By: H. Leon Aussprung Scott Burkhart, Individually IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

Transcription

1 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 1 of 32 LAW OFFICE OF LEON AUSSPRUNG MD, LLC Attorneys for the Plaintiff, By: H. Leon Aussprung Scott Burkhart, Individually I.D. No.: and as Executor of the James E. Hockenberry Estate of Donna Burkhart I.D. No.: One Commerce Square, Suite Market Street Philadelphia, PA IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA ) SCOTT BURKHART, Individually and ) as Executor of the Estate of Donna ) Burkhart, deceased, ) ) CIVIL ACTION v. ) ) 5:14-cv-1557 LiNA MEDICAL USA, INC.; a Georgia, USA, ) corporation; LiNA MEDICAL ApS, a business ) in Denmark; LiNA Medical Polska Sp. Z.O.O, ) a limited liability company in Poland; and ) KEBOMED, AG, a business in Switzerland, ) ) ) JURY TRIAL DEMANDED Defendants. ) ) PLAINTIFF'S SECOND AMENDED COMPLAINT COMES NOW Scott Burkhart, Individually and as Executor of the Estate of Donna Burkhart, deceased, to plead his Second Amended Complaint for damages against the Defendants set forth below. 1. This is a lawsuit for negligence, misrepresentation, breach of warranties, product liability, and concerted action against LiNA Medical USA, Inc. ("LiNA

2 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 2 of 32 Medical"); LiNA Medical ApS ("LiNA ApS"); LiNA Medical Polska Sp. Z.O.O ("LiNA Polska"); and Kebomed, AG ("Kebomed") (collectively, "Defendants"). The claims arise from the design, manufacture, importation, distribution, marketing, promotion, and sale of the Defendants LiNA Xcise Morcellator, a surgical device which caused the wrongful death of Plaintiff's Decedent, Donna Burkhart, on or about Feburary 2, The Plaintiff is entitled to the relief he seeks because the Defendants, individually and in concerted action, (a) negligently designed the LiNA Xcise Morcellator, (b) manufactured it with a design defect, (c) failed to warn about the device, as designed and manufactured, (d) undertook and voluntarily assumed a duty to inform doctors and thereby patients about the device, and in so doing, negligently failed to warn of the device's risks to patients including the Plaintiff's Decedent, (e) negligently misrepresented and falsely warranted the device's safety and effectiveness, (f) intentionally misrepresented the risks of the device to patients including the Plaintiff's Decedent. These acts and omissions wrongfully caused the death of Donna Burkhart. Jurisdiction and Venue 3. The Plaintiff and the Defendants are diverse within the meaning of 28 U.S.C. 1332, and the amount in controversy exceeds $75,000 (seventy-five thousand dollars), exclusive of interest and costs, so this Court has subject-matter jurisdiction to hear and decide this tort and product liability case. 2

3 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 3 of Venue in the Eastern District of Pennsylvania is proper under 28 U.S.C. 1391(b)(2) as a substantial part of the events or omissions giving rise to the claim occurred in this District. The Parties 5. Plaintiff Scott Burkhart is Executor of the Estate of Donna Burkhart. He is an adult individual residing at 200 Summit Avenue, in Reading, Pennsylvania. He is a citizen of the Commonwealth of Pennsylvania, and he was the spouse of Donna Burkhart, who until her death resided in the Commonwealth of Pennsylvania at all times material to this lawsuit. 6. Defendant LiNA ApS is a business entity organized and operated under the laws of Denmark, and its principal place of business is in Denmark. It is a citizen of Denmark. It sought and obtained approval to market the LiNA Xcise Morcellator in the U.S.A. on application to the Food and Drug Administration ("FDA"). Exhibit No. 1, attached hereto. It applied for the approval pursuant to Section 510(k) of the Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended, 21 U.S.C. 301 et seq. LiNA ApS is the entity principally responsible for the device. 7. LiNA ApS has been served with the complaint in this case, and the Court has personal jurisdiction over it. 8. LiNA Medical is a business incorporated in the State of Georgia with its principal place of business in Norcross, Georgia. It is a citizen of Georgia. 3

4 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 4 of LiNA Medical has been served with the complaint in this case, and the Court has personal jurisdiction over it. 10. LiNA Polska is a business entity organized and operated under the laws of Poland, and its principal place of business is in Poland. It is a citizen of Poland. 11. Service of the complaint on LiNA Polska has commenced, and the Court has personal jurisdiction over the Defendant. 12. Kebomed is a business entity organized and operated under the laws of Switzerland, and its principal place of business is in Switzerland. It is a citizen of Switzerland. It has not been named in this lawsuit before, and service of the complaint on it has not commenced. Service will be commenced with the filing of this Second Amended Complaint. 13. The Court has personal jurisdiction over Kebomed. 14. Each Defendant is an establishment within the meaning of FDA rules and regulations for entities which design, manufacture, label, export, import, and distribute medical devices. Each Defendant is registered with FDA as one or more of those establishment types. Allegations 15. The claims in this lawsuit relate to and arose out of the Defendants' contacts with the Commonwealth of Pennsylvania. The Defendants purposefully directed their activities at residents of Pennsylvania, including Donna Burkhart, and this lawsuit against 4

