Date: 03-04-2013

Case Style: Susan Ferguson v. Genentech, Inc.

Case Number: CJ-2009-10726

Judge: Barbara G. Swinton

Court: District Court, Oklahoma County, Oklahoma

Plaintiff's Attorney: Pro Se

Defendant's Attorney: Robert Brock, John Kenney, Harry Arthur Woods and Charles Barnes Goodwin for Genentech, Inc.

Jennifer Rae Annis and Martha J. Phillips for Michael M. Keefer, M.D.

Joseph G. Blute and Amy D. White for Bigen IDEC, Inc.

Description: Susan Ferguson, as next of kin of Wanda Parr, deceased, sued Genentech, Inc., Biogen, Inc. and Michael Keefer, M.D. on products liability theories claiming:

1. Wanda Parr is deceased, having departed this life on February 23, 2009.

2. Wanda Parr was a resident of Oklahoma County, Oklahoma.

3. This action is brought pursuant to 12 O.S. § 1054 by Susan Ferguson, surviving daughter and next of kin of Wanda Parr.

4. Defendant Michael Keefer, M.D. is a resident of Oklahoma County, Oklahoma and provides medical services for compensation in Oklahoma,

5. Defendants Genentech, Inc. and Biogen Idec, Inc. are non-resident corporations, doing business and distributing products in Oklahoma County, Oklahoma. Prior to July 3, 2007, Defendants Genentech, Inc., hereinafter referred to as “Genentech,” and Biogen Idec, Inc., hereinafter referred to as “Biogen,” manufactured and placed into the stream of commerce the prescription drug known as Rituxan or, generically, Rituximab.

FACTUAL BACKGROUND

1. Progressive multifocal leulcoencephalitis hereinafter referred to as PML is an almost always fatal disease of the nervous system caused by a polyomavirus (the “JC Virus”) that typically strikes people with severely impaired immune systems, such as persons with AIDS. PML presents symptoms such as impaired cognition, cortical blindness and weakness on one side of the body. PML usually results in death within one to four months of the onset of the disease.

2. The JC virus, which causes PML, is latent in the kidneys of almost all adults following infection in childhood adolescence and only invades the brain when the immune system is severely impaired, which allows the virus to replicate uncontrollably.

3. The symptoms of PML are the result of an infection that causes the loss of white matter (which is made up of myelin, a substance that surrounds and protects nerve fibers) in multiple areas of the brain. Without the protection of myelin, nerve signals can’t travel successfully from the brain to the rest of the body.

4. The most prominent symptoms are clumsiness; progressive weakness; and visual, speech, and sometimes, personality changes. The progression of deficits leads to life-threatening disability and death over weeks to months.

5. Rituxan has been associated with progressive multifocal leukoencephalopathy (PML).

6. Rituxan has also been associated with fatal infusion reactions, tumor lysis syndrome, severe mueocutaneous reactions, cardiovascular injuries, as well as other opportunistic infections, including: pneumocystis jirovecii pneumonia, Epstein-Barr-virus (EBV) - associated hepatitis, generalized herpes zoster, BALT-lymphoma, and herpes encephalitis.

7. In 1995, Genentech and IDEC signed a collaboration to develop and commercialize Rituxan.

8. In November of 1997, the FDA approved Rituxin for the treatment of cancer.

9. In 2001, a supplemental Biological License Application (sBLA) was approved by the
FDA for Rituxan adding several new uses, including: the retreatment of patients with
Rituxan who have relapsed following initial Rituxan therapy, the use of eight weekly
doses per course of treatment, and the treatment of patients with bulky disease (lesions>
10cm).

10. In 2003, Biogen, Inc. and IDEC Pharmaceuticals Corporation merged to form Biogen Idee Inc.

11. In 2006, Rituxan was approved for the treatment of patients with diffuse large B-cell, CD2O-positive, non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens; in combination with methotrexate in adult patients with rheumatoid arthritis; and for the treatment of patients with relapsed or refractory, low- grade or follicular, CD2O-positive, B-cell non-Hodgkin’s lymphoma (NHL) as a single agent.

12. In 2006 and 2007, the FDA announced safety alerts describing two patients who developed PML after treatment with rituximab.

13. Defendant Biogen received FDA approval to market the drug Tysabri in November 2004. Tysabri is an immunosuppressant drug which is utilized by multiple sclerosis patients.

14. On February 25, 2005, Biogen withdrew Tysabri from the market pending an investigation into two patients who had been diagnosed with PML who subsequently died.

15. Even though Tysabri eventually returned to the market, Biogen was forced to impose many warnings regarding the drug due to the significant risks that left patients vulnerable to serious opportunistic infections including PML.

16. Because of the possession of the information described above, Biogen knew, or recklessly disregarded the significant risks associated with Rituxan’s severe immunosuppressive effect and consequently would result in severe opportunistic infections.

17. Biogen, as a result of the marketing of both Tysabri and Rituxan, two monoclonal, antibodies, knew or should have known that the ingestion of Rituxan virtually “turns off’ the immune system and ultimately can lead to a patient contracting PML,

18. Rituxan and Rituximab were prescribed for and ingested by Plaintiff’s decedent Wanda Parr from approximately July 3, 2007 until approximately December 28, 2007.

19. As a result of the usage of the defective products, manufactured by both Genentech and Biogen, to wit Rituxan and Rituximab, Plaintiffs decedent developed a rare, catastrophic, and fatal brain infection known as progressive multifocal leukoencephalitis.

20. As a result of the defective medications manufactured and marketed by Genentech and Biogen, Plaintiffs decedent suffered and died on the 23rd day of February, 2009.

I. FIRST CAUSE OF ACTION

(Strict Liability - Failure to Warn - Against Genentecli and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though filly set
forth herein.

2. The drug products previously described were defective at the time of their
manufacture, development, production, testing, inspection, endorsement, prescription,
sale and distribution, in that, and not by way of limitation, said products and their
warnings, instructions and directions failed to warn of the dangerous propensities of said products, which risks were known or reasonably scientifically knowable to Defendants. Defendants, and each of them, kiiew or should have known of the defective condition, characteristics and risks associated with said products as previously set forth herein.

3. At all times herein mentioned, the aforementioned products were defective, and Defendants and each of them, knew that the products were to be used by the user without inspection for defects therein. Moreover, Decedent neither knew, nor had reason to know at the time of the use of said products, of the existence of the aforementioned defects.

4. As a result of the defective condition of the aforementioned products, Decedent and Decedent’s heirs including Plaintiff, suffered injuries and damages as alleged herein.

II. SECOND CAUSE OF ACTION

(Strict Product Liability - Design Defect - Against Gcnentech and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though fully set
forth herein.

2. Defendants and each of them are the manufacturers, distributors, seller, and/or
suppliers of the medications administered to Decedent.

3. The aforementioned products manufactured and/or supplied by Defendants were
defective in design or formulation in that, when it left the hands of Defendants, the
foreseeable risks of harm grossly exceeded the benefits associated with the design or
formulation of the drugs.

4. The aforementioned products were expected to and did reach Decedent without
substantial change in their condition as manufactured, created, designed, tested, labeled,
sterilized, packaged, supplied, marketed, sold, advertised, warned and otherwise
distributed.

5. Decedent used the medications in a manner for which it was intended or in a
reasonably foreseeable manner.

6. Defendants’ medications caused increased risks of personal injury and harm upon
consumption, and therefore constitute a product unreasonably dangerous for normal use due to their defective design, defective manufacture, and the Defendants’ misrepresentations and inadequate facts disclosed to the Decedent.

7. The medications manufactured andlor supplied by Defendants were defective due
to:

a. Defective design or formulation in that when it left the hands of the manufacturer and/or suppliers, the foreseeable risks exceeded the benefits associated with the design or formulation;

b. Defective marketing in that Defendants made inappropriate, misleading, inaccurate and incomplete representations about this product in advertisements, news, commercials, and direct to consumer advertisements. These deceptive marketing representations were made to the FDA, healthcare providers, pharmacists and the public. These deceptive marketing representations were made in order to induce sales and increase profits;

c. Defective design or formulation, in that when it left the hands of the manufacturer and/or suppliers, it was unreasonably dangerous, it was more dangerous than an ordinary consumer would expect, and more dangerous than other treatment options;

d. Inadequate warnings or instructions because Defendants knew or should have known that the product created a risk of dangerous side effects and other related conditions and diseases;

e. Inadequate pre-marketing testing which, if conducted properly, would have revealed the serious problems with this drug prior to the first sale; and/or

f. Inadequate post-marketing warning or instruction because, after Defendants knew or should have known of the risk of dangerous side effects and other related conditions and diseases, they failed to provide adequate warnings to users or consumers of the product and continued to promote the product.

