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Medtronic Infuse Bone Graft Lawsuit

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Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 1 of 32


PATRICIA CAPLINGER, ) ) Plaintiff, ) ) v. ) Case No.

) MEDTRONIC, INC., a Minnesota ) corporation, and MEDTRONIC ) SOFAMOR DANEK USA, INC., ) a Tennessee corporation, ) ) Defendants. )

DePuy Pinnacle Hip Replacement Recall ImplantPlaintiff PATRICIA CAPLINGER ("Plaintiff'), for her claims against Defendants Medtronic,
Inc. and Medtronic Sofamor Danek USA, Inc., alleges and states the following:
1. Plaintiff Patricia Caplinger is an individual who is a resident of Lebanon, Missouri.
2. Defendant MEDTRONIC, INC. is a Minnesota corporation, with its principal place
of business at 710 Medtronic Parkway, Minneapolis, Minnesota 55432.
3. Defendant MEDTRONIC SOFAMOR DANEK USA, INC. is a Tennessee
corporation, with its principal place of business at 2600 Sofamor Danek Drive, Memphis, Tennessee
4. This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
§1332 because there is complete diversity of citizenship between Plaintiff and the Defendants, and
because Plaintiff alleges an amount in controversy in excess of $75,000, exclusive of interest and

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Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 2 of 32
5. This Court has personal jurisdiction over Defendants because at all relevant times
they have engaged in substantial and regular business activities in the State of Oklahoma and have
continuously and systematically conducted business in Oklahoma including the marketing, selling,
and promotion of the INFUSE® Bone graft product.
6. Venue is proper in this District pursuant to 28 U.S.C. § 139l(b)(1) because both
defendants are corporations deemed to reside in this district pursuant to 28 U.S.C. §1391( c)(2).
7. This case involves a spinal surgery in which a bio-engineered bone graft device
known as the Infuse® Bone Graft ("Infuse®") was used in a posterior-approach spine surgery for
Plaintiff, Patricia Caplinger.
8. Infuse® was made by MEDTRONIC, INC., and MEDTRONIC SOFAMOR DANEK,
USA, INC. (collectively "the Medtronic Defendants" or "Medtronic") and was promoted and sold
by Medtronic to be used off-label in Patricia Caplinger’s posterior lumbar interbody fusion (L5 - S1)
on August 25, 2010 in Missouri.
9. Infuse® is approved and indicated for lumbar surgery that is performed through the
abdomen (anterior). It is not approved for use in lumbar surgery through the back (posterior).When
Infuse® is used off-label, such as in a posterior-approach spine surgery, it often causes"ectopic" or
"exuberant" bone growth onto or around the spinal cord. When nerves are compressed by
ectopic/exuberant bone growth, a patient can experience, among other side effects, intractable pain,
weakness, and foot drop, as it did in Patricia Caplinger’s right leg and foot.
10. Medtronic either recklessly or intentionally minimized and/or downplayed the risks
of serious side effects related to the use of Infuse®, including but not limited to the risk of ectopic

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Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 3 of 32
or uncontrolled bone growth. According to articles in the June 2011 issue of The Spine Journal (an
international medical journal that publishes peer-reviewed research articles related to evidence-based
spine care), earlier Medtronic-sponsored studies and articles inaccurately reported the safety of
rhBMP-2 (the active fusion ingredient in Infuse®) by underestimating its risks.
11. For example, these Medtronic-sponsored articles omitted mention of adverse effects
seen in the earliest trials of Infuse®, such as uncontrolled or ectopic bone growth, inflammatory
reactions, adverse back and leg pain events, radiculitis, retrograde ejaculation, urinary retention, bone
resorption, and implant displacement. They also omitted mention of the risks of sterility and cancer
associated with rhBMP-2 use, as reported in Food and Drug Administration documents and hearings.
12. The actual rate of incidence of these serious side effects is much greater than the rate
disclosed by Medtronic or these Medtronic-sponsored studies to physicians or to the public. With
respect to posterior lumbar interbody fusion-which Plaintiff Patricia Caplinger underwent-Medtronic
failed to disclose significant risks that it knew of or should have known of, including ectopic bone
formation, radiculitis, osteolysis, and worse overall outcomes.
13. Because of Medtronic's wrongful conduct, hundreds of patients, like Patricia
Caplinger, underwent surgeries without knowing the risks created by off-label use of Infuse®.These
patients' doctors were persuaded by Medtronic and Medtronic' s consultant "opinion leaders," who
are paid physician promoters, and Medtronic sales representatives, to use Infuse® for dangerous off-
label uses such as posterior lumbar fusion surgery.
14. As a result of her off-label, posterior-approach Infuse® spine surgery, Patricia
Caplinger suffered severe bodily injuries and lost income. She has also suffered a foot drop condition
which resulted in a torn anterior cruciate ligament in her right knee which required surgery. She has

