The following lawsuit, filed in the U.S. District Court for the Western District of Oklahoma, alleges that users of Reglan risk developing movement disorders such as tardive dyskinesia. Further, the lawyers allege that after showing signs of tardive dyskinesia, Susan Schrock in fact developed that movement disorder:
3.10 Upon information and belief, in prescribing the Reglan/metoclopramide to Mrs. Schrock on a long-term basis, her prescribing doctor relied upon information published in the package inserts and/or the Physicians' Desk Reference (hereinafter referred to as “PDR”) or otherwise disseminated by the Reference Listed Drug Company (hereinafter referred to as “RLD”) and/or the New Drug Application Holder (hereinafter referred to as “NDA Holder”).
3.11 Mrs. Schrock ingested the Reglan/metoclopramide as prescribed.
3.12 Mrs. Schrock used the pharmaceutical drugs Reglan/metoclopramide without substantial change in the condition of the drugs between the time of design and manufacture of the drugs and the time she used the drugs as directed.
3.13 Mrs. Schrock's long-term ingestion of the Reglan/metoclopramide caused her injuries.
3.14 Mrs. Schrock was not aware of information different from or contrary to the inaccurate, misleading, materially incomplete, false and/or otherwise inadequate information disseminated in the PDR, RLD, or by the NDA Holders.
3.15 In June of 2006, Mrs. Schrock was exhibiting abnormal movements which have since been linked to her use of Reglan/metoclopramide.
3.16 Mrs. Schrock's use of Reglan/metoclopramide, as prescribed, resulted in overexposure to the drugs which have caused her to suffer serious, permanent and disabling injuries, including but not limited to, injuries of or associated with the central nervous and extrapyramidal motor systems, specifically Tardive Dystonia, a severe and often permanent disfiguring neurological movement disorder.
3.17 Mrs. Schrock's serious and permanent injuries, as described above, came about as a foreseeable and proximate result of Defendants' dissemination of inaccurate, misleading, materially incomplete, false and otherwise inadequate information concerning the potential effects of exposure to and long-term ingestion of Reglan/metoclopramide to the medical community, Mrs. Schrock, and other foreseeable users of the drug.
TO THE HONORABLE U.S. DISTRICT JUDGE:
Plaintiffs state:
Allegations Common to All Claims
1. PARTIES
1.01 Plaintiff Susan Schrock (hereinafter referred to as “Mrs. Schrock”) is an individual who is a resident and citizen of Alva, Woods County, Oklahoma. Plaintiff Steve Schrock is an individuals, and the husband of Susan Shrock, and is a resident and citizen of Alva, Woods County, Oklahoma.
1.02 Defendant Wyeth, Inc. d/b/a Wyeth (hereinafter referred to as “Wyeth”) is a Delaware corporation with its principal place of business in New Jersey. References to Wyeth include Wyeth individually, and collectively all divisions and/or subsidiaries, as well as successor-in-interest to A.H. Robins, Inc., American Home Drugs Corporation and ESI, Lederle, Inc. Wyeth may be served through its registered agent: The Prentice-Hall Corporation System, Oklahoma, Inc., 115 SW 89th, Oklahoma City, Oklahoma 73139-8511.
1.03 Defendant Schwarz Pharma, Inc., (hereinafter referred to as “Schwarz”) is a Delaware corporation with its principal place of business in Mequon, Wisconsin. References to Schwarz include Schwarz individually, and collectively all of its predecessors in interest and divisions. Schwarz may be served with process through its registered agent: CSC Entity Services, LLC, 103 Foulk Road, Suite 200, Wilmington, Delaware 19803.
1.04 Defendant Pliva USA, Inc., (hereinafter referred to as “Pliva”) is a New York corporation with its principal place of business in New Jersey. Pliva is a wholly owned subsidiary of Barr Pharmaceuticals, Inc. Pliva may be served with process through its registered agent: Corporation Trust Company, 820 Bear Tavern Road, 3rd Floor, West Trenton, New Jersey 08628. Barr Pharmaceuticals, Inc. is being sued herein as the owner of Pliva and may be served with process at 225 Summit Avenue, Montvale, New Jersey 07645. Hereafter, Pliva and Barr Pharmaceuticals, Inc. will be collectively referred to as “Pliva.”
1.05 Defendant Actavis Elizabeth LLC, (hereinafter referred to as “Actavis”) is a Delaware corporation with its principal place of business in New Jersey. Actavis is a wholly owned subsidiary of Actavis, Inc. Actavis may be served with process at its principal place of business: 200 Elmora Avenue, Elizabeth, New Jersey 07207. Actavis, Inc. is being sued herein as the owner of Actavis and may be served with process at 14 Commerce Drive, Suite 301, Cranford, New Jersey 07016. Hereafter, Actavis and Actavis, Inc. will be collectively referred to as “Actavis.”
