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In Ohler v. Purdue Pharma, L.P., No. 01-3061, 2002 WL 88945 (E.D. Jan. 22, 2002) La) (Engelhardt, J.), the undersigned granted remand under similar circumstances.
Summary of this case from Garcia v. Covidien, Inc.Opinion
Civil Action No. 01-3061 Section "n" (2)
January 22, 2002
ORDER AND REASONS
Before the Court is a Motion to Remand filed on behalf of the plaintiff, Jeffrey Ohler and the intervenors (hereinafter collectively referred to as "Plaintiffs"). The matter was noticed for hearing on January 9, 2002. The drug company defendants (hereinafter collectively referred to as "Purdue-Abbott"), jointly filed formal opposition to the Motion to Remand. Both plaintiffs and defendants filed supplementary briefs. For the following reasons, the Motion to Remand is GRANTED.
FACTUAL AND PROCEDURAL BACKGROUND
On August 22, 2001, plaintiff Jeffrey Ohler filed his original Petition for Damages in the Civil District Court for the Parish of Orleans for damages against his treating physician, Dr. Jacqueline Cleggett-Lucas. His claims against Dr. Cleggett-Lucas for negligent and/or intentional tortious medical treatment (medical malpractice), involve the alleged excessive prescription of narcotic pain medications, including OxyContin, Hydrocodon, Carisoprodol, Butalbital, and Alprazolam. Plaintiff claims that treatment with OxyContin on a continuous basis without proper medical monitoring, testing or warnings caused injury, his addiction, and consequent damages which enured to the benefit of the physician's practice. Suit against J.C.L. Enterprises (JCL), the physician's company, is essentially a derivative claim under the theory of respondeat superior for acts allegedly committed by Cleggett-Lucas during the course and scope of her employment. See Plaintiff's Verified Petition for Damages against Dr. Jacqueline Cleggett-Lucas, J.C.L., Enterprises, L.L.C. and ABC Insurance Company filed on August 22, 2001 in Civil District Court for the Parish of Orleans bearing Docket Number 2001-12691 "B" [Exhibit B to Motion to Remand].
Defendants aptly characterize Ohler's original petition for damages as a "garden-variety malpractice claim against an alleged Louisiana physician" and the professional corporation through which she billed her medical services, under the theory of respondeat superior. Several of the plaintiffs claims overlap the supplemental claims later filed against Purdue-Abbott, the drug company defendants, via Amended Petition. Overlapping claims include the failure to monitor and failure to warn regarding use of prescription pain medication OxyContin.
On September 4, 2001, less than two weeks after plaintiff's original petition was filed, the state court granted the plaintiff's motion for leave to file a First Supplemental and Amending Petition. Ohler's Amended Petition, also filed on behalf of four putative classes of persons "who have used or have been adversely affected by the prescription drug, OxyContin," added five defendant companies, which allegedly "manufactured, marketed, promoted, sold and/or distributed" OxyContin, to wit: Purdue Pharma, L.P.; Purdue Pharma, Inc.; Purdue Frederick Company; Partners Against Pain; and Abbott Laboratories. See Plaintiff's First Supplemental and Amending Petition [Exhibit "C" to Motion to Remand]. It is apparent that the claims stated via Amended Petition against the drug manufacturers "parrot" the allegations raised by the lead plaintiff McCallister in a class action filed against Purdue-Abbott in Putnam County, West Virginia, which was removed to the United States District Court for the Southern District of West Virginia. See McCallister v. Purdue Pharma L.P., 164 F. Supp.2d 783 (S.D.W. Va. 2001) (granting the McCallister plaintiffs' Motion to Remand)[Exhibit "D" to Plaintiff's Motion to Remand].
Plaintiff alleges that OxyContin, an opioid analgesic tablet, the controlled release form of Oxycodone Hydrochloride, is a highly addictive Schedule II controlled drug approved by the FDA in 1996 for use in management of severe pain. See Amended Petition, paras. 4-9.
The McCallister case involved no allegation of fraudulent joinder, and instead defendants' arguments against remand focused on field, conflict and complete preemption by the FDCA and/or the Controlled Substances Act. Considering the plaintiffs' claims of inadequate warning, labeling, and request for equitable relief in the form of notice and medical monitoring, the court concluded that the McCallister plaintiffs' claims were not completely preempted and no substantial federal question existed that would allow removal. McCallister v. Purdue Pharma L.P., 164 F. Supp.2d at 795-794.
On September 10, 2001 plaintiff's counsel filed a "Petition for Intervention" on behalf of Brenda Rodriguez, William Price, Guy Rotondi, and Christopher Kimball alleging, inter alia, that they have a right related or connected with the object of the principal suit." Plaintiffs' and putative class members' claims against Purdue-Abbott target the below listed alleged wrongful conduct under the various theories of negligent and intentional tort liability, strict products liability, deceptive practices, inter alia, all such claims being framed as claims under Louisiana law. The allegations of fact against the defendant drug companies include:
See Petition for Intervention, at para. 2.
• employing an aggressive marketing strategy which utilized highly coercive and seductive tactics including misrepresenting the appropriate use of the drug and failing to adequately disclose appropriate warnings, which was tantamount to promoting, marketing and selling the drug OxyContin in a misleading manner;
• courting, recruiting and seducing physicians in an effort to influence doctors to deploy the federally regulated drugs to an unintended or inappropriate market;
• marketing/promoting OxyContin directly to consumers utilizing multimedia and the internet and otherwise facilitating the inappropriate unsafe use of the drug to increase its market, and concomitantly to multiply its profits;
• manufacturing a defective product; and
• knowingly suppressing and concealing material facts about the unsafe and harmful nature of the product from the medical community and the public.
Plaintiff's amended complaint alleges, inter alia, that OxyContin is an "unreasonably dangerous product," currently marketed unaccompanied by "proper adequate warnings." The thrust of plaintiffs allegations is that presently the warnings that follow distribution of the product to the consumer do not "accurately reflect the scope and severity of possible side effects," making it impossible for proposed class member to make "a fully informed decisions regarding the proper use of the drug." In addition to general and special monetary damages for past, present, and future losses, including future medical costs, the relief sought via Amended Petition includes "injunctive or equitable relief" in the form of "a comprehensive medical monitoring program" which is "implemented under Court supervision" apparently as an adjunct to that required by FDA regulations currently in effect. According to plaintiff's allegations, such relief should include a mandate that Purdue-Abbott "create, maintain and operate a 'registry' in which relevant demographic and medical information concerning all OxyContin users is gathered, maintained and analyzed" along with "treating physicians' information related to the diagnosis and treatment of injuries which may result from using OxyContin."
Id., at paras. 56-58.
See Amended Petition, at Count VI and VII relative equitable relief and breach of warranty.
Id., at Prayer for Relief, para. (10)(E) (F).
