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Gadolinium Lawyers File Nephrogenic Systemic Fibrosis (NSF) lawsuit

Posted in Misc. Drugs

This lawsuit was filed in November of 2008 and alleges that Scott Smiley died after contracting NSF:

8. At all times relevant hereto, Defendants knew or should have known about the significant risk of gadolinium-based contrast agents administered to patients with renal insufficiency, including but not limited to the risk of NSF/NFD in the skin and other body organs.

9. NSF/NFD has been reported in medical literature for at least the last decade.

10. Prior to a decade ago, the group of symptoms now known as NSF/NFD had been variously described as scleromyxedema, scleroderma, or other connective tissue diseases. Regardless of the name ascribed to it, however, it has always been the case that this clinical entity now known as NSF/NFD develops only in patients with renal insufficiency who have been given an injection of gadolinium-type contrast agent.

11. NSF/NFD is predominantly characterized by discoloration, thickening, tightening, and swelling of the skin within days or weeks after receiving a gadolinium-based contrast injection. These fibrotic and edematous changes produce muscular weakness and inhibit flexion and extension of joints, resulting in contractures. NSF/NFD often progresses to painful inhibition of the ability to use the arms, legs, hands, feet, and other joints. The skin changes that begin as darkened patches or plaques progress to a "woody" texture and are accompanied by burning, itching, or severe pain in the areas of involvement. NSF/NFD also progresses to a fibrotic or scarring condition of other body organs such as the lungs, heart, liver, and musculature. This scarring can inhibit the ability of body organs to function properly and may lead to death. NSF/NFD is a progressive disease as to which there is no known cure.

12. NSF/NFD has been reported thus far only in people whose kidney function was compromised at the time of injection with gadolinium containing contrast solution.

13. NSF/NFD did not exist until gadolinium containing contrast solutions came into use for enhancing MRI and MRA scans.

14. At all times relevant hereto, Defendants and/or their corporate predecessors knew or should have known about the significant health risk of their gadolinium -based magnetic resonance contrast media being administered to patients with renal insufficiency, including but not limited to the risk of nephrogenic fibrosis in the skin and other body organs.

15. Defendants and/or their corporate predecessors consistently failed to warn consumers and/or their health care providers that NSF/NFD could result when their gadolinium-based magnetic resonance contrast media products were administered to patients with renal insufficiency.

16. During the years that Defendants and/or their corporate predecessors manufactured, marketed, and sold their respective gadolinium-based magnetic resonance contrast media products, there were numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of certain gadolinium-based contrast agents, including Defendants' and/or their corporate predecessors'
gadolinium-based magnetic resonance contrast media products. Despite this, Defendants and/or their corporate predecessors repeatedly failed to adequately revise their package inserts, Material Safety Data Sheets, and other product-related literature, and to conduct appropriate post-marketing communications in order to convey adequate warnings.

17. Defendants and/or their corporate predecessors repeatedly and consistently failed to advise consumers and/or their health care providers of the causal relationship between their gadolinium-based magnetic resonance contrast media and NSF/NFD in patients with renal insufficiency.

18. Defendants and/or their corporate predecessors failed to take prompt, reasonable, and effective measures to alert the appropriate members of the health care community and its patients, including but not limited to renal patients, nephrologists and other physicians, radiologists, administrators, technicians, and hospital/radiology supply personnel, to the serious adverse health risks presented by administration of their gadolinium-based magnetic resonance contrast media.

United States District Court, S.D. Indiana.

    Indianapolis Division

    Jill A. Smiley, Individually and As Personal Representative for the Estate of
Scott D. Smiley Plaintiffs,

v.

  General Electric Company; Ge Healthcare, Inc.; Ge Healthcare Bio-sciences Corp.;
   General Healthcare As, a/k/a Ge Healthcare As Bayer Healthcare Pharmaceuticals,
 Inc., f/k/a Berlex Inc., f/k/a Berlex Laboratories, Inc. Bayer Schering Pharma AG,
  f/k/a Schering AG; Mallin, Inc.; Tyco Healthcare Group, LP; Covidien; and Bracco
    Diagnostics Inc. Defendants.

   No. 08CV01534.

November 13, 2008.

Complaint and Demand for Jury Trial

Cohen & Malad, LLP, Jeff S. Gibson, One Indiana Square Suite 1400, Indianapolis,
in 46204, Telephone: (317) 636-6481, Facsimile: (317) 636-2593, Attorneys for
Plaintiffs.Of Counsel:, Janet, Jenner & Suggs, Llc, Robert K. Jenner, John J. Cord
, 1829 Reisterstown Road, Suite 320, Baltimore, Maryland 21208, Telephone: (410)
653-3200, Facsimile: (410) 653-6903.Pogust, Braslow & Millrood, LLC, Tobias L.
Millrood, Derek T. Braslow, Robert N. Wilkey, 8 Tower Bridge, Suite 1520, 161
Washington Street, Conshohocken, Pennsylvania 19428, (610) 941-4204, (610)
941-4245 (Fax).