2. VENUE AND JURISDICTION
2.01 Both jurisdiction and venue are proper in the Western District of Oklahoma. The Defendants conduct or have conducted business activity in Woods County, Oklahoma and the Defendants have distributed products throughout Woods County. Mrs. Schrock was prescribed, purchased and consumed the Defendants' products in the Western District of Oklahoma.
2.02 Jurisdiction is based on complete diversity between the Plaintiffs and all of the Defendants pursuant to 28 U.S.C. § 1332.
2.03 Venue is proper as to causes of action against all Defendants because:
1. A substantial part of the cause of action accrued in the State of Oklahoma in that Mrs. Schrock received and consumed the Defendants' pharmaceutical products in Woods County, Oklahoma and sustained injury in Woods County, Oklahoma.
2. All of the Defendants have directed their products into Woods County, Oklahoma.
3. All of the Defendants have sold their products in Woods County, Oklahoma.
4. Woods County sits in the Western District of Oklahoma.
2.04 The amount in controversy exceeds $75,000.00.
3. STATEMENT OF FACTS
A. Mrs. Schrock Developed Tardive Dystonia after Ingesting Reglan/metoclopramide
3.01 Plaintiffs bring this action for the purpose of recovering damages for the personal injuries Mrs. Schrock has suffered as a result of being prescribed and ingesting Reglan, metoclopramide and/or metoclopramide HC1 (hereinafter referred to as “Reglan/metoclopramide”).
3.02 At all times material hereto, Defendant Wyeth was engaged in the business of testing, developing, manufacturing, labeling, marketing, distributing, promoting and/or selling, either directly or indirectly, through third parties, as successor in interest, or other related entities Reglan/metoclopramide in the state of Oklahoma and in interstate commerce. Wyeth manufactures and distributes generic metoclopramide through its ownership of ESI Lederle, Inc. (hereinafter “ESI”), a former subsidiary which merged into Wyeth.
3.03 At all times material hereto, Defendant Schwarz, one of its predecessors in interest, and/or one of its family of wholly owned divisions was engaged in the business of testing, developing, manufacturing, labeling, marketing, distributing, promoting and/or selling, either directly or indirectly, through third parties, as successor in interest, or other related entities, Reglan/metoclopramide in the State of Oklahoma and in interstate commerce.
3.04 At all times material hereto, Defendant Pliva was engaged in the business to testing, developing, manufacturing, labeling, marketing, distributing, promoting and/or selling, either directly or indirectly, through third parties or related entities, Reglan/metoclopramide in the State of Oklahoma and in interstate commerce.
3.05 At all times material hereto, Defendant Actavis was engaged in the business to testing, developing, manufacturing, labeling, marketing, distributing, promoting and/or selling, either directly or indirectly, through third parties or related entities, Reglan/metoclopramide in the State of Oklahoma and in interstate commerce.
3.06 At all relevant times, Defendants were acting by and through their agents, servants and/or employees, each of whom were acting within the scope and course of their employment by agency or authority on their behalf.
3.07 At all times relevant hereto, Defendants were in the business of researching, designing, formulating, compounding, testing, manufacturing, producing, processing, assembling, inspecting, distributing, marketing, labeling, promoting, packaging, and/or advertising the pharmaceutical drugs known as Reglan/metoclopramide in the State of Oklahoma and in interstate commerce.
3.08 In March of 2000, Mrs. Schrock's physician prescribed Reglan at a dosage of 10mg to treat her reflux.
3.09 The active ingredient, metoclopramide and metoclopramide HC1, is a dopamine antagonist.
3.10 Upon information and belief, in prescribing the Reglan/metoclopramide to Mrs. Schrock on a long-term basis, her prescribing doctor relied upon information published in the package inserts and/or the Physicians' Desk Reference (hereinafter referred to as “PDR”) or otherwise disseminated by the Reference Listed Drug Company (hereinafter referred to as “RLD”) and/or the New Drug Application Holder (hereinafter referred to as “NDA Holder”).
3.11 Mrs. Schrock ingested the Reglan/metoclopramide as prescribed.
3.12 Mrs. Schrock used the pharmaceutical drugs Reglan/metoclopramide without substantial change in the condition of the drugs between the time of design and manufacture of the drugs and the time she used the drugs as directed.