5 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 5 of 32 them results from the alleged wrongful death of Ms. Burkhart which was caused by those activities. 16. The device the Plaintiff blames for the injury to and death of his Decedent is the LiNA Xcise Morcellator. The device was approved for marketing, sale, and use in the U.S.A. in March, Exhibit No. 1. LiNA ApS sought the approval from the FDA in Id. 17. LiNA ApS, in its application to the FDA, described the purpose of the instrument as "cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy." Exhibit No. 1. It was used for that purpose on Donna Burkhart. 18. Burkhart underwent the uterine surgery in which the LiNA Xcise Morcellator was used on or about March 6, It was used on her to, among other purposes, remove one or more large uterine fibroids, consistent with the purpose of the device described by LiNA ApS. The surgery is described in the medical records as a supracervical hysterectomy and bilateral salpingectomy with uterine morcellation, performed by surgeon John J. Dougherty, M.D. It was performed at Reading Hospital, in Reading, Pennsylvania. 19. LiNA ApS is the specification developer of the LiNA Xcise Morcellator used in the Burkhart surgery, meaning that it designed and manufactured the device. LiNA ApS developed the specifications for the device and caused it to be manufactured, 5

6 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 6 of 32 marketed, and distributed under its own name. It dictated the information for its use, including the labeling of the device and all other safety and effectiveness information conveyed about it to physicians and hospitals. It arranged for the manufacturing of the device under its own name, and it did so with LiNA Polska, which is LiNA ApS's contract manufacturer. LiNA ApS is the owner and operator of LiNA Polska, and LiNA Polska, as the contract manufacturer, made the device to LiNA ApS's specifications. 20. In 2010, prior to the Burkhart surgery, LiNA ApS created LiNA Medical to import, distribute, and market the LiNA Xcise Morcellator in the U.S.A., including in the Commonwealth of Pennsylvania, where LiNA ApS sold other of its products for uterine surgery. 21. LiNA ApS owned and operated LiNA Medical when LiNA Medical was created, and it continues to own and operate it, directly or indirectly. The president of LiNA Medical reports to LiNA ApS and did so at all times material to this lawsuit. 22. LiNA Medical is the initial importer of the LiNA Xcise Morcellator used in the Burkhart surgery, and as such, it is a manufacturer of the device within the meaning of FDA rules and regulations. It is a distributor of the device as well within the meaning of those rules and regulations. 23. LiNA Medical, at its principal place of business in Georgia, receives LiNA Xcise Morcellators from the overseas manufacturer and/or exporter. It did so at all times 6

7 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 7 of 32 material to this lawsuit, and did so in the case of the LiNA Xcise Morcellator used in the Burkhart surgery. It thereafter distributed the device for that surgery. 24. LiNA Medical, prior to the Burkhart uterine surgery, furnished promotional brochures, other printed materials, and other information about the LiNA Xcise Morcellator to physicians in the Commonwealth of Pennsylvania, including the surgeon who performed the Burkhart uterine surgery. Its name appears on the printed material along with LiNA ApS. 25. LiNA Medical, prior to the Burkhart uterine surgery, provided training to the local sales agent (Active Medical, Inc.) which promoted the LiNA Xcise Morcellator to physicians in the Commonwealth of Pennsylvania, including the surgeon who performed the Burkhart uterine surgery. It did so in person, directly in Pennsylvania, and it made marketing calls in person with the sales agent on surgeons in Pennsylvania for the purpose of obtaining purchase orders for the device. 26. LiNA Medical supplied the LiNA Xcise Morcellator used in the Burkhart surgery, and it did so as a "trial" of the product for which it and its local sales agent did not charge the hospital where the surgery occurred. Such trials of the LiNA Xcise Morcellator are prerequisites or preconditions of later sales of the device to the hospital. That was the case at Reading Hospital where the Burkhart surgery occurred and at many other hospitals in Pennsylvania. The device was sold to Reading Hospital multiple times 7

