MEMORANDUM AND ORDER
THE COURT’S PRIOR MEMORANDUM AND ORDER, ISSUED ON NOVEMBER 8, 2011, IS WITHDRAWN. THIS MEMORANDUM AND ORDER IS ISSUED IN ITS PLACE.
Pending before the Court is Defendant Abbott Laboratories’ (“Defendant” or “Abbott”) Motion to Dismiss Complaint for Failure to State a. Claim. (Doc. No. 16.) After considering the parties’ filings, all responses and replies thereto, and the applicable law, the Court concludes that Abbott’s motion should be GRANTED in part and DENIED in part.
I. BACKGROUND
This products liability case arises out of Gayathri Murthy’s (“Plaintiff’ or “Mur
In January 2005, before participating in the HERO study, Murthy signed a document entitled “Consent to Participate.” The document was also signed by Dr. Popovich as the “Person Explaining Authorization.” The “Risks of Adalimumab (HU-MIRA®)” are discussed on page five of the agreement. With regard to lymphoma or other cancers, it states the following: “Occasionally (about 2%), various types of cancer including lymphoma (cancer of lymph node) are observed in subjects taking adalimumab. The relationship of adalimumab with these cancers is currently unknown.” Murthy alleges that, at the time she signed the document, Abbott was aware that Humira could cause cancer, a fact not reflected in the “Consent to Participate” agreement.
Murthy claims that the FDA-approved full package insert in effect during the relevant period was incomplete and misleading. For example, in the “Warnings” section, Murthy alleges that it stated, in part, that in controlled portions of the clinical trials of all TNF-blockers, “more lymphoma cases were observed in patients receiving the TNF-blockers” and that “2 lymphomas were observed among 1880 Humira-treated patients with moderate to severe rheumatoid arthritis versus 0 among 690 control patients.” Murthy alleges that the increased risk of lymphoma was statistically significant. According to Murthy, the labeling further informed the consumer that, “in the controlled and open-label portions of the clinical trials, 10 lymphomas were observed in 2,468 patients” and warned that this incidence “is approximately 5-fold higher than expected in the general population.” Murthy alleges that this “is presumptively causal.”
At or about the time that she began participating in the HERO study, Murthy was shown a 14 minute, 50 second videotape, produced and provided by Abbott to Dr. Popovich. Murthy claims that the video was designed for patients who might potentially participate in the HERO study. According to Murthy, the video, which was not approved by the FDA, “paints a rosy picture of therapy with Humira, and does little if anything to alert the patient to the very real risk of life-threatening Humirainduced cancer.”
Murthy alleges that the direct and actual cause of her lymphoma was her infusion with Humira. In addition to suffering personal physical injury, Murthy alleges that, as a result of her diagnosis of lymphoma, she incurred medical bills and suffered lost wages and other economic injury for which Abbott is liable. Murthy brings claims against Abbott for breach of the Consent to Participate agreement, breach of warranty, strict products liability, and negligence. Abbott has moved to dismiss all of Murthy’s claims under Federal Rule of Procedure 12(b)(6).
II. LEGAL STANDARD
A. Rule 12(b)(6)
“To survive a Rule 12(b)(6) motion to dismiss, a complaint ‘does not need detailed factual allegations,’ but must provide the plaintiffs grounds for entitlement to relief — including factual allegations that when assumed to be true ‘raise a right to relief above the speculative level.’ ” Cuvillier v. Taylor,
Ultimately, the question for the court to decide is whether the complaint states a valid claim when viewed in the light most favorable to the plaintiff. The court must accept well-pleaded facts as true, but legal conclusions are not entitled to the same assumption of truth. Iqbal,
Importantly, the court should not evaluate the merits of the allegation, but must satisfy itself only that the plaintiff has adequately pled a legally cognizable claim.' United States ex rel. Riley v. St. Luke’s Episcopal Hosp.,
As a threshold matter, this Court must determine which state’s law applies to Murthy’s claims. District courts sitting in diversity apply the choice-of-law rules of the state in which they sit. Klaxon v. Stentor Elec. Mfg., Inc.,
(a) the place where the injury occurred,
(b) the place where the conduct causing the injury occurred,
(c) the domicile, residence, nationality, place of incorporation and place of business of the parties, and,
(d) the place where the relationship, if any, between the parties is centered.