8. Defendants, therefore, are strictly liable in this matter.

9. As the proximate cause and legal result of the defective condition of the
medications as manufactured andlor supplied by Defendants, and as a direct and legal
result of the negligence, carelessness, and other wrongdoing and actions of Defendants
herein:

a. Decedent was seriously injured in health, strength, and activity and suffered injuries to her body and mind, including but not limited to PML, which resulted in her death. Decedent also sustained economic loss, including loss of earnings and diminution or loss of earning capacity, of which the exact amount is presently unknown; and

b. During her lifetime, Decedent required reasonable, necessary, and constant health care, attention, and services and thereby incurred extreme medical, health, incidental and related expenses. Plaintiff suffered loss of consortium damages.

c. Decedent’s heirs suffered wrongful death damages, including but not limited to medical and burial expenses, loss of consortium, loss of companionship and grief.

10. Defendants’ actions, described above were performed willftilly, intentionally, with malice and/or with reckless disregard for the rights of Decedent and the public. As such, Plaintiff is entitled to punitive damages against Defendants.

III. THIRD CAUSE OF ACTION

(Negligence - Against Genentech and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though ftilly set
forth herein.

2. At all times herein mentioned, Defendants and each of them, had a duty to properly manufacture, design, formulate, compound, test, produce, process, assemble, inspect, research, distribute, market, label, package, prepare for use, sell, prescribe and adequately warn of the risks and dangers of the aforementioned products.

3. At all times herein mentioned, Defendants and each of them, negligently and carelessly manufactured, designed, formulated, compounded, produced, processed, assembled, inspected, distributed, marketed, labeled, packaged, prepared for use and sold the aforementioned products arid failed to adequately test and warn of the risks and dangers of the aforementioned products.

4. As a result of said negligence and carelessness of the Defendants and each of them, Decedent and Decedent’s heirs, including Plaintiff, suffered injuries and damages as alleged herein.
(Negligence — Against Defendant Michael Kecfer MD)

5. Defendant Michael Keefer, M.D. was negligent in prescribing Rituxan and Rituximab to Plaintiff’s decedent when such defendant knew, or reasonably should have known, that a) the risk of the medication outweighed its benefit; b) that Plaintiff’s decedent was not a proper candidate for usage of Rituxan and Rituximab.

6. Defendant Michael Keefer, M.D. failed to appropriately and adequately warn and caution Plaintiffs decedent about the usage of Rituxan and Rituximab, and failed to obtain her informed consent to use such medication.

7. Defendant Michael Keefer, M.D. failed to properly monitor the health and progress of Plaintiff’s decedent during the time that she was using Rituxan and Rituximab. The above actions and omissions of Defendant Michael Keefer, M.D. were both negligent and below the acceptable standard of care. As a result of the negligence of Michael Keefer, M.D., and as a foreseeable consequence thereof, Plaintiffs decedent developed progressive multifocal leukoencephalitis, which caused her suffering and death, as described herein.

IV. FOURTH CAUSE OF ACTION

(Negligence Per Sc - Against Gencntcch and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though fully set forth herein.

2. At all times herein mentioned, Dcfendants and each of them, had an obligation not to violate the law, in the manufacture, design, formulation, compounding, testing, production, processing, assembly, inspection, research, distribution, marketing, labeling, packaging, preparation for use, sale and warning of the risks and dangers of the aforementioned products.

3. At all times herein mentioned, Defendants and each of them, violated the Federal Food, Drug and Cosmetic Action 21, U.S.C. section 301, et. seq. related amendments and codes and federal regulations provided thereunder, the Sherman Food, Drug and Cosmetic Law and regulations promulgated thereunder and other applicable laws, statutes
and regulations.

4. Decedent as a purchaser and consumer of the products is within the class of persons the statutes and regulations described above are designed to protect, and the injuries suffered by Decedent are the type of harm these statutes are designed to prevent. Defendants failed to meet the standard of care set by the following statutes and regulations, which were intended for the benefit of individuals such as Decedent, making Defendants negligent per se.

5. As a result of the violations of the statutes described above, Decedent and Decedent’s heirs, including Plaintiff, suffered injuries and damages alleged herein.

V. FIFTH CAUSE OF ACTION

(Breach of Implied Warranty - Against Genentcch and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though frilly set forth herein

2. Prior to the time that the aforementioned products were used by Decedent, Defendants and each of them, impliedly warranted to Decedent and her agents and physicians that the said products were of merchantable quality and safe and fit for the use for which they were intended.

3. Decedent was unskilled in the research, design and manufacture of the aforementioned products and reasonably relied entirely on the skill, judgment and implied warranty of the Defendants in using the aforementioned products.

4. The aforementioned products were neither safe for their intended use nor of merchantable quality, as warranted by Defendants, in that they had dangerous propensities when put to their intended use and would cause severe injuries to the user.

5. As a result of the aforementioned breach of implied warranties by the Defendants and each of them, Decedent and Decedent’s heirs, including Plaintift suffered injuries and damages as alleged herein.

VI. SIXTH CAUSE OF ACTION

(Breach of Express Warranty - Against Genentccli and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though fully set forth herein.

2. At all times herein mentioned, Defendants expressly warranted to Decedent and the agents and physicians of Decedent by and through statements made by Defendants and or their authorized agents or sales representatives, orally and in publications, package inserts and other written materials intended for physicians, medical patients and the general public, that the aforementioned products were safe, effective, fit and proper for their intended use.

3. In utilizing the aforementioned products, Decedent relied upon the skill, judgment, representations and foregoing express warranties of the Defendants and each of them. Said warranties and representations were false in that the aforementioned products were not safe and were unfit for the uses for which they were intended.

4. As a result of the foregoing breach of express warranties by the Defendants and each of them, Decedent and Decedent’s heirs, including Plaintiff, suffered injuries and damages as alleged herein.

VII. SEVENTH CAUSE OF ACTION

(Deceit By Concealment - Against Genentech and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though hilly set
forth herein.

2. Defendants, and each of them, from the time that the aforementioned products were first manufactured, marketed and distributed and up to the present, willfhlly deceived Decedent by concealing from her, her physicians and the general public, the true facts concerning said pharmaceutical products, which the Defendants, as manufacturers marketers and
distributors of the products had a duty to disclose.

3. As a result of the fraudulent and deceitfhl conduct by the Defendants, Decedent and Decedent’s heirs, including Plaintiff, suffered injuries and damages as alleged herein.

VIII. EIGHTH CAUSE OF ACTION

(Negligent Misrepresentation - Against Genentech and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though fully set forth herein.

2. Defendants and each of them, from the time that the aforementioned products were first manufactured, marketed and distributed and up to the present, and made false misrepresentations, as previously set forth herein, to Decedent, her physicians and the general public, including but not limited to the misrepresentation that said pharmaceutical products, alone and in combination, were safe, fit and effective for human consumption. At all times herein mentioned, Defendants and each of them, conducted a sales and marketing campaign to promote the sale of the aforementioned drug products and willfully deceive Decedent, her physician and the general public as to the health risks and consequences associated with the use of the aforementioned products.

3. The Defendants made the foregoing representations without any reasonable ground for believing them to be true. These representations were made directly by Defendants, by sales representatives and other authorized agents of said Defendants and in publications and other written materials directed to physicians, medical patients and the public, with the intention of inducing reliance and the prescription, purchase and use of the subject products.

4. The foregoing representations by the Defendants and each of them, were in fact, false, in that the aforementioned products were not safe, fit and effective for human consumption, the use of said products is hazardous to health, and said products have a serious propensity to cause serious injuries to users, including but not limited to the injuries suffered by Decedent and Decedent’s legal heirs, including Plaintiff, as delineated herein.

5. The foregoing representations by Defendants, and each of them, were made with the intention of inducing reliance and the prescription, purchase and use of the subject products.

