Monthly Archives: December 2012

Blog Post » Autism Progress

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Every year the Interagency Autism Coordinating Committee (IACC) updates its Strategic Plan for Autism Spectrum Disorder ResearchExternal Link: Please review our disclaimer., identifying progress and new opportunities across the range of autism spectrum disorder (ASD) research. Each year this task gets more difficult. In 2012, the speed of progress was so rapid that each draft of the Plan was out of date by the time the IACC reviewed it. The sheer volume of research was overwhelming. According to PubMed, there were over 1,000 ASD papers related to genetics or brain imaging since January 2011 – more than three times the number of papers from the same interval a decade ago.

What have we learned from this recent wave of research? A great deal. Although clinicians usually identify 18 to 24 months as the earliest time to make a diagnosis of ASD, electroencephalography (EEG) and brain imaging studies of children at risk show reproducible differences in brain activity before 12 months.1,2 Early detection means the possibility of early intervention. One of Time magazine’s top 10 medical breakthroughs of this year was a randomized controlled trial (RCT) of intensive behavioral treatment in 18 - 30 month old toddlers with ASD, which showed striking results.3,4 Relative to a comparison group of children with ASD who were receiving standard treatment, children receiving an early, intensive treatment showed twice the level of improvement, with some losing their diagnosis altogether. In addition to the profound behavioral gains, the early intervention children also showed EEG responses that resembled the EEG patterns seen in typically-developing children.

We still do not know enough about what causes ASD. The high concordance in identical twins and the association with several genetic disorders, like Fragile X and Rett syndrome, have encouraged a search for genomic causes. With the power of modern technology, we are getting an early picture of the genomic architecture of ASD. The emerging picture is more complex than most scientists would have predicted even a few years ago: over 100 genes have now been implicated.5,6,7 Genomic variations are present in at least 25 percent of children,8,9 but none of these variants accounts for more than 1 or 2 percent of cases and some appear to be “private” – occurring in only a single child or single family. Not only do many genes contribute to this one disorder, but each of these genes appears to be a risk factor for many neurodevelopmental disorders, including schizophrenia, attention deficit hyperactivity disorder (ADHD), and epilepsy.10

One of the most surprising findings from ASD genomics has been the high rate of spontaneous, or de novo, variation. Sequencing studies have found a great many base strands of DNA that are duplicated or deleted, so called copy number variations (CNVs), in addition to spontaneous single base or short strands of variants.11,12,13 These changes are not found in parental DNA, hence the idea that these mutations are not being inherited, but instead are arising spontaneously prior to or just after conception. Some of these changes may accumulate in the father’s sperm, which replicate throughout life and may acquire mutations with increasing parental age. Dads over 40 have more of these mutations and they are at higher risk for having a child with ASD, relative to fathers under age 30.14

What about environmental causes? Several environmental factors, such as exposure to air pollution,15 agricultural pesticides,16 and antidepressants,17 have been reported to increase ASD risk, mostly based on exposure during pregnancy. While most scientists assume that environmental factors interact with genetic susceptibility, we still know far too little about either genetic or environmental factors to make this link. Reports of specific genetic mutations that cause alterations in the synthesis of carnitine, a chemical involved in fat metabolism, suggest that dietary treatments may be helpful in treating some forms of ASD, reminding us that genetic diseases often have environmental corrections.18

The increasing prevalence of ASD adds urgency to finding the causes. The most recent report from the Centers for Disease Control and Prevention, based on the 2008 survey of children born in 2000, describes 1 in 88 children affected, a 78 percent increase since 2002.19 The drivers for this increasing prevalence are still unclear. A recent study from England reported a prevalence of roughly 1 percent in adults, many of them not previously diagnosed.20 These results suggest the possibility that there may not be much of an increase in the population affected by ASD, just much better ascertainment. Indeed, the highest prevalence figures come from population studies with the most careful ascertainment. A population-based study in South Korea found a rate of 1 in 38, with two-thirds not previously detected.21 While the rate in the population here in the U.S. is lower than this, the 1 in 88 figure in 2008 may still fall short of the mark. In the absence of a more complete explanation, as I have said in an earlier blog, the safest assumption is “more affected not just more detected” – a disorder that affects 1 in 88 children needs urgent attention.