Restatement (Second) of Conflict of Laws § 145 (1971). These contacts are to be evaluated according to their relative importance with respect to the particular issue before the court. Spence v. Glock, Ges.m.b.H,
(a) the needs of the interstate and international systems,
(b) the relevant policies of the forum,
(c) the relevant policies of other interested states and the relative interests of those states in the determination of the particular issue,
(d) the protection of justified expectations,
(e) the basic policies underlying the particular field of law,
(f) certainty, predictability and uniformity of result, and
(g) ease in the determination and application of the law to be applied.
Spence,
The Fifth Circuit has held that the location of injury is an “important factor” in determining the most appropriate law to apply. Huddy v. Fruehauf Corp.,
Texas courts also look to the Restatement (Second) of Conflict of Laws when determining choice-of-law for contract disputes. Sonat Exploration Co. v. Cudd Pressure Control, Inc.,
Abbott argues that Texas law should apply because Murthy participated in the Abbott study, received Humira, and developed and was treated for lymphoma while resident in Texas. Murthy has not raised any arguments to the contrary. Given Murthy’s lack of opposition, the Court will apply Texas law to the resolution of Abbott’s Motion to Dismiss.
III. APPLICATION
The Court concludes that only Murthy’s breach of contract claim survives the Motion to Dismiss. Murthy’s negligent failure to warn claim is barred by § 82.007 of the Texas Civil Practices and. Remedies Code, as are Murthy’s breach of warranty, strict liability, and negligence claims. However, Murthy’s contract claim is not barred by the statute of limitations, as it “relates back” to her original pleading.
A. Murthy’s Claims for Breach of Warranty, Strict Liability, and Negligence
The Court will first examine Murthy’s claims for negligent failure to warn. Abbott alleges that the learned intermediary doctrine and § 82.007 of the Texas Civil Practice and Remedies Code provide independent bases . for dismissal of these claims. While the Court declines to dismiss Murthy’s claims because of the learned intermediary doctrine, the Court must dismiss Murthy’s claims pursuant to § 82.007(a).
i. Learned Intermediary Doctrine
The Court finds that at this stage in the litigation, dismissal on learned intermediary doctrine grounds is inappropriate. First, Abbott arguably directly marketed to Murthy by creating a promotional video. Second, Murthy’s doctor was compensated by Abbott. For these two reasons, further discovery would be necessary to ascertain whether Abbot may avail itself of the learned intermediary doctrine.
1. Foundations of the Learned Intermediary Doctrine
“Under Texas law, a manufacturer must instruct consumers as to. the safe use of its product and warn consumers of dangers of which it has actual or constructive knowledge at the time the product is sold.” Pustejovsky v. Pliva, Inc.,
“Texas law generally holds that the adequacy of a product’s warning is a question of fact to be determined by the jury.” McNeil v. Wyeth,
The learned intermediary doctrine is premised on the assumption that “the physician understands the potential dangers involved in the use of a given drug and, as the prescriber, stands between the drug and the ultimate consumer.” WyethAyerst Laboratories Co. v. Medrano,
In Reyes v. Wyeth Laboratories, the Fifth Circuit recognized an exception to the learned intermediary doctrine when a
Other courts have developed similar rationales when finding exceptions to the learned intermediary doctrine. The Supreme Court of New Jersey has determined that the foundations justifying the learned intermediary doctrine — “(1) reluctance to undermine the doctor patient-relationship; (2) absence in the era of ‘doctor knows best’ of need for the patient’s informed consent; (3) inability of drug manufacturer to communicate with patients; and (4) complexity of the subject” — “are all (with the possible exception of the last) absent in the direct-to-consumer advertising of prescription drugs.” Perez v. Wyeth Laboratories Inc.,
Nonetheless, many state courts have declined, in recent years, to find any exceptions to the learned intermediary doctrine. See Beale v. Biomet, Inc.,
Recently, however, a Texas state appellate court recognized an exception to the learned intermediary doctrine in cases where a drug manufacturer practices “consumer marketing that fraudulently touts the drug’s efficacy while failing to warn of the risks.” See Centocor, Inc. v. Hamilton,
2. Learned Intermediary Doctrine in Murthy’s Case: Direct-to-Consumer Advertising and Pharmaceutical Companies’ Compensation of Physicians
“The central theme, consistent among all of the cases finding an exception to the learned intermediate doctrine, is that the physician-patient relationship is not the same as in typical treatment scenarios.” Jeffrey J. Wiseman, Another Factor in the “Decisional Calculus”: The Learned Intermediary Doctrine, the Physician-Patient Relationship, and Direct-to-Consumer Marketing, 52 S.C.-L. Rev. 993, 1007 (2001). Murthy’s situation departs from the typical treatment scenario in two respects. First, Abbott directly marketed to Murthy by creating and disseminating a promotional video. Second, Abbott compensated Murthy’s physician.