6. In reliance on the misrepresentations by the Defendants and each of them, Decedent was induced to purchase and use the aforementioned products. If Decedent had
known the true facts and the facts concealed by Defendants, he would not have used the subject products. The reliance of Decedent upon Defendant’s misrepresentations was justified because such misrepresentations were made and conducted by individuals and entities, who were in a position to know the true facts.

7. As a result of the foregoing negligent misrepresentations by the Defendants, and each of them, Decedent and Decedent’s heirs, including Plaintiff, suffered injuries and damages as alleged herein.

IX. NINTH CAUSE OF ACTION

(Fraud and Deceit - Against Genentech and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though fully set forth herein.

2. At all times during which Defendants and each of them tested, produced, formulated, manufactured, sold, distributed, marketed, processed, and supplied the drugs, Rituxan and Rituxan, up to the present, defendants and each of them, knowingly, intentionally, willfhlly, and purposefully deceived Decedent by (1) making false and fraudulent misrepresentations to the Decedent, her physicians, and the general public including, but not limited to, that said medications were safe, fit, and effective for human use; and (2) concealing from Decedent, her physicians, and the general public the true facts known by Defendants concerning the safety and efficacy of said medications and their administration.

3. At all times relevant to this action, Defendants and each of them, knew that their representations were in fact false and inaccurate. The true and accurate facts knowingly and intentionally concealed by defendants and each of them were, among others, that the drugs were directly associated with and known to fatal conditions, including PML. This information was known to Defendants, and each of them, and Defendants and each of them intentionally withheld this information from Decedent and other patients who were prescribed and used Defendants’ product and formulation of the drugs.

4. At all times during which Defendants and each of them made the above
mentioned misrepresentations to and intentional concealment from Decedent, Defendants knew that the misrepresentations were false and inaccurate. Defendants and each of them made the misrepresentations with intent to deceive Decedent and induce her to choose the use of the thugs.

5. Decedent had no knowledge of the falsity of Defendants’ and each of their misrepresentations and intentional concealments at the time Decedent decided to take defendants’ medications and in reliance upon Defendants’ misrepresentations, she believed Defendants’ products were safe and effective.

6. Decedent reasonably relied upon Defendants’ and each of their misrepresentations and was induced to and did in fact use Defendants’ products. Decedent would not have agreed to the use of Defendants’ products if he had known and had been informed of the true facts concerning the causal nexus between the use of Defendants’ products and the aforementioned severe and life threatening medical conditions and disorders that led to Decedent’s untimely death.

7. Decedent justifiably and reasonably relied upon Defendant’s misrepresentations because Defendants were in a special and fiduciary relationship to him in that Defendants held themselves out to have skill and expertise in the field and knew that patients like Decedent needed and would ingest such medications for the treatment of her condition. Decedent’s reliance upon Defendants’ misrepresentations was reasonable, as she did not, at all times relevant to this action, have the knowledge and/or expertise necessary to independently evaluate whether or not the drugs in the dosage that he was ingesting was, in fact, unsafe for human ingestion.

8. At all times herein mentioned, Defendants and each of them, conducted a sales and marketing campaign via physicians, written pamphlets, and Defendants’ internet website to promote the sale, distribution and use of the drugs and to willfully deceive Decedent, her physicians and the general public as to the health risks and unhealthfiul consequences of the aforementioned products when improperly prescribed and lacking warnings when administered. These representations were made directly by Defendants to Decedent, via written materials and brochures, internet website advertising, publications, literature, product labels, and other written materials regarding the product and directed to him.

9. The foregoing misrepresentations and intentional concealments by Defendants and each of them, were made and conducted with the intent to induce Decedent to use, consume, and ingest the aforementioned products for treatment of Decedent’s condition.

10. The misconceptions as to the true risks and benefits of Defendants’ medications were pervasive throughout the medical and scientific communities due to the marketing
methods employed by Defendants that included but were not limited to the following:

a. The publication of fraudulent scientific papers in scientific and medical literature;

b. Providing false and misleading information to doctors during sales and detailing calls at the doctors’ offices or at medical or scientific conferences and meetings;

c. Funding third-party organizations to disseminate false and misleading scientific and medical information through its publications and its members to physicians and patients;

d. Funding continuing medical education to disseminate false and misleading information to doctors;

e. Providing false and misleading information to the FDA to support inaccurate risk and benefit information contained in the product labeling; and/or

f. Disseminating direct to consumers advertising to drive patients to their doctors’ offices to ask for the drugs based on false and misleading information regarding the risks and benefits of the drugs.

In particular, in the materials disseminated by Defendants, they falsely and deceptively
misrepresented or omitted a number of material facts regarding their medications, including, but not
limited to, the following:

a. The presence and adequacy of the testing of the medications, both pre-and post- marketing;

b. The severity and frequency of adverse health effects caused by the medications;

c. The range of injuries caused by the medications; andlor

d. The lack of any reliable science to support representations about the benefits of the medications.

II. Defendants were in possession of evidence demonstrating that the aforementioned
products caused serious side effects. Neverthe]ess, Defendants continued to market such products by providing false and misleading information with regard to its safety and efficacy to Decedent and her treating physicians.

12. Decedent and her treating physicians justifiably relied to their detriment on Defendants’ intentional and fraudulent misrepresentations as set out above concerning their medications.

13. As a direct and proximate result of the foregoing fraudulent and deceitful conduct by Defendants and each of them, Decedent was prescribed and accepted the use of the aforementioned products to Decedent for the treatment of her condition and Decedent and Decedent’s heirs, including Plaintiff, suffered injuries and damages as set forth herein.

X. TENTH CAUSE OF ACTION


(Negligence, Recklessness and Gross Neglect - Against Genentech and Biogen Defendants)

1. Plaintiff incorporates by reference all previous Paragraphs as though filly set
forth herein.

2. Defendants herein, as pharmaceutical manufacturers, distributors, and suppliers,
had a duty to warn of adverse drug reactions of which they knew, or had reason to know,
to be inherent in the use of the medications

3. Defendants, and all of them, knew, or should have known, the following:

a. That Defendants’ failed to adequately warn of the health risks in the delivery of these medicines;

b. That Decedent and other users of Defendants’ products were at significant risk of suffering serious health problems from the medications; andlor

c. A safer alternative design of the medications was available to Defendants to manufacture, sell, and distribute.

4. In light of their knowledge of the dangers and risks associated with the use of Defendants’ products and drug formulation, Defendants had a duty to: (a) timely and adequately warn Plaintiffs Decedent and consumers of the known andlor knowable, and/or suspected risks of, inter cilia, PML, arising from use of Defendants’ products; and (b) timely implement a safer, alternative design for its products, i.e., to incorporate a
warning and/or to formulate a safer drug combination.

5. The medications manufactured and/or supplied by Defendants were defective due
to:

a. Defective design or formulation in that when it left the hands of the manufacturer and/or suppliers, the foreseeable risks exceeded the benefits associated with the design or formulation;

b. Defective marketing in that Defendants made inappropriate, misleading, inaccurate and incomplete representations about this product in advertisements, news, commercials, and direct to consumer advertisements. These deceptive marketing representations were made to the FDA, healthcare providers, pharmacists and the public. These deceptive marketing representations were made in order to induce sales and increase profits;

c. Defective design or formulation, in that when it left the hands of the manufacturer and/or suppliers, it was unreasonably dangerous, it was more dangerous than an ordinary consumer would expect and more dangerous than other medications;

d. Inadequate warnings or instructions because the defendants knew or should have known that the product created a risk of dangerous side effects and other related conditions and diseases;

e. Inadequate pre-marketing testing which, if conducted properly, would have revealed the serious problems with this drug prior to the first sale; andJor

f. Inadequate post-marketing warning or instruction because, after Defendants knew or should have known of the risk of dangerous side effects and other related conditions and diseases, they failed to provide adequate warnings to users or consumers of the product and continued to promote the products.

6. Defendants, therefore, are strictly liable in this matter.

7. As a direct and proximate result of these Defendants’ manufacturing, creating, designing, testing, labeling, sterilizing, packaging, supplying, marketing, selling, advertising, warning, and otherwise distribution of drugs in interstate commerce, Decedent and Decedent’s heirs, including Plaintiff, have suffered injury and have suffered compensatory and punitive damages.

8. Defendants’ actions, described above were performed willfully, intentionally, with malice and/or with reckless disregard for the rights of Decedent and the public. As such, Plaintiff is entitled to punitive damages against Defendants.

