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29 Jun 10:37 am
... 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer. Medtronic
Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27 ... of
their products in state tort actions. The purpose of this act is to negate the Supreme Court's holding in Reigel v. Medtronics and to provide some recourse to patients and
families that have been injured as a result of a defective ...
4 Feb, 2008 10:00 pm
FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10,
8626L-10, 8626-18, 8626L-18, 8627-10, ... not be taken lightly. Explanation of the Issue - Between December, 2005 and March, 2006 Medtronic
received reports of nine patient deaths within three days after the initiation - or ... . The cases involved new system implants, catheter revisions, and system replacements.
Medtronic has concluded the patient deaths were most likely caused by opioid and/or sedative ...
2 Mar 8:16 pm
At least three personal injury lawsuits have been filed against Medtronic Inc. onbehalf of patients
injured or killed by complications with the Medtronic Infuse Bone Graft. According to whistleblower lawsuits, Medtronic actively promoted and marketed the Infuse Bone Graft off-label for use in the cervical spine. When used during cervical fusion surgery, the Infuse
Bone Graft has been associated with a high ...
13 Jun, 2008 7:17 pm
The American Association for Justice (AAJ) is lobbying for the rights of consumers injured by defective medical devices. In Riegel v. Medtronic, Inc. the U.S. Supreme Court ruled that manufacturers of medical products weren't liable for damages if
their ... mimic the 1976 Medical Device Act (MDA), which is what the U.S. Supreme Court relied on for its decision in Riegel v. Medtronic,
Inc. The new act seeks to add the following language to the section titled "No Effect on Liability Under State Law": ...
6 Mar 6:56 am
... 2008 decision by the Supreme Court stands as a barrier to patients who desire to sue for medical device liability. The Supreme Court ruling in Riegel v. Medtronic, Inc. holds that patients or their surviving heirs would be barred from suing makers of complex medical
devices like the Medtronic's heart device product, if the Food and Drug Administration (FDA) approved its sale. Since that ruling, judges
nationwide have applied the ...
8 Apr, 2008 6:00 am
You've probably already heard about the U.S. Supreme Court's decision in Riegel v. Medtronic, Inc.,
___ U.S. ___ (Feb. 20, 2008), earlier this year. Last Thursday, The American Lawyer had an interesting article, "For Defendants Alone?" (subscription), about that and other preemption
cases now before the Supreme Court: "All three cases turn on the court's developing view of federal preemption of state ...
30 Oct, 2007 3:44 pm
... October 30th, '07 issue, the Wall Street Journal reported that the Sprint Fidelis 6949 defibrillator, manufactured by Medtronic,
Inc. has been recalled. Defibrillators are implanted devices that treat cardiac arrest and restore normal ... September -- Medtronic sought to reassure doctors, at times blaming the problems largely on physicians' technique. In March, a Medtronic letter to doctors said its investigation "suggests that variables within the implant procedure may contribute significantly to ...
3 Dec, 2007 6:56 pm
... Medtronic Recalls Sprint Fidelis Cardiac Leads Questions and Answers for Consumers What are Sprint Fidelis Leads? Manufactured by
Medtronic, Inc., Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that
connect an ... devices are set to more effectively monitor for potential fractures. These patient management recommendations are available at [www.medtronic.com] How should problems with Sprint Fidelis leads be reported? Problems should be reported to FDA's MedWatch Adverse ...
16 Oct, 2007 1:57 pm
... Wall Street Journal about the Fidelis Sprint leads recall presented the current situation: In announcing the recall early yesterday, Medtronic said that its Sprint Fidelis leads have broken at a rate apparently higher than that of competing leads, ... prompted by this medical journal
article by Dr. Hauser, reporter Janet Moore of the Star-Tribune newspaper in Minnesota -- where Medtronic Inc. is headquartered -- picked up the Sprint Fidelis story in a July 30, 2007 article, "Medtronic device under ...
2 Feb 2:42 am
... 2009 WL 35467 (D.Minn. 2009). The Judicial Panel on Multidistrict Litigation transferred related cases involving Medtronic Inc.'s recalled Sprint Fidelis defibrillator leads to the District of Minnesota last February. The leads were ... . Plaintiffs simply could not identify any
specific requirements in the CGMPs/QSR that were purportedly violated by Medtronic. It is noteworthy that the court found dismissal with
prejudice was appropriate. This complaint was filed after extensive preparation by the ...
