peter kuhnmuench, and theresa … · 3200 greenfield, suite 260 dearborn, mi 48120-1802 (313)...

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN

PETER KUHNMUENCH, and THERESA KUHNMUENCH, Plaintiffs, Case No. 17-cv-11719 vs. Hon. Mag. LIVANOVA PLC, SORIN GROUP DEUTSCHLAND GMBH, and SORIN GROUP USA, INC., Defendants. ____________________________/ JEFFREY T. MEYERS (P34348) JUSTIN J. HAKALA (P72996) Attorneys for Plaintiff 3200 Greenfield, Suite 260 Dearborn, MI 48120-1802 (313) 961-0130 (Fax: 8178) [email protected] ____________________________/

COMPLAINT AND

DEMAND FOR JURY TRIAL

NOW COME the above-named Plaintiffs, by and through their attorneys,

MORGAN & MEYERS, PLC, and state as their cause of action and Complaint against

the above-named Defendants the following:

1. This is a product liability action against Defendants based upon the design

and manufacture of a cardioplegia machine, which precipitated an infection sustained by

Plaintiff, Peter Kuhnmuench.

2:17-cv-11719-PDB-SDD Doc # 1 Filed 05/31/17 Pg 1 of 25 Pg ID 1

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JURISDICTION AND VENUE

2. The amount in controversy exceeds seventy-five thousand dollars

($75,000.00), exclusive of interest, costs and attorney fees.

3. Plaintiff Peter Kuhnmuench is a resident of the State of Michigan.

4. Plaintiff Theresa Kuhnmuench is a resident of the State of Michigan

5. Defendant LivaNova PLC is a foreign corporation incorporated under the

laws of England and Wales, with its principal place of business outside of the State of

Michigan in London, England.

6. Defendant Sorin Group Deutschland GmbH is a foreign corporation formed

under the laws of Germany with its principal place of business in Munich, Germany.

7. Defendant Sorin Group USA, Inc. is a corporation formed under the laws of

Delaware with its principal place of business in Colorado.

8. This Court has subject matter jurisdiction based upon diversity over this

action because it was brought by citizens of the State of Michigan against corporations

domiciled in other States and/or countries. 28 U.S.C. § 1332.

9. Venue is proper in this jurisdiction because a substantial part of the events

or omission giving rise to Plaintiff’s injuries and claims took place in this judicial district. 28

U.S.C. § 1391(2).

FACTS

Pathogen Background

10. Nontuberculous mycobacterium (“NTM”) is a naturally occurring, slow

growing, gram-positive bacteria.


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11. Mycobacterium chimaera (“M. Chimaera”) is one type of NTM.

12. Symptoms of NTM infections following open cardiac surgeries can appear

years after the surgery due to the long incubation period and slow growth of the NTM

involved.

13. A study published in Clinical Infectious Disease on July 1, 2015 reported

onset of symptoms in patients with known NTM (Mycobacterium chimaera) ranging from

1.5 to 3.6 years after the procedure.

14. Symptoms associated with NTM infections are often general and may

include fever, pain, redness, drainage from the surgical incision, night sweats, joint pain,

muscle pain, and fatigue.

15. Definitive diagnosis of NTM requires targeted culturing, molecular diagnostic

testing, and other screening processes that are not typically performed unless clinicians

are aware of a potential NTM infection.

16. Most NTM infections, including mycobacterium chimaera, are resistant to

antibiotics, particularly where artificial graft or other material has been implanted during

surgery.

Device Background

17. Defendants design, manufacture, market and sell thermal regulator devices

to be used on patients in the operating room, including the Sorin 3T Heater-Cooler

System (“Sorin 3T System”).

18. Prior to June 2, 2014, the Defendants manufactured, introduced, and/or

delivered for introduction into interstate commerce, the Sorin 3T System.


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19. The Sorin 3T System used at the University of Michigan Health System

during the relevant time period was designed, manufactured, marketed, and/or sold by

Defendants LivaNova, PLC, Sorin Group Deutschland GmbH, and Sorin Group USA, Inc.,

to the University of Michigan Health System in the State of Michigan.