XI. VIOLATIONS OF THE OKLAHOMA CONSUMER

PROTECTION ACT

1. Plaintiff incorporates by reference all previous Paragraphs as though hilly set
forth herein.

2. Defendants engaged in the unfair trade practices set forth above and specifically declared unlawful under 15 Oklahoma Statute 753. Such practices include making false or misleading representations, knowingly or with reason to know, as to the characteristics of Rituxan (Rituxan) and by committing a deceptive trade practice as defined by 15 Oklahoma Statute Section 752;

3. Plaintiff demands judgment against Defendant for actual damages plus costs and attorney’s fees incurred in bringing this action as provided for in 15 Oklahoma Statute section 761.1(a). In addition, Plaintiff prays for an award of a civil penalty against Defendant in the amount of $2,000.00 per violation, pursuant to 15 Oklahoma Statute section 761.1 due to Defendant’s unconscionable conduct.

XII. VIOLATIONS OF THE OKLAHOMA DECEPTIVE TRADE PRACTICES ACT

1. Plaintiff incorporates by reference all previous Paragraphs as though filly set
forth herein.

2. The actions of Defendants constituted deceptive trade practices within the
meaning of the Oklahoma Deceptive Trade Practices Act, 78 Oklahoma Statute section
51, et.seq.

3. Plaintiff demands judgment against Defendants for damages suffered by Decedent
and Decedent’s legal heirs including Plaintiff, SUSAN FERGUSON and Debby Kelly.
as a result of Defendant’s deceptive trade practices plus attorney fees and costs incurred
in bringing this action.

XIII. SURVIVAL BENEFITS

1. Plaintiff, SUSAN FERGUSON is the personal representative and/or successor in
interest of Decedent, WANDA PARR

2. Plaintiff realleges the wrongful and tortious conduct of the defendants as alleged in Paragraphs 1 through 156 and incorporates them by reference as though frilly set forth herein.

3. That as a result of such conduct, Decedent suffered personal injuries that resulted in her death. On her behalf, Plaintiff seeks all recoverable damages pursuant to relevant law, including but not limited to the remedies set forth in 12 Oklahoma Statute 1053. Those include but are not limited to all general, special and exemplary damages available by law.

MV. WRONGFUL DEATH

1. Plaintiff, SUSAN FERGUSON and Debby Kelly, Ms.Parr’s second daughter, are the heirs at law of Decedent WANDA PARR

2. Plaintiff realleges the wrongful and tortuous conduct of Defendants as alleged in Paragraphs 1 through 159 and incorporates them by reference as though fully set forth herein.

3. As a result of the wrongful and tortuous conduct of the Defendants, Decedent died on October 11, 2007.

4. That as a direct and proximate result of the acts and omissions of Defendants, and each of them, the Plaintiff and her children incurred expenses for medical treatment, hospital, funeral and burial of Decedent.

5. As a further, direct and proximate result of the acts and omissions of Defendants, Plaintiff and Debby Kelly, the legal heirs of Decedent, have been damaged in that they have and will continue to suffer grief, loss of companionship, loss of care, comfort, society, protection, support, love and services of Decedent, all to their general and special monetary damage in a sum to be ascertained according to proof at the time of trial and in excess of the jurisdictional limit of this Court.

6. That as a further direct and proximate result of the acts and omissions of Defendant and each of them, Plaintiff, SUSAN FERGUSON and Debby Kelly have sustained and will in the future sustain loss of earnings, loss of earning capacity, loss of household services and other economic damages.

XV. PUNITIVE DAMAGE ALLEGATIONS

1. Plaintiff incorporates by reference paragraphs 1 through 164 as if fully set forth here and further alleges as
follows:

2. The acts, conduct, and omissions of defendants and each of them, as alleged throughout this complaint were willfiil and malicious and were done with a conscious disregard for the rights of Plaintiff and other users of the Defendants’ product and for the primary purpose of increasing Defendant’s profits from the sale, distribution, and use of Defendants’ products. Defendants’ outrageous and unconscionable conduct warrants an award of exemplary and punitive damages against each defendant in an amount appropriate to punish and make an example of each Defendant.

3. Prior to the manufacturing, sale, distribution, programming and formulation of the drugs Rituxan and Rituxan, Defendants and each of them knew that said medications were defectively fonnulated and defectively delivered, and knew that upon the administration of the medications to persons such as Plaintiff; would experience and did experience severe physical, mental, and emotional injuries. Further, Defendants and each of them through their officers, directors, managers, employees, partners, representatives, joint venturers, and agents, had knowledge that the administration Rituxan medications as formulated by Defendants and contained in Defendants’ product presented a substantial and unreasonable risk of harm to Plaintiff and to the public, and as such, consumers of Defendants’ products were unreasonably subjected to risk of injury or death from the use of said products.

4. Despite such knowledge, Defendants and each of them acting through their officers, directors, agents, managing agents, employees, partners and joint venturers, for the purpose of enhancing Defendant’s profits, knowingly and deliberately programmed the combination medications in an unsafe manner, failed to remedy the known defects in said product and failed to warn the public, including Plaintiff’s Decedent, of the extreme
risk of injury occasioned by said defects inherent in the use of the product and medication. Said Defendants and their individual employees, agents, officers, directors, managers, representatives, partners, and joint venture’s intentionally proceeded with the manufacturing, sale, and distribution and marketing of said product and formulated pain medication knowing persons would be exposed to serious danger in order to advance Defendants’ own pecuniary interest and monetary profits. Defendants’ conduct was so contemptible that it would be looked down upon and resented by ordinary people, and was carried on by Defendants with willfUl and conscious disregard for the safety of Decedent, entitling Plaintiff to exemplary damages.

WHEREFORE, Plaintiff prays for judgment against Defendants and each of them, as
follows:

1. For past and future general damages in an amount in excess of the minimum jurisdictional limits of this Court;

2. For general wrongful death damages in an amount in excess of the minimum jurisdictional limits of this Court;

3. For special damages in an amount within the jurisdiction of this Court

4. For past and future medical and incidental expenses;

5. For past and fUture loss of earnings and/or earning capacity;

6. For punitive and exemplary damages;

7. For prejudgment interest on all damages as is allowed by the laws of the State of Oklahoma;

8. For past and future mental and emotional distress;

9. For past and future costs of suit incurred herein; and/or

10. For all damages available under the Oklahoma Consumer Protection Act, including but not limited to actual damages plus costs and attorneys fees in addition to a civil penalty of $2000.00 per violation pursuant to 15 Oklahoma Stat.
761.1;

11. For all damages available under Oklahoma Deceptive Trade Practices Act, including but not limited to actual damages plus attorney fees and costs.

12. For such other and further relief as the Court deems just and proper.
Respectfully submitted,

Defendant Dr. MIchael Keefer, M.D., appeared and answered as follows:

This Defendant denies generally and specifically each and every material allegation contained in Plaintiffs Petition, except those that are expressly admitted hereafter.

Parties

Paragraphs I through 3, this Defendant is without sufficient facts to admit or deny, and therefore, denies same and demands strict proof thereof.

Paragraph 4, Defendant, Michael Keefer, M.D., admits that he is a physician who practices medicine and provides his services in Oklahoma.

Paragraph 5 does not address Dr. Keefer and no response is necessary.

Factual Background

Paragraphs 1 through 20 is a recitation ofgeneral statements and alleged medical information without citations or sources ofreference. This Defendant is without sufficient facts to admit or deny,
and therefore, denies same, and requires strict proof thereof

I. Dr. Keefer’s Answer to Plaintiffs First Cause of Action (Strict Liability)

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though hilly set forth herein.
Paragraphs 2 through 4 do not address Dr. Keefer, and therefore no response is necessary. Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and requires strict proof thereof

II. Dr. Keefer’s Answer to Plaintiff’s Second Cause of Action
(Strict Product Liability and Design Defect)

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though hilly set forth herein.

Paragraphs 2 through 10, including subsections, do not address Dr. Keefer, and therefore no response is necessary.
Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and demands strict proof thereof

HI. Dr. Keefer’s Answer to Plaintiff’s Third Cause of Action
(Negligence - Against Genentech and Biogen Defendants)

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though hilly set forth herein.

