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FDA Requires Black Box Warning for IV Antibacterial Tygacil® After Analyses Confirm Higher Risk of Death

On September 27, 2013, the FDA sent a Drug Safety Announcement warning that “an additional analysis shows an increased risk of death when intravenous (IV) Tygacil® (tigecycline) is used for FDA-approved uses as well as non-approved uses.” The FDA also required a Black Box Warning to be added to the Tygacil® label to inform doctors […]

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Study Finds Da Vinci® Robotic Hysterectomies Cost More, But Not Safer than Alternative Procedures

A new study published in the medical journal Obstetrics & Gynecology concludes that hysterectomies performed with the Da Vinci® Surgical Robot are no safer than laparoscopic hysterectomies – and may actually increase the risk of certain injuries. Researchers from the University of Texas Southwestern Medical Center suggest that performing a hysterectomy with the Da Vinci® […]

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New Study Finds that Complications From Da Vinci® Robotic Surgery Are Vastly Underreported

The Da Vinci® Surgical Robot is manufactured and marketed by Intuitive Surgical, Inc. It is used in a number of surgical procedures across the country, including hysterectomies, gastric bypasses, prostate removals, gallbladder removals, and thyroid cancer surgeries. In July, the FDA issued a Class 2 Recall on approximately 30 Da Vinci® Surgical Robots after one […]

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Pradaxa® Lawsuit Update: Roger C. Denton, MDL Co-Lead Counsel and Partner at Schlichter, Bogard & Denton, Provides Update on Discovery Abuse Hearing

Roger C. Denton, Plaintiffs’ Co-Lead Counsel, reports on the current developments of the Pradaxa® Multidistrict Litigation and the hearing that took place on September 18, 2013 to address Plaintiffs’ Motion for Sanctions filed against the manufacturers and distributors of Pradaxa®, namely Boehringer Ingelheim. Roger C. Denton has been appointed by Judge Herndon to serve as […]

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Transvaginal Mesh Lawsuit Update: Settlement Reached in New Jersey State Court Case Against C.R. Bard

Bloomberg News reports that C.R. Bard has agreed to settle a case set for trial this month in the New Jersey state court consolidation. The case involving Melanie Virgil was set to begin on September 23, 2013 in Atlantic City, New Jersey. Ms. Virgil is a junior high music teacher from Colorado who alleges that […]

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Takeda, Manufacturer of Actos® Type 2 Diabetes Drug, Accused of Prioritizing Sales Over Safety in Second Trial Case

According to a recent report from Bloomberg News, in a case pending in Maryland State Court (the second Actos® case to go to trial), it has been alleged that Takeda, the manufacturer of Actos®, put sales over safety by failing to warn consumers that Actos® could cause bladder cancer. The attorney representing the family of a man […]

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C-8 Lawsuit Update: Over Four Dozen Lawsuits Have Been Filed in Ohio Federal Court for Exposure to C-8 Contaminated Water

As of August 15, 2013, there are 46 C8 lawsuits filed in federal court that have been consolidated in the Multidistrict Litigation (MDL) In Re: E.I. du Pont de Nemours and Company C-8 Personal Injury Litigation (MDL 2433). The MDL is currently pending in the United States District Court for the Southern District of Ohio […]

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Pradaxa® Clinical Trial Aborted Due to Health Risks Posed for Study Participants Using Pradaxa®

According to a recent study published in the New England Journal of Medicine, patients with mechanical heart valves who were treated with Pradaxa® in a clinical trial suffered more instances of strokes, heart attacks, and bleeding problems than those patients treated with warfarin – which is a blood thinning medication that has been the standard […]

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FDA to Fast-Track Even More Pharmaceutical Drugs to the Market

According to a recent report from NaturalNews, the United States Food and Drug Administration (FDA) wants to expand the types of drugs eligible for its so-called “Fast Track” process, which is a shortcut method for drugs to receive accelerated approval and priority review. In particular, the FDA plans to allow certain drugs, including obesity treatments […]

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GranuFlo® Lawsuit Update: Over Two Hundred Lawsuits Filed in MDL 2428 Pending in Federal Court

Nationwide, hundreds of lawsuits have been filed against Fresenius Medical Care for inadequate warnings about risks associated with GranuFlo® and NaturaLyte®. In March, the Judicial Panel on Multidistrict Litigation (JPML) announced that all GranuFlo® federal lawsuits would be consolidated for pretrial proceedings before the Honorable Judge Douglas P. Woodlock in the United States District Court […]

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