Lawsuit Information Center

The promise of robotic surgery is exciting.

A recent study has raised additional questions about the need for robotic-assisted surgery in many cases. The research suggests that the da Vinci surgical robot should be reserved for much more complicated procedures that cannot be easily handled by laparoscopic surgery.

At the American Congress of Obstetricians and Gynecologists annual meeting, researchers from St. Lukes-Roosevelt Hospital Center reported that 10% of patients operated on through robotic surgery for pelvic lesions suffered significant postoperative complications, compared to 7% of those who underwent laparoscopy. Patients are more likely to suffer complications, pay more, and are under the knife longer than patients treated through laparoscopic surgery.

Vaginal prolapse is incredibly common, with approximately 30-50% of women having some sort of prolapse during their lives. Our lawyers are investigating vaginal mesh lawsuits involving Cook Medical, in addition to other manufacturers of vaginal mesh systems.

Cook Medical Transvaginal Mesh Cases

Cook Medical held its products out as breakthrough technology

Pelvic organ prolapse is a condition in which structures such as the uterus, rectum, bladder, urethra, small bowel, or the vagina itself may begin to fall or “prolapse” out of their normal positions. These structures may eventually prolapse farther and farther into the vagina, or even through the vaginal opening, without medical treatment or surgery. Enter synthetic mesh devices. No doubt a great idea.

According to the FDA, between January 2008 and December 2010, there were nearly 3,000 adverse event reports involving transvaginal mesh devices. Side effects reported with vaginal mesh can include:

• Infections
• Internal bleeding
• Vaginal scar tissue
• Vaginal wall narrowing
• Painful urination
• Fistulas
• Mesh shrinkage
• Mesh migration
• Urinary problems
• Punctures to the bladder, blood vessels, bowels, or other organs in the lower abdomen
• Mesh erosion into the vagina, bladder, intestines, and uterus
• Pain
• Painful sexual intercourse for both partners
• Recurrence of incontinence
• Recurrence of both pelvic organ prolapse or stress urinary incontinence, or both

Cook Medical held its product out as breakthrough technology, resistant to infection, and “unlike synthetic mesh, nothing is left permanently in the body to cause problems down the road.” On the contrary, Cook Medical transvaginal mesh products have had more than their fair share of problems. (In fairness, they have all put out awful products. Cook Medical is no exception.).

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Fresenius Granuflo and NaturaLyte lawsuits filed throughout the federal court system will now be consolidated before one Massachusetts’ judge for coordinated pretrial proceedings, as part of a multidistrict litigation (MDL).

This affects all product liability lawsuits filed over heart attacks or sudden deaths allegedly caused by the use of GranuFlo or NaturaLyte dialysate products during hemodialysis – including at least 119 complaints filed throughout 16 different U.S. District Courts. These complaints all involve similar allegations that plaintiffs’ hearts suddenly stop during or shortly after dialysis treatment involving the use of Granuflo Acid Concentrate or NaturaLyte Liquid Acid Concentrate manufactured and sold by Fresenius Medical Care.

The lawsuits allege that Fresenius failed to adequately research the side effects of their dialysate products or warn about the potential risks including the importance of monitoring bicarbonate levels of patients receiving the products to avoid sudden cardiac arrest and death.

We’ve known for some time that Pradaxa has problems—this drug, intended to replace the time-tested blood thinner Warfarin (Coumadin), has been shown to cause internal bleeding and hemorrhaging. Unlike Warfarin, the bleeding cannot be quickly countered, which can cause death in serious cases. There were at least 260 deaths of people on Pradaxa between October 2010 and November 2011, which were confirmed by the drug’s manufacturer.

But when a drug is not properly tested and evaluated for safety before it comes on the market, you often see more than one problem with the drug. Now, new information has come out showing that patients with artificial heart valves are particularly at risk for Pradaxa injuries.

The warning comes from the FDA, which advises that a European clinical trial called RE-ALIGN was stopped mid-study because people with mechanical heart valves were more likely to experience strokes, blood clots and heart attacks, as compared to Warfarin users. The FDA is going so far as to require a labeling change warning doctors and patients that Pradaxa is contraindicated for patients with prosthetic heart valves.

Importantly, the FDA is not recommending Pradaxa use in patients with other types of heart valves called bioprosthetic valves. Those are made with natural biological tissue, but the effects of Pradaxa have not been specifically studied for those patients.

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