At last count, more than 1,300 lawsuits have been filed against the 3M Company for their very popular Bair Hugger warming blanket—most commonly used for post-operative hip and knee patients.
A key development, the December 11, 2015, transfer of 14 federal lawsuits against 3M Bair Hugger to Judge Joan N. Ericksen’s U.S. District Court room, District of Minnesota and its designation as a multidistrict litigation (MDL) set in motion a series of events that have transformed this obscure case into one of the biggest medical device lawsuit involving ortho patients ever.
Forced Air Warming Blanket and Infections
The plaintiffs are alleging that the company’s “forced air warming blanket,” commonly prescribed after hip and knee replacements, is connected to post-operative joint infections. The December 11 Order from the U.S. Judicial Panel on Multidistrict Litigation allowed all new 3M Bair Hugger cases filed in federal courts to be eligible for transfer to the MDL. An MDL ensures a single judge will address the lawsuits, which reduces duplicative discovery. That speeds the case up.
Bernstein Liebhard LLP, based in New York, is representing the plaintiffs. Partner Sandy A. Liebhard stated in 2015 that “numerous patients … allegedly developed painful and debilitating deep joint infections due to this device. This litigation has the potential to be large.”
The forced air warming blanket is used after some surgical procedures to help regulate body temperature. However, plaintiffs in the case—all of whom had knee or hip replacements—claim the device has a design defect that can allow the surgical site to be exposed to bacteria and contaminants in the operating room. Additionally, plaintiffs claim that 3M Company and its subsidiary, Arizant Healthcare Inc., were aware of the dangers “since at least 2009.” The Bair Hugger warming blanket system was developed by Arizant Healthcare, which 3M acquired in 2006.
According to the plaintiffs, the companies never changed the design or release any warnings and “aggressively marketed” the blankets as safe for orthopedic surgeries. “No reasonable and competent physician” would use the blanket if they were aware of the risks, the plaintiffs claim.
200 Million Surgeries Since 1987
Since the 2015 formation of the MDL, more plaintiffs have stepped forward claiming they developed debilitating infections from hip and knee replacements due to the popular air warming blanket. The 3M Bair Hugger warming blankets are used in over 80% of all knee and hip replacements. The Minneapolis Star Tribune reported that between 1987 and 2015, the device was used in over 200 million surgeries. Currently, about 50,000 units are in use around the country. The blankets have generated $31 billion in revenue since it was introduced by Arizant in 1986, according to Drug Safety News. The apparatus includes a flexible hose connected to a disposable blanket to deliver a regular stream or warm air to the patient.
However, plaintiffs claim that the blanket interrupts laminar air flow in operating rooms. This allegedly allows contamination from the operating floor to be transported to the warming area, potentially infiltrating the otherwise sterile surgical site. Sepsis and Methicillin-resistant Staphylococcus aureus (MRSA) are two of the most common infections named in the lawsuits. Such infections may result in more surgeries and/or permanent disability according to the claims.
Bundle Up
On January 13, 2016, the first Pretrial Order was issued. In less than one month, the 14 initial cases transferred to the MDL had grown to 82. Discovery was stayed for all pending cases, and an Initial Status Conference was scheduled for February 2016. On March 24, 2016, another Pretrial Order was issued, which suggested the first bellwether trials could start in November 2017. According to the Order, parties had to draft a plan for bellwether case selection by October 17, 2016. Bellwethers are where verdicts might offer insight into how a jury may decide the case. Bellwether selections were ordered to be submitted by March 1, 2017 so case-specific discovery could start on March 2, 2017. Discovery would be completed by July 1, 2017 for the first bellwether trial scheduled for November 6, 2017.
By April 2016, 217 lawsuits were pending in the MDL. By April 15, 2016, the MDL was one of the fastest-growing in the country according to Reuters. Three new Pretrial Orders were issued on April 29, 2016, which included a Protective Order. This order describes how confidential data would be handled during discovery. Another order approved direct filing of the lawsuits within the District of Minnesota, while the other detailed process service through e-mail for summons and complaints of plaintiffs.
