DOE v. SOLVAY PHARMACEUTICALS, INC. — (United States District Court, D. Maine)

SSRI Ed note: Lawsuit against Luvox manufacturer fails; court does not believe woman's claim of terrible side effects, and co was compliant with law and FDA requirements.

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Jane DOE, Plaintiff. v. SOLVAY PHARMACEUTICALS, INC., Defendant.

No. CIV.03-74-B-W.

United States District Court, D. Maine

December 21, 2004.


WOODCOCK, District Judge.

Jane Doe[ 1 ] sincerely believes her ingestion of the prescriptive medicine Luvox caused her to suffer a severe manic episode, resulting in her involuntary admission to a mental health institution. She sued Solvay Pharmaceuticals, the manufacturer of Luvox, under a number of theories, alleging in essence that Solvay improperly manufactured and distributed Luvox and that it failed adequately to warn her of its risks, specifically the risk of a manic episode. Solvay moved for summary judgment. This Court grants Solvay’s Motion, based on Ms. Doe’s failure to raise a genuine issue of material fact on her claim that the Luvox she took was defective and based on the application of the learned intermediary rule on the failure to warn question.[ 2 ]


A. Summary Judgment Standard.

Summary judgment is appropriate only if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed.R.Civ.P. 56(c); Santoni v. Potter, 369 F.3d 594, 598 (1st Cir.2004). Not every factual dispute is “sufficient to thwart summary judgment; the contested fact must be `material’ and the dispute over it must be `genuine.'” Navarro v. Pfizer Corp., 261 F.3d 90, 93 (1st Cir.2001). A “material” fact is one that “might affect the outcome of the suit under the applicable legal standard.” Santoni, 369 F.3d at 598 (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)). An issue is “genuine” if the evidence is such that “a reasonable jury could resolve it in favor of either party.” Santoni, 369 F.3d at 598 (citation omitted). In deciding whether a genuine issue of material fact exists, the Court “construes the evidence in the light most favorable to the non-moving party.” Id. (citing Flowers v. Fiore, 359 F.3d 24, 29 (1st Cir.2004)).

B. Local Rule 56.

The evidence the Court may consider in deciding whether genuine issues of material fact exist for purposes of a summary judgment motion is circumscribed by the Local Rules of this District. See Local Rule 56. The moving party must first file a statement of material facts that it claims are not in dispute. Local Rule 56(b). Each fact must be set forth in a numbered paragraph and supported by a specific record citation. Id. The nonmoving party is then required to submit a responsive “separate, short and concise” statement of facts in which it must “admit, deny, or qualify the facts by reference to each numbered paragraph of the moving party’s statement of material facts.” Local Rule 56(c). The nonmovant likewise must support each denial or qualification with an appropriate record citation. Id. The moving party may then respond with a reply statement of material facts in similar format. Local Rule 56(d). Failure to comply with the Rule can result in serious consequences: “Facts contained in a supporting or opposing statement of material facts, if supported by record citations as required by this rule, shall be deemed admitted unless properly controverted.” Local Rule 56(e).

In general, Local Rule 56 contemplates the Court will discount any statement of material fact or a response containing irrelevant argument or factual assertions unsupported by appropriate record citation. See Local Rule 56(e); Toomey v. Unum Life Ins. Co., 324 F.Supp.2d 220, 222 (D.Me.2004); Cadle Co. v. Hayes, 116 F.3d 957, 960 (1st Cir.1997) (the “evidence illustrating the factual controversy cannot be conjectural or problematic” and “effusive rhetoric and optimistic surmise” is not enough to establish a genuine issue of material fact.”). In accordance with these principles, the Court has disregarded unsupported or argumentative portions of Plaintiff’s Opposing Statement of Material Facts and Additional Facts.[ 3 ]


In accordance with “conventional summary judgment praxis,” the Court recounts the facts in a light most favorable to Jane Doe’s theory of the case consistent with record support. Gillen v. Fallon Ambulance Serv., 283 F.3d 11, 16 (1st Cir.2002). The Court has relied either on the uncontested facts or on Ms. Doe’s version, if properly placed in conflict.

Jane Doe is a resident of Maine, and Solvay Pharmaceuticals, Inc. (“Solvay”) is a Georgia corporation with a principle place of business in Marietta, Georgia.[ 4 ] (DSMF ¶¶ 1, 24). In 1994, Ms. Doe was treated for obsessive-compulsive disorder (“OCD”) by a Maine psychiatrist. (DSMF ¶ 23). After moving in 1997, Ms. Doe again sought treatment for OCD from her psychiatrist. (DSMF ¶ 27). Ms. Doe began to take Luvox on July 21, 1997 to treat her OCD. (DSMF ¶ 27; POSMF ¶ 27). A prescriptive medication, Luvox, or fluvoxamine maleate, a selective serotonin reuptake inhibitor (“SSRI”), was used to treat obsession and compulsive behavior. (DSMF ¶¶ 3, 4, 11; POSMF ¶ 11). On September 3, 2003, the U.S. Food and Drug Administration (FDA) withdrew its approval of the New Drug Application for Luvox, noting possible inaccuracies in the chemical, manufacturing, and controls (CMC) section of the application. (POSMF ¶ 11, Exhibit 1 at 1). In withdrawing Luvox’s application, the FDA noted that although the findings in the CMC section “raised concerns about the drug product as manufactured by Solvay, they do not affect the safety or efficacy of fluvoxamine maleate in treating obsessive compulsive disorder.” (POSMF ¶ 11, Exhibit 1 at 2).

