Articles Posted in Recalls

An initial conference for the parties involved in the multi-district litigation (MDL) of the dialysis injury lawsuits against Fresenius Medical Care has been scheduled for late next month. granuflo naturalyte lawsuits In April, the MDL panel that decides these things centralized all product liability complaints against Fresenius and the use of Granuflo or NaturaLyte dialysis treatments. Approximately 188 Fresenius Ganuflo lawsuits have been consolidated in Massachusetts before a judge who appointed a group of attorneys to serve leadership roles in the Fresenius Granuflo MDL. On August 30, 2013, the judge will meet with the lawyers involved to review any outstanding issues and pending motions. The purpose of the MDL is to avoid duplicative discovery given the number of cases, hoping to save money and providing the same justice to all parties. Ultimately, when the pre-suit discovery has been completed,  what will probably happen is a few of the cases will go to trial.  These bellwether help us all gauge the real settlement value of these claims.   If the cases don’t reach a resolution, they will get sent back to the courts around the country where they were originally filed. If settlement or other resolution is not reached following the MDL proceedings, each case may ultimately be remanded back to the U.S. District Court.

Fresenius Recall and the Suits That Followed…. and Will Follow 

Fresenius Medical Care, one of the largest providers of dialysis treatments in the United States, owns and operates thousands of clinics as well as manufactures many products used during dialysis treatment. In November 2011, Fresenius conducted an internal review of the use of Granuflo and NaturaLyte, products used during hemodialysis, not only in their clinics but in other dialysis centers across the country. During the internal review, Fresenius identified at least 941 instances in which patients suffered cardiac arrest during treatment in 2010. The company issued a warning memo to the doctors within their clinics but did not inform outside clinics that used their products. In March 2012, the memo was leaked to the FDA and pushed Fresenius to provide a warning to all health care providers. The FDA classified the issue as a NaturaLyte and Granuflo Recall. There are currently at least 188 complaints in the MDL, and that number is expected to increase to the thousands as product liability lawyers review Fresenius’s lawsuits. The cases involve similar allegations: sudden cardiac arrest, heart attack, or death after Granuflo or NaturaLyte dialysis treatments.  The plaintiffs’ attorneys have alleged that  Fresenius withheld information from consumers about the possible risk of problems during dialysis with their Granuflo and NaturaLyte products. According to the suits, both products contain sodium acetate that converts bicarbonate at levels that were just not safe.

Fear of E. Coli contamination has prompted the United States Food Safety and Inspection Service (FSIS) to recall 22,737 pounds of ground beef products. Wow, that’s a lot of meat.

The recall affects cases of beef from National Beef Packing Company in Kansas, including the following:

  • National Beef 80/20 Coarse Ground Chuck, 10 lb packages, package code 0481

According to a transfer order issued last week, The U.S. Judicial Panel on Multidistrict Litigation (JPML) has agreed to consolidate all Stryker Rejuvenate hip replacement lawsuits filed throughout the federal court system, centralizing the cases before one judge. This will include both Rejuvenate and ABG II Implants.

Complaints filed involving any Stryker Rejuvenate or Stryker ABG II hip components will be transferred to one U.S. Judge in the District of Minnesota as part of an MDL or multidistrict litigation. There are currently at least 41 lawsuits filed against Stryker, filed in 16 different U.S. District Courts. This figure is expected to increase greatly over the coming months as individuals throughout the country continue to experience hip failures, which often result in the need for revision surgery. Typically designed to last 15 to 20 years, a recall was issued for Stryker Rejuvenate and ABG II hips in July 2012 after data suggest that the implants were prone to corrode or fret at the modular junction, increasing the risk of inflammation, loosening and eventual failure of the artificial hip within a few years.

As all the complaints involve similar allegations, the MDL has been created to reduce duplicative discovery, eliminate conflicting rulings from different judges, and to serve the convenience of the parties, witnesses, and the courts. As additional cases are filed in the future, they too will be transferred to the Minnesota Judge for coordinated handling before trial.

Diabetes is one of the most problematic illnesses of our society today. It is not a disease that stands by itself, but those who have it know all too well that the chances of it leading to many other illnesses for them are tremendous. A diabetic is most likely also going to end up with one or more of heart disease, kidney disease (resulting in dialysis), blindness, and peripheral neuropathy (incapacitating pain in the legs) to name just a few. The studies done on the disease and the medicines to treat it are too numerous to count. And yet, the incidence of this disease is steadily increasing every year. It’s no wonder that there is such a quest to get it under control.