8 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 8 of 32 after the Burkhart surgery, and other hospitals in Pennsylvania purchased it scores of times after such trials. 27. LiNA Medical, in conducting itself as described above, communicated with the local sales agent on the progress of trials of the LiNA Xcise Morcellator. It did so to obtain sales of the device to the hospital where the Burkhart surgery occurred and to other hospitals in Pennsylvania where the device was supplied at no charge as a trial. It did so in concert with LiNA ApS, which operated LiNA Medical and concerted its activities at all times material. 28. LiNA Medical, in conducting itself as described above, undertook and voluntarily assumed a duty to inform doctors and thereby patients about the LiNA Xcise Morcellator, including the surgeon who performed the uterine surgery on Ms. Burkhart. It did so in concert with LiNA ApS, which operated LiNA Medical and concerted its activities at all times material. 29. LiNA Medical, in conducting itself as described above, aimed to obtain sales of the LiNA Xcise Morcellator to the hospital where the Burkhart surgery occurred, and it succeeded in that goal. It did so in concert with LiNA ApS, which operated LiNA Medical and concerted its activities at all times material. LiNA Medical earned a commission on all such sales to other hospitals in Pennsylvania. LiNA ApS profited from those sales. 8

9 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 9 of LiNA Medical, in conducting itself as described above, misrepresented and falsely warranted the LiNA Xcise Morcellator as safe and effective for uterine surgeries of the type performed on Donna Burkhart. It did so in concert with LiNA ApS, which operated LiNA Medical and concerted its activities at all times material. 31. Ms. Burkhart had one or more large uterine fibroids which were a circumstance of and reason for her surgery. LiNA Medical, in conducting itself as described above, expressly warranted to her surgeon that the LiNA Xcise Morcellator is safe and effective for removing large uterine fibroids. It did so in concert with LiNA ApS, which operated LiNA Medical and concerted its activities at all times material. 32. Kebomed was created in or about 2010 by LiNA ApS, and Kebomed thereafter registered with FDA as an exporter, putatively because LiNA ApS owns and operates it to export the LiNA Xcise Morcellator to the U.S.A. According to one or more written agreements between Kebmed and LiNA Medical and Active Medical, Inc., Kebomed also supplies the device to medical providers in the Commonwealth of Pennsylvania, and it may have served that function at the time of the Burkhart surgery. If that is true, it did so in concert with LiNA Medical and with LiNA ApS, which operated Kebomed and LiNA Medical and concerted their activities at all times material. 33. LiNA ApS continues to own and operate Kebomed, directly or indirectly, and to concert its activities. On that basis, and for the reasons given above, the Plaintiff alleges that Kebomed initially imported and distributed the LiNA Xcise Morcellator used 9

10 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 10 of 32 in his Decedent's surgery. He does so pursuant to Fed.R.Civ.P. 20, because (a) the fact question of which entity -- LiNA Medical or Kebomed, if not both -- imported and distributed the device should be submitted at one time for determination, and (b) his right to relief against one or the other Defendant, if not both, arises out of the same transaction, occurrence, or series of transactions or occurrences, and questions of law and fact are common to the Defendants. 34. The Defendants, in informing Burkhart's surgeon about the LiNA Xcise Morcellator, did not inform him of the material and significant fact that in at least one in 350 cases, Ms. Burkhart s included, use of the morcellator would disseminate and fulminate a fatal but undetected and undetectable uterine cancer. That occurred in Ms. Burkhart's case, and she died from the cancer disseminated and fulminated by the device. 35. The Defendants, acting in concert as alleged, knew or should have known the material and significant fact that in at least one in 350 cases, Ms. Burkhart s included, use of the LiNA Xcise Morcellator would disseminate and fulminate a fatal but undetected and undetectable uterine cancer. The Defendants information to doctors about the device, including Ms. Burkhart's surgeon, promoted that risk and ensured harm to her by falsely and negligently misrepresenting the device safety and effectiveness. 36. The Defendants, acting in concert as alleged, knew or should have known that the LiNA Xcise Morcellator should have been designed and utilized at all times with a closed system to contain and extract tissue shredded by the device. They knew or 10

11 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 11 of 32 should have known that (a) the device is unsafe for use without containment of tissue fragments even when cancer is not suspected and detected by standard procedures prior to morcellation, and (b) in at least 1 in 350 cases, Ms. Burkhart s included, the device will disseminate and fulminate cancer which is not suspected and detected prior to the surgery. 37. The risk which materialized in Ms. Burkhart's case and killed her, namely dissemination and fulmination of fatal uterine cancer by the the LiNA Xcise Morcellator, would have been avoided had (a) the device been designed by LiNA ApS and made by it and LiNA Polska with a closed system to contain and extract tissue shredded by the device, or (b) the Defendants warned Ms. Burkhart's surgeon of the material and significant fact that in at least one in 350 cases, use of the device would disseminate and fulminate a fatal but undetected and undetectable uterine cancer. None of the Defendants took any of those actions. 38. The Defendants, acting in concert as alleged, intended to induce physicians, including Ms. Burkhart's surgeon, to order and use the device. It did so via the negligent and false information it conveyed to them, and by concealing from them the true risk to patients of using the morcellator. In so doing, they led doctors, including Ms. Burkhart's surgeon, to believe the device was safe when it was not. In so doing, they acted recklessly, wantonly, with gross negligence, and with outrageous and reckless disregard for human life and safety. 11