If there is a true increase in children affected, what environmental factor or factors are driving this increase? The absence of the kind of clusters we see with infectious diseases or environmental toxicants makes the search for environmental contributors to ASD risk especially difficult. But we need to search carefully, following the clues that emerge. Most experts believe that prenatal exposure is the critical period of risk. And the growing evidence for brain changes in the first year, well before behavioral changes, would be consistent with an early period of risk.

While there are still more questions than answers, ASD has emerged as one of the hottest areas for biomedical research. The debate over ASD is frequently contentious, with some seeing it as an illness, some as an injury, and some as an identity. Many scientists now see ASD as a source of insight, teaching investigators from many disciplines, and studying a wide variety of disorders, new lessons about genetics, brain development, and behavior. Whatever your perspective on this complex issue, this is a period of unprecedented scientific progress, with many people from diverse fields now joining the ASD research community. This growth in our community, and the surge of investments made in ASD research over the past decade, are paying off by deepening our understanding of this complex disorder and laying the groundwork for future advances that will ultimately improve the lives of people with ASD and their families.

 1Bosl W, Tierney A, Tager-Flusberg H, et al. EEG complexity as a biomarker for autism spectrum disorder risk. BMC Med. 2011 Feb 22;9:18. PMID: 21342500

 2Tierney AL, Gabard-Durnam L, Vogel-Farley V, et al. Developmental trajectories of resting EEG power: an endophenotype of autism spectrum disorder. PLoS One. 2012;7(6):e39127. PMID: 22745707

 3Park, Alice (2012 Dec 4) Top 10 Medical Breakthroughs: Hope for Reversing Autism. Time magazine. Available at: http://healthland.time.com/2012/12/04/top-10-health-lists/slide/hope-for-reversing-autismExternal Link: Please review our disclaimer..

 4Dawson G, Jones EJ, Merkle K, et al. Early behavioral intervention is associated with normalized brain activity in young children with autism. J Am Acad Child Adolesc Psychiatry. 2012 Nov;51(11):1150-9. PMID: 23101741

 5Simons Foundation. SFARI Gene WebsiteExternal Link: Please review our disclaimer.. Accessed on December 14, 2012.

 6Betancur C. Etiological heterogeneity in autism spectrum disorders: more than 100 genetic and genomic disorders and still counting. Brain Res. 2011 Mar 22;1380:42-77. PMID: 21129364

 7Geschwind DH. Genetics of autism spectrum disorders. Trends Cogn Sci. 2011 Sep;15(9):409-16. PMID: 21855394

 8Sanders SJ, Murtha MT, Gupta AR, et al. De novo mutations revealed by whole-exome sequencing are strongly associated with autism. Nature. 2012 Apr 4;485(7397):237-41. PMID: 22495306

 9Devlin B, Scherer SW. Genetic architecture in autism spectrum disorder. Curr Opin Genet Dev. 2012 Jun;22(3):229-37. PMID: 22463983

 10Malhotra D, Sebat J. CNVs: harbingers of a rare variant revolution in psychiatric genetics. Cell. 2012 Mar 16;148(6):1223-41. PMID: 22424231

 11Coe BP, Girirajan S, Eichler EE. The genetic variability and commonality of neurodevelopmental disease. Am J Med Genet C Semin Med Genet. 2012 May 15;160C(2):118-29. PMID: 22499536

 12Neale BM, Kou Y, Liu L, et al. Patterns and rates of exonic de novo mutations in autism spectrum disorders. Nature. 2012 Apr 4;485(7397):242-5. PMID: 22495311

 13O'Roak BJ, Vives L, Girirajan S, et al. Sporadic autism exomes reveal a highly interconnected protein network of de novo mutations. Nature. 2012 Apr 4;485(7397):246-50. PMID: 22495309

 14Kong A, Frigge ML, Masson G, et al. Rate of de novo mutations and the importance of father’s age to disease risk. Nature. 2012 Aug 23;488(7412):471-5. PMID: 22914163

 15Volk H, Lurmann F, Penfold B, et al. Traffic related air pollution, particulate matter, and autismExternal Link: Please review our disclaimer.. Arch Gen Psychiatry. 2012. Epub ahead of print.

