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IN THE UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF TEXAS

DALLAS DIVISION

CHRISTOPHER TYLER LOFTON, §

Individually and on behalf of the ESTATE §

of CHRISTOPHER M. LOFTON, et al., §

§

Plaintiffs, §

§

v. § Civil Action No. 3:05-CV-1531-L

§

MCNEIL CONSUMER & SPECIALTY §

PHARMACEUTICALS, a Division of §

MCNEIL-PPC, INC., and JOHNSON & §

JOHNSON, §

§

Defendants. §

MEMORANDUM OPINION AND ORDER

Before the court is Plaintiffs’ Motion for New Trial and/or Motion for Reconsideration of

Ruling on Motion for Summary Judgment, filed February 5, 2010. After carefully considering the

motion, response, record, and applicable law, the court denies Plaintiffs’ Motion for New Trial

and/or Motion for Reconsideration of Ruling on Motion for Summary Judgment.

I. Background and Procedural History

This case involves product liability claims relating to the over-the-counter drug Motrin.

Plaintiffs Christopher Tyler Lofton, individually and on behalf of the estate of Christopher M.

Lofton, and Sandy Lynn Lofton, as next friend for Tegan Lofton and Lauren Lofton, on their behalf

and on behalf of the estate of Christopher M. Lofton (collectively, “Plaintiffs”) brought claims of

defective design, marketing defect, breach of express warranty, breach of implied warranty,

negligence, and violation of the Texas Deceptive Trade Practices Act as a wrongful death action and

 

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as a survival action. Plaintiffs assert claims against Defendants McNeil Consumer & Specialty

Pharmaceuticals (“McNeil”) and Johnson & Johnson (“J&J”) (collectively, “Defendants”). 

On January 27, 2010, the court granted in part and denied in part Defendants’ Motion for

Summary Judgment. The court dismissed with prejudice Sandy Lofton’s wrongful death and

survival claims, Plaintiffs’ marketing defect, breach of express warranty, negligence, and DTPA

claims. In dismissing Plaintiffs’ marketing defect, negligence, and breach of warranty claims, the

court determined that Defendants were entitled to the rebuttable presumption pursuant to section

82.007(a) of the Texas Civil Practice and Remedies Code that the Motrin label was adequate.

Defendants originally filed their Motion for Summary Judgment on May 2, 2008. The

parties jointly moved to abate these proceedings pending the decision by the Supreme Court in

Wyeth v. Levine, 552 U.S. 1161 (2008). The court administratively closed the case on July 30, 2008.

The Supreme Court reached its decision in Wyeth on March 4, 2009. 555 U.S. ___, 129 S. Ct. 1187

(2009) (hereinafter, “Wyeth”). The parties subsequently moved to reopen the case, and the court

reopened the case on July 30, 2009. The court gave the parties an opportunity to file supplemental

briefs regarding the effect of Wyeth on the pending motion. Plaintiffs and Defendants both filed

supplemental briefs, and the court ruled on the Motion for Summary Judgment on January 27, 2010.

Plaintiffs now ask the court to reconsider its decision to dismiss with prejudice their claims

for marketing defect, breach of warranty, and negligence. They argue that the decision in Wyeth

precludes the court’s decision with respect to those claims. Defendants oppose the motion, and

Plaintiffs did not file any reply in support of their motion.

 

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II. Legal Standard

Plaintiffs move for a new trial or for reconsideration of the court’s January 27, 2010

memorandum opinion and order, but they do not cite the legal basis for their motion. Defendants

respond that the court should apply the standard of Rule 59(e) of the Federal Rules of Civil

Procedure in considering the motion and that Plaintiffs have failed to meet that standard. The court

finds that Rule 59(e) does not apply because it has not yet entered judgment. It does, however, have

the inherent power to revise or reconsider its orders. Melancon v. Texaco, Inc., 659 F.2d 551, 553

(5th Cir. 1981); see also Enlow v. Tishomingo County, Miss., 962 F.2d 501, 507 n. 16 (5th Cir. 1992)

(“As this Court has repeatedly said, the district court has broad discretion in controlling its own

docket. In fact, the district court may reconsider a previously denied summary judgment motion

even in the absence of new material presented.”) (internal quotations, brackets, and citations

omitted). In light of the court’s ability to reconsider its own interlocutory orders, it turns to

Plaintiffs’ arguments.

III. Analysis

Plaintiffs argue generally that the Supreme Court’s decision in Wyeth requires

reconsideration of the court’s decision that the fraud-on-the-FDA exception to the statutory

presumption is preempted by federal law. Much of their motion simply repeats verbatim sections

of their original response to the Motion for Summary Judgment and their supplemental brief. To

the extent that Plaintiffs simply repeat the arguments that were already considered, the court will not

reconsider them, as Plaintiffs do not even attempt to make a new argument but simply reurge the

same argument. Plaintiffs’ argument that Wyeth affects the court’s decision about the fraud-on-theFDA exception is largely a new argument, and so the court will consider it.