12 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 12 of Prior to the Burkhart uterine surgery on or about March 6, 2012, there was no evidence of disseminated and/or metastatic cancer/disease. Shortly after the surgery, on March 15th, she was informed that she had cancer. She died in March, 2013, as a result of it. She was 53 years old at the time of death. 40. All Defendants, acting in concert, failed to warn about the risk of disseminating and fulminating an undiagnosed sarcoma throughout the peritoneal cavity. That risk materialized in this case, killing Ms. Burkhart. 41. The Defendants were each aware of the risks, complications, and/or adverse events associated with their products used for uterine morecellation, specifically the LiNA Xcise Morcellator. 42. Each of the Defendants herein was acting as the agent, servant, workmen, and/or employee of the others with regard to the manufacturing and/or selling and/or supplying and/or marketing and/or distributing minimally invasive gynecological surgical products, specifically, the LiNA Xcise Morcellator used upon Decedent. 43. Upon information and belief, LiNA Medical was the agent, servant, workmen, and/or employee of each of the other Defendants for all marketing, distribution, sales, activities, conduct, transactions, business, distribution, and/or legal affairs within the U.S.A., including in the Commonwealth of Pennsylvania, specifically including, by way of example, obtaining a trademark for "Xcise" for LiNA ApS. 12

13 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 13 of The LiNA Xcise Morcellator used in the Burkhart uterine surgery is model number MOR It was supplied by the Defendants acting in concert as alleged, and they placed into the stream of commerce within the Commonwealth of Pennsylvania specifically for use at the hospital where the surgery occcurred. Counts COUNT I NEGLIGENCE SCOTT BURKHART, INDIVIDUALLY AND AS EXECUTOR OF THE ESTATE OF DONNA BURKHART, DECEASED, V. ALL DEFENDANTS 45. The paragraphs above are incorporated by reference hereto as if set forth at length. 46. The Defendants had duties to design the LiNA Xcise Morcellator in a manner making it safe for use, to adequately warn doctors about the device's risks to patients, including Donna Burkhart, and to otherwise convey truthful information about the device to doctors and thereby patients. They breached those duties, negligently and proximately causing injury to and the death of the Plaintiff's Decedent, resulting in actual loss and damage. 47. The Defendants, in acting in concert as alleged, undertook and voluntarily assumed specific duties to convey truthful information about the LiNA Xcise Morcellator, and the Decedent and her surgeon properly relied on their representations about the device. The Defendants breached those duties, negligently and proximately causing 13

14 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 14 of 32 injury to and the death of the Decedent, resulting in actual loss and damage, by failing to properly warn of the device's true risks and by falsely conveying that it was safe for use for the Decedent's surgery. The breaches profoundly increased the danger and risk to the Decedent. 48. The Defendants, in acting in concert as alleged, failed to convey, or misrepresented, one or more material facts under circumstances in which they knew or should have known the falsity of their representations. They did so with the intent to induce another to act on the information conveyed and after they failed to make a reasonable investigation of the truth of their words, resulting in injury and death of the Decedent, who acted in justifiable reliance on this information omitted from and misrepresented to her surgeon. 49. The Defendants owed a duty to manufacture, compound, label, market, distribute, and supply and/or sell products, including minimally invasive gynecologic products, including the LiNA Xcise Morcellator, used for uterine morcellation, in such a way as to avoid harm to persons upon whom they are used, such as Decedent herein, or to refrain from such activities following knowledge and/or constructive knowledge that such product is harmful to persons upon whom it is used. 50. Defendants owed a duty to warn of the hazards and dangers associated with the use of its products, specifically minimally invasive gynecologic products, including 14

15 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 15 of 32 the LiNA Xcise Morcellator, used for uterine morcellation, for patients such as Decedent herein, so as to avoid harm. 51. The Defendants, acting in concert as alleged, and by and through their authorized divisions, subsidiaries, agents, servants, and employees, were guilty of carelessness, recklessness, negligence, gross negligence and willful, wanton, outrageous and reckless disregard for human life and safety in manufacturing, designing, labeling, marketing, distributing, supplying and/or selling and/or placing into the stream of commerce, minimally invasive gynecologic products, including the LiNA Xcise Morcellator, used for uterine morcellation, both generally, and in the following particular respects: a. failing to conduct adequate and appropriate testing of minimally invasive gynecologic products, specifically including, but not limited to, the LiNA Xcise Morcellator, used for uterine morcellation; b. putting products used for uterine morcellation, including the LiNA Xcise Morcellator, on the market without first conducting adequate testing to determine possible side effects; c. putting products used for uterine morcellation, including the LiNA Xcise Morcellator, on the market without adequate testing of its dangers to humans; 15

