Full opinion text
MEMORANDUM AND OPINION, [Resolving Doc. No. 232, 240, 266, 299, 302] GWIN, District Judge. On December 5, 2003, Abbott Laboratories, Abbott Laboratories International Co., Abbott Laboratories Inc., and Knoll Pharmaceutical Co. (collectively “Pharmaceutical Defendants” or “Defendants”) moved the Court for summary judgment in the present matter. [Doc. 232] On January 12, 2004, Plaintiffs responded, opposing the motion. [Doc. 264] Defendants replied on January 26, 2004. [Doc. 270] In a related matter, Defendants move the Court for an order striking the affidavit of Keith Altman [Docs. 266, 269, 280, 299, 302] and for an order excluding Plaintiffs’ expert witnesses. [Docs. 240, 261, 271] For the reasons described below, the Court GRANTS, in part, Defendants’ motion to exclude the expert testimony of Arnold Schwartz, Ph.D. and DENIES as moot Defendants’ motion to strike the affidavit of Keith Altman. Ultimately, the Court GRANTS Defendants’ motion for summary judgment as to all of Plaintiffs’ claims against the Pharmaceutical Defendants. BACKGROUND This action, consolidated for pretrial proceedings by the Judicial Panel on Mul-tidistrict Litigation, involves the diet drug Meridia (a.k.a., Sibutramine Hydrochloride Monohydrate). With their actions, Meridia Plaintiffs allege that their use of Meridia caused cardiovascular and cere-brovascular injuries. The claimed injuries include heart attack, stroke, tachycardia, heart palpitations, chest pain, high blood pressure, hypertension, and death. While Plaintiffs do not describe their injuries in detail, some Plaintiffs allege that their injuries are “serious and permanent.” See e.g., Outlaw v. Abbott Labs., Inc., 5:04-cv-8001, compl. at ¶ 29. Other Meridia Plaintiffs allege that the drug was ineffective for weight loss or that they are at increased risk for developing future injury as a result of their ingestion of Meridia. Abbott Laboratories manufactures, markets, and distributes Meridia within the United States. Before being absorbed by Abbott, Defendant Knoll Pharmaceuticals Co. did the same. In this action, the Meri-dia Plaintiffs sued Knoll Pharmaceutical Co. (“Knoll”), Abbott Laboratories (“Abbott”), BASF Aktiengesellschaft (“BASF AG”), BASF Corp., and SmithKline Beec-ham Corp., doing business as GlaxoS-mithKline. With their amended complaint, the Meridia Plaintiffs state claims for strict product liability, negligence, negligence per se, violation of state consumer protection statutes, breach of express and implied warranties, and medical monitoring. The Meridia Plaintiffs seek to recover damages for deaths and personal injury, refunds, restitution, and equitable relief. Meridia acts as an anti-obesity medication by slowing the body’s dissipation of serotonin, a brain chemical associated with satiety, and norepiniphrine. Around 1980, Boots Pharmaceuticals developed Meridia as an anti-depressant, but never applied for FDA approval as an obesity medication. Boots Pharmaceuticals sold the drug formulation to Knoll. In 1990, Knoll began specifically testing Meridia as a diet drug. On November 22, 1997, the FDA approved the marketing of Meridia in the United States as a diet drug, at dosages of 5, 10, and 15 milligrams. Knoll began marketing Meridia through pharmacies in February 1998. On March 2, 2001, Abbott Laboratories acquired Knoll Pharmaceuticals. According to Plaintiffs, between November 22, 1997 and September 30, 2000, the FDA received 397 complaint reports from people using Meridia. Those complaints included reports of 152 hospitalized patients and 29 deaths, with 19 of those deaths from cardiovascular causes. On March 19, 2002, the consumer watchdog group Public Citizen petitioned the FDA to remove Meridia from the market. Litigation followed in both state and federal courts. Responding to the state court actions, Abbott removed a large number of actions to federal court, principally based upon diversity jurisdiction. On August 15, 2002, the Judicial Panel on Multidistrict Litigation (“the MDL Panel”) transferred the pending federal cases to this Court for consolidated pretrial proceedings. Subsequently, additional tag-along cases have followed. As the transferee court, this Court now determines if Plaintiffs’ claims survive summary judgment. STANDARD OF REVIEW Summary judgment is appropriate when the evidence submitted shows “that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed.R.Civ.P. 56(c). In