1 Nov, 2007 1:32 pm
... products (over 3000) than there are PMAs. For all intents and purposes Medtronic, Inc. v. Lohr,
518 U.S. 470 (1996), killed preemption ... comes from an FDA regulation where the Agency put a "gloss" on the statute that the Lohr court accepted. Medtronic uses (pp. 38-39) this same regulation , 21 C.F.R ... common-law claims that would be uniquely applicable to a single medical device. That done,
Medtronic gets to the "easy part" (our words): that the tort claims in Riegel are "different from or in addition ...
7 Nov, 2007 8:28 pm
... returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information. Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional ... whatever other
actions may be necessary. Questions and Answers for Consumers What are Sprint Fidelis Leads? Manufactured by Medtronic, Inc., Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect ...
3 Dec, 2008 11:02 pm
... use the product. What's also interesting is that although identified in the lawsuit, the surgeon is not a defendant. The lawsuit holds Medtronic solely responsible for Ms. Nisbet's death. It turns out that lawsuits from former employees were filed in 2002 ... product -- called Infuse Bone
Graft -- for purposes not approved by the Food and Drug Administration. Associated Press Medtronic Inc.'s Fridley, Minn., corporate headquarters. Government investigators are probing the off-label use of Infuse, ...
27 Nov, 2007 5:09 am
... after announcing a global recall of defibrillator leads. Luisi et al. v. Medtronic Inc. et al.,
No. 047-cv-4250 (D. Minn. 2007). According to the U.S. Food and Drug Administration (FDA), the recall of Medtronic's Sprint Fidelis
defibrillator leads is due to a chance of fracture in the leads that may ... earlier model, which had a lower failure rate. The lawsuit further alleges that Medtronic negligently concealed problems with the leads from the public and the medical community by waiting until ...
22 Oct, 2007 12:23 pm
... Scrutiny on Safety Issues By ANNA WILDE MATHEWS and THOMAS M. BURTON October 17, 2007; Page B7 Medtronic Inc.'s decision to stop selling potentially defective defibrillator leads has prompted scrutiny of the devices and of ... leads, which are electrical wires
that connect the hearts of patients to the defibrillators implanted in their chests. On Monday, Minneapolis-based Medtronic disclosed that the
Sprint Fidelis wires have fractured in about 2.3% of the 268,000 models made, 235,000 of which are ...
17 Jun 2:18 pm
... of these have been implanted for five years or longer. The recall process was set into effect May 18th of this year when Medtronic
Inc. sent a letter to physicians warning them about wire separation problems in the pace maker. On May 27th, the company ... Kappa series
600/700/900. The agency has advised patients who have been fitted with these models to visit the Medtronic website to determine if their device
is included in the recall. Patients who are not sure if their pacemakers are affected by ...
2 Jan, 2008 7:26 pm
Medtronic Inc. will settle 2682 lawsuits filed by plaintiffs who claim that the implantable
biomedical device maker knew that its Marquis line of implanted cardiac defibrillators was defective but didn't do enough to pull the ... , says it is not admitting liability or
affirming to the plaintiffs' claims by settling the products liability lawsuits. In a statement made by Medtronic's Cardiac Rhythm Disease
Management Unit President Pat Mackin affirmed that Implantable defibrillators made by Medtronic ...
15 Jul 7:47 am
... paid for by Medtronic. Documents indicate that for more than a year, while Dr. Kuklo was at Washington University, Medtronic financed a separate study by the doctor that also involved reviewed the use of Infuse on Walter Reed patients. Both the ... are also of great
concern to us[.]" It should be noted that regardless of what fraudulent study Dr. Kuklo created at the behest of Medtronic, and no matter how
it was used to promote potentially defective products, and no matter how many individuals are ...
27 Jul 10:45 pm
Press release (MarketWatch) on July 27: Medtronic Inc. said Monday, July 27 that it has resolved all
outstanding intellectual-property litigation with Abbott Laboratories As part of the agreement, Medtronic will pay $400 milion to Abbott and
$42 million to evYsio Medical Devices LLC. The medical-technology company said that under terms of the settlement, neither party will sue the other in the field of ...
27 Sep, 2007 5:09 pm
The StarTribune reported today, September 27, 2007, the following Bloomberg News item: Medtronic Inc.
was told to pay $226.3 million to Johnson & Johnson's DePuy ... a $24.3 million verdict won by DePuy over Medtronic's MAS screws. Johnson
& Johnson, based in New Brunswick, N.J., can ask the ... it is phasing in a new screw design that it says won't use the patented technology. Medtronic said a federal jury in California, in a separate case, had determined that the patent was invalid. Medtronic ...
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