Articles Posted in Product Liability

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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Statins are a group of drugs used to lower cholesterol by inhibiting the enzyme HMG-CoA reductase. HMG-CoA reductase plays a role in the synthesis of cholesterol in the liver. Increased blood levels of cholesterol are associated with cardiovascular diseases. Statins have shown benefit in treating people with hypercholesterolemia (high cholesterol), and they are also now being used in people at low risk of cardiovascular disease as prevention.

The benefits of statins are quite clear. They work, and they help a lot of people.  Any talk of the risk of statins has to be there. But there has been uncertainty regarding the safety of these drugs in recent years. The most common side effects reported with statins include increases in liver function tests, muscle aches, and rhabdomyolysis, a breakdown of muscle fibers. This would lead to questions of just what the drug companies should be telling doctors and end users about the risks of these drugs.

In recent years, there has been another concern: the possible relationship of the development of diabetes in patients taking statins. In 2008, a study on rosuvastatin (Crestor) to determine efficacy on vascular events suggested that statin use may result in the development of diabetes.

In 2010, an article published in The Lancet reviewed and analyzed 13 placebo-controlled trials to determine if the finding of the development of diabetes was consistent between trials. Results of this meta-analysis showed that there was a 9% increase in the risk of development of diabetes, mostly seen in patients over 60 years of age. Though this finding may seem odd, especially when statins have been shown to lower cholesterol in diabetic patients, other cardiovascular drugs such as thiazide diuretics, and beta-blockers have also been shown to lead to a higher risk of developing diabetes.

• Diabetes drug causes gastroparesis: new lawsuit in 2024

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This blog post is about defective Windows made by MI Windows and Doors. I am writing about this because I find it interesting. There are lawyers handling these cases all around the country. Our law firm is not handling these cases. So while you are always welcome to call us, we will not be of much help to you in these cases. I don’t think it is a terrible idea, however, to listen to some thoughts from a lawyer that does not have any chips on the table.

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Biomet Hip Defect Lawsuits Have Many Chapters

Biomet is one of the manufacturers of the much-maligned metal-on-metal hip implants. It makes the M2A Magnum, an all-metal implant that plaintiffs and scientists believe causes serious medical problems, including failure and blood poisoning.

In late June 2012, plaintiffs in several federal Biomet hip implant lawsuits filed a motion with the Judicial Panel on Multidistrict Litigation, asking that all federal Biomet hip implant injury cases be grouped together in one court, before one judge. Specifically, the plaintiffs asked the court to move the cases to the Northern District of California, or the Southern District of New York.

This move is basically a request to open up a metal-on-metal hip implant class action lawsuit. In multidistrict litigation (MDL), all cases of the same type that are filed in federal courts are automatically sent to one judge. That judge oversees the cases and ensures that there is unified (and not duplicative) discovery. The judge may encourage early test trials (called bellwether cases), from which the parties can determine the relative strengths and weaknesses of their cases, as decided by a jury. Those test cases often allow the lawsuits to settle en masse. If they don’t settle, or if an individual plaintiff chooses not to settle with the group, the non-settling cases are sent back to their home federal court for further proceedings, including trial.

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People on dialysis have enough problems without having to worry about heart attacks. But it seems that the nation’s leading supplier of dialysis products (mostly through its own dialysis centers) may be causing an untold number of dialysis patients to have heart attacks and other cardiac problems.

Fresenius Medical Care creates two products for use in dialysis—GranuFlo (a dry acid dissolution system) and NaturaLyte (the liquid version). Patients who need dialysis have problems with kidney function. One of the side effects of kidney problems is that the body builds up acid in the bloodstream. To treat this, physicians often prescribe bicarbonate. If you remember your high school chemistry (I didn’t), bicarbonate can neutralize the acid.

The problem with GranuFlo and NaturaLyte is that some of the ingredients can be converted by the body into bicarbonate. If the physician doesn’t know that, then the patient can receive a double-dose of bicarbonate. Too much bicarbonate can cause cardiac problems, like heart attacks.

There is a growing concern there there is a compound in Teflon® that may cause cancer. No one is filing any lawsuits about this, at least not yet. Science has to dig a lot deeper into all of this. The purpose of this post is just to give you an overview of the concern about the possible.

Teflon® is the brand name for DuPont’s product, has been used as a non-stick coating surface for pans and cookware, as well as in other products such as fabric protectors since the 1940’s. Teflon® is the brand name for polytetrafluoroethylene (PTFE), a man-made chemical. C8, otherwise known as Perfluorooctanoic acid (PFOA), is another man-made chemical that is used during the manufacturing of Teflon® and other flurotelormers. C8 is not present in significant amounts in the end product, as it is burned off during the manufacturing process of Teflon®.

PTFE is known for its exceptional chemical resistance and non-stick properties, making it useful in a wide range of applications, including non-stick cookware, electrical insulation, industrial coatings, and biomedical implants. PTFE is also known for its low friction, high melting point, and excellent resistance to UV radiation and weathering, which makes it an ideal material for applications that require high performance under extreme conditions.

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Beyaz is Bayer’s new and improved birth control. Its big selling point: it is not Yaz/Yasmin (If this does not leave you cynical, you are a better person than I am.). But, alas, just like YAZ and Yasmin, Beyaz’s active ingredients are drospirenone and ethinyl estradiol. These ingredients work to prevent pregnancy by altering the lining of the uterus and cervix. They also come with the same risks of serious and life threatening injuries such as heart attack, stroke, pulmonary embolism, and deep vein thrombosis.