seeking summary judgment, the moving party bears the initial burden of showing an absence of a genuine issue of material fact as to an essential element of the nonmoving party’s case. Waters v. City of Morristown, 242 F.3d 353, 358 (6th Cir.2001). A fact is material if its resolution will affect the outcome of the lawsuit. Daughenbaugh v. City of Tiffin, 150 F.3d 594, 597 (6th Cir.1998) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)). In deciding whether the moving party has met this burden, a court must view the facts and all inferences drawn from them in the light most favorable to the nonmoving party. Adickes v. S.H. Kress & Co., 398 U.S. 144, 158-59, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970). However, “a complete failure of proof concerning an essential element of the nonmoving party’s case necessarily renders all other facts immaterial.” Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Once the moving party satisfies this burden, the burden shifts to the nonmoving party to set forth specific facts showing a triable issue. Matsushita Elec. Indus. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). It is not sufficient for the nonmoving party merely to show that there is some existence of doubt as to the material facts. See id. A factual dispute stops summary judgment only if it is material, that is, if it relates to a matter essential to adjudication. The dispute must concern facts that, under the substantive law governing the issue, might affect the outcome of the suit. Anderson v. Liberty Lobby, 477 U.S. at 248, 106 S.Ct. 2505. The factual dispute also must be genuine. The facts must be such that if proven at trial a reasonable jury could return a verdict for the nonmov-ing party. Id. at 248, 106 S.Ct. 2505. “The disputed issue does not have to be resolved conclusively in favor of the non-moving party, but that party is required to present significant probative evidence that makes it necessary to resolve the parties’ differing versions of the dispute at trial.” 60 Ivy Street Corp. v. Alexander, 822 F.2d 1432, 1435 (6th Cir.1987) (citing First Nat’l Bank of Arizona v. Cities Serv. Co., 391 U.S. 253, 288-89, 88 S.Ct. 1575, 20 L.Ed.2d 569 (1968)); see also Celotex, 477 U.S. at 322, 106 S.Ct. 2548. ANALYSIS With their motion for summary judgment, the Defendants claim that Plaintiffs do not create a material dispute of fact as to matters essential to Plaintiffs’ claims. First, Defendants assert that Plaintiffs fail to offer sufficient evidence to create a material dispute of fact that Meridia causes harm in patients. Second, Defendants argue that their warnings to physicians were sufficient. Third, Defendants claim that Plaintiffs’ design defect claim fails because (i) the Plaintiffs do not show material evidence that the-risks of Meridia outweigh its benefits, (ii) there was no alternative design, and (iii) one cannot bring a design defect claim against “unavoidably unsafe” products. Fourth, Defendants argue that Plaintiffs have not offered evidence tending to establish a manufacturing defect. Fifth, Defendants state that there is no evidence of negligence per se. Sixth, Defendants assert that there is no material dispute of fact with regard to Plaintiffs’ breach of warranty claims. Seventh, Defendants assert that Plaintiffs are unable to create a material dispute of fact with regard to a negligent or fraudulent misrepresentation, either under common law or statutory law. Finally, Defendants argue that Plaintiffs have not offered sufficient evidence to support their medical monitoring claim. If all of Defendants’ assertions are true, none of Plaintiffs’ claims against the Pharmaceutical Defendants survive summary judgment. The Court will analyze, in turn, the merits of Defendants’ assertions. I. Causation In support of their motion for summary judgment, Defendants primarily argue that the Plaintiffs have failed to come forth with any evidence that Meridia causes compensable injury. If Defendants are correct, then Plaintiffs’ claims for strict liability (all theories thereof), negligence, and negligence per se must fail. After all, causation of an alleged injury is an element of each of these claims. See In re Norplant Contraceptive Products Liability Litig., 215 F.Supp.2d 795, 830 (E.D.Tex.2002). Toxic tort cases present a unique challenge to the classical conception of causation. Other tort cases, such as slip-and-fall or car accident cases, feature