Complete Tort Immunity For Drug Manufacturers Is Bad For The Public Health 2018-11-15T16:03:21+00:00

Complete Tort Immunity For Drug Manufacturers Is Bad For The Public Health

Tort Immunity for Drug Manufacturers

A Commentary On Colacicco v. Apotex And Other Recent Preemption Decisions

Introduction

Thomas Jefferson once wrote, “I consider trial by Jury as the only anchor ever yet imagined by man, by which a government can be held to the principles of its constitution.” (Thomas Jefferson, in a letter to Thomas Paine, 1789).  The wisdom of Jefferson’s words and the ideals they represent are being seriously threatened by a relatively new and troubling trend in pharmaceutical litigation – federal preemption (or complete tort immunity).  Consumers harmed by pharmaceutical drugs know the argument all too well.  Since the early 2000s, it has become the pharmaceutical industry’s affirmative defense du jour.  Essentially, drug manufacturers claim that actions taken by the Food and Drug Administration (FDA) pursuant to its authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §301 Shepardize et seq., and the corresponding regulatory scheme, preempt plaintiffs’ state-law failure-to-warn claims.

Roots of The Preemption Defense

The doctrine of preemption is rooted in the Supremacy Clause, U.S. Const. Art. VI, cl.2, which provides that the “Constitution, and the Laws of the United States which shall be made in Pursuance thereof . . . shall be the supreme Law of the Land.”  In the seminal case Gibbons v. Ogden, the Supreme Court interpreted this language to invalidate state laws that “interfere with” or are contrary to federal law. 1 Since then, the Supreme Court has identified three major situations where there is preemption:  (1) “express” preemption, applicable when Congress expressly states its intent to preempt state law; (2) “field” preemption, applicable when Congress’ intent to pre-empt all state law in a particular area may be inferred because the scheme of federal regulation is sufficiently comprehensive or the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject;  and (3) “conflict” preemption, applicable when “state law is nullified to the extent that it actually conflicts with federal law,” even though Congress has not displaced all state law in a given area. 2

While Congressional Acts governing medical devices contain an express preemption clause, 3 the Acts that govern prescription drugs do not contain a preemption clause. Thus, “express” preemption does not apply to prescription drugs.  Furthermore, “field” preemption is usually not applied to FDA regulations and is rarely encountered in drug product liability litigation 4.  Rather, with respect to prescription drugs, manufacturers primarily and almost exclusively argue that plaintiffs’ state law claims are preempted under “conflict” preemption principles.

Conflict Preemption

Conflict preemption applies when (a) “compliance with both federal and state regulations is a physical impossibility,” 5 or (b) when state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” 6  Manufacturers generally argue that,  since the FDA approved their products’ labeling, any subsequent modification (including the addition of enhanced warnings) by the manufacturer would render the drug misbranded and subject the manufacturer to potential prosecution or enforcement action. They thus contend that it would be impossible for them to comply with both federal law and state law (i.e., potential jury verdicts).   Manufacturers further contend that a jury verdict would result in over-warning and thus stand as an obstacle to the FDA’s accomplishment of regulatory objectives.  When successful, the preemption defense results in complete immunity since claims based on state law would be barred.  Further, since there is no federal cause of action for a manufacturer’s failure-to-warn, an injured party has no right of recourse.

The FDA – Interested In Promoting Sales Not Safety

Prior to the Bush Administration (2000), the issue of conflict preemption was rarely raised by the pharmaceutical industry, and in the few cases where pharmaceutical companies interposed a preemption defense, the defense was unsuccessful. 7  Following the arrival of the Bush Administration, however; the pharmaceutical industry began to more actively argue conflict preemption and assert that plaintiffs’ failure-to-warn claims were preempted.  For the most part, courts have overwhelmingly found that such suits are not preempted. 8  However, more recently, some courts have become more acceptable of the preemption defense.

This shift may largely be due to the FDA’s new involvement and support of the preemption defense.  Much to the dismay and astonishment of those injured by adverse drug reactions, the FDA, an agency whose primary purpose should be to protect the safety of consumers, has taken an about-face, abrogating its allegiance to American consumers, and has chosen (through its Bush-appointed lawyers) to take sides with the pharmaceutical industry on this issue.  FDA lawyers have not only submitted amicus briefs in favor of drug manufacturers in a number of cases, but have also promulgated rules and regulations to assist the pharmaceutical industry with its preemption defense.

