LAWSUITS NEWS & LEGAL INFORMATION
Operating Room Equipment Legal News Articles & Interviews
Filing a Bair Hugger Lawsuit: Attorney Weighs In

Last-Ditch Effort for 3M Bair Hugger Appeal

Two Open-Heart Surgery Outcomes Involving Stockert 3T Heater-Cooler System

Stockert 3T Heater Cooler System and the FDA

Canadian Class Action Accuses Sorin Heater-Cooler System Makers of Failure to Warn

Stockert 3T Heater-Cooler Case Awaits Consolidation Decision

More Stockert 3T Heater-Cooler Lawsuits after Slow-Developing Infections

St. Paul, MN: Seventeen months after open-heart surgery where a Stockert 3T heater-cooler system device was used, a man died from M. chimaera and doctors associated the deadly infection with the heater-cooler unit. His wife is one of several people who, in the past few months is seeking legal action against the manufacturer.
Plaintiff Danna Brackenbury filed a complaint in September, 2017 in the U.S. District Court for the District of Minnesota against manufacturer Sorin Group Deutschland GmbH and the Sorin Group USA, Inc. After Brackenbury’s husband suffered a heart attack and underwent surgery at Regions Hospital in St. Paul, he developed a slow-growing, Mycobacterium chimaera (M. chimaera) infection. The operative word here is “slow”: the deceased complained to his doctor in July 2016 of fatigue and sudden, rapid weight loss. Two months passed until he was prescribed antibiotics to treat the infection, but it was too late. Hospital doctors confirmed that the Stockert 3T device was used during surgery.
Less than one month after his death the
But the manufacturer knew about the link for several years. And tracking the source of NTM began more than a decade ago in Western Europe hospitals. In 2015 a hospital in Eastern Pennsylvania identified such infections among patients who had undergone open-heart surgery there.
Also in Pennsylvania, a lawsuit was filed in July 2016 against the Stockert 3T manufacturer (the hospital in question is not mentioned). According to the Pennsylvania Record, plaintiff Richard Whipkey underwent an aortic valve replacement in May 2015 and one year later he developed “unexplained symptoms” that lab tests determined was the deadly infection. Richard and Elizabeth Whipkey are requesting a jury trial for both compensatory and punitive damages. The case is: U.S. District Court for the Middle District of Pennsylvania case number 1:17-cv-01233-JEJ.
Several parents have filed complaints against Children's Hospital of New Orleans after their children developed mycobacterium abscessus bacterial infections after undergoing heart surgery this past summer, reported Fox 8 News (Sept 13, 2017). At least one dozen children have been diagnosed with the infection and a hospital spokesperson says that many more children could be infected. The Children's Hospital infections showed up nine months after the CDC warning was issued last October.
Part of the CDC report warned the following: "Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger. Over 250,000 procedures using cardiopulmonary bypass are performed in the United States each year.”
Children's Hospital Chief Medical Officer Dr. John Heaton said the hospital had two 'Stockert 3Ts' when they received the CDC report. And one of the devices was involved in the FDA advisory. The hospital has assumed all cost of treatment for families affected by this infection, Fox 8 reported. An attorney for the parents of Children's Hospital patients said that "Our goal and charge is to figure out what Children's Hospital knew, when and what they should have done." The parents may also file a product liability suit against the manufacturer.
Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States

Washington, DC: The US Food and Drug Administration (FDA) has provided the medical community with guidance on the use of ultrasonic surgical aspirators. Specifically, the agency is advising companies that make the devices to label them as contraindicated for the removal of uterine fibroids. The non-binding guidance from the agency serves to strengthen its recent warnings about the use of power morcellators to remove uterine fibroids.
Read [ Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States ]
Stockert 3T Bacterial Infection Can Linger

Santa Clara, CA: Many warnings, complaints and investigations linking the Stockert 3T heater-cooler system to nontuberculous mycobacteria (NTM) infections and other serious side effects seems to have cooled down. But NTM infections can take years to manifest, and many of the Stockert 3T systems used to regulate body temperature during cardiopulmonary surgeries have not been replaced.
Read [ Stockert 3T Bacterial Infection Can Linger ]
Children Infected by Stockert 3T Surgical Device at New Orleans Children’s Hospital