scenarios where causation is fairly obvious-if one car collides with another, common sense dictates that a range of injuries from broken limbs to internal bleeding to death can result. Toxic tort cases, however, generally involve less-common injuries that often function at the cellular level. The causation inquiry in toxic tort cases is more complicated because the injuries themselves are usually not immediately obvious and the connection between exposure and injury is not a matter of common sense or everyday experience. Moreover, a variety of exposures frequently can associate with the condition. Using one example, both smoking and exposure to asbestos increase the risk of lung cancer. When smoking and exposure to asbestos combine, the risk of cancer increases precipitously. Similarly, Meridia users are typically obese, a condition that, alone, is a risk factor for cardiovascular disease. When cardiovascular injury occurs, it is difficult to precisely identify the precipitating cause. In toxic tort cases, the causation inquiry is two-pronged. First, a plaintiff must show that the substance to which she was exposed can cause the type of injury alleged. Next, a plaintiff must show that in her case, exposure to the substance actually caused the alleged injury. Sterling v. Velsicol Chem. Corp., 855 F.2d 1188 (6th Cir.1988); Bonner v. ISP Techs. Inc., 259 F.3d 924, 928 (8th Cir.2001) (“[t]o prove causation in a toxic tort case, a plaintiff must show both that the alleged toxin is capable of causing injuries like that suffered by the plaintiff in human beings subjected to the same level of exposure as the plaintiff, and that the toxin was the cause of the plaintiffs injury”); In re Breast Implant Litig., 11 F.Supp.2d 1217, 1224 (D.Colo.1998) (collecting cases). The first prong is called “generic” or “general” causation; the second goes by the moniker “specific” or “individual” causation. In re Hanford Nuclear Reservation Litig., 292 F.3d 1124, 1129 (9th Cir.2002) (“‘Generic causation’ has typically been understood to mean the capacity of a toxic agent ... to cause the illnesses complained of by plaintiffs. If such capacity is established, ‘individual causation’ answers whether that toxic agent actually caused a particular plaintiffs illness.”); Jack v. Glaxo Wellcome, Inc., 239 F.Supp.2d 1308, 1320-21 (N.D.Ga.2002) (“General causation is the capacity of a product to cause injury; specific causation is proof that the product in question caused the injury of which the plaintiff complains.”) (citation omitted). See also Goebel v. Denver & Rio Grande Western Ry. Co., 346 F.3d 987, 990 (10th Cir.2003) (identifying “two separate aspects of causation ... in this case: (1) general causation, meaning that the particular circumstances in the tunnel could have caused Mr. Goebel’s injury, and (2) specific causation, meaning that those circumstances did in fact cause Mr. Goebel’s injury.”) With a large number of discrete clinical settings associated with each plaintiffs claims, the examination regarding individual causation is unwieldy. The more appropriate course restricts the inquiry on consolidated motions for summary judgment to the logically prior issue, general causation. Multidistrict Litigation (“MDL”) seeks to promote judicial economy and litigant efficiency by allowing the transferee court to preside over matters common among all cases. Given this function, the transferee court typically does not rule on cumbersome, case-specific legal issues. Cf. Zicherman v. Korean Air Lines Co., 516 U.S. 217, 220, 116 S.Ct. 629, 133 L.Ed.2d 596 (1996) (noting that the transferee court dealt with “consolidated procedures on common issues of liability.”). By its nature, specific causation is not common to all plaintiffs. Rather, it involves a “determination [that] is highly individualistic, and depends upon the characteristics of individual plaintiffs.” In re “Agent Orange” Product Liab. Litig., MDL No. 381, 818 F.2d 145, 165 (2d Cir.1987). Therefore, the Court limits its inquiry to general causation, i.e., whether the plaintiff shows sufficient evidence that the substance in question has the capacity to cause harm. Indeed, other MDL cases have reserved specific causation questions to cases that are remanded. See Schmerling v. Danek Med., Inc., No. 96-2749, 1999 U.S. Dist. LEXIS 13952, 1999 WL 712591 (E.D.Pa. Sept. 10, 1999) (on remand from MDL, the court found insufficient evidence of specific