Purdue-Abbott timely noticed removal based on diversity and federal question jurisdiction. Citing 28 U.S.C. § 1441, plaintiff's counsel argues that the removal was procedurally flawed in that all defendants must agree to removal, noting that Dr. Cleggett-Lucas did not consent. Plaintiffs' counsel further submits that Purdue-Abbott's fraudulent joinder argument is "nonsensical," in light of the fact that suit was originally filed against the doctor and her employer. Plaintiffs counsel submits that the event which triggered Ohler's suit against Dr. Cleggett-Lucas, was the flurry of publicity concerning the physician's alleged misconduct involving the prescription pain medication OxyContin and which aired just prior to the time Ohler's original suit was filed. Counsel for plaintiff further notes that the defendant drug companies were not joined until sometime later and submits that the allegation of fraudulent joinder is a calculated effort on the part of Purdue-Abbott to circumvent 28 U.S.C. § 1332's jurisdictional requirement of complete diversity. Finally, plaintiff challenges Purdue-Abbott's misjoinder argument as simply a transparent attempt to revisit fraudulent joinder. Counsel submits that the Plaintiff's Amended Petition unequivocally alleges conduct which gives rise to joint liability on the part of the physician and Purdue-Abbott.
Such alleged misconduct included intentionally causing her patient's addiction, prescribing OxyContin even though not medically necessary, knowing that resulting patient addiction to OxyContin would enure to her monetary benefit in the form of frequent return visits. See Petition for Damages, at para. 5(a-g).
Purdue-Abbott argues that the plaintiff waived all procedural defects in the removal by filing his motion to remand one day late (more than 30 days after the filing of the notice of removal). Defendants contend that Dr. Cleggett-Lucas was fraudulently joined because the plaintiff had no valid claim against his qualified health care provider, Cleggett-Lucas, under Louisiana law at the time of removal.
Counsel for the defendants submits that 28 U.S.C. § 1447(c)'s 30-day limit for filing a motion for remand on the basis of any defect other than lack of jurisdiction has been strictly construed to run from the date of filing of the notice of removal. Utilizing the federal counting rules (Fed.R.Civ.P. 6(a) and 28 U.S.C. § 1447(c)), a timely motion to remand had to be filed on or before November 8, 2001 and mailing the notice does not extend the time period. Plaintiffs Motion to Remand was untimely filed on November 9, 2001.
Counsel explains that no action was "commenced" against the physician and her employer at the time of removal, since Louisiana law applicable through the Erie doctrine requires that filing with the review panel constitutes the mandatory initial step in commencing a malpractice claim and is required before filing any suit. See La.Rev.Stat. 40:1299.47(A)(1); and Nathan v. Touro Infirmary, 512 So.2d 352, 353-54 (La. 1987).
For reasons explained below, the Court disagrees with the defendants' argument regarding "fraudulent joinder," a judicially-crafted and strictly construed exception to the complete diversity requirement for purposes of removal jurisdiction. However, Purdue-Abbott's challenge of "fraudulent joinder" cannot in utter candidness be characterized as "nonsensical." Understandably, Purdue-Abbott has real concerns as to whether Ohler's malpractice claims against Cleggett-Lucas were erected at the outset as a stumbling block to removal, and in anticipation of the joinder of the drug company defendants. To this day, plaintiffs have yet to institute medical review panel proceedings against Cleggett-Lucas, though certain of her status as a qualified health care provider for the year 2000. Plaintiffs tenuously blame their deferral of the institution of any medical review panel proceedings on the fact that they are unsure as to the status of Cleggett-Lucas for the years straddling the year 2000.
As discussed in more detail below, all doubts as to the governing law must be construed in favor of remand. Also, all genuine issues of fact germane to the determination of "fraudulent joinder" must be resolved in favor of the plaintiffs. These two principles figure prominently in this Court's ruling.
ANALYSIS
1. Waiver of Objection 28 U.S.C. § 1447(c)
Where a plaintiff moves to remand more than thirty days after a notice of removal is filed, the sole permissible basis for remand is lack of subject matter jurisdiction. See 28 U.S.C. § 1447(c) (providing that a motion to remand must be made within 30 days after the filing of the notice of removal). The plaintiff has thirty days within which to challenge removal, after which time the plaintiff is considered to have waived all procedural flaws in the removal. All procedural defects in the removal were waived in this case when the plaintiff filed the motion to remand one day late. The sole issue for the Court's determination regarding the issue of remand is whether the Court also has original subject matter jurisdiction.
See generally, In re Shell Oil Co., (Shell II), 932 F.2d 1523, 1527 n. 6, n. 7 (5th Cir. 1991).
It is well-settled that a defendant may remove a state court action to federal court only if the action originally could have been filed in the federal court. 28 U.S.C. § 1441(a). Filing in federal court is permitted if there is diversity of citizenship between the parties pursuant to 28 U.S.C. § 1332(a), or there is federal question jurisdiction. 28 U.S.C. § 1331. Purdue-Abbott removed this case on the grounds of (1) complete diversity, claiming both fraudulent joinder and misjoinder of non-diverse defendants; and (2) federal question and supplemental jurisdiction, specifically citing the FDCA, 21 U.S.C. § 321, et seq., which governs the manufacture and distribution of OxyContin, and 21 C.F.R. § 10.30, which provides that the administrative procedure of a citizen's petition to challenge the prescribing information provided for federally approved drugs, inter alia. The issues of complete diversity and federal question jurisdiction are addressed serially below.
2. Fraudulent Joinder.
It is axiomatic that incomplete diversity between the parties destroys the federal court's diversity jurisdiction. Strawbridge v. Curtis, 7 U.S. (3 Cranch) 267, 2 L.Ed. 435 (1806). Defendants contend that Dr. Cleggett-Lucas and her employer are "fraudulently joined," since the medical malpractice claims against the physician are not ripe. Claims against a qualified health care provider must first be administratively presented to a medical review panel before they can be commenced in any court. See La. R.S. 40:1299.47(B). Claims of negligent treatment against the non-diverse physician are premature because the plaintiff has failed to satisfy the necessary pre-condition to filing suit or commencing an action in any court. Essentially the defendants submit that Cleggett-Lucas was improperly and fraudulently joined because at the time of removal, commencement of an action by filing a lawsuit was not possible.