The self-proclaimed architect of the FDA’s newfangled position on preemption was the 2001-appointed Chief Counsel of the FDA, Daniel Troy.  Congressional investigations have revealed that, in the months prior to taking the position at the FDA, Troy’s firm was paid over $350,000 by Pfizer Inc. for legal services he had rendered to the company. 10  Upon his arrival at the FDA, Mr. Troy, as the agency’s chief counsel, began to draft amicus briefs promoting preemption (i.e., tort immunity) in cases in which Pfizer was the defendant.  Since leaving the FDA, Troy has returned to his roots and, once again, is representing Big Pharma. 11

While most Courts have not given much deference to the FDA’s amicus briefs or its “preemption preamble,” a few court’s appear to have been swayed by the FDA’s involvement and have thus found preemption. 12 Rather than go through the myriad of cases that have touched upon the preemption issue, an analysis of two decisions issued earlier this year exemplifies the division amongst the courts. The two cases are Collins v. SmithKline Beecham Corp (Pennsylvania state court), and Colacicco v. Apotex, Inc. (U.S. Third Circuit Court of Appeals). Ironically, both decisions involve the same class of drugs (antidepressants) and both decisions were rendered in the birthplace of our nation’s constitution – Philadelphia, Pennsylvania.

Collins v. SmithKline Beecham ­- No Preemption

On March 11, 2008, Judge Allan L. Tereshko, presiding over the Philadelphia Mass Tort Paxil Program, held in the case of Collins v. SmithKline Beecham that plaintiffs’ failure-to-warn claims were not preempted by the FDCA.  In Collins, the plaintiffs were one of number of plaintiffs in the State Court’s Mass Tort Paxil Program alleging that SmithKline Beecham d/b/a GlaxoSmithKline (“GSK”), the manufacturer of Paxil, failed to warn that the drug increased the risk of suicide and suicidal behavior. 13  GSK filed a motion for summary judgment claiming that the plaintiffs’ causes of action were preempted by the FDCA and accompanying FDA regulations.

The Court disagreed with GSK’s proposition and, in a scholarly opinion, held that “Defendant’s position is clearly not sustainable.  Federal law in question unquestionably places the duty [to warn] upon the manufacturer and does not preempt a State’s ability to allow one of its citizens to inquire into whether the manufacturer breached that duty.” 14  The Court also analyzed numerous Supreme Court decisions from the 1800’s to the present. Highlighting the principals of federalism, the Court noted that “[h]istorically, the several States have possessed broad powers to protect the lives, limbs, health, comfort and quiet of all persons’ within the State.” 15

In reaching its decision, the Court refused to consider FDA amicus briefs that had been filed in other cases.  The Court held that, under Pennsylvania law, the amicus briefs constitute hearsay and were inadmissible.  The Court further noted that, even if the amicus briefs were considered, neither the briefs nor the “preemption preamble” would be accorded any weight since the FDCA and supporting regulations were not ambiguous and thus it was not necessary to resort to the FDA’s interpretation of the FDCA and its regulations. 16

Judge Tereshko’s opinion allowed the Collins case to proceed past the preemption defense.  In addition, the decision assures that, for the time being, all of the other plaintiffs within that Court’s Mass Tort Paxil Program will be able to have their cases adjudicated on the merits (as opposed to having them barred by the preemption defense). 17

Third Circuit Finds Preemption

While the Collins decision was still hot off the presses, just down the street, the Third Circuit was drafting its own opinion on the issue of preemption.  Pending before the Third Circuit were two consolidated appeals – Colacicco v. Apotex, Inc. and McNellis v. Pfizer, Inc.

