Tag Archives: Allegation

da Vinci Surgical Robot News: Rottenstein Law Group LLP Comments on FDA Allegation That Intuitive Surgical Failed to Report Warning to Regulators

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(PRWEB) June 28, 2013

The U.S. Food and Drug Administration has alleged that da Vinci surgical robot maker Intuitive Surgical warned customers before the FDA about a potentially hazardous problem with the da Vinci in 2011, breaking an established regulatory protocol. The Rottenstein Law Group LLP, a da Vinci law firm that explains da Vinci lawsuits and side effects at http://www.davincilawsuit.us, notes that this is however another FDA announcement involving the business following a preceding a single in April 2013.

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According to CNBC*, Intuitive notified surgeons about appropriate protocols for tip covers and for the correct generators to be utilized with those instruments. The FDA stated the correction was in response to complaints about problems with electrical currents jumping from the equipment to sufferers throughout surgery, major to injury. Nonetheless, the article said, the firm did not initial warn the FDA.

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The sort of letter the FDA sent Intuitive is not a final determination, but it does imply that the FDA considered Intuitive in violation of regulations, stated Rochelle Rottenstein, principal of the Rottenstein Law Group LLP. The situation addressedthe arcing of electricity from the surgical tools to the patientcould cause the patient internal burns, an alleged side impact that we usually hear about when fielding telephone calls from possible plaintiffs.

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Intuitive Surgical asserts that it is fully committed to superior instruction opportunities for surgeons and surgical teams in the use of its items, but notes that it does not participate in determining when a surgeon is adequately prepared to operate employing the da Vinci Surgical Method. According to a USA Nowadays post, the da Vinci surgical robot was employed in about 400,000 surgeries in 2012.** Recently CNBC aired a documentary about the da Vinci, focusing on the prospective dangers. In May 2013 Intuitive defeated a negligent instruction claim in court (Estate of Fred E. Taylor v. Intuitive Surgical Inc. 09-2-03136-5, Superior Court, Port Orchard, Wash.).

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The Rottenstein Law Group LLP encourages men and women to pay a visit to its site to download a free brochure to aid them determine if they are eligible to file a da Vinci lawsuit.

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For the most current news on defective medicines and healthcare devices and associated lawsuits, visit the Rottenstein Law Group LLPs Injury Lawyer Newswire at injurylawyernewswire.com. Readers can subscribe to the news websites stories and videos to remain on prime of individual injury news.

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*cnbc.com/id/100843549 (June 25, 2013)&#13

**usatoday.com/story/news/nation/2013/04/09/robot-surgery-fda/2067629/ (April 9, 2013)

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About THE ROTTENSTEIN LAW GROUP LLP&#13

The Rottenstein Law Group LLP is a New York-primarily based firm that represents clientele nationwide in mass tort actions. The firm was founded by Rochelle Rottenstein, who has much more than two decades of encounter as a lawyer, to represent consumers hurt by defective healthcare devices and medicines. (Attorney advertising. Prior final results do not guarantee a similar outcome.)

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Get in touch with:&#13

The Rottenstein Law Group LLP&#13

Rochelle Rottenstein, Esq.&#13

321 W. 44th Street&#13

# 804&#13

New York NY 10036&#13

(212) 933-9500 (office phone)&#13

(212) 933-9980 (facsimile)&#13

rochelle (at) rotlaw (dot) com

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Medtronic Infuse Bone Graft Failure Allegation Lawsuits Update: Resource4thePeople Reports New Analysis Findings Raise Issues about Side Effects

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San Diego, CA (PRWEB) July 05, 2013

http://www.resource4thepeople.com/defectivemedicaldevices/medtronic.html

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Resource4thePeople, in its latest update to customers impacted by operations involving healthcare devices, these days announced that the findings of a two-year study by Yale University researchers have raised issues about the marketing and advertising and security of Medtronic Infuse bone grafts similar to those integrated in allegations now being reviewed.