The Texas Supreme Court has not directly addressed either of these unique circumstances in the learned intermediary context. Murthy’s case thus requires this Court to determine unsettled issues of state law. “ When confronted with an unsettled issue of state law, a federal court sitting in diversity must make its best effort to predict how the state courts would decide the issue.’ ” Haralson v. State Farm Mut. Auto. Ins. Co.,
Given the underlying justifications for the learned intermediary doctrine, the Court believes that the Texas Supreme Court will likely agree with the Court of Appeals’ reasoning in Centocor, Inc. The learned intermediary doctrine in Texas assumes that “the physician understands the potential dangers involved in the use of a given drug and, as the prescriber, stands between the drug and the ultimate consumer.” Wyeth-Ayerst Laboratories Co.,
Similarly, when a physician is compensated by a drug company, some of the assumptions underlying the learned intermediary doctrine no longer hold. The doctrine is premised on the notion that the physician is an objective intermediary who will draw an independent judgment about the best course of treatment for his or her patient. Ackermann,
Studies have documented, however, that gifts or compensation from drug compa
ii. Section 82.007 of the Texas Civil Practice and Remedies Code
1. Legal Standard
In 2003, the Texas legislature enacted Texas Civil Practice and Remedies Code § 82.007 as part of a broader tort reform effort. This section- provides, in relevant part:
(a) In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, there is a- rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not hable with respect to the allegations involving failure to provide adequate warnings or information if:
(1) the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration for a product approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended —
Tex. Civ. Prac. Rem. Code § 82.007. For purposes of § 82.007, a “products liability action” is defined as
any action against a manufacturer or seller for recovery of damages arising out of personal injury, death, or property damage allegedly caused by a defective product whether the action is based in strict tort liability, strict products liability, negligence, misrepresentation, breach of express or implied warranty, or any other theory or combination of theories.
Tex. Civ. Prac. Rem. Code § 82.001(2).
Where a fact is a “presumption” or “presumed,” it means that the trier of fact must presume the existence of the fact unless and until evidence is introduced to support a finding of its. nonexistence. Tex. Bus. & Com. Code Ann. § 1.201(b)(29). The effect of a presumption “is to shift the burden of producing evidence to the party against whom it operates.” Gen. Motors
Section 82.007(b) enumerates specific ways in which a claimant may rebut the presumption set out in Subsection (a):
(1) the defendant, before or after premarket approval ór licensing of the product, withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury;
(2) the pharmaceutical product was sold or prescribed in the United States by the defendant after the effective date of an order of the United States Food and Drug Administration to remove the product from the market or to withdraw its approval of the product;
' (3)(A) the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the United States Food and Drug Administration; (B) the product was used as recommended, promoted, or advertised; and (C) the claimant’s injury was causally related to the recommended, promoted, or advertised use of the product;
(4)(A) the defendant prescribed the pharmaceutical product for an indication not approved by the United States Food and Drug Administration; (B) the product was used as prescribed; and (C) the claimant’s injury was causally related to the prescribed use of the product; or
(5) the defendant, before or after premarket approval or licensing of the product, engaged in conduct that would constitute a violation of 18 U.S.C. Section 201 and that conduct caused the warnings or instructions approved for the product by the United States Food and Drag Administration to be inadequate.
Tex. Civ. Prac. Rem. Code § 82.007(b).