Colacicco I, like Collins, involved a failure-to-warn claim involving paroxetine, the generic name for Paxil).  However, whereas in Collins the state court found no preemption, in Colacicco I, Eastern District of Pennsylvania Judge Michael Baylson found that the plaintiffs’ claims against GSK and Apotex (the manufacturer of the generic version of Paxil) were preempted and dismissed the plaintiff’s complaint. 18 In reaching its decision, the Court gave “significant” deference to the FDA’s preemption preamble and amicus briefs. 19

In McNellis, the District Court of New Jersey Judge Jerome B. Simandle held that the plaintiff’s failure-to-warn claims against the manufacturer of Zoloft (an SSRI antidepressant that is in the same class as Paxil) were not preempted. 20  In particular, the court held that it would not give substantial deference to the FDA’s position due to the fact that there were no ambiguities in the federal regulation that would warrant the FDA’s interpretation and since the FDA’s interpretation had not been consistent. 21

Noting the diametrical division amongst the district courts (i.e. Colacicco I and McNellis), the Third Circuit was poised to bring some clarity to the confusion.  As the Third Circuit noted, its job was to decide which of these two prior district court decisions most closely expressed the circuit’s view on the issue of preemption.  Unfortunately, on April 8, 2008, the Third Circuit in a 2-1 split decision chose to adopt the reasoning of Colacicco I and held that plaintiffs’ failure-to-warn claims against the drug manufacturers were preempted. 22

The Court noted that its reasoning was limited to the SSRI class of antidepressants and was further limited to adults.  Specifically, the Court found that the FDA had been actively involved in monitoring the possible association between SSRIs and suicide “for nearly twenty years,” and that the FDA, through its recent amicus briefs, indicated that it had “repeatedly rejected the scientific basis for the warnings that plaintiffs argue should have been included in the labeling.”  While two of the judges on the panel found in favor of preemption, Judge Thomas Ambro issued a dissenting opinion pointing out the errors of the majority opinion. 23

Third Circuit Majority’s Errors

The Third Circuit’s decision is grounded upon a number of factual and legal errors.  First, the Court based its decision that a warning had been rejected on the fact that, during the 1990’s, the FDA denied citizen petitions to take Prozac (another SSRI) off the market or to require the manufacturer to include a suicide warning in its label.  First, it was inappropriate for the Court to base its holding on the FDA’s treatment of Prozac (a drug that was not even involved in the litigation).  In denying the citizen petitions, the FDA had not considered much less rejected data regarding Paxil (or Zoloft) or any proposed warnings related to Paxil (or Zoloft), only Prozac.  Further, the FDA merely denied the Citizen Petitions sought – the FDA never made a finding that Eli Lilly and Company, the maker of Prozac, (or any other SSRI manufacturer) were prohibited from voluntarily enhancing their warnings. 24   Thus, the denial of the third party citizen petitions should not have formed the basis for the conclusion that the FDA would have rejected an enhanced warning had one been proposed by the manufacturer.

Factual Errors And Omissions

There are a number of facts underlying the FDA’s decision not to force antidepressant manufacturers to add suicide warnings to their labels, which were either not before the Colacicco Court or were ignored by the Court.  The Colacicco Court’s proclamation that the FDA has been carefully monitoring the antidepressants for suicide risks for “nearly two decades” (and by inference, the FDA’s decision not to require warnings necessarily means it would have rejected any proposed warning by manufacturers) is seriously flawed and deserves comment.

Prior to its denial of the Citizen Petitions, the FDA assembled a panel of experts to advise the agency on whether sufficient data existed to establish that Prozac causes suicide, thus warranting stronger warnings.  A meeting of the advisory panel took place on September 20, 1991. Lilly was the only antidepressant manufacturer to submit clinical trial data for the committee’s review.  Several members of the FDA advisory panel expressed concern about the paltry data presented to them.  For example, the chairperson, Dr. Daniel Casey, stated that “I don’t feel I have all the data.” Another member, Dr. Nina Schooler stated: “I felt we were working with half a deck in terms of data.” 25  In a June 1992 letter sent by the FDA to one of the citizen petitioners, the FDA described the conclusions of the advisory committee:  “There was a consensus [amongst the FDA advisory committee] that more research is needed to further explore the relationship between suicidality and the use of not only Prozac, but other antidepressants as well.” 26  The FDA also stated during the advisory committee meeting that it did “not dismiss the possibility that antidepressants in general or fluoxetine [Prozac] in particular may have the capacity to cause untoward injurious behaviors and acts, and/or to intensify them.” The FDA itself concluded that “more research is needed” and “asked [Lilly] to develop plans to conduct new studies, including clinical trials and epidemiological studies, studies that could provide more direct answers to the questions that have been raised” in the advisory committee meeting. 27  However, no such studies were ever conducted by Lilly or any other SSRI-producing company, including GSK.

