment, for which the only cure is a lung transplant. Popcorn Lung inflames the bronchioles—small lung airways—causing scarring and “obliterating” appropriate airflow. The condition received its nickname in 2007 when it was found to be occurring in popcorn plant workers.

In 2003 and 2004, the National Institute on Occupational Safety and Health found a link between diacetyl and the development of Popcorn Lung among hundreds of workers at six Midwestern popcorn factories. In April 2007, the Centers for Disease Control and Prevention reported that workers at food flavoring factories, as well as popcorn plants, were at risk for the disease.

Since the link between the disease and diacetyl has been established, hundreds of food industry workers have filed Popcorn Lung lawsuits.

According to the Joplin Globe, the verdict in this latest case was awarded to Gerardo Solis, 45, who worked at the Flavorchem plant between1998 and 2006 when he was diagnosed with Popcorn Lung. The lawsuit named BASF Corp., a supplier of diacetyl and the world’s largest chemical company, as a defendant.

Solis’ lawsuit said he is totally disabled with 25 percent of normal lung capacity and is projected to require a lung transplant within the next 10 years.

Prior to the Solis verdict, the largest judgment awarded to a Popcorn Lung victim was $20 million, the Joplin Globe said. That verdict was granted in 2004 to a man who worked at the former Jasper Popcorn Co. plant. and his wife.

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Few Aware That Zinc in Denture Creams Pose Health Risk http://www.yourlawyer.com/articles/read/17852 Mon, 28 Jun 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17852 Scores of denture wearers who have suffered unexplained neurological injuries are now only beginning to realize that zinc-containing denture creams could be to blame for their ailments. Excessive exposure to zinc, which is used as a bonding agent and odor blocker in Procter & Gamble’s Fixodent, and until recently, GlaxoSmithKline’s Super Poligrip line, can cause copper depletion and eventually nerve damage.

The human body does need zinc – but only in small amounts. Studies show that consuming at least 50 milligrams of zinc a day for a few months could lead to copper deficiency, which can cause anemia, bone loss, nerve damage and other problems. Ingesting 80 or 100 milligrams or more for months or even years can lead to irreversible damage.

Compelling evidence exists that long-term exposure to the zinc in denture cream can lead to not only irreversible nerve damage, but to disability, as well. In August 2008, the peer reviewed journal Neurology reported on four patients suffering from neuropathy and other neurological symptoms typical of zinc poisoning and copper depletion. The article specifically linked excessive exposure to zinc in denture cream to “profound neurologic disease” in the patients reviewed.

In October 2009, the journal “NeuroToxicology” published an article on 11 patients who had suffered from significant injuries and neurological disorders for a period of years. The study authors discovered that all 11 patients had used Fixodent or another zinc-containing denture cream. Blood test confirmed that each suffered from zinc poisoning and copper deficiency. he authors of the “NeuroToxicology” article concluded that: “It appears the (11 patients’) disease is fully explained by denture cream use.”

Scores of people have sued Glaxo and Procter & Gamble, claiming their neurological injuries were the result of zinc in Fixodent and Super Poligrip. Last year, denture cream lawsuits pending in federal courts were consolidated in a multidistrict litigation in the United States District Court for the Southern District of Florida, Miami Division (MDL No. 2051). The first trials in that litigation could start in early 2011.

Procter & Gamble took steps in March to inform users that excessive exposure to zinc in Fixodent could pose health risks. Without much fanfare, the company placed new information on its Web site, www.dentureliving.com, stating that some reports suggest that excessive and prolonged zinc intake may be linked to adverse health effects. Procter & Gamble also began shipping Fixodent with updated label instructions on how to apply the product.

The month prior, Glaxo went even further, and made the decision to stop the manufacture, distribution and advertising of three versions of Super Poligrip that contained zinc. Glaxo said that the denture creams would be reformulated without zinc. The company’s statement read in part:

“We are taking these actions because we have become aware of potential health problems associated with the long-term excessive use of our zinc-containing denture adhesive products.”

Still, many denture cream users are unaware of this risk. And so are a lot of their doctors.

“A lot of my clients were complaining of symptoms and go to their doctors, and the doctors will simply ignore them; they are unaware of the zinc poisoning issues.” Andy a partner with the law firm of Parker Waichman LLP, and a Co-Lead Counsel to the Plaintiffs’ Steering Committee in the denture cream litigation, recently told Dallas’ News 8. “They are unaware that these products even contain zinc.”

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Omniscan, Magnevist and OptiMARK Associated with Most NSF Cases http://www.yourlawyer.com/articles/read/17845 Thu, 24 Jun 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17845 Omniscan by GE Healthcare, Magnevist by Bayer Healthcare Pharmaceuticals and Covidien’s OptiMARK are linked to the highest number of nephrogenic systemic fibrosis (NSF) cases, according the American College of Radiology. The group has advised radiologists to avoid using these three gadolinium contrast agents when administering MRIs to patients with chronic or acute kidney disease.

According to the American College of Radiology advisory, as of December 2009, NSF has been documented in 382 patients who received Omniscan; in 195 patients who received Magnevist; and in 35 patients who received OptiMARK.

In addition to recommending that these agents not be used in people with kidney disease, the group also suggests doctors should obtain renal function tests on their patients at least six weeks before performing an MRI that requires contrast injection.

NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.

While not much is known about the disease, a growing mountain of evidence indicates that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes. Since 2007, all gadolinium agents sold in the U.S. have carried the same black box warning – the Food & Drug Administration’s (FDA) strongest safety notice – regarding the risk of NSF.

GE Healthcare and the other makers of gadolinium agents are named in approximately 500 lawsuits filed by NSF patients, most of which have been consolidated in the U.S. District Court for the Northern District of Ohio as part of a multidistrict litigation (MDL) before Judge Dan Polster. The first trial in the multidistrict litigation, involving Omniscan, had been scheduled to start later in May, but that case has settled. The next Omniscan trial is slated for later this year.

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Drug Reaction Takes Life of NBA Hero Manute Bol http://www.yourlawyer.com/articles/read/17841 Wed, 23 Jun 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17841 Adverse drug reactions are the fourth-leading cause of death in the United States. Recently, one such reaction called Stevens Johnson Syndrome, or SJS, took the life of beloved NBA hero Manute Bol.

According to the Associated Press, Bol died last week at the University of Virginia Hospital in Charlottesville, where he was being treated for severe kidney trouble and Stevens Johnson Syndrome. It is believed Bol contracted the skin disease as a reaction to kidney medication he took while in Africa. He was only 47.

Bol played 10 seasons in the NBA with Washington, Golden State, Philadelphia and Miami and later worked closely as an advisory board member of Sudan Sunrise, which promotes reconciliation in Sudan. Bol averaged 2.6 points, 4.2 rebounds and 3.3 blocked shots.

According to the Associated Press, Bol was hospitalized in mid-May during a stopover in Washington after returning to the United States from Sudan. An official with Sudan Sunrise told the Associated Press that the skin around Bol’s mouth was so sore that he went 11 days without eating and could barely talk. Stevens-Johnson Syndrome also caused Bol to lose patches of skin.

“Anyone, at any age, can contract Stevens Johnson Syndrome,” Jean McCawley, the founder of the Stevens Johnson Syndrome Foundation, said in a statement. “The biggest issue we see is a lack of awareness about adverse drug reactions. Even with the unfortunate passing of Mr. Bol, there have been many incorrect statements made about SJS.”

Stevens-Johnson Syndrome causes blistering of mucous membranes, typically in the mouth, eyes, and vagina and patchy areas of rash. According to the Stevens Johnson Syndrome Foundation, almost any medication including over-the-counter drugs, such as Ibuprofen, can cause the disorder. Most commonly implicated drugs are anti-convulsants, antibiotics (such as sulfa, penicillin and cephalosporin) and anti-inflammatory medications. If left untreated, the disorder can lead to death.

Early signs and symptoms of Stevens Johnson Syndrome include:

• Rash, blisters, or red splotches on skin

• Persistent fever

• Blisters in mouth, eyes, ears, nose, genital area

• Swelling of eyelids, red eyes

• Conjunctivitis

• Flu-like symptoms

• Recent history of having taken a prescription or over-the-counter medication

As the Stevens Johnson Syndrome Foundation points out, that there is no mandatory reporting for allergic drug reactions, so there’s no way to know how many people contract Stevens Johnson Syndrome each year.

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Dutch Regulators Fault GE for Failing to Report Omniscan NSF Case http://www.yourlawyer.com/articles/read/17832 Fri, 18 Jun 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17832 The Danish Medicines Agency has charged that GE Healthcare violated Dutch law when it failed to promptly and completely inform regulators about a patient who died after developing nephrogenic systemic fibrosis (NSF) following exposure to Omniscan contrast dye. According to a report on ProPublica’s Web site, because the statute of limitations had expired, the agency said it would not pursue further action against the company.

GE Healthcare’s Omniscan is a gadolinium contrast dye. Such agents have been linked to NSF, a disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.

While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a gadolinium contrast dyes like Omniscan. Since 2007, all gadolinium agents sold in the U.S. have carried the same black box warning – the Food & Drug Administration’s (FDA) strongest safety notice – regarding the risk of NSF.