The most common type of diabetes is Type 2. With this type, whereas the pancreas used to secrete enough insulin to take care of the sugar eaten, over time it becomes less and less efficient and produces less and less insulin. And the cells become more and more resistant to the insulin it produces. At some point, medication is needed to help the pancreas produce more insulin, and eventually, nothing can get it up to producing enough so the body then needs to be given the insulin that it so desperately needs, by way of injection. Type 1 diabetes is usually diagnosed in childhood. In this case, the pancreas is either not producing any insulin, or is producing a dreadfully small amount, and for whatever reason cannot be boosted by medication to produce more, so insulin injections must be started right away.

Diabetes Solutions

Shortly after Byetta was approved in 2005, questions about the risk of pancreatitis arose for that and other diabetic drugs such as Januvia. Now, new and more serious is the possible risk of pancreatic cancer, a virtually untreatable disease that kills most victims within a year.

januvia byetta cancer

Should these drugs be recalled?

With annual sales of more than $9 billion dollars, the futures of Januvia and other drugs in its class are being threatened due to latest studies by Dr. Peter C. Butler. A former editor of Diabetes, the flagship journal of the American Diabetes Association, he is not easy to ignore. Though he faces powerful opponents in the makers of the drugs, the Food and Drug Administration (FDA) and the European Medicines Agency have begun investigations based on his latest study that could lead to new warnings on the drugs, or possibly their removal from the market altogether. On the other hand, they may make no impact at all.

Byetta and Januvia, as well as other drugs in the class known as incretin mimetics, are used by hundreds of thousands of people with Type 2 diabetes. These drugs increase the level of incretin hormones in the body which in turn, raises insulin production in response to meals and decreases the amount of glucose (sugar) that the liver produces.

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Intuitive Surgical, maker of the da Vinci Surgical robot, has issued an “urgent medical device notification.” They are announcing that certain -09 and -10 versions of the MCS instruments may develop micro-cracks near the distal (scissor) end of the shaft following reprocessing. The micro-cracks may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause internal burns.

The following products are affected:

  • Part Number: 420179-09 and -10 Description: 8 mm Monopolar Curved Scissors (Hot Shears)

A Louisville, Kentucky jury awarded an eleven year old girl and her family $7.25 million dollars in compensatory and punitive damages as the result of a defective cochlear ear device.

Born deaf, the little girl had a cochlear ear device implanted in her head when she was four years old. Four years later, an electrical short from the device shocked her horrifically; she was thrown to the ground vomiting and convulsing.

Before the device was removed and replaced 13 months later, she was shocked two more times. The open-head surgery to remove the device from her skull took more than seven hours.

We can’t win every case. Everyone knew that. Johnson & Johnson won a hip implant case. The Plaintiff, a 54 year old nurse, received her implant in 2008. It was replaced three years later. The jury was clearly very split.

johnson johnson hip implant trial

J&J Sneaks Out Hip Replacement Win

The jury was told about the chromium and cobalt implant that shed metal into the Plaintiff’s body, poisoning her tissue and sending metal ions into her blood dream. But, in the end, Plaintiff’s case was not strong enough for all twelve jurors to agree, according to one juror. The majority were for DePuy, with a minority siding with the Plaintiff. But, after sending a note to the Judge inquiring if they must be unanimous, the Jury came back with a defense verdict.

The FDA says it knows of additional death and injury reports related to the recalled Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System. The Neptune Waste Management System is a vacuum used by surgeons to clear out smoke and fluids during surgery.

The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied and [was] associated with users of the device who had not been properly trained on how to use the device… Stryker and the FDA are particularly concerned about these cases, since a requirement for continuing to use these devices under the Certificate of Medical Necessity is to ensure that all users are adequately trained and have implemented the use of the Pre-use Checklist.

Stryker provided updated recall notifications back in February for the Neptune 1 Silver and the Neptune 2 Ultra reminding customers of the steps they need to take to continue using these devices.

depuy hip verdicts

DePuy Hip Verdict

A Los Angeles jury awarded $8.3 in damages today to a defective ASR hip implant victim after a hard-fought month-long jury trial in California. The jury sent a loud message, spanking DePuy/Johnson & Johnson.

Let’s be blunt about what this does: it raises the settlement value of these DePuy hip replacement cases. I really thought DePuy would back down on the courthouse steps for this very reason: the risk of inflating the settlement value. But they seem willing to stick their chests out for some reason I can’t figure.

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