NOW COME the Plaintiffs, Jill A. Smiley, Individually and as Personal
Representative for the Estate of Scott D. Smiley, by and through counsel, Cohen &
Malad, LLP, Janet, Jenner & Suggs, LLC and Pogust Braslow & Millrood, LLC, and for
their causes of action, sue the Defendants and allege and aver as follows:

  PREAMBLE

 Gadolinium is an injected substance used to help patients and doctors receive
optimum results from Magnetic Resonance Imaging (MRI) tests. It is a
non-radioactive chemical that acts as a contrast agent, so when it is absorbed by
the patient's unhealthy or damaged tissue, the affected areas show up as bright
areas on the MRI scans, making it easier for doctors to diagnose the patient's
medical condition.

Patients with kidney insufficiency who receive gadolinium-based agents are at risk
for developing a debilitating, and a potentially fatal disease known as
Nephrogenic Systemic Fibrosis ("NSF"), also known as Nephrogenic Fibrosing
Dermopathy ("NFD"). Patients with NSF/NFD develop thickening of the skin and
connective tissues that severely inhibits their ability to move and may result in
broken bones. Other organs are at risk of thickening as well. There is no
consistently effective treatment for the condition of NSF/NFD.

The Defendant manufacturers of Gadolinium were aware of the dangers associated
with gadolinium before their contrast dye was introduced to the market. The
manufacturers failed to warn the Scott D. Smiley or his physicians about this risk
of gadolinium-based agents to people with preexisting kidney damage. The
Defendants knowingly and recklessly left the defective product on the market to be
given to unsuspecting patients when safer alternatives were available. Because of
Scott D. Smiley's exposure to gadolinium-containing contrast agents, the he
developed NSF, and sustained fatal, disabling, and horrific injuries.

STATEMENT OF FACTS

   A. Case Specific Facts

1. Scott D. Smiley was administered varying dosages of injected gadolinium-based
contrast dye in conjunction with MRIs/MRAs.

2. Scott D. Smiley had renal insufficiency before, during and after his ingestion
of gadolinium based contrast agents.

3. As a result of being administered gadolinium, Scott D. Smiley contracted
NSF/NFD.

4. As a further direct and proximate cause of being administered gadolinium based
contrast agents and contracting NSF/NFD, Plaintiff Scott D. Smiley suffered
injuries, including but not limited to the following:

a. Significant scarring and thickening of the skin;

b. Swelling of affected parts of his body;

c. Itchiness, dryness and flaking of the skin over affected parts of his body;

d. Loss of reliable use of his legs, and inability to walk for normal distances
without resting;

e. Inability to stand;

f. Sleeplessness;

g. Pain in his body;

h. Inability to work; and

i. Death

5. As a further direct and proximate cause of receiving gadolinium and developing
NSF/NFD, the Scott D. Smiley and his estate suffered and continues to suffer
untold injuries, disfiguration, pain, suffering, mental anguish, loss of wages,
health care costs, death and other damages.

6. As a further direct and proximate cause of receiving gadolinium and developing
NSF/NFD, the Scott D. Smiley suffered and therefore claims a loss of life's
enjoyment, including but not limited to compensation for the loss of Plaintiff's
ability to enjoy any of the pleasures of life as a result of his injuries.

7. As a further direct and proximate cause of receiving gadolinium and developing
NSF/NFD, Scott D. Smiley's wrongful death beneficiaries suffered damages pursuant
to Ind. Code s 34-23-1-1.

  B. General Facts

8. At all times relevant hereto, Defendants knew or should have known about the
significant risk of gadolinium-based contrast agents administered to patients with
renal insufficiency, including but not limited to the risk of NSF/NFD in the skin
and other body organs.

9. NSF/NFD has been reported in medical literature for at least the last decade.

10. Prior to a decade ago, the group of symptoms now known as NSF/NFD had been
variously described as scleromyxedema, scleroderma, or other connective tissue
diseases. Regardless of the name ascribed to it, however, it has always been the
case that this clinical entity now known as NSF/NFD develops only in patients with
renal insufficiency who have been given an injection of gadolinium-type contrast
agent.

11. NSF/NFD is predominantly characterized by discoloration, thickening,
tightening, and swelling of the skin within days or weeks after receiving a
gadolinium-based contrast injection. These fibrotic and edematous changes produce
muscular weakness and inhibit flexion and extension of joints, resulting in
contractures. NSF/NFD often progresses to painful inhibition of the ability to use
the arms, legs, hands, feet, and other joints. The skin changes that begin as
darkened patches or plaques progress to a "woody" texture and are accompanied by
burning, itching, or severe pain in the areas of involvement. NSF/NFD also
progresses to a fibrotic or scarring condition of other body organs such as the
lungs, heart, liver, and musculature. This scarring can inhibit the ability of
body organs to function properly and may lead to death. NSF/NFD is a progressive
disease as to which there is no known cure.