3.13 Mrs. Schrock's long-term ingestion of the Reglan/metoclopramide caused her injuries.
3.14 Mrs. Schrock was not aware of information different from or contrary to the inaccurate, misleading, materially incomplete, false and/or otherwise inadequate information disseminated in the PDR, RLD, or by the NDA Holders.
3.15 In June of 2006, Mrs. Schrock was exhibiting abnormal movements which have since been linked to her use of Reglan/metoclopramide.
3.16 Mrs. Schrock's use of Reglan/metoclopramide, as prescribed, resulted in overexposure to the drugs which have caused her to suffer serious, permanent and disabling injuries, including but not limited to, injuries of or associated with the central nervous and extrapyramidal motor systems, specifically Tardive Dystonia, a severe and often permanent disfiguring neurological movement disorder.
3.17 Mrs. Schrock's serious and permanent injuries, as described above, came about as a foreseeable and proximate result of Defendants' dissemination of inaccurate, misleading, materially incomplete, false and otherwise inadequate information concerning the potential effects of exposure to and long-term ingestion of Reglan/metoclopramide to the medical community, Mrs. Schrock, and other foreseeable users of the drug.
3.18 Mrs. Schrock has experienced and will continue to experience medical and related expenses, loss of ability to provide household services, disfigurement, disability, pain, suffering, psychological injury and other injuries and damages doe to the prescription and ingestion of this drug. Her husband has and will continue to suffer consortium damages.
B. Defendants' Wrongful Conduct
3.19 This case involves Defendants' failure to warn doctors and patients of information within their knowledge or possession which indicated that the subject Reglan/metoclopramide, when taken for long periods of time, caused serious, permanent and debilitating side effects, including tardive dystonia.
3.20 Defendants jointly and severally marketed, manufactured and distributed Reglan/metoclopramide and encouraged the long term use of these drugs, misrepresented the effectiveness of these drugs and concealed the drug's dangerous side effects.
3.21 Reglan/metoclopramide is indicated only as short-term therapy for symptomatic gastroesophageal reflux and acute and recurrent diabetic gastric stasis.
3.22 Reglan/metoclopramide is indicated only for use for no greater than 12 weeks; however, Defendants represented that Reglan/metoclopramide was safe for use to treat nausea and/or esophageal reflux for durations that exceed 12 weeks.
3.23 Patients who use Reglan/metoclopramide for long periods are at a significantly increased risk of developing a severe and permanent neurological movement disorder.
3.24 Other serious side effects caused by ingesting Reglan/metoclopramide for long periods include, but are not limited to, central nervous system disorders, depression with suicidal ideation, akathesia, tardive dyskinesia, tardive dystonia, visual disturbances and interference with drug metabolism.
3.25 Patients who use Reglan/metoclopramide for long periods who are not able to effectively metabolize it are at a greater risk of developing these serious and permanent injuries.
3.26 Tardive dystonia, one of the serious side effects associated with the ingestion of Reglan/metoclopramide is a debilitating neurological disorder that often results in involuntary and uncontrollable movements of the head, neck, face, arms, legs and trunk, in addition to facial grimacing, uncontrollable tongue movements and other involuntary movements. Presently, there is no cure for tardive dystonia.
3.27 Mrs. Schrock's diagnosed tardive dystonia, caused by the ingestion of metoclopramide, is permanent.
3.28 Wyeth is the successor-in-interest to A.H. Robins Company, Inc., which first obtained approval by the United States Food and Drug Administration (hereinafter referred to as “FDA”) to distribute metoclopramide, under the brand name “Reglan” under the FDA's New Drug Application (NDA)[FN1] schema in 1983.
FN1. Upon information and belief, Wyeth is the holder of multiple NDAs for Reglan, metoclopramide and metoclopramide HC1.
3.29 Defendant Wyeth's predecessor in interest, A.H. Robins Company, Inc. expressly warranted to physicians that Reglan/metoclopramide is safe for long-term use.
3.30 A.H. Robins knew that its warranties regarding safety for long-term use would be relied upon by ordinary, reasonable and prudent physicians who would share that information with other physicians in their communities and that eventually physicians would come to rely on A.H. Robins' express warranties about Reglan/metoclopramide's safety for long-term use.
3.31 A.H. Robins' express warranties about the safety of Reglan/metoclopramide for long-term use were false and intentionally and negligently misleading.
3.32 As successor-in-interest to A.H. Robins Company, Inc., Wyeth is legally responsible for the conduct, fraudulent and negligent acts, intentional and willful omissions, and misleading representations and warranties made my A.H. Robins Company, Inc. concerning the safety and adequacy of Reglan/metoclopramide, and all liabilities stemming therefrom.