20. The Sorin 3T System is intended to provide temperature-controlled water to

heat exchanger devices (cardio-pulmonary bypass heat exchangers, cardioplegia heat

exchangers, and thermal regulating blankets) to warm or cool a patient during cardio-

pulmonary bypass procedures lasting six (6) hours or less. The Sorin 3T System is a

Class II Medical Device that is subject to the Food and Drug Administration’s (“FDA”)

Section 510K premarket notification process (“510K” or“510K process”).

21. Before commercial distribution in the United States of the Sorin 3T System,

the

22. Defendants submitted a 510K premarket notification of intent to market the

Sorin 3T System with the Secretary of Health and Human Services for FDA approval. The

FDA determined that the Sorin 3T System was substantially equivalent to legally marketed

predicate devices that do not require approval of a premarket approval (“PMA”)

application. This determination was relayed to the Defendants via letter on June 6, 2006,

510K number K052601.3 Essentially, the 510k process differs from the PMA process in

how carefully the FDA examines the safety of the medical device. The PMA process is

required for Class III medical devices while Class I and Class II predicate medical devices

can be approved through the less rigorous 510K process.

23. The FDA approval allows the Defendants to commercially distribute the

Sorin 3T System in accordance with the conditions and regulations described in the


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approval letter. Any commercial distribution of the Sorin 3T System that does not comply

with the conditions set forth in the letter are violations of the Federal Food, Drug, and

Cosmetic Act (“the Act”). Generally, the manufacturer must comply with all of the Act’s

requirements, including but not limited to: “Registration and Listing (21 C.F.R. part 807);

Labeling (21 C.F.R. part 801); Good Manufacturing Practice Requirements as set forth in

the Quality Systems Regulation (21 C.F.R. part 820); and if applicable, the Electronic

Product Radiation Control Provisions (Sections 531-542 of the Act); 21 C.F.R. 1000-1050.”

24. The Sorin 3T System works as a heat exchanger by aerosolizing

temperature controlled water and passing blood through adjacent structures.

25. Bypassed patient blood does not come into physical contact with water from

the 3T reservoir.

26. Trace amounts of NTM in the reservoir of a 3T unit will colonize and multiply.

27. NTM like M. Chimaera form biofilm that is resistant to easy removal with

cleaning and/or sanitation.

28. Operation of the unit aerosolizes the NTM and exhausts it from the unit into

the operative suite and often directly into the surgical field.

29. Reasonable and feasible alternative designs existed at the time of design,

manufacture, and at the time the Sorin 3T System was placed into the stream of

commerce, that would have eliminated or vastly reduced the risk of bacterial colonization

and transmission to the air and/or patients.

30. Reasonable and feasible alternative designs for the Sorin 3T System

included, but were not limited to, isolating the exhaust from the surgical suite and surgical

field, reducing the exhaust rate, utilizing a closed loop exhaust circuit, utilizing an isolated


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cooling circuit, utilizing disposable parts for the portions of the device that could colonize

bacteria, utilizing filters in the cooling loop to remove bacteria, adding clean in place

features that could clean and sterilize the cooling loop chemically or with high

temperatures on a regular basis, and several other possibilities used alone or in

combination.

General Background Facts

31. Airborne transmission of NTM from a contaminated heater-cooler unit was

recognized as a patient risk as early as 2011 in Europe.

32. On July 18, 2014, the Greenville Health System notified patients who had

undergone certain procedures in which the Sorin 3T System was used that there had been

a potential outbreak involving a pathogen called mycobacterium abscessus; the Greenville

Health System also revealed that there had been four deaths associated with the outbreak

and that cardiopulmonary perfusion machines had been removed from use a part of the

remedial measures taken to prevent further spread of the pathogen.

33. Testing conducted by Defendants in August of 2014 revealed a

mycobacterium chimaera contamination on the production line and in the water supply at

the Sorin 3T System manufacturing facility; cleaning and disinfecting procedures were

added to the production line in September of 2014 in response to the test results.

34. On June 15, 2015, the FDA issued a recall of Sorin 3T Systems, Product

code 16-02-85, Serial numbers 16S10958-16S15634 (a total of 1755 machines); the

customers using the systems were provided new Instructions for Use of the machine with

changes to the maintenance procedures.


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35. On October 15, 2015, the FDA issued a safety communication

recommending cleaning, disinfecting, directing vent exhaust away from surgical fields, and

other recommendations for safely handing the Sorin 3T systems.

