Opinion
CV-98-TMP-2649-S
March 5, 2001
ORDER REGARDING PLAINTIFFS' DAUBERT CHALLENGES
The plaintiffs in the above-styled case have filed a motion seeking to limit and exclude four categories of evidence on the basis of Daubert. The motion has been fully briefed, and was argued before the court on Monday, March 5, 2001. Having considered the evidence and the arguments of counsel, the court finds as follows:
The motion is filed in the case of Elizabeth Brasher v. Sandoz Pharmaceuticals Corp., CV 98-TMP-2648, but applies to this case, as well as Brasher and another case, Ruby Quinn v. Sandoz, CV 98-TMP-2650. The court's ruling herein is limited in application to the instant case, and Daubert challenges will be addressed in Brasher and Quinn at a later time.
1. The motion is GRANTED as to the unpublished Sibai/Witlin study because the court finds that, in the absence of any of the underlying data, there is not sufficient evidence to support defendant's contention that the study is either relevant or reliable. Consequently, the defendant is precluded from making any mention of the study.
2. The motion is DENIED as to the published studies authored by Dr. Lanska.
3. The court DEFERS ruling on the motion as to study until such time as Dr. LeBarthe is made for testimony, outside the hearing of the jury, his reliance on the HCIA study.
4. The motion is DENIED as to the testimony of Dr. and he will be allowed to testify as to his concerning Mrs. Globetti's medical condition.
ORDER REGARDING SUMMARY JUDGMENT
This cause is before the court on several motions in the nature of motions for summary judgment filed by defendant Sandoz Pharmaceuticals Corporation and based on the Supreme Court's recent decision in Buckman Company v. Plaintiffs' Legal Committee, ___ U.S. ___, 2001 U.S. LEXIS 1701 (February 21, 2001). These motions include defendant's motion for summary judgment based on Buckman (Doc. 190), defendant's motion in limine based on Buckman (Doc. 188), defendant's motion requesting the court to withdraw it previous summary judgment order of February 2, 2001 (Doc. 187), defendant's renewed motion for summary judgment on fraud-on-the-FDA claims (Doc. 157), and defendant's renewed motion to amend its answer to assert a preemption defense based on Buckman.The essential link among all of these motions is the assertion that theBuckman decision precludes any claim, and indeed any evidence, relating to defendant's communications with the FDA and any other communications "controlled" by the FDA. Defendant argues that, not only are plaintiff's fraud-on-the-FDA claims now barred, but so are virtually all of plaintiffs' other claims relating to fraud on the medical community and the adequacy of the warnings contained in the FDA-approved package insert. These claims, Sandoz contends, are preempted by Buckman because all are grounded on communications between defendant and the FDA.
While the court agrees that Buckman expressly preempts fraud-on-the-FDA claims, it is unpersuaded that the rest of plaintiffs' claims of misrepresentation, suppression, negligence, and inadequate warning are preempted. First, it appears that the only claim set forth in Buckman, and therefore the only claim considered by the Supreme Court, was that certain information had been misrepresented to the FDA, thereby causing the FDA to find that the medical device at issue was a "substantial equivalent" of a predicate device. There is nothing in Buckman to suggest that the plaintiffs in that case alleged other grounds for relief, such as fraud on the medical community or that the product was defective and unreasonably dangerous. The exclusive focus of the Supreme Court's analysis is on the "fraud-on-the-agency" theory and its unavoidable conflict with the agency's own enforcement schemes.
Second, Buckman must be read against the backdrop of Medtronics, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) andSilkwood v. Kerr-McGee Corporation, 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984). While it is true that Buckman is based on implied or conflict preemption and Lohr is grounded on express preemption, Silkwood also is an implied preemption case. In Buckman the Supreme Court distinguished (rather than overruled) Silkwood on the very basis discussed in the preceding paragraph, that is, that Silkwood involved state-law claims beyond simply a "fraud-on-the-agency" theory. Read together, these cases make clear that the only theory preempted is that resting exclusively on the fact that the federal agency was itself the victim of the fraud. Although Buckman precludes a plaintiff from seeking damages because the defendant lied to the FDA, it is something completely different to contend that plaintiff is precluded from seeking damages for injuries due to lies to her. Notwithstanding that information may have been misrepresented to or concealed from the FDA, once defendant undertook to misrepresent those facts to plaintiff, or to conceal from plaintiff facts it was bound to disclose, the plaintiff's claim no longer rests simply on the assertion that the agency was defrauded but on the additional fact that she was defrauded.