Ironically, in one of its citizen petition denials, the FDA stated: “On the other hand, an actual court finding of a causal relationship between Prozac and violent behavior would be relevant.  In that event, the agency would be able to evaluate the scientific basis for the court’s conclusion and consider whether [the] court’s conclusion warranted a modification of its own position.”

Years later, we discovered that the FDA advisory committee meeting was, to the FDA, more for show than a legitimate examination of a serious and life threatening risk.  According to an October 1990 GSK memorandum obtained during discovery, the FDA believed the suicide risk was not “a real issue,” but rather “a public relations problem.” 28

One scientist within the FDA, however, took the issue seriously.  Unfortunately, FDA bureaucrats did not take heed.  This lone scientist was none other than Dr. David Graham, the FDA epidemiologist who many years later blew the whistle on Vioxx and other hazardous drugs.  Dr. Graham was critical of the analysis Lilly had submitted to the FDA.  In a September 1990 memorandum obtained from the FDA through the Freedom of Information Act, Dr. Graham pointed out that “the capacity of these trials to identify and describe the quality and intensity of suicidality was low.” Dr. Graham criticized Lilly’s improper exclusion of 76 Prozac patients from its analysis.  He questioned Lilly’s reliance on a study by Fava & Rosenbaum, which Lilly asserted showed “no statistically significant differences among rates of treatment-emergent suicidal ideation associated with five classes of antidepressant therapy.”  When Dr. Graham re-analyzed Fava & Rosenbaum’s data, he found that “[t]reatment-emergent suicidality was more frequent among ‘fluoxetine alone’ than ‘tricyclics with or without lithium’ patients. The relative risk of suicidality was 3.3. (95% CL 0.9, 12.2), p-0.07.”) 29  Dr. Graham also noted that “the proportion of patients with treatment-emergent suicidality on fluoxetine in this study was similar to that reported by Teicher et al” (the Harvard researchers who were the first to sound the alarm concerning the suicide risk).  In conclusion, Dr. Graham stated: “The firm’s analysis of suicidality does not resolve the issue.” 30

Not until 2004 did senior FDA officials finally acknowledge, during Congressional hearings (and Advisory Committee meetings in 2004), that its cursory review of the potential relationship between antidepressants and an increased risk of suicide over the past decade and a half had been inadequate.  Dr. Robert Temple testified to Congress that, although the FDA “had been systematically looking at the adult data for almost that entire decade,” he admitted that the FDA’s analyses could have been far “better, more structured, [and] more careful, . . . but we didn’t know to do that.” 31

At a Feb. 2, 2004, FDA advisory committee meeting concerning the risk of suicidality in children and adolescents taking antidepressants, the FDA’s Dr. Thomas Laughren similarly explained: “Just one follow up on a suggestion that has come up from several committee members now about looking at items from the rating scales. That was actually done here, and it turned out not to be very helpful. Now, this was a similar analysis that had been done with the adult data years ago,” but he admitted, the method being used “was not particularly productive.” 32

In 2000, Pfizer attempted to rely upon the exact same evidence as the Third Circuit (that the FDA had considered and rejected suicide warnings regarding Prozac) in  Motus v. Pfizer, 137 F. Supp. 2d 1085, 1089-1090 Shepardize (C.D. Cal., 2000).  In contrast to the Third Circuit, however; the Motus court rejected Pfizer’s preemption claims, holding that “the FDA never stated that it would be impermissible to include additional warnings.”  Motus at 1096 (emphasis added) Shepardize.

When the adult clinical trials of Paxil were finally re-analyzed in 2006, the data showed that adults with Major Depressive Disorder treated with Paxil compared to placebo were at a significant increased risk of attempting suicide.  The results showed that the odds ratio for suicide attempt on Paxil was 6.7, a statistically significant result.  This was according to GSK’s own analysis.  As a result of this analysis, GSK sent out “Dear Doctor” letters to alert physicians to the increased risk, and changed the Paxil label. 33  The FDA did not object to GSK’s label change.  The studies analyzed by GSK were not new, thus, based on this alone, GSK could have discovered the risk sooner and warned of the risk prior to the suicides at issue in Colacicco and McNellis.  The Third Circuit’s finding of preemption in this case when it was GSK’s duty to monitor its drug for safety risks and it was GSK’s duty to warn of known or reasonably knowable risks, was a clear factual error.