36. The Centers for Disease Control issued an updated interim practice

guideline on October 27, 2015, which including information on identifying patients infected

with NTM.

37. On December 29, 2015, the FDA issued a warning letter to Defendants,

which indicated that its inspection of manufacturing facilities in Germany and Colorado

revealed that the Sorin 3T System devices had been adulterated.

38. On June 6, 2016, a paper entitled “Transmission of Mycobacterium

Chimaera,” was published in Emerging Infectious Disease based upon experiments

performed in Zurich, which substantiated the airborne pathway of a contagion with

heater/cooler units, including the Sorin 3T unit.

39. On October 13, 2016, the CDC warned healthcare providers and patients

about the potential risk of infection from the Sorin 3T. The FDA issued a concurrent safety

alert recommending removal of the heater/cooler units from service that were associated

with any infections or that tested positive for mycobacterium.

Plaintiff’s Medical Course

40. On April 30, 2014, Peter Kuhnmuench presented to the office of Dr. George

Michael Deeb for evaluation of an ascending aortic aneurysm. He had a history of

diagnostic catheterization on April 1, 2014, which showed normal coronary arteries with


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normal pressures and good hemodynamics. Transesophageal echocardiogram showed

no significant disease and minimal mitral, tricuspid and pulmonary regurgitation. CT scan

revealed that he had a distal splenic arch aneurysm at 1.9 centimeters and significant

anterior wall abnormality. It was Dr. Deeb’s impression that Mr. Kuhnmuench had an acute

event, possibly bleeding in a contained hematoma, which became chronic and left him

with a 5.4 millimeter ascending aortic aneurysm. Dr. Deeb’s plan was to perform an

ascending aortic replacement under circulatory arrest.

41. On June 24, 2014, Mr. Kuhnmuench was taken to the operating room for the

replacement of ascending aorta procedure performed by Dr. George Deeb. After a

peripheral IV was inserted and intravenous Vancomycin and Cefuroxime was

administered, Mr. Kuhnmuench was anesthetized under general anesthesia via an

endotracheal tube with monitoring. Access was obtained with a median sternotomy and

three units of the patient’s blood were removed and heparinized. Arterial access for

cardiopulmonary bypass was obtained at the lesser curvature of the ascending aorta,

which was free of pathology. Access was also obtained at the superior vena cava and

after placement was confirmed via echocardiogram, venous access was obtained at the

right atrial appendage and retrograde cannula was inserted through the right atrium in the

coronary sinus. After vascular access was obtained, cardiopulmonary bypass was

commenced, the heart was decompressed, and cooling was initiated. Cardioplegia was

maintained with retrograde cold blood perfused regularly. The aorta was examined and

transected at the level of the left subclavian vessel. Several grafts were placed to

reconstruct the aorta. The total circulatory arrest time to that point was 32 minutes; total

cross-clamp time was 78 minutes; total antegrade cerebral perfusion time was 118


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minutes. Subsequently, they began rewarming the patient. Sinus rhythm was obtained

after the patient was brought to approximately 37 degrees centigrade and ventilation was

initiated. Good ventricular function was noted on echocardiogram as bypass was weaned.

42. Bleeding was noted around the proximal anastomosis, which was found to

be torn at the suture line in the area of the right coronary artery. Dr. Deeb felt that the

patient’s root tissue was abnormal and could not withstand systemic pressure and so he

was recannulated in the right atrium with a two-stage venous cannula. Heparin had not

been reversed and activated clotting time remained over 500 seconds so cardiopulmonary

bypass was resumed. Preparation to recross-clamp the aorta and arrest the heart were

made.

43. On examination, the root tissue was destroyed under the proximal

anastomosis and the right sinus was ripped and shredded to the base of the right main

coronary ostia at the upper margin of the ostia. Due to accumulating 73 minutes of aortic

cross-clamp time with hypothermic circulatory arrest already, Dr. Deeb elected to do a

Freestyle root replacement in lieu of a valve sparing approach.

44. At the conclusion of that portion of the procedure, the aortic cross-clamp

was, again, released and the patient was cardioverted and came back to sinus rhythm.