According to ProPublica, the woman at the center of the Danish case, Birthe Madsen, is believed to be among the first patients to develop NSF after exposure to a gadolinium agent. She had been injected with Omniscan for a magnetic resonance scan in 2002 and gradually became immobilized and died of a lung embolism the following year.

A Danish government insurance agency determined in 2004 that Omniscan caused her immobility and in turn her death, ProPublica said. GE Healthcare received this information, but the company did not immediately report it to the Danish Medicines Agency as required by law. A follow-up also did not mention the insurance agency’s conclusion.

GE Healthcare and the other makers of gadolinium agents are named in approximately 500 U.S. lawsuits filed by NSF patients, most of which have been consolidated in the U.S. District Court for the Northern District of Ohio as part of a multidistrict litigation. As ProPublica points out, a key debate in the litigation concerns what GE Healthcare knew and disclosed to regulators about Omniscan’s risks. Critics of the company say more forthright disclosure might have helped doctors and regulators respond earlier and more effectively.

One such critic, ProPublica says, is Madsen’s son, Casper Schmidt, a Copenhagen lawyer.

“If my mother’s case had been reported more accurately, and if the company had to explain why a patient died,” Schmidt said in an e-mail to ProPublica, “it would have helped enable doctors and regulators to better understand the disease earlier.”

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Judge’s Omniscan Ruling Good News for Plaintiffs http://www.yourlawyer.com/articles/read/17742 Thu, 06 May 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17742 Attorneys representing hundreds of plaintiffs in Omniscan lawsuits have been given a wide berth by a judge overseeing the litigation. In a 58-page procedural ruling, U.S. District Judge Dan Polster restricted important parts of GE Healthcare’s case, but said most of the plaintiffs’ expert witnesses will be allowed to testify at trials.

GE Healthcare’s Omniscan is a gadolinium contrast agent used in MRI procedures. Such agents have been linked to a debilitating disease called nephrogenic systemic fibrosis (NSF). The disease leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.

While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a gadolinium contrast dyes like Omniscan. Since 2007, all gadolinium agents have carried the same black box warning – the Food & Drug Administration’s (FDA) strongest safety notice – regarding the risk of NSF.

GE Healthcare and the other makers of gadolinium agents are named in approximately 500 lawsuits filed by NSF patients, most of which have been consolidated in the U.S. District Court for the Northern District of Ohio as part of a multidistrict litigation (MDL) before Judge Polster.

GE Healthcare had attempted to exclude many of the plaintiffs’ theories and witnesses from the proceedings. But Judge Polster has rejected those attempts, including one that would have barred a plaintiff theory that Omniscan breaks down chemically, releasing a toxic metal that triggers the disease. He also ruled to allow the testimony of two medical school professors that the company failed to properly warn radiologists about Omniscan.

In addition, Judge Polster ruled that he would not permit GE Healthcare’s in-house expert to testify that NSF has occurred in the absence of exposure to gadolinium-based agents because the two studies that served as the basis for that opinion are “fundamentally flawed.” He also said GE Healthcare would not be allowed to introduce testimony by a former FDA official that the agency would have stopped the company from unilaterally changing its label to include stronger warnings on the NSF risk.

Judge Polster’s decision will likely make it easer for plaintiffs to present their case, and much more difficult for GE Healthcare to mount a defense.

The first trial in the multidistrict litigation, involving Omniscan, had been scheduled to start later this month, but that case has settled. The next Omniscan trial is slated for later this year.

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GE Healthcare Advised to Restrict Omniscan in 2006 http://www.yourlawyer.com/articles/read/17712 Mon, 19 Apr 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17712 GE Healthcare’s own experts recommended in May 2006 that it proactively restrict the use of Omniscan, a gadolinium contrast dye, after it was linked to nephrogenic systemic fibrosis (NSF). According to a ProPublica investigation, rather than take that advice, GE spent the next year arguing that approach wasn’t necessary.

According to ProPublica, the recommendation came at a meeting convened by GE Healthcare’s vice president for drug safety. It was prompted by reports in Europe that linked Omniscan to a potentially crippling disease that would be come to be known as NSF. Details of the meeting were revealed in a newly unsealed order in a lawsuit against the company, ProPublica said.

Instead of following the advice of its owns safety experts to restrict the use of Omniscan in high risk patients, GE publicly took the position that its drug was no more dangerous than those of its competitors and argued against putting an exclusive warning on the drug’s label.

According to ProPublica, the order also references previously sealed evidence indicating that doctors and the U.S. Food & Drug Administration (FDA) had not seen internal company research that raised questions about Omniscan’s propensity to break down chemically, releasing the potentially toxic metal gadolinium into the body.

Plaintiffs’ lawyers see the May 2006 meeting as pivotal because many patients were exposed to Omniscan afterward, ProPublica said.

NSF is a debilitating leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death. While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a gadolinium contrast dyes like Omniscan.

Since 2007, all gadolinium agents have carried the same black box warning – the FDA’s strongest safety notice – regarding the risk of NSF. But last fall, the FDA released a risk assessment that indicated that Omniscan, along with two other dyes called OptiMark and Magnevist, carried a higher risk of the disease. The assessment cited 382 cases in which Omniscan was named as the single imaging agent in an NSF report. Magnevist was named in 195 reports and OptiMark in 35.

GE Healthcare and Omniscan are named in approximately 500 lawsuits filed by NSF patients. Most of these are pending in federal court. However, the unsealed order revealing the May 2006 meeting was issued in an Illinois case presided over by Cook County Circuit Judge Deborah Mary Dooling. According to ProPublica, Judge Dooling said the evidence she reviewed was sufficient to add a claim of punitive damages. However, the parties were able to reach a confidential settlement before it went to trial.

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Multivitamin, Breast Cancer Link Seen http://www.yourlawyer.com/articles/read/17679 Fri, 02 Apr 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17679 Could taking a multivitamin increase a woman's chance of breast cancer?  A new study, published in the American Journal of Clinical Nutrition, says it's possible.

The researchers pointed out that the study results do not prove that the supplements directly contribute to the disease. For example, it is possible that factors the study did not measure could explain the association between multivitamins and breast cancer. However, the researchers said the matter warrants further research.

The study authors recommend that until more is known about the possible association between multivitamins and breast cancer, women would be best served if they get vitamins and minerals from a well-balanced diet rather than pills.

The study involved 35,000 Swedish women aged 49 to 83. Just over a quarter said they took multivitamins. Overall, those women were 19 percent more likely to develop breast cancer. During about 10 years of follow-up, 974 women were diagnosed with breast cancer, and 293 of these diagnoses occurred among the 9,017 women who reported using multivitamins, WebMD said.

The women in the study did not provide information on what brands of vitamins they took. Other factors, like age, family history of breast cancer, weight, fruit and vegetable intake, and exercise, smoking and drinking habits, were taken into account.

According to a Reuters report, there are some plausible explanations for why multi-vitamin use would be associated with higher breast cancer rates. For example, other research has found that women who take multivitamins have increased breast density, which is linked to a relatively higher risk of breast cancer. However, Reuters said it is not clear if multivitamins actually cause the higher density.

Animal studies have also linked breast cancer to the B vitamin folic acid, Reuters said, though human studies have found varying results.

 

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FDA Urged to Reclassify, Restrict Tanning Beds http://www.yourlawyer.com/articles/read/17663 Fri, 26 Mar 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17663 Following a five hour hearing yesterday, a panel of outside experts urged the  Food & Drug Administration (FDA) to reclassify tanning beds and subject them to stricter regulations.

According to the American Journal of Dermatology, more than 30 million people tan indoors every year, and nearly three quarters of them are women between the ages of 16 and 29. Using a tanning bed before the age of 35 increases the risk of melanoma by 75 percent. It is one of the most common cancers among young adults in the United States, and it is on the rise in all age groups.

Concerns about the cancer risks associated with tanning beds have been growing in recent years. The International Agency for Research on Cancer, which is affiliated with the World Health Organization, just added tanning beds to its “Group One” list, which identifies the most harmful forms of radiation.

Earlier this year the Federal Trade Commission charged the Indoor Tanning Association with making false claims about the health benefits of their products. The group has entered a settlement agreement with the government and pulled the ads in question.

At yesterday’s panel meeting, representatives from the Skin Cancer Foundation, American Cancer Society and American Academy of Dermatologists, along with melanoma survivors, urged the FDA to reclassify tanning beds.

Members of the panel agreed that the devices should be reclassified, and said that more restrictions are needed to protect teenagers from the cancer risks of tanning beds. “Given the absence of any demonstrated benefit, I think it’s an obligation for us to ban artificial tanning for those under 18,” said panelist Dr. Michael Olding.

Not all panel members were in agreement with the idea of a ban, however, calling it unrealistic. Instead, they pushed for a requirement for strong warnings and parental notification.

Tanning beds and tanning lamps are listed as FDA Class I devices — those least likely to cause harm. But the FDA is considering reclassifying them as class II or class III medical devices, which would subject them to stricter regulation. By increasing their classification to Class II, the FDA could limit the levels of radiation the devices emit and make other changes to their design.Melanoma is the deadliest form of skin cancer. More than three-quarters of all skin cancer-related deaths are from melanoma. About one person dies of melanoma every hour in the United States.

