CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 1 of 30
UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA Susan Borroughs,
Civil Action No: Plaintiff, COMPLAINT AND DEMAND FOR JURY TRIAL
v. 3M COMPANY, a Delaware corporation, and ARIZANT HEALTHCARE, INC., a Delaware corporation, Defendants.
1.
Plaintiff,
Susan
Borroughs,
brings
this
Complaint
against
Defendants 3M Company (3M) and Arizant Healthcare, Inc. (Arizant) (hereinafter referred to collectively as “Defendants”), for injuries caused by Defendants’
design,
development,
testing,
assembling,
manufacturing,
packaging, promoting, marketing, distribution, supplying and/or selling the defective device sold under the trade name of Bair Hugger Forced Air Warming device (hereinafter “Bair Hugger” or “Defective Device”). PARTIES 2.
Plaintiff is a citizen and resident of New Mexico.
3.
Defendant 3M is a corporation organized and existing under the
laws of the State of Delaware, with its principal place of business located in
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 2 of 30
Maplewood, Minnesota. 3M is engaged in the business of researching, developing, designing, licensing, manufacturing, distributing, supplying, selling, marketing and introducing into interstate commerce, either directly or indirectly through third parties or related entities, its products, including the Bair Hugger. 4.
Defendant Arizant is a corporation organized and existing under the
laws of the State of Delaware, with its headquarters located in Eden Prairie, MN. Arizant conducts business throughout the United States, including the State of Minnesota, and is a wholly owned subsidiary of Defendant 3M. JURISDICTION AND VENUE 5.
The Court has subject matter jurisdiction pursuant to 28 U.S.C. §
1332 insofar as the parties are citizens of different states and the amount in controversy in this matter exceeds Seventy-Five Thousand Dollars ($75,000), exclusive of interest and costs. 6.
Venue is proper in this jurisdiction pursuant to 28 U.S.C. § 1391
because a substantial number of the events, actions, or omissions giving rise to the Plaintiff’s claims occurred in this district. Moreover, Defendants regularly solicited and engaged in business in this district. Defendants did (and do) business within the state of Minnesota and have had substantial, continuous, and systematic contacts with the state of Minnesota.
2
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 3 of 30
FACTUAL ALLEGATIONS 7.
Defendants, directly, or through their agents, apparent agents,
servants, or employees, designed, manufactured, marketed, advertised, distributed and sold the Bair Hugger. 8.
More than 50,000 Bair Hugger units are currently in use across the
country. 9.
The Bair Hugger consists of a portable heater/blower connected by a
flexible hose to a disposable blanket that is positioned over (or in some cases under) surgical patients. The system warms patients during surgery by blowing hot air on a patient’s exposed skin. 10.
The hot air produced by Bair Hugger accumulates under the
surgical drape covering the patient and escapes from under the surgical drape below the level of the surgical table or at the head end of the surgical table. This escaped air creates air flow currents that flow against the downward air flow of the operating room. As this warmed air rises, it can deposit bacteria from the floor of the surgical room into the surgical site. 11.
Upon information and belief, at some point between 2002 and 2009
Defendants reduced the efficiency of the air filtration of Bair Hugger blowers. This action reduced the safety of such blowers. 12.
As a result of these actions by Defendants, the internal airflow paths 3
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 4 of 30
of Bair Hugger blowers can become contaminated with pathogens. 13.
The contaminating pathogens incubate and proliferate within the
internal airflow paths of Bair Hugger blowers. 14.
These pathogens are then expelled from the interior of the Bair
Hugger blower by the outward airflow, travel through the hose into the disposable blanket and escape into the operating room. 15.
Upon information and belief, Defendants have been aware of the
pathogenic contamination of the airflow paths of Bair Hugger blowers since at least 2009. 16.
Defendants have actively and aggressively marketed the Bair
Hugger as safe in both general and orthopedic surgeries despite their knowledge to the contrary. 17.
In June of 1997, in a letter to the Food and Drug Administration
(“FDA”), Defendants admitted that “air blown intraoperatively across the surgical wound may result in airborne contamination.” Defendants addressed this flaw in their products by making further misrepresentations to the FDA when they stated that the risk of contamination by air flow is obviated because all “Bair Hugger Blankets designed for use in the operating room feature a tape barrier which prevent [sic] air from migrating toward the surgical site.” This statement was and is patently false. A number of Bair Hugger blankets 4
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 5 of 30
marketed as safe for use in surgeries do not utilize a taped edge at all. Instead, those blankets blow contaminated air directly toward the surgical field. Also, the statement that the taped barrier would contain the contaminated air is false because it ignores the fact that the heated air from the Bair Hugger rises against the general downward airflow of the operating theatre. The presence of a tape edge does nothing to prevent the Bair Hugger from facilitating the movement of pathogens from the floor of the operating room to the surgical site. When Defendants made these representations, they had actual knowledge of their falsity. 18.
In a communication to the FDA in September 2000, Defendants
represented that the Bair Hugger’s filtration system meets HEPA (“High Efficiency Particulate Air”) Standards. 19.
Upon information and belief, Defendants’ statement in September
2000 was false at the time Defendants made it and remains false today. To meet HEPA standards, an air filter must be capable of removing 99.97% of all particles 0.3 microns or larger. The filter of the Bair Hugger, which is marketed as HEPA compliant, is capable of removing at most 65% of all such particles. 20.