They began ventilating Mr. Kuhnmuench and weaned him from cardiopulmonary bypass,

noting no bleeding and hemostasis. TEE showed good ventricular function on both sides

and the Freestyle repair held with pressure across the valve. No tricuspid or mitral

regurgitation was observed and Protamine was administered to reverse Heparin. The

cardiopulmonary bypass blood was transfused back into the patient and the anastomoses

were checked and cannulation and pacing wires removed. Minimal drainage was


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observed from a chest tube placed after closure and the patient was taken to the Intensive

Care Unit in stable condition in his own sinus rhythm without needing additional blood

transfusion.

45. A heater/cooler device manufactured by Defendants, the 3T System, was

utilized for cardioplegia during Mr. Kuhnmuench’s surgery.

46. Mr. Kuhnmuench was extubated on post-operative day one and his post-

operative course was complicated by him being slow to wake with delirium and agitation

thought to be related to the total circulatory arrest time. His symptoms gradually improved

with medication and rest. He also was noted to have atrial fibrillation, which was relieved

when Coreg was resumed. He was transferred from the cardiovascular center ICU to a

step-down unit on post-operative day six and subsequently discharged without fever and

with stable vital signs.

47. On October 1, 2015, Mr. Kuhnmuench reported to Dr. Deeb that he was

experiencing muscle stiffness and tenderness around the surgical area.

48. Electronic communication between Mr. Kuhnmuench and Dr. Deeb on

October 16, 2015, reported fatigue and night sweats. Mr. Kuhnmuench had a telephone

call with Diane Susan Hughes from Dr. Deeb’s staff in which she suggested that he

present to the emergency department for a work-up of these symptoms.

49. At approximately 6:35 p.m. on October 16, 2015, Mr. Kuhnmuench

presented to the emergency department at the University of Michigan Hospital with a

history of three to four days of fatigue and night sweats. Mr. Kuhnmuench reported that he

had an upper respiratory infection about two weeks previously, with symptoms of sore

throat and congestion. His symptoms improved with over-the-counter medication. Mr.


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Kuhnmuench reported that his night sweats were severe enough that they would require a

change of clothes and he characterized his fatigue as extreme.

50. A history of present illness in the emergency department indicated that a

member of the cardiothoracic surgery team told Mr. Kuhnmuench to present to the ER for

evaluation of endocarditis. Labs in the emergency department included urinalysis, CBC,

CRP and ESR, which were largely within normal limits. A chest X-ray was also normal. He

was discharged home in stable condition and advised to follow-up with the cardiothoracic

surgery team. After completing the evaluation, emergency department physician Mark

Lowell, M.D. instructed Mr. Kuhnmuench to follow up with his cardiothoracic surgeon and

discharged him home.

51. Subsequently, on November 2, Mr. Kuhnmuench indicated that he was still

having night sweats and fatigue to Linda Quillin, N.P., a Nurse Practitioner working with

Dr. Deeb on the cardiothoracic surgery team.

52. Subsequently on August 31, 2016, Mr. Kuhnmuench e-mailed Linda Quillin,

N.P. regarding his continued fatigue.

53. On September 27, 2016, Mr. Kuhnmuench, again, corresponded with Ms.

Quillin regarding his continued fatigue, night sweats and stiffness, as well as weight loss

and blood work results.

54. On October 14, 2016, the UMHS issued an advisory to the general public,

as well as to certain patients that had undergone procedures using the Sorin 3T System,

that indicated the Sorin 3T System may have been contaminated with Mycobacterium

chimaera, a type of nontuberculous mycobacterium


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55. On October 16, 2016, Mr. Kuhnmuench contacted Linda Marie Quillin, N.P.

He reported seeing an article regarding NTM linked to heating/cooling devices used during

open heart surgery, and inquired about whether one of these devices was utilized during

his surgery. Mr. Kuhnmuench also reported that he had nearly all of the symptoms

reported with NTM infections, including night sweats, muscle aches, weight loss, and

fatigue. He requested that a culture be performed to make this diagnosis.

56. On or about October 17, 2016, cultures for acid-fast bacilli (“AFB”) were

ordered by Mr. Kuhnmuench primary care physician, Dr. Cynthia Buchoweitz. Mr.

Kuhnmuench began trying to schedule an appointment with an infectious disease

specialist at UMHS.

57. On October 21, 2016, Mr. Kuhnmuench had an appointment with Laraine

Washer, M.D. Dr. Washer obtained bloodwork and an echocardiogram.