On May 24, 2016, the federal court managing the MDL approved the Master Long and Short Form Complaints. This allowed all plaintiffs, from May 24 onwards, to file their claims directly with the District of Minnesota via Short Form Complaints (which are faster and easier to complete). Also on May 24, 2016, a Pretrial Order was issued which created a Common Benefit Fee and Expense Fund. This Fund guaranteed that services and expenses incurred by attorneys for the plaintiffs would be equally shared and distributed.
Closing in on 1,500 Cases
By September 15, 2016, there were 693 lawsuits pending in the MDL. From August 15 to September 15, 2016, 147 new claims joined the MDL. Liebhard stated, “We are not at all surprised to see the Bair Hugger litigation growing at this rate … we have received numerous inquiries from individuals concerned that the forced air warmer system may have contributed to post-op deep joint infection following hip or knee implant surgery.”
On September 28, 2016, the federal court created new protocols for the Plaintiff Fact Sheets and Service. It dictated that all plaintiffs must electronically file a Plaintiff Fact Sheet with signed medical authorization for the defendant’s attorneys. Plaintiffs with pending lawsuits in the MDL had 90 days to comply. Any plaintiffs who join in the future would also have 90 days to file the Plaintiff Fact Sheet and medical authorization.
By October 17, 2016 809 cases were pending in the MDL. Since September 15, 2016, there were 116 new filings. An Order was issued in the U.S. District Court of Minnesota November 16, 2016, in which 150 pending lawsuits were randomly chosen as potential bellwether cases. To be eligible, lawsuits had to be pending in the MDL since at least December 19, 2016. Of the 150 randomly selected, both plaintiffs and defendants got to choose 16. Both parties were required to reveal their selections to the District of Minnesota by January 20, 2017. The first bellwether trial was scheduled for November 6, 2017.
Case-specific discovery was scheduled for January 21 – March 1, 2017. Prior to case discovery, the parties had to agree on eight total lawsuits from the potential cases by February 10, 2017. Afterward, the Court would select a maximum of eight for the Final Bellwether Trial Pool.
The 2017 Proceedings
Both parties met the January 5, 2017 deadline, each choosing 16 cases. However, there was one overlapping case, making the grand total 31 possible bellwether cases. As of January 15, 2017, 1,105 cases were included in the MDL. There were 166 new lawsuits filed or transferred from December 15, 2016 to January 15, 2017. By March 15, 2017, that number had grown to 1,343.
In May 2017, the federal court chose eight lawsuits of the 31 for bellwether trials. However, two of those cases were nixed by the parties. The federal court has also bumped the beginning of the bellwether trials from November 2017 to February 26, 2018. As of June 2017, 1,988 lawsuits were pending within the MDL. On June 15, 2017, the six cases were officially scheduled via an Amended Order. They include the surnames Kamke, Nugier, Wlaker, Knueson, Skaar and Gareis (all versus 3M Co.).
Going to Bat for the Blanket
3M has remained largely quiet in regards to the lawsuit—until this past June 1—when it released a research compendium providing a literature review, years of review articles, and letters to the editor and case studies which attest to the safety and efficacy of Bair Hugger. Many of the clinical articles were from peer review journals from databases like Medline, Elsevier Biobase, Embase, and Chemical Abstracts. With a welcome message by Medical Director Michelle Hulse-Stevens, the packet calls Bair Hugger the “gold standard” in patient warming.
Bair Hugger products have been reviewed in more published research than any other similar product, according to 3M. With over 50,000 patients being treated with the warming blanket every day, 3M’s Bair Hugger is well known and trusted in hospitals and clinics around the world.
While the MDL is pending and the bellwether trials have yet to begin, many eyes are on one of the biggest medical device MDLs in history.
No doubt about it. This MDL is just starting to warm up.