On Defendants’ website, www.fawfacts.com/laminar_airflow/ (last
visited September 28, 2015), Defendants make the following misrepresentations: a.
Contamination mobilized by the convection currents generated by the Bair Hugger cannot reach the surgical site 5
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 6 of 30
because “[a]ir velocity within the operating room is many times stronger than that of a forced-air warming blanket”;
21.
b.
“The air emerging from the blanket is directed downward by the surgical drape and emerges under the operating room table and is drawn away through the laminar system’s return air inlets;”
c.
“It’s been suggested that warm air rising above the Bair Hugger blanket could interfere with the downward laminar flow toward the surgical site. It should be noted that the Bair Hugger warming unit delivers less than one percent of the airflow of a laminar flow system and the momentum of the downward air is far greater than the upward momentum imparted to the air above the blanket.”
Upon information and belief, these statements on Arizant’s website,
itemized in the preceding paragraph, are false and intentionally misleading. Through these statements, Defendants disguise the fact that the issue is not the strength of the airflow in a laminar system but the heat of the air generated by the Bair Hugger. The cold air circulated with the operating room, having a higher density than the air heated by the Bair Hugger, falls to the floor which forces the contaminated air at the floor of the operating room, now warmed by the waste heat from the Bair Hugger, to rise into the sterile field and the surgical site. The heated air rises, and is not “drawn away” as Defendants falsely claim in their advertisement. 22. as
In an advertisement that appeared in multiple medical publications early
as
2010,
available 6
online
at:
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 7 of 30
http://www.fawfacts.com/_asset/zn062p/AJIC.pdf (last visited September 28, 2015), Defendants made the following false and deliberately misleading claims: “While simple logic makes it clear that forced air warming has no impact on laminar conditions, science also supports this. A forced air warming blanket delivers less than one percent of the airflow of a laminar flow system and therefore is unable to affect laminar flow ventilation systems.” As published scientific research has demonstrated, this statement is untrue. The exhaust generated by the Bair Hugger creates convective airflow patterns which disrupt the laminar flow of the operating theater. 23.
In a communication that appeared in Healthcare Purchasing News
in July of 2012, Defendants’ public relations and communications specialist Greta Deutsch stated “some conductive-warming manufacturers have alleged that forced-air warming increases bacterial contamination of operating rooms or interrupts laminar airflow. These accusations have no factual basis.” Again, this statement ignores numerous published studies documenting the adverse effects the Bair Hugger has on laminar airflow. 24.
The publication of numerous peer-reviewed studies identifying and
documenting the critical safety shortcomings of the Bair Hugger should have prompted Defendants to redesign or discontinue their product. Instead, those criticisms only caused Defendants to increase their efforts to promote the Bair Hugger. These publications include, but are not limited to, the following: 7
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 8 of 30
25.
a.
Albrecht M, et al. Forced-air warming blowers: An evaluation of filtration adequacy and airborne contamination emissions in the operating room. Am J Infect Control 2010; 39:321-8;
b.
Leaper D, et al. Forced-air warming: a source of airborne contamination in the operating room? Orthopedic Rev. 2009;1(2):e28;
c.
McGovern, P.D., et al. Forced-air warming and ultra-clean ventilation do not mix. J Bone and Joint Surg-Br. 2011;93B(11):1537-1544;
d.
Legg, A. et al. Do forced air patient-warming devices disrupt unidirectional downward airflow? J Bone and Joint Surg-Br. 2012;94-B:254-6;
e.
Belani, K., et al. Patient warming excess heat: The effects on orthopedic operating room ventilation performance. Anesthesia & Analgesia 2012 (prepublication on-line) 2013;117(2):406-411; and
f.
Dasari, K.B., et al. Effect of forced air warming on the performance of operating theatre laminar flow ventilation. Anaesthesia 2012;67:244-249.
These misrepresentations mislead healthcare providers about the
safety of the Bair Hugger for use in surgical procedures. Defendants were aware of the falsity of their misrepresentations at the time those misrepresentations were authored. 26.
Rather than alter the design of their product or warn physicians of
the dangers associated with the Bair Hugger, as numerous studies confirm, Defendants have chosen to “double down” on their efforts to promote their 8
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 9 of 30
defective product. 27.
Plaintiff’s physicians relied upon the above representations and
advertisements to Plaintiff’s detriment. However, through misrepresentations to the public, the medical community, and the FDA, Defendants actively and knowingly concealed the propensity of these devices to cause infection in orthopedic implant surgeries. 28.
As a result of the failure of Defendants’ Bair Hugger to maintain the
sterility of the surgical area and Defendants’ wrongful conduct in designing, manufacturing, and marketing this defective product, Plaintiff and Plaintiff’s physician were unaware, and could not have reasonably known or have learned through reasonable diligence, that Plaintiff had been exposed to the risks identified in this complaint, and that those risks were the direct and proximate result of Defendants’ acts, omissions and misrepresentations. PLAINTIFF’S SPECIFIC EXPERIENCE 29.
As a result of the defective design of the Bair Hugger, Plaintiff has
suffered and may continue to suffer severe and permanent personal injuries. 30.