58. Mr. Kuhnmuench was subsequently diagnosed with NTM, specifically

mycobacterium chimaera and was started on antibiotics. He continues to undergo

treatment, evaluation, testing. Mr. Kuhnmuench is expected to continue on antibiotics and

undergo a surgical revision to remove graft and valve material infected with NTM.

59. Letters were sent by UMHS to patients to warn them of potential NTM

infections following surgeries where the Sorin 3T System was used on November 18,

November 28, and November 29 of 2016.


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COUNT I – NEGLIGENCE

PLAINTIFFS HEREBY restate, reallege, and incorporate by reference each and

every paragraph set forth above, as though fully set forth herein and further states in the

alternative the following:

60. At all times pertinent to this Complaint, Defendants owed the general

public, including Plaintiff, a duty to design, label, manufacture, assemble, inspect, test,

and market the Sorin 3T System reasonably.

61. Notwithstanding said obligation, and in breach thereof, Defendants were

negligent in the design, manufacture, assembly, testing, marketing, packaging, and sale

of the Sorin 3T in the following ways:

a. Failing to conduct adequate safety testing before placing the device into the stream of commerce;

b. Failing to timely establish and utilize procedures for revising the design of the 3T System after learning that patients were developing bacterial infections following surgeries using the system;

c. Failing to timely establish procedures for validation or, when appropriate, review and approval of design changes for the 3T System;

d. Failing to design the system to eliminate or mitigate bacterial growth and colonization;

e. Failing to design the system to eliminate or mitigate that transmission of pathogens and/or bacterial present in cooling liquid;

f. Failing to make design changes after learning the device was causing infections in patients;

g. Designing the system such that it did not include adequate sanitation measures;

h. Failing to design the system to have an isolated exhaust that would direct potential contaminants away from the operative suite and operative field;


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i. Failing to provide hospitals, customers, and other consumers with specific instructions for cleaning and sanitizing the water reservoir to prevent colonization and contamination of NTM and other pathogens;

j. Failing to provide hospitals, customers, and other consumers with specific instructions to install the system to direct vent exhaust away from the surgical suite;

k. Failing to warn hospitals, customers, and patients of the potential of NTM and other infections;

l. Manufacturing the system in a facility and with components that were infected with NTM and other pathogens;

m. Failing to maintain sanitation procedures at their manufacturing facilities to prevent contamination with NTM and similar pathogens;

n. Other acts or omissions to be determined over the course of discovery.

62. Defendants knew, or should have known, that the Sorin 3T System was

defective and there was a substantial likelihood that the defect would expose patients to

NTM, mycobacterium chimaera, and/or other dangerous pathogens.

63. As a direct and proximate result of the aforementioned negligent acts

and/or omissions of Defendants, the Plaintiff suffered the following injuries and

damages:

a. Exacerbation of preexisting infection, disease, and symptoms such as fatigue, pain, and others, past, present, and future;

b. Infection requiring antibiotics and other treatment;

c. Necessity of revisionary surgery to remove and replace infected graft and other foreign material that have become infected;

d. Additional risks of anesthesia, operative revision, and recovery;

e. Night sweats, fatigue, weight loss, and kidney damage;

f. Pain and suffering, past, present, and future;


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g. Disability and disfigurement, past, present, and future;

h. Emotional distress and anxiety, past, present, and future;

i. Denial of social pleasures and enjoyments; j. Lost wages, earnings and earning capacity; k. Future attendant care; l. Necessary physical accommodations to living environment and

vehicle, past, present, and future;

m. Other injuries and damages to be determined throughout the course of discovery and described in Plaintiff’s medical records.

WHEREFORE, the Plaintiffs respectfully request that this Honorable Court enter a

judgment against the Defendants in any amount in excess of SEVENTY-FIVE

THOUSAND ($75,000.00) DOLLARS, together with interest, costs and attorney fees, to

which the Plaintiffs are deemed to be entitled.

COUNT II – BREACH OF IMPLIED WARRANTY OF FITNESS

PLAINTIFF HEREBY restates, realleges, and incorporates by reference each and



64. At all times pertinent to this Complaint, the Sorin 3T System was not

reasonably fit for its intended, anticipated, or reasonably foreseeable use because it

fostered NTM and other pathogens, which colonize in the unit and are subsequently

aerosolized under normal foreseeable usage conditions.