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Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 4 of 32
required a September 9, 2011 revision surgery for the resulting exuberant bone growth and will
require additional revision surgeries. She has also incurred a significantly higher risk of cancer.
15. Because of her off-label surgery using Infuse®, Patricia Caplinger has been forced
to take significant time off of work, and has great difficulty working. She suffers continuous pain
in her back and legs from everyday activities.
A. The Infuse® Bone Graft Device
16. Medtronic designed and marketed Infuse® for lumbar spine fusion surgery.
17. Infuse® is a bio-engineered bone filling material containing a bone morphogenetic
protein ("BMP"), and is used as an alternative to grafting a patient's own bone, typically from the
patient's hip. The purpose of Infuse® is to accomplish the same clinical outcomes as grafting a
patient's own bone into these locations but without the difficulties of grafting bone from the hip and
other sites, since grafting sites sometimes have side effects such as pain.
18. It uses a genetically engineered protein - rhBMP -to help fuse vertebrae in the lower
(lumbar) spine in order to treat degenerative disc disease.
19. The device consists of three components split among two parts: (1) a metallic spinal
fusion cage; and, (2) the bone graft substitute which consists of a genetically-engineered human
protein (rhBMP-2) along with a sponge-like carrier or scaffold for the protein (manufactured from
bovine collagen) that is placed inside the fusion cage.
20. The fusion cage component maintains the spacing and temporarily stabilizes the
diseased region of the spine, while the Infuse® bone graft component is used to form bone, which
is intended to permanently stabilize (fuse) this portion of the spine.

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Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 5 of 32
21. During surgery, rhBMP-2 is soaked onto and binds with the absorbable collagen
sponge that is designed to resorb, or disappear, over time. As the sponge dissolves, the rhBMP-2
stimulates the cells to produce new bone.
B. Background on Bone Morphogenetic Proteins in the Infuse® Bone Graft
22. The active ingredient in the INFUSE® Bone Graft is rhBMP-2, a genetically modified
version of protein already present in the human body that promotes new bone growth.
23. Certain BMPs have been studied for decades because of their ability to heal bone and
eliminate the need for bone graft harvesting from other parts of the body. Approximately twenty (20)
BMPs have been discovered, but only six appear capable of initiating bone growth. Of these,
rhBMP-2 has been studied more than any other BMP and is FDA-approved for use only in the lower
(lumbar) spine, some types of tibia fractures, an some dental surgeries.
24. Naturally-occurring BMP is found within the bone itself, but only in small amounts.
To provide clinically useful and reproducible amounts of isolated, human BMP, it must be
genetically modified in a special facility.
25. Scientists isolated the gene for one protein (BMP-2) from bone tissue and used
molecular biology techniques to create genetically engineered cells. These cells then produce large
quantities of rhBMP-2.
C. The FDA Approval Process
26. Infuse® was approved by the United States Food and Drug Administration ("FDA")
on July 2, 2002, for use only in the lower, or lumbar, region of the spine (at levels L4 through S 1)
to treat degenerative disc disease, and was approved only for anterior-approach surgeries at L4
through S 1. That meant that it was initially approved only to be used by surgeons in spinal fusions

Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 6 of 32

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when going in through the patient's abdomen.
27. Infuse® is also used to fill space where bone is needed in order to place dental
implants (for example, dental implants with an exposed head used to secure dental devices such as
crowns, fixed bridges, or dentures.) In dental surgeries, Infuse® is used to make enough bone in the
sinus area to place dental implants in the upper jaw. Infuse® is also used to increase bone in
extraction sites prior to implant placement.
28. Infuse® was approved by the FDA on March 9, 2007, for dental use.
29. In addition to use in lower spine fusion surgeries and dental surgeries, Infuse® has
been approved for only one other use: repair of certain tibial fractures.
30. Infuse® has never been approved by the FDA for use in other parts of the body or for
use in any other type of procedure. Any such uses are "off-label" uses.
31. Physicians may use FDA-approved medical devices in any way they see fit, but
companies are not permitted to promote off-label uses for their medical devices or to pay doctors
inducements or kickbacks to promote off-label uses or to perform procedures using the devices off-
32. The use of Infuse® for posterior lumbar fusion surgery has never been approved by
the FDA, and the use of this product through a posterior approach is an off-label use.
D. Infuse® is a Very Profitable Part of Medtronic's Business
33. Infuse® has become a best seller for Medtronic. One market analyst has publicly
estimated that the product's sales were approximately $815 million for the fiscal year ending in April
2008. Medtronic has been depending heavily on Infuse® since sales in so many of its other products,
such as cardiac defibrillators, have slowed because of the recalls of those defective defibrillators.

Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 7 of 32
E. Off-Label Use of Infuse® in the Lumbar Spine is Not Safe or Effective
34. Questions about off-label use cropped up before the product was approved. For
example, in early 2002, one member of an FDA advisory committee reviewing Infuse® asked agency
staff for recommendations on "guarding against off-label use of this product."
35. A number of patients say they have been harmed in off-label uses of Infuse®, which
is approved by the FDA only for anterior-approach surgery in a small section of the spine in the
lower, or lumbar, region. At least 280 reports of adverse events involving Infuse® have been made
to the FDA. Approximately 75% of those reports involve off-label use.

F. Despite Lack of Safety and Effectiveness, Medtronic Improperly Promoted and Marketed to Physicians the Off-Label Use of Infuse® Through a Posterior Approach

36. Medical device companies look for surgeons who are known as "Opinion Leaders"
and who will use a high volume of their devices. Opinion leaders are physicians whose opinions on
medical procedures and medical devices are held in high regard. If these influential physicians are
willing to promote the use of a certain device, then other surgeons are likely to follow suit and use
that device, sometimes including the improper promotion of off-label uses.
37. Many medical device companies, including Medtronic, cultivate relationships with
these opinion leaders, paying them handsome (and in the case of Infuse®, sometimes seven figure)
consulting fees, travel expenses for seminars, and other perks, to encourage these physicians to
promote the use of a particular medical device.
38. Not only did Medtronic engage in such activities with respect to Infuse®, it
improperly paid doctors to promote, both directly and indirectly, the off-label use of Infuse® through
the posterior and lateral approaches in lumbar spine fusions.

Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 8 of 32
39. The Wall Street Journal, for example, has reported that Timothy Kuklo, M.D., while
an orthopedic surgeon at Walter Reed Army Hospital, submitted an article to a British medical
journal with fabricated claims of the efficacy of Infuse® and forged the signatures of four "co-
authors." Medtronic confirmed that Dr. Kuklo was a paid consultant for Medtronic and that the
company has paid him over $800,000.
USA, INC., have been named as defendants in two prior qui tam actions, United States ex ref.
(UNDER SEAL) v. Medtronic. Inc., et al., Civil Action No. 02-2709 (W. D. Tenn.), and United
States ex rel. Poteet v. Medtronic, Inc., et al., Civil Action No. 03-2979 (W. D. Tenn.) (collectively
the "qui tam lawsuits"), both of which allege that Medtronic violated the False Claims Act, 31
U.S.C. § 3729, et seq., by paying illegal kickbacks to certain physicians in connection with
promoting the off-label use of Infuse® in the spine, which resulted in the submission of false or
fraudulent claims to federal health care programs.
41. In these lawsuits, the United States Department of Justice ("DOJ") contends that
between January 1, 1998 and April 30, 2003, Medtronic made payments and provided other
remuneration to a number of physicians and entities in connection with its spinal products in the
form of ( 1) payments and other remuneration for physicians' attendance and expenses at medical
education events, "think tanks", YIP/opinion leader events, and meetings at resort locations; (2)
services and payments for services to physicians through Medtronic's Healthcare Economic Services
and eBusiness Departments; and (3) payments made pursuant to consulting, royalty, fellowship and
research agreements with various physicians and entities.

Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 9 of 32
42. Based on its investigation, the DOJ contends that certain of the payments, services,
and remuneration mentioned above were improper and resulted in the submission of false or
fraudulent claims.
43. In July 2006, Medtronic agreed to pay $40 million to the United States of America
to settle these lawsuits under the False Claims Act, 31 U.S.C. §§ 3729-3733, the Civil Monetary
Penalties Law, 42 U.S.C. § 1320a-7a, and the Program Fraud Civil Remedies Act, 31 U.S.C. §§
44. As a result of this settlement, Medtronic and Medtronic Sofamor Danek agreed to
enter into a Corporate Integrity Agreement with the Department of Health and Human Services
Office of Inspector General.
45. Also, as a result of this settlement, Medtronic agreed to negotiate with representatives
of the National Association of Medicaid Fraud Control Units to reach an agreement that provides
for distribution of certain sums to the several states with which Medtronic agreed to a settlement
concerning the conduct at issue in the lawsuits.
46. Despite its 2006 settlement with the DOJ, and on information and belief, Medtronic
has continued from 2006 to the present to improperly and illegally promote the off label use of
Infuse® in non-FDA-approved spine surgeries.

G. September 30,2008 Letters from United States Senators Herb Kohl and Charles Grassley to Medtronic Regarding Ongoing Concerns over Medtronic's Payments to Doctors Related to the Promotion and Marketing of Infuse®

47. Despite this July 2006 Settlement with the DOJ, concerns regarding Medtronic's off-
label marketing activities and related payments to doctors continued.

Case 5:12-cv-00630-M Document 1 Filed 06/04/12 Page 10 of 32
48. On September 30, 2008, U.S. Senator Herb Kohl sent a letter to Medtronic noting that
earlier in 2008, Medtronic' s outside counsel provided to the Special Committee on Aging a written
account of Medtronic's efforts to comply with the July 2006 Settlement Agreement it reached with
the DOJ concerning allegations that Medtronic and its subsidiary improperly compensated surgeons
and physicians in connection with the Infuse® device.
49. Senator Kohl's letter expressed several concerns, including the following:

That account also addressed the corporate integrity agreement (CIA) that Medtronic and its subsidiary entered into with the Office of the Inspector General of the United States Department of Health and Human Services stemming from those same allegations. In that same letter to the Committee, Medtronic and its subsidiary both denied that "improper payments were made to physicians in the first place (Medtronic's agreement with DOJ does not contain any admission of liability), much less that improper payments 'have continued.''' Consequently, it was with concern that I read recent articles, in the Wall Street Journal and elsewhere, which outlined highly disturbing allegations of improper, if not illegal, payments by Medtronic to surgeons and physicians. These continuing allegations are directly relevant to the Committee's oversight of inappropriate physician compensation practices within the medical device industry. All of the major orthopedic device companies that settled with DOJ over such allegations were required to publicly reveal information related to their payments to physicians. Medtronic's response to the Committee's initial inquiry articulated no specific reasons as to why Medtronic has yet to voluntarily make the same disclosures.

50. In this letter, Senator Kohl requested both documentation of Medtronic's efforts
to comply with the July 2006 Settlement Agreement and interviews with corporate witnesses and
documents "given the ongoing, serious concerns publicly raised regarding the integrity and
transparency of Medtronic' s physician compensation practices."
51. Senator Kohl also asked Medtronic to explain "the circumstances that led Medtronic's
former counsel to file suit against the company [alleging improper payments to physicians] and how
that matter was subsequently settled."

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