On December 5, 2012, the Bair Hugger was used on Plaintiff during
the course of Plaintiff’s knee replacement surgery. 31.
Plaintiff began experiencing persistent pain related to a deep joint
infection in the left knee and was diagnosed with an MRSA infection. 9
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 10 of 30
32.
Several weeks later, on January 4, 2013, Plaintiff was forced to
undergo surgery for wound irrigation and debridement and the surgical implantation of an antibiotic spacer. 33.
Plaintiff underwent another surgery in April 2013 to remove the
spacer and revise her knee. 34.
Over the next several months, Plaintiff underwent three additional
surgeries to revise her knee. 35.
Because the Bair Hugger was used on the initial knee replacement
surgery for Plaintiff, contaminants were introduced to Plaintiff’s open surgical wound, resulting in a severe infection. 36.
Due to the infection, Plaintiff was forced to undergo multiple
additional surgical procedures to remove the implant and clean the infected area, and Plaintiff continues to suffer substantial damages, including but not limited to impaired mobility, as she cannot walk without assistance and suffers from chronic knee pain. 37.
Plaintiff now suffers and will continue to suffer from permanent
damages as a result of the Bair Hugger-induced infection. 38.
Defendants concealed and continue to conceal their knowledge of the
Bair Hugger’s unreasonably dangerous risks from Plaintiff, other consumers, and the medical community. 10
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 11 of 30
39.
Defendants failed to conduct adequate and sufficient post-marketing
surveillance after they began marketing, advertising, distributing and selling the Bair Hugger. 41.
As a result of Defendants’ actions and inactions, Plaintiff was
injured due to the use of the Bair Hugger, which has caused and will continue to cause Plaintiff’s various injuries and damages. Accordingly, Plaintiff seeks compensatory damages. CAUSES OF ACTION COUNT I - NEGLIGENCE 42.
Plaintiff hereby incorporates by reference all preceding paragraphs
as if fully set forth herein. 43.
Defendants owed Plaintiff a duty to exercise reasonable care when
designing, manufacturing, marketing, advertising, distributing, and selling the Bair Hugger. 44.
Defendants failed to exercise due care under the circumstances and
therefore breached this duty by: a.
Failing to properly and thoroughly test the Bair Hugger before releasing the device to market;
b.
Failing to properly and thoroughly analyze the data resulting from the pre-market tests of the Bair Hugger; Failing to conduct sufficient post-market testing and surveillance of the Bair Hugger;
c.
11
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 12 of 30
45.
d.
Designing, manufacturing, marketing, advertising, distributing, and selling the Bair Hugger to consumers, including Plaintiff, without an adequate warning of the significant and dangerous risks of the Bair Hugger and without proper instructions to avoid the harm which could foreseeably occur as a result of using the device;
e.
Failing to exercise due care when advertising and promoting the Bair Hugger; and
f.
Negligently continuing to manufacture, market, advertise, and distribute the Bair Hugger after Defendants knew or should have known of its adverse effects.
As a direct and proximate result of Defendants’ actions, omissions
and misrepresentations, Plaintiff suffered an infection, requiring additional treatment. Consequently, Plaintiff has suffered damages and incurred and will continue to incur medical expenses as a result of using the Bair Hugger. 46.
Plaintiff has also suffered and will continue to suffer diminished
capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting condition and activation of latent conditions, and other losses and damages. Plaintiff’s direct medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. Plaintiff has incurred and will continue to incur mental and physical pain and suffering and loss of wages and wage earning capacity. 47.
Defendants’ conduct as described above was committed with 12
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 13 of 30
knowing, conscious, wanton, willful and deliberate disregard for the value of human life and the rights and safety of consumers such as Plaintiff. Defendants’ conduct warrants, if allowed by the Court upon motion, an award of punitive damages against Defendants in an amount appropriate to punish Defendants and deter them from similar conduct in the future. COUNT II - VIOLATION OF MINNESOTA’S DECEPTIVE TRADE PRACTICES LAWS 48.
Plaintiff hereby incorporates by reference all preceding paragraphs
as if fully set forth herein. 49.
Defendants have violated and continue to violate Minnesota’s
Deceptive Trade Practices statutes, Minn. Stat. § 325D.44. 50.
Defendants are corporations who intentionally sell merchandise,
including the Bair Hugger, to consumers, including consumers in Minnesota. 51.
In advertising the Bair Hugger through various means in Minnesota,
including but not limited to television, radio, internet, the products label, pamphlets and letters, Defendants made material assertions, representations, or statements of fact which are untrue, deceptive, or misleading. 52.
Defendants violated the Minnesota Deceptive Trade Practice Statute
through, inter alia, the following: a.
Representing, through statements and advertisements, that the Bair Hugger has approval, characteristics, uses, or benefits that 13
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 14 of 30
it does not have;
53.
b.
Representing through statements and advertisements, that the Bair Hugger and its filtration system is of a particular standard, quality, or grade when it differs materially from that representation;
c.
Representing, through statements and advertisement, that the Bair Hugger has uses, benefits, or characteristics that have been otherwise proven incorrect; and
d.
Falsely stating, knowingly or with reason to know, that services or repairs are not needed.
As a direct and proximate result of Defendants’ actions, omissions,
and misrepresentations, Plaintiff suffered an infection, requiring additional, extensive treatment. Consequently, Plaintiff has suffered damages and incurred and will continue to incur medical expenses as a result of using the Bair Hugger. 54.