 16Shelton JF, Hertz-Picciotto I, Pessah IN. Tipping the balance of autism risk: potential mechanisms linking pesticides and autism. Environ Health Perspect. 2012 Jul;120(7):944-51. PMID: 22534084

 17Croen LA, Grether JK, Yoshida CK, et al. Antidepressant use during pregnancy and childhood autism spectrum disorders. Arch Gen Psychiatry. 2011 Nov;68(11):1104-12. PMID: 21727247

 18Celestino-Soper PB, Violante S, Crawford EL, et al. A common X-linked inborn error of carnitine biosynthesis may be a risk factor for nondysmorpohic autism. Proc Natl Acad Sci USA. 2012 May 22;109(21):7974-81. PMID: 22566635

 19Centers for Disease Control and Prevention (CDC); Autism and Developmental Disabilities Monitoring Network - Surveillance Year 2008 Principal Investigators. Prevalence of autism spectrum disorders - Autism and Developmental Disabilities Monitoring Network, 14 Sites, United States, 2008. MMWR Surveill Summ. 2012 Mar 30; 61(3):1-19 PMID: 22456193

 20Brugha TS, McManus S, Bankart J, et al. Epidemiology of autism spectrum disorders in adults in the community in England. Arch Gen Psychiatry. 2011 May;68(5):459-65. PMID: 21536975

 21Kim YS, Leventhal BL, Koh YJ, et al. Prevalence of autism spectrum disorders in a total population sample. Am J Psychiatry. 2011 Sep;168(9):904-12. PMID: 21558103

Naturalyte and Granfuflo Lawsuit Information Uncovered

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12/20/2012 Dialysis Lawsuit News :   On November 4, 2011, German pharmaceutical company, Fresenius Medical Care Inc. allegedly released an internal memo that contained some of their deepest secrets regarding the medications Granuflo and NaturaLyte. The information uncovered by Naturalyte and Granuflo Lawyers could have significant implications for the Granuflo and Naturalyte Lawsuit.   Included in the memo were acknowledgements of potential Granuflo side effects and warnings to doctors to adjust dosage to decrease likelihood of serious complications. Prior to the exposure of this document, the company had claimed that they were unaware of the side effects that were being attached to their products.

 

Granuflo and NaturaLyte were once commonly-prescribed additives to dialysis treatment. Dialysis treatments, which may raise levels of acidity in patients, are often mixed with products, such as Granuflo, which offset the acidity.  Unfortunately these products can cause a drastic increase in bicarbonate which can offset the pH of the blood. If left untreated, the increased levels of bicarbonate can affect major functions, like the heart’s ability to pump blood. If this happens, a patient may experience a heart attack. Since Fresenius did not alert doctors to this problem, they did not know to adjust dosages and in 2010 alone, 941 Granuflo patients passed away.

 

Because of this apparent deception, many patients that had poor experiences with Fresenius began seeking Granuflo lawyers to help the launch their own case. Before the memo was released it was already unlikely that Fresenius could come out on top, seeing as they were “unaware” of side effects of drugs that they were in charge of testing. However, now that a document was released showing that Fresenius were informed, there is very little chances of finding a jury that will take their side.

Also notable in this case: in March of 2012, the FDA placed a Class 1 recall on Granuflo and NaturaLyte. This is important seeing as the Class 1 is the strongest action the FDA can take, and is reserved for especially threatening medications.