A portion ofParagraph 2 does not address Dr. Keefer, and therefore no response is necessary. As to the portion(s) that may be ascribed to Dr. Keefer, those are denied.

Paragraph 3 does not address Dr. Keefer, and therefore no response is necessary. Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and demands strict proof thereof
Paragraph 4 is denied.

(Negligence - Against Defendant Michael Keefer)

Paragraph 5 is denied and Defendant demands strict proof thereof.

Paragraph 6 is denied and Defendant demands strict proof thereof

Paragraph 7 is denied and Defendant demands strict proof thereof.

Further, this Defendant specifically denies any acts of negligence, wrongdoing or providing substandard care to the Plaintiffs decedent.

IV. Dr. Keefer’s Answer to Plaintiff’s Fourth Cause of Action

(Nelieuce Per Se - Against Genentech and Biogen Defendants)

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though fully set forth herein.

Paragraphs 2 through 5 do not address Dr. Keefer, and therefore no response is necessary. Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and demands strict proof thereof

V. Dr. Keefer’s Answer to Plaintiff’s Fifth Cause of Action

(Breach of Implied Warranty - Against Genentech and Biogen Defendants) Paragraph 1, Defendant incorporates by reference all previous paragraphs as though fully set
forth herein.

Paragraphs 2 through 5 do not address Dr. Keefer, and therefore no response is necessary. Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and demands strict proof thereof

VI. Dr. Keefer’s Answer to Plaintiff’s Sixth Cause of Action
(Breach of Express Warranty - Aaainst Genentech and Biogen Defendants)

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though fully set forth herein.

Paragraphs 2 through 4 do not address Dr. Keefer, and therefore no response is necessary. Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and demands strict proof thereof.

VII. Dr. Keefer’s Answer to Plaintiff’s Seventh Cause of Action

(Deceit By Concealment - Against Genentech and Biogen Defendants)

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though fully set forth herein.

Paragraphs 2 and 3 do not address Dr. Keefer, and therefore no response is necessary. Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and demands strict proof thereof

VIII. Dr. Keefer’s Answer to Plaintiff’s Eighth Cause of Action

(Negligent Misrepresentation - Against Genentech and Biogen Defendants)

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though fully set forth herein.

Paragraphs 2 through 7 do not address Dr. Keefer, and therefore no response is necessary. Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and demands strict proof thereof

IX. Dr. Keefer’s Answer to Plaintiffs Ninth Cause of Action

(Fraud and Deceit - Against Genentech and Biogen Defendants)

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though fully set forth herein.

Paragraphs 2 through 13, including subsections, do not address Dr. Keefer, and therefore no response is necessary. Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and demands strict proof thereof.

X. Dr. Keefer’s Answer to Plaintiff’s Tenth Cause of Action

(Negligence. Recklessness and Gross Neglect - Against Genentech and Biogen Defendants)

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though fully set forth herein.

Paragraphs 2 through 8, including subsections, do not address Dr. Keefer, and therefore no response is necessary.
Furthermore, this Defendant is without sufficient facts to admit or deny the allegations, and therefore, denies same, and demands strict proof thereof

XI. Dr. Keefer’s Answer to Plaintiffs Eleventh Cause of Action Violations of the Oklahoma Consumer Protection Act

Paragraph I, Defendant incorporates by reference all previous paragraphs as though fully set forth herein.

Paragraph 2, denied and demands strict proof thereof.

Paragraph 3, denied and demands strict proof thereof.

XII. Dr. Keefer’s Answer to Plaintiff’s Twelfth Cause of Action

Violations of the Oklahoma Deceptive Trade Practices Act

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though fully set forth herein.

Paragraph 2, denied and Defendant demands strict proof thereof

Paragraph 3, denied and Defendant demands strict proof thereof

XIII. Dr. Keefer’s Answer to Plaintiffs Thirteenth Cause of Action
Survival Benefits

Paragraph 1, Defendant is without sufficient facts to admit or deny the allegations and therefore, denies same and demands strict proof thereof.

Paragraph 2, Defendant incorporates by reference all previous paragraphs as though fully set forth herein and specifically denies the allegations of wrongful and tortious conduct and demands strict proof thereof
Paragraph 3, denied and Defendant demands strict proof thereof.

XIV. Dr. Keefer’s Answer to Plaintiffs Fourteenth Cause of Action

Wrongful Death

Paragraph 1, Defendant is without sufficient facts to admit or deny the allegations and, therefore, denies same and demands strict proof thereof.

Paragraph 2, Defendant incorporates by reference all previous paragraphs as though fully set forth herein and specifically denies the allegations of wrongful and tortious conduct and demands strict proof thereof.

Paragraph 3, denied and Defendant demands strict proof thereof.

Paragraph 4, denied and Defendant demands strict proof thereof

Paragraph 5, denied and Defendant demands strict proof thereof

Paragraph 6, denied and Defendant demands strict proof thereof

XV. Dr. Keefer’s Answer to Plaintiffs Fifteenth Cause of Action

Punitive Dama2e Allegations

Paragraph 1, Defendant incorporates by reference all previous paragraphs as though fully
set forth herein.

Paragraph 2, denied and Defendant demands strict proof thereof

Paragraph 3, denied and Defendant demands strict proof thereof.

Paragraph 4, denied and Defendant demands strict proof thereof.

Defendant, Dr. Keefer, denies any and all entitlement of the relief that Plaintiff seeks.

AFFIRMATIVE DEFENSES

1. Plaintiff has failed to state a claim upon which relief can be granted.

2. Discovery may show that Plaintiffs claims are barred, in whole or in part, by the applicable statute of limitations

3. For further answer and defense, this Defendant specifically denies that he was guilty of medical malpractice or negligence in the care and treatment of Plaintiffs decedent.

4. This Defendant affirmatively states that at all times herein the care, treatment and services performed by him and to the Plaintiffs decedent were commensurate with the standard of care of other physicians practicing under the same or similar conditions.

5. Should this Defendant be found guilty ofprofessional negligence or negligence, which is not admitted, but expressly denied, this Defendant states that his professional negligence or negligence was not the proximate cause of Plaintiffs alleged injuries and damages, if any.

6. This Defendant alleges and states that any injuries and damages complained of in Plaintiffs Petition were the natural, probable and proximate result of the physical condition, anatomy and physiology of the decedent and any injuries or damages which the Plaintiff or Plaintiffs decedent may have sustained were not the result of any acts or omissions of this Defendant.

7. This Defendant alleges and states that any injuries or damages sustained by the Plaintiff or Plaintiffs decedent were the result of the normal and natural occurrences within the body of the decedent, over which this Defendant had no control and for which this Defendant is not responsible.

8. Any damages allegedly suffered by the Plaintiff or Plaintiffs decedent were caused by preexisting or post developed unrelated medical conditions, diseases, illnesses, infections or injuries of the decedent of which this Defendant is not responsible.

9. Decedent’s alleged injuries and damages are the result ofintervening and superceding causes over which this Defendant had no control.

10. Ifthis Defendant were negligent, as alleged, which is specifically denied, then his negligence should be compared to the negligence, fault or liability of other persons and entities, both parties and non-parties to this action, and any recovery against this Defendant should be reduced accordingly.

11. Plaintiff is precluded from recovering medical bills that have been paid for by a third party for which that third party does not possess, claim, demand or assert a right of subrogation or recovery. In this regard, this Defendant reserves the right under 63 O.S. § 1-1708.1(D) to strike any and all evidence of payment of any medical bills for which there is no claim, demand or right of subrogation or recovery.

12. For further answer and defense, this Defendant asserts the defense of contributory negligence, comparative fault, and assumption of risk.

13. Plaintiffs non-economic damages are subject to the limitations of 63 O.S. § 1-1708.1(F).

14. This Defendant asserts all the liability limitations found in 63 O.S. § 1-1708.1(F-l).

15. For further answer and defense, this Defendant exercised conscientious, careful and appropriate treatment and care to the decedent at all times and, therefore, is not subject to exemplary damages as contemplated within Oklahoma’s punitive statutes.