Legal Errors

The Colacicco decision contains a number of glaring legal errors as well. Most notably, the Court based its decision upon a “hypothetical conflict” (i.e., the FDA probably would have rejected a warning if it had been proposed by the manufacturers of Paxil or Zoloft).  However, the Supreme Court has specifically held that a “hypothetical or potential conflict is insufficient to warrant pre-emption.” 34 Thus, it was an error for the court to base its decision upon a hypothetical conflict.

Judge Ambro’s dissenting opinion in Colacicco II provides the better-reasoned analysis.  Specifically, Judge Ambro properly would not have given the FDA’s pronouncements much deference in light of the FDA’s lack of consistency on this issue. He went on to note that the FDA’s position on the preemption issue constitutes “backdoor federalization.” 35  Judge Ambro further noted that FDA regulation, including 21 C.F.R. §§ 201.57 Shepardize(e) and 314.70, permit and encourage a manufacturer to voluntarily enhance its warnings.  He stated: “[t]hus I find it hard to believe that, if a drug manufacturer augmented its warning in response to or in anticipation of a state tort lawsuit, the FDA would sanction the manufacturer for over-warning consumers.” 36

Judge Ambro also rightly noted that the tort system complements the regulation of drug safety providing the FDA with new safety information that is uncovered during the discovery process.  Furthermore, the tort system provides a check on the agency’s power.  He went on to note that the argument by advocates of preemption, that jurors are biased towards plaintiffs and this results in over-warning, was not well taken since  juries properly apply the negligence cost/benefit analysis – including the cost of over-warning. 37

Settling All Bets – Enter The Supreme Court

The preemption issue exemplifies how judges looking at the same set of facts can come to completely divergent decisions.  With respect to the Colacicco appeal as well as the Collins decision, six different judges analyzed whether the FDCA preempts state failure-to-warn lawsuits concerning  SSRI antidepressants –  three of the judges (two justices in the Third Circuit and the District Court judge in Colacicco) found preemption while the other three (Judge Ambro’s dissenting Third Circuit opinion, the District Court Judge in McNellis and Judge Tereshko in Collins) concluded that the lawsuits were not preempted.   The Supreme Court will soon weigh in on this debate when it decides Wyeth v. Levine during its October 2008 term. While Levine does not involve an SSRI antidepressant, it does involve a prescription drug and the Court’s opinion is expected to generally affect most prescription drug product liability lawsuits.  The question presented in Levine is:

Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (“FDA”) pursuant to FDA’s comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 Shepardize et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use. 38

It is difficult to imagine the Supreme Court, in ruling on Levine, will conclude that all state failure-to-warn actions regarding prescription drugs are preempted by the FDCA and its accompanying regulations.  The plaintiffs’ bar is hopeful that the High Court will join the company of Judges Tereshko and Ambro.  However, the recent preemption ruling by the Supreme Court in Riegel (which involved “express” preemption of class III pre-market approved medical devices) as well as the Third Circuit’s opinion in Colacicco have given some jurists reason to pause.

Recently, Judge William Wilson Jr., of the  District Court of Arkansas, stated that, while he was “‘as confident as a Christian with four aces’ with respect to [his] FDA preemption ruling” denying preemption, in light of the Riegel and Colacicco decisions, his “confidence, while still in place, is at a lower level.” 39  He went on to note that advocates of preemption demonstrate an unnecessary distrust of jurors and the jury system:

In political campaigns these citizens [jurors] are paragons of virtue; but when they are called for jury service, they somehow become incapable of making important decisions. The language in the decisions favoring preemption is high flown; but, at bottom, it reflects distrust of the randomly selected citizens who sit on juries. Perhaps our public officials, including judges, have read too much Plato and too little Alexis de Tocqueville. 40 

Conclusion

Preemption is a draconian measure that leaves consumers who have been harmed by the negligence and, often times, fraud of drug manufacturers, without any remedy.  It provides complete immunity to an industry that has proven time and again that it is incapable of policing itself.  And, it places the FDA, an agency that has been described as “broken” and “incapable of protecting the public health,” 41 as the sole arbiter of drug safety.

