The first study results may come out in 2023. Of the remaining 87, 25 reports relate to 23 adult deaths; 25 reports relate to 22 incidences of pregnancy loss; five reports relate to five incidents of a death of an infant after live birth; two reports relate to two incidences of ectopic pregnancies (a complication of pregnancy in which the fertilized egg attaches outside the uterus); one report specifies a death but does not indicate whether the death occurred before or after birth; and 29 reports reference information on deaths posted in social media or other media outlets. No cases have proceeded to trial. Pedal Error Accidents- What to Do After the Crash, Dyspareunia (difficulty or pain during sexual intercourse), Failed to warn the consumers of the risks and side effects, Were negligent in training the medical practitioners on the implant, Costs of surgical procedures and follow-up treatment. Assisting patients and their families since 2008. After insertion by a physician, the coils are supposed to prevent the fertilization of eggs and stop eggs from reaching the uterus. If a case goes to trial, liability is determined and damages are awarded. Retrieved from, Ward, P.R. Update your browser for more security, speed and compatibility. In fact, there are more than 70 reports of death associated with the device. Bayer purchased Conceptus in 2013, which has resulted in Bayer Pharmaceuticals becoming liable for damages caused by Essure. Prior to interim results being available from the Essure postmarket surveillance ("522") study, the FDA completed an extensive evaluation of medical device reports submitted in 2017 and 2018 that mentioned issues involving potential device removal to learn more about why women were choosing to have the device removed, which usually requires a surgical procedure. Among the 2,325 pregnancy losses reported: 589 were reported as ectopic pregnancies; 279 were reported as elective terminations of pregnancies, and 1,190 were reported as other pregnancy losses. The most frequent device problem codes reported were patient-device incompatibility/biocompatibility (for example, possible nickel allergy or patient's anatomy related to failure) (8,765), migration of the device or device component (5,770), device breakage/material fragmentation/fracture (2,981), dislodged or dislocated device (2,899), device operating differently than expected, for example, implant failure or pregnancy (1,137), malposition of the device (415), device difficult to remove (354), and device difficult to insert (342). As a result, the FDA increased scrutiny of the device, eventually putting a black box warning on it. She sued Bayer in 2015, alleging that Bayer failed to warn her of the risks. ALL RIGHTS RESERVED. Our writers are members of professional associations, including American Medical Writers Association, American Bar Association, The Alliance of Professional Health Advocates and International Society for Medical Publication Professionals. Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. 4.8 Stars from 338 Reviews. Through December 31, 2022, there have been 95 reports coded by the submitter as death. Most of the reports were related to potential device removal (91%) which is consistent with the MDRs for Essure from 2017 to 2021. 1 South Orange Ave, Suite 201, Orlando, FL 32801. Bayer has tried to shift blame to the gynecologist to absolve itself of liability for Essure injuries mentioned in lawsuits. In the Essure settlement amount agreements, Bayer makes no admission of guilt or responsibility. The top six reported reasons in the device removal reports were: Device dislocation/migration/expulsion: 12%. Lets plunge into the blog to learn more. Thousands of American women filed lawsuits against Bayer after they say Essure caused devastating side effects and ruined their lives. Since Essure was given federal approval by a significant body, the FDA, it protected Bayer against accusations that it failed to adequately inform the public of physical harm. She had to have a hysterectomy to remove Essure and subsequently died. Since it came on the market in 2002, more than three-quarters of a million devices have been implanted. Although there has never been an actual class action lawsuit over Essure, many women affected by Essure pursued their own independent lawsuits. Essure has materials not approved for use. Drugwatch writers gather lawsuit information by studying court records, watching lawsuit proceedings and speaking with experienced attorneys. However, unfortunately, she lost her life. However, women must endure pain during and immediately following the procedure. US District Court in the Northern District of California. Breaking into Expert Witness Work:The Ultimate Guide, Techniques for WritingPersuasive Expert Witness Reports, 7 Must-Haves in YourExpert Witness Resume/CV. The FDA continues to evaluate other sources of postmarket data, including results from mandated postmarket studies, in addition to medical device reports to gather more information about