16 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 16 of 32 d. failing to recognize the significance of their own and other testing of, and information regarding, products used for uterine morcellation, including the LiNA Xcise Morcellator, which testing evidenced such products potential harm to humans; e. failing to respond promptly and appropriately to their own and other testing of, and information regarding products used for uterine morcellation, including the LiNA Xcise Morcellator, which indicated such product s potential harm to humans; f. failing to promptly and adequately warn of the potential of the products used for uterine morcellation, including the LiNA Xcise Morcellator, to be harmful to humans in violation of Pennsylvania law; g. failing to promptly and adequately warn of the potential for the metastases of cancer when using products used for uterine morcellation, including the LiNA Xcise Morcellator, in violation of Pennsylvania law; h. failing to promptly, adequately, and appropriately recommend testing and monitoring of patients upon whom products used for uterine morcellation, including the LiNA Xcise Morcellator, in light of such product s potential harm to humans; i. failing to properly, appropriately, and adequately monitor the post-market performance of products used for uterine morcellation, including the LiNA Xcise Morcellator, and such product s effects on patients; j. concealing from the FDA, National Institutes of Health, the general medical community and/or physicians, their full knowledge and experience regarding the potential 16

17 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 17 of 32 that products used for uterine morcellation, including the LiNA Xcise Morcellator, are harmful to humans; k. promoting, marketing, advertising and/or selling products used for uterine morcellation, including the LiNA Xcise Morcellator, for use on patients given their knowledge and experience of such products potential harmful effects; l. failing to withdraw products used for uterine morcellation, including the LiNA Xcise Morcellator, from the market, restrict its use and/or warn of such product s potential dangers, given their knowledge of the potential for its harm to humans; m. failing to fulfill the standard of care required of a reasonable, prudent, minimally invasive gynecological surgical products company engaged in the manufacture of said products, specifically including the LiNA Xcise Morcellator, used for uterine morcellation; n. placing and/or permitting the placement of the products used for uterine morcellation, including the LiNA Xcise Morcellator, into the stream of commerce without warnings of the potential for said products to be harmful to humans and/or without properly warning of said product s dangerousness; o. failing to disclose to the medical community in an appropriate and timely manner, facts relative to the potential of the products used for uterine morcellation, including the LiNA Xcise Morcellator, to be harmful to humans; 17

18 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 18 of 32 p. failing to respond or react promptly and appropriately to reports of products used for uterine morcellation, including the LiNA Xcise Morcellator, causing harm to patients; q. disregarding the safety of users and consumers of products used for uterine morcellation, including Plaintiff s Decedent herein, under the circumstances by failing adequately to warn of said products, including the LiNA Xcise Morcellator s, potential harm to humans; r. disregarding the safety of users and consumers of the products used for uterine morcellation, to wit, the LiNA Xcise Morcellator, including Plaintiff s Decedent herein, and/or her physicians and/or hospital, under the circumstances by failing to withdraw said products from the market and/or restrict their usage; s. disregarding publicity, government and/or industry studies, information, documentation and recommendations, consumer complaints and reports and/or other information regarding the hazards of the products used for uterine morcellation, including the LiNA Xcise Morcellator, and their potential harm to humans; t. failing to exercise reasonable care in informing physicians and/or hospitals using the products used for uterine morcellation, including the LiNA Xcise Morcellator, about their own knowledge regarding said products potential harm to humans; u. failing to remove products used for uterine morcellation, including the LiNA Xcise Morcellator, from the stream of commerce; 18

19 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 19 of 32 v. failing to test products used for uterine morcellation, including the LiNA Xcise Morcellator, properly and/or adequately so as to determine its safety for use; w. failing to use due care under the circumstances; x. such other acts or omissions constituting negligence and carelessness as may appear during the course of discovery or at the trial of this matter y. promoting the products used for uterine morcellation, including the LiNA Xcise Morcellator, as safe and/or safer than other comparative methods of lesion removal; z. promoting the products used for uterine morcellation, including the LiNA Xcise Morcellator, on websites aimed at creating user and consumer demand; aa. failing to conduct and/or respond to post-marketing surveillance of complications and injuries resulting from products used for uterine morcellation, including the LiNA Xcise Morcellator; and bb. failing to design and manufacture the device with a closed system to contain and extract tissue shredded by it. 52. As a direct and proximate result of the negligent and/or reckless and/or wanton acts and/or omissions of Defendants, Plaintiff and/or Plaintiff s Decedent suffered serious injuries, death, and/or financial losses and harm. 19