An article titled “The Role of Litigation in Defining Drug Risks,” published in the Journal of the American Medication Association, by Jerry Avorn, M.D., Professor of Medicine at Harvard Medical School, and a colleague, illustrates the importance of pharmaceutical litigation in “help[ing] uncover previously unavailable data on adverse effects, questionable practices by manufacturers, and flaws in drug regulatory systems.”  JAMA, January 17, 2007 – Vol. 297, No. 3, p. 308.  Litigation, the authors write, has uncovered companies that have “downplayed and kept secret research.”  Id. 309.  Lawsuits have “exposed important limitations in the FDA information collection and dissemination procedures” they explain.  Id.  Of the drug safety issues highlighted in the article, they state that “the legal system played an important role in spurring change in regulatory or corporate procedures, as well as extending knowledge about drug risks by adding to the evidence available for evaluation by physicians, patients and regulators.”  Id.  The authors warn that “limiting legal involvement in the prescription drug arena is likely to increase the nation’s problem of poorly defined and inadequately presented drug risk information.”  Id. p., 311.  Clearly, prohibiting lawsuits that have long provided oversight and incentive to companies to disclose known risks would have devastating consequences on the public health.

Findings of conflict preemption based upon the FDCA contradict the very spirit and public safety goals that Congress sought to accomplish in enacting the FDCA. 42  The FDCA was enacted to promote the safety and well being of consumers, it was not enacted as a shield providing total tort immunity to the pharmaceutical industry.  A finding of preemption runs contrary to our 200 year history of common law, administered pursuant to the several states’ power to protect its citizens’ health and safety.  When all is said and done, we can only hope that Judge Wilson’s four aces hold up and that the Supreme Court does not open up a royal flush in favor of complete tort immunity for the pharmaceutical industry.

By Bijan Esfandiari | Google+
Published in LexisNexis Mealey’s Litigation Report: Antidepressant Drugs, May 2008

Bijan Esfandiari is the lead law and motion attorney at Baum, Hedlund, Aristei & Goldman in Los Angeles and is a member of the firm’s pharmaceutical drug product liability litigation team.  For more than 18 years, Baum Hedlund has been at the forefront of the SSRI antidepressant litigation and has represented thousands of victims of Paxil injury and death including more than 100 individuals across the country in suicide and suicide attempt cases involving SSRI antidepressants, including Paxil, Zoloft and Prozac. The firm has successfully argued against preemption in numerous cases, including Collins v. SmithKline Beecham Corp., Case No. 00762 (Court of Common Pleas, Philadelphia County, March 11, 2008), Steinberg v. SmithKline Beecham Corp. Case No. 1-04-CV-029096 (Santa Clara Sup. Ct., Jan. 25, 2007), Witczak v. PfizerInc., 377 F.Supp.2d 726 (D. Minn 2005); Zikis v. Pfizer, Inc., 2005 U.S. Dist. LEXIS 9591 (N.D. Ill. 2005); Cartwright v. Pfizer, Inc., 369 F.Supp.2d 876 (E.D. Tex. 2005); Miles v. Pfizer, Inc., Case No. 03-731-C (M.D. La. March 31, 2005) (order without opinion); Szybinski v. Pfizer, Inc., Case No. YC 047439 (Los Angeles Sup. Ct. July 12, 2005) (minute order striking FDA Amicus Briefs and denying preemption), and; Motus v. Pfizer Inc., 137 F. Supp. 2d 1085 (C.D. Cal., 2000). Copyright 2008, the author.

Endnotes


1. Gibbons v. Ogden, 22 U.S. 1, 211 Shepardize (1824).


2. Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 713 Shepardize (1985).


3. Riegel v. Medtronic, Inc. 128 S.Ct. 999 Shepardize (2008).


4. See e.g., Colacicco v. Apotex Inc., __ F.3d ___, 2008 WL 927848  (3rd Cir. April 8, 2008) (defendant drug manufacturers “conceded that express and field preemption are not implicated.”)


5. Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 Shepardize (1963).


6. Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 699 Shepardize (1984).


7. See, e.g., Tobin v. Astra Pharmaceutical Prods., Inc., 993 F.2d 528, 537-538 Shepardize (6th Cir. 1993); Hill v. Searle Labs., 884 F.2d 1064, 1068 Shepardize (8th Cir. 1989); see also Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1017, n.11 Shepardize (2008) (J. Ginsberg dissenting).


8. Some of the cases that have rejected the preemption defense include: In re Vioxx Prods. Liability Litigation, 501 F.Supp.2d 776, 788-789 Shepardize (E.D.La.2007); In re Zyprexa Prods. Liability Litigation, 489 F.Supp.2d 230, 275-278 Shepardize (E.D.N.Y.2007); Weiss v. Fujisawa Pharmaceutical Co., 464 F.Supp.2d 666, 676 Shepardize (E.D.Ky.2006); Perry v. Novartis Pharma. Corp., 456 F.Supp.2d 678, 685-687 Shepardize (E.D.Pa.2006); Jackson v. Pfizer, Inc., 432 F.Supp.2d 964, 968 Shepardize (D.Neb.2006); Laisure-Radke v. Par Pharmaceutical, Inc., 426 F.Supp.2d 1163, 1169 Shepardize (W.D.Wash.2006); Witczak v. Pfizer, Inc., 377 F.Supp.2d 726, 732 Shepardize (D.Minn.2005); Zikis v. Pfizer, Inc., No. 04 C 8104, 2005 WL 1126909, *3 (N.D.Ill., May 9, 2005); Cartwright v. Pfizer, Inc., 369 F.Supp.2d 876, 885-886 Shepardize (E.D.Tex.2005); Eve v. Sandoz Pharmaceutical Corp., No. IP 98-1429-C-Y/S, 2002 WL 181972, *1 (S.D.Ind., Jan.28, 2002); Caraker v. Sandoz Pharmaceuticals Corp., 172 F.Supp.2d 1018, 1044 Shepardize (S.D.Ill.2001); Motus v. Pfizer, Inc., 127 F.Supp.2d 1085, 1087 Shepardize (C.D.Cal.2000).


9. For example, in 2006, the FDA issued  new regulations regarding the labeling of prescription drugs.  In the preamble of the 2006 amendments, the FDA stated that failure-to-warn claims are preempted (“Preemption Preamble”).  See 71 Fed.Reg. 3922, 3936 (Jan. 24, 2006).  In addition, earlier this year the FDA issued a proposed rule regarding labeling changes which, as noted by various members of Congress, appears to have been promulgated solely to assist the pharmaceutical industry with its preemption defense.  See 73 Fed.Reg. 2848 (FDA proposed rule regarding labeling changes); see also January 23, 2008 letter by Senator Ted Kennedy et al. to the FDA regarding his displeasure with the proposed rule ­- copy available at http://oversight.house.gov/documents/20080123120931.pdf  (last visited April 17, 2008).


10. See Report by Congressman Hinchey – http://www.house.gov/hinchey/issues/fda.shtml


11. Coincidentally, the Solicitor General, Paul Clement, who “determines whether the government will participate as an amicus curiae, or intervene, in cases in any appellate court” is a former partner at King & Spalding, counsel for GlaxoSmithKline, the defendant in Colacicco. See http://www.usdoj.gov/osg/about_us.htm and http://www.usdoj.gov/osg/aboutosg/paul_d_clementbio.htm


12. See e.g., In re Vioxx Litigation, 501 F.Supp.2d 776, 785 Shepardize (E.D.La 2007) (no deference to FDA);  Levine v. Wyeth, __, A.2d __, 2006 WL 3041078 at §32 (Vt. 2006) (no deference to FDA), cert granted, Wyeth v. Levine, No. 06-1249, __ U.S.  ___, 2008 WL 161474 (Jan. 18, 2008).  But cf. Colacicco v. Apotex, Inc., 432 F.Supp.2d 514 Shepardize (E.D.Pa. 2006) (giving “significant” deference to FDA), affirmed Colacicco v. Apotex Inc., 2008 WL 927848 (3rd Cir. April 8, 2008) (giving deference to certain pronouncements of the FDA).