device removals. You must also have supporting documentation showing the use of the device was likely the cause of the health complications. Essure is an implantable contraceptive device developed by Conceptus. According to the German pharmaceutical giant, who in June inked a $10.5 billion settlement to end lawsuits across the U.S. claiming the Roundup weedkiller caused cancer, the $1.6 billion deal will cover 90 percent of the nearly 39,000 resolved and outstanding cases that alleged Essure caused internal perforation, abdominal pain, miscarriages . The Essure is simple to implant because it does not require any surgical intervention. Bayer said the Essure settlement is for . (2017). This bill takes effect retroactively and applies to pending civil actions. Bayer submitted the adverse event information under the variance in ten reporting spreadsheets, during the reporting period of June 2020 through March 2021. Learn more about Essure's brushes with the FDA here. For example, in many states, there is a two year statute of limitations for product liability claims so you must file your case within two years from the date of injury. 12% stated patient symptoms were not resolved or improved. 2023 CSO Technology Partners, LLC. Boarding & Prep School Sexual Abuse Lawsuit, Device placement occurs in a doctor's office, Patients were promised rapid recovery from the procedure, Essure has a 99.8% success rate in preventing pregnancy, Prolonged bleeding after device placement. Retrieved from, Whitman, E. (2017, February 22). Essure cases against Conceptus and Bayer became more challenging due to the pre-emption debate, and several judges dismissed cases due to pre-emption. Has anyone won an Essure lawsuit in 2021? Please read our disclaimer for more information about our website. Keep people safe from potentially harmful drugs, medical devices and procedures by informing them of medical conditions, severe side effects and ways to take action. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. She continued to have problems such as painful and heavy periods, unexplained weight gain, autoimmune conditions such as chronic fatigue syndrome, dental troubles, gastrointestinal complaints, and mental fog pertaining to the implant. This website and its content may be deemed attorney advertising. That's roughly $118,000-$200,000 payout per lawsuit. Violating the FDAs conditional pre-market approval of Essure by failing to follow FDA guidelines, Using non-conforming materials when manufacturing Essure devices, Manufacturing Essure devices at unlicensed facilities, Concealing complications of Essure and failing to report them to the FDA, Failing to follow FDA guidelines when providing training to doctors on implanting Essure, Negligently marketing Essure by overpromoting it, Failing to properly train doctors by providing Essure simulator training instead of hands-on training, Allowing doctors to implant devices without proper training, Encouraging unqualified doctors to purchase and sell Essure kits to patients each month. In America, the window for new Essure implantations closed at the end of 2019. This is a fact-finding effort that allows both sides to see the evidence their opponents will be presenting. To get started give us a call (866) 494-0370 or apply online. (2018, April 23). Beginning in 2016, Bayer (the company that manufactured Essure) submitted most of the reports received by the FDA. New FDA restrictions and disclosure requirements were [&hellip Written by Anjelica Cappellino, J.D. The settlement was expected to resolve around 90% of the 39,000 cases that had been filed at the. Retrieved from, Welch, A. ", Women are rightfully suing Bayer for the pain and suffering caused by the Essure device. Conceptus, Inc. developed and manufactured the Essure birth control system. The most common device problem reported was breakage. The settlement includes all of the jurisdictions in which the majority of lawsuits were filed the state of California Joint Council Coordinated Proceedings and the U.S. District Court for the Eastern District of Pennsylvania. She also suffered weight gain, stomach issues and mental and emotional anguish. According to Fortune.com, the $10 billion payout was intended to settle between 50,000 and 85,000 lawsuits. You may still be able to bring an individual case against Bayer if the statute of limitations has not yet expired in your case. Many women have complained that the coils became loose or pierced the walls of their fallopian tubes, causing pain and other serious side effects such as autoimmune conditions. The total number of medical device reports received related to Essure in 2022 is 1,606. The Journal of Minimally Invasive Gynecology. These reports are expected to be available in the near future. Side effects of Lexapro Are you depressed with the antidepressants? Three of the death reports provided a date of the death: one in 2012 for a reported death of an infant after birth, and two in 2013, both for reported adult deaths. Tucker Carlson ousted