20 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 20 of 32 COUNT II INTENTIONAL MISREPRESENTATION SCOTT BURKHART, INDIVIDUALLY AND AS EXECUTOR OF THE ESTATE OF DONNA BURKHART, DECEASED, V. ALL DEFENDANTS 53. The paragraphs above are incorporated by reference hereto as if set forth at length. 54. The Defendants, acting in concert, as alleged, misrepresented to Decedent and her surgeon the material risks of the LiNA Xcise Morcellator and did so with knowledge of the falsity of their communications or with recklessness as to whether the representations were true or false, with the intent of misleading Decedent and her surgeon into relying on the representations, which reliance was reasonable, proximately causing the injury and death alleged. 55. As a direct and proximate result of these acts, Plaintiff and/or Plaintiff s Decedent suffered serious injuries, death, and/or financial losses and harm. COUNT III - STRICT LIABILITY SCOTT BURKHART, INDIVIDUALLY AND AS EXECUTOR OF THE ESTATE OF DONNA BURKHART, DECEASED, V. ALL DEFENDANTS 56. The paragraphs above are incorporated by reference hereto as if set forth at length. 57. As a result of the unreasonably dangerous and defective condition of the products used for uterine morcellation, including the LiNA Xcise Morcellator, which 20

21 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 21 of 32 Defendants manufactured, designed, labeled, marketed, distributed, supplied and/or sold, and/or placed into the stream of commerce, they are strictly liable to the Plaintiff and Plaintiff s Decedent for their injuries and/or losses, specifically including Decedent s death, which they directly and proximately caused, based on the following: a. failing to properly and adequately design the products used for uterine morcellation; b. failing to properly and adequately manufacture the products used for uterine morcellation; c. failing to design and manufacture the LiNA Xcise Morcellator with a closed system to contain and extract tissue shredded by it; and d. such other defects as shall be revealed in the course of discovery. 58. In addition, the aforesaid incident and Plaintiff s and Decedent s injuries and losses were the direct and proximate result of Defendants manufacturing, designing, labeling, marketing, distributing, supplying and/or selling and/or placing into the stream of commerce the products used for uterine morcellation, including the LiNA Xcise Morcellator, without proper and adequate warnings regarding the potential for said product s harm to humans and as otherwise set forth supra, when said Defendants knew or should have known of the need for such warnings and/or recommendations. 59. As a direct and proximate result of the foregoing, Plaintiff and/or Plaintiff s Decedent suffered serious injuries, death, and/or financial losses and harm. 21

22 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 22 of 32 COUNT IV - BREACH OF EXPRESS WARRANTY SCOTT BURKHART, INDIVIDUALLY AND AS EXECUTOR OF THE ESTATE OF DONNA BURKHART, DECEASED, V. ALL DEFENDANTS 60. The paragraphs above are incorporated by reference hereto as if set forth at length. 61. In the advertising and marketing of the products used for uterine morcellation, including the LiNA Xcise Morcellator, which was directed to both physicians and hospitals and consumers, the Defendants warranted that said product or products, were safe for the use, which had the natural tendency to induce physicians and hospitals to use the same for patients and for patients to want to be treated with the same. That occurred in this case, when the Defendants, acting in concert as alleged, warranted to the Decedent's surgeon that the device was effective and safe for use, including for removal of large uterine fibroids, when in fact it was profoundly unsafe for such use in the absence of a closed containment system to prevent dissemination of undetected cancer. 62. The aforesaid warranties were breached by Defendants in that the products used for uterine morcellation, constituted a serious danger to the patient. 63. As a direct and proximate result of Defendants breach of express warranty, Plaintiff and/or Plaintiff s Decedent suffered serious injuries, including death, and financial losses and harm. 22

23 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 23 of At all times material and relevant hereto, Defendants had actual and/or constructive notice of the danger and defect at issue with regard to the same product, to wit, the LiNA Xcise Morcellator, from third parties, which actual and/or constructive notice provided Defendants with sufficient opportunity to cure the defect. COUNT V - WRONGFUL DEATH SCOTT BURKHART, INDIVIDUALLY AND AS EXECUTOR OF THE ESTATE OF DONNA BURKHART, DECEASED, V. ALL DEFENDANTS 65. The paragraphs above are incorporated by reference hereto as if set forth at length. 66. Plaintiff brings this Wrongful Death action on behalf of the beneficiaries, under and by virtue of the Acts of 1855, P.L. 309, as amended, 42 Pa.C.S.A. 8301, the applicable Rules of Civil Procedure and decisional law. 67. As a result of the negligence, wrongful conduct, and misconduct of Defendants, as set forth above, Decedent was caused grave injuries and death resulting in the entitlement to damages by said beneficiaries under the Wrongful Death Act. 68. Plaintiff claims damages for all administrator s expenses suffered by reason of the death of Decedent, including, but not limited to medical, hospital, funeral and burial expenses and expenses of estate administration and other expenses recoverable under the Wrongful Death Act. 23