12. NSF/NFD has been reported thus far only in people whose kidney function was
compromised at the time of injection with gadolinium containing contrast solution.

13. NSF/NFD did not exist until gadolinium containing contrast solutions came into
use for enhancing MRI and MRA scans.

14. At all times relevant hereto, Defendants and/or their corporate predecessors
knew or should have known about the significant health risk of their gadolinium
-based magnetic resonance contrast media being administered to patients with renal
insufficiency, including but not limited to the risk of nephrogenic fibrosis in
the skin and other body organs.

15. Defendants and/or their corporate predecessors consistently failed to warn
consumers and/or their health care providers that NSF/NFD could result when their
gadolinium-based magnetic resonance contrast media products were administered to
patients with renal insufficiency.

16. During the years that Defendants and/or their corporate predecessors
manufactured, marketed, and sold their respective gadolinium-based magnetic
resonance contrast media products, there were numerous case reports, studies,
assessments, papers, and other clinical data that have described and/or
demonstrated NSF/NFD in connection with the use of certain gadolinium-based
contrast agents, including Defendants' and/or their corporate predecessors'
gadolinium-based magnetic resonance contrast media products. Despite this,
Defendants and/or their corporate predecessors repeatedly failed to adequately
revise their package inserts, Material Safety Data Sheets, and other
product-related literature, and to conduct appropriate post-marketing
communications in order to convey adequate warnings.

17. Defendants and/or their corporate predecessors repeatedly and consistently
failed to advise consumers and/or their health care providers of the causal
relationship between their gadolinium-based magnetic resonance contrast media and
NSF/NFD in patients with renal insufficiency.

18. Defendants and/or their corporate predecessors failed to take prompt,
reasonable, and effective measures to alert the appropriate members of the health
care community and its patients, including but not limited to renal patients,
nephrologists and other physicians, radiologists, administrators, technicians, and
hospital/radiology supply personnel, to the serious adverse health risks presented
by administration of their gadolinium-based magnetic resonance contrast media.

    C. Federal Standards and Requirements

19. The Defendants, upon information and belief, have or may have failed to comply
with all federal standards and requirements applicable to the sale of their
contrast dye Omniscan and Magnevist(R), including, but not limited to, one or more
of the following violations:

a. The Defendants' contrast dye is adulterated pursuant to 21 U.S.C. s 351
because, among other things, it fails to meet established performance standards,
and/or the methods, facilities, or controls used for its manufacture, packing,
storage or installation are not in conformity with federal requirements. See 21
U.S.C. s351.

b. The Defendants' contrast dye is adulterated pursuant to 21 U.S.C. s 351
because, among other things, its strength differs from or its quality or purity
falls below the standard set forth in the official compendium for the drug and
such deviation is not plainly stated on its label.

c. The Defendants' contrast dye is misbranded pursuant to 21 U.S.C. s352 because,
among other things, the labeling is false or misleading.

d. The Defendants' contrast dye is misbranded pursuant to 21 U.S.C. s352 because
words, statements, or other information required by or under authority of chapter
21 U.S.C. s 352 are not prominently placed thereon with such conspicuousness and
in such terms as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.

e. The Defendants' contrast dye is misbranded pursuant to 21 U.S.C. s352 because
the labeling does not bear adequate directions for use, and/or the labeling does
not bear adequate warnings against use in those pathological conditions or by
children where its use may be dangerous to health or against unsafe dosage or
methods or duration of administration or application, in such manner and form as
is necessary for the protection of users.

f. The Defendants' contrast dye is misbranded pursuant to 21 U.S.C. s352 because
it is dangerous to health when used in the dosage or manner, or with the frequency
or duration prescribed, recommended, or suggested in the labeling thereof.

g. The Defendants' contrast dye does not contain adequate directions for use
pursuant to 21 CFR s 201.5, because, among other reasons, of omission, in whole or
in part, or incorrect specification of (a) statements of all conditions, purposes,
or uses for which it is intended, including conditions, purposes, or uses for
which it is prescribed, recommended or suggested in their oral, written, printed,
or graphic advertising, and conditions, purposes, or uses for which the drug is
commonly used, (b) quantity of dose, including usual quantities for each of the
uses for which it is intended and usual quantities for persons of different ages
and different physical conditions, (c) frequency of administration or application,
(d) duration or administration or application, and/or (d) route or method of
administration or application.

h. The Defendants violated 21 CFR s 201.56 because the labeling was not
informative and accurate.

i. The Defendants' contrast dye is misbranded pursuant to 21 CFR s 201.56 because
the labeling was not updated as new information became available that caused the
labeling to become inaccurate, false, or misleading.