at Fox News following network's $787 million settlement. The allegations against Bayer in the Essure lawsuits were that they. Retrieved from, Walsh v. Bayer Corp. et al. However, notwithstanding pre-emption, Essure coil lawsuits were permitted to continue by the Alameda Superior Court Judge Winifred Smith in California, and he handled more than 13,000 Essure lawsuits as of March 2018. Summary information about the events in each spreadsheet is also accessible in the FDA's MAUDE database. More than 700 Canadian women are suing Essures owner, Bayer, for compensation as a result of complications from the birth control device. A year after Potts was implanted with the device, she developed headaches, joint pain, cramping, and fatigue, which resulted in a hysterectomy to remove the device. Bayer to Pay $1.6 Billion to Settle Defective Essure Contraceptive Device Lawsuits The latest in an eventful year for Bayer Pharmaceuticals is a $1.6 billion settlement to resolve claims against its Essure contraceptive device. Retrieved from, Walsh V. Bayer. (2017). Thus, it successfully creates a barrier keeping the sperm away from the eggs and prevents conception. For many women, Essure side effects started immediately after implantation. The Essure Problems Facebook page was started in 2011 by Angie Firmalino. The final hearing on the settlement will be held on October 20, 2021. Essure lawsuit updated 2021: If you weren't part of the initial Essure lawsuit, you may be able to recover in the next round of settlements. A preeminent entity the FDA approved Essure at the federal level, giving Bayer protection from claims it failed to warn the public of risks, the company argued. Essure is a type of contraceptive device consisting of two coils that are inserted into the fallopian tubes, which prevents fertilization of a woman's eggs. Multiple different damages classes including fully insured and self-funded plans are eligible to receive payment under the settlement. However, as required by the new California Consumer Privacy Act (CCPA), you may record your preference to view or remove your personal information by completing the form below. We'd love to hear from you, please enter your comments. Call an Essure Lawyer today. You can file a claim for Essure complications if you are within the statute of limitations and you have documentation that you experienced medical complications as a result of the permanent birth control. Some of the most common side effects of the birth control device are nausea, vomiting, bleeding, dizziness, cramping, and pelvic discomfort. Based on the limited information in the event descriptions for the reports, it is difficult to identify duplicate reports for events within the variance as well. The Matching search results: At Coxwell & Associates, PLLC, we have been helping Mississippians for over 35 years. This is a type of breach of contract claim that arises when a warrantor expressly or implicitly provides assurances about the quality of an item and those assurances are proved to be untrue. Jury Trial Demand, Petition for Damages. In the United States District Court Northern District of California. The reports do not necessarily represent unique cases, but rather events identified in comment threads from social media posts received as part of litigation. As of November 2022, there have been no new updates in this litigation. As one complaint filed in Pennsylvania alleges, Essure migrates from the [fallopian] tubes, perforates organs, breaks into pieces, and/or corrodes wreaking havoc on the female body. Remaining fragments and other materials left in the body are also alleged to have caused autoimmune conditions. Physician reporting of adverse occurrences is optional under present rules and regulations, and that is made mandatory under this bill. One such threat is pedal error accidents, Pressure Ulcers and Bedsore Lawsuits: Unravel the Complexities, Humira lawsuits: Expert Guidance for Patients Seeking Justice. By the end of the year, after being faced with numerous Essure lawsuits by the affected women, Bayer announced that it would discontinue production and sales of Essure. In lawsuits, some say their devices moved out of the fallopian tubes and cut into nearby organs. David Kessler, a former FDA commissioner and expert witness for the plaintiffs, stated that regulators may have demanded stricter labeling as early as 2006 if theyd been aware of all the problems patients claimed. As Kessler explained in a 2019 report to the court, [a] medical device company has a responsibility, independent of what FDA directs it to do, to alert physicians and patients to risks that were unknown to or poorly understood by FDA but were known to the company.. After women in the Essure Problems group met with the FDA and the agency placed sale restrictions and black box warnings on the device, Bayer announced it would stop selling it on Dec. 31, 2018 in the U.S. Furthermore, the complaints alleged that Bayer encouraged unqualified doctors to sell the devices to patients, in