The standard for determining "fraudulent joinder" is well-established in the Fifth Circuit. In Badon v. R J R Nabisco, Inc., 224 F.3d 382 (5th Cir. 2000), the court restated the applicable law, noting that:
[W]e have consistently recognized that diversity removal may be based on evidence outside of the pleadings to establish that the plaintiff has no possibility of recovery on the claim or claims asserted against the named resident defendant and that hence the defendant is fraudulently joined and his citizenship must be disregarded for jurisdictional purposes. Thus it is clear that although a state court complaint on its face may allege a state law claim against an in-state defendant that does not preclude it from being removable (by a non-resident defendant), when filed, if the plaintiffs pleading is pierced and it is shown that as a matter of law there is no reasonable basis for predicting that the plaintiff might establish liability on that claim against the instate defendant.Id. at 390 (citations omitted and emphasis added). In Burden v. Dynamics Corp., 60 F.3d 213 (5th Cir. 1995), the Fifth Circuit succinctly stated: "If the plaintiff has any possibility of recovery under state law against the party whose joinder is questioned, then the joinder is not fraudulent in fact or in law. Id. at 216 (emphasis added). The focus of the inquiry is whether there is "any possibility of recovery under state law" or "a reasonable basis for predicting that plaintiff might establish liability on that claim." Burden v. Dynamics, 60 F.3d at 216.
Considering Circuit precedent, the issue of whether or not a claim was "commenced" in state court, is not relevant to the determination of "fraudulent joinder" allegations against the plaintiff Any uncertainties as to the current state of the controlling law must be resolved in favor of the plaintiff See B., Inc. v. Miller Brewing Co., 663 F.2d 545, 549 (5th Cir. 1981).
The jurisdictional facts presented in the captioned proceeding are not unusual. Without attempting to satisfy the Louisiana Malpractice Act's pre-condition of presenting malpractice claims to a Medical Review Panel, a Louisiana patient filed suit against his in-state treating physician (a qualified health care provider), and out-of-state prescription drug or medical device manufacturers. Louisiana law provides in La.R.S. 40:1229.47(B)(1)(a)(i) that:
No action against a health care provider covered by this Part, or his insurer, may be commenced in any court of this state. before the claimant's proposed complaint has been presented to a medical review panel established pursuant to this Section and an opinion rendered by the panel. By agreement of both parties, the use of the medical review panel may be waived.
A pending review panel action suspends prescription on the medical malpractice claims. See Section 1299.47(A)(2)(a). A pending panel review should also serve to suspend prescription against all joint and solidary tortfeasors. Id. However, suspension of prescription may not be effective against persons presumed to be a joint tortfeasor, if ultimately it is determined that the health care provider is not liable. See Spott v. Otis Elevator Co., 601 So.2d 1355, 1359-61 (La. 1992). Review of the applicable case law indicates that the cautious approach (filing suit prematurely against the resident qualified health care provider) is not an uncommon phenomenon at all.
In this vein, the Court notes that there is long unbroken line of cases in the Eastern District of Louisiana addressing the issue raised here — whether a non-diverse physician defendant is "fraudulently joined" when suit is filed in state court prematurely (before completion of medical review panel proceedings). The lead case issued out of the Middle District of Louisiana. See Erdey v. American Honda Co., Inc. 96 F.R.D. 593, 596 (M.D. La. 1983) (holding that a premature petition under Louisiana's Medical Malpractice Act does not preclude a finding that the petition states a cause of action against medical defendants).
In Erdey, Judge Parker held that despite prematurity, the allegations of the original state court petition clearly alleged facts which supported a malpractice cause of action, and thus the malpractice defendants were not fraudulently joined. Judge Parker explained that Louisiana law requires a dilatory exception of prematurity. In a malpractice suit filed prior to the completion of medical review panel proceedings, the filing of a dilatory exception of prematurity requires that the case be dismissed without prejudice. The court further noted the "vast difference" between the peremptory exception of no cause of action, which results in a dismissal with prejudice and the exception of prematurity, which results in a dismissal "without prejudice, or as of non-suit." 96 F.R.D. at 596. Judge Parker's reasoning was simply that the medical defendants were merely subject to involuntary dismissal without prejudice and not a dismissal with prejudice, and therefore, it could not be said that the original petition did not state a cause of action. The court observed that if an exception of no cause of action had been filed, it would have been denied. Erdey, 96 F.R.D. at 595-597.
The courts in this district have uniformly followed the rationale set forth by Judge Parker in Erdey, beginning with Judge Feldman in Doe v. Cutter, 774 F. Supp. 1001 (E.D.La. 1991). In the Doe decision, Judge Feldman held that: "Procedural prematurity is not a conceptually accurate measure of fraudulent joinder if the claim theory asserted can be said to have plausible merit." 774 F. Supp. at 1004. More to the point, "[p]rematurity does not trump viability." Id. Judge Feldman noted that the "key inquiry to a claim of fraudulent joinder is whether the plaintiff made a nondiverse party a defendant under a claim that has substantive merit." Id.; see also Duffy v. Pendleton Memorial Hospital, 1998 WL 273114 (E.D.La. May 28, 1998) (Vance J.) (finding joinder of the nondiverse physician proper and remanding the case); Kelly v. Danek Medical, Inc., 1994 WL 321074 (E.D. La. June 28, 1994) (granting remand, noting that plaintiffs did not name non-diverse defendants as parties in deference to the Medical Malpractice Act, but they nevertheless stated a cause of action against the defendants); Doe v. Armour Pharmaceutical Co., 837 F. Supp. 178, 182-84 (E.D.La. 1993)(Mentz, J.) (finding that removal was improper because the plaintiffs stated a cause of action against medical defendants, despite the outcome of a dilatory exception of prematurity); and Perry v. McNulty, 794 F. Supp. 606, 608 (E.D. La. 1992)(Arceneaux, J.) (granting remand because the plaintiff stated a cause of action against the non-diverse defendant even though the state court already dismissed the premature claims).
In Cooper v. Sofamor, Inc., 1993 WL 17634 (E.D. La.), Judge Clement denied remand in a case where the non-diverse medical defendants were dismissed by the state court pursuant to a dilatory exception of prematurity because the medical review panel had not yet been completed. Judge Clement distinguished the decision in Doe v. Cutter on the basis that the non-diverse defendants in Doe had not been dismissed by the state court, noting that removal was wrongful in Doe because no complete diversity existed at the time the defendants' petition for removal was filed. It is also noteworthy that Judge Clement granted the plaintiff's alternative motion for a stay in the Cooper case pending the outcome of the medical review panel proceedings, and explicitly recognized that the defendants had stated a cause of action against the non-diverse medical defendants. Judge Clement explained her ruling granting the alternative motion to stay as follows:
[T]he medical malpractice and products liability elements of this case cannot be neatly separated as SOFAMOR suggests. Having one jury determine the cause(s) of Cooper's injury (if any) will prevent procedural confusion, "avoid piecemeal resolution of these claims and enhance all notions of judicial economy." Id.
Judge Clement's ruling granting a stay of proceedings left open the possibility that post-removal joinder of the non-diverse medical defendants would destroy diversity for jurisdictional purpose and require remand in any event.
See Cobb v. Delta Exports, Inc., 186 F.3d 675, 678 (5th Cir. 1999) (recognizing that doctrine of "fraudulent joinder" does not apply to defendants who are joined after an action is removed, for in such cases, the defendants have a chance to argue against joinder before leave to amend is granted.).