causation to survive summary judgment). The Court first turns to examining whether the Plaintiffs show sufficient evidence that Meridia is capable of causing compensable injury. Because the Court examines this ease on a motion for summary judgment, the issue may be better phrased, “Have Plaintiffs offered sufficient evidence that Meridia causes the types of injuries of which they complain?” If the answer to this question is negative, it stops plaintiffs from demonstrating specific causation. See Soldo v. Sandoz Pharm. Corp., 244 F.Supp.2d 434, 525 (W.D.Pa.2003) (“The issue of specific causation is material, however, only if plaintiff can demonstrate general causation ... ”) (quoting Brumbaugh v. Sandoz Pharm. Corp., 77 F.Supp.2d 1153, 1155 (D.Mont.1999)). For Defendants, Meridia operates safely and effectively, and has few serious side effects. More critical for the issues presently before this Court, the Defendants claim that Plaintiffs show no evidence sufficient to make out a case that Meridia causes compensable injury. Supporting this conclusion, Defendants cite the opinions of numerous scientific and medical experts, as well as epidemiological studies. Restating their argument: The obese population using Meridia suffer from increased risk of cardiovascular conditions. Unless epidemiological studies show this risk increases with Meridia ingestion, there is no way to attribute the condition to the Meridia use. Plaintiffs do not respond with epidemiological studies of their own. Instead, they primarily offer three arguments. First, Plaintiffs rely on the opinion testimony of their expert, Arnold Schwartz, Ph.D, D.Sci (Hon), R.Ph, FACC, FAHA. Schwartz finds Meridia causes increases in heart rate and blood pressure, which lead to adverse cardiac events. Further, Schwartz says Meridia causes little beneficial weight loss. Second, Plaintiffs rely on a proportional reporting rate (PRR) analysis performed by Keith Altman, Ph.D. Plaintiffs provide data regarding allegedly greater incidence of cardiovascular reports with Meridia, when compared to other types of adverse event reports. Plaintiffs argue that the data establishes that Meri-dia causes harmful cardiovascular events. Finally, Plaintiffs argue that the Meridia product inserts given to both doctors and patients state that Meridia can cause injury. To Plaintiffs, this constitutes an admission of Meridia’s harmful propensities. As evidence of a further admission, Plaintiffs point to internal company adverse report records in which Abbott and Knoll themselves conclude that Meridia “probably” or “possibly” caused various Meridia patients’ adverse events. The Court examines Plaintiffs’ three arguments on general causation seriatim. As a threshold matter, the Court first determines the form evidence need take to establish a material issue of fact. The Court then reviews each of Plaintiffs’ attempts to create a material dispute of fact with regard to causation. A. Epidemiological Evidence and Expert Testimony Defendants argue that Plaintiffs must present this Court with experts who can present epidemiological evidence to establish that Meridia doubles the risk of harm of compensable injuries. The Court examines the merits of this argument. Generally, “[ejpidemiologists compare rates of disease in various populations to determine whether there is an increased risk of disease in those who used a particular substance in comparison to non-users.” In re Diet Drugs Products Liab. Litig., MDL No. 1203, 2000 U.S. Dist. LEXIS 9661, CCH Prod. Liab. Rep. p15, 855 (E.D. Pa June 28, 2000). It is notable that Plaintiffs need not prove disease to establish compensable injury. The Restatement (Second) of Torts § 7 states: “Harm” implies a loss or detriment to a person, and not a mere change or alteration in some physical person, object or thing. Physical changes or alterations may be either beneficial, detrimental or of no consequence to a person. In so far as physical changes have a detrimental effect on a person, that person suffers harm. Restatement (Second) Of ToRts § 7, cmt. b. Thus, Plaintiffs may create a material dispute of fact with regard to tortious conduct without necessarily proffering evidence of cardiovascular disease. In establishing a causal chain, epidemiological evidence is just one method of proof. Defendants correctly argue that some courts express a preference for epidemiological evidence. However, such evidence is not mandatory: “Epidemiologic studies are the primary generally accepted methodology for demonstrating a causal relation between the chemical compound and a set of symptoms or a disease. When an expert does not rely on the primary methodology for establishing causation, then that places a burden on the expert to explain his choice of methodologies ...” Conde v. Velsicol Chem. Corp., 804 F.Supp. 972, 1025-26 (S.D.Ohio 1992). The Western District of Pennsylvania, while also observing its preference for epidemiological evidence, noted: “This does not mean that conclusive published epide-miologic studies are required in every case alleging cause and effect. In this case, however, other types of evidence upon which plaintiff might reasonably rely are equally absent.” Soldo, 244 F.Supp.2d at 536 (W.D.Pa.2003). No requirement exists that a party must offer epidemiological evidence to establish causation. Plaintiffs burden of establishing causation “does not necessarily require them to produce scientific studies[.j” Wells v. Ortho Pharm. Corp., 788 F.2d 741, 745 (11th Cir.1986). The D.C. Circuit clarified this area of the law when it stated that a cause effect relationship need not be established by animal or epidemiological studies before a doctor can testify that, in his opinion, such a relationship exists. As long as the basic methodology employed to reach such a conclusion is sound ... products liability law does not pi-eclude recovery until a “statistically significant” number of people have been injured or until science has had the time and resources to complete sophisticated laboratory studies on the chemical. Ferebee v. Chevron Chem. Co., 736 F.2d 1529, 1536-37 (D.C.Cir.1984). See also Bloomquist v. Wapello County, 500 N.W.2d 1, 5 (Iowa 1993) (Supreme Court of Iowa declined to apply a per se requirement of epidemiological evidence) (“In our view, while epidemiological evidence is helpful, it should not be held to be an absolute requirement in establishing causation.”). All of the cases in the preceding paragraph were decided before the Supreme Court handed down its landmark decision in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). It is important to understand how Daubert shaped the landscape of this area of law, further discouraging mandates of epidemiological evidence. The Daubert Court held that Rule 702 of the Federal Rules of Evidence superceded the more “restrictive test” found in Frye v. United States, 293 F. 1013 (D.C.Cir.1923). The Daubert Court held that, for expert testimony to be admissible, the opinion need not have gained “general acceptance,” as required under the Frye test. Daubert, 509 U.S. at 588, 113 S.Ct. 2786. In particular, the Daubert Court addressed whether the district court erred in excluding certain expert testimony because the experts did not offer epidemiological evidence to establish that the drug Bendeetin caused birth defects. Finding that the District Court based its conclusion on the general acceptance standard, the Daubert Court vacated and remanded the case. The Court noted that “there are important differences between the quest for truth in the courtroom and the quest for truth in the laboratory.” Id. at 596-97, 113 S.Ct. 2786. Since Daubert, courts have continued to reject a mandate for epidemiological evidence. “Epidemiological studies are not necessarily required to prove causation, as long as the methodology employed by the expert in reaching his or her conclusion is sound.” Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378, 1384 (4th Cir.1995) (applying Daubert); see also Heller v. Shaw Indus., Inc., 167 F.3d 146, 154 (3d Cir.1999) (“We do not believe that the [lower] court’s reading of Rule 702-as requiring research studies supporting a finding of general causation-is correct.”) Ultimately, no court has held that epidemiological evidence is necessary to establish general causation when other methods of proof are available. Defendants argue that Plaintiffs have failed to establish a genuine issue of material fact regarding causation because Plaintiffs have not offered any admissible expert testimony indicating that Meridia can cause compensable injury. To defendants, expert testimony is a prerequisite to get to a jury. They are correct, in part. The Court of Appeals for the Third Circuit concluded that there is no federal rule requiring expert testimony in support of general causation in mass tort claims. In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 