j. The Defendants violated 21 CFR s 201.57 by failing to provide information that
is important to the safe and effective use of the drug including degree and rate
of absorption, pathways of biotransformation, percentage of dosage as unchanged
drug and metabolites, rate or half-time of elimination, concentration in body
fluids associated with therapeutic and/or toxic effects, degree of binding to
plasma proteins and/or the degree of update by a particular organ.

k. The Defendants violated 21 CFR s 201.57 because evidence was only available to
support the safety and effectiveness of the drug in selected subgroups of the
larger population with a disease, syndrome, or symptom and the labeling failed to
describe the available evidence and state the limitations of usefulness of the
drug.

1. The Defendants violated 21 CFR s 201.57 because they failed to identify
specific tests needed for selection or monitoring of patients who took the
contrast dye.

m. The Defendants violated 21 CFR s 201.57 because the safety considerations
regarding the contrast dye is such that the drug should be reserved for certain
situations, and the Defendants failed to state such information.

n. The Defendants' contrast dye is mislabeled pursuant to 21 CFR s 201.57 because
the labeling fails to describe serious adverse reactions and potential safety
hazards, limitations in use imposed by them, and steps that should be taken if
they occur.

o. The Defendants' contrast dye is mislabeled pursuant to 21 CFR s 201.57 because
the labeling was not revised to include a warning as soon as there was reasonable
evidence of an association of a serious hazard with the drug.

p. The Defendants violated 21 CFR s 201.57 because the labeling failed to list the
adverse reactions that occur with the contrast dye and other drugs in the same
pharmacologically active and chemically related class.

q. The Defendants violated 21 CFR s 201.57 because the possibility that a patient
could develop NSF/NFD is significantly more severe than the other reactions listed
in the adverse reactions, and yet the Defendants failed to list the development of
NSF/NFD before the other adverse reactions on the labeling of the contrast dye.

r. The Defendants' contrast dye is mislabeled pursuant to 21 CFR s 201.57 because
the labeling does not state the recommended usual dose, the usual dosage range,
and, if appropriate, an upper limit beyond which safety and effectiveness has not
been established.

s. The Defendants' contrast dye violates 21 CFR s 210.1 because the process by
which it is manufactured, processed, and/or held fails to meet the minimum current
good manufacturing practice of methods to be used in, and the facilities and
controls to be used for, the manufacture, packing, or holding of a drug to assure
that it meets the requirements as to safety and have the identity and strength and
meets the quality and purity characteristic that it is purported or is represented
to possess.

t. The Defendants' contrast dye violates 21 CFR s 210.122 because the labeling and
packaging materials does not meet the appropriate specifications.

u. The Defendants' contrast dye violates 21 CFR s 211.165 because the test methods
employed by the Defendants are not accurate, sensitive, specific, and/or
reproducible and/or such accuracy, sensitivity, specificity, and/or
reproducibility of test methods have not been properly established and documented.

v. The Defendants' contrast dye violates 21 CFR s 211.165 in that the contrast dye
fails to meet established standards or specifications and any other relevant
quality control criteria.

w. The Defendants' contrast dye violates 21 CFR s 211.198 because the written
procedures describing the handling of all written and oral complaints regarding
the contrast dye were not followed.

x. The Defendants' contrast dye violates 21 CFR s 310.303 in that the contrast dye
is not safe and effective for its intended use.

y. The Defendants violated 21 CFR s 310.303 because the Defendants failed to
establish and maintain records and make reports related to clinical experience or
other data or information necessary to make or facilitate a determination of
whether there are or may be grounds for suspending or withdrawing approval of the
application to the FDA.

z. The Defendants violated 21 CFR ss310.305 and 314.80 by failing to report
adverse events associated with the contrast dye as soon as possible or at least
within 15 days of the initial receipt by the Defendants of the adverse drug
experience.

aa. The Defendants violated 21 CFR s s310.305 and 314.80 by failing to conduct an
investigation of each adverse event associated with the contrast dye, and
evaluating the cause of the adverse event.

bb. The Defendants violated 21 CFR ss310.305 and 314.80 by failing to promptly
investigate all serious, unexpected adverse drug experiences and submit follow-up
reports within the prescribed 15 calendar days of receipt of new information or as
requested by the FDA.

cc. The Defendants violated 21 CFR ss310.305 and 314.80 by failing to keep records
of the unsuccessful steps taken to seek additional information regarding serious,
unexpected adverse drug experiences.

dd. The Defendants violated 21 CFR ss310.305 and 314.80 by failing to identify the
reports they submitted properly, such as by labeling them as "15-day Alert r or
"15-day Alert report follow-up."