The Court does not find the decision in Glaze v. Ahmad, 954 F. Supp. 137, 138 (W.D. La. 1996) persuasive. The case itself is inapposite and the holding is indeed narrow, being expressly limited to the situation in which it arose, to wit:
In this case we follow Walker and hold that for the purpose of establishing diversity jurisdiction after removal, we are bound by the state law determination of the time the action was commenced. The effect of our ruling is that a non-diverse defendant cannot create removal jurisdiction by acquiring a new domicile after a state medical review panel has been commenced.Id., at 140 (all emphasis added). The issue before the Glaze court was not whether the physician defendant was "fraudulently joined" by the plaintiff Instead, Glaze involved the wrongful removal by the same non-diverse defendant who manufactured diversity jurisdiction after the medical review panel proceedings were instituted, and then removed the case when the state court suit was filed. In Glaze, there is absolutely no discussion of "fraudulent joinder" or federal cases discussing the pertinent inquiry concerning that allegation. Indeed, Glaze is not a "fraudulent joinder" case at all; the court was concerned with wrongful removal by a defendant who unilaterally created diversity jurisdictionafter the institution of state proceedings, i.e., the medical review panel proceedings. The Glaze court's ruling bears no relation to the issue of "fraudulent joinder" and does not discuss any controlling Circuit precedent on that issue. The focus of this Court's inquiry is whether there is a possibility of recovery against that physician under state law.
Having reviewed the applicable law and the memoranda of counsel, the Court is not persuaded that there is no "possibility of recovery under state law" or that there is no reasonable basis for predicting recovery" against non-diverse physician for medical malpractice, intentional tort, or deceptive practices. Having found that the resident physician was not fraudulently joined, the court need not address whether JCL was fraudulently joined also.
Burden, 60 F.3d at 216.
Badon, 236 F.3d at 285.
3. Misjoinder.
Plaintiffs' claims include that his physician over-treated and over-prescribed controlled drug pain medications, while failing to monitor, to warn, and to protect petitioner from addiction and other serious risks attending the use of such pain medications, including OxyContin, inter alia. That these allegations clash with allegations against Purdue-Abbott is of no moment. At some point in the proceedings, some form of the "the learned intermediary doctrine" will surface; it is a veritable certainty considering the "failure to warn" allegations against the drug manufacturers. That doctrine, which invariably arises in context of failure to warn cases involving both the prescription drug manufacturers and the treating/prescribing physician as party defendants, dismembers any misjoinder argument.
In cases involving the manufacture of prescription drugs and medical devices, under Louisiana's learned intermediary doctrine the duty to warn the patient is owed to the physician, and not the patient. See Grenier v. Medical Engineering Corp., 243 F.3d 200 (5th Cir. 2001). Underpinning the "learned intermediary doctrine" is the notion that the treating physician is generally in the best position to relate contraindications, and warnings as to the safety or efficacy of a particular prescription drug or medical device insofar as they relate to the particular patient's idiosyncracies and condition.
The connexity between Ohler's allegations against his physician and the allegations against Purdue-Abbott are best illustrated by the claims of "over-promotion." Over-promotion is indeed a hybrid claim, which draws elements from each of the plaintiffs theories of liability, including negligent misrepresentation, deceptive practices, failure to warn, absence of appropriate warnings, and product defect. The over-promotion theory of liability is simply that, by over-promoting the drug product, the manufacturer diluted the full effect of the warnings, and in "playing down" the risks, deceived the physician, the consumer, or both, all of which resulted in the product drug finding its way to an inappropriate market via prescription, but not within the intended warnings.
See Hill v. Searle Laboratories, 884 F.2d 1064, 1071 n. 3 (8th Cir. 1989) (noting that over-promotion by a drug manufacturer may cause the prescribing physician not to rely on the warnings and package inserts associated with the particular drug product); Plummer v. Lederle Laboratories, 819 F.2d 349, 358 (2nd Cir. 1987) (distinguishing a case involving a drug manufacturer's over-promotion coupled with gross minimization of the risk of prescribing the drug within the product wamings); and Salmon v. Parke Davis Co., 520 F.2d 1359, 1363 (4th Cir. 1975) (noting that over-promotion nullifies the effect of valid warnings).
It is not unusual that allegations against multiple defendants are inconsistent, and clearly plaintiff has alleged other specific acts against Dr. Cleggett-Lucas, in addition to the failure to warn, including failure to monitor and failure to test. 4. Federal Question Jurisdiction and Preemption.
See Ritchie v. Warner-Lambert Company, 2001 WL 527501 (E.D.La) (rejecting the defendants' argument that the physician cannot be liable for failure to warn, where it is also alleged in the petition that the manufacturer represented to the physicians that the drug was safe and effective). In Ritchie, Judge McNamara observed that in cases involving multiple defendants that "the allegations against multiple defendants are often inconsistent" and noted that in addition to the failure to warn, "other specific acts were alleged against the resident physician." Id.
The question presented is whether the plaintiffs' various and sundry state law claims, including but not limited to tort, products liability, failure to warn, and deceptive practices with respect to the prescription drug OxyContin should be restated as a claim "arising under" federal law due to the extensive regulation of prescription drugs under the FDCA.
The Amended Petition alleges(1) deceptive practices proscribed by Louisiana's Consumer Protection Laws (LUTPA), Count I; (2) negligence and redhibition (Count II); (3) products liability, failure to warn, monitor, or test and adulteration and misbranding in violation of the La.Rev.Stat. 40:601, the State Food, Drug, and Cosmetic Act (Count III); (4) manufacturing defect (Count 4);(5) negligence per se under the Louisiana Consumer Protection Act (Count V); (6) negligent medical monitoring and LUTPA (Count 6); and (7) state law breach of warranty (Count VII).
As previously discussed, Congress has provided for removal of cases from state court to federal court only if the federal court would have had original jurisdiction over the action. 21 U.S.C. § 1441(a). Congress gave the federal courts general "federal question" jurisdiction in the Judiciary Act of 1875, providing "[t]he district courts shall have original jurisdiction of all civil actions arising under the Constitution, laws or treaties of the United States." 28 U.S.C. § 1331 (emphasis added). Federal removal statutes are to be strictly construed, and all doubts regarding removal are to be resolved in favor of remand and against removal, accommodating the principles of comity and fundamental fairness. See Shamrock Oil Gas Corp. v. Sheets, 313 U.S. 100, 61 S.Ct. 868, 85 L.Ed. 1214 (1941); Leffall v. Dallas Independent School District, 28 F.3d 521, 524 (5th Cir. 1994).
The presence of federal question jurisdiction is governed by reference to the "well-pleaded complaint" doctrine. Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 808, 106 S.Ct. 3229, 92 L.Ed.2d 650 (1986) (citing Franchise Tax Board v. Construction Laborers Vacation Trust, 463 U.S. 1, 9-10, 103 S.Ct. 2841, 77 L.Ed.2d 420 (1983)). Pursuant to this doctrine, a case "arises under" federal law, and is therefore removable only if a federal claim exists on the face of the plaintiffs complaint. Id.