3.33 Wyeth manufactured, marketed and distributed Reglan, metoclopramide, and/or metoclopramide HC1 through its Wyeth-Ayerst Laboratories Division in St. Davids, Pennsylvania and through its ownership of “ESI.”[FN2]
FN2. Upon information and belief, ESI was a former subsidiary which merged into Wyeth on or about December 15, 1998.
3.34 Wyeth knew that it must fully disclose material safety data and information regarding a new drug's chemistry, proposed manufacturing process, proposed model labeling, including warnings about risks and side effects, and test results involving animal studies, clinical studies, and the drug's bioavailability.
3.35 Wyeth knew that the data and information would be relied upon by the medical community, physicians, Plaintiffs and other foreseeable users of Reglan/metoclopramide once the NDA was approved and Wyeth was listed and the Reference Listed Drug Company for the drug.
3.36 Wyeth intentionally and negligently disseminated misleading information to physicians across the county, through the PDR, about the risks of long-term ingestion of Reglan/metoclopramide and the increased risk of extrapyramidal side effects, including tardive dystonia.
3.37 Defendant Schwarz purchased from Wyeth the rights and liabilities associated with Reglan/metoclopramide, the terms of which, upon information and belief, obligated Schwarz to be responsible for claims related to the ingestion or use of Reglan/metoclopramide.
3.38 Defendant Schwarz entered into an indemnification agreement with Wyeth over the purchase of the innovator, Wyeth's, Reglan, which included disclosure of clinical studies on Reglan/metoclopramide that were not publicly available.[FN3]
FN3. Plaintiff does not have information regarding the maximum amount of liability under the defendants' indemnification agreement.
3.39 Because Defendant Schwarz acquired Defendant Wyeth's Reglan/metoclopramide assets and liabilities while Wyeth was involved in ongoing litigation regarding Reglan/metoclopramide, and nevertheless agreed to indemnify Wyeth against all claims related to the ingestion of the drug, Schwarz knew or should have known that the NDA label for Reglan/metoclopramide (Wyeth's label) misrepresented the safety of the drug, withheld warnings of the known side effects of the drug, and knew or should have known of the safety issues surrounding it.
3.40 Under the FDA schema, Wyeth was and is the Reference Listed Drug Company (RLD), under a specific NDA, for Reglan/metoclopramide.
3.41 Under the FDA schema, Defendant Schwarz was and remains the RLD and/or NDA Holder for Reglan/metoclopramide.
3.42 At all times material hereto, Defendants Wyeth and Schwarz, as the NDA Holder and/or RLD companies, were aware of the serious side effects caused by Reglan/metoclopramide including, but not limited to, central nervous system disorders, depression with suicidal ideation, akathesia, tardive dyskinesia, tardive dystonia, visual disturbances and interference with drug metabolism.
3.43 Defendants Wyeth and Schwarz have a duty to ensure their warnings to the medical community are accurate and adequate, to conduct safety surveillance of adverse events for the drug, and to report any data related to the safety and/or accuracy of the warnings and information disseminated regarding the drug.
3.44 Defendants Wyeth and Schwarz represented that Reglan/metoclopramide was safe for use to treat gastritis/gastroesophageal reflux knowing that the drug was not safe for that purpose and was dangerous to the health and body of Mrs. Schrock.
3.45 Defendants Wyeth and Schwarz represented that Reglan/metoclopramide caused minimal side effects knowing that the drug caused central nervous system side effects, and extrapyramidal symptoms, among other side effects, far more frequently than represented.
3.46 Defendants Wyeth and Schwarz had actual knowledge, through their own studies and studies by independent investigators, that doctors frequently prescribed Reglan/metoclopramide for long-term use that was not safe for patients.
3.47 Defendants Wyeth and Schwarz had, through their own studies and studies by independent investigators, that nearly one-third of all patients who used Reglan/metoclopramide received it on doctor's prescriptions for 12 months or longer, rather than 12 weeks or less.
3.48 Defendants Wyeth and Schwarz also had actual knowledge, through research by independent investigators, that the risk of tardive dyskinesia and other extrapyramidal side effects of Reglan/metoclopramide in patients who receive the drug for 12 weeks or longer is approximately 100 times greater than disclosed in package inserts and the PDR.
3.49 Defendants Wyeth and Schwarz knew, or through the exercise of reasonable care should have known, that many patients who use Reglan/metoclopramide are not able to effectively metabolize it and that as a foreseeable consequence of their inability to effectively metabolize, those patients have a greater risk of developing serious and permanent injuries.
3.50 Defendants Wyeth and Schwarz had actual knowledge of facts which demonstrated that representations in the Reglan/metoclopramide package insert, the PDR and literature they distributed to physicians were false and misleading.