Plaintiff has also suffered and will continue to suffer diminished
capacity for the enjoyment of life, a diminished qualify of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages. Plaintiff’s direct medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. Plaintiff has incurred and will continue to incur mental and physical pain and suffering and loss of wages and wage-earning capacity. 55.
Defendants’ conduct as described above was committed with 14
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 15 of 30
knowing, conscious, wanton, willful and deliberate disregard for the value of human life and the rights and safety of consumers such as Plaintiff. Defendants’ conduct warrants, if allowed by the Court upon motion, an award of punitive damages against Defendants in an amount appropriate to punish Defendants and deter them from similar conduct in the future. COUNT III - STRICT LIABILITY FAILURE TO WARN 56.
Plaintiff hereby incorporates by reference all preceding paragraphs
as if fully set forth herein. 57.
Defendants, or entities under their control, manufactured, sold,
distributed, marketed or supplied the Bair Hugger in a defective and unreasonably dangerous condition to consumers, including Plaintiff. 58.
Specifically, Defendants failed to warn of the injuries suffered by
Plaintiff as a result of using the Bair Hugger, and they introduced into the stream of commerce a defectively designed or manufactured product. 59.
Defendants designed, manufactured, sold, distributed, supplied,
marketed or promoted the Bair Hugger, which was expected to reach and did in fact reach consumers, including Plaintiff, without substantial change in the condition in which it was manufactured and sold by Defendants. 60.
Plaintiff and Plaintiff’s physicians used the Bair Hugger in a manner
normally intended, recommended, promoted and marketed by Defendants. 15
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 16 of 30
61.
The Bair Hugger failed to perform safely when used by ordinary
consumers, including Plaintiff, including when it was used as intended and in a reasonably foreseeable manner. 62.
The propensity of the Bair Hugger’s internal air flow passageways,
including its non-HEPA compliant filter, to become contaminated with pathogens makes the Bair Hugger unreasonably dangerous when used in the way it is ordinarily used and is dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchased it, with the ordinary knowledge common to the community as to its characteristics. 63.
Because Defendants researched, designed, tested, manufactured,
inspected, labeled, distributed, marketed, promoted, sold and otherwise released into the stream of commerce the Bair Hugger and in doing so, directly advertised or marketed the product to the FDA, health care professionals, and consumers, or persons responsible for consumers, they had a duty to warn of the risks associated with the use of the Bair Hugger. 64.
Defendants failed to adequately warn health care professionals and
the public, including Plaintiff and Plaintiff’s physician, of the true risks of the Bair Hugger, including that the Bair Hugger would circulate contaminated air in the operating room and that the vented heat from Bair Hugger would mobilize floor air contaminated with pathogens into the surgical site, causing deep joint 16
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 17 of 30
infections, and requiring further treatment, including surgery or amputation. 65.
Defendants failed to provide timely and reasonable warnings
regarding the safety and efficacy of the Bair Hugger. Had they done so, proper warnings would have been heeded and no health care professional, including Plaintiff’s physicians, would have used Bair Hugger, and no patient, including Plaintiff, would have allowed use of the Bair Hugger. 66.
The failure to provide timely and reasonable warnings, instructions,
and information regarding the Bair Hugger to Plaintiff or Plaintiff’s physician rendered the Bair Hugger unreasonably dangerous. 67.
As a direct and proximate result of Defendants’ actions, omissions
and misrepresentations, Plaintiff suffered an infection, requiring additional surgical procedures to clean the infected area and/or remove the orthopedic implant. Consequently, Plaintiff has suffered damages and incurred and will continue to incur medical expenses as a result of using the Bair Hugger. Plaintiff has also suffered and will continue to suffer diminished capacity of the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages. Plaintiff’s direct medical losses and costs include care for hospitalizations, physician care, monitoring, treatment, medications and supplies. Plaintiff has incurred and will continue to incur mental and physical 17
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 18 of 30
pain and suffering and loss of wages and wage earning capacity. 68.
Defendants’ conduct described above was committed with
knowing, conscious, wanton, willful, and deliberate disregard for the value of human life and the rights and safety of consumers such as Plaintiff. Defendants’ conduct warrants, if allowed by the Court upon motion, an award of punitive damages against Defendants in an amount appropriate to punish the Defendants and deter them from similar conduct in the future. COUNT IV - STRICT LIABILITY DEFECTIVE DESIGN AND MANUFACTURE 69.
Plaintiff hereby incorporates by reference all preceding paragraphs
as if fully set forth herein. 70.
Defendants, or entities under their control, manufactured, sold,
distributed, marketed or supplied the Bair Hugger in a defective and unreasonably dangerous condition to consumers, including Plaintiff. 71.
Specifically, Defendants failed to warn of the injuries suffered by
Plaintiff as a result of using the Bair Hugger, and they introduced into the stream of commerce a defectively designed or manufactured product. 72.
Defendants designed, manufactured, sold, distributed, supplied,
marketed or promoted the Bair Hugger, which was expected to reach and did in fact reach consumers, including Plaintiff, without substantial change in the 18
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 19 of 30
condition in which it was manufactured and sold by the Defendants. 73.