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The Yale University study, which was published* June 18, 2013 in the Annals of Internal Medicine, was undertaken as an independent study following the health-related devices were the topic of a Class 1 Recall by the Meals and Drug Administration** and a highly vital report*** from a U.S. Senate committee that raised concerns about conflicts of interest simply because of payments the organization produced to health-related researchers and physicians.

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Studies funded by Medtronic underplayed the advantages of the Infuse bone grafts and failed to report numerous critical side effects, according to both Yale researchers and Senate investigators. The Yale researchers reported such severe side effects as excessive bone development, male sterility, inflammations and paralysis, according to the report.

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The findings of this study are constant with some of the allegations that we have been getting in rising numbers considering that the release of the Senates report, said Resource4thePeople.

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We anticipate that the news of the Yale researchers findings will generate even a lot more inquiries from customers about the legal possibilities they might have to seek compensation and consequently, we will continue to provide totally free legal consultations and overview these claims.

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The Yale researchers had been crucial of prior Medtronic-funded study research which provided endorsements of the safety and effectiveness of the Infuse bone grafts. The Yale researchers help those research had been biased, as did Senate investigators in their report.

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The Yale researchers summarized their findings in comparing the Medtronic Infuse bone graft (rhBMP-2) to conventional therapy by saying:

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In conclusion, we discovered substantial proof of reporting bias and no proof that rhBMP-2 is a lot more effective than ICBG in spinal fusion, with some evidence of an association with crucial harms. Far more study is needed to offer a lot more trustworthy estimates of danger for cancer and other adverse events and to determine patient populations in which use of rhBMP-two could be beneficial, such as circumstances where use of bone graft alone is related with a high danger for pseudarthrosis. On the basis of the currently offered evidence, it is difficult to recognize clear indications for rhBMP-two in spinal fusion.

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Resource4thePeople stated it will also continue to offer normal updates supplying buyers who might have been impacted by remedy with Medtronic Infuse bone grafts with data about research and legal developments involving the devices.

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This will continue to be an region of prime concentrate for us as we provide buyers legal options involving allegations that the Medtronic Infuse Bone Grafts might have caused critical, life-threatening health issues, mentioned Resource4thePeople.

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Amongst the allegations we are investigating are claims from buyers alleging that the Medtronic Infuse Bone Grafts had been utilised improperly in medical operations and caused serious side effects to sufferers.

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Resource4thePeople also mentioned that its national network of attorneys will continue to review claims from customers who are alleging they could have suffered extreme back and leg discomfort, infections, bone deterioration, sterility and cancer, amongst other troubles.

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In the FDAs Feb. 16, 2011 Class 1 Recall** of Medtronic Infuse Bone Graft pumps and refill kits, the FDA warned that the merchandise “may outcome in patient harm, serious injury, and/or death due to drug overdose or underdose.

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Class I recalls are the most severe variety of recall and involve situations in which there is a reasonable probability that use of these merchandise will lead to significant adverse overall health consequences or death.

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Resource4thePeoples legal group is also investigating claims similar to those contained in a federal lawsuit**** filed in March in the Southern District of Ohio against Medtronic Inc. and an Ohio surgeon who, according to complaint, was a paid Medtronic consultant in addition to his professional duties.

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The lawsuit includes allegations that 88 sufferers are claiming that underwent spine surgeries involving bone protein that they did not consent to and have suffered detrimental side effects for which they are searching for compensation.

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The lawsuit claims that “medically unnecessary, experimental spine surgeries” had been performed “using falsely and improperly marketed Medtronic healthcare devices and drugs,” according to allegations contained in the court file.

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Resource4thePeople also stated that the allegations filed in the lawsuit raise far more inquiries about the relationships between physicians and Medtronic over costs paid to the medical doctors that have come beneath criticism from the U.S. Senate Finance Committee investigators.

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The revelations integrated in the Oct. 25, 2012 report by the Senate Finance Committee involving payments to doctors and the downplaying of dangerous side effects from this healthcare device have raised significant questions amongst patients who underwent these surgeries and have contacted us,” mentioned Resource4thePeople.