3.51 Defendants Wyeth and Schwarz failed to correct their monograph and/or disclose that knowledge to the medical community, Plaintiffs, and other foreseeable users.
3.52 It is the public policy of the United States and of this state, as reflected in the Hatch-Waxman Act, to encourage the availability of cheaper, generic drug products that are therapeutically equivalent to name brand products and to encourage the substitution, as appropriate, of such generic products for name brand products in patients' medical therapy.
3.53 Defendants Wyeth and Schwarz, as prescription drug manufacturers and/or distributors, knew or should have realized that so-called “drug product selection laws,” enacted in every state, including this state, authorize or require a prescription for a drug identified by product brand name or by generic name to be filled, subject to certain limitations, with a generic drug product that is therapeutically equivalent to the name brand drug product.
3.54 Defendants Wyeth and Schwarz knew or ought to have realized that generic drug manufacturers customarily copy verbatim the package insert for the name brand prescription drug product to give the impression that the information contained in the package inserts accompanying their own generic prescription drugs is accurate and not misleading.
3.55 Defendants Wyeth and Schwarz knew or ought to have known that the generic drug manufacturers also typically rely upon the marketing efforts of the name brand manufacturer to generate sales of their own products.
3.56 Defendants Wyeth and Schwarz knew or ought to have realized that physicians commonly consult the information disseminated by the name brand manufacturer, in the PDR or otherwise, and rely upon that information in their decisions concerning the prescribing of those products for their patients.
3.57 Defendants Wyeth and Schwarz knew of should have known, specifically, that physicians would rely upon the information disseminated to them by the name brand manufacturer, regardless of whether the prescriptions might be filled with either the name brand product, Reglan, or generic Reglan/metoclopramide, and that many patients, in accordance with those prescriptions, would be likely to ingest generic Reglan/metoclopramide.
3.58 Defendants Pliva and Actavis each submitted an Abbreviated New Drug Application (ANDA) to the FDA, based on representations made by the RLD companies, requesting permission to manufacture, market, and distribute generic Reglan/metoclopramide.
3.59 Under the ANDA process, the Code of Federal Regulations required Pliva and Actavis to submit labels for Reglan/metoclopramide initially identical in all material aspects to the reference listed drug label.
3.60 Under the Code of Federal Regulations, Pliva and Actavis had a duty to ensure their Reglan/metoclopramide warnings to the medical community were accurate and adequate, to conduct post market safety surveillance, to review all adverse drug event information, and to report any information bearing on the risk and/or prevalence of side effects caused by Reglan/metoclopramide.
3.61 Under the Code of Federal Regulations, if Pliva and Actavis discover information in the course of the fulfillment of their duties as outlined above, they must report that information to the medical community, Plaintiffs and other foreseeable users of Reglan/metoclopramide to ensure that their warnings are continually accurate and adequate.
3.62 Defendants Pliva and Actavis failed to investigate the accuracy of their metoclopramide and/or metoclopramide HC1 drug labels.
3.63 Defendants Pliva and Actavis failed to review the medical literature for the metoclopramide drug and/or metoclopramide HC1 drug.
3.64 Defendants Pliva and Actavis relied upon the name brand manufacturer and the referenced listed drug companies to review the aforementioned medical literature for Reglan/metoclopramide.
3.65 Under the FDA schema, if the FDA approves a label change as requested by an ANDA holder, the NDA holder (also referred to as the RLD company) must also amend its label.
3.66 Defendants Pliva and Actavis failed to communicate the true and accurate risks and/or prevalence of severe neurological side effects resulting from the ingestion of drugs containing Reglan/metoclopramide.
3.67 Defendants disseminated to physicians, through package inserts, the publication of the PDR, and otherwise, information concerning the properties and effects of Reglan/metoclopramide, with the intention that physicians would rely upon that information in their decisions concerning the prescription of drug therapy for their patients.
3.68 Defendants knew, or should have known through the exercise of reasonable care, that the package insert for Reglan/metoclopramide substantially understated the prevalence of acute and long-term side effects on ingesting the drug.
3.69 Defendants failed to use reasonable care to modify the package insert to adequately warn physicians about the true risks of both short-term and long-term use, even after several injured patients filed lawsuits alleging inadequate warnings and produced competent expert testimony supporting their allegations.
3.70 Defendants owed a duty in all of their several undertakings, including the dissemination of information concerning Reglan/metoclopramide, to exercise reasonable care to ensure that they did not create unreasonable risks of personal injury to others.