The court also is convinced that Buckman does not preclude plaintiff's inadequate warning claims, even though the warning itself — the package insert — was approved by the FDA. Aside from whether the FDA approved the package insert based on misrepresented or suppressed information, plaintiff asserts simply that the warning was not reasonably adequate to alert physicians and their patients to risks associated with prescribing Parlodel for one of its intended purposes, the suppression of post-partum lactation. The duty ran to the consumer, not just to the FDA. As the Supreme Court emphasized in Buckman, the claim there was grounded entirely on the duty of disclosure to the FDA, not any separate duty owned to the plaintiff. Indeed, the Court distinguished Medtronics by pointing out that the earlier case rested on "the manufacturer's alleged failure to use reasonable care in the production of the product, not solely from the violation of the FDCA requirements." In the case before the court, plaintiff's claims also do not arise "solely from the violation of the FDCA requirements." Defendant owed separate duties beyond simply full and fair disclosure to the FDA, duties not to market a defective and unreasonably dangerous product, not to misrepresent or suppress the facts needed by physicians and consumers to assess the safety of the product, and to adequately warn of known risks associated with it. These duties existed irrespective of the FDCA. Thus, while plaintiff cannot recover simply because defendant defrauded a federal agency, nothing in Buckman suggests that she cannot recover where the misrepresentations or suppression were directed at her (through her physician) or when the warning given (even though FDA approved) inadequately disclosed the hazards of the product.
This case may be a good example of why the duty to warn is not limited to what the FDA has approved. Plaintiff contends that the FDA tried several times to get defendant to update the warning in the package insert, but defendant refused. To argue that, once the FDA approves a package insert, the defendant has no further duty to give an adequate warning creates an incentive for pharmaceutical companies to oppose all efforts by the FDA to secure clearer package inserts. If that were the case, drug manufacturers could avoid liability simply by resting on the formerly approved package insert (regardless of how long ago the approval occurred and how much information about the drug had changed) and resist all efforts to change it. The FDA approval of the package insert becomes a complete bar to liability, regardless of how inadequate it may have become over time.
The defendant's reliance on Irving v. Mazda Motor Corp., 136 F.3d 764 (11th Cir. 1998) and James v. Mazda Motor Corp., 222 F.3d 1323 (11th Cir. 2000) is misplaced. The Eleventh Circuit expressly distinguishedIrving in Goodlin v. Medtronics, Inc., 167 F.3d 1367 (11th Cir. 1999), finding that defendant's argument for implied preemption based on Irving was "meritless." Id. at note 5. Interestingly, the panel that decidedGoodlin included Judges Edmondson and Tjoflat, who authored Irving andJames, respectively. The holding in Goodlin that the assertion of implied or conflict preemption in the context of a medical device (a pacemaker lead), is certainly more instructive for this case than Irving andJames, which were decided under the National Traffic and Motor Vehicle Safety Act of 1966 and the Federal Motor Vehicle Safety Standards. TheGoodlin court clearly rejected implied preemption with respect to common-law claims arising from medical devices, notwithstanding the FDCA and the MDA. See also, Brooks v. Howmedica, Inc., 236 F.3d 956 (8th Cir. 2001)
Based on the foregoing reasoning and reading of Buckman, the court enters the following orders:
(1) The defendant's renewed motion to amend its answer to assert a preemption defense based on Buckman is GRANTED.
(2) The defendant's renewed motion for partial summary judgment on plaintiff's fraud-on-the-FDA claim is due to be and hereby is GRANTED.
(3) The defendant's motion for the court to withdraw its earlier summary judgment order date February 2, 2001, is due to be and hereby is DENIED.
(4) The defendant's motion for summary judgment pursuant to Buckman (Doc. 190) is due to be and hereby is DENIED.
(5) The defendant's motion in limine based on Buckman is due to be and hereby DENIED. While plaintiff may not offer evidence simply to show misrepresentations to or concealment from the FDA, such evidence may be relevant to showing the defendant's knowledge relating to the adequacy of the warning or the truth of information represented to or concealed from plaintiff or her physician. FRE 403 may dictate that some such evidence be excluded to avoid confusing the jury about the exact nature of plaintiff's claims. Defendant remains free to raise appropriate objections during the course of trial.