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Health Canada Warns of Accutane Skin Reactions http://www.yourlawyer.com/articles/read/17573 Tue, 16 Feb 2010 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17573 Health Canada has issued a public health alert regarding Accutane and its association with severe, and possibly fatal, skin reactions, including erythema multiforme [EM], Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN].

According to Health Canada,a review of the Roche global safety database found that as of November 22, 2009, 66 cases of severe skin reactions including EM, SJS and TEN, in adults and children have been reported worldwide in association with Accutane side effects. Since two of the cases were fatal, everyone who associates his/her health problems with taking this drug should contact his/her doctor immediately and may start thinking to initiate an Accutane lawsuit in Canada or elsewhere to get both moral and financial compensation. While there are confounding factors for the majority of the reports received, a causal association between Accutane and these severe skin reactions cannot be excluded, Health Canada said.

These severe skin reactions can start with mild non-specific symptoms such as fever, malaise, chills, aching muscles, headache, sore throat or stinging eyes. It can take up to 3 days for the skin lesions to develop.

People taking Accutane have been advised to stop taking the medication immediately and contact their doctor if they experience any of the following:

• rash, especially if associated with fever and/or malaise or conjunctivitis (red or inflamed eyes, like “pink eye”)

• blisters on legs, arms or face and/or sores in mouth, throat, nose or eyes

• peeling skin

Accutane has been associated with a number of serious side effects, incluing  severe birth defects, inflammatory bowel disease, problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the U.S.

Last summer, Roche AG announced it would start Accutane recall in the U.S. and 11 other countries. The company cited declining sales as one of the major reasons behind the decision, as well as the high-cost of product liability suits and competition from generics. The last date for distribution of Accutane in the U.S. was June 25, 2009. At that time, Roche stopped direct distributions, but patients could still get Accutane from pharmacies that still had it in stock.

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Popcorn Lung Reported in Consumers http://www.yourlawyer.com/articles/read/17564 Fri, 12 Feb 2010 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17564 Popcorn Lung”, an illness once thought to be confined to snack food industry workers, is turning up in consumers with increasing frequency.  Popcorn Lung has been linked to diacetyl, a chemical used in microwave popcorn and other foods, to impart them with a rich, buttery flavor.

Popcorn Lung, known formally as Bronchiolitis obliterans, is a potentially life-threatening, irreversible ailment, for which the only cure is a lung transplant. Popcorn Lung inflames the bronchioles—small lung airways—causing scarring and “obliterating” appropriate airflow.

Some of the larger microwave popcorn manufacturers, such as ConAgra, have stopped using diacetyl. But the chemical is still used in thousands of products, including microwave popcorn, frozen foods, cake mixes and butter-flavored cooking oils. Unfortunately, it is not often listed on ingredient labels, so there is no way for consumers to protect themselves from exposure. When the chemical is heated, say in a microwave, it is released into the air in vapor form.

In 2007, a Colorado man named Wayne Watson became the first consumer to be diagnosed with Popcorn Lung. He had never worked around diacetyl, but he did have a decade-long, 2-bag-a-day microwave popcorn habit. Watson’s doctor theorized that the inhalation of diacetyl fumes from bags of microwave popcorn caused his illness. 

According to a report on www.10tv.com, Watson’s case prompted his doctor, Cecile Rose, to send a letter to the Food & Drug Administration (FDA) and three other government agencies, warning that diacetyl was a potential health threat not just to workers, but also to consumers. The agency said it followed up with Dr. Rose, and also assigned a team of scientists to examine scientific research into types of diacetyl exposure, according to www.10tv.com.

But so far, the FDA has not taken any regulatory action, and officially considers diacetyl safe. The agency hasn’t indicated when it will finish its diacetyl review and issue findings.

Since the link between diacetyl and Popcorn Lung was established, hundreds of stricken snack industry workers have filed lawsuits against flavorings manufacturers. Consumers stricken with the disease have also filed Popcorn Lung lawsuits. Watson did so, and according to 10tv.com, has reached a confidential settlement with one defendant, a flavor developer. Watson’s lawyer also told 10tv.com that he recently filed Popcorn Lung lawsuits on behalf of three other consumers.

According to the Associated Press, more than 300 other  Popcorn Lung cases are pending around the country, and verdicts as high as $20 million have been awarded in previous lawsuits.

 

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Pratt & Whitney Named in First Lawsuit Filed Over The Acreage Cancer Cluster http://www.yourlawyer.com/articles/read/17566 Fri, 12 Feb 2010 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17566 childhood cancer cluster exists in The Acreage.

According to wsnv.com, Pratt & Whitney owned the land that is now The Acreage about 50 years ago. It was used to test rocket engines, and since the 1950’s Pratt & Whitney has been storing toxic pollutants inside of a plant located near the community.

The residents of The Acreage have been concerned about a cancer cluster since several children living in close proximity to each other were diagnosed with brain tumors or brain cancer. Earlier this summer, residents’ concerns prompted the Florida Department of Health to begin a study of cancer rates in the area. The department’s eight month study found higher rates of brain tumors and brain cancer among children, especially girls.

The lawsuit against Pratt & Whitney was filed by four residents of The Acreage. It doesn’t explicitly blame the company for the high rates of cancer among children in The Acreage. However, the complaint does accuse Pratt & Whitney of negligence when dumping hazardous waste where the community now stands, and claims it failed to take adequate measures to prevent the escape of contaminants and other hazardous materials from its property. The lawsuit also points out that one of the chemicals stored at the nearby Pratt & Whitney facility is 1, 4-Dioxane, which the U.S. Department Of Health And Human Services considers as reasonably anticipated to be a human carcinogen.

The plaintiffs, all of whom own homes in The Acreage, claim the presence of the cancer cluster has caused their property values to plummet. They want Pratt & Whitney to compensate residents for their declining home values.

Confirmation of the cancer cluster in The Acreage has also spurred residents to approach Governor Charlie Crist for help. According to cbs12.com, the governor’s office has called on the state Department of Environmental Protection to conduct more tests of well water at homes in the Acreage. On Thursday, representatives from the department were working on getting permission from homeowners to conduct the tests.

Tests that the state Department of Environmental Protection conducted last summer concluded that well water quality in The Acreage is “generally good,” despite some instances of elevated radiation that might stem from natural causes.

In addition, a task force made up of homeowners, elected officials, parents of children who’ve had cancer, and others is being set up to oversee the cancer cluster investigation.

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Answers Sought in The Acreage Cancer Cluster http://www.yourlawyer.com/articles/read/17544 Wed, 03 Feb 2010 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17544 Calls for a probe into the cause of a childhood cancer cluster in a Florida community called The Acreage are growing louder. The presence of the pediatric cancer cluster was confirmed earlier this week by The Florida Department of Health.

The residents of The Acreage have been concerned about a cancer cluster since several children living in close proximity to each other were diagnosed with brain tumors or brain cancer. Earlier this summer, residents’ concerns prompted the Florida Department of Health to begin a study of cancer rates in the area.

The results of the first phase of the study were unveiled in late August. According to the Palm Beach Post, investigators found 1,369 cases of all types of cancer among residents in The Acreage between 1995 and 2007. A similar-sized area elsewhere in Florida could be expected to have 1,055 cases in that time, the Post said. The report revealed six cases of brain cancer in children 14 and younger from 1997 to 2007. Of those, three were diagnosed in 2008, the report said.

Those findings prompted the health department to launch a second phase, which consisted of interviewing he families of 13 children previously diagnosed with cancer. All of the children were younger than 18 when diagnosed with a brain tumor or brain cancer from 1993-2008. On Monday, health officials announced that preliminary findings from that phase found higher rates of brain tumors and brain cancer among children, especially girls. The health department confirmed that the findings indicated a cancer cluster in The Acreage.

Now, U.S. Sen. Bill Nelson and other lawmakers have called for an investigation to determine the cause of the cluster. According to The Palm Beach Post, Nelson said environmental tests should start “as soon as possible.” He pledged to work with the U.S. Environmental Protection Agency and the federal Centers for Disease Control and Prevention to get them to “lend their resources and expertise to the investigation.”

But already, state health officials are predicting that they won’t be able to find the cause of the cancer cluster. On Monday the director of the Palm Beach County Health Department also said health officials are not planning to conduct environmental tests at this point.

According to the Post, State Rep. Joseph Abruzzo, D-Wellington, rejected those assertions. “We need to give them the resources to make sure they can identify a cause,” Abruzzo said.

The state health department expects to finish and report on the second phase of its cancer investigation in The Acreage by mid-March. If it decides to start a third phase, which could include environmental tests, it would be at least a year before its completed, the Post said.

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Childhood Cancer Cluster Confirmed in The Acreage http://www.yourlawyer.com/articles/read/17541 Tue, 02 Feb 2010 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17541 The Florida Department of Health has confirmed a pediatric cancer cluster in The Acreage. According to The Miami Herald, an eight month study has found higher rates of brain tumors and brain cancer among children, especially girls.

The residents of The Acreage have been concerned about a cancer cluster since several children living in close proximity to each other were diagnosed with brain tumors or brain cancer. Earlier this summer, residents’ concerns prompted the Florida Department of Health to begin a study of cancer rates in the area.

The results of the first phase of the study were unveiled in late August. According to the Palm Beach Post, investigators found 1,369 cases of all types of cancer among residents in The Acreage between 1995 and 2007. A similar-sized area elsewhere in Florida could be expected to have 1,055 cases in that time, the Post said. The report revealed six cases of brain cancer in children 14 and younger from 1997 to 2007. Of those, three were diagnosed in 2008, the report said.