3.71 Reglan/metoclopramide was widely advertised by Defendants as a safe and effective treatment of diabetic gastroparesis, gastroesophageal reflux disease (GERD) and other gastrointestinal disorders.
3.72 Defendants failed to conduct and report post market safety surveillance on Reglan/metoclopramide.
3.73 Defendants failed to review all adverse drug event information[FN4] and to report any information bearing upon the adequacy and accuracy of their warnings, efficacy, or safety, including the risks and/or prevalence of side effects caused by Reglan/metoclopramide.
FN4. Defendants are required to review all adverse drug experience information obtained or otherwise received ... from any source ... including derived from postmarketing clinical investigations, postmarketing epidemiological/surveillance studies, reports from the scientific literature, and unpublished scientific reports. 21 C.F.R. § 317.80(b).
3.74 Defendants failed to monitor all relevant scientific literature related to Reglan/metoclopramide.
3.75 Defendants failed to disclose material safety information regarding the serious and permanent side effects caused by taking Reglan/metoclopramide for long periods of time.
3.76 Defendants failed to report data, regardless of the degree of significance, regarding the adequacy and/or accuracy of their warnings, efficacy or safety of Reglan/metoclopramide.
3.77 Defendants knowingly concealed from physicians material facts bearing on the interpretation of package insert disclosures that exposure to Reglan/metoclopramide can lead to tardive dystonia and other extrapyramidal side effects, that the risk is “believed” to increase with duration of therapy and total cumulative dose, and that therapy for longer than 12 weeks “cannot be recommended.”
3.78 Defendants concealed the fact that earlier false information disseminated by A.H. Robins Company and/or Wyeth representing long-term Reglan/metoclopramide therapy to be reasonably safe, was unscientific and false.
3.79 Defendants concealed the fact that Reglan/metoclopramide is a neuroleptic agent and dopamine antagonist, which can be expected to lead to tardive dystonia and other extrapyramidal side effects with approximately the same high frequency, particularly in longer term use, as other neuroleptic drugs and that epidemiological studies have consistently confirmed this expectation.
3.80 ODefendants also concealed the fact that the treatment of chronic or intermittent gastroesophageal reflux and/or diabetic gastroporesis and/or other gastric disorders with Reglan/metoclopramide for longer than 12 weeks is unlikely to be reasonably safe.
3.81 Some or all of the Defendants, as a result of their participation as defendants in previous litigation concerning Reglan/metoclopramide products received clear notice of Wyeth's suppression of important safety information concerning Reglan/metoclopramide, yet despite this notice chose to ignore the information and join consciously in the suppression.
4. CLAIMS FOR RELIEF
A. Negligence
4.01 Defendants owed a duty to the general public and specifically to Plaintiffs to exercise reasonable care in the design, study, development, manufacture, promotion, sale, marketing and distribution of their prescription medications, including the Reglan/metoclopramide at issue in this lawsuit. Defendants failed to exercise reasonable care in the design of Reglan/metoclopramide because as designed, it was capable of causing serious personal injuries such as those suffered by Mrs. Schrock during foreseeable use. Defendants also failed to exercise reasonable care in the marketing of Reglan/metoclopramide because they failed to warn that, as designed, Reglan/metoclopramide was capable of causing serious personal injuries such as those suffered by Plaintiffs during foreseeable use.
4.02 Defendants breached their duty and were negligent in their actions, misrepresentations, and omissions toward Plaintiffs in that Defendants:
a. Failed to use due care in developing, testing, designing and manufacturing Reglan/metoclopramide so as to avoid the aforementioned risks to individuals when Reglan/metoclopramide was being used for treatment of patients;
b. Failed to accompany their product with proper or adequate warnings regarding adverse side effects and health risks associated with the use of Reglan/metoclopramide and the comparative severity and duration of such adverse effects;
c. Failed to accompany their product with proper or adequate rate of incidence or prevalence of permanent irreversible neurological damage;
d. Failed to provide warnings that accurately reflected the symptoms, scope or severity of the side effects and health risks;
e. Failed to conduct adequate pre-clinical and clinical testing and post-marketing surveillance to determine the safety of Reglan/metoclopramide;
f. Failed to provide adequate training or information to medical care providers for appropriate use of Reglan/metoclopramide;
g. Failed to adequately warn consumers and medical prescribers (but instead actively encouraged the sale of Reglan/metoclopramide), about the following: (1) that Reglan/metoclopramide should not be prescribed for more than 12 weeks; (2) that Reglan/metoclopramide can cause neuromuscular side effects, including, but not limited to, tardive dystonia; (3) that Reglan/metoclopramide should be discontinued in the face of involuntary facial, tongue, jaw, limb or trunk movements; and (4) that the health risks posed by Reglan/metoclopramide may become debilitating, difficult, and painful, necessitating lengthy and/or repeated visits to the doctor, clinic, or hospital;
h. Failed to adequately test and/or warn about the use of Reglan/metoclopramide, including, without limitation, the possible adverse side effects and health risks caused by the use of Reglan/metoclopramide;
i. Failed to adequately warn users, consumers and physicians about the severity, scope and likelihood of neurological damage and related dangerous conditions to individuals taking Reglan/metoclopramide; and
j. Representing to physicians, including but not limited to Mrs. Schrock's prescribing physician, that this drug was safe and effective for use.
