Moretti v. Wyeth, Inc. et al

Filing 263

ORDER that plaintiff Mary Karen Moretti's motion to alter and/or amend judgment 260 is GRANTED. The Court's Order (255-1) is VACATED. Defendants' motion for summary judgment 206 is DENIED. This case is REINSTATED. Case reopened. Signed by Judge James C. Mahan on 6/28/11. (Copies have been distributed pursuant to the NEF - ECS)

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UNITED STATES DISTRICT COURT
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DISTRICT OF NEVADA
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MARY KAREN MORETTI,

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2:08-CV-396 JCM (GWF)

Plaintiff,
v.
WYETH, INC., et al.,

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Defendants.

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ORDER

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Presently before the court is plaintiff Mary Karen Moretti’s motion to alter and/or amend

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judgment. (Doc. #260). Defendants filed an opposition (doc. #261), and plaintiff filed a reply (doc.

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#262).

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This case stems from the alleged injuries suffered by plaintiff as a result of ingesting the

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defendants’ generic drug, metoclopramide. In her complaint, plaintiff asserts several claims against

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the defendants, including strict products liability, breach of warranty, negligence and fraud.

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Plaintiff’s claims relate to the alleged false or misleading nature of the labeling on the drug. It is

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undisputed that the labeling and packaging used by the defendants for their generic drug was at all

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times approved by the Federal Food and Drug Administration.

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Procedural History

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After holding a hearing on the parties’ respective motions for summary judgment and

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defendants’ motion to dismiss, the court granted the defendants’ motion for summary judgment (doc.

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#206), denied defendants’ motion to dismiss based on federal preemption (doc. #198), and denied

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James C. Mahan
U.S. District Judge

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the plaintiff’s motion for summary judgment (doc. #196). (Doc. #252). Following the court’s ruling,

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defendants filed a motion to amend/correct the judgment (doc. #254), asserting that (1) the proposed

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and signed order did not accurately reflect the court’s findings of fact and conclusions of law in

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support of the granting of their motion, and (2) it does not accurately reflect the court’s statements

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at the oral hearing regarding the resolution of their motion to dismiss.

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Subsequently, the court issued an order (doc. #259) addressing these concerns, which

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accurately reflected what the court stated during the hearing. Specifically, the order held that (1)

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“[r]ather than ruling that the claims were not preempted by federal law, the court actually held that

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it was “reluctant to handle the case on that basis,” and instead ruled on the merits of the motion for

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summary judgment with regards to the issue of adequate warning, and (2) that the court stated during

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oral argument that “it wouldn’t have made any difference here [if the statistics on the label were

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correct], because she didn’t read the label.” Further, the court vacated the proposed signed order

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(doc. #252), and entered the revised proposed order (doc. #255-1) as the final order in the case. (Doc.

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#259).

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In the final judgment (doc. #255-1), the court held that “there is no genuine issue of material

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fact that (1) the labeling (also known as the package insert) for Pilva’s metoclopramide met the

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applicable statutory and regulatory requirements of being the same as the labeling for the [r]eference

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[l]isted [d]rug, Reglan; (2) the labeling was approved by the FDA; and (3) the labeling warned that

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tardive dyskinesia was a risk of metoclopramide use.” Further, the court concluded that “as a result,

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the label and warnings that accompanied the metoclopramide ingested by plaintiff were adequate as

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a matter of law.” Additionally, the court held that the plaintiff “cannot prove that any alleged

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deficiency in Pliva’s labeling was the proximate cause of any injury to [p]laintiff,” because no

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genuine issue exists as to the fact that she did not read the labeling or other information provided for

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Pliva’s drug.

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Motion to Alter and/or Amend Judgment

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In the plaintiff’s motion (doc. #260), she asserts that this court’s final order of judgment

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contains errors of law and fact, and that a reconsideration is appropriate. Further, she contends that

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James C. Mahan
U.S. District Judge

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the case should be reinstated in light of the Ninth Circuit’s recent ruling in Gaeta v. Perrigo

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Pharmaceuticals Company. 630 F.3d 1225, 2011 WL 198420 (C.A. 9 (Cal.)), 11 Cal. Daily Op.

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Serv. 987, 2011 Daily Journal D.A.R. 1269. Since plaintiff is presenting the court with a change in

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controlling law that is relevant to the court’s ruling, it is treating the motion as one for

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reconsideration.

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“Reconsideration is appropriate if the district court (1) is presented with newly discovered

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evidence, (2) committed clear error or the initial decision was manifestly unjust, or (3) if there is an

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intervening change in controlling law.” School Dist. No. 1J v. ACandS, Inc., 5 F.3d 1255, 1263 (9th

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Cir. 1993); see Fed. R. Civ. P. 59(e); see also Fed. R. Civ. P. 60(b).

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A.

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As previously stated, the court held that the warning was adequate as a matter of law because

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it was approved by the FDA and complied with the requirement to be the same as the brand name

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drug. In the motion to amend (doc. #260), plaintiff relies on the court’s ruling in Gaeta in asserting

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that this finding was in error. She contends that the facts are essentially the same in both cases–that

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the generic drug manufacturer failed to adequately warn by changing its labeling once it became

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aware of newly discovered risks.