13. Paxil is an antidepressant within the class of drugs known as selective serotonin reuptake inhibitors (“SSRI”).


14. Collins v. SmithKline Beecham Corp., Case No. 0762, slip op. at 9 (Phil. Ct. Com. Pleas., March 11, 2008).


15. Id. at 6 quoting Slaughter House Cases, 16 Wall 36, 62 (1873) Shepardize.


16. Id. at 5 and 10 Shepardize.


17. It is estimated that there are currently approximately 60 cases in the Paxil Mass Tort Program.


18. Colacicco v. Apotex, Inc., 432 F.Supp.2d 514 Shepardize (E.D.Pa. 2006).


19. Colacicco, 432 F.Supp.2d at 529 Shepardize.


20. McNellis v. Pfizer, Inc., 2006 WL 2819046  (D.N.J. Sept. 29, 2006).


21. As to the consistency issue, the Court noted that, prior to 2000, the FDA had stated that its regulations do not have preemptive effect.  McNellis v. Pfizer, Inc., 2006 WL 2819046, * 8 (D.N.J. Sept. 29, 2006).


22. Colacicco  v. Apotex Inc., 2008 WL 927848 (3rd Cir. April 8, 2008) (“Colacicco II“).


23. Colacicco II, 2008 WL 927848 at *18.


24. Colacicco II, 2008 WL 927848, * 23, n.29 (J. Ambro dissenting opinion).


25. Psychopharmacological Drugs Advisory Committee (PDAC) Meeting Transcript, September 20, 1991, http://www.baumhedlundlaw.com/13.pdf


26. FDA letter to Ida Hellendar, Public Citizen, June 3, 1992, http://www.baumhedlundlaw.com/15.pdf


27. September 1991 PDAC Transcript at 128:18-24, http://www.baumhedlundlaw.com/13.pdf


28. FDA Conversation Record, October 3, 1990, http://www.baumhedlundlaw.com/12.pdf


29. FDA Memorandum, David Graham, September 11, 1990, p. 4,
http://www.baumhedlundlaw.com/17.pd


30. Id., p. 6.


31. Committee on Energy and Commerce hearing, September 23, 2004
http://www.baumhedlundlaw.com/21.pdf
, p. 100.


32. February 2, 2004, PDAC transcript, pp. 342-343, http://www.baumhedlundlaw.com/22.pdf


33. In the FDA’s 2006 analysis, Paxil increased the risk of suicidality in adult patients with an odds ratio of 2.76 with a 95% Confidence Interval of 1.16-6.60 and a p-value of 0.02.  When the clinical tials of a number of antidepressants were pooled and age ranges parsed, the FDA found a risk for all antidepressants up to age 24.   Thereafter, the FDA asked all antidepressant manufacturers to add language to their existing black box warnings regarding the suicidal risk extending beyond children and adolescents, to young adults.


34. Rice v. Norman Williams Co., 458 U.S. 654, 659 Shepardize (1982) (preemption cannot be based on hypothetical conflict).  Ironically though, the dissent in Colacicco II also makes the mistake of concluding that “hypothetical conflicts can give rise to conflict preemption.” Colacicco II, 2008 WL 927848, * 23 (J. Ambro dissenting opinion).


35. Colacicco II, 2008 WL 927848 at * 25.


36. Colacicco II, 2008 WL 927848 at * 23.


37. Colacicco II, 2008 WL 927848 at * 24, n.30.


38. Wyeth v. Levine, No. 06-1249, __ U.S.  ___, 2008 WL 161474 (Jan. 18, 2008).


39. Scroggin v. Wyeth, MDL Docket No. 4:03CV1507-WRW, slip opinion (D.Ark. April 16, 2008).


40. Id.


41. Testimony of Dr. David Graham before Senate Energy and Commerce Committee, November 2004 http://www.senate.gov/~finance/hearings/testimony/2004test/111804dgtest.pdf


42. Witczak v. Pfizer, Inc., 377 F.Supp.2d 726, 732 Shepardize (D.Minn.2005) (“The primary purpose of both the FDCA and FDA’s regulatory scheme is to protect the public.  State-law protections reinforce and enhance this objective.”)