At the time, officials said the findings pointed to elevated cancer rates in the community. Those findings were enough to convince the health department to launch a second phase of the cancer cluster study, which started in December. That phase involved interviewing the families of 13 children previously diagnosed with cancer. All of the children were younger than 18 when diagnosed with a brain tumor or brain cancer from 1993-2008.

According to The Miami Herald, conclusions from the first phase were based on numbers from the 2000 U.S. Census, when the population was smaller — possibly making the cancer rates look incorrectly elevated in comparison. But now the health department says that even accounting for population growth, preliminary results from the second part of the study show childhood cancer rates are still abnormally high.

According to findings from the second phase of the study, in 2005 through 2007 three new cases of brain cancer were reported in The Acreage, three times higher than the norm.

Unfortunately, there is a chance that residents of The Acreage won’t ever know what is behind the high cancer rates in their community. According to The Miami Herald, until the health department finishes analyzing those interviews in the next two months, the state wouldn’t conduct any environmental tests, if at all, to look for a potential cause.

As we reported previously, initial soil and water samples conducted by state health officials tested negative for toxins. Earlier this month, health officials screened for radon gas in about a dozen homes of the children who had been diagnosed with brain tumors.

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Oil Refinery Emissions Suspect in PA Lung Disease Cases http://www.yourlawyer.com/articles/read/17503 Tue, 19 Jan 2010 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17503 Are oil refinery emissions in Marcus Hook, PA causing residents there to develop serious lung problems? Apparently, some residents of the Delaware county, PA community have reported symptoms such as chronic coughing, headaches and fatigue. These symptoms are often associated with a serious lung ailment called sarcoidosis.

Recently, one of the refineries in the Marcus Hook area - Sunoco's - was fined for illegal air emissions by the Pennsylvania Department of Environmental Protection (DEP). The fines just came after Sunoco reported several air-emission releases in 2008 to the agency. Those incidents occurred as follows:

• In May 2008, according to DEP, a boiler malfunction released 8.3 tons of carbon monoxide.
• In June 2008, two incidents resulted in 18.1 tons of volatile organic compounds being released into the air, as well as 1,300 gallons of oil.
• In December 2008, another 3.93 tons of nitrogen oxide and 8.09 tons of volatile organic compounds were released into the atmosphere after a compressor shutdown.

DEP inspectors also found numerous air permit and storage tank violations during that time period. Violations that occurred in June, September and November 2008 allegedly involved seal problems and an unreported oil leak. Sunoco was cited for not performing various inspections of instruments, tank hatches and ventilation systems.

Sarcoidosis is a disease that results from inflammation of tissues of the body. It can appear in almost any body organ, but most often starts in the lungs or lymph nodes. The disease can appear suddenly and disappear, or it can develop little by little and go on to produce symptoms that come and go, sometimes for a lifetime. As sarcoidosis progresses, small lumps, or granulomas, appear in the affected tissues. In the majority of cases, these granulomas clear up, either with or without treatment. In the few cases where the granulomas do not heal and disappear, the tissues tend to remain inflamed and become scarred (fibrotic).

Though the exact cause of sarcoidosis is unknown, it is believed to be caused through an alteration in the immune response after exposure to an environmental, occupational, or infectious agent.


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Cancer Concerns Raised by Airport X-Ray Plan http://www.yourlawyer.com/articles/read/17480 Mon, 11 Jan 2010 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17480 The specter of more cancer deaths has been raised by the U.S. Transportation Security Administration's (TSA) plan to use a type of X-ray scanner - known as a backscatter scanner - to increase airport security following the Christmas day bombing attempt.

According to The New York Times, the TSA says the dose from scanner is about the same amount as an average American receives from natural background sources in four minutes on the ground. A spokesperson for the agency told The Times that even for pregnant women, children and people whose genetic makeup made them more susceptible to X-ray damage, each person would have to undergo 1,000 screenings per year to exceed radiation standards.

But according to The New York Times, some experts believe the use of the scanners will “incrementally increase the risk of fatal cancers among the thousands or millions of travelers who will be exposed.”

In a 2002 report on the safety of backscatter scanners, the National Council on Radiation Protection and Measurements said it “cannot exclude the possibility of a fatal cancer attributable to radiation in a very large population of people exposed to very low doses of radiation.” An author of the report, David J. Brenner, a professor of radiation biophysics at Columbia and director of the university’s Center for Radiological Research, told The New York Times that risks might increase as airports begin using backscatter scanners as a first-line screening system.

Arjun Makhijani, a nuclear physicist, told the Times that if a billion passengers were screened with the dose assumed by the radiation protection council, that would mean 10 more cancer deaths a year. That number would represent only a tiny increase in the cancer death rate.

But others do not agree that the cancer rate would increase. Robert Barish, a radiation consultant in New York and the author of a 1996 book, “The Invisible Passenger,” told the Times that the doses delivered by the scanners were tiny by any standard, and passengers would get the same dose in a few minutes in a high-altitude jet.


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Faulty Disinfectant Use Could Lead to Antibiotic Resistance http://www.yourlawyer.com/articles/read/17448 Wed, 30 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17448 The improper use of the disinfectant benzalkonium chloride, could cause some germs to develop antibiotic resistance, Business Week just reported, citing emerging research published in the January issue of the journal Microbiology.

According to Business Week, the findings do not fault proper disinfectant use and have only been found in laboratory testing. "It is OK to use disinfectants. Just don't misuse or overuse them," said study co-author Gerard T.A. Fleming—a scientist at the National University of Ireland in Galway—quoted Business Week. The disinfectant is found in an array of products including skin cleansers and face creams, spermicides, and some disinfectant products, noted Business Week, citing Fleming.

As we have long written, overuse and misuse of antibiotics is believed to make germs stronger as the germs learn to fight the effects of the drugs. This study found that the germ, Pseudomonas aeruginosa, was able to develop a resistance to antibiotics, explained Business Week, adding that the germ can lead to sickness in those with weakened immune systems and is key in hospital-acquired infections.

The researchers added benzalkonium chloride to a solution with Pseudomonas aeruginosa, said Business Week; Pseudomonas aeruginosa mutated and developed a resistance to Cipro (generic: Ciprofloxacin) after exposure to benzalkonium chloride and also developed a resistance to the disinfectant. Cipro is often used to treat anthrax.

According to Fleming, disinfectants must be used correctly and people should "not be tempted to dilute them down so that they go further in an attempt to save money…. Disinfectants work at the concentration stated on the bottle, but if they are diluted to a level where microorganisms can evolve, resistance can build up," quoted Business Week. "… disinfectants are our first line of defense against harmful germs. Antibiotics are our second line of defense in case of infection. Our study has shown that it is possible to corrupt the first and second line of defense. What then are we left with?" Fleming added.

Meanwhile, last week, another study funded by the Robert Wood Johnson Foundation and which appears in the December 23 online and February print edition of Infection Control and Hospital Epidemiology—found that Acinetobacter—a very resistant bacteria—appears to be thriving in hospitals nationwide, according to Business Week. Looking at data (1999-2006) from 300 hospitals across the country, the researchers saw an excess of a 300-percent increase in cases of Acinetobacter resistant to Primaxin (generic: Imipenem).

Acinetobactor is generally found in patients being treated in the intensive care units of hospitals and often results in significant “pneumonias or bloodstream infections,” said Business Week, adding that the infections are not always cured with the most powerful of antibiotics.

Last month we wrote that a large study on the effects of antibiotics used during pregnancy and birth defects—the first of its kind to review the use of antibiotics during pregnancy—found a link between medications for urinary tract infections and birth defects. That study appeared in the November issue of Archives of Pediatrics and Adolescent Medicine, said the Associated Press.

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Cell Phone Cancer Warnings Pushed in San Francisco http://www.yourlawyer.com/articles/read/17440 Mon, 28 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17440 Officials in San Francisco are mulling possible mandatory cancer warnings on cell phones.  According to a recent New York Times report, Mayor Gavin Newsom is expected to propose such an ordinance next month.  If passed, San Francisco would become the first state to require such warnings.

According to The New York Times, San Francisco's environment commission will discuss eight recommendations related to radiation emitted by cell phones and local, state and federal policies regarding it.   The Associated Press is reporting that the San Francisco cell phone cancer warning would require manufacturers to display electromagnetic radiation absorption rate level next to each phone in print at least as big as the price.

As we reported previously, a lawmaker in the state of Maine has also proposed a cell phone cancer warning.  Rep. Andrea Boland, D-Sanford, wants manufacturers to  put labels on phones and packaging warning of the potential for brain cancer associated with electromagnetic radiation. Boland has persuaded Maine’s legislative leaders to allow her cell phone warning proposal to come up for discussion during the 2010 legislative session that begins in January.

Concerns over the possible health consequences of cell phone use are growing. Just this past October, we reported that a preliminary analysis of the World Health Organization’s (WHO) groundbreaking Interphone study found a “significantly increased risk” of some brain tumors “related to use of mobile phones for a period of 10 years or more.”