ee. The Defendants violated 21 CFR s 312.32 because they failed to review all
information relevant to the safety of the contrast dye or otherwise received by
the Defendants from sources, foreign or domestic, including information derived
from any clinical or epidemiological investigations, animal investigations,
commercial marketing experience, reports in the scientific literature, and
unpublished scientific papers, as well as reports from foreign regulatory
authorities that have not already been previously reported to the agency by the
sponsor.

ff. The Defendants violated 21 CFR s 312.32 because they failed to notify the FDA
in a written IND safety report of the adverse experiences associated with the use
of the contrast dye that was serious and unexpected.

gg. The Defendants violated 21 CFR s 314.80 by failing to report adverse drug
experiences at quarterly intervals for three (3) years from the date of approval
of the application, and then at annual intervals.

hh. The Defendants violated 21 CFR s 314.80 by failing to provide periodic reports
to the FDA containing (a) a narrative summary and analysis of the information in
the report and an analysis of the 15-day Alert reports submitted during the
reporting interval, (b) an Adverse Reaction Report for each adverse drug
experience not already reported under the Post marketing 15-day Alert report,
and/or (c) a history of actions taken since the last report because of adverse
drug experiences (for example, labeling changes or studies initiated).

ii. The Defendants violated 21 CFR s 314.80 by failing to submit a copy of the
published article from scientific or medical journals along with one or more
15-day Alert reports based on information from the scientific literature.

THE PARTIES

Plaintiffs

20. Plaintiff Jill A. Smiley is an individual residing in Brownsburg, Indiana. She
was a citizen and resident of Indiana and married to Scott D. Smiley at all times
relevant to the events giving rise to the cause of action alleged in this
complaint.

21. Plaintiff Jill A. Smiley has been appointed personal representative of the
estate of Scott D. Smiley.

22. Plaintiff alleges an amount in controversy in excess of Seventy Five Thousand
Dollars ($75,000.00), exclusive of interest and costs.

GE and Omniscan" Defendants

23. Defendant General Electric Company is a New York corporation with its
principal place of business at 3135 Easton Turnpike, Fairfield, Connecticut 06431.
Defendant General Electric Company is the parent company of Defendant GE
Healthcare, Inc. and Defendant GE Healthcare Bio-Sciences Corp.

24. Defendant GE Healthcare, Inc. is a Delaware corporation with its principal
place of business at 101 Carnegie Center, Princeton, New Jersey. Defendant GE
Healthcare, Inc. is a subsidiary of General Electric Company.

25. Defendant GE Healthcare Bio-Sciences Corp. is a Delaware corporation with its
principal place of business at 800 Centennial Avenue, Piscataway, New Jersey
08854. Defendant GE Healthcare Bio-Sciences Corp. is a subsidiary of General
Electric Company.

26. Defendants General Electric Company, GE Healthcare, Inc. and GE Healthcare
Bio- Corp. are corporate successors to Amersham PLC and as such are obligated for
their predecessor's liabilities. Amersham PLC was engaged in the business of
designing, licensing, manufacturing, distributing, selling, marketing, and/or
introducing into interstate commerce, either directly or indirectly through third
parties or related entities, the prescription drug Omniscan

27. Defendant General Healthcare AS, a/k/a GE Healthcare AS is organized pursuant
to the laws of the Kingdom of Norway with its principal place of business in
Norway. Defendant General Healthcare AS manufactures the OmniscanTM that is
distributed, marketed and sold in the United States.

28. OmniscanTM is an injectable paramagnetic contrast agent for magnetic resonance
imaging and arteriography. It contains the metal gadolinium which is highly toxic
in its free state. OmniscanTM, the chemical name of which is gadolinium
diethylenetriamine pentaacetic acid bismethylamide (gadodiamide), is represented
by Defendants to be safely and effectively indicated for intravenous
administration to facilitate the visualization of lesions with abnormal
vascularity.

29. OmniscanTM (gadodiamide) was originally developed in the early 1990s by
Salutar, Inc. which subsequently transferred the rights to OmniscanTM (gadodiamide)
to Sterling Winthrop, a subsidiary of Eastman Kodak Company.

30. In 1994, the diagnostic imaging division of Sterling Winthrop, which held the
rights to OmniscanTM (gadodiamide), was sold to Hafslund Nycomed AS, a Norwegian
company.

31. In 1997, Nycomed merged with Amersham International, a British company, and
the resulting entity that held the rights to Omniscan (gadodiamide) was Amersham
PLC.

32. In January 2004, Defendant General Electric purchased Amersham PLC, combined
it with its own GE Medical Systems, and created a new subsidiary called GE
Healthcare, Inc.

33. Omniscan (gadodiamide) is cleared from the body by glomerular filtration in
the kidneys. As a result, it has a prolonged half-life in patients with renal
insufficiency and who, therefore, are at increased risk for adverse health effects
in connection with Omniscan (gadodiamide) administration.