Plaintiff and Plaintiff’s physicians used the Bair Hugger in a manner
normally intended, recommended, promoted and marketed by Defendants. 74.
The Bair Hugger failed to perform safely when used by ordinary
consumers, including Plaintiff, including when it was used as intended and in a reasonably foreseeable manner. 75.
The propensity of the Bair Hugger’s internal air flow passageways,
including its non-HEPA compliant filter, to become contaminated with pathogens makes the Bair Hugger unreasonably dangerous when used in the way it is ordinarily used and is dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchased it, with the ordinary knowledge common to the community as to its characteristics. 76.
The design of the Bair Hugger or its component parts, makes the Bair
Hugger unreasonably dangerous, taking into consideration the utility of the device and the risk involved in its use. 77.
At all times relevant to this action, an economically and
technologically feasible safer alternative design existed, which in reasonable medical probability: a.
would have prevented or significantly reduced the risk of Plaintiff’s infection and subsequent injuries (including additional surgical procedures to clean the infected area and/or remove the implant); and 19
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 20 of 30
b. 78.
would not have impaired the utility of the device
Specifically, the Bair Hugger is defective in its design in that it is not
reasonably fit, suitable or safe for its intended purpose or its foreseeable risks exceed the benefits associated with its design. 79.
The defective condition of the Bair Hugger rendered it unreasonably
dangerous or not reasonably safe and the Bair Hugger was in this defective condition at the time it left the hands of Defendants. The Bair Hugger was expected to and did reach Plaintiff and Plaintiff’s physicians without substantial change in the condition in which it was designed, manufactured, labeled, sold, distributed, marketed, promoted, supplied, and otherwise released into the stream of commerce. 80.
Defendants knew or should have known of the danger associated
with the use of the Bair Hugger, as well as the defective nature of the Bair Hugger, but have continued to design, manufacture, sell, distribute, market, promote, or supply the Bair Hugger so as to maximize sales and profits at the expense of the public health and safety, in conscious disregard of the foreseeable harm caused by Bair Hugger. 81.
As a direct and proximate result of Defendants’ actions, omissions
and misrepresentations, Plaintiff suffered an infection, requiring additional surgical procedures to clean the infected area and/or remove the orthopedic 20
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 21 of 30
implant. Consequently, Plaintiff has suffered damages and incurred and will continue to incur medical expenses as a result of using the Bair Hugger. Plaintiff has also suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages. Plaintiff’s direct medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. Plaintiff has incurred and will continue to incur mental and physical pain and suffering and loss wages and wage earning capacity. 82.
Defendants’ conduct as described above was committed with
knowing, conscious, wanton, willful, and deliberate disregard for the value of human life and the rights and safety of consumers such as Plaintiff. Defendants’ conduct warrants, if allowed by the Court upon motion, an award of punitive damages against Defendants in an amount appropriate to punish Defendants and deter them from similar conduct in the future. COUNT V - BREACH OF IMPLIED WARRANTY 83.
Plaintiff hereby incorporates by reference all preceding paragraphs
as if fully set forth herein. 84.
The Defendants designed, manufactured, distributed, advertised,
promoted and sold the Bair Hugger for use in sterile, surgical environments. 21
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 22 of 30
85.
At all relevant times, Defendants knew of the use for which the Bair
Hugger was intended and impliedly warranted the product to be of merchantable quality and safe and fit for such use. 86.
Defendants were aware that consumers, including Plaintiff, would
use the Bair Hugger for treatment in conjunction with orthopedic surgical procedures. 87.
Plaintiff,
Plaintiff’s
physician,
and
the
medical
community
reasonably relied upon the judgment and sensibility of Defendants to sell the Bair Hugger only if it was indeed of merchantable quality and safe and fit for its intended use. 88.
Defendants breached their implied warranty to consumers, including
Plaintiff; the Bair Hugger was not of merchantable quality or safe and fit for its intended use. 89.
Consumers, including Plaintiff, Plaintiff’s physician, and the medical
community reasonably relied upon Defendants implied warranty for the Bair Hugger. 90.
Plaintiff and Plaintiff’s physician, by the use of reasonable care,
would not have discovered the breached warranty and realized its danger. 91.
As a direct and proximate result of Defendants’ actions, omissions
and misrepresentations, Plaintiff suffered an infection, requiring additional 22
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 23 of 30
surgical procedures to clean the infected area and/or remove the orthopedic implant. Consequently, Plaintiff suffered damages and incurred and will continue to incur medical expenses as a result of using the Bair Hugger. Plaintiff has also suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages. Plaintiff’s direct medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. Plaintiff has incurred and will continue to incur mental and physical pain and suffering and loss of wages and wage earning capacity. 92.
Defendant’s conduct as described above was committed with
knowing, conscious, wanton, willful and deliberate disregard for the value of human life and the rights and safety of consumers such as Plaintiff. Defendants’ conduct warrants, if allowed by the Court upon motion, an award of punitive damages against Defendants in an amount appropriate to punish the Defendants and deter them from similar conduct in the future. COUNT VI - NEGLIGENT MISREPRESENTATION 93.
Plaintiff restates the allegations set forth above as if fully rewritten
herein. 94.
Defendants made negligent misrepresentations with respect to the 23
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 24 of 30
Bair Hugger including, but not limited to, the following particulars:
95.
a.
