Articles Posted in Medical Devices

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This page is about the Bair Hugger lawsuits that were filed claiming the product caused infections. But these suits did not go very far and I don’t know of any lawyers filing warning blanket lawsuits in 2021. Not all mass tort lawsuits work out and these Bair Hugger lawsuits certainly did not.

Let’s back up first to the start of this litigation.  I’m backfilling this first the original post…

As of September 2018, there are over 1,500 Bair Hugger warming blanket lawsuits pending in the MDL in Minnesota.

In one typical case, a New York couple claims that a surgical warming blanket used after the husband’s hip replacement operation caused severe infections, resulting in four additional surgeries. A man and his wife filed a lawsuit in New York on Nov. 25, 2015, against 3M, the manufacturer of the Bair Hugger forced-air warming system. Medical facilities commonly use this blanket during knee and hip replacement operations. In addition to 3M, the lawsuit lists Arizant Healthcare, Inc. and its subsidiaries as Defendants.

The value of surgical blanket lawsuits is still being determined

The value of surgical blanket lawsuits is still being determined, but many of these infection cases involve serious injury and death.

During the surgery on Oct. 24, 2012, medical personnel used a Bair Hugger on the man’s left hip, supposedly to help regulate body temperature. However, the warming blanket might have introduced bacteria into the surgical site, resulting in infection. Plaintiff received five surgeries within 16 months, including the original surgery, and he now struggles with mobility and needs crutches to walk.

Per the lawsuit: “Due to the infection, Plaintiff needed four additional surgical procedures to remove the implant and clean the infected area within sixteen months from the original implant surgery, and he continues to suffer limited mobility, requiring crutches to ambulate.”

According to diverse news reports, this Plaintiff is far from alone; many consumers across the nation have taken legal action after illnesses they’ve acquired after using the Bair Hugger, following hip and knee surgeries.

The Plaintiffs noted that 3M sent a letter to the FDA way back in June 1997, which warned of possible contamination issues with this product.


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da-Vinci-FlagstaffThe da Vinci lawsuits involve both medical malpractice and product liability claims.  Some of these are wrongful death cases, some of these claims are very minor, and there are a lot of cases in between.

The Insurance Journal reports on a malpractice case in Oregon where the plaintiff received a $100,000 award from an Oregon gynecologist who she alleges improperly removed a healthy ovary.

A jury verdict of $100,000?  Huh?  They took her ovary, and they found negligence.  The plaintiff asked for over a million.  So what gives?

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davinciThis week, a Washington state court granted the first verdict for a slew of cases concerning the da Vinci Surgical System robots. The jury found that the robot’s creators, Intuitive Surgical, was not liable for the death of a surgery patient who succumbed to complications of a robot-assisted prostatectomy. These robots, part of a $2.2 billion dollar industry, have allegedly resulted in patient injury and death. This case was the first of approximately thirty that are currently working their way through the courts with many, many more sitting on the sidelines that may settle before suit is ever filed.

The plaintiff settled for an undisclosed amount with his doctor and then sued Intuitive Surgical. The plaintiffs alleged that Intuitive failed to properly instruct the robot’s handler and that they also failed to inform of the potential dangers. The doctor, who had performed a hundred successful traditional prostatectomies, was only trained for a single day and performed two supervised surgeries before being cleared to work on his own.  Let’s put it this way: would you ever allow this doctor to use the da Vinci on you if you knew that?  The answer?  Of course not.

Intuitive agreed with the plaintiffs on the doctor’s negligence and claimed he never should have used the da Vinci system on the particular patient because of his obesity.

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mirenaiudlawsuitMuch to the objection of Bayer Healthcare, Mirena IUD lawsuits at the federal level have been centralized into multidistrict litigation or MDL. The cases will be transferred to a U.S. District Court Judge in the Southern District of New York.  This makes the claim a mini-class action.  What does this mean?  The Mirena lawsuits are consolidated for discovery purposes.  They become one class case for a while.  If a global settlement of these Mirena lawsuits cannot be achieved, they will be sent back to their individual states for trial.

Last week, we told you that similar consolidation was being reconsidered at the state level, where more than 60 Mirena IUD lawsuits are currently pending.  Currently, there are only about 40 lawsuits in federal court, however, it is anticipated by some plaintiffs’ attorneys that several thousand cases will be filed by women who have experienced complications from Mirena IUD.

If you used Mirena and experienced complications, including surgical removal, infection, or Pelvic Inflammatory Disease (PID) and want to inquire as to whether you have a lawsuit, contact our Mirena defect lawyers at 1.800.553.8082, or online here.