exchange for fees, and that Bayers statements regarding the efficacy of Essures safety constituted a breach of express warranty. In 2008, she went to her doctors office to have the device implanted, according to her lawsuit. The complaints reported to the FDA were as follows: More than 80 percent of the devices were removed due to pain. Retrieved from, Atkins, D. (2018, March 28). The discovery phase occurs after the pleadings and involves an exchange of information between parties. The terms of the $1.6 billion settlement are mostly confidential, with negotiations still ongoing for the remaining 10% of suits that did not settle. Please try again later. (2015). Bayer's Essure Settlement Details Settlement Size: $1.6 Billion Approximate Share Per Plaintiff: $45,600 It was also advertised as 100% effective. The claims of Stephanie Baily, Tanya de la Paz and Heather Walsh are some of the first lawsuits filed and only three out of thousands. The complaints alleged that Bayer acted negligently in failing to properly train doctors on how to implant the device, relying on Essure Simulator Training rather than real, hands-on experience and that the completion of said training was never verified. The statute of limitations can vary by state and type of claim, but in most cases is two years from the time of injury. When she returned to her doctor three months later for a follow-up, the examination revealed that a coil in her right fallopian tube was broken. During that time, we've worked on cases against companies and helped clients win . Most reports received between 2013 and 2015 were voluntary reports submitted from women who received Essure implants. Bayer settled most Essure lawsuits in August 2020. Despite its commercial success, reports of serious Essure side effects began surfacing around 2009. 80% of the device removal reports cite litigation. Defective product lawsuits are filed when a person is injured because of a manufacturing defect, design defect, or (as in the apparent case of Essure) the manufacturers failure to warn of a products dangers. When Bayer decided to discontinue the sale of the device starting in 2018, the company cited issues regarding the overall declining use of birth control, the rise of long-acting reversible contraceptives, as well as inaccurate and misleading publicity about the device. Bayers official discontinuance of Essure also fell right before the premiere of a Netflix documentary, The Bleeding Edge, which investigates the medical device industry and features a group of women who had lobbied Congress for years regarding Essures dangers. It has the name of a stillborn child named Ariel Grace Burrell. Of the total reports: 1,064 live births were reported; 1,688 did not indicate whether the pregnancy resulted in a live birth or pregnancy loss; and 2,325 pregnancy losses were reported. The FDA subsequently required Bayer to conduct additional clinical trials in February 2016, and a black box warning of potential complications was placed on the product in November 2016. According to the reports, Bayer Healthcare paid out $413 million in legal birth control lawsuit settlements related to Essure in 2017. However, plaintiffs who sustained more serious damage will receive more compensation. ParaGard and Essure are two different types of birth control devices used by women in the U.S. LEVERKUSEN, Germany-- ( BUSINESS WIRE )--Bayer announced today that it has reached agreements with plaintiff law firms to resolve approximately 90% . Conceptus was purchased by Bayer AG in 2013, and since then, it has been a subsidiary of Bayer. Case No. Testing Positive for COVID-19: It Felt Like I Had a Compression Belt Around My Chest, COVID-19: A Consumers Guide to the Coronavirus, Trial Attorney and Pharmaceutical Litigation Expert, Philips Recalls Some Remediated DreamStation CPAP, BiPAP Devices, Erika Sward of American Lung Association Reveals the Dangers of Vaping and IQOS. The FDA is taking all possible measures it can to assure the safety of women by trying to understand the long-term complications of Essure. It has requested women who are still successfully having implants in their bodies for years continue and is expected to collect the details of the long-term effects. Due to Essure, she required a hysterectomy and bilateral salpingo-ophorectomy. Women in the Pennsylvania lawsuits said Essure migrates from the [fallopian] tubes, perforates organs, breaks into pieces, and/or corrodes wreaking havoc on the female body. Manufacturing defects could cause the device to crack, injuring surrounding tissues and organs, according to one complaint. Following the serious symptoms, she had to undergo a hysterectomy to remove the Essure birth control device. We will direct you to one of our trusted legal partners for a free case review. The Essure Facebook group boosted media coverage of device side effects. Bayer took this pre-emption as its protective gear from the Essure lawsuits. In February 2016, the FDA ordered Bayer Healthcare to conduct a new clinical