 

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Plaintiffs contend that Wyeth held that “state law tort warnings claims in pharmaceutical

cases are not pre-empted by federal law, even where the labels are approved by the FDA, rejecting

the drug company’s claim that by approving a warning label, the state law warnings claims are

impliedly preempted.” Pls.’ Brief (doc. 115) 2. They contend that the “logical extension” of this

decision is that “any claims of federal preemption which affect a claimant’s state common law tort

rights for warnings should not be precluded either, including an exception which requires proof that

the defendant failed to provide material and relevant information to the FDA . . . as is included in

§ 82.007(b)(1).” Id. Plaintiffs also distinguish the Texas fraud-on-the-FDA exception from the

statute considered by the Sixth Circuit Court of Appeals in Garcia v. Wyeth-Ayerst Labs., 385 F.3d

961 (6th Cir. 2004), a case that this court explicitly followed in reaching its decision. Plaintiffs also

urge the court to adopt the reasoning in the Second Circuit Court of Appeals decision in Desiano

v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d, 552 U.S. 440 (2008). Plaintiffs argue

that the court’s decision prevents litigants in Texas from bringing common law marketing defect

claims in Texas for drug-related injuries if the FDA approved the label. They contend that they have

not brought a claim for fraud on the FDA, that the Supreme Court’s decision in Buckman Co. v.

Plaintiffs’ Legal Committee, 531 U.S. 341 (2000), should not be extended to fraud-on-the-FDA

exceptions to state statutory presumptions, and that there is evidence that Defendants withheld

information from the FDA relating to Motrin. 

Defendants contend that Plaintiffs have failed to meet the legal standard justifying

reconsideration of the court’s earlier order. They argue that Plaintiffs make the same arguments and

present the same evidence that the court has considered and rejected. Because they contend that

Plaintiffs have simply rehashed the same arguments made in prior briefing, Defendants stand on

 

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their prior briefs as well. They contend that none of the evidence cited by Plaintiffs is newly

discovered and that the court has already considered it. 

The court has already stated that it would not consider the arguments advanced by Plaintiffs

in their prior briefing, but Plaintiffs do make a new argument with respect to the effect of Wyeth on

the court’s holdings regarding section 82.007 of the Texas Civil Practice and Remedies Code. The

court, however, is not persuaded that the application of Wyeth warrants any change to its prior

decision on this issue.

The court’s holding with respect to Buckman and the fraud-on-the-FDA exception was

narrow. It held:

The court finds that the concerns in Buckman hold true not only

where a plaintiff brings a fraud-on-the-FDA claim but also where it

seeks to show an exception to the presumption here. To avoid any

intrusion upon the FDA’s right to police fraud itself, the court follows

Garcia and finds that section 82.007(b)(1) is preempted in some

circumstances, including as here, where Plaintiffs ask the court to

reach the conclusion opposite of that reached by the FDA, that

Defendants did not withhold information or mislead it. Accordingly,

the court finds that Defendants are entitled to the rebuttable

presumption of section 82.007(a).

Mem. Order and Op. (Jan. 27, 2010) 20 (emphasis added). Its holding was limited to the facts

before it, which included a specific finding by the FDA that “we have no evidence that there is

additional undisclosed safety information that was withheld by ibuprofen manufacturers.” Id. at 17

(quoting Defs.’ App. 407). 

The court’s narrow holding in this case does not interfere with the application of Wyeth, in

which the Supreme Court held that certain state law claims were not preempted by federal law. In

Wyeth, the Court specifically rejected the argument that the FDA’s labeling requirements were “both

a floor and a ceiling,” and held that a plaintiff could bring state law claims even where a drug bore

 

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a warning label approved by the FDA. This holding, however, does not implicate the FDA’s right

to determine whether parties have committed fraud upon it, and the court maintains that Plaintiffs’

claims, which are based upon an argument already rejected by the FDA, are preempted. The only

claims that are barred by the court’s holding are claims that assert fraud on the FDA that have

already been considered and rejected by the agency. The court finds that, in those narrow

circumstances, the Texas statutory exception to the rebuttable presumption should not apply because

it risks creating a conflict between the court’s possible findings and the FDA’s conclusion. This

holding does not otherwise affect the conclusion of the Court in Wyeth that plaintiffs may bring state

claims even where the FDA approved the label.

To the extent that Plaintiffs argue that the court should follow Desiano in light of the Wyeth

decision and that the statute in Garcia can be distinguished from section 82.007, the court also

rejects these arguments. The court carefully considered authority from several courts when it

determined the effect of Buckman on fraud-on-the-FDA exceptions to state statutory presumptions

regarding drug labels. It accepted the view held by the majority of courts that Buckman’s rationale

extends beyond state fraud-on-the-FDA claims to fraud-on-the-FDA exceptions to state statutory

presumptions. As stated above, the court finds that its narrow holding should not be altered by the

decision in Wyeth; it further finds that its reliance on Garcia and similar cases and rejection of

Desiano also should not be altered.

For these reasons, the court determines that Wyeth does not provide a basis for reconsidering

its earlier memorandum opinion and order. The court will not reverse its decision with respect to

Plaintiffs’ claims of marketing defect, breach of warranty, and negligence.

 

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IV. Conclusion

For the reasons stated herein, the court denies Plaintiffs’ Motion for New Trial and/or

Motion for Reconsideration of Ruling on Motion for Summary Judgment.

It is so ordered this 17th day of June, 2010.

_________________________________

Sam A. Lindsay

United States District Judge

 

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