24 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 24 of Plaintiff claims damages for loss of the monetary support that Decedent Donna Burkhart would have provided to beneficiaries during her lifetime, including, but not limited to earnings, maintenance, support, and other similar losses recognized under the Wrongful Death Act that they would have received from her for the rest of her natural life. 70. Plaintiff claims damages, under the Wrongful Death Act, for all pecuniary losses suffered by the beneficiaries. 71. Plaintiff claims, under the Wrongful Death Act, an amount to compensate beneficiaries for the losses of contribution between the time of death and today, and the amount of support that Decedent would have contributed to them in the future. 72. Plaintiff claims, under the Wrongful Death Act, damages for services provided or which could have been expected to have been provided in the future by Decedent, as well as household services. 73. Plaintiff claims, under the Wrongful Death Act, damages for loss of guidance, tutelage and other similar losses recognized under the Wrongful Death Act that would have been provided to the beneficiaries. 74. Plaintiff Scott Burkhart, as the husband of Decedent, claims, under the Wrongful Death Act, damages for his past and future loss of spousal consortium, services, society, support, guidance, tutelage, comfort and other similar losses recognized under the Wrongful Death Act. 24

25 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 25 of Plaintiff claims, under the Wrongful Death Act, the full measure of damages allowed under the law and under the categories of administrator s expenses, support and services as defined under the laws of the Commonwealth of Pennsylvania. COUNT VI SURVIVAL ACTION SCOTT BURKHART, INDIVIDUALLY AND AS EXECUTOR OF THE ESTATE OF DONNA BURKHART, DECEASED, V. ALL DEFENDANTS 76. The paragraphs above are incorporated by reference hereto as if set forth at length. 77. Plaintiff brings this Survival Action on behalf of the Estate of Decedent Donna Burkhart, under and by virtue of 42 Pa.C.S.A. 8302, the applicable Rules of Civil Procedure and decisional law. 78. The beneficiaries, as described above, are entitled to the entire distribution of the Estate of Decedent Donna Burkhart. 79. As a result of the negligence, wrongful conduct, and misconduct of all Defendants, as set forth above, Decedent was caused grave injuries and death resulting in the entitlement to damages by said beneficiaries under the Survival Act. 80. As a result of the death of Decedent, her Estate has been deprived of the economic value of her life expectancy and Plaintiff, Scott Burkhart, as Executor of the Estate of Donna Burkhart and/or her spouse, respectively, claim, under the Survival Act, damages for all pecuniary losses suffered by the Estate of Donna Burkhart as a result of 25

26 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 26 of 32 her death, including all loss of income, earnings, retirement income and benefits and Social Security income, until death, as a result of said Decedent s death. 81. Plaintiff further claims under the Survival Act the total amount that Decedent would have earned between today and the end of her life expectancy; Plaintiff especially seeks the total amount of future lost earning capacity, including, but not limited to the total amount of future lost earnings and earning capacity, including, but not limited to the total lost future net earnings for Decedent, less her cost of personal maintenance. 82. Plaintiff further claims under the Survival Act, damages for embarrassment, humiliation, and mental anguish. 83. Plaintiff further claims under the Survival Act damages for the conscious pain and suffering, and inconvenience endured by Decedent prior to her death, including, but not limited to physical pain and suffering, mental pain and suffering, and the fright and mental suffering attributed to the peril leading to said Decedent s death. 84. Plaintiff claims the full measure of damages under the Survival Act and decisional law interpreting said Act. COUNT VII BREACH OF IMPLIED WARRANTY SCOTT BURKHART, INDIVIDUALLY AND AS EXECUTOR OF THE ESTATE OF DONNA BURKHART, DECEASED, V. ALL DEFENDANTS 85. The paragraphs above are incorporated by reference hereto as if set forth at length. 26

27 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 27 of At all relevant and material times, Defendants manufactured, distributed, advertised, promoted, placed into the stream of commerce, and sold the foregoing products used for uterine morcellation, including the LiNA Xcise Morcellator. 87. At all relevant times, Defendants intended that the products used for uterine morcellation be used in the manner that the Decedent s surgeons in fact used it and Defendants impliedly warranted the product to be of merchantable quality, safe and fit for such use, and was adequately tested. 88. Defendants breached various implied warranties with respect to the products used for uterine morcellation, including: a. Defendants represented through their labeling, advertising, marketing materials, detail persons, seminar presentations, publications, notice letters, and regulatory submissions that the products used for uterine morcellation, including the LiNA Xcise Morcellator, were safe, and withheld and concealed information about the substantial risks of serious injury and/or death associated with using the products for uterine morcellation; b. Defendant represented that the products used for uterine morcellation, including the LiNA Xcise Morcellator, were as safe and/or safer than other alternative surgical approaches that did not include the use of the said products, and concealed information, which demonstrated that said products were not safer than alternatives available on the market; and, 27