Although Subsection (b)(1) still appears in the statute as a valid avenue to rebut the presumption articulated in Subsection (a), drug manufacturers, including Abbott in this case, frequently argue that Subsection (b)(1) is preempted. Whether the exception articulated § 82.007(b)(1) is preempted is an issue that has not yet been decided by the Supreme Court, and there is a split of authority among the courts that have addressed it. See Garcia v. Wyeth-Ayerst Labs.,
Defendant argues that Murthy’s products liability claims should be dismissed under § 82.007 because it is undisputed that Humira’s warnings were approved by the FDA for an FDA-approved indication, the treatment of RA, and Murthy has not alleged grounds for rebutting the statutory presumption. Murthy responds that § 82.007 does not bar her tort claims for five reasons. First, she argues, “by its terms, § 82.007 does not apply to an ‘indication not approved’ by the FDA. Therefore, it is highly questionable whether it applies to patients enrolled in any kind of clinical trial.” (Pl.’s Resp., Doc. No. 23 at 8-9.) Second, Murthy argues, § 82.007 does not apply because she has made plausible allegations that not all of the information given to her was FDA approved. Third, Murthy contends, her allegations that the FDA subsequently mandated stricter warnings rebut the statutory presumption. Fourth, Murthy maintains, the cases Abbott cites in support of its argument that the case should be dismissed involved motions for summary judgment where the court concluded that the record lacked sufficient evidence to create a fact issue vis-a-vis rebuttal of the presumption. Because § 82.007 is a defensive statutory presumption, Murthy argues, it is not necessary for her to anticipate and negate it in her complaint. Finally, Murthy argues that Subsection (b)(1) is not preempted and that, if it were preempted, the entirety of § 82.007 would be constitutionally invalid because the remaining sections are not severable. As Murthy anticipates being able to rebut the presumption by demonstrating that Abbott withheld evidence from the FDA sufficient to rebut the presumption within the ambit of Subsection (b)(1), she argues, her case should not be dismissed.
2. Analysis
The Court can easily dispose of two of Murthy’s arguments against dismissal. Murthy’s first contention that, by its terms, § 82.007 does not apply to an ‘indication not approved’ by the FDA fails for two reasons. First, it is not a correct statement of the law. Section 82.007 applies to all products liability actions “alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product.” Under § 82.007(b)(3)(A), a plaintiff may rebut § 82.007(a)’s presumption by proving, among other facts, that “the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by” the FDA, but it erroneous to say that § 82.007 does not “apply to an indication not approved” by the FDA. Second, it is undisputed that, at the time of the HERO study, Humira was approved for the treatment of moderately to severely active RA, the condition for which Murthy was treated with Humira. Murthy has presented no authority suggesting that the mere fact that Murthy received Humira in a clinical trial setting changes the Court’s analysis.
Murthy’s argument that she may rebut the statutory presumption with evidence that the FDA subsequently mandated stricter warnings also fails. Murthy reasons that, because a plaintiff can rebut the presumption by showing that the relevant
Murthy’s argument that § 82.007(a) does not apply because “not all” of the information given to her was FDA approved is similarly unpersuasive. As Abbott points out, Murthy’s argument is based solely on dicta from a recent state appellate court opinion. See Centocor, Inc. v. Hamilton,
Murthy does state that she believes, once the evidence is developed, she will be able to support exemption under § 82.007(b)(1). (Resp. to Mot. Dismiss 10-11.) When the Court issued its first Memorandum and Order on Abbott’s Motion to Dismiss in November 2011, the Fifth Circuit had not yet determined whether § 82.007(b)(1) was preempted. On February 22, 2012, however, the Fifth Circuit held that § 82.007(b)(1) is preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”) unless the FDA itself finds fraud. Lofton v. McNeil Consumer & Specialty Pharmaceuticals,
Having determined that Murthy’s claims resting on allegations that Abbott failed to warn of Humira’s dangerous side effects survive Abbott’s Motion to Dismiss, the Court must analyze whether any of Murthy’s remaining claims survive. In addition to breach of contract, which the Court will deal with separately, Murthy brings strict liability, breach of warranty, and negligence claims. “Products liability action” under § 82.007(a) means “any action against a manufacturer or seller for recovery of damages arising out of personal injury, death, or property damage allegedly caused by a defective product whether the action is based on strict tort liability, strict products liability, negligence, misrepresentation, breach of express or implied warranty, or any other theory or combination of theories.” Tex. Civ. Prac. & Rem. Code § 82.001(2). As Murthy’s strict liability and breach of warranty claims are premised on failure to warn, they must be dismissed pursuant to § 82.007(a). Similarly, all but one of Murthy’s negligence claims arise from failure to warn. Murthy does not plead any facts to support her ■remaining allegation that Abbot negligently failed “to adequately and properly test the drug both before and after placing the drug on the market.” (Pl.’s Am. Compl. ¶ 36(b).) As' such, none of Murthy’s negligence claims survives the Motion to Dismiss.