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Natrualyte Lawsuit resulting from the death of dialysis patients

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In March of this year (2012), after overwhelming evidence and a possible cover-up, the FDA placed a Class 1 recall on Fresenius Medical Care Inc.’s dialysis treatments, Granuflo and NaturaLyte. A Class 1 recall is the most serious action that the FDA can take and is only applied tot products that are shown to have a significant risk attached to them.

Naturalyte Lawsuit

Granuflo and NaturaLyte are popular additives in dialysis treatments that are used to alleviate the inherent acidity found in dialysis. Unlike other additives designed to do the same thing, however, Granuflo and NaturaLyte have been shown to dramatically increase levels of bicarbonate in patients. Excesses of bicarbonate (also called alkalosis) at first will cause minor symptoms such as nausea, but if these solutions are continuously to an alkalosis patient, it will eventually interfere with important bodily functions. This may often include heart disturbances. Granuflo Side Effects, therefore, often include heart attacks.

 

When their medications were undergoing the approval process, Fresenius did not alert the FDA to the possibility of alkalosis, so when it was commercially released, doctors did not to adjust dosages to accommodate for the increases of bicarbonate. Initially, Fresenius claimed that they were not aware of these side effects, but new evidence suggests otherwise.

According to the New York Times, an internal memorandum, dated November 4, 2011 was released to clinics owned by Fresenius. This memo warned their doctors that excesses of Granuflo and NaturaLyte can eventually lead to heart attacks. They cited the 941 Granuflo patients who had died in 2010. This memo was allegedly sent out months before the FDA had any indication about how harmful Granuflo may be; therefore, it could show that Fresenius was not as clueless as they tried to indicate.

This revelation has left many involved in lawsuits against Fresenius incredulous that the company would hide such an important development from them. In addition, if Fresenius is found guilty of hiding information, their likelihood of developing support from juries greatly diminishes.

 

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Natrualyte Lawsuit resulting from the death of dialysis patients

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In March of this year (2012), after overwhelming evidence and a possible cover-up, the FDA placed a Class 1 recall on Fresenius Medical Care Inc.’s dialysis treatments, Granuflo and NaturaLyte. A Class 1 recall is the most serious action that the FDA can take and is only applied tot products that are shown to have a significant risk attached to them.

Naturalyte Lawsuit

Granuflo and NaturaLyte are popular additives in dialysis treatments that are used to alleviate the inherent acidity found in dialysis. Unlike other additives designed to do the same thing, however, Granuflo and NaturaLyte have been shown to dramatically increase levels of bicarbonate in patients. Excesses of bicarbonate (also called alkalosis) at first will cause minor symptoms such as nausea, but if these solutions are continuously to an alkalosis patient, it will eventually interfere with important bodily functions. This may often include heart disturbances. Granuflo Side Effects, therefore, often include heart attacks.

 

When their medications were undergoing the approval process, Fresenius did not alert the FDA to the possibility of alkalosis, so when it was commercially released, doctors did not to adjust dosages to accommodate for the increases of bicarbonate. Initially, Fresenius claimed that they were not aware of these side effects, but new evidence suggests otherwise.

According to the New York Times, an internal memorandum, dated November 4, 2011 was released to clinics owned by Fresenius. This memo warned their doctors that excesses of Granuflo and NaturaLyte can eventually lead to heart attacks. They cited the 941 Granuflo patients who had died in 2010. This memo was allegedly sent out months before the FDA had any indication about how harmful Granuflo may be; therefore, it could show that Fresenius was not as clueless as they tried to indicate.

This revelation has left many involved in lawsuits against Fresenius incredulous that the company would hide such an important development from them. In addition, if Fresenius is found guilty of hiding information, their likelihood of developing support from juries greatly diminishes.