16. The Plaintiff’s claim for punitive damages is unconstitutional and violates the due process clauses of the Fifth and Fourteenth Amendments to the United States Constitution and of Article 2, Section 7 of the Oklahoma Constitution for the following reasons: (a) the standards under which such claims are submitted are so vague as to be effectively meaningless and threaten a deprivation of property for the benefit of society without the protection of fundamentally fair procedures; (b) the highly penal nature ofpunitive damages threatens the possibility of excessive punishment and almost limitless liability without the benefit of fundamentally fair procedures or any statutory limitations; ©) the introduction of evidence of this Defendant’s financial worth is so prejudicial as to impose liability and punishment in a manner bearing no relation to the extent of any injury allegedly inflicted or to any benefit to this Defendant from any alleged wrongdoing and, therefore, any verdict would be the result of bias and prejudice in a fundamentally unfair manner.

Plaintiffs’ claim for punitive damages constitutes an unconstitutional excessive fine under Article 2, Section 9 of the Oklahoma Constitution because such highly penal sanctions may be imposed for the benefit of society under standards so vague and effectively meaningless as to threaten unlimited punishment bearing no relation to the extent of any injury allegedly inflicted at the unbridled discretion of the jury.

17. This Defendant hereby reserves the right to plead any and all affirmative defenses available to him under the Oklahoma Pleading Code, now or which may hereinafter be applicable.

18. This Defendant would reserve the right to plead additional defenses, delete or modify defenses pled, upon the completion of discovery or as the facts warrant.

WHEREFORE, for the reasons stated above, the Defendant, Michael Keefer, M.D.,
respectfully requests that judgment be granted in his favor and against the Plaintiff, and that he be allowed to recover his costs, fees, and such other and further relief as this Court deems just and equitable.


Genentech appeared and answered as follows:

Defendant, Genentech, Inc. (“Genentech”), by and through its attorneys, answers Plaintiff’s Third Amended Petition (“Petition”) as follows:

Genentech denies generally and specifically each and every material allegation contained in the Petition, except those that are expressly admitted hereafter.

Genentech’s Response to Plaintiffs Allegations Regarding the Panics

1. Genenteeh does not have knowledge or information sufficient to form a belief as to the allegations in paragraph
l.Genentech acknowledges that Decedent’s certificate of death states that February 23, 2009 was Decedent’s date of death.

2. Genentech does not have knowledge or information sufficient to form a belief as to the allegations in paragraph 2.

3. No answer is required because the Petition speaks for itself To the extent that a further answer is required, Genentech does not have knowledge or information sufficient to form a belief as to the truth of the allegations in paragraph 3.

4. No answer is required because this paragraph is not directed to Genentech. To the extent any further answer is required, Genentech admits upon information and belief that Dr. Keefer provides medical services for compensation to residents of Oklahoma. Genentech does not have knowledge or information sufficient to form a belief as to the truth of the remaining allegations in paragraph 4.

5. Genentech admits only that (1) Genentech is not incorporated in Oklahoma,(2) Genentech’s products have been sold in Oklahoma, and (3) Genentech manufactured Rituxan®, which contains the active ingredient, rituximab, prior to July 3, 2007. No answer from Genentech is required with regard to the allegations in this paragraph directed to Biogen Idec, Inc. (“Biogen”). To the extent that a ifirther answer is required, Genentech denies all remaining allegations.

Genentech’s Answer to Plaintiff’s Factual Allegations

1. This paragraph contains general statements regarding a medical condition without any reference or source. As set forth on Rituxan’s label and medication guideji) progressive multifocal leukoencephalopathy (“PML”) is caused by the JC virus, (2) “PML can lead to death or severe disability,” (3) “people with weakened immune systems can get PML,” and (4) PML may result in the following symptoms: “confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of your body, blurred vision or loss of vision.” Genentech further admits that symptoms associated with PML are diverse and can include clumsiness, ataxia (inability to coordinate movements), mental deterioration, and changes in personality. Genentech lacks information sufficient to form a belief as to the remaining allegations in this paragraph.

2. This paragraph contains general statements regarding a medical condition without any reference or source. Genentech admits that the JC virus is a latent virus present in a large number of adults. Genentech admits that PML is an infection caused by the JC virus and typically only occurs in patients who are immunocompromised. Genentech is without knowledge or information sufficient to form a belief as to the truth or falsity of the remaining allegations in this paragraph.

3. This paragraph contains general statements regarding a medical condition without any reference or source. Genentech lacks knowledge or information sufficient to form a belief as to the truth of the allegations in this paragraph.

4. This paragraph contains general statements regarding a medical condition without any reference or source. As set forth on Rituxan’s medication guide, “PML can lead to death or severe disability” and PML may result in the following symptoms: “conThsion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of your body, blurred vision or loss of vision.” Genentech further admits that symptoms associated with PML are diverse and can include clumsiness, ataxia (inability to coordinate movements), mental deterioration, and changes in personality. Genentech otherwise lacks knowledge or information to form a belief as to the truth of the matters in this paragraph.

5. As set forth in Genentech’ s October 2009 notification letter to healthcare professionals, “Rituxan has been associated with ... progressive multifocalleukoencephalopathy(PML).” Genentech ftrther refers Plaintiff to Rituxan’s label, prescribing information, medication guide, and notices to healthcare professionals for additional information regarding Rituxan and denies all allegations inconsistent with Rituxan’ s product infonnation.

6. As set forth in the Black Box warning and elsewhere on Rituxan’s label, medication guide, and prescribing information, “Rituxan administration can result in serious fatal infusion reactions,” including “tumor lysis syndrome (“TLS”),” and “severe mucocutaneous reactions.” As set forth in the prescribing information on Rituxan’ s label, “Rituxan-induced infusion reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.” Genentech refers Plaintiff to Rituxan’s label, prescribing information, medication guide, and notices to healthcare professionals for additional information regarding Rituxan and denies all allegations inconsistent with Rituxan’ s product information.

7. Genentech admits that in 1995 Genentech and IDEC Pharmaceuticals Corporation signed a collaboration agreement to develop and commercialize Rituxan.

8. Genentech admits that in 1997, Rituxan was approved [by the FDAI for the treatment of cancer (relapsed or refractory, CD2O+, B-celllow-grade non-Hodgkin’s lymphoma). Otherwise, denied.

9. Admitted.

10. No answer is required because this paragraph contains allegations that are not directed to Genentech. To the extent that a further answer is required, Genentech lacks sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

11. As set forth on Genentech’s website, in 2006 the FDA approved Rituxan for “the first-line treatment of patients with diffuse large B-cell, CD2O-positive, non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens;”“in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies;” and “for the treatment of patients with relapsed or refractory, low-grade or follicular, CD2O-positive, B-cell non-Hodgkin’s lymphoma (NHL) as a single agent; for previously untreated diffuse large B-cell, CD2O-positive, NHL in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracyclinebased chemotherapy regimens; for previously untreated follicular, CD2O-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy; and for the treatment of non-progressing (including stable disease), low-grade, CD2O-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy.” Otherwise, denied.

12. Genentech admits that (1) in 2006, the FDA and Genentech informed healthcare professionals about emerging safety information regarding Rituxan and this amiouncement contained a description of two patients who developed PML after treatment with rituximab and(2) the FDA also issued a public health advisory regarding these two patients in 2006. Otherwise, denied.

13. No answer is required because this paragraph contains allegations that are not directed to Genentech. Genentech does not have sufficient knowledge or information to form a belief as to truth of the allegations in this paragraph.

14. No answer is required because this paragraph contains allegations that are not directed to Genentech. To the extent that a further response is required, Genentech does not have sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

15. No answer is required because this paragraph contains allegations that are not directed to Genentech. To the extent that a further response is required, Genentech does not have sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

16. No answer is required because this paragraph contains allegations that are not directed to Genentech. To the extent that a further response is required, Genentech does not have sufficient knowledge or information sufficient to form a belief as to the truth of the allegations in this paragraph.

17. No answer is required because this paragraph contains allegations that are not directed to Genentech. Genentech does not have sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

18. Genentech does not have sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

19. Genentech co-marketed Rituxan with Biogen. Genentech does not have sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph relating to the Decedent andlor Plaintiff. Genentech further denies all remaining allegations in the paragraph, including (without limitation) the paragraph’s characterization of Rituxan as “defective.”

20. Genentech co-marketed Rituxan with Biogen. Genentech does not have sufficient knowledge or information to form a belief as to the allegations relating to Plaintiff and/or the Decedent. Genentech further denies all remaining allegations in the paragraph, including (without limitation) the paragraph’s implication that medications manufactured by Genentech are “defective.”