4.03 The Reglan/metoclopramide was in substantially the same condition when it was ingested by Mrs. Schrock as it was in when it left the control of Defendants. Reglan/metoclopramide's capability to cause serious personal injuries and damages such as those suffered by Plaintiffs was not due to any voluntary action or contributory negligence of Plaintiffs. The Reglan/metoclopramide was consumed by Mrs. Schrock as directed and without change in its form or substance.
4.04 Defendants' failure to exercise reasonable care in the design and/or marketing of Reglan/metoclopramide was a proximate cause of Plaintiffs' injuries and damages. Plaintiffs seek all damages to which they may be justly entitled.
B. Strict Liability
4.05 Plaintiffs claim that Defendants are liable under the theory of strict products liability. Defendants were at all times relevant to this suit, and now are, engaged in the business of designing, manufacturing, testing, marketing, and placing into the stream of commerce pharmaceuticals for sale to, and use by, members of the public, including the Reglan/metoclopramide at issue in this lawsuit. The Reglan/metoclopramide manufactured by Defendants reached Mrs. Schrock without substantial change and was ingested as directed. The Reglan/metoclopramide was defective and unreasonably dangerous when it entered into the stream of commerce and when used by Mrs. Schrock.
4.06 Reglan/metoclopramide was unreasonably defective in design and marketing, considering the utility of the product and the risk involved in its use, because as designed and marketed, Reglan/metoclopramide could cause injuries such as those suffered by Mrs. Schrock during foreseeable use. This fact was known to Defendants at the time Reglan/metoclopramide was placed into the stream of commerce, but was not readily recognizable to an ordinary consumer, including Plaintiffs. Nonetheless, Defendants failed to warn that Reglan/metoclopramide as designed and marketed was capable of causing serious personal injuries such as those suffered by Plaintiffs during foreseeable use. Such a failure to warn rendered the Reglan/metoclopramide unreasonably dangerously defective as designed and marketed.
4.07 The defective and unreasonably dangerous design and marketing of Reglan/metoclopramide was a direct, proximate and producing cause of Plaintiffs' injuries and damages. Under strict products liability theories set forth in Restatement (Second) of Torts, Defendants are liable to Plaintiffs for all damages claimed in this case, including punitive damages.
C. Breach of Warranties
4.08 Defendants were at the time of the acts forming the basis of this lawsuit, and now are, merchants with respect to the Reglan/metoclopramide at issue in this lawsuit. Defendants marketed and promoted their Reglan/metoclopramide as safe and efficacious for its intended uses. The Reglan/metoclopramide consumed by Mrs. Schrock reached her without substantial change in its condition and was used by her as intended by Defendants. Defendants expressly and impliedly warranted that the Reglan/metoclopramide were not unreasonably dangerous and instead were merchantable and fit for its intended use by Mrs. Schrock.
4.09 Defendants breached these warranties (both express and implied) as the Reglan/metoclopramide was not merchantable, was unfit for its intended use and was unreasonably dangerous when comparing the benefits to the risks associated with its use. Plaintiffs were injured as a result of these breaches of warranties.
D. Misrepresentation and Fraud
4.10 Defendants, through their advertising, labeling, marketing, and sales/detail persons, made significant representations, which were false, knowing that such representations were false and/or with reckless disregard for the truth or falsity of such representations, with the intent that Plaintiffs rely on such material representations; Plaintiffs acted in actual and justifiable reliance on such material misrepresentations and Mrs. Schrock was injured as a result.
4.11 In addition, and in the alternative if necessary, Defendants knowingly omitted and downplayed material information, which omission constitutes a positive misrepresentation of material fact, with the intent that Plaintiffs rely on Defendants' misrepresentations; Plaintiffs acted in actual and justifiable reliance on Defendants' representations and Mrs. Schrock was injured as a result.
4.12 Defendants committed constructive fraud by breaching one or more legal or equitable duties owed to Plaintiffs relating to the Reglan/metoclopramide at issue in this lawsuit, said breach or breaches constituting fraud because of their propensity to deceive others or constitute an injury to public interests or public policy.