The fact that the plaintiff's state law claims may be preempted by federal law is insufficient to confer federal jurisdiction, and thus removal is not proper if based on a defense or an anticipated defense which is federal in nature, even both parties admit that the federal deft defense is the only real question in the case. See Caterpillar Inc. v. Williams, 482 U.S. 386, 393, 107 S.Ct. 2425, 96 L.Ed.2d 318 (1987)("The fact that a defendant might ultimately prove that a plaintiffs claims are preempted under [a federal statute] does not establish that they are removable to federal court."); see also Gully v. First National Bank, 299 U.S. 109, 116, 57 S.Ct. 96, 81 L.Ed. 70 (1936)("By unimpeachable authority, a suit brought upon a state statute does not arise under an Act of Congress or the Constitution of the United States because prohibited thereby") (emphasis supplied). In the Gully decision, Justice Cardoza observed:
Not every question of federal law emerging in a suit is proof that federal law is the basis of the suit. * * * [A] finding upon the evidence that [State] law has been obeyed may compose the controversy altogether, leaving no room for a contention that federal law has been infringed. The most one can say is that a question of federal law is lurking in the background, just as farther in background there lurks a question of constitutional law, the question of state power in our federal form of government. A dispute so doubtful and conjectural, so far removed from plain necessity, is unavailing to extinguish the jurisdiction of the states.299 U.S. at 117.
One corollary to the doctrine of the well-pleaded complaint is the doctrine of "complete preemption." Caterpillar, Inc. v. Williams, 482 U.S. 386, 393, 107 S.Ct. 2425, 2430 (1987). Usually federal preemption only provides a defense, and therefore does not permit removal. Complete preemption arises when Congress intends a federal statute to preempt a field of law so completely that state law claims are considered converted into a federal cause of action. See Metropolitan Life Insurance Company v. Taylor, 481 U.S. 58, 63-65, 107 S.Ct. 1542, 95 L.Ed.2d 55 (1987); and Caterpillar, Inc., 482 U.S. at 393, 107 S.Ct. at 2430 ("On occasion, the Court has concluded that the pre-emptive force of a statute is so 'extraordinary' that it 'converts an ordinary common-law complaint into one stating a federal claim for purposes of the well-pleaded complaint rule.'").
Complete preemption has its roots in the Supremacy Clause of the Constitution which provides that the law of the United States "shall be the supreme law of the land. . . ." U.S. Const. art. VI, cl. 2.; see Louisiana Public Service Commission v. F.C.C., 476 U.S. 355, 369, 106 S.Ct. 1890, 90 L.Ed.2d 369 (1986). A federal law or regulation may preempt states by allowing a common law right of action to private citizens. Even in cases of express preemption, such as the Medical Device Act's (MDA's) provision § 360k(a), courts must identify the domain expressly pre-empted by the language. See Medtronic, 518 U.S. at 500-501, 116 S.Ct. at 2258.
See Cipollone v. Liggett Group, Inc., 505 U.S. 504, 515, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992) (held federal Cigarette Labeling and Advertising Act preempted requirements and prohibitions based on smoking and health "imposed under State law with respect to advertising and promotion" of cigarettes in packages that were labeled in conformity with the Act."); and CSX Transporation, Inc. v. Easterwood, 507 U.S. 658, 113 S.Ct. 1732, 123 L.Ed.2d 387 (1993) (held federal regulations setting maximum speed for train at a particular type of crossing, with which the defendant train complied, preempted state claims allowing the plaintiff a common law recovery).
Notwithstanding the ruling in Cipollone that requirements under State law with respect to advertising and promotion of cigarettes labeled and packaged in conformity with the federal Smoking Act were preempted, the Court held that the fraudulent misrepresentation claims, including those made in advertisements, were not preempted because they were "predicated not on a duty 'based on smoking and health' but rather on a general obligation — the duty not to deceive." 505 U.S. at 528-528, 112 S.Ct. at 2623-2624.
Congress may preempt a statute in three ways: (1) state action may be foreclosed by express language in a congressional enactment; (2) by implication from the breadth and depth of the congressional scheme that occupies the legislative field; or (3) by implication because of a conflict with a congressional enactment.
See Cipollone, 505 U.S. at 517.
See Fidelity Federal Savings Loan Association v. De La Cuesta, 458 U.S. 141, 102 S.Ct. 3014, 3019, 73 L.Ed.2d 664 (1982) (holding that the Federal Home Loan Bank Board's due-on-sale regulation pre-empts conflicting state limitations on the due-on-sale practices of federal savings and loan associations considering, inter alia, the expressed intent that due-on-sale practices of federal savings and loans be governed "exclusively by federal law," and that "federal associations . . . not be bound by . . . conflicting State law which imposes different . . . due-on-sale requirements.").
See Freightliner Corp. v. Myrick, 514 U.S. 280, 115 S.Ct. 1483, 1488 (1995) (holding common-law suits for negligent design on account of the absence of anti-lock braking system (ABS) in tractor trailers not expressly preempted, noting that saving clause § 1397(k) (compliance with the standards of the Safety Act does not exempt any person from any liability under common law), and finding no implied or conflict preemption because nothing in the federal Safety Act regulated the use of ABS devices such that it was impossible to comply with both State and Federal law, and therefore a finding of liability would not undermine federal objectives with respect to ABS brakes since none exist).
The application of the several principles used in preemption analysis and examination of the three factors which must be investigated to determine whether complete preemption exists, does not compel a finding of complete preemption in this particular case. First, the evidence does not reveal a Congressional intent to make each and every cause of action under which the plaintiffs' suit is being brought within the scope of the federal statute. Secondly, the evidence presented does not clearly demonstrate either that Congress or the FDA intended to preempt the field by implementing regulations pursuant to statutory mandate in the field of prescription drugs labeling, and thereby completely displacing State laws and regulations which may have the affect of elevating the standards and duties owed by manufacturers with respect to warnings and labeling of prescription drugs. Thirdly, Purdue-Abbott has failed to demonstrate that the FDCA (the federal law in question) finds a close parallel in ERISA's and LMRA's jurisdictional and enforcement provisions. Purdue-Abbott contends that the extraordinary injunctive relief sought to remedy the alleged inadequacy of warnings is "startling in its sweep," and clearly constitutes a request for "labeling." Considering the field of federal regulations relating to the drug OxyContin, Purdue-Abbott argues the imperative that regulations affecting manufacture, labeling, monitoring, and warning of the prescription drug OxyContin be uniform. Their contention is that since the sole authority to review and approve "labeling" of a federally-regulated Schedule II controlled substance resides with the FDA, plaintiffs necessarily invoke "federal question" jurisdiction, which cannot now be disavowed either by attempting to characterize the claims as solely state law claims or by simply denying the applicability of federal law to the claims made and relief actually sought.