750-52 (3d Cir.1994), reh’g denied, cert. denied, 513 U.S. 1190, 115 S.Ct. 1253, 131 L.Ed.2d 134 (1995). The court noted that such a rule would be, in part, (1) a rule regarding what types of evidence are admissible in mass tort cases, and (2) an aspect of a party’s burden of proof. To the extent that such a rule affects a party’s burden of proof, it is a substantive law under Erie analysis, and federal courts operating under diversity jurisdiction must apply state law on that issue. Id. Therefore, in cases originating from states that require expert testimony in mass tort cases, Plaintiffs’ claims would fail if the Plaintiffs did not offer admissible expert testimony tending to establish general causation. However, Plaintiffs who originally filed their cases in states that lack such a rule would not need expert testimony to get to a jury. Therefore, the Court need not dismiss their claims. Rather than undertake an analysis of all fifty states’ laws to determine which do and which do not require expert testimony on the issue of general causation, the Court assumes arguendo that no states’ laws erect such a requirement. Regardless, the Court ends up in the same place: summary judgment for Defendants. B. Conclusions of Schwartz Plaintiffs assert that they have created a material issue of fact with regard to causation based on the expert testimony of Dr. Schwartz. Schwartz works as a pharmacologist and holds his Ph.D. in pharmacy/pharmacology. Schwartz defines pharmacology as “the science of the mechanism of action of chemical entities called drugs on the human organism, and the action of the human organism on the drug.” (Schwartz rep. at 3). Schwartz currently serves as a professor and director of the Institute of Molecular Pharmacology and Biophysics at the University of Cincinnati’s College of Medicine. Schwartz also acts as the president and sole employee of CVR Inc., a company which conducts cardiovascular research. Finally, Schwartz serves as a consultant for the United States Air Force, Otsuka Pharmaceutical Company, and Tanabe Pharmaceutical Company. In this capacity, Schwartz has drafted package inserts and answered questions concerning drug doses and side effects. In his preliminary report, Schwartz concludes that the risks associated with Meri-dia do not outweigh the benefits. Schwartz opines that Meridia results in only “very modest decrease in weight” but causes “very serious side effects and contraindications.” (Schwartz Rep. at 6). Schwartz states that Meridia causes an increase in blood pressure and heart rate which “could lead to a fatal heart attack.” Id. Specifically, Schwartz opines that Meri-dia causes adverse cardiovascular effects in patients because the drug increases levels of norepinephrine throughout the body. (Id. at 4,6; Schwartz Dep. at 214-223). Schwartz’s conclusions revolve around his assumption that Meridia increases levels of norepinephrine throughout the body. Schwartz explains that Meridia operates as a blocker or inhibitor which inhibits “re-uptake” (the body’s dissipation) of norepi-nephrine as well as serotonin (a brain chemical associated with satiety). As a result of this, the norepinephrine or serotonin in the synaptic cleft of the brain increases considerably. (Schwartz rep. at 4). Using his knowledge base about how the body metabolizes drugs, Schwartz gives the hypothesis that norepinephrine crosses the blood brain barrier. “[Meri-dia is] metabolized into Ml and M2, the drug, and Ml and M2 is distributed all over the body, including the brain. That’s been shown.” (Schwartz dep. at 216). Defendants assert that any increases in NE would not cross the blood brain barrier in any significant manner. In a study conducted with rats, there were concentrations of the drug twice as high in the brain as in the plasma. Meanwhile, Defendants point out that the exact amount of the drug distributed in the human body is unknown. Moreover, to refute Schwartz’ hypothesis, Defendants point to a study which found that individuals on Meridia had lower levels of norepinephrine in their blood than subjects on a placebo. Nevertheless, Defendants’ rebuttals-while they may be persuasive to a jury-do not establish that Schwartz’ testimony should be excluded. At issue here is whether Schwartz has sufficient expertise and basis for his opinion so that he may survive the test for expert witnesses promulgated in Daubert. Daubert stands for