4.13 Defendants misrepresented to the FDA, Plaintiffs, and the health care industry the safety and effectiveness of Reglan/metoclopramide and/or fraudulently, intentionally and/or negligently concealed material information, including adverse information regarding the safety and effectiveness of Reglan/metoclopramide.
4.14 Defendants made these misrepresentations and actively concealed adverse information at a time when they knew, or should have known, that Reglan/metoclopramide had defects, dangers, and characteristics that were other than what they had represented to Plaintiffs and the health care industry generally. Specifically, Defendants misrepresented to and/or actively concealed from Plaintiffs and the consuming public that:
a. Reglan/metoclopramide had statistically significant increases in neuromuscular side effects which could result in serious injury;
b. Patients on Reglan/metoclopramide should not take it more than 12 weeks;
c. Reglan/metoclopramide was not fully and adequately tested for the neuromuscular side effects.
4.15 As a direct and proximate result of the fraudulent acts and omissions, suppression and misrepresentation of Defendants, Plaintiffs suffered significant and ongoing injuries and damages. Further, because Defendants' conduct was willful, reckless, intentional and maliciously fraudulent, Plaintiffs are entitled to an award of exemplary damages.
5. GROSS NEGLIGENCE
5.01 Plaintiffs would further show that the negligent acts and/or omissions of Defendants, as set forth above, constitute an entire want of care so as to indicate that the acts and/or omissions in question were the result of conscious indifference and/or malice so as to give rise to the award of exemplary damages.
5.02 Plaintiffs would further show that the negligent acts and/or omissions of Defendants, as set forth above, constitute an act or omission,
a. which, when viewed objectively from the standpoint of Defendants, involved an extreme degree of risk, considering the probability and magnitude of the potential harm to Plaintiffs, and
b. of which Defendants had actual, subjective awareness of the risks involved, but nevertheless proceeded with conscious indifference to the rights, safety or welfare of Plaintiffs.
5.03 The gross negligence of the Defendants was a proximate cause of the injuries and damages suffered by Plaintiffs.
6. DAMAGES
As a producing and proximate result of the above-described acts and omissions of Defendants Wyeth, Inc., Schwarz Pharma, Inc., Pliva USA, Inc., Barr Pharmaceuticals, Inc. Actavis, Inc., and Actavis Elizabeth LLC, Plaintiffs have incurred actual damages in excess of $75,000.00:
(1) Reasonable and necessary medical expenses incurred in the past;
(2) Reasonable and necessary medical expenses reasonably likely to be incurred in the future;
(3) Conscious physical pain and suffering experienced in the past;
(4) Conscious physical pain and suffering reasonably likely to be experienced in the future;
(5) Mental anguish in the past;
(6) Mental anguish likely to be experienced in the future;
(7) Physical disfigurement in the past;
(8) Physical disfigurement likely to be experienced in the future;
(9) Physical impairment in the past;
(10) Physical impairment likely to be experienced in the future;
(11) Loss of earnings in the past;
(12) Loss of earnings/earning capacity likely to be experienced in the future;
(13) Pre and post-judgment interest at the lawful rate;
(14) Exemplary damages;
(15) Plaintiff Steve Shrock has suffered loss of consortium, both past and future; and
(16) Such other applicable damages as the Court deems appropriate.
7. PUNITIVE DAMAGES AGAINST ALL DEFENDANTS
The actions of Defendants were in reckless disregard of the rights of Mrs. Schrock, thus authorizing her to collect as punitive damages a further sum in excess of $75,000.00.
8. PRAYER
WHEREFORE, Plaintiffs Susan Schrock and Steve Schrock pray that upon final determination of these causes of action Plaintiffs receive a judgment against Defendants Wyeth, Inc., Schwarz Pharma, Inc., Pliva USA, Inc., Barr Pharmaceuticals, Inc. Actavis, Inc. and Actavis Elizabeth LLC as follows:
(a) Actual damages as alleged, jointly and/or severally against Defendants, in excess of $75,000.00;
(b) Punitive damages alleged against Defendants, including Plaintiffs' attorney fees, in excess of $75,000.00;
(c) Costs of court and reasonable attorney fees necessary for preparation of this case for trial;
(d) Prejudgment interest at the highest lawful rate allowed by law;
(e) Interest on the judgment at the highest legal rate from the sate of judgment until collected; and
(f) All such other and further relief at law and in equity to which Plaintiffs may show themselves to be justly entitled.
JURY DEMAND
Plaintiffs hereby demand a trial by jury.
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