Adequate As A Matter Of Law

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In Gaeta v. Perrigo Pharmaceuticals Company, the court held that despite the approval by

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the FDA and the compliance with the “same as” requirement, it is “clear that generic manufacturers,

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just like their name counterparts, must take specific steps when they learn of new risks associated

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with their products,” and “shall revise their drug labeling to include a warning as soon as there is

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reasonable evidence of an association of a serious hazard with a drug.” Gaeta, 630 F.3d 1231–1232;

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21 C.F.R. § 201.57(e) (2004) (emphasis added)(internal quotations omitted). Further, the court held

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that there are several ways in which a generic manufacturer may amend its labeling or packaging to

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strengthen the warnings; “(1) the CBE process approved by the Supreme Court...; (2) the “prior

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approval” process; and (3) by asking the FDA to send “Dear Doctor” warning letters to health care

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professionals.” Id.

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Here, plaintiff alleges facts to support her assertion that the defendants were aware of new

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James C. Mahan
U.S. District Judge

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risks associated with the drug, yet failed to take “specific steps” to revise the labeling. Specifically,

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in the plaintiff’s second amended complaint (doc. #161), she contends, among other things, that the

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defendants (1) failed to investigate the accuracy of the drug label once they became aware of signals

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indicating a safety issue, (2) failed to review the medical literature, (3) relied upon the name brand

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to review the aforementioned literature, (4) failed to communicate the true and accurate risks and/or

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prevalence of severe neurological side effects resulting from the drug, (5) failed to modify the

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package insert “even after several injured patients filed lawsuits alleging inadequate warnings and

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produced competent expert testimony supporting their allegations,” and (6) failed to monitor, review,

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and report any information relating to the long term use of the drug and ultimately “concealed”

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material facts from physicians and patients.

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Since plaintiff’s complaint is premised upon the assertion that defendants knew of recently

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discovered risks and failed to make any effort to change their labeling, this court finds that the case

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fits squarely within the case before the Ninth Circuit in Geata. As in that case, summary judgment

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is not appropriate here, because defendants, if they had knowledge of the new risks, should have

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taken steps available to them to adequately warn of the risks associated with the drug. In light of

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Geata, the label’s mere compliance with the “same as” requirement and approval by the FDA do not

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bar recovery and do not necessarily deem the warnings “adequate as a matter of law.” Therefore, the

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court’s order (doc. #255-1) granting the motion for summary judgment based on this theory is

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vacated.

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B.

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In the court’s final judgment, it held that the plaintiff admittedly did not read any of the

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packaging, labels, or inserts associated with the drug, and that, “as a matter of law,” any alleged

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deficiency could not be the proximate cause of the injury. (Doc. #255-1). In the plaintiff’s motion

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to alter or amend (doc. #260), she contends that the court erred, because the testimony clearly

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indicated that although she did not read a “package insert,” she did in fact read the actual bottle and

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did ask her physician about possible side effects.

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Proximate Causation

There is a duty not only to create an adequate warning, but also to communicate that warning

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James C. Mahan
U.S. District Judge

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to its intended recipients. See United Stated v. State of Washington, 251 F.2d 913, 916 (9th Cir.

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1965), citing Indian Towing Co. v. United States, 350 U.S. 61 (1955). The FDA has clearly stated

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that for certain drugs “the safe and effective use of the drug requires additional labeling in

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nontechnical language to be distributed directly to patients by their healthcare provider or

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pharmacist.” See Guidance: Drug Safety Information – FDA’s Communication to the Public (2007),

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p. 7.1 Therefore, plaintiff contends, if defendants had taken the steps necessary to adequately warn,

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using the plethora of means available to communicate to the patients and physicians, she would have

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seen the labeling on the bottle or been warned by her physician, and would “have stopped taking [the

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drug] immediately.”

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This, she asserts, creates a genuine issue as to whether an adequate warning, sufficiently

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communicated to the physicians and patients, would have reached her. In light of the “intervening

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change in controlling law” in Gaeta that there are means by which generic manufacturers can amend

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their warnings once they learn of risks, i.e. adding an additional warning on the bottle itself, the court

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is inclined to vacate its ruling on the issue.

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Accordingly,

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IT IS HEREBY ORDERED ADJUDGED AND DECREED that plaintiff Mary Karen

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Moretti’s motion to alter and/or amend judgment (doc. #260) be, and the same hereby is,

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GRANTED.

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IT IS THEREFORE ORDERED that the court’s order (doc. #255-1) be, and the same hereby
is, VACATED.

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IT IS FURTHER ORDERED that defendants’ motion for summary judgment (doc. #206)

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be, and the same hereby is, DENIED.

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James C. Mahan
U.S. District Judge

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Found at: http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125411.pdf
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IT IS FURTHER ORDERED that the above captioned case be reinstated.

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DATED June 28, 2011.

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UNITED STATES DISTRICT JUDGE
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James C. Mahan
U.S. District Judge

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