B. Murthy’s Contract Claims
In addition to her products liability claims, Murthy alleges in her Amended Complaint that Abbott breached the terms of the Consent to Participate agreement she signed before participating in the HERO study. Abbott argues in its Motion to Dismiss that this claim should be dismissed as untimely because the statute of limitations has run.
i. Fraudulent Concealment and the Discovery Rule
The statute of limitations for breach of contract is four years, and begins to accrue once a plaintiff is provided with sufficient facts from which to seek a judicial remedy. Tex. Civ. Prac. & Rem. Code § 16.051; Johnson & Higgins v. Kenneco Energy Inc.,
The Court finds that the statute of limitations for Murthy’s contractual cause of action was not suspended because of fraudulent concealment. The doctrine of fraudulent concealment “suspend[s] the running of limitations until such time as the plaintiff learned of, or should have discovered, the deceitful conduct or the facts giving rise to the cause of action.” Earle v. Ratliff,
Murthy also alleges that “her cause of action did not necessarily accrue for limitations purposes when she was diagnosed with cancer,” as “[t]he mere diagnosis did not put her on notice that Humira probably caused her lymphoma.” (Pl.’s Resp. at 16.) She further alleges that Abbott did not “do[] anything to tell her that Humira was a likely culprit.” (Id.) Murthy is presumably raising a discovery rule issue here. The discovery rule applies when “the nature of the injury ... [is] inherently undiscoverable and the injury itself ... [is] objectively verifiable.” Barker v. Eckman,
A contract cause of action normally accrues when the contract is breached. Id. (citing Slusser v. Union Bankers Ins. Co.,
Murthy does not offer facts to support her contention that the limitations period was tolled beyond her diagnosis with cancer. Indeed, Murthy’s rheumatologist even instructed Murthy to cease taking Humira when she was diagnosed, which suggests she may have known at that time that Humira may have been a contributing cause of her cancer. (PL’s Am. Compl. ¶ 29.) “A statute of limitations may support dismissal under Rule 12(b)(6) where it is evident from the plaintiffs pleadings that the action is barred and the pleadings fail to raise some basis for tolling or the like.” Jones v. Alcoa, Inc.,
ii. Relation-Back Doctrine
Under federal law, an amendment to a pleading relates back to the date of the original pleading when “the amendment asserts a claim or defense that arose out of the conduct, transaction, or occurrence set out — or attempted to be set out — in the original pleading.” Fed. R.Civ.P. 15(c)(1)(B). By contrast, under Texas law, the “relation back” doctrine provides that new facts or claims raised in subsequent pleadings relate back to timely filed pleadings “unless the amendment or supplement is wholly based on a new, distinct, or different transaction or occurrence.” Tex.' Civ. Prac. Rem. Code § 16.068. “A transaction is defined as a set of facts that gives rise to the cause of action premised thereon.” Brewster v. Columbia Medical Center of McKinney Subsidiary, L.P.,
Relation back is determined by whichever is more forgiving between state law or federal law. Thus, if state limitations law “affords a more forgiving principle of relation back than” Rule 15(c), such state law “should be available to save the claim.” Fed.R.Civ.P. 15(c) Comm. N to 1991 Amendment. “If there is a difference between Texas and federal relation-back law, the federal rule appears to be more lenient.” Schirle v. SOKUDO USA LLC, Action No. 4:08-CV-555-Y,
The Court concludes that, under either Texas or federal law, Murthy’s breach of contract claim does in fact relate back to her initial pleadings. The rationale for Rule 15(c) “ ‘is that, once litigation involving a particular transaction has been instituted, the parties should not be protected [by the statute of limitations] from later asserted claims that arose out of the same conduct set forth in the original pleadings.’ ” Flores v. Cameron County, Tex.,
Under Texas law, “ ‘[a] transaction is defined as a set of facts that gives rise to the cause of action premised thereon.’ ” Brewster,
As Murthy’s breach of contract claim relates back under either federal or Texas law, it is not barred by the statute of limitations. Therefore, the Court determines that it should not dismiss Murthy’s breach of contract claim.