Genentech’s Answer to Plaintiff’s First Cause of Action (Strict Liability)

1. No response is required because the Petition speaks for itself. To the extent that a further response is required, Genentech incorporates by reference its responses set forth above and further denies any remaining allegations.

2. Denied.

3. Denied.

4. Denied.

Genentech’s Answer to Plaintiff’s Second Cause of Action (Design Defect)

1. No answer is required because the Petition speaks for itself. To the extent that a further response is required, Genentech incorporates by reference its responses set forth above and further denies any remaining allegations.

2. Genentech lacks sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

3. Denied.

4. Genentech lacks sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

5. Genentech lacks sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

6. Denied.

7. Denied.

8. Denied.

9. Denied.

10. Denied.

Genentech’s Answer to Plaintiff’s Third Cause of Action (Negligence)

1. No answer is required because the Petition speaks for itself. To the extent that a further response is required, Genentech incorporates by reference its responses set forth above and further denies the allegations in this paragraph.

2. This paragraph states legal conclusions to which no response is required. To the extent that Plaintiff seeks to impose duties on Genentech that exceed those existing under the law, Genentech denies the allegations in this paragraph.

3. Denied.

4. Denied.

Genentech’s Response to Plaintiff’s Allegations Against Defendant Michael Keefer

5. No response is required because the allegations in this paragraph are not directed to Genentech. To the extent that any response is required, Genentech lacks sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

6. No response is required because the allegations in this paragraph are not directed to Genentech. To the extent that any response is required, Genentech lacks sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

7. No response is required because the allegations in this paragraph are not directed to Genentech. To the extent that any response is required, Genentech lacks sufficient knowledge or information to form a belief as to the truth of the allegations in this paragraph.

Genentech’s Answer to Plaintiff’s Fourth Cause of Action (Negligence Per Sc)

1. No response is required because the Petition speaks for itself To the extent that a further response is required, Genentech incorporates by reference its responses set forth above and further denies the allegations in the paragraph.

2. This paragraph states legal conclusions to which no response is required. To the extent that Plaintiff seeks to impose duties on Genentech that exceed those existing under the law, Genentech denies the allegations in this paragraph.

3. Denied.

4. (lenentech lacks sufficient knowledge or information to form a belief about the accuracy of statements concerning the Decedent andlor her heirs. Genentech further denies all remaining allegations in this paragraph.

5. Denied.
Genentech’s Answer to Plaintiff’s Fifth Cause of Action (Breach of Implied Warranty)

1. No response is required because the Petition speaks for itself To the extent that any further response is required, Genentech incorporates by reference its responses set forth above and further denies the allegations in this paragraph.

2. Genentech lacks sufficient knowledge or information to form a belief as to the allegations regarding Deeedent andlor her agents. Genentech further denies all remaining allegations.

3. Genentech lacks sufficient knowledge or information to form a belief as to the truth of the allegations regarding the Decedent. To the extent that the paragraph makes statements or characterizations that are legal conclusions, no response is required.

4. Denied.

5. Denied.

Genentech’s Answer to Plaintiffs Sixth Cause of Action (Breach of Warranty)

1. No response is required because the Petition speaks for itself To the extent that any further response is required, Genentech incorporates by reference its responses set forth above and further denies the allegations in this paragraph.

2. No answer is required because Genentech’ s label and product information speaks for itself.

3. Genentech lacks sufficient infonnation or knowledge to form a belief as to the truth of the allegations regarding Decedent. Genentech further denies all such allegations.

4. Denied.
Genentech’s Response to Plaintiff’s Seventh Cause of Action (Deceit By Concealment)

1. No response is required because the Petition speaks for itself. To the extent that a further response is required, Genentech incorporates by reference its responses set forth above and further denies the allegations in this paragraph.

2. Denied.

3. Denied.

Genentech’s Response to Plaintiff’s Eighth Cause of Action (Negligent Misrepresentation)

1. No response is required because the Petition speaks for itself. To the extent that a further response is required, Gerientech incorporates by reference its responses set forth above and further denies the allegations in this paragraph.

2. Denied.

3. Denied.

4. Denied.

5. Denied.

6. This paragraph contains legal conclusions to which no response is required.To the extent further response is required, Genenteeh flurther denies all allegations in the paragraph.

7. Denied.

Genentech’s Answer to Plaintiff’s Ninth Cause of Action (Fraud and Deceit)

1. No response is required because the Petition speaks for itself. To the extent that any further response is required, Genentech incorporates by reference its responses set forth above and thither denies the allegations in this paragraph.

2. Denied.

3. Denied.

4. Denied.

5. (lenentech lacks sufficient knowledge and information to form a belief as to the truth of the statements in this paragraph regarding the Decedent. Genentech further denies all of the remaining allegations in the paragraph.

6. Genentech lacks sufficient information to form a belief as to the truth of the statements in this paragraph regarding the Decedent. Genentech further denies all remaining allegations in the paragraph including, without limitation, allegations that Genentech made “misrepresentations.”

7. Genentech lacks sufficient knowledge or information to form a belief as to the truth of the statements regarding Decedent. Genentech further denies all the remaining allegations.

8. Denied.

9. Denied.

10. Denied.

11. Genentech admits only that it possesses information regarding adverse reactions or other adverse events that may be associated with its product. Genentech denies all remaining allegations in this paragraph.

12. Genentech lacks information sufficient to form a belief as to the truth of the allegations in this paragraph with regard to Decedent and Decedent’s physician. Genentech further denies all remaining allegations.

13. Denied.

Genentech’s Answer to Plaintiff’s Tenth Cause of Action

(Negligence, Recklessness and Gross Neglect)

1. No response is required because the Petition speaks for itself. To the extent that a further response is required, Genentech incorporates by reference its responses set forth above and further denies the allegations in this paragraph.

2. This paragraph contains statements that are legal conclusions to which no response is required. To the extent that a further response is required, Genentech denies all allegations that seek to impose a duty on Genentech not recognized under existing law.

3. Denied.

4. Denied.

5. Denied.

6. Denied.

7. Denied.

8. Denied.

Genentech’s Answer to Plaintiff’s Eleventh Cause of Action

(Violation of the Oklahoma Consumer Protection Act)

1. No answer is required because the Petition speaks for itself. To the extent that a further response is required, Genentech incorporates by reference its responses set forth above and further denies the allegations in this paragraph.

2. Denied.

3. No answer is required because the Petition speaks for itself To the extent that a further response is required, Genentech denies all allegations.

Genentech’s Answer to Plaintiff’s Twelfth Cause of Action

(Violation of the Oklahoma Deceptive Trade Practices Act)

1. No response is required because the Petition speaks for itself To the extent that a further response is required, Genentech incorporates by reference its responses set forth above and further denies all of the allegations in this paragraph.

2. Denied.

3. No answer is required because the Petition speaks for itself To the extent that a further response is required, Genentech denies all allegations.

Genentech’s Answer to Plaintiffs Survival Benefits Allegations

1. Genentech lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained in this paragraph.

2. No answer is required because the Petition speaks for itself To the extent that a further response is required, Genentech denies all allegations.

3. Denied.

Genentech’s Answer to Plaintiffs Wrongful Death Allegations

1. Genentech lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained in this paragraph.

2. No answer is required because the Petition speaks for itself To the extent that a further response is required, Genentech incorporates by references its responses above and further denies all allegations.

3. Denied.

4. Denied.

5. Denied.

6. Denied.

Genentech’s Answer to Plaintiff’s Punitive Damage Allegations

1. No answer is required because the Petition speaks for itself. To the extent that a thrther response is required, Genentech denies all remaining allegations in this paragraph.

2. Denied.

3. Denied.

4. Denied.
Genentech further denies any and all entitlement to the relief that Plaintiff seeks.
Genentech denies and demands proof of all allegations in Plaintiff’s Petition unless expressly admitted above.

DEFENSES

1. Plaintiff has failed to state a claim upon which relief can be granted.

2. Discovery may show that Plaintiff’s claims are barred, in whole or in part, by the applicable statute of limitations andlor statute of repose or are otherwise untimely.

3. Plaintiff’s claims are preempted in whole or in part by the Federal Food, Drug & Cosmetic Act (“FDCA”) and the regulations promulgated thereunder, the Supremacy Clause of Article VI of the United States Constitution, and/or federal and/or state laws and regulations governing the labeling, manufacturing, advertising, and sale of prescription pharmaceutical products.