New Orleans, LA:. Officials at Children’s Hospital in New Orleans have acknowledged that a dozen children were infected with mycobacterium abscessus following heart surgery during June and July of this year. Hospital officials fear that more cases may still appear. The source of the infections appears to be a contaminated Stockert 3-T heater-cooler device, and parents are reportedly considering heart surgery infection lawsuits.
Read [ Children Infected by Stockert 3T Surgical Device at New Orleans Children’s Hospital ]
- FDA Clears Bair Hugger for Post-Surgical Use By Lucy Campbell (Sep-12-17)
- Heart Surgery Patient Blames Stockert 3T Heater-Cooler System for Infections By Jane Mundy (Aug-22-17)
- Study Finds That Heater-Cooler Devices Used in Surgery Could Be Contaminated By Deb Hipp (Jul-29-17)
- ED-530XT Duodenoscopes Recalled By Lucy Campbell (Jul-21-17)
- Power Morcellation Cancer Warning One Year Too Late for Doctor By Jane Mundy (Jul-10-17)
- Olympus Settles Four Power Morcellator Lawsuits By Deb Hipp (Jun-18-17)
- Is the FDA Doing Enough to Prevent Stockert 3T Heater-Cooling Device Infection? By Jane Mundy (Jun-5-17)
- South Carolina Stockert 3T Lawsuits Won't Head to MDL By Deb Hipp (May-22-17)
- Ovarian Cancer Survivor Blames Power Morcellator By Jane Mundy (May-9-17)
- Stockert 3T Not the Only Heater-Cooler Unit Associated with Infection discovered Years Ago By Jane Mundy (May-2-17)
- Power Morcellation Suits Wrap Up but Doctors Still Like Procedure By Brenda Craig (Apr-18-17)
- Australian Researchers Urge Sharing Data On Contaminated Medical Devices By Deb Hipp (Apr-17-17)
- Power Morcellators Fast-Tracked Through FDA 510(k) Clearance By Gordon Gibb (Apr-16-17)
- 3M Bair Hugger Blanket Bellwether Cases Chosen for Trial By Lucy Campbell (Apr-11-17)
- Stockert 3T Heater-Cooler System Letter: Evidence, Explanation or Apology? By Jane Mundy (Mar-18-17)
- Regulatory Concern Mounting Over Power Morcellators, Adverse Events Reports By Gordon Gibb (Feb-21-17)
- Stockert 3T Heater-Cooler System Confusion and Concern By Jane Mundy (Feb-19-17)
- Surgery Patients Demand Monitoring for Potentially Deadly Infection in Class Action By Brenda Craig (Feb-9-17)
- Damning Report on FDA Approval of Power Morcellators Released By Lucy Campbell (Feb-9-17)
- Federal Bair Hugger Lawsuits Climbing, Now Number 1105 in MDL By Gordon Gibb (Feb-8-17)
- More Warnings Sent Out About Stockert Heater-Coolers By Heidi Turner (Jan-27-17)
- Power Morcellator Patient Advocate Dies By Heidi Turner (Jan-19-17)
- Older Model Duodenoscopes Pulled from Market By Lucy Campbell (Jan-13-17)
- Bair Hugger Lawsuits Keep Coming, Class Actions in US and Canada By Gordon Gibb (Jan-13-17)
- Stockert 3T Infections Widespread By Jane Mundy (Jan-10-17)
- Stockert 3T System “No Easy Fix” and the FDA’s Catch-22 By Jane Mundy (Dec-27-16)
- Olympus America Attempts a Power Morcellation Comeback By Gordon Gibb (Dec-19-16)
- Court Spells Out Bair Hugger Bellwether Trial Timelines By Gordon Gibb (Dec-13-16)
- More Hospitals, Not FDA, Warn Patients of Stockert 3T Heater Cooler Infection Risk By Jane Mundy (Dec-10-16)
- Stockert 3T Heater Concerns Rising, Not Awareness By Jane Mundy (Nov-26-16)
- Stockert 3T Heater-Cooler System: A Condensed Time Frame By Jane Mundy (Nov-16-16)
- Power Morcellators May Be Doing More Harm than Good By Heidi Turner (Nov-15-16)
- Bair Hugger Lawsuits Continue to Climb By Gordon Gibb (Nov-14-16)
- Canadian Study: Surgical Warming Blankets and Link to Infection By Gordon Gibb (Oct-21-16)
- Laparoscopic Uterine Surgery for Women Morcellation Lawsuits Continue By Gordon Gibb (Oct-8-16)
- Should Women Still Undergo Power Morcellation? By Heidi Turner (Sep-27-16)
- Almost 700 Bair Hugger Lawsuits Consolidated in MDL By Heidi Turner (Sep-26-16)
- Bair Hugger Lawsuits Mounting By Jane Mundy (Aug-24-16)
- Proposed Government Bill Aims to Increase Reporting of Defective Medical Devices By Gordon Gibb (Aug-9-16)
- Olympus Failed to Warn US Hospital of Duodenoscope Infections By Lucy Campbell (Jul-26-16)