IV. CONCLUSION
For the reasons stated above, only Murthy’s breach of contract claim survives the Motion to Dismiss. Abbott’s Motion to; Dismiss is therefore GRANTED in part and DENIED in part.
IT IS SO ORDERED.
ORDER
Before the Court is Plaintiffs Motion for Reconsideration of this Court’s Memorandum and Order, Issued March 6, 2012, to the Extent it Dismisses Plaintiffs Failure-to-Warn Claims Under Tex. Civ. Prac. & Rem. Code. § 82.007 (“Motion”). (Doc. No. 66.) Defendant Abbott Laboratories filed a Response (Doc. No. 67); Plaintiff did not file a Reply. After considering the Motion, the Response, and the applicable law, the Court concludes that the Motion must be DENIED.
The Court has extensively detailed the facts of this case in its March 2012 Memorandum and Order on Defendant’s Motion to Dismiss. (Doc. No. 62.) In that Memorandum and Order, the Court dismissed all of Plaintiffs claims except for Plaintiffs contractual claims. The Court concluded that it was bound by the Fifth Circuit’s decision in Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672- F.3d 372, 381 (5th Cir.2012), to find that Tex.R. Civ. P. § 82.007(b)(1) was preempted. (Id. at 24.) Additionally, the Court found that § 82.007(b)(1) was severable from § 82.007(a). {Id. at 24 n. 8.) Plaintiff now seeks reconsideration of that Memorandum and Order. First, Plaintiff urges that the Court was mistaken in concluding that § 82.007(a) is independent of § 82.007(b)(1). (Mot. Reconsideration at 3.) Second, Plaintiff insists that, in the alternative, § 82.007(b)(1) is not preempted. (Id. at 21.) Third, Plaintiff contends that § 82.007 does not apply to claims of failure to warn consumers directly. (Id. at 24.)
For motions for reconsideration filed within 28 days of a Court’s order or for reconsideration of interlocutory orders, the Court applies Federal Rule of Civil Procedure 59(e). Amegy Bank Nat. Ass’n v. Monarch Flight II, LLC, No. H-11-3218,
The Court concludes that the extraordinary relief afforded under Rule 59(e) is inappropriate here. Plaintiff has rehashed old arguments and presented arguments that she could have provided in earlier briefing. Plaintiff nowhere points out a manifest error of law or fact or presents newly discovered evidence. As such, the Court DENIES Plaintiffs Motion for Reconsideration.
IT IS SO ORDERED.
Notes
. The facts contained in this section are derived from the allegations in Murthy's First Amended Complaint. (Doc. No. 7.)
. Murthy previously filed suit against Abbott, and one of its subsidiary companies, in the United States District Court for the District of Massachusetts (C.A. No. 2008-00328). That case was dismissed without prejudice pursuant to a stipulation between the parties.
. All references to the Restatement are to the Restatement (Second) of Conflict of Laws uriless otherwise indicated.
. Murthy's response states that it will "assume arguendo” for purposes of this motion that Texas substantive law applies. Accordingly, she does not advance an argument that Texas law does not apply for purposes of this Motion.