See Metropolitan Life Insurance Co. v. Taylor, 481 U.S. 58, 66, 107 S.Ct. 1542, 1547 (1987).
See Metropolitan Life Insurance Co. v. Taylor, 481 U.S. at 60.
See Employee Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. § 1132(f)("District courts of the United States shall have jurisdiction, without respect to amount in controversy or citizenship of the parties to grant relief provided in subsection (a) of this section in any action."); see also H.R.Conf. Rep. No. 93-1280, p. 327 (1974) (noting that all such actions are to be regarded as arising under the laws of the United States in similar fashion to those brought under the LMRA).
See Labor-Management Relations Act of 1947 (LMRA), 29 U.S.C. § 185(a)("Suits for violation of contracts between employer and labor organization representing employees in an industry affecting commerce as defined in this chapter, or between any such labor organizations, may be bought in any district court of the United States having jurisdiction between the parties, without respect to amount in controversy or without regard to citizenship of the parties.").
See Metropolitan Life Insurance Co. v. Taylor, 481 U.S. at 66.
Distilled to its essence, defendants' position is that: (1) the extraordinary mandatory injunctive relief sought by the plaintiffs constitutes a request for "labeling;" (2) that remedy is exclusively governed by the FDA as a matter of unassailable federal law; and (3) suit to redress that wrong necessarily arises under federal law, displacing any remedy the state may have for it.
Purdue-Abbott directs the Court's attention to 21 C.F.R. § 314.70 which requires a manufacturer to submit a supplemental new drug application to the FDA in order to "strengthen a contraindication, warning, precaution, or adverse reaction" in the labeling of an approved drug.
Plaintiffs' reply notes that the requested relief by its terms seeks no modification to the "label" per se. Plaintiffs submit that the notification and medical monitoring sought are not subject to the FDCA's labeling or advertising provisions. Instead, the relief sought is in the nature of "promotional labeling" discussed in 21 C.F.R. § 314.70(c) and 314.81(b)(3)(i), which requires no advance FDA approval. In the case of such "promotional labeling," the manufacturer need only provide a copy of to the FDA. See 21 C.F.R. § 314.81(b)(3)(i). Plaintiffs submit their request for "notification" does not raise any "federal question." Addressing defense counsel's argument relative to the existence of citizen's petition process afforded within the context of 21 C.F.R. § 10.30 and judicial review under the Administrative Procedures Act ("APA"), plaintiff's counsel points out that there is no provision in the FDCA which would permit the FDA to require that the drug company defendants pay damages to the plaintiffs remunerating their losses sustained on account of the alleged negligence, intentional tort, breach of warranty, failure to warn, or defective product liability.
In other words, equitable relief sought in the form of notification and enhanced monitoring is in addition to monetary damages, and there is no private remedy for damages under the FDCA.
Claims about Ritalin, similar to those raised by defendants in the case at bar, were rejected by the district court in Dawson. See Dawson v. Ciba-Geigy Corp., 145 F. Supp.2d 565, 571 (D.N.J. 2001) (concluding that "without a doubt there is no civil remedy available to plaintiffs under the FDCA."). Insofar as defendants suggest that, in the prescription drug context, FDA approval is a shield to liability under state law, the weight of authority is to the opposite effect. FDA regulations appear to be minimum standards except in cases of express preemption.
The applicable regulation states that changes in labeling that "add or strengthen a contraindication, warning, precaution, or adverse reaction" fall within the category of adjustments that "may be made before FDA approval." 21 C.F.R. § 314.70. In Motus v. Pfizer 127 F. Supp.2d 1085 (C.D. Cal. 2000), the court observed that the FDA Commissioner's own comments support the view that labeling requirements do not prohibit a manufacturer from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered and that supplementing the labeling with additional warnings is not prohibited by federal regulations. Id. at 1094 (citing 21 Federal Register 37447 (1979)). In Geier, the Supreme Court observed that federal agencies might reasonably view their safety standard "as a minimum standard" of care. 529 U.S. at 874-875, 120 S.Ct. 1913.
See Hill v. Searle Laboratories, 884 F.2d 1064, 1068 (8th Cir. 1989) (federal approval not a shield to liability and rather generally are minimum standards of conduct); and In re Tetracycline Cases, 747 F. Supp. 543, 550 (W.D. Mo. 1989) (supplemental warning actions not precluded by preemption).
There is no express preemption under either the FDCA or the control and enforcement provisions of the Uniform Controlled Substances Act. Nearly every State in the United States, along with the Virgin Islands and Puerto Rico, have adopted either the 1970, 1990, or 1994 Version of the Federal Uniform Controlled Substances Act, or some combination thereof Clearly, the various States have statutes, laws, or regulations effecting control, enforcement and punishment of wrongful or illegal distribution or trafficking of Schedule II narcotic drug controlled substances, including OxyContin. These state laws coexist and operate in tandem with and as an adjunct to the federal criminal provisions. These state and federal laws or regulations have operated in tandem for decades, and permit the conduct of operations jointly on a case-by-case basis. A Joint Task Force comprised of members of various federal agencies, including the DEA, the BATF, inter alia, working together with members of various State and local law enforcement agencies on particular projects aimed at interdicting illicit drug trafficking, is not an unusual occurrence.
In the absence of express preemption (and there is none with respect to State laws or regulations imposing more rigid warning requirements), there is a strong basic assumption that Congress did not intend to displace state law. See Maryland v. Louisiana, 451 U.S. 725, 726, 101 S.Ct. 2114, 68 L.Ed.2d 576 (1981). The presumption is greater where the federal legislation or regulations involve areas in which the States "have traditionally occupied," and the court must presume "that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress."
Geier v. American Honda Motor Co., 529 U.S. 861, 907 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000)("a court should not find preemption too readily in the absence of clear evidence of conflict"); see also Medtronic v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (recognizing "the historic primacy of state regulation of matters of health and safety").
In Medtronic, Inc. v. Lohr, 518 U.S. 471, 485, 116 S.Ct. 2240 (1996), the Supreme Court highlighted two presumptions about the nature of preemption: (1) "Congress does not cavalierly preempt state law causes of action . . . particularly in those cases in which Congress has "legislated . . . in a field which the States have traditionally occupied;"' and (2) "the presumption against pre-emption of state police power" applies to both the question of whether Congress intended preemption at all and to the determination of the scope of an intended invalidation of state law. 518 U.S. at 485 (citations omitted). The Medtronic Court emphasized: "That approach is consistent with both federalism concerns and the historic primacy of state regulation of matters of health and safety. Id.