34. In pre-clinical safety assessment during which Omniscan (gadodiamide) was
injected into laboratory animals, consistent patterns of toxicity including
nephrogenic fibrotic changes in the skin and other body organs occurred.

35. Despite these nephrogenic fibrotic changes and other data warranting caution
and further evaluation, Omniscan (gadodiamide) was marketed and sold without
appropriate clinical evaluation of the nephrotoxic effect of this drug on patients
with renal insufficiency, without appropriate clinical evaluation of the
propensity of this drug to produce nephrogenic fibrosis in humans, and without
appropriate and effective warning with respect to either.

36. Omniscan (gadodiamide) is chemically distinct from other gadolinium-type
contrast agents, in that it carries no molecular charge and is arranged in a
linear structure with excess chelate such that it permits the release of free
gadolinium ions and the extravasation of toxic gadolinium.

  Bayer and Magnevist(R) Defendants

37. Defendant Bayer Healthcare Pharmaceuticals, Inc., f/k/a Berlex, Inc., f/k/a
Berlex Laboratories, Inc., is incorporated in Delaware and has its principal place
of business at 6 West Belt, Wayne, New Jersey. Defendant Bayer Healthcare
Pharmaceuticals, Inc., is the U.S.-based pharmaceuticals unit of Bayer Healthcare
LLC.

38. Berlex, Inc., f/k/a Berlex Laboratories, Inc., and now known as Defendant
Bayer Healthcare Pharmaceuticals, Inc., is the corporate entity responsible for
submitting the NDA for Magnevist(R), which was approved in 1988. Because Defendant
Bayer Healthcare Pharmaceuticals, Inc. is a corporate successor to Berlex, Inc.
and Berlex Laboratories, Inc., it is obligated for its predecessor's liabilities.
Berlex, Inc., and Berlex Laboratories, Inc. were engaged in the business of
designing, licensing, manufacturing, distributing, selling, marketing, and/or
introducing into interstate commerce, either directly or indirectly through third
parties or related industries the prescription drug Magnevist(R).

39. Defendant Bayer Schering Pharma AG, f/k/a Schering AG, located in Berlin,
Germany, is the corporate entity responsible for designing and manufacturing
Magnevist(R). Defendant Bayer Schering Pharma AG, f/k/a Schering AG was engaged in
the business of designing, licensing, manufacturing, distributing, selling,
marketing and/or introducing into interstate commerce, either directly or
indirectly through third parties or related industries the prescription drug
Magnevist(R).

40. Magnevist(R) is an injectable paramagnetic contrast agent for magnetic
resonance imaging and arteriography. It is a patented, proprietary formulation
that contains the metal gadolinium which is highly toxic in its free state.
Magnevist(R), the chemical name of which is gadopentetate dimeglumine, was
represented by Berlex to be safely and effectively indicated for intravenous
administration to facilitate the visualization of cranial and spinal anatomy as
well as tumors, lesions, and immediately adjacent areas. Magnevist(R) was further
represented by Berlex to be superior to two of its competitors (Omniscan and
Optimark) in its thermodynamic and conditional stability, its low volume of excess
chelate, and its ability to prevent the release of gadolinium into the body.

41. Berlex obtained FDA approval of its New Drug Application (App. No. 019596) for
Magnevist(R) (gadopentetate dimeglumine) on June 2,1988.

42. In 2006, Bayer AG, which has its legal domicile in Berlin, completed its
acquisition of Schering AG. Berlex was a U.S. affiliate of Schering AG. Bayer AG
is a holding company that owns and operates Defendants Bayer Healthcare LLC and
Bayer Healthcare Pharmaceuticals, Inc.

  Covidien, Tyco, Mallinckrodt and the OptiMARK Defendants

43. Defendant Mallinckrodt, Inc. is incorporated in the state of New York and has
its principal place of business in St. Louis, Missouri. Mallinckrodt, Inc. is a
business unit of Tyco Healthcare Group LP.

44. Tyco Healthcare Group LP has its principal place of business in Mansfield,
Massachusetts.

45. On July, 2 2007, Tyco Healthcare Group LP became Covidien. Covidien is
incorporated in Bermuda and has its U.S. headquarters in Mansfield, Massachusetts.
Mallinckrodt, Inc. is a U.S. subsidiary of Covidien.

46. Defendants Mallinckrodt, Inc., Tyco Healthcare Group LP, and Covidien are
referred to collectively hereinafter as "Covidien."

47. Covidien is the manufacturer and distributor of OptiMARK, a contrast solution
containing gadolinium and used in MRIs and MRAs.

48. At all times relevant hereto, Covidien was engaged in the business of
designing, licensing, manufacturing, distributing, selling, marketing, and/or
introducing into interstate commerce, either directly or indirectly through third
parties or related industries the prescription drug OptiMARK.