. The responsibilities of pharmaceutical companies and physicians are, according to the Accreditation Council on Graduation Medical Education, irreconcilably different: "[T]he responsibility of the pharmaceutical industry [is] to act in the best interests of its shareholders by maximizing their return on investment. In contrast, however, the altruism expected of medical professionals dictates that doctors put patients first. The doctor-patient relationship ... is the foundation of medical professionalism; the good of the patient must be preeminent.” Accreditation Council on Continuing Medical Education, Principles to Guide the Relationship Between Graduate Medical Education and Industiy 2 (Sept. 10, 2002), available at http://www.acgme.org/ac Website/positionpapers/pp_index.asp (accessed Nov. 1, 2011). This conflict of interest has led to concerns that medical industry may influence medical decision-making. Id. These fears are well founded: Researchers have documented that gifts and drug-company sponsored continuing medical education are associated with increased prescription rates of the sponsor’s medication. Ashley Wazana, Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?, 283 J. Am. Med. Ass’n 373 (2000). See also Institute of Medicine, Report Brief: Conflict of Interest in Medical Research, Education, and Practice (April 2009). According to researchers, physicians may even be influenced by "token gifts”: "Social science research continues to show that the impulse to reciprocate from even a token gift can be a powerful influence on behavior, thereby producing a possible conflict of interest for the recipient (physician).” David W. McFadden, The Devil is in the Details: The Pharmaceutical Industry's Use of Gifts to Physicians as Marketing Strategy, 140 J. Urgical Research 1, 2 (June 1, 2007). This is because even a small gift giving encourages reciprocity: "Reciprocity is one of the key tools of persuasion that is used in the interaction between physician and the pharmaceutical industry. In that all societies subscribe to a norm that obligates individuals to repay in kind what they have received, when a physician receives a gift, irrespective of its value, the beginning of a relationship of psychological indebtedness is established.” Ashley Wazana, Ethical Considerations in the Relationship between Physicians and the Pharmaceutical Industry, 25 Psychatr. Clin. N. Am. 647, 652 (2002).
Physicians, of course, may be unaware of any bias. ”[P]romotional support has been proven to influence medical decision-making, and studies have found decision makers unable to recognize its impact." Accreditation Council on Continuing Medical Education, supra, at 2. Indeed, the number of promotional items received by physicians is correlated with the belief that pharmaceutical representatives have little impact on their prescribing behavior. Catherine A. Marco, et ah, Gifts to Physicians from Pharmaceutical Industry: An Ethical Analysis, 48 Annals of Em. Med. 513, 517 (Nov. 2006). Strangely, most physicians (61%) believe that they are not influenced by pharmaceutical company gifts, but believe the same is true for only 16% of their colleagues. McFadden, supra, at 2. Despite most physicians’ assumptions, "there is strong evidence that bias behaviors exist.” Id. Thus, ”[a]s with many instances of conflict of interest, the bias created in physicians by pharmaceutical promotions tends to be unintentional and unconscious.” Susan Poser, Unlabeled Drug Samples and the Learned Intermediary: The Case for Dn¿g Company Liability without Preemption, 62 Food & Drug L.J. 653, 668 (2007). Therefore, even if physicians do not acknowledge the bias, it may nonetheless exist; indeed, physicians’ self-interest may affect their choices indirectly. Jason Dana & George Lowenstein, A Social Science Perspective on Gifts to Physicians from Industry, 290 J. Am. Med. Ass'n 252, 254 (2003).
. Researchers have also documented that conflicts of interest may arise when clinicians stand to gain from enrolling their own patients as subjects in clinical trials:
Extensive literature demonstrates the shortcomings of the current informed consent process in the experimental setting. The informed consent might be compromised even further when the physician/investigator who is responsible for enrolling participants in the trial and obtaining their consent stands to gain financially from each participant who is enrolled. The physician/investigator may be less inclined to emphasize how the experimental treatment differs from the care that is ordinarily provided, the additional risks involved, or lack of direct benefit to the participant.
. Desiano was affirmed by an equally-divided Supreme Court without an opinion.
. The Court does not agree with Murthy that if § 82.007(b)(1) is unconstitutional, § 82.007(a) must also be unconstitutional. "The unconstitutionality of one part of a statute does not require us to invalidate the entire statute unless the unconstitutional provision is not separable from the remainder.” Commission for Lawyer Discipline v. Benton,
. In its reply, Abbott raises for the first time the argument that Murthy's breach of contract is factually insufficient under Rule 12(b)(6). Abbott argues that Murthy fails to allege facts to show that Abbott breached the agreement. The Fifth Gircuit deems arguments raised for the first time in a reply brief to be forfeited. See Yohey v. Collins,