trial, and in November 2016, it received a black box warning label. Drugwatch is located at: Essure is a device that provides a permanent birth control solution for women who no longer wish to have children. Essure supposedly has a number of advantages over surgical sterilization: For women considering permanent sterilization, the lure of an office-based option proved effective. Most of the reports received listed multiple patient problem codes in each report. Before sharing sensitive information, make sure you're on a federal government site. Essure Permanent Birth Control, Recalls, Market Withdrawals and Safety Alerts, Information for Patients and Health Care Providers: Essure, to gather more information about device removals, Essure postmarket surveillance ("522") study, ESSURE Medical Device Reporting Variance Spreadsheet - March 2021, ESSURE Medical Device Reporting Variance Spreadsheet -February 2021, ESSURE Medical Device Reporting Variance Spreadsheet -January 2021, ESSURE Medical Device Reporting Variance Spreadsheet - December 2020, ESSURE Medical Device Reporting Variance Spreadsheet - November 2020, ESSURE Medical Device Reporting Variance Spreadsheet - October 2020, ESSURE Medical Device Reporting Variance Spreadsheet - September 2020, ESSURE Medical Device Reporting Variance Spreadsheet - August 2020, ESSURE Medical Device Reporting Variance Spreadsheet - July 2020, ESSURE Medical Device Reporting Variance Spreadsheet - June 2020. Updated on April 27, 2022, Connect with industry-leading professionals whose credentials meet all your case requirements. So, keep in touch. the research found that in the period of eight years, more than 17.8% of women got their devices removed. You might be using an unsupported or outdated browser. 2:15cv384. You may know by a handful the whole sack- is a proverb that goes well with these sample cases from the Essure lawsuits to get to know the size of the iceberg that is hidden below. Although the payments were legal, the report caused controversy due to the obvious concern of money unduly influencing a doctors recommendation of the device. According to doctors, injuries have discouraged new patients from receiving the device. Learn about your legal options and get free evaluations from attorneys experienced with product liability and personal injury cases. In 2020, Bayer AG finally agreed to settle with the litigants in a class-action lawsuit for a $1.6 billion Essure settlement. According to her lawsuit, [Bayer] actively and fraudulently concealed adverse reports of migrations and perforations from the Plaintiff and from the FDA.. We do not offer financial advice, advisory or brokerage services, nor do we recommend or advise individuals or to buy or sell particular stocks or securities. Drugwatch's trusted legal partners support the organization's mission to keep people safe from dangerous drugs and medical devices. Essure is a hysteroscopic sterilization procedure, a type of tubal sterilization that does not require an incision. This means the high-quality information we provide comes from credible sources, such as peer-reviewed medical journals and expert interviews. (2018, January 25). Bipartisan legislation known as Ariel Graces Law seeks to eliminate federal pre-emption safeguards for any Class III PMA devices that endanger patients. In these reports, the mean and median time from implant to explant were both approximately 4.5 years. Last month, a California state court judge unsealed thousands of documents filed as part of the litigation in Essure Products Cases, JCCP No. A medical record review company will have expert professionals peruse your medical charts and scoop out the valid ones that can turn the lawsuit in your favor. The device, however, has a history of complications. However, if you or your loved one has an Essure implant, suffered pain or injuries, and underwent surgery to remove the device, contact an experienced lawyer to know the chances of proceeding with a lawsuit. Since the FDA approved Essure in 2002 to January 2018, the agency had received 26,272 adverse event reports about the device, former FDA and CEO of device events analyst Madris Tomes told Drugwatch. The flexible device can be inserted into the fallopian tube path through the vagina and cervix. Bayer will make no admission of wrongdoing or liability within the settlement. August 20, 2020 01:00 PM Eastern Daylight Time. One of our content team members will be in touch with you soon. essure settlement payout date 27th February 2021 / 0 Comments / in Uncategorised / by Punky Brewster Spin Off , Joanna Gaines Classic Minestrone Soup , Japji Sahib - Sikh Prayer , Interposition Depth Cue , Bissell Spinwave Plus Reviews , Quotes From The Monster In Frankenstein , Modern Bowl Cut Male , People's Court Complaints , After two years and four hospitalizations for severe pain, fainting and fever, she underwent a CT scan. Drugwatch.com doesnt believe in selling customer information. The documentary, The Bleeding Edge, alerted her of the risk, and