Based on his professional judgment and information from Solvay, Ms. Doe’s psychiatrist considered Luvox to be a safe and appropriate medication to prescribe to treat her OCD.  8-32; POSMF ¶ 28-32). He discussed with Ms. Doe potential adverse side effects of the drug, particularly that the drug can cause mania in some patients. (DSMF ¶¶ 33-44). The Physicians Desk Reference (PDR), which he consulted, confirms Luvox has been prescribed for treatment of OCD and sets forth the following warning:

[d]uring premarketing studies involving primarily depressed patients, hypomania or mania occurred in approximately 1% of patients treated with fluvoxamine. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorder who were treated with other marketed antidepressants. As with all antidepressants, LUVOX Tablets should be used cautiously in patients with a history of mania.

(DSMF ¶ 32). In addition, Ms. Doe and her physician read the label and package insert that accompanies Luvox, which states in premarketing studies involving primarily depressed patients, “hypomania or mania occurred in approximately 1% of patients treated with fluvoxamine.” (DSMF ¶ 15). There is no indication Ms. Doe has ever been diagnosed with depression. (POSMF ¶ 22).

After taking Luvox for approximately five months, Ms. Doe became delusional and manic. (POSMF ¶ 36). While in the manic state, Ms. Doe came to believe there were no longer any diseases in the world, and therefore felt there was no longer any need to take medication, including Luvox. (POSMF ¶ 37). Ms. Doe’s manic episode caused her to experience high energy, delusions, an inability to sleep, reduced appetite, and weight loss. Id. As a result, Ms. Doe was involuntarily committed to a Maine state mental institution on January 27, 1998. (POSMF ¶ 38). She was diagnosed with bipolar disorder, another term for manic depression. (POSMF ¶ 39). After discharge five weeks later, she was placed on Zoloft, which she continues to take for her OCD, and she has experienced no adverse effects. (POSMF ¶ 41). However, she now suffers from post traumatic stress disorder resulting from her manic episode and its sequelae. (POSMF ¶ 39).

On April 23, 2003, Ms. Doe filed a complaint against Solvay, alleging she suffered the severe manic reaction as a consequence of taking Luvox. The Complaint contains eight counts. Count I alleges negligent manufacture and delivery of a defective product. Count II alleges a violation of the Deceptive Trade Practices Act, 10 M.R.S.A. § 1212. Count III alleges a violation of the Unfair Trade Practices Act, 5 M.R.S.A. § 207, et seq. Count IV alleges a breach of implied warranty of fitness for a particular purpose, 11 M.R.S.A. § 2-315. Count V alleges a violation of Maine’s strict liability law,

[ 350 F.Supp.2d 257, 262 ]

14 M.R.S.A. § 221, et seq. Count VI claims a failure to warn, alleging that Solvay knew or should have known that Luvox was dangerous and that adults with obsessive compulsive disorder could experience a manic reaction when taking Luvox. Count VII alleges fraudulent misrepresentation. Finally, Count VIII[ 5 ] seeks punitive damages, alleging Solvay acted with malice in the design, manufacture, sale, and distribution of Luvox.


As a preliminary matter, the Court notes Ms. Doe consistently confuses argument with evidence. There is no doubt Ms. Doe is extremely knowledgeable about the factual issues in this case. She has thoroughly researched Solvay, Luvox, OCD, FDA filings, and the scientific literature and she has impressively marshaled these facts in her memoranda. Despite her commanding level of understanding, there is no evidence she is qualified by virtue of knowledge, skill, experience, training or education to express expert opinions under Rule 702 on these matters. Fed.R.Evid. 702. Some documents she has submitted in response to Solvay’s motion for summary judgment have sufficient indicia of authenticity and reliability to be considered under Rule 803(8), Fed.R.Evid. 803(8), see Stewart v. Waldo County, 2004 WL 2397403, *3 n. 1 (D.Me.2004); however, the vast bulk has been attached without any attempt at authentication and cannot be considered. Moreover, Ms. Doe’s extrapolations from these documents are expert opinions in the guise of legal argument. Her sole designated expert in this claim is her treating psychiatrist and he fails to provide expert corroboration on many of the critical issues in this case, leaving the Court with an expansive argument in an evidentiary void.[ 6 ]

Secondly, Solvay categorizes Ms. Doe’s complaints into two broad types: 1) the medicine was defective (Counts I, IV and V); and, 2) the warnings were inadequate (Counts II, III, V, VI, and VII).[ 7 ]

A. Whether The Medicine Was Defective.

1. Negligent Manufacture and Delivery (Count I).

Ms. Doe alleges Solvay negligently manufactured and delivered Luvox, and her use of the drug caused her manic episode. In its motion for summary judgment, Solvay asserts there is no evidence supporting negligent manufacture or delivery. Alternatively, Solvay argues even if the product were negligently manufactured, Ms. Doe has not produced any evidence of causation, i.e. that any defect caused her manic episode.