The Medtronic case involved an express pre-emption provision ( 21 U.S.C. § 360k(a) of the Medical Devices Act (MDA)), which proscribed State regulation of devices intended for human use (1) that were different from or in addition to any requirement applicable under MDA to the device, and (2) any requirement related to the safety or effectiveness of the device. The Supreme Court rejected the device manufacturer's argument that the Court of Appeals should have found the plaintiffs' entire action completely pre-empted. 518 U.S. at 486. In Medtronic, the plaintiffs' claims included defective manufacturing, design and labeling of a pacemaker under State tort law ( i.e., "a situation implicating federalism concerns and the historic primacy of state regulation of matters of health and safety."). See Buckman v. Plaintiffs' Legal Committee, 121 S.Ct. 1012, 1017 (2001) (an MDA case finding conflict preemption with respect to claims of "fraud-on-the-FDA").
The state regulations at issue in the Medtronic case, which were not expressly preempted, involved general labeling and manufacturing requirements, did not specifically address medical devices, and did not have the effect of establishing substantive requirements for the device. The state law claims in Buckman concerned allegations of fraud-on-the-FDA, and conflicted with the federal statutory scheme which empowered the FDA to punish and deter fraud against the Administration.
In Buckman, the Supreme Court observed that "[p]olicing fraud against federal agencies is hardly "a field which the States have traditionally occupied"' and concluded that "no presumption against pre-emption" applied under those circumstances. 121 S.Ct. at 1017. The Buckman plaintiffs' state law fraud claims, their only claims, arose solely from the violation of FDCA requirements. Buckman applied no anti-preemption presumption because the petitioner asserted "fraud-on-the FDA" and petitioner's relationship and dealings with the FDA were not traditionally matters of state concern. Id.
The Supreme Court's decision in Medtronic did settle some issues which bear on Purdue-Abbott's complete preemption arguments. A majority of the Court held that FDA Good Manufacturing Practices and labeling requirements are not sufficiently specific and do not relate only to medical devices, so they do not preempt state law claims from manufacturing defects and failure to warn. 518 U.S. at 501. The Court explained that "the federal requirements reflect important but entirely generic concerns about device regulation generally, and not the sort of concerns regarding a specific device or a field of device regulation that the statute or regulations were designed to protect from potentially contradictory state requirements." Id.
In the case of prescription drugs, there is no indication that the FDA has stepped in and expressly preempted State and local warning requirements, as it has in fact done with respect to certain Over-The-Counter (OTC) drug warnings. The fact that the FDA has carved out certain fields, such as OTC drugs, and expressly preempted State and local labeling requirements with respect to those particular fields, militates in favor of a conclusion that there is no intent to preempt State and local labeling and warning requirements with respect to prescription drugs where it has not done so.
See e.g. 51 Fed. Reg. 8180, 8181 (1986) (Reye syndrome warning; "making it clear that this final rule preempts State and local labeling requirements that are not identical to it:); 47 Fed. Reg. 54,750, 54,756 (1982) (general pregnancy warning for OTC drug products); 47 Fed. Reg. 50,442, 50,447-48 (1982)(tamper-resistant packaging and associated labeling requirements) (noting that, in issuing this final rule, "the FDA intends that the regulations issued in this document preempt State and local packaging requirements that are not identical to it in all respects. . ."); and 62 Fed. Reg. 9024, 9040-42 (implementing regulations requiring specific information on the labeling of all OTC drug products and explaining that notwithstanding the fact that Congress did not expressly preempt State law, the FDA tentatively does so for the reasons that (1) State regulation would significantly interfere with the goals of Federal law and the methods of achieving those goals, (2) State and local laws would significantly undermine the Agency's objectives of ensuring safe and effective use of OTC drug products, and (3) the need for a national standard outweighs the interests of the individual States and localities).
The FDA has required that prescription drugs which it has deemed to "pose a serious and significant public health concern" be dispensed with patient information to ensure these prescription drugs' safe and effective use, and expressly acknowledged its statutory authority to regulate prescription product labeling. However, addressing comments urging that the FDA provide for Federal preemption of State regulation with respect to civil tort liability claims and other labeling requirements, the Agency has expressly disavowed any intention to do so. Dismissing such comments, the FDA responded:
See 63 Fed. Reg. 66382-66383.
Tort liability can not be a major consideration for the FDA which must be guided by the basic principles and requirements of the act in its regulatory activities. Nevertheless, FDA does not believe this rule [ i.e., requiring package inserts], would adversely affect tort liability for several reasons. First, tort liability depends on a number of factors surrounding the manufacture, distribution, sale, and use of a product, and the nature of the injury, and not just on the information provided or not provided to patients. Second, the agency believes that providing patients with written information about the proper use of prescription drug products of "serious and significant concern" could reduce potential liability by improving patient compliance and patient monitoring of serious adverse events, thus decreasing drug-induced injuries or hospitalizations. . . . Third, written patient medication information provided does not alter the duty, standard of care for manufacturers, physicians, pharmacists and other dispensers. Fourth, no evidence has been presented that patient labeling currently required by the FDA regulation has caused a noticeable change in tort rules affecting civil liability. . . . FDA believes that the information required by these regulations is necessary for patients to safely and effectively use prescription drug products that have been determined to be of "serious and significant concern." In most cases, the information required by the FDA will be such that States will have little reason to impose additional labeling requirements. Additionally, Federal preemption could unduly interfere with the goals and objectives of existing State programs imposed under the Omnibus Budget Reconciliation Act (OBRA) of 1990, which requires that pharmacists offer to counsel Medicaid patients about their prescription drugs. Many States have extended this requirement to all patients who receive prescription drugs, and some States have required that patients receive written medication information. This final rule is intended to complement these State efforts, not replace or hinder them . FDA does not believe the evolution of state tort law will cause the development of standards that would be at odds with the agency's regulations. FDA's regulations establish the minimal standards necessary, but were not intended to preclude the states from imposing additional labeling requirements. States may authorize additional labeling but they cannot reduce, alter, or eliminate FDA-required labeling.
See 63 Fed. Reg. 66383-84 (emphasis added).
Hence we have, in back-and-white, the FDA's intention with respect to "labeling" of prescription drugs. It would be difficult to discern an opposite or contrary intention on the part of Congress, since it has not seen fit to step in and legislate otherwise. As to the suggestion that as a matter of unassailable Federal law, labeling of prescription drugs is exclusively within the province of the FDA, this Court cannot agree. Intent is clear in that area, to wit: (1) "to complement State efforts;" and (2) "to establish the minimal standards." Id.