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65. The Sorin 3T System breached its implied warranty of fitness in the

following ways:

a. Adequate safety testing had not been performed to validate the system’s safety prior to entering the stream of commerce;

b. The system did fostered bacterial growth and colonization;

c. The system transmitted pathogens and/or bacterial present in cooling liquid into the air by aerosolizing or otherwise transmitting them;

d. The system did not include adequate sanitation measures;

e. The system did not have an isolated exhaust that would direct potential contaminants away from the operative suite and operative field;

f. Hospitals, customers, and other consumers were not given specific instructions for cleaning and sanitizing the water reservoir to prevent colonization and contamination of NTM and other pathogens;

g. Hospitals, customers, and other consumers were not given specific instructions to install the system to direct vent exhaust away from the surgical suite;

h. The system was manufactured in a facility and with components that were infected with NTM and other pathogens;

i. Other acts or breaches, acts, and omissions to be determined over the course of discovery.

66. At all times pertinent to this Complaint, Plaintiff, and others similarly

situated, were entitled to rely upon and did rely upon the implied warranty of fitness and

suitability, which attended the design, manufacture, distribution, and sale of the Sorin 3T

System.

67. Plaintiff suffered injuries as a result of his reliance on the implied warranty

of fitness and suitability, which attended the manufacture, distribution, and sale of the

Sorin 3T System.


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68. As a direct and proximate result of the aforementioned breach of the

implied warranty of fitness and/or omissions of Defendants, the Plaintiff suffered and

continues to suffer the following injuries and damages:



c. Necessity of open heart surgery to remove and replace infected graft and other foreign material that have become infected;














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COUNT III – BREACH OF EXPRESS WARRANTY




69. Defendants expressly warranted, through their marketing, advertising,

distributors, and sales representatives, that the Sorin 3T System was of merchantable

quality and fit for the ordinary purposes and uses for which it was sold.

70. These statements made constitute express warranties regarding the Sorin

3T System.

71. Defendants breached these express warranties by designing, labeling,

manufacturing, and selling the defective and unreasonably dangerous Sorin 3T System

that was neither of merchantable quality nor fit for the ordinary purposes for which it was

sold, presenting an unreasonable risk of injury to patients, including Plaintiff, during

foreseeable use.

72. Notwithstanding those statements, the Subject Press was sold in breach of

the attendant express warranties.

73. Defendants knew, or should have known, that the Sorin 3T System was

defective and dangerous and there was a substantial likelihood that the defects set forth

above would cause the injuries which are the basis of this action.

74. At all times pertinent to this Complaint, Plaintiff, and others similarly situated,

were entitled to rely upon and did rely upon the express warranties, which attended the

sale of the Sorin 3T System.


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75. Plaintiff suffered injuries as a result of his and the University of Michigan

Health System’s reliance on the express warranties, which attended the sale of the Sorin

3T System.

76. As a direct and proximate result of the aforementioned breach of the

express warranties made by Defendants, Plaintiff suffered and continues to suffer the

following injuries and damages:












WHEREFORE, Plaintiff respectfully requests that this Honorable Court enter a



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which the Plaintiff is deemed to be entitled.

COUNT IV – GROSS NEGLIGENCE




77. At all times pertinent to this complaint Defendants designed, tested

manufactured and assembled the Sorin 3T System and placed it in the stream of

commerce.

78. The Sorin 3T System was expected to, and did, reach Plaintiff in the

condition in which it was sold, without substantial alteration.

79. The Sorin 3T System was not reasonably safe at the time it left

Defendants control and alternative design, testing and manufacturing practices were

practical, technically feasible and available which would have prevented Plaintiff’s

injuries and damages, and which would not have significantly impaired the usefulness

or desirability of the Sorin 3T System.