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The FDA proposed last month that makers of automated external defibrillators (AEDs) be required to submit pre-market approval (PMA) applications for these devices.  Why?  They have received 45,000 reports – not a typo – of failures of these devices in the last 8 years.  My gosh, I’m surprised they are so ubiquitous that they even have been used 45,000 times.

But these things – these literal life and death machines – have had 8 recalls in the last eight years.  Pathetic.  The problems usually involve the AEDs powering off during use, error messages caused by software anomalies, or just component failure.

I don’t trust these things. Yet I still dutifully carry one on the court when I play tennis with my father.  Can you imagine the horror of needing to use one of these things and you are getting an error message?

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Should all transvaginal mesh products be recalled?


Should we get rid of the vaginal mesh product completely?

It is a fair question. These products – and we see juries starting to prove this point – are a train wreck.  These companies – all of them, it seems – were chasing profits and ignoring the harm they were causing women.  It really is as simple as that.

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Last month, a group of plaintiffs filed a motion requesting that all federal Mirena IUD lawsuits be consolidated into an MDL. The defendant, Bayer, is fighting this motion.

The technical definition of an MDL is a “sort of class action.” Okay, maybe not so technical.

But the nutshell is that this type of coordination allows the cases to be combined before one federal judge for the purpose of common discovery. In this instance, all product liability lawsuits filed against Bayer over the IUD would be transferred to one U.S. District Judge for coordinated handling during the pretrial proceedings.

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Since its introduction to the medical world over 10 years ago, the da Vinci Surgical System has been hailed as a major advancement in patient care. A surgeon makes a small incision and uses the da Vinci camera and four robotic instruments to operate by remote control. Hysterectomies, prostate removal, thyroid cancer removal, and gastric bypass are among the most common procedures performed with the da Vinci System.

Though the system has benefitted many patients by offering less invasive surgical options with quicker recovery periods, a few distinct patterns of complications have also emerged. While no surgery can be made risk-free, we believe that the da Vinci System presents several increased risk factors to patients. These risks can be caused by design defects, inadequate surgeon education, manufacturing defects, and other problems that multiply the likelihood of patient complications.
The more prevalent complications include:

  • Surgical burns to organs and arteries
  • Tears or punctures to blood vessels, organs, and arteries
  • Sepsis
  • Excessive bleeding
  • Vaginal cuff dehiscence

Surgical burns to organs and arteries

There have been several cases that suggest using the da Vinci System is correlated to surgical burns. In March 2010, a 24-year-old female patient suffered severe burns to the intestines and to an artery during a hysterectomy. Her family’s lawsuit claims that a design defect in the da Vinci robot caused the machine’s electrical current to jump. This resulted in a fatal shock to healthy tissue. Additionally, the lawsuit states that the un-insulated surgical hands of the da Vinci robot contributed to the fatal injuries. The patient died two weeks after surgery.

Tears or punctures to blood vessels, organ, and arteries

Because the da Vinci System separates a surgeon’s hands from the patient’s body, there is an increased risk for slight tears or punctures to go unnoticed during surgery. There have been several fatalities and lifelong injuries because of minor nicks and scratches unknowingly inflicted by the robotic arms.

During a 2002 kidney cancer removal surgery in Tampa, the patient’s inferior vena cava and abdominal aorta were cut by the da Vinci equipment. The mistake was caught 90 minutes after the injury occurred after the surgeons abandoned the da Vinci System for a traditional approach. The extent of the injuries was not known after the operation and the patient died the next day.

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It is hard to make sense of the Fresenius dialysis debacle. People have been hurt – the most vulnerable among us – and it could have been so easily prevented. What I try to do below is lay out what happened and explain what I believe the future of these lawsuits to be.

Fresenius Medical Care is the nation’s largest provider of dialysis treatments, with over 130,000 patients. Their dialysis facilities use GranuFlo and NaturaLyte acid dissolution products in treatments, which are products created by Fresenius. Countless non-Fresenius dialysis centers also use those products, which are sold by Fresenius. Defects in those products are terrifying not only because of the harm they could cause but because Fresenius has such a ridiculously high market share. This is not a product people want, it is a product they absolutely need.

Dialysis and Kidney Disorders: Background

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In the past few years, orthopedic surgeries to replace failing body parts have become incredibly common. We live active lives, and the damage done to our joints, from high school sports, skiing, running, and other outdoor activities, is correctable using modern technology and science.

Problems With Zimmer Hip Replacements

Zimmer’s Duron Cup hip replacements are one metal-on-metal implant that has been making the news as causing problems for patients. We’ve seen evidence of problems with other metal device manufacturers, including DePuy, Wright, and Stryker.