  Braco, Multihance and ProHance Defendants

49. Defendant Bracco Diagnostics Inc. is incorporated in a state other than New
Jersey and has its headquarters at 107 College Road East, Princeton, New Jersey.
It is referred to hereinafter as "Bracco."

50. Bracco is the manufacturer and distributor of MultiHance and ProHance,
contrast solutions containing gadolinium and used in MRIs and MRAs.

51. At all times relevant hereto, Bracco was engaged in the business of designing,
licensing, manufacturing, distributing, selling, marketing, and/or introducing
into interstate commerce, either directly or indirectly through third parties or
related industries the prescription drugs MultiHance and ProHance.

    VENUE

52. The Defendants do, and at all relevant times did, business in Indiana through
the sale of the contrast solutions identified above to businesses, hospitals and
other institutions.

53. The Defendants do, and at all relevant times did, business in Indiana, through
the sales of various healthcare products other than contrast solutions to
hospitals, businesses, institutions, distributors, and individuals in this state.

  COUNT I: PRODUCT LIABILITY (Indiana Product Liability Act, Ind. Code Ann. § 34-20
  et seq.)

54. Plaintiffs repeat and re-allege, as if fully set forth herein, each and every
allegation contained in the above paragraphs and further allege:

55. Smiley is in the class of persons that Defendants should reasonably foresee as
being subject to the harm caused by Gadolinium based contrast agents, being
defectively designed or formulated, insofar as he was the type of person for whom
the Gadolinium based contrast agents were intended to be used

56. Defendants, which are engaged in the business of selling Gadolinium based
contrast agents, manufactured and supplied Gadolinium based contrast agents and
placed them into the stream of commerce in a defective and unreasonably dangerous
condition such that the foreseeable risks exceeded the benefits associated with
the design and/or formulation of the products.

57. The Gadolinium based contrast agents used by Smiley were defective in design
and formulation and unreasonably dangerous when they left the hands of the
Defendant(s) manufacturer and supplier, and reached the user and consumer of the
product, Scott D. Smiley, without substantial alteration in the condition in which
they were sold.

58. Gadolinium based contrast agents were unreasonable and dangerously defective
beyond the extent contemplated by ordinary patients with ordinary knowledge
regarding the products.

59. As a direct and proximate result of the Scott D. Smiley being administered
Gadolinium based contrast agents, as manufactured, designed, sold, supplied and
introduced into the stream of commerce by Defendants, Scott D. Smiley suffered
serious physical injury, harm, and death, and his estate and wrongful death
beneficiaries suffered damages and economic loss, including but not limited to
medical bills, funeral and burial expenses.

WHEREFORE, Plaintiffs pray for judgment against the Defendants in an amount which
will compensate them for injuries and damages, and punitive damages in an amount
which will deter the Defendants and others from like conduct, including attorneys'
fees, interest and costs of this action.

    COUNT II: NEGLIGENCE: FAILURE TO WARN

60. Plaintiffs repeat and re-allege, as if fully set forth herein, each and every
allegation contained in the above paragraphs and further allege:

61. The Gadolinium based contrast agents manufactured and supplied by the
Defendants was defective due to inadequate warning or instruction because
Defendants knew or should have known that their products created significant risks
of serious bodily harm and death to consumers and they failed to adequately warn
persons who were administered these products and/or their healthcare providers of
such risks.

62. The Gadolinium based contrast agents manufactured and supplied by Defendants
were defective due to inadequate post-marketing warning or instruction because,
after Defendants knew, or should have known, of the risk of serious bodily harm
and death from the administration of Gadolinium based contrast agents, Defendants
failed to provide an adequate warning to users of these products and/or their
healthcare providers, knowing the products could cause serious injury and death.
The failure to warn breached the duty that Defendants owed Scott D. Smiley.

63. As a direct and proximate result of the Scott D. Smiley being administered
Gadolinium based contrast agents, as manufactured, designed, sold, supplied and
introduced into the stream of commerce by Defendants, Scott D. Smiley suffered
serious physical injury, harm, and death, and his estate and wrongful death
beneficiaries suffered damages and economic loss, including but not limited to
medical bills, funeral and burial expenses.

WHEREFORE, Plaintiffs pray for judgment against the Defendants in an amount which
will compensate them for injuries and damages, and punitive damages in an amount
which will deter the Defendants and others from like conduct, including attorneys'
fees, interest and costs of this action.

    COUNT III: BREACH OF EXPRESS WARRANTY

64. Plaintiffs repeat and reallege, as if fully set forth herein, each and every
allegation contained in the above paragraphs and further allege:

65. The Defendants expressly warranted that Gadolinium based contrast agents were
a safe and effective paramagnetic contrast agent for magnetic resonance imaging.

66. The Gadolinium based contrast agents manufactured and sold by Defendants did
not conform to these express representations because it caused serious injury and
eventual death when administered in recommended dosages.