in 2020, she had it removed through another surgery. Some of these individuals say they experienced complications. As of 2020, more than 270,000 women world-wide have received Essure implants. Bayer had received adverse event information between November 2016 through November 2020 as part of litigation. The Essure settlements will resolve about 90 percent of the nearly 39,000 claims. The Essure settlement was largely expected after Bayer said earlier this month that it had reserved 1.25 billion euros (S$2.03 billion), primarily to settle litigation over the contraceptive implant. Helped more than 12,000 people find legal help. (2016). The deadline when the statute of limitations runs out can vary depending on the type of claim you are bringing and where you live. Please call us using the phone number listed on this page. Information provided on Forbes Advisor is for educational purposes only. In 2021, 63% of submitted reports cited litigation, followed by 91% of all submitted reports citing litigation in 2020, 95% in 2019, and 73% in 2018 and 2017. In 2017, 2018, 2019, 2020, and 2021, 92.7%, 87.5%, 91%, 93.5%, and 85.7% respectively, of all reports received used terms related to device removal. The announcement comes just months after Bayer agreed to a $12.1 billion plan in June to settle various lawsuits it had inherited from its $63 billion acquisition of Monsanto. When complications arose, there was a lack of attention to detail. In its Aug. 20, 2020, announcement, the company said there is no admission of wrongdoing or liability by Bayer in the settlement agreements. If your Essure lawsuit proceeds to the litigation stage, you will get to present your case and Bayer will be eligible to raise defenses. According to the lawsuit, in July 2012, de la Paz had her first Essure procedure. Essure allegedly causes many different types of complications for women after the birth control device is implanted. Essure was sued on the following grounds: Since Bayer had settled the first set of Essure lawsuits, the graph has not had many movements. The court continued the trial to a later undetermined date and set all pre-trial motions to be heard on 4/21/2020. As the door on this litigation closes, we thought it would be a good time to review exactly how Bayer and Essure got here. Examples of trusted legal reviewers include qualified mass torts lawyers and certified paralegals. Bayer has announced a $1.6 billion dollar settlement covering 90% of pending Essure lawsuits in the United States. Updated on April 27, 2022 EXPERT SEARCH Retain world-class experts The defendants include Bayer and Conceptus, the original manufacturer of the device before Bayers acquisition of the company in 2013. According to Bayer, the company is not admitting any wrongdoing or liability but rather, offers the settlement to distractions and uncertainties associated with this litigation. The settlement does not have any impact on pending litigation in countries outside the United States. Bayer Announces Resolution of U.S. Essure Claims. Failure to report to the FDA 16,047 complaints of potential device malfunction. (2018, September 18). Complaints or adverse event reports do not necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to establish or compare rates of event occurrence. In fact, the official company position still asserts the safety and efficacy of Essure. Her husband is seeking damages for loss of love, comfort, care, companionship, affection as well as emergency care, funeral expenses and medical bills. The information on this website is proprietary and protected. (2013) In the Court of Common Pleas, Philadelphia County. Conceptus provided the implant to thousands of women before its acquisition by Bayer in 2013. https://images.law.com/contrib/content/uploads/documents/402/23649/McLaughlin-v-Bayer-Essure.pdf, https://www.law360.com/articles/1027239/essure-users-must-combine-13k-injury-suits-judge-says, https://www.jmig.org/article/S1553-4650(17)30177-2/pdf, https://www.bayer.com/en/media/quarterly-reports, https://www.businesswire.com/news/home/20200820005665/en/Bayer-Announces-Resolution-U.S.-Essure%E2%84%A2-Claims, https://www.modernhealthcare.com/article/20170222/NEWS/170229972/essure-problems-cost-bayer-413-million-last-year-alone, https://www.cbsnews.com/news/bayer-essure-implant-sales-halted-outside-us/, https://www.quarterly-report-2017-q3.bayer.com/notes/explanatory-notes/legal-risks.html, https://www.reuters.com/article/essure-clinical-trials-in-missouri-not-g/essure-clinical-trials-in-missouri-not-grounds-for-jurisdiction-there-judge-idUSL2N1PL013, http://www.post-gazette.com/local/city/2018/04/23/Bayer-conceptus-essure-birth-control-pittsburgh-lawsuit-contraceptive-fda-allegheny-county/stories/201804230138, http://www.cbgnetwork.org/downloads/Essure_Charge_Philadelphia.pdf, https://docs.justia.com/cases/federal/district-courts/pennsylvania/paedce/2:2015cv00384/500267/108, https://www.leagle.com/decision/infdco20160203a36.
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