In Maine, as elsewhere, a prima facie case of negligence requires a plaintiff to establish four elements: duty, breach, causation, and damages. Mastriano v. Blyer, 2001 ME 134, 779 A.2d 951, 954. There is “little to distinguish a negligence action predicated upon negligence in the manufacture or design of a product from other types of negligence actions well known to the common law.” Adams v. Buffalo Forge Co., 443 A.2d 932, 938 (Me.1982).

A duty is “an obligation, to which the law will give recognition and effect, to conform to a particular manner of conduct toward another.” Budzko v. One City Ctr. Assocs. Ltd. P’ship, 2001 ME 37, P 10, 767 A.2d 310, 313. A manufacturer or seller owes a duty to exercise reasonable care to foreseeable users of its products and to persons who are foreseeably endangered by the use of those products. Adams, 443 A.2d at 939; Donald N. Zillman et al, Maine Tort Law § 12.12. The degree of care depends on the nature of the item and “a manufacturer must exercise a higher degree of care when manufacturing an automobile or drug than when manufacturing a notebook,” since there is a great risk of harm if such an item is negligently manufactured. Zillman at § 12:13 (citing Restatement (Second) of Torts § 388, cmts. a, d; § 395 cmt. g.). Solvay owed this duty of reasonable care to foreseeable patients, including Ms. Doe, in manufacturing Luvox.

However, even viewing the evidence in a light most favorable to Ms. Doe, there is no evidence of a breach of that duty in the manufacturing and distribution process. In support of its Motion, Solvay has asserted that it is unaware of “any instances in which Luvox distributed in 1997 failed to comply with product specifications.” DSMF ¶ 8. It has also alleged that Luvox was “distributed, marketed, packaged, and labeled in accordance with all applicable FDA regulations.” DSMF ¶ 10. Ms. Doe posited extensive denials of each statement.

Denying paragraph 8, Ms. Doe cites the FDA Enforcement Report dated July 31, 2002 in which the FDA informed Solvay that all strengths of Luvox were being recalled from the United States market, because of “inaccuracies in data submitted to the New Drug Application by Solvay (stability).” POSMF ¶ 8, Ex. 2. Pointing to the 2002 recall for stability problems, Ms. Doe, who has clearly thought about these matters, contends these problems reach back to at least 1997, when Solvay manufactured the Luvox she ingested. Id. She notes Solvay admitted that in September 1997, it was
“placed under the Application Integrity Policy (AIP)” and as a result, a “thorough audit and validity assessment” of Luvox was conducted, revealing “instances where inaccurate or unsubstantiated chemistry, manufacturing and controls (CMC) data had been submitted to the FDA…” Id. She also refers to an audit by Biotechnical Services, Inc. (BSI) completed in 2000, which concluded Solvay’s records “contained inaccurate and insufficient documentation…selective reporting, and (data manipulation).” Id. Finally, she makes note of an audit by Lamar Furr of Lamar Furr Consulting, covering the time period from 1986 through 1999. She contends Mr. Furr concluded Solvay had made “retrospective changes to batch production records for

[ 350 F.Supp.2d 257, 264 ]

several Luvox batch lots” and in April 1997, Solvay had made 19 changes to the batch records. Id. Referencing these audits and FDA records, Ms. Doe argues there are genuine issues of material fact as to whether Solvay improperly manufactured Luvox in 1997, whether she ingested improperly manufactured Luvox, and whether the improperly manufactured Luvox then caused the untoward consequences she has suffered.

The Achilles’ heel in Ms. Doe’s argument is the absence of any expert testimony on the issues of defect and causation. The Court is left with a number of critical unanswered questions. What is the significance of these audits within the context of this case? Are the Solvay recordkeeping miscues evidence of a particular defect? Do they support the later withdrawal for “stability” problems? Even assuming arguendo she has raised a factual question about whether some Luvox manufactured in 1997 had stability problems, was her array of symptoms in 1997-98 caused by whatever occurred during the manufacturing process? The record before the Court contains no direct evidence of: 1) the nature of the defect in 1997; 2) whether the defect, if it existed, was present in the medication she ingested; and, 3) whether the symptoms she experienced would have been consistent with or caused by the defect. Further, the record does not allow inferences that would fill these gaps. To the contrary, her treating psychiatrist, who is her only expert, testified he has no reason to believe the Luvox she took was negligently manufactured, much less that there was a manufacturing defect that caused her difficulties in 1998.[ 8 ]

Even when viewed in a light most favorable to Ms. Doe, there is just simply no evidentiary basis to conclude Solvay breached its duty to exercise reasonable care in the manufacture of Luvox, that a defect from improper manufacture existed in any of the Luvox she ingested, or that this defect caused her any injuries. This Court grants Solvay’s motion for summary judgment on Count I.