 

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Granuflo Dialysis Lawsuit in the News

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Dialysis Lawsuit News   

12/13/2012 According to an article published in the New York Times, drug manufacturer, Fresenius Medical Care Inc., have hid vital information regarding the dialysis additives , Granuflo and NaturaLyte. Both drugs are designed to lower acid levels in patients undergoing dialysis treatment. Unfortunately for the patients, Granuflo and NaturaLyte also caused a dramatic increase in bicarbonate levels. An increase in bicarbonate (a condition also called alkalosis), causes an offset in the body’s natural pH. Unnatural shifts in pH can leave the body unable to function properly. As in Granuflo with the cases of Granuflo and NaturaLyte, many people who suffer from alkalosis have shut down of heart functions leading to heart attacks.

Granuflo Heart Attacks

When people on Granuflo and NaturaLyte began experiencing said heart attacks, many customers were frustrated with Fresenius. When submitting Granuflo and NaturaLyte to the FDA for approval they did not cite alkalosis as a possible side effect, so when it was experienced by dialysis patients, some filed suits against the pharmaceutical giant. The Granuflo and NaturaLyte lawsuit targets Fresenius for either not being aware of their drug’s side effects, or possibly withholding the necessary information.

As mentioned before, right now the scale seems to be tipping toward the idea that Fresenius is withholding information. Almost five months before the company admitted to their mistakes, Fresenius allegedly circulated an internal memo that warned doctors to adjust dosages on people using Granuflo and NaturaLyte in hopes to avoid alkalosis. This memo also mentioned that in 2010, 941 patients died of side effects like heart attacks. If this memo is to be believed, this shows the company knew about the side effects at least by the end of 2011; however, many involved in the lawsuit seem to believe the company had been fully aware of their actions from the beginning.

In response to the numerous complaints associated with these medications, the FDA has enacted their most serious course of action by placing a Class 1 Recall on Granuflo and NaturaLyte.

 

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Granuflo Dialysis Lawsuit in the News

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Dialysis Lawsuit News   

12/13/2012 According to an article published in the New York Times, drug manufacturer, Fresenius Medical Care Inc., have hid vital information regarding the dialysis additives , Granuflo and NaturaLyte. Both drugs are designed to lower acid levels in patients undergoing dialysis treatment. Unfortunately for the patients, Granuflo and NaturaLyte also caused a dramatic increase in bicarbonate levels. An increase in bicarbonate (a condition also called alkalosis), causes an offset in the body’s natural pH. Unnatural shifts in pH can leave the body unable to function properly. As in Granuflo with the cases of Granuflo and NaturaLyte, many people who suffer from alkalosis have shut down of heart functions leading to heart attacks.

Granuflo Heart Attacks

When people on Granuflo and NaturaLyte began experiencing said heart attacks, many customers were frustrated with Fresenius. When submitting Granuflo and NaturaLyte to the FDA for approval they did not cite alkalosis as a possible side effect, so when it was experienced by dialysis patients, some filed suits against the pharmaceutical giant. The Granuflo and NaturaLyte lawsuit targets Fresenius for either not being aware of their drug’s side effects, or possibly withholding the necessary information.

As mentioned before, right now the scale seems to be tipping toward the idea that Fresenius is withholding information. Almost five months before the company admitted to their mistakes, Fresenius allegedly circulated an internal memo that warned doctors to adjust dosages on people using Granuflo and NaturaLyte in hopes to avoid alkalosis. This memo also mentioned that in 2010, 941 patients died of side effects like heart attacks. If this memo is to be believed, this shows the company knew about the side effects at least by the end of 2011; however, many involved in the lawsuit seem to believe the company had been fully aware of their actions from the beginning.

In response to the numerous complaints associated with these medications, the FDA has enacted their most serious course of action by placing a Class 1 Recall on Granuflo and NaturaLyte.

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New Jersey Insurance Claims Lawyer

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New Jersey Insurance Claims Lawyer

New Jersey Insurance Claims Lawyers

New Jersey Insurance Claims Lawyers

Getting help from a New Jersey Insurance Claims Lawyer is the essential first step in recovering from the devastation wrought by Hurricane Sandy. The East Coast is littered with literally billions of dollars’ worth of damage. As the long process of rebuilding begins, more damage will likely be discovered. Homeowners facing devastation look to their insurance companies to honor their claims. Insurance companies are generally looking to settle, quickly and cheaply. A New Jersey Insurance Claims Lawyer is the only real advocate you may have. Do not accept an insurance claim settlement without the protection legal counsel affords. Call toll-free and arrange a free consultation with a New Jersey Insurance Claims Lawyer.