Defendants represented through the labeling, advertising, marketing materials, seminar presentations, publications, notice letters, and regulatory submissions that Bair Hugger has been tested and found to be safe and effective for the warming of patients during orthopedic implant surgery; and
b.
Defendants represented the Bair Hugger was safer than other patient warming systems.
Defendants did not exercise reasonable care or competence in
obtaining or communicating the information to the public regarding the characteristics and qualities of the Bair Hugger. 96.
Plaintiff and Plaintiff’s physicians did, in fact, reasonably rely upon
the representations. 97.
As a direct and proximate result of Defendants’ actions, omissions
and misrepresentations, Plaintiff suffered an infection, requiring additional surgical procedures to clean the infected area and/or remove the orthopedic implant. Consequently, Plaintiff has suffered damages and incurred and will continue to incur medical expenses as a result of using the Bair Hugger. Plaintiff has also suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages. Plaintiff’s direct medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and 24
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 25 of 30
supplies. Plaintiff has incurred and will continue to incur mental and physical pain and suffering and loss of wages and wage earning capacity. 98.
Upon information and belief, Defendants’ conduct as described
above was committed with knowing, conscious, wanton, willful and deliberate disregard for the value of human life and the rights and safety of consumers such as Plaintiff. Defendants’ conduct warrants, if allowed by the Court upon motion, an award of punitive damages against Defendants in an amount appropriate to punish the Defendants and deter them from similar conduct in the future. COUNT VII - FRAUDULENT MISREPRESENTATION 99.
Plaintiff hereby incorporates by reference all preceding paragraphs
as if fully set forth herein. 100.
The Defendants made fraudulent misrepresentations with respect to
the Bair Hugger including, but not limited to, the following particulars:
101.
a.
The Defendants represented through the labeling, advertising, marketing materials, seminar presentations, publications, notice letters, and regulatory submissions that the Bair Hugger has been tested and found to be safe and effective for the warming of patients during orthopedic implant surgery; and
b.
The Defendants represented Bair Hugger was safer than other patient warming systems.
Defendants knew that their representations were false, yet they
willfully, wantonly, and recklessly disregarded their obligation to provide 25
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 26 of 30
truthful representations regarding the safety and risks of Bair Hugger to consumers, including Plaintiff, and the medical community. 102.
The representations were made by Defendants with the intent that
doctors and patients, including Plaintiff, rely upon them. 103.
Defendants’ representations were made with the intent of
defrauding and deceiving Plaintiff, other consumers, and the medical community to induce and encourage the sale of Bair Hugger. 104.
Plaintiff and Plaintiff’s physicians did in fact rely upon the
representations. In the absence of Defendants’ representations, the Bair Hugger would not be used in implantation surgeries such as the one at issue in this case. 105.
Defendants’ fraudulent representations evidence their callous,
reckless, and willful indifference to the health, safety, and welfare of consumers, including Plaintiff. 106. As a direct and proximate result of the Defendants’ actions, omissions and misrepresentations, Plaintiff suffered an infection, requiring additional surgical procedures to clean the infected area and/or remove the orthopedic implant. Consequently, Plaintiff has suffered damaged and incurred and will continue to incur medical expenses as a result of using the Bair Hugger. Plaintiff has also suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, 26
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 27 of 30
aggravation of preexisting conditions and activation of latent conditions, and other losses and damages. Plaintiff’s direct medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. Plaintiff has incurred and will continue to incur mental and physical pain and suffering and loss of wages and wage earning capacity. 107. Upon information and belief, Defendants’ conduct as described above was committed with knowing, conscious, wanton, willful and deliberate disregard for the value of human life and the rights and safety of consumers such as Plaintiff. Defendants’ conduct warrants, if allowed by the Court upon motion, an award of punitive damages against Defendants in an amount appropriate to punish the Defendants and deter them from similar conduct in the future. COUNT VIII - FRAUDULENT CONCEALMENT 108. Plaintiff hereby incorporates by reference all preceding paragraphs as if fully set forth herein. 109. Defendants fraudulently concealed information with respect to the Bair Hugger including, but not limited to, the following particulars: a.
Defendants represented through the labeling, advertising, marketing materials, seminar presentations, publications, notice letters, and regulatory submissions that the Bair Hugger was safe and fraudulently withheld and concealed information about the substantial risk of using Bair Hugger; and
b.