4. Plaintiff’s claims are barred, in whole or in part, because adequate warnings regarding, among other things, adverse events, side effects, and risks associated with Rituxan and/or rituximab were transmitted to the prescribing health care provider, and under Oklahoma law, Genentech’ s only obligation with respect to warnings is to warn the prescribing health care provider, and said obligation was fulfilled.

5. Plaintiff’s claims are barred, in whole or in part, by the “learned intermediary” doctrine.

6. Plaintiffs claims are barred in whole or in part by the doctrines of laches, waiver, and estoppel.

7. Decedent’s alleged injuries and any damages alleged by Plaintiff were caused by factors other than, and unrelated to, Rituxan andlor rituximab, including but not limited to, preexisting medical, genetic, and/or environmental conditions, diseases, or illnesses. Genentech had no control over such factors, nor were such factors due to or caused by the fault, lack of care, negligence, or breach of any duty by Genentech.

8. If the alleged injuries to Decedent were related to Rituxan and/or rituximab, such injuries were the result of an idiosyncratic reaction.

9. Plaintiff’s claims are barred because the alleged injuries to the Decedent were caused, solely, partially, or proximately, by the intervening actions, omissions, representations, misrepresentations, negligence, or breach of duty, of other persons, firms, or corporations that Genentech does not control and for whom Genentech is not legally liable and show conduct that Genentech could not foresee or anticipate.

10. Plaintiff’s alleged damages and injuries (and any injuries suffered by the Decedent) resulted from new and independent, unforeseeable, superseding, and/or intervening causes unrelated to any conduct of, or product manufactured or placed in the stream of commerce by, Genentech.

11. If Decedent sustained injuries or incurred the expenses as alleged, which is denied, the injuries or expenses were caused by the alteration, improper handling, noncompliance, or other misuse of Rituxan and/or rituximab, and Genentech is not liable for this alteration, improper handling, non-compliance, or other misuse.

12. (3enentech asserts the defense of contributory negligence, comparative fault, and assumption of risk.

13. In the event any settlement is or has been made by any alleged joint tortfeasor, then Genentech is entitled to full credit, offset, pro rata reduction, or percentage reduction, based on the percentage of fault attributable to each settling party, person, or other entity herein.

14. Any alleged danger associated with the use of Rituxan and/or rituximab was open and obvious, and Plaintiff is therefore barred from recovery.

15. Any product manufactured, labeled, advertised, and/or distributed by Genentech complied with all applicable industry and governmental standards and regulations reflected in the current state of the art at such time.

16. The conduct of Genentech and its activities with respect to Rituxan have been and are under the supervision of the FDA. Accordingly, this action is barred by the doctrine of primary jurisdiction and failure to exhaust administrative remedies.

17. The imposition of punitive or exemplary damages against Genentech
would violate its constitutional rights under the Due Process Clauses in the Fifth and Fourteenth
Amendments of the United States Constitution, the excessive fines clause in the Eighth
Amendment of the United States Constitution, the double jeopardy clause of the Fifth
Amendment of the United States Constitution, the commerce clause of the United States
Constitution, and similar provisions under the Oklahoma constitution andlor applicable statutes or Court Rules.

18. With respect to Plaintiff’ s demand for punitive damages, Genentech specifically incorporates by reference any and all standards and limitations regarding the determination and/or enforceability of punitive damage awards that arose in the decisions of BMW of No. America v. Gore, 517 U.S. 559 (1996), Cooper Indus., Inc. v. Leatherman Tool Group, Inc., 532 U.S. 424 (2001), and State Farm Mist. Automobile Ins. Co. v. Campbell, 123 S.Ct. 1513 (2003).

19. To the extent that Plaintiff’s claims are based on alleged misrepresentations made to the FDA, such claims are barred pursuant to Buckman Co. v. P1aintffs’Legal Committee,53 1 U.S. 341 (2001).

20. Genentech alleges that Decedent was filly informed of the risks of the use of Rituxan by her treating physician, and the informed consent and/or release given by Decedent is pleaded as an affimiative defense.

21. Plaintiff’s claims are barred, in whole or in part, by Decedent’s and/or Plaintiff’s failure to mitigate the alleged damages.

22. To the extent that Plaintiff seeks recovery for benefits entitled to be received or actually received from any other source of injuries alleged in the Petition, such benefits are not recoverable in this action.

23. Because of the lack of clear standards, the imposition of punitive damages against Genentech is unconstitutionally vague and/or overbroad.

24. Further, as to any punitive damages claims pursued by Plaintiff, Genentech is entitled to a trial which bifurcates the issue of liability and punitive damages.

25. Any and all damages claimed by Plaintiff, whether compensatory, punitive, actual, attorney’s fees, or otherwise, are subject to all statutory exclusions and limitations, including but not limited to those contained in 23 Okla. Stat. § 9.1.

26. Plaintiff’s claim of negligent misrepresentation and claims seeking to hold Genentech liable for representations that it made are barred in whole or in part by the First Amendment of the United States Constitution.

27. Plaintiffs claims for relief are barred in whole or in part because Plaintiff lacks standing for the remedies that she seeks.

28. Genentech complied with all of its legal and regulatory obligations and therefore claims by Plaintiff are barred in whole or in part.

29. The damages that Plaintiff seeks are too remote and speculative and therefore Plaintiff should be denied recovery.

30. Plaintiff’s claims are barred in whole or in part because there is no private right of action for consumers under the Oklahoma Deceptive Trade Practices Act.

31. Plaintiff’s claims of fraud are barred by reason of Plaintiffs failure to allege circumstances constituting fraud with particularity.

32. Genentech denies that it breached any warranties.

33. To the extent that Plaintiff relies upon any theory of breach of warranty, such claims are also barred for lack of timely notice of breach and lack of privity and because the alleged warranties were disclaimed.

34. Plaintiffs claims are barred in whole or in part under the applicable state law because any drug or pharmaceutical was subject to and received pre-market approval by the FDAunder, e.g., 52 Stat. 1040, 21 U.S.C. § 301.

35. (}enentech’s advertisements and labeling were not false or misleading and therefore constitute protected commercial speech.

36. Plaintiff’s claims are barred in whole or in part under comment k to Section4O2A of the Restatement (Second) of Torts.

37. Plaintiffs claims are barred in whole or in part because Genentech provided legally adequate “directions or warnings” as to any drug or pharmaceutical Plaintiffs Decedent alleges to have taken within the meaning of comment jto Section 402A of the Restatement(Second) ofTorts.

38. Plaintiffs claims are barred in whole or in part because the drug at issue provides “net benefits for a class of patients” within the meaning of comment f to Section 6 of the Restatement (Third) of Torts: Products Liability.

39. Plaintiffs claims are barred under Section 4 et. seq., of the Restatement(Third) of Torts: Products Liability.

40. To the extent that Plaintiff s claims are based on allegations of strict liability against Genentech, those claims are barred under relevant Oklahoma law.

41. Plaintiffs claims are barred in whole or in part because Genentech did not make any false statement or material omission in relation to Rituxan.

42. Plaintiffs claims are barred in whole or in part because Plaintiff andlor Decedent did not detrimentally rely on statements from Genentech.

43. Genentech incorporates by reference the defenses set forth by any other Defendant in this action to the extent consistent with Genentech’ s Answer as set forth herein.

RESERVATION OF RIGHTS

Genentech reserves the right to assert, and hereby gives notice that it intends to rely upon, any other defense that may become available or appear during discovery proceedings or otherwise in this case and hereby reserves the right to amend its answer to assert any such defense.

JURY DEMAND

Defendant Genentech hereby demands a trial by jury in the above-captioned lawsuit.

PRAYER FOR RELIEF

WHEREFORE, Genentech respectfully requests that the Court dismiss the Petition in its entirety with prejudice and grant any other relief as the Court deems just and proper.

Outcome: Dr. Keefer was dismissed without prejudice on February 15, 2011. Dismissed without prejudice as to all parties.

Plaintiff's Experts:

Defendant's Experts:

Comments: Editor's Note: It appeared from the docket for this case that Plaintiff's attorneys lost interest in the case and withdrew and Plaintiff was unable to proceed and the case was dismissed without prejudice.