Aren’t all insurance settlements cut and dried, based on the policy?

Insurance policies are full of pages of complex language. A sentence on one page may refer back to a stipulation on another page of your multi-page policy. Policies often read like a circle within a circle, putting the most knowledgeable lay person at a disadvantage.  Only a New Jersey Insurance Claims Attorney can weed through all of the endorsements, exclusions and limits to insure you get what you have paid for when you trusted your future to the insurance company. Don’t leave this vital decision in the hands of a company that has every reason to pay as little as possible to victims suffering the ravages of Hurricane Sandy. Fill out the contact from to the right or call our toll-free number to arrange a confidential, compassionate consultation with a New Jersey Insurance Claims Lawyer. Your call and consultation is free. You have nothing to lose.

How do I hire a New Jersey Insurance Claims Lawyer?

One toll-free call may change the outcome you face right now. With one toll-free call you can arrange a consultation with  knowledgeable, experienced New Jersey Insurance Claims Lawyers. During your free consultation, you can learn about all of the protections and options you have, not just those your insurance company wants you to hear about. The want you to believe they are looking out for you. They will seek the opportunity to make a quick assessment of your most visible damage, make a seemingly fair and appealing offer of fast cash and be done. Case closed. If you find hidden damage as little as a week later, no matter how bad and costly it might be, you will find you have signed away valuable options. Case closed. Do not let this happen to you. You and those you love need a lawyer that knows the ropes and can face a powerful, well-funded insurance company head on, fighting for you. A  New Jersey Insurance Claims Lawyer has the knowledge and experience to get you the best possible outcome. A free consultation with a compassionate New Jersey Insurance Claims Lawyer is a toll-free call away. Fill our easy contact from or for faster service, call our toll-free number now.

Why do I Need a New Jersey Insurance Claims Lawyer?

Twenty billion in damages and mounting say the early estimates. What will be the final tally? No one is certain at this point. People caught in the path of this deadly storm have no real idea how much it will cost to get their lives back in order.  Insurance companies are Johnny on the spot with settlement offers hoping desperate, vulnerable people will quickly accept their “help”. If you are among those just starting the process of rebuilding your life, take heed. Historical statistics speak volumes about the need for legal representation. Call a New Jersey Insurance Claims Lawyer before you lose your right to proper, just compensation. From the perspective of this stark moment in time, your damages may seem much less than they actually are. What seems like a more than satisfactory offer may cost you hundreds or thousands in the weeks and months to come. Once you accept an offer, you give up the your  rights to further compensation. Don’t let potential financial ruin happen to you. Call our toll-free number. A consultation with a New Jersey Insurance Claims Lawyer is completely free. Call Now!

I paid for a policy. Doesn’t my insurance company have to pay me now?

You have paid your policy premiums and have the right to believe getting what you are entitled to is a safe and easy process.  That is not the reality of the situation. Your insurance company has more than one lawyer.  They have an entire staff of lawyers working on their behalf. Their lawyers are already preparing to minimize the amount they pay out in settlements to people like you, people with a real possibility of losing everything. You must have a New Jersey Insurance Claim Lawyer working on your behalf to make absolutely sure you get the compensation you are entitled to. Insurance policies are typically pages and pages long, all written to benefit the insurance companies. Their lawyers are more than familiar with the complex language of the policies they write. A New Jersey Insurance Claims Lawyer will be equally knowledgeable and able to interpret your policy to your best benefit.  Have knowledge and experience on your side, working to protect your future. You must make the call. It is free, easy and may be the most important call you make. Call toll-free now and arrange a free consultation.

Business, families, homes, children, the elderly and people with disabilities need help now.