Defendants represented that Bair Hugger was safe and safer 27
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 28 of 30
than other alternative systems and fraudulently concealed information that demonstrated that Bair Hugger was not safer than alternatives available on the market. 110. Defendants had sole access to material facts concerning the dangers and unreasonable risks of the Bair Hugger. 111. The concealment of information by Defendants about the risks of the Bair Hugger was intentional, and the representations made by Defendants were known by Defendants to be false. 112. The concealment of information and the misrepresentations about Bair Hugger were made by the Defendants with the intent that doctors and patients, including Plaintiff and Plaintiff’s doctors, rely upon them. 113. Plaintiff and Plaintiff’s physicians relied upon the representations and were unaware of the substantial risks of the Bair Hugger which Defendants concealed from the public, including Plaintiff and Plaintiff’s physicians. 114. As a direct and proximate result of Defendants’ actions, omissions and misrepresentations, Plaintiff suffered an infection, requiring additional surgical procedures to clean the infected area and/or remove the orthopedic implant. Consequently, Plaintiff has suffered damaged and incurred and will continue to incur medical expenses as a result of using the Bair Hugger. Plaintiff has also suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, 28
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 29 of 30
aggravation of preexisting conditions and activation of latent conditions, and other losses and damages. Plaintiff’s direct medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. Plaintiff has incurred and will continue to incur mental and physical pain and suffering and loss of wages and wage earning capacity. 115. Defendants’ conduct as described above was committed with knowing, conscious, wanton, willful and deliberate disregard for the value of human life and the rights and safety of consumers such as Plaintiff. Defendants’ conduct warrants, if allowed by the Court upon motion, an award of punitive damages against Defendants in an amount appropriate to punish the Defendants and deter them from similar conduct in the future. PRAYER FOR RELIEF WHEREFORE, Plaintiff prays for judgment against Defendants, jointly and/or severally, as follows: 1.
For an award of compensatory damages in excess of Seventy-Five
Thousand Dollars ($75,000.00); 2.
If allowed by the Court upon motion, an award of punitive damages
in the amount to be proven at the time of trial, and sufficient to punish the Defendants or to deter the Defendants and others from repeating the injurious conduct alleged herein; 29
CASE 0:16-cv-00005 Document 1 Filed 01/04/16 Page 30 of 30
3.
For pre-judgment and post-judgment interest on the above general
and special damages; 4.
For costs of this suit and attorneys’ fees;
5.
For all other relief that Plaintiff may be entitled to at equity or at
law; and 6.
For such further and other relief that this Court deems just and
equitable. DEMAND FOR JURY TRIAL Plaintiff demands a trial by jury on all counts and issues so triable. Dated: January 4, 2016
Respectfully submitted, ZIMMERMAN REED, LLP s/Charles S. Zimmerman Charles S. Zimmerman – MN #120054 J. Gordon Rudd, Jr. – MN #222082 Kirsten D. Hedberg – MN #344369 Jacqueline A. Olson – MN #391848 1100 IDS Center, 80 South 8th Street Minneapolis, MN 55402 Telephone: (612) 341-0400 Facsimile: (612) 341-0844 Email:
[email protected] [email protected] [email protected] [email protected] ATTORNEYS FOR PLAINTIFF
30
CASE 0:16-cv-00005 Document 1-1 Filed 01/04/16 Page 1 of 2
CIVIL COVER SHEET
JS 44 (Rev. 09/11)
The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
I. (a) PLAINTIFFS Susan Borroughs (b)
DEFENDANTS 3M Company and Arizant Healthcare, Inc.
County of Residence of First Listed Plaintiff
Bernalillo, NM
County of Residence of First Listed Defendant
(EXCEPT IN U.S. PLAINTIFF CASES)
(IN U.S. PLAINTIFF CASES ONLY) IN LAND CONDEMNATION CASES, USE THE LOCATION OF THE TRACT OF LAND INVOLVED.
NOTE:
(c)
Attorneys (If Known)
Attorneys (Firm Name, Address, and Telephone Number)
Charles S. Zimmerman, Zimmerman Reed, LLP, 1100 IDS Center, 80 South 8th Street, Minneapolis, MN 55402 II. BASIS OF JURISDICTION
(Place an “X” in One Box Only)
(For Diversity Cases Only) PTF Citizen of This State 1
1
U.S. Government Plaintiff
3 Federal Question (U.S. Government Not a Party)
2
U.S. Government Defendant
4 Diversity (Indicate Citizenship of Parties in Item III)
IV. NATURE OF SUIT CONTRACT 110 Insurance 120 Marine 130 Miller Act 140 Negotiable Instrument 150 Recovery of Overpayment & Enforcement of Judgment 151 Medicare Act 152 Recovery of Defaulted Student Loans (Excl. Veterans) 153 Recovery of Overpayment of Veteran’s Benefits 160 Stockholders’ Suits 190 Other Contract 195 Contract Product Liability 196 Franchise
REAL PROPERTY 210 Land Condemnation 220 Foreclosure 230 Rent Lease & Ejectment 240 Torts to Land 245 Tort Product Liability 290 All Other Real Property
V. ORIGIN
III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff)
(Place an “X” in One Box Only) TORTS PERSONAL INJURY PERSONAL INJURY 310 Airplane 365 Personal Injury 315 Airplane Product Product Liability Liability 367 Health Care/ 320 Assault, Libel & Pharmaceutical Slander Personal Injury 330 Federal Employers’ Product Liability Liability 368 Asbestos Personal 340 Marine Injury Product 345 Marine Product Liability Liability PERSONAL PROPERTY 350 Motor Vehicle 370 Other Fraud 355 Motor Vehicle 371 Truth in Lending Product Liability 380 Other Personal 360 Other Personal Property Damage Injury 385 Property Damage 362 Personal Injury Product Liability Med. Malpractice CIVIL RIGHTS PRISONER PETITIONS 440 Other Civil Rights 510 Motions to Vacate 441 Voting Sentence 442 Employment Habeas Corpus: 443 Housing/ 530 General Accommodations 535 Death Penalty 445 Amer. w/Disabilities 540 Mandamus & Other Employment 550 Civil Rights 446 Amer. w/Disabilities 555 Prison Condition Other 560 Civil Detainee 448 Education Conditions of Confinement