When preemption by FDA regulation is considered, courts are reluctant to find preemption by federal regulations when the agency does not make very clear an intent to preempt since agencies normally address problems in a detailed manner. See Hillsborough County, Fla. v. Automated Medical Laboratories, Inc., 471 U.S. 714, 105 S.Ct. 2371, 2376-77 (1985)("Given the clear indication of the FDA's intention not to pre-empt and the deference with which we must review the challenged ordinances, we conclude these ordinances are not pre-empted by the federal scheme.") (emphasis in original). In Hillsborough County, the Supreme Court rejected the respondent's contention that the FDA's plasma regulations pre-empted all provisions of the county's ordinances on that subject. The Court noted that whether regulation of an entire field has been reserved to the Federal Government is, essentially, a question of ascertaining the intent underlying the federal scheme, and that the FDA's statement is dispositive on a question of implicit intent to preempt unless either the agency's position is inconsistent with clearly expressed congressional intent, or subsequent developments reveal a change in that position. 105 S.Ct. at 2375-2376. The Court explained:
We are even more reluctant to infer preemption from the comprehensiveness of regulations than from the comprehensiveness of statutes. As a result of their specialized functions, agencies normally deal with problems in far more detail than does Congress. To infer pre-emption whenever an agency deals with a problem comprehensively is virtually tantamount to saying that whenever a federal agency decides to step into a field, its regulations will be exclusive. Such a rule, of course, would be inconsistent with the federal-state balance embodied in our Supremacy Clause jurisprudence. Id. at 2377.
The plaintiff has not yet identified any particular warnings that should have been included but were not, and therefore Purdue-Abbott can not argue specific conflict in that any specific warning is either "false or misleading," or is "not based on scientific information needed." The defendants have failed to demonstrate that the conclusion of "fraud-on-the-FDA" a la Buckman is either elemental or a necessary prerequisite to liability on any one of the plaintiffs' claims against Purdue-Abbott in this case.
21 C.F.R. § 201,56(a); Fed. Reg. 37441.
Even assuming arguendo that the plaintiffs in fact seek "labeling" contra the express FDA labeling requirements for prescription drugs, defensive preemption as to a particular cause exists to serve its salutary purpose but is insufficient to form the basis of a plea of complete preemption.
However and as previously mentioned, the FDA has specifically disavowed any intention of preempting State tort law, failure to warn, or labeling requirements which are in addition to and not inconsistent with FDA labeling requirements with respect to prescription drugs, including prescription drugs which are determined to be of"significant and serious concern." Moreover, the FDA has determined that its regulations are intended to complement state regulations, that Federal preemption could unduly interfere with the goals and objectives of existing State programs imposed under the Omnibus Budget Reconciliation Act (OBRA) of 1990, ergo Agency regulations in the field of prescription drug labeling were not intended to displace State regulation, but instead to establish minimum standards. See 63 Fed. Reg. 66383-84 (emphasis added).
This fail safe was the topic of some discussion in Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 815, 106 S.Ct. 3229 (1986). The Supreme Court observed:
To the extent that petitioner is arguing that state use and interpretation of the FDCA pose a threat to the order and stability of the FDCA regime, petitioner should be arguing, not that federal courts should be able to review and enforce state FDCA based causes of action as an aspect of federal question jurisdiction, but that the FDCA pre-empts state court jurisdiction over the issue in dispute. Petitioner's concern about the uniformity of interpretation, moreover, is considerably mitigated by the fact that, even if there is not original district court jurisdiction for these kinds of action, this Court retains power to review the decision of a federal issue in a state cause of action.Merrell Dow Pharmaceuticals, Inc., 478 U.S. at 815, 106 S.Ct. 3229.
Independent research has revealed a dearth of jurisprudence which would support conflict or field preemption with respect to prescription drug warnings and labeling requirements. Preemption jurisprudence with respect to prescription drugs warnings is to the opposite effect — no intent to preempt.
See Mazur v. Merck Co., 742 F. Supp. 239, 247 (E.D.Pa. 1990) (requiring that manufacturers meet state safety requirements, whether codified or embodied in the common law, in addition to satisfying FDA requirements); Motus v. Pfizer, 127 F. Supp.2d 1085, 1092 (C.D. Ca. 2000) (FDA regulations as to design and warning establish minimal requirements and do not preempt state law defective design and failure to warn claims); and cf. Hurley v. Lederle Laboratories, 863 F.2d 1173, 1176 n. 2 (5th Cir. 1988) (citing 14 federal district court and 3 state court decisions * involving vaccines, all rejecting preemption); Abbott by Abbott v. American Cyanamid Co., 844 F.2d 1108, 1112 n. 1 (4th Cir. 1988) (citing nine federal district court decisions involving vaccines and rejecting the preemption defense), cert denied, 488 U.S. 908, 109 S.Ct. 260, 102 L.Ed.2d 248 (1988); Osburn v. Anchor Laboratories, Inc., 825 F.2d 908, 912 n. 4 (5th Cir. 1987) (relying on parallel provisions with respect to warnings on animal drugs, the court concluded that even after FDA approval, additional and more forceful warnings may, in the drug manufacturer's judgment, be added to labeling without the need to first obtain FDA approval and on the drug manufacturers own initiative, and citing Feldman v. Lederle Laboratories, 479 A.2d 374 390 (1984) (reaching the same conclusion in the context of the human antibiotic tetracycline)); and Pharmaceutical Society of the State of New York v. Lefkowitz, 586 F.2d 953, 958 n. 6 (2nd Cir. 1978) (state requirement that drug manufacturer be identified on label not preempted).
Considering the evidence presented, the arguments of counsel, and the applicable law, the Court cannot conclude on this record that Congress intended to preempt all state remedies, and to remove all means of judicial redress and monetary damages for those allegedly injured. Not one controlling case has been cited which holds that the FDA's prescription drug warning, standards or labeling requirements were intended either by Congress or by the Agency to preempt all State regulations mandating labeling in over-and-above FDA requirements.
There is no question but that the pharmaceutical industry is highly-regulated, however that does not dictate a finding of implied preemption. See Silkwood, 464 U.S. 238, 104 S.Ct. 615 (finding that the highly regulated scheme established by the Atomic Energy Act of 1954 did not implicitly preempt state tort law liability for nuclear power plant accidents); Medtronic, 518 U.S. at 507, 116 S.Ct. 2240 (noting that "this Court has previously said that it would "seldom infer, solely from the comprehensiveness of federal regulations, an intent to pre-empt in its entirety a field related to health and safety."'). Mindful that courts should be reluctant to cavalierly imply "clear evidence" of an intent to immunize an entire industry from liability, even a highly-regulated one, the Court believes that it would be improper to cavalierly do so in this case. See Medtronic, 518 U.S. at 485, 116 S.Ct. 2240.
To the extent that applicable federal regulations may provide a preemption defense to one or more of the plaintiffs' state law causes of action or a particular claim for relief because of a conflict, this Court expresses no opinion and has no intention of ruling on the merits of any such defense. Whereas here, the federal district court is without removal jurisdiction, it would be inappropriate to rule on the merits of any such defense.
Accordingly and considering that this Court is without removal jurisdiction, IT IS ORDERED that the plaintiffs' Motion to Remand is GRANTED.