Hurricane Sandy has been called one of the most singularly destructive natural disasters to impact the eastern seaboard in nearly a century. Sandy left behind death, destruction and economic decline as the massive storm made a path northward. Businesses closed, rivers appeared where once there were streets, power failures impacted millions and public transportation came to a standstill. The most densely populated cities and the financial hub of our nation has been torn apart. We can rebuild but it will take the strength and resolve of the American people to do so. It will also take personal strength and the ability to see past the moment to make the necessary decisions for a better future. A  New Jersey Insurance Claims Lawyer is among a group of experienced lawyers that will be working tirelessly in the months to come to protect the rights of victims of this disaster. Your New Jersey Insurance Claims Lawyer will look past the visible present to your future recovery and fight to insure your compensation is just. Seek the help of a New Jersey Insurance Claims Lawyer with the willingness, compassion and experience to do what must be done.  A free consultation can easily be arranged. Call our toll-free number and begin your recovery now.

New Jersey Insurance Claims Attorneys

New Jersey Insurance Claims Attorneys

New Jersey Insurance Claims Lawyer

New Jersey Insurance Claims Lawyer

 

 

New Jersey Insurance Claims Attorney

New Jersey Insurance Claims Attorney

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Maize controversy

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The study by Gilles-Eric Séralini and colleagues at the University of Caen in France linking cancer tumours in rats with maize modified to resist the herbicide Roundup, has been judged by the European Food Safety Authority to be scientifically unsound because of inadequacies in its design, reporting and analysis (8 December, p 7).

As the EFSA report recommended, it is now time for the journal that published it, Food and Chemical Toxicology, to retract the study.

Due to intense scrutiny post-publication, this paper has been peer-reviewed to a far greater degree than most papers, yet despite no independent scientific expert being able to support its design, reporting or analysis, it remains, gathering citations and increasing the impact factor for the journal.

• The latest position of the journal is outlined in a statement on its website.

To continue reading this article, subscribe to receive access to all of newscientist.com, including 20 years of archive content.

Lawsuits Filed Over Contraceptive Products

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12/11/2012: Lawsuits filed against Bayer over Yaz being settled.  Bayer is currently settling Yaz Lawsuit and Yasmin Lawsuit cases it currently faces while the maker of Nuvaring faces trial on its first Nuvaring Lawsuit cases as early as May of next year. The Yaz, Yasmin and Nuvaring Lawsuits are very similar however, the defendants in these cases have taken a very different approach to dealing with their potential liability.

Over the period of several years, German pharmaceutical company, Bayer, released Yaz and Yasmin, two birth control medications with similar ingredients. Key among them is a synthetic hormone known as drospirenone. A similar generic version, Ocella, was released independently. These three medications are the only contraceptives known that contain drospirenone.

Exposures to drospirenone can cause unhealthy effects on a woman’s body; the chief concern here being an increase in potassium. High levels of potassium can lead to heart troubles that, in turn, can harmful blood clots. If left untreated these clots may break off and cause such problems as deep vein thrombosis, pulmonary embolism, or stroke. Most cases in the Yaz, Yasmin, and Ocella Lawsuit all site side effects such as these after using the contraceptive.

Recently, the American College of Obstetricians and Gynecologists has reissued their warning that using a drospirenone-based birth control pill may have a higher risk of blood colts. Medical journals have urged women to choose older birth control, preferably Generation 2 or older, as these have traditionally proven to be the safer route. The FDA released findings that Yaz and other similar products could increase the chances of a blood clot by up to 74%. Women are being warned that time using the medication has no obvious effect on the likelihood of clotting, as cases have come in citing various lengths of time between exposure and side effects.

Bayer has begun settling cases, spending an average of $212,000 per case, for a total of about $750 million over 3490 cases. With over 8,000 cases left to settle, the company will likely spend into the billions by time they are finished. Currently the Yaz lawsuit holds the highest amount of pending cases in the United States.

Despite the complications associated with these drugs, according to Bayer, Yaz remains within the top three earners for the company.

 

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