80. In designing, manufacturing, and marketing the Sorin 3T System,

Defendants were grossly negligent and acted with a wanton disregard for the safety of

the ultimate users of the Sorin 3T System including Plaintiff and his medical providers,

out of a concern only for its own pecuniary benefit for the reasons described below:

a. Failing to conduct adequate safety testing before placing the device into the stream of commerce;


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b. Failing to timely establish and utilize procedures for revising the design of the 3T System after learning that patients were developing bacterial infections following surgeries using the system;

c. Failing to timely establish procedures for validation or, when appropriate, review and approval of design changes for the 3T System;

d. Failing to design the system to eliminate or mitigate bacterial growth and colonization;

e. Failing to design the system to eliminate or mitigate that transmission of pathogens and/or bacterial present in cooling liquid;

f. Failing to make design changes after learning the device was causing infections in patients;

g. Designing the system such that it did not include adequate sanitation measures;

h. Failing to design the system to have an isolated exhaust that would direct potential contaminants away from the operative suite and operative field;

i. Failing to provide hospitals, customers, and other consumers with specific instructions for cleaning and sanitizing the water reservoir to prevent colonization and contamination of NTM and other pathogens;

j. Failing to provide hospitals, customers, and other consumers with specific instructions to install the system to direct vent exhaust away from the surgical suite;

k. Failing to warn hospitals, customers, and patients of the potential of NTM and other infections;

l. Manufacturing the system in a facility and with components that were infected with NTM and other pathogens;

m. Other acts or omissions to be determined over the course of discovery.

81. At all times pertinent to this Complaint, Defendants owed the general

public, including Plaintiffs, a duty to design and manufacture the Sorin 3T System in a

condition reasonably fit for its intended, anticipated, or reasonably foreseeable use, so

that it would perform as an ordinary consumer would expect for its intended use.


22

82. Notwithstanding said obligation, and in breach thereof, Defendants were

grossly negligent in the design, manufacture and testing of the Sorin 3T System as

Defendants failed to design, test and manufacture the Sorin 3T System in the manner

described above.

83. The above-cited conduct was so reckless as to demonstrate a substantial

lack of concern for whether an injury resulted to the individuals using the Sorin 3T

System and as such, Defendants were grossly negligent in the design, manufacture and

testing of the Sorin 3T System.

84. As a direct and proximate result of the aforementioned acts of gross

negligence, Plaintiff is entitled to such damages as are deemed fair and just, including,

but not limited to, damages for the following:









i. Denial of social pleasures and enjoyments; j. Lost wages, earnings and earning capacity; k. Future attendant care;


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l. Necessary physical accommodations to living environment and vehicle, past, present, and future;

m. Other injuries and damages to be determined throughout the course of

discovery and described in Plaintiff’s medical records.





COUNT V: LOSS OF CONSORTIUM THERESA KUHNMUENCH




85. At all times pertinent to this Complaint, Theresa Kuhnmuench was the

lawfully wedded wife of Peter Kuhnmuench.

86. As a direct and proximate result of the Defendants’ aforementioned

negligence, Theresa Kuhnmuench has suffered and will continue to suffer a loss of her

husband’s society, companionship and household services.






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Respectfully submitted,

MORGAN & MEYERS, PLC BY: s/Justin J. Hakala JEFFREY T. MEYERS (P34348) JUSTIN J. HAKALA (P72996) Attorneys for Plaintiff 3200 Greenfield, Suite 260 Dearborn, MI 48120-1802

(313) 961-0130 Fax: 8178 DATED: May 31, 2017


UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN

PETER KUHNMUENCH, and THERESA KUHNMUENCH, Plaintiffs, Case No. 17-cv-11719 vs. Hon. Mag. LIVANOVA PLC, SORIN GROUP DEUTSCHLAND GMBH, and SORIN GROUP USA, INC., Defendants. ____________________________/ JEFFREY T. MEYERS (P34348) JUSTIN J. HAKALA (P72996) Attorneys for Plaintiff 3200 Greenfield, Suite 260 Dearborn, MI 48120-1802 (313) 961-0130 (Fax: 8178) [email protected] ____________________________/

DEMAND FOR JURY TRIAL NOW COME Plaintiffs, by and through their attorneys, MORGAN & MEYERS,

PLC, and hereby demand a jury trial in the above causes of action.

Respectfully submitted, MORGAN & MEYERS, PLC BY: s/Justin J. Hakala JEFFREY T. MEYERS (P34348) JUSTIN J. HAKALA (P72996) Attorneys for Plaintiff 3200 Greenfield, Suite 260 Dearborn, MI 48120-1802

(313) 961-0130 Fax: 8178 DATED: May 31, 2017


peter kuhnmuench, and theresa … · 3200 greenfield, suite 260 dearborn, mi 48120-1802 (313)...

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