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Resource4thePeople said that over the final few months such inquiries have enhanced as a outcome of news media reports about the findings of the committees investigation into Medtronics spending of millions of dollars to physicians and researchers in return for studies favorable to the Infuse device.

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The Medtronic Infuse bone graft was approved by the Food and Drug Administration as a sanctioned medical device made to stimulate spinal bone development in individuals suffering from reduce spine degenerative diseases.

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Sources:&#13

*http://annals.org/post.aspx?articleid=1696646&#13

**http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm243634.htm&#13

***http://www.finance.senate.gov/newsroom/chairman/release/?id=b1d112cb-230f-4c2e-ae55-13550074fe86&#13

****Case # 1:13cv0202 U.S. District Court, Southern District of Ohio

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New Time Eligibility Announced for Byetta Pancreatic Cancer Allegation Circumstances Getting Reviewed by Resource4thePeople Attorneys

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San Diego, CA (PRWEB) June 28, 2013

http://www.resource4thepeople.com/defectivedrugs/byetta.html

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Resource4thePeople announced right now extended time eligibilities for customers who are in search of legal consultations more than allegations that their use of a class of diabetes drug including Byetta might have triggered them to suffer severe side effects of the pancreas.

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“This announcement is being created in order to clarify the status of buyers who have been inquiring about their legal rights because the Meals and Drug Administration’s March 14, 2013 announcement* about its investigation into feasible hyperlinks among these medicines and pancreatitis and cancer,” stated Resource4thePeople.&#13

“Therefore, we are announcing that shoppers who may possibly have been using the drugs just before and soon after the announcement are each eligible to seek consultations with our national legal network.”

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Resource4thePeople is informing customers that if they have any confusion about their status in possibly looking for compensation for alleged side effects they should take actions now to preserve their legal rights.

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The complimentary consultations have been offered in response to a large volume of inquiries from shoppers triggered by the FDA’s announcement that it is investigating reports of feasible enhanced risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs such as Byetta for type 2 diabetes.

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The FDA identified these drugs as exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).

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There are a substantial quantity of Americans who treat their diabetes with these drugs and the FDA announcement has had widespread ramifications in terms of individuals seeking info about their legal possibilities, stated Resource4thePeople.

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As a outcome, our national legal network will continue to provide cost-free legal consultations in which customers might decide their eligibility to file a claim or lawsuit and seek compensation for the healthcare expenses, discomfort and suffering and other charges that might have been incurred.

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In its announcement, an FDA spokesman said that the findings were based on examination of a modest number of pancreatic tissue specimens taken from patients following they died from unspecified causes.

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The FDA has asked researchers to provide the methodology utilised to gather and study these specimens and to give the tissue samples so the agency can additional investigate possible pancreatic toxicity linked with the incretin mimetics.

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Resource4thePeople notes that there may possibly be legal time limits involved in such actions and is requesting buyers to make make contact with as soon as achievable in order to preserve all legal options obtainable.

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Byetta was initially authorized by the FDA and released onto the marketplace in 2005, with its primary function being to help individuals with diabetes manage their situation.

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It is applied by injection and it and the other incretin mimetics, according to the FDA, mimic the incretin hormones that the body typically produces naturally to stimulate the release of insulin in response to a meal.

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The agency stated the medications are used along with diet and workout to reduced blood sugar in adults with sort two diabetes.

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In its announcement, the FDA reiterated a preceding public warning about postmarketing reports of acute pancreatitis, such as fatal and serious nonfatal situations, associated with the use of incretin mimetic drugs exenatide and sitagliptin.

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An agency official also mentioned that a not too long ago published study that examined insurance coverage records also found the use of exenatide or sitagliptin could double the risk of building acute pancreatitis.

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The official mentioned that the Warnings and Precautions section of the drug labels and the patient Medication Guides for incretin mimetics contain warnings about the threat of acute pancreatitis.

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Resource4thePeople also is delivering consumers some of the cautionary analysis about Byetta and its sister drugs. Right here are some of the warnings and precautions taken from the agencys internet internet site:**

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What is the most essential info I should know about BYETTA?&#13