Last month, the Washington D.C. Court of Appeals  reversed a lower court decision that found that cell phone cancer lawsuits were preempted by federal law.   While the appeals court ruled that plaintiffs could not pursue claims that they were injured by phones which met the Federal Communications Commission’s (FCC) emissions standards, it ruled that personal injury claims were not pre-empted if they were based on phones that were either built before 1996, when the FCC purportedly began applying its radiation limits to cell phones, or failed to meet the commission’s requirements.  

The decision came in a case called Murray v. Motorola, and involves Verizon, Motorola, AT&T, Sprint, Nokia and other cell phone providers. The plaintiffs had claimed that they or their loved ones suffered illness, including brain cancer, as a result of the use of cell phones manufactured, sold or distributed by the defendants. They also alleged that defendants have long been aware of numerous studies revealing that radio frequency radiation from cell phones can cause tissue destruction, a precursor to cancer.

 

 

 

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Omniscan UK Libel Case Stifles Criticism, Doctor Claims http://www.yourlawyer.com/articles/read/17422 Mon, 21 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17422 A Danish radiologist who was among the first to warn that gadolinium contrast dyes could be associated with nephrogenic systemic fibrosis (NSF) says GE Healthcare, the maker of Omniscan, is using a libel suit in the United Kingdom (UK) to shut him up. 

Henrick Thomsen began speaking out about NSF and its association with gadolinium dyes in 2007, after about 30 patients at Copenhagen University Hospital developed the condition.  According to The Guardian, GE Healthcare says the alleged defamation occurred during a 15-minute presentation Thomas made to fellow radiologists in 2007 at Oxford University, and in statements made in an article published in Thomsen's name in the journal Imaging Management.

Thomsen's lawyers are using a concept known as "qualified privilege" to defend him.  As a doctor, Thomsen claims he had a duty to report his experience with Omniscan, and his audience had a legitimate interest in receiving it. For its part, GE Healthcare asserts  that  qualified privilege doesn't protect Thomsen because he acted "maliciously".

For now, because of the libel claim against him, The Guardian says Thomsen has stopped lecturing in the UK.  He also claims patients in England are  being put at serious risk because he and other scientists are prevented from sharing their knowledge as a result of the way the libel courts in the country operate.

GE Healthcare has already spent £380,000, or $614,000 USD, to sue Thomsen in the UK.  According to The Guardian, if the drug giant wins, Thomsen will have to pay its costs.  The case is not expected to reach court for another 18 months. 

Strangely, even though Omniscan's possible side effects have been much discussed in both the US and Denmark, GE Healthcare has not taken any legal action in either of those countries.  Critics of the UK's tough - some would say draconian - libel laws have claimed for a while that they have a chilling effect" on democracy, and many are now pointing to Thomsen's case as an example.

 NSF is a rare, debilitating and often fatal disease that appears to only affect people with severe kidney disease who have been exposed to these gadolinium contrast dyes during MRI and MRA procedures. In the U.S., Omniscan and all other gadolinium dyes currently in use have been required to bear a black box warning regarding the potential for NSF since 2007, and the Food & Drug Administration (FDA) is currently considering even tougher labeling requirements for the drugs.  

 

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Push on For Cell Phone Cancer Warning in Maine http://www.yourlawyer.com/articles/read/17425 Mon, 21 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17425 brain cancer.  According to an Associated Press report, if Rep. Andrea Boland, D-Sanford,  has her way, Maine would become the first state to require a cell phone cancer warning.

Rep. Boland's push for such a warning comes at time when concerns over the possible health consequences of cell phone use are growing. Just this past October, we reported that a preliminary analysis of the World Health Organization's (WHO) groundbreaking Interphone study found a “significantly increased risk” of some brain tumors “related to use of mobile phones for a period of 10 years or more.” The Interphone project conducted studies in 13 countries, interviewing tumor sufferers and people in good health to see whether their cell phone use differed. Interviews were conducted with 12,800 people between 2000 and 2004.

Six of eight Interphone studies found some rise in the risk of glioma (the most common brain tumor), with one finding a 39 percent increase. Two of seven studies into acoustic neurinoma (a benign tumor of a nerve between the ear and brain) reported a higher risk after using mobiles for 10 years. A Swedish report said it was 3.9 times higher. An Israeli study found heavy users were about 50 per cent more likely to suffer tumors of the parotid salivary gland.

The Interphone authors did say the study was not definitive, and limited because it depended on subjects’ memories to determine frequency of cell phone use. But the study’s head, Dr Elisabeth Cardis, said she backed new warnings for cell phones based on its findings.

Boland, who the Associated Press says uses a cell phone with a speaker to keep the device away from her head, has persuaded Maine's legislative leaders to allow her cell phone warning proposal to come up for discussion during the 2010 legislative session that begins in January.  If adopted, manufacturers would have to put labels on phones and packaging warning of the potential for brain cancer associated with electromagnetic radiation. The warnings would recommend that users, especially children and pregnant women, keep the devices away from their head and body. The warning would also include a color graphic of a child's brain.

According to the Associated Press, San Francisco Mayor Gavin Newsom is also pushing  to make his city  the first in the nation to require cell phone cancer warnings.  His proposal goes farther than Rep. Boland's, and would require manufacturers to display the electromagnetic radiation absorption rate level next to each phone in print at least as big as the price.

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More Brain Tumors Reported in The Acreage http://www.yourlawyer.com/articles/read/17412 Thu, 17 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17412 brain tumors.  The news comes just as an investigation into a possible cancer cluster in the Florida community is gearing up.  

The residents of The Acreage have been concerned about a cancer cluster since several children living in close proximity to each other were diagnosed with brain tumors or brain cancer. Earlier this summer, residents’ concerns prompted the Florida Department of Health to begin a study of cancer rates in the area.

The results of the first phase were unveiled in late August. According to the Palm Beach Post, investigators found 1,369 cases of all types of cancer among residents in The Acreage between 1995 and 2007. A similar-sized area elsewhere in Florida could be expected to have 1,055 cases in that time, the Post said. The report revealed six cases of brain cancer in children 14 and younger from 1997 to 2007. Of those, three were diagnosed in 2008, the report said.

Those findings were enough to convince the health department to launch a second phase of the cancer cluster study.  That phase began earlier this month,  and health officials have been interviewing the families of 13 children previously diagnosed with cancer. All of the children  were younger than 18 when diagnosed with a brain tumor or brain cancer from 1993-2008.  Interviews are expected to be complete by January 1.

According to The Miami Herald, the latest brain tumor victims in The Acreage are a 13-year-old girl and a boy the same age.  The girl, who had been suffering from headaches, had a tumor removed before Thanksgiving.  The boy's tumor was discovered after he suffered a seizure last Wednesday, and his tumor was removed on Friday.  Both families are still waiting results of pathology reports.

According to the Herald, these two children are not part of the cancer cluster study.  But the health officials will note new cases reported to the Florida Cancer Data Registry, which gathers reports of tumors from physicians across the state.

People in the area have speculated that a nearby Pratt & Whitney jet engine plant and/or citrus groves in the area, which used potentially dangerous pesticides for decades, may have tainted well water in the area. There were also concerns about soil contamination. As we reported previously, tests on wells conducted by the state Department of Environmental Protection (DEP) did not reveal any toxins, but tests on four wells did reveal levels of alpha particles, radium-226 or radium-228, that exceed drinking water standards. Radium-226 and radium-228 are naturally occurring radioactive metals that could cause cancer at elevated levels.

The four wells where elevated levels of radium-225 or radium-228 were detected did not appear to be near the locations where residents have reported brain cancer in children. The DEP said the contamination may require homeowners with affected wells to install water treatment systems. Ground water in the community was deemed safe by the DEP.

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Studies Point to CT Scan - Cancer Link http://www.yourlawyer.com/articles/read/17404 Tue, 15 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17404 Two new studies are raising more concerns about the connection between radiation from CT scans and an increased risk of cancer.  According to The Wall Street Journal, both studies were just published in the "Archives of Internal Medicine."

CT scans are extremely popular as a diagnostic tool.  According to the Journal, use of the scans has  tripled in the U.S. since the early 1990s to more than 70 million in 2007.   Though there have always been concerns regarding the cancer risks associated with radiation from CT scans, but it hasn't been clear how high those risks actually are.

Concerns over the safety of CT scans were heightened recently, when the Food & Drug Administration (FDA) announced in October that it was probing 206 radiation overdoses from CT brain scans reported at Cedars-Sinai Medical Center in Los Angeles.  Last week, the agency said it had found 50 more instances of such overdoses at several other hospitals.

The first study detailed by The Wall Street Journal found that radiation doses received in a single CT scan varied greatly among the hospitals, with some patients receiving only one-tenth the radiation that others got.  For this study, researchers looked at 1,000 adult patients at four hospitals.  They projected that the dose of radiation received in a single heart CT scan at age 40 would later result in cancer in 1 in 270 women and 1 in 600 men.  For those receiving a head CT scan, 1 in 8,100 women and 1 in 11,080 men would likely develop cancer from the radiation, the study said. 

The second study, which analyzed information from several databases, estimated that 29,000 future cancers could be related to CT scans received in 2007, The Wall Street Journal said.  The cancer risk was greatest for younger patients, and the study projected that the greatest number of cancers would occur the abdomen and pelvis.