28 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 28 of 32 c. Defendants represented that the products used for uterine morcellation, including the LiNA Xcise Morcellator, were more efficacious than other alternative surgical approaches and techniques and concealed information, regarding the true efficacy of said products. 89. In reliance upon Defendants implied warranty, Decedent s surgeons used said products as prescribed and in the foreseeable manner normally intended, recommended, promoted, instructed, and marketed by Defendant. 90. Defendants breached their implied warranty to Decedent in that said products used for uterine morcellation, including the LiNA Xcise Morcellator, were not of merchantable quality, safe and fit for their intended use, or adequately tested. 91. As a direct and proximate consequence of Defendants breach of implied warranty and/or intentional acts, omissions, misrepresentations and/or otherwise culpable acts described herein, the Plaintiff and Decedent sustained injuries and damages alleged herein including pain and suffering. 92. As a further direct and proximate result of the acts of Defendants, Plaintiffs suffered emotional distress and loss of consortium. 93. At all times material and relevant hereto, Defendants had actual and/or constructive notice of the defect at issues with regard to the same product, to wit, the LiNA Xcise Morcellator from third parties, which actual and/or constructive notice provided Defendants with sufficient opportunity to cure the defect. 28

29 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 29 of 32 PRAYER FOR RELIEF WHEREFORE, Plaintiff prays for relief as follows: 1. Compensatory damages in excess of the jurisdictional amount, including, but not limited to, damages for pain, suffering, emotional distress, loss of enjoyment of life, loss of life, wrongful death, loss of society, and other non-economic damages in an amount to be determined by a jury at trial of this action, to the utmost amount allowed by law; 2. Medical expenses and other economic damages in an amount to be determined by a jury at trial of this action; 3. All punitive damages allowed by law, to the utmost amount, to be determined by a jury at trial of this action; 4. Restitution and disgorgement of profits; 5. Reasonable attorneys' fees; 6. The costs of these proceedings; and 7. Such other and further relief as this Court deems just and proper. PLAINTIFF DEMANDS A TRIAL BY JURY OF ALL ISSUES Respectfully submitted by: /s/ H. Leon Aussprung, III, M.D. H. Leon Aussprung, III, M.D. I.D. No.:

30 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 30 of 32 /s/ James E. Hockenberry James E. Hockenberry I.D. No.: LAW OFFICE OF LEON AUSSPRUNG MD, LLC One Commerce Square, Suite Market Street Philadelphia, PA OF COUNSEL: W. Lewis Garrison, Jr. Brandy L. Robertson Christopher B. Hood William L. Bross, IV HENINGER GARRISON DAVIS LLC 2224 FIRST AVENUE NORTH BIRMINGHAM, AL François M. Blaudeau, MD JD FACHE FCLM Alabama Bar No D32F Southern Institute for Medical & Legal Affairs Of Counsel: HENINGER GARRISON DAVIS, LLC st Avenue North Birmingham, Alabama Phone: (205)

31 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 31 of 32 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA SCOTT BURKHART, Individually and ) as Executor of the Estate of Donna ) Burkhart, deceased, ) ) Plaintiff, ) ) v. ) ) LiNA MEDICAL USA, INC., et al., ) ) Defendants. ) CERTIFICATE OF SERVICE I, James E. Hockenberry, Esquire, as one of the attorneys for the Plaintiff, hereby certify that on this 3rd day of November, 2014, the foregoing Second Amended Complaint was filed with the Court and served on all counsel of record for the Defendants, via first class U.S. mail, correctly addressed, as set forth below, in accordance with Rule 5 of the Federal Rules of Civil Procedure: ERNEST FRANK KOSCHINEG CIPRIANI & WERNER, P.C. 450 SENTRY PARKWAY SUITE 200 BLUE BELL, PA ekoschineg@c-wlaw.com CAROLYN PURWIN CIPRIANI & WERNER, P.C. 450 SENTRY PARKWAY SUITE 200 BLUE BELL, PA cpurwin@c-wlaw.com 31

32 Case 5:14-cv EGS Document 56 Filed 11/03/14 Page 32 of 32 JESSICA HEINZ Cipriani & Werner, P.C. 450 Sentry Parkway Suite 200 Blue Bell, PA /s/ James E. Hockenberry James E. Hockenberry 32

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