67. As a direct and proximate result of Defendants' breach of warranty, Scott D.
Smiley suffered serious physical injury, harm, and death, and his estate and
wrongful death beneficiaries suffered damages and economic loss, including but not
limited to medical bills, funeral and burial expenses.

WHEREFORE, Plaintiffs pray for judgment against the Defendants in an amount which
will compensate them for their injuries and damages, and punitive damages in an
amount which will deter the Defendants and others from like conduct, including
attorneys' fees, interest and costs of this action.

    COUNT IV: BREACH OF IMPLIED WARRANTY

68. Plaintiffs repeat and reallege, as if fully set forth herein, each and every
allegation contained in the above paragraphs and further allege:

69. At the time Defendants designed, manufactured, marketed, sold, and distributed
Gadolinium based contrast agents, Defendants knew of the use for which Gadolinium
based contrast agents were intended and impliedly warranted it to be of
merchantable quality and safe for such use.

70. Scott D. Smiley reasonably relied upon the skill and judgment of Defendants as
to whether Gadolinium based contrast agents were of merchantable quality and safe
for its intended use and upon Defendants' implied warranty as to such matters.

71. Contrary to such implied warranty, Gadolinium based contrast agents were not
of merchantable quality or safe for their intended use because they were
unreasonably dangerous as described herein.

72. As a direct and proximate result of Defendants' breach of warranty, Scott D.
Smiley suffered serious physical injury, harm, and death, and his estate and
wrongful death beneficiaries suffered damages and economic loss, including but not
limited to medical bills, funeral and burial expenses.

WHEREFORE, Plaintiffs pray for judgment against the Defendants in an amount which
will compensate them for their injuries and damages, and punitive damages in an
amount which will deter the Defendants and others from like conduct, including
attorneys' fees, interest and costs of this action.

   COUNT V: WRONGFUL DEATH (Ind. Code § 34-23-1-1)

73. Plaintiffs repeat and reallege, as if fully set forth herein, each and every
allegation contained in the above paragraphs and further allege:

74. The Gadolinium based contrast agents manufactured and supplied by the
Defendants were defective due to inadequate warning or instruction because
Defendants knew or should have known that their products created significant risks
of serious bodily harm and death to consumers and they failed to adequately warn
persons who were administered these products and/or their healthcare providers of
such risks.

75. The Gadolinium based contrast agents manufactured and supplied by Defendants
was defective due to inadequate post-marketing warning or instruction because,
after Defendants knew, or should have known, of the risk of serious bodily harm
and death from the administration of Gadolinium based contrast agents, Defendants
failed to provide an adequate warning to users of these products and/or their
health care providers, knowing the products could cause serious injury and death.

76. As a direct and proximate result of Defendants' negligent acts, Scott D.
Smiley suffered serious physical injury, harm, and death, and his estate and
wrongful death beneficiaries suffered damages and economic loss, including but not
limited to medical bills, funeral and burial expenses.

WHEREFORE, Plaintiffs pray for judgment against the Defendants in an amount which
will compensate them for their injuries and damages, and punitive damages in an
amount which will deter the Defendants and others from like conduct, including
attorneys' fees, interest and costs of this action.

    COUNT VI: LOSS OF CONSORTIUM

77. Plaintiffs repeat and reallege, as if fully set forth herein, each and every
allegation contained in the above paragraphs and further alleges:

1

78. Jill Smiley and Scott D. Smiley were at all relevant times hereto, husband and
wife.

79. Jill Smiley, as a direct and proximate cause of the injuries sustained by
Scott D. Smiley, described above, has suffered loss of consortium. She has
suffered, and will continue to suffer in the future, the loss of support, love,
protection, services, care, companionship, affection, society, sexual relations,
solace and other damages. She has paid and has become liable to pay medical aid,
treatment and for medications.

WHEREFORE, Jill Smiley prays for judgment against the Defendants in an amount
which will compensate her for injuries and damages, and punitive damages in an
amount which will deter the Defendants and others from like conduct, including
attorneys' fees, interest and costs of this action.

  PRAYER FOR RELIEF

WHEREFORE, Plaintiff prays for relief as follows:

1. General damages, including but not limited to, pain and suffering, mental
anguish, emotional distress, and loss of enjoyment of life;

2. Special damages, including but not limited to, medical, incidental, hospital,
service, and rehabilitation, costs, and expenses;

3. Loss of earnings and/or earnings capacity and other economic losses;

4. Punitive or exemplary damages;

5. Pre and post judgment interest, as provided by law;

6. Attorneys' fees, costs, and expenses of this action, as provided by law;

7. Treble damages, as provided by law; and

8. For such other and further relief, as the Court deems just and proper.

    DEMAND FOR JURY TRIAL

Plaintiffs hereby demand a jury trial on all issues presented in this action.