 

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First NSF Lawsuit to Go to Trial in California http://www.yourlawyer.com/articles/read/17390 Thu, 10 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17390 gadolinium contrast dye - Magnevist - and nephrogenic systemic fibrosis (NSF)  is set to begin in January.  According to a report on Law.com, the outcome of the Magnevist trial could be a good indicator of how  NSF plaintiffs in similar lawsuits will fare.

Bayer's Magnevist, as well other gadolinium contrast dyes, including General Electric's Omniscan and Covidien's OptiMark, have been named in over 500 lawsuits filed by people who claim they or their loved ones developed NSF following exposure to one or more of the gadolinium-based MRI contrast dyes.  

NSF is an often-fatal disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness.

There are no effective treatments for NSF, and the disease  can progress to the point of causing severe stiffness in joints, and it can lead to death.  While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a gadolinium contrast dye.

In 2007, the U.S. Food & Drug Administration (FDA) mandated a black box warning about the risk of NSF for all gadolinium agents.  The agency is now considering tougher warnings that could restrict the use of some gadolinium agents to only patients without severe kidney disease, following a risk assessment that found Omniscan, OptiMark and Magnevist appeared to carry a higher risk of NSF than other gadolinium products on the market.

Most NSF lawsuits filed around the country have been consolidated in federal court in the Northern District of Ohio.  However, according to Law.com, the Magnevist lawsuit scheduled for trial in January is one of  20 to 30 California NSF lawsuits that have been consolidated before San Francisco Superior Court Judge Richard Kramer.  While this suit only names Bayer as a defendant, General Electric is also a major defendant in the California litigation.



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OptiMark, Omniscan and Magnevist Carry Higher Risk, FDA Panel Says http://www.yourlawyer.com/articles/read/17387 Wed, 09 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17387 nephrogenic systemic fibrosis (NSF), according to a panel of medical experts.  The Food & Drug Administration (FDA) advisory panel, which met yesterday, has recommended a stronger NSF warning for  both Covidien Inc.'s OptiMark and General Electric's Omniscan that contraindicates the use of these agents in people with severe kidney disease, according to a Reuters report.

Reuters is also reporting that some on the FDA panel also pushed for a similar warning on Bayer's Magnevist, but the advisers were not able to reach a consensus on that issue.

The panel was not asked by the FDA to actually vote on the issue of a new warning for any of the gadolinium products, but the recommendation on OptiMark and Omniscan did represent a "preponderance" of opinion on the issue.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.  A mountain of evidence indicates that NSF only affects people with severe kidney disease who have been exposed to gadolinium agents.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. As we've reported previously, all gadolinium contrast dyes already bear a black box warning - the FDA's strongest safety warning - about the risk of NSF.  That black box was mandated in 2007.  But since the warning was added to the product labels, additional studies have shown that some gadolinium agents may be more dangerous than others.  

According to documents released last month by the FDA in advance of today’s meeting, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMark. The lowest risk was associated with Prohance and Multihance, both marketed by Bracco Diagnotics. However, the FDA was unable to rule out a risk for any of the agents.

FDA staff said it was too early to reach conclusions about Bayer’s Eovist and Lantheus Medical Imaging’s Ablavar, two recently approved gadolinium agents.

According to a Dow Jones report, radiologists speaking at yesterday's meeting  told the FDA that clinicians have essentially stopped using gadolinium products in patients with severe kidney disease.  The panel was also told that the number of NSF reports have dropped significantly since the FDA mandated the black box.

Members of the FDA advisory panel said labeling for the products needs to keep pace with how the drugs are being used in the real world.

According to Reuters, Dr. Dr. Sidney Wolfe, a panel member and head of Public Citizen's Health Research Group, was among those pushing for stronger warnings on Omniscan and Optimark.  Leaving the same warning on all the drugs "may cause more problems than if you distinguish between the drugs as best as you can," Dr. Wolfe said.

The FDA will make the final decision on any label changes.  The agency does not have to follow recommendations of advisory panels, but it usually does so.




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Restrict Some Gadolinium Contrast Dyes, FDA Panel Says http://www.yourlawyer.com/articles/read/17385 Tue, 08 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17385 The use of some gadolinium contrast dyes should be restricted because of their association with nephrogenic systemic fibrosis (NSF), according to a recommendation just made by a Food & Drug Administration (FDA) advisory panel.  

Reuters is reporting that the panel supported new warnings for General Electric's  Omniscan and Covidien Inc.'s OptiMark that say they should not be used in patients with severe kidney disease. The panel felt that Omniscan and OptiMark. along with Bayer's Magnevist, appeared to carry  a higher NSF risk than similar products. The recommendation represented a "preponderance of opinion" on the panel,  and not a formal vote, Reuters said.

Meanwhile, Dow Jones News Service is reporting that the same FDA panel also recommended restricting the use of Magnevist to patients without kidney severe kidney disease.  However, according to Reuters, there was less consensus on the panel in regards to Magnevist.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does so.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies.  It appears that NSF only develops in people with pre-existing kidney disease. In 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about their association with NSF.  Since the warning, the FDA and the makers of gadolinium contrast dyes have continued to collect data about their association with NSF.

According to documents released last month by the FDA in advance of today's meeting, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMark. The lowest risk was associated with Prohance and Multihance, both marketed by Bracco Diagnotics.   However, the FDA was unable to rule out a risk for any of the agents.

FDA staff said it was too early to reach conclusions about Bayer's Eovist and Lantheus Medical Imaging's Ablavar, two recently approved gadolinium agents.

According to Dow Jones, at today's FDA advisory panel meeting, radiologists said that clinicians have essentially stopped using gadolinium agents  in  patients with severe kidney disease.  The panel was also told that reports of NSF have  dropped significantly since the black box warning was mandated.

Last month, Europe's health regulatory agency said Omniscan, Magnevist and OptiMark  shouldn't be used in patients with severe kidney problems.

As we previously reported, Covidien has already decided to modify the label of OptiMark to contraindicate its use in patients with severe kidney impairment because of its association with NSF.

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Mammograms Risky For Some Women http://www.yourlawyer.com/articles/read/17352 Wed, 02 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17352 breast cancer risks in susceptible young women, reported Reuters. The researchers site family history or genetics as indicators for this demographic.

According the research team, the high-risk women, specifically younger women under the age of 30, might want seek alternative testing methods, suggesting magnetic resonance imaging (MRI) in which there is no radiation exposure, said Reuters. "Our findings suggest that low-dose radiation increases breast cancer risk among these young, high-risk women, and a careful approach is warranted," said Marijke Jansen-van der Weide of the University Medical Center Groningen in the Netherlands, quoted Reuters.

"I should recommend to be careful with radiation before 30 and to think about alternatives," Jansen-van der Weide, added, according to Reuters, who noted that Jansen-van der Weide announced her findings at the Radiological Society of North America. Jansen-van der Weide looked at combined information from six published studies of 12,000 high-risk European and American women.

The study findings revealed that of the women, 8,500 who were exposed to mammogram or chest X-ray radiation prior to turning 20, or those who underwent at least five such exposures, experienced a 2.5 times increased risk of developing breast cancer versus high-risk women who did not experience the exposure, explained Reuters.

The Daily News said that perhaps less might be better for higher risk women, citing the researchers presentation at Monday’s conference. Reuters noted that the results are only applicable to women at a higher risk of developing breast cancer; however, the findings can add to the confusion regarding mammography screening benefits and risks. For instance, the U.S. Preventative Services Task Force—a federal advisory panel—issued a recommendation to women in their 40s against routine mammograms due to concern over the expense of additional testing, said Reuters.

Meanwhile, experts have been recommending yearly mammograms for women age 40 and older to screen and encourage early diagnosis of breast cancer. Now, breast cancer specialists are concerned that the new recommendation will confuse women and increase breast cancer deaths, said Reuters. The American Cancer Society, among other groups, said that very high risk women should undergo both an MRI and a mammogram; while MRIs are more sensitive than mammograms, false positives are more common with MRI testing, reported Reuters.

"We know that breast tissue is susceptible to the harmful effects of radiation when women are at a young age, and that this risk diminishes as women age," said Robert Smith, director of cancer screening from the American Cancer Society, regarding the Dutch study, in an email Reuters quoted. According to Smith, no one study has confirmed an increased risk of breast cancer linked to mammograms performed on average or high-risk women, said Reuters. Smith added, "For now, the unavoidable conclusion is that the benefits of early breast cancer detection in women at very high risk outweigh the low possibility of a radiation-induced breast cancer," quoted Reuters. The Dutch findings, while based on a small sampling did provide a “statistical significance,” noted Reuters, citing the researchers.

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Gadolinium Contrast Dyes FDA Advisory Panel Review Next Week http://www.yourlawyer.com/articles/read/17347 Tue, 01 Dec 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17347 gadolinium contrast dyes this month.  The Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee  will meet on December 8 to review data from gadolinium contrast manufacturers to, among other things, differentiate the risk of nephrogenic systemic fibrosis (NSF) between gadolinium agents, and provide the agency guidance on labeling.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. They are: OptiMARK, by Covidien Inc., Prohance and Multihance, both by Bracco Diagnostics, Bayer Healthcare’s Magnevist and GE Healthcare’s Omniscan.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

It appears that NSF only develops in people with pre-existing kidney disease. In September 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

Since the 2007 black box warning, the FDA has continued to collect data on gadolinium contrast dyes and NSF.  According to documents released last month by the FDA, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMARK. The lowest risk was associated with Prohance and Multihance. However, the agency said “the data do not appear to rule out an NSF risk for each of the agents.” FDA reviewers said the extent of risk from any of the agents was unknown. One study of Omniscan estimated the chances of developing NSF was 4 percent among patients with severe kidney impairment.

Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product.

That issue will be addressed at the December 8 advisory panel meeting.  However, as we previously reported, Covidien has already decided to modify the label of OptiMark to contraindicate its use in patients with severe kidney impairment because of its association with NSF.  At the time, a spokesperson for the company told Reuters that “it was prudent to act now, rather than wait for a causal link… to be established” between the imaging drugs and NSF.

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NSF Lawsuit Claims Hospital Negligent For Using Gadolinium Contrast Dyes http://www.yourlawyer.com/articles/read/17321 Tue, 24 Nov 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17321 nephrogenic systemic fibrosis (NSF).  The plaintiff was administered a gadolinium based contrast dye at St. Luke's several times starting in 2005, and was diagnosed with  NSF in early 2007.  

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s. There are currently five such agents sold in the U.S.: Covidien’s OptiMARK; Prohance and Multihance, both by Bracco Diagnostics; Bayer Healthcare’s Magnevist; and GE Healthcare’s Omniscan.

It appears that NSF only develops in people with pre-existing kidney disease who are exposed to the gadolinium agents. In September 2007, the U.S. Food & Drug Administration (FDA) asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided

According to the St. Luke's Hospital lawsuit, the plaintiff, who suffered from kidney disease, was administered a contrast dye in January 2005 in conjunction with an MRI.  The plaintiff was administered a contrast agent and underwent magnetic resonance angiography (MRA) on Oct. 10, 2007, at St. Luke’s. On Nov. 6, 2007, MRA, again requiring the use of a contrast agent, was performed on the plaintiff at the hospital.

Following these procedures, the plaintiff began to suffer symptoms typical of NSF, and was diagnosed with the disorder in early 2007.

The lawsuit alleges that the hospital was negligent when it administered gadolinium contrast dyes to a patient with renal failure. The suit also asserts that the unknown makers of the dyes are strictly liable for the patient’s injury because they defectively designed the contrast agents and knowingly failed to warn consumers about the health risks. Finally, the suit alleges, the products were negligently designed and that the companies negligently and fraudulently represented to patients that they were safe.

This lawsuit is just one of hundreds filed in the past couple of years by victims of NSF.   Since the FDA mandated the black box warning for all gadolinium contrast dyes in 2007, evidence of a link between the products and NSF has only grown stronger.

Earlier this month, we reported that the  FDA is still looking into the association between gadolinium agents and NSF. An FDA review had found that OptiMARK, Magnevist and Omniscan carried a higher risk of NSF than other gadolinium agents on the market. Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

Following the news from the FDA, Covidien announced it would be modifying the label on OptiMARK to contraindicate its use in patients with severe kidney impairment. Mallinckrodt Inc., a Covidien company, has submitted this label change to the FDA and says it is implementing the new label in the U.S. effective immediately. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of OptiMARK.

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Dialysis, Kidney Transplant Patients Face Higher Risk of NSF from Gadolinium Agents http://www.yourlawyer.com/articles/read/17309 Fri, 20 Nov 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17309 gadolinium contrast dyes at the Mayo Clinic has revealed that hemodialysis patients had a  77-fold higher risk of developing nephrogenic systemic fibrosis (NSF), while kidney transplant patients had a 69-fold higher risk of the disease.  The NSF study was published in the October issue of the Archives of Dermatology.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. There are currently five such agents sold in the U.S.: Covidien's OptiMARK; Prohance and Multihance, both by Bracco Diagnostics; Bayer Healthcare’s Magnevist; and GE Healthcare’s Omniscan.

It appears that NSF only develops in people with pre-existing kidney disease who are exposed to the gadolinium agents. In September 2007, the U.S. Food & Drug Administration (FDA) asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

The Mayo Clinic study involved 94,917 patients exposed to gadolinium agents at the Mayo Clinic between January 1, 1999 and December 31, 2006.   Of that group, 3,779 patients were on hemodialysis, 1,694 patients had undergone a kidney transplant, and 717 patients had liver transplants.  A total of 61 patients had a clinical diagnosis of NSF.

The study found that 1% of patients undergoing hemodialysis, and 0.8% of patients who have undergone kidney transplant were at risk of developing NSF.  The risk for liver transplant patients was 0%.

The study authors advocated for the development of new guidelines for the administration of gadolinium agents.

We reported previously this week that the FDA is still looking into the association between gadolinium agents and NSF.  On Wednesday, we reported that an FDA review had found that OptiMARK, Magnevist and Omniscan carried a higher risk of NSF than other gadolinium agents on the market. Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

Following the news from the FDA, Covidien announced it would be modifying the label on OptiMARK to contraindicate its use in patients with severe kidney impairment.  Mallinckrodt Inc., a Covidien company, has submitted this label change to the FDA and says it is implementing the new label in the U.S. effective immediately. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of OptiMARK.

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OptiMARK Gadolinium Contrast Agent Label Changed Over NSF Risk http://www.yourlawyer.com/articles/read/17298 Thu, 19 Nov 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17298 gadolinium contrast agent is modifying the product's label to contraindicate its use in patients with severe kidney impairment because of  its association with nephrogenic systemic fibrosis (NSF).  Mallinckrodt Inc., a Covidien company, has submitted this label change to the U.S. Food and Drug Administration (FDA) and says it is implementing the new label in the U.S. effective immediately.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition OptiMARK, other agents on the market include Prohance and Multihance, both by Bracco Diagnostics, Bayer Healthcare's Magnevist and GE Healthcare's Omniscan.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

It appears that NSF only develops in people with pre-existing kidney disease. In September 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

Yesterday, we reported that an FDA review had found that OptiMARK, Magnevist and Omniscan carried a higher risk of NSF than other gadolinium agents on the market.    Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

In a statement released by Covidien yesterday, the company said it is  implementing its OptiMARK label change in all countries where OptiMARK contrast agent has been approved for sale, in accordance with local regulatory requirements. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of OptiMARK

“For the small percentage of the U.S. population – less than 0.5 percent – with severe renal impairment, we believe it is prudent to act now, rather than wait for a causal link between GBCAs (gadolinium based contrast agents) and NSF to be established. Although the label already advises caution when using GBCAs with these patients, we are voluntarily taking this next step to help ensure this small, at-risk population does not receive administration of a contrast agent that could pose a risk of NSF.” said Dr. Herbert Neuman, Vice President, Medical Affairs and Chief Medical Officer, Pharmaceuticals, Covidien.

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Magnevist, Omniscan and OptiMARK Have Highest Risk of NSF, FDA Says http://www.yourlawyer.com/articles/read/17296 Wed, 18 Nov 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17296 nephrogenic systemic fibrosis (NSF) than other agents on the market, according to the U.S. Food & Drug Administration (FDA).  Though the agency's drug safety unit said the risk associated with the gadolinium contrast dyes "does not compel removal of specific (imaging agents) from the U.S. market",  it has recommended that the drug labels note the varying levels of risks with each product. An  outside panel of experts will take up the issue in December.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition to Omniscan, Magnevist and OptiMARK, other agents on the market include Prohance and Multihance, both by Bracco Diagnotics.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. NSF is a relatively new disease. In fact, the first known diagnosis of NSF only occurred in 1997, but it wasn’t until September 2000 that details of the disease were published in the medical journal Lancet.

It appears that NSF only develops in people with pre-existing kidney disease. In 2006, Dutch researchers were the first to link NSF with the use of gadolinium contrast dyes. In September 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

According to documents released yesterday by the FDA,  the highest risk of NSF was associated with Omniscan, Magnevist and OptiMARK.  The lowest risk was associated with Prohance and Multihance.  However, the agency said "the data do not appear to rule out an NSF risk for each of the agents." FDA reviewers said the extent of risk from any of the agents was unknown. One study of Omniscan estimated the chances of developing NSF was 4 percent among patients with severe kidney impairment.

According to a Reuters report, Covidien has already decided to modify the labeling of OptiMARK.  A spokesperson for the company  told Reuters that "it was prudent to act now, rather than wait for a causal link... to be established" between the imaging drugs and NSF.

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Thyroid Cancer Rates Near Indian Point Among Highest in U.S http://www.yourlawyer.com/articles/read/17285 Tue, 17 Nov 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17285 thyroid cancer, according to a study released Monday.  The study found  that rates of thyroid cancer  in the four counties surrounding the Indian Point nuclear plant  - Orange, Putnam, Rockland and Westchester -  were the highest in New York state, and among the highest in the United States.

The Indian Point nuclear power plant is located just north of New York City.  The two nuclear reactors there went online in1973 and 1976.  The plant, originally run by Consolidated Edison, is now owned and operated by Louisiana-based Entergy, a $13 billion company which runs nuclear plants in four other states.  Entergy is awaiting renewal of the licenses for Indian Point's two reactors, one of which expires in 2013 and the other in 2015.

According to an article published by anti-nuclear activist Joseph Mangano in the International Journal of Health Services, before the Indian Point reactors began operating, the thyroid cancer rate in the four surrounding counties was 1.5 percent below that of the state.  Now they are 54 percent higher.