DEF 1
and One Box for Defendant) PTF DEF Incorporated or Principal Place 4 4 of Business In This State
Citizen of Another State
2
2
Incorporated and Principal Place of Business In Another State
5
5
Citizen or Subject of a Foreign Country
3
3
Foreign Nation
6
6
FORFEITURE/PENALTY 625 Drug Related Seizure of Property 21 USC 881 690 Other
BANKRUPTCY 422 Appeal 28 USC 158 423 Withdrawal 28 USC 157 PROPERTY RIGHTS 820 Copyrights 830 Patent 840 Trademark
LABOR 710 Fair Labor Standards Act 720 Labor/Mgmt. Relations 740 Railway Labor Act 751 Family and Medical Leave Act 790 Other Labor Litigation 791 Empl. Ret. Inc. Security Act
SOCIAL SECURITY 861 HIA (1395ff) 862 Black Lung (923) 863 DIWC/DIWW (405(g)) 864 SSID Title XVI 865 RSI (405(g))
FEDERAL TAX SUITS 870 Taxes (U.S. Plaintiff or Defendant) 871 IRS—Third Party 26 USC 7609
OTHER STATUTES 375 False Claims Act 400 State Reapportionment 410 Antitrust 430 Banks and Banking 450 Commerce 460 Deportation 470 Racketeer Influenced and Corrupt Organizations 480 Consumer Credit 490 Cable/Sat TV 850 Securities/Commodities/ Exchange 890 Other Statutory Actions 891 Agricultural Acts 893 Environmental Matters 895 Freedom of Information Act 896 Arbitration 899 Administrative Procedure Act/Review or Appeal of Agency Decision 950 Constitutionality of State Statutes
IMMIGRATION 462 Naturalization Application 463 Habeas Corpus Alien Detainee (Prisoner Petition) 465 Other Immigration Actions
(Place an “X” in One Box Only)
Transferred from 2 Removed from 3 Remanded from 4 Reinstated or 5 another district 6 Multidistrict Reopened State Court Appellate Court Litigation (specify) Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity): 28 U.S.C.§ 1332 VI. CAUSE OF ACTION Brief description of cause: Healthcare/Pharmaceutical Personal Injury Product Liability CHECK YES only if demanded in complaint: DEMAND $ 75,000.00 VII. REQUESTED IN CHECK IF THIS IS A CLASS ACTION UNDER F.R.C.P. 23 Yes No JURY DEMAND: COMPLAINT: 1 Original Proceeding
VIII. RELATED CASE(S) IF ANY
(See instructions):
JUDGE
Joan N. Ericksen
DATE
SIGNATURE OF ATTORNEY OF RECORD
01/04/2016
s/Charles S. Zimmerman
DOCKET NUMBER 15-md-2666 (JNE/FLN)
FOR OFFICE USE ONLY RECEIPT #
AMOUNT
APPLYING IFP
JUDGE
MAG. JUDGE
JS 44 Reverse (Rev. 09/11)
CASE 0:16-cv-00005 Document 1-1 Filed 01/04/16 Page 2 of 2
INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44 Authority For Civil Cover Sheet The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of Court for each civil complaint filed. The attorney filing a case should complete the form as follows: I. (a) Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and then the official, giving both name and title. (b) County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land condemnation cases, the county of residence of the “defendant” is the location of the tract of land involved.) (c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting in this section “(see attachment)”. II. Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.C.P., which requires that jurisdictions be shown in pleadings. Place an “X” in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below. United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here. United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an “X” in this box. Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes precedence, and box 1 or 2 should be marked. Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the citizenship of the different parties must be checked. (See Section III below; federal question actions take precedence over diversity cases.) III. Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this section for each principal party. IV. Nature of Suit. Place an “X” in the appropriate box. If the nature of suit cannot be determined, be sure the cause of action, in Section VI below, is sufficient to enable the deputy clerk or the statistical clerks in the Administrative Office to determine the nature of suit. If the cause fits more than one nature of suit, select the most definitive. V.
Origin. Place an “X” in one of the seven boxes.
Original Proceedings. (1) Cases which originate in the United States district courts. Removed from State Court. (2) Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section 1441. When the petition for removal is granted, check this box. Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use the date of remand as the filing date. Reinstated or Reopened. (4) Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date. Transferred from Another District. (5) For cases transferred under Title 28 U.S.C. Section 1404(a). Do not use this for within district transfers or multidistrict litigation transfers. Multidistrict Litigation. (6) Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C. Section 1407. When this box is checked, do not check (5) above. Appeal to District Judge from Magistrate Judgment. (7) Check this box for an appeal from a magistrate judge’s decision. VI. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service VII.
Requested in Complaint. Class Action. Place an “X” in this box if you are filing a class action under Rule 23, F.R.Cv.P.
Demand. In this space enter the dollar amount (in thousands of dollars) being demanded or indicate other demand such as a preliminary injunction. Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded. VIII. Related Cases. This section of the JS 44 is used to reference related pending cases, if any. If there are related pending cases, insert the docket numbers and the corresponding judge names for such cases. Date and Attorney Signature. Date and sign the civil cover sheet.