the proposition that, pursuant to Rule 702 of the Federal Rules of Evidence, courts serve as “gatekeepers” to ensure that “any scientific testimony or evidence admitted is not only relevant, but reliable.” Daubert, 509 U.S. at 589, 113 S.Ct. 2786. This gatekeeping function “make[s] certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999). To be admissible, proffered expert testimony must be based “on a reliable and scientifically valid methodology that fits with the facts of a case.” Heller v. Shaw Industries, 167 F.3d 146, 152 (3d Cir.1999). Daubert set forth guideposts for trial courts in assessing the reliability of scientific expert testimony. Among the factors the court may consider are (1) whether the theory or technique has been tested-that is, whether the expert’s theory can be challenged in some objective sense; (2) whether the technique or theory has been subjected to prior review and publication; (3) the known or potential rate of error of the technique or theory when applied; (4) the existence and maintenance of standards and controls; and (5) whether the theory has gained general acceptance within the scientific community. Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. This list is non-exclusive and district courts applying Daubert have broad discretion to consider a variety of other factors. See Kumho Tire, 526 U.S. at 145, 119 S.Ct. 1167. The advisory committee notes to Rule 702 of the Federal Rule of Evidence explain other factors which a court may consider. Some of those factors include: (1) Whether experts are “proposing to testify about matters growing naturally and directly out of research they have conducted independent of the litigation, or whether they have developed their opinions expressly for purposes of testifying.” Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1317 (9th Cir.1995) (2) Whether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion. See General Elect. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) (noting that in some cases a trial court “may conclude that there is simply too great an analytical gap between the data and the opinion proffered.”) (3) Whether the expert has adequately accounted for obvious alternative explanations. See Claar v. Burlington N.R.R., 29 F.3d 499 (9th Cir.1994) (testimony excluded where the expert failed to consider other obvious causes for the plaintiffs condition). Compare Ambrosini v. Labarraque, 101 F.3d 129 (D.C.Cir.1996) (the possibility of some uneliminated causes presents a question of weight, so long as the most obvious causes have been considered and reasonably ruled out by the expert.) Advisory Committee Note to Fed. R. Evid. 702. The court has “considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony is reliable.” Kumho Tire, 526 U.S. at 152, 119 S.Ct. 1167. However, the court does not have the “discretion to abandon the gatekeeping function.” Id. at 159, 119 S.Ct. 1167 (Scalia, J., concurring). Ultimately, as the proponents, Plaintiffs bear the burden of showing that Schwartz is qualified to render an expert opinion, that his opinion is reliable, and that it would assist the trier of fact in resolving a disputed issue of material fact, i.e. causation. See Bourjaily v. United States, 483 U.S. 171, 107 S.Ct. 2775, 97 L.Ed.2d 144 (1987); Fed. R. Evid. 104(a). In applying the Daubert standard to the testimony of Schwartz, the Court is concerned regarding both the scope and content of Schwartz’s conclusions. As to the scope of Schwartz’ testimony, “a district court must continue to perform its gatek-eeping role by ensuring that the actual testimony does not exceed the scope of the expert’s expertise, which if not done can render testimony unreliable under Rule 702.” Wheeling Pittsburgh Steel Corp. v. Beelman River Terminals, Inc., 254 F.3d 706, 715 (8th Cir.2001); see also Marquardt v. Joseph, No. 98-5163, 1999 WL 196569, 1999 U.S.App. LEXIS 5984, at *4 (6th Cir. Mar. 30, 1999) (“We have said that if a trial court allows an expert to testify beyond her expertise it failed to perform its gatekeeping function under the Daubert case.”). Under Daubert, “the inquiry as to the appropriateness of a given expert’s testimony is fact specific.” Laski v. Bellwood, No. 99-1063, 2000 U.S.App. LEXIS 12068, 2000 WL 712502 (6th Cir. May 25, 2000). Here, Schwartz does not hold himself out as a cardiologist. Plaintiffs make no showing that Schwartz’s expertise in pharmacology provides him