At a news conference yesterday, Mangano  called for the facility to be shut down. “Indian Point shouldn’t be allowed to keep unless it proves that it’s safe and it should only address issues such as this,” he said.

To reach his conclusions Mangano analyzed data from the U.S. Centers for Disease Control and Prevention, which he says showed that from  2001-2005, the  thyroid cancer rate for the four counties was 66% above the U.S. average  The rate of the disease in Rockland County is 106 percent above the national average; 102 percent above in Putnam; 87 percent higher in Orange and 42 percent higher than average in Westchester, Mangano said.

Mangano asserted that a major risk factor for thyroid cancer is exposure to radioactive iodine, which is produced only in nuclear weapons and nuclear reactors.

Mangano heads the nonprofit Radiation and Public Health Project. Yesterday's event was also attended by representatives of the Indian Point Safe Energy Council, the Hudson River Sloop Clearwater, and the Atlantic chapter of the Sierra Club.

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Illness Reported After H1N1 Vaccine http://www.yourlawyer.com/articles/read/17269 Thu, 12 Nov 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17269 Guillain-Barre syndrome, MSNBC is reporting.

Jordan McFarland (14), is wheelchair-bound and developed severe headaches, spasms, and leg weakness, said MSNBC, and is expected to need to use a walker for up to six weeks and will have to undergo “extensive physical therapy,” following his shot. Jordon is not the only case, and this is not the first time a swine flu vaccine has been associated with the serious disorder, noted MSNBC. In 1976, there were increased reports of Guillain-Barre connected to that year’s swine flu vaccine; to date, the U.S. Centers for Disease Control and Prevention (CDC) has received five reports of the syndrome since October 6, reported MSNBC, in addition to Jordan’s.

While less than what is expected, according to Dr. Claudia J. Vellozzi, deputy director of immunization safety, about 40 million H1N1 vaccine doses have been made available, said MSNBC. Guillain-Barre is expected to develop in about one in each one million regular flu vaccinations, with one more case of the syndrome in every 100,000 people receiving swine flu vaccinations in 1976, said the CDC, reported MSNBC.

And, while the CDC says it has received some 1,700 reports of adverse events associated with the new swine flu shot—four percent, or 68, were deemed serious—Guillain-Barre Syndrome is considered one of the most severe of the reactions, said MSNBC. Experts believe the adverse effects experienced with the H1N1 virus are more serious than the vaccine.  “The H1N1 illness is making lots of children very ill," Vellozzi said. Over 4,000 have died, to date, said MSNBC, citing recent CDC estimates.

Since the implementation of the H1N1 inoculation program, the CDC has issued warnings about an array of conditions, such “miscarriage, heart attack and even GBS” that can take place with or without the vaccine and has urged the public to report any potential side effects, but not to assume the vaccine is connected, said MSNBC.

Barbara Lowe Fisher, president of the National Vaccine Information Center in Vienna, Virginia, explained that adverse events are underreported with a mere one-to-ten percent reported to the government's Vaccine Adverse Event Reporting System (VAERS), according to MSNBC. While a law implemented in 1986 mandates reactions be reported, there are no so-called sanctions for failing to report, said Fisher; the CDC confirmed that reporting is voluntary, noted MSNBC.

The Associated Press (AP) just reported that, according to federal health officials, at least 4,000 Americans have died from the swine flu, which is an increase of four-fold over what is being released in estimated figures. The AP noted that the increased figure was previously reported by The New York Times and also includes fatalities resulting from swine flu complications, such as infections and pneumonia.

The AP also said that, according to the CDC, "many millions" of Americans have been diagnosed with the pandemic virus since in April and that the World Health Organization (WHO) said physicians should not wait for lab results when dealing with pregnant women and at-risk groups who may have the swine flu.

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Hepatitis Scare In Colorado Not Over Yet http://www.yourlawyer.com/articles/read/17214 Mon, 02 Nov 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17214 hepatitis scandal that originated in Colorado is not yet over. The Denver Post reports that hundreds of patients remain untested for the dangerous liver disease that was potentially spread due to scrub tech Kristen Diane Parker’s shoddy practices and drug addiction.

Hepatitis C is spread by contact with infected body fluids, especially blood. The disease attacks the liver, and can lead to cirrhosis or cancer of the liver. There is no vaccine for hepatitis C and the incurable disease can be fatal. Hepatitis C is considered the leading cause of liver transplants.

The Denver Post said that Rose Medical Center is still trying to track down about 375 patients who have yet to be tested. Of these, some patients have refused testing or have received private testing and are not sharing results; the Center does not have accurate or current telephone numbers for about 100 patients. After Parker left Rose she worked at Audubon Surgery Center of Colorado Springs; 57 patients from that facility have not yet been reached, said the Denver Post. Both centers are facing at least one lawsuit each as a result of the debacle, said the Denver Post.

Parker, 26, is infected with hepatitis C and recently agreed to a plea agreement on charges stemming from her alleged theft of Fentanyl syringes and was sentenced to 20 years in federal prison. Parker allegedly stole the syringes for her own use, replacing them with saline after injecting herself and potentially infecting others with the disease.

Parker was indicted on July 23 on 42 counts by a federal grand jury: 21 counts of product tampering and 21 counts of obtaining a controlled substance by deceit, reported the Denver Post previously; charges only related to Parker’s alleged activities at Rose, one of several facilities in which Parker worked. Parker was also charged with three criminal counts connected to stealing Fentanyl, the Denver Post noted previously.

The Denver Post reported that more charges could be made and that, if convicted, Parker—who was jailed without bond—could have faced life in prison. The original counts were later reduced because prosecutors were looking to focus on the cases that were “easiest to prove,” said the Denver Post earlier. Parker pleaded not guilty to the indictment of 42 counts but acknowledged guilt on 10 counts, said the Associated Press (AP) earlier. The plea enables Parker to avoid a potential life sentence, noted BizJournals previously.

Fentanyl is a narcotic pain medication used for surgical patients and, as a result of swapping saline for the surgical pain medication, patients who were supposed to receive Fentanyl, clearly were not administered their prescribed medication, noted BizJournals in an earlier piece.

Of the Rose patients tested—some 4,158—15 patients were infected with hepatitis C from Parker, said the Denver Post, citing genetic tests. The Colorado Hospital Association has since implemented a task force, said the Denver Post, in order to look into so-called hospital "drug diversion," which is a term that related to drug theft that stems from staff, patients, or others with access to the hospital. The Association is also looking into hiring and drug policies at hospitals and is also reviewing state and federal regulations and for ways in which to enforce patient safety, said the Denver Post.

Rose is working on installing “drug-dispensing machines,” said the Denver Post, and is posting them in operating rooms; the Center is also conducting training on understanding drug theft and has geared it to managers and employees.

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Personal Injury Attorneys: Parker Waichman LLP Can Help You http://www.yourlawyer.com/practice_area/diseases Mon, 02 Nov 2009 00:00:00 -0500 http://www.yourlawyer.com/practice_area/diseases Harmful Diseases Lawsuit Lawyer

Parker Waichman LLP is a leading personal injury law firm with experienced personal injury attorneys who have been investigating the links between disease and defective drugs and toxins for many years.

Many people with a particular disease or disorder may not realize there's often a link to their illness and either a defective drug or exposure to hazardous chemical substances. Some of these injury-related diseases and disorders can cause serious health issues and/or death.

Because these cases are often very complex, anyone who suspects they may be suffering negative health consequences as a result of a drug they were prescribed needs to make sure they're dealing with a law firm that’s qualified in this area. Our attorneys and other professionals have the experience and knowledge to properly investigate every disease-related case and properly determine any link that may exist between the disease and a drug, environmental condition or any other cause. We've handled cases on matters ranging from defective drugs to Benzyne and mercury exposure, lead poisoning and many other toxic substances that can cause serious or life-threatening illnesses.

When you choose Parker Waichman LLP to represent your personal injury, disease or defective drug claim, you can be sure your case will be handled by a staff of attorneys and professionals that is uniquely suited to get you the best possible outcome. If you think you may need an experienced toxic tort or defective drug lawyer, please fill out the form at the right for a free case evaluation by a qualified personal injury attorney.

One of the most common forms of environmentally-related diseases is mesothelioma, a rare form of lung cancer directly caused by inhaling fibres of asbestos. Mesothelioma cases are complicated by the fact that Mesothelioma symptoms sometimes go years before they’re detected.

If you or someone you love has been impacted by this disease, it’s important to remember that you may be entitled to compensation from companies that manufactured Asbestos and related products.

With many years of experience working on Asbestos and Mesothelioma cases, the attorneys of Parker Waichman LLP are uniquely experienced to handle these cases. We work with a large network of asbestos specialists including physicians and other experts, which gives us the ability to properly handle any case across the country. You can also rest assured that our attorneys are working with the most current information on asbestos and mesothelioma available to the public, which is vital to understanding your illness and assuring you or your loved ones get the best treatment available.

Finally, the members of our well-versed legal staff can advise you on which legal options are available to you in order to preserve the financial security of you and your family, even after you have passed on.

If any of the Diseases lawsuits you are looking for is not listed in the links below please Visit our Diseases Archives Page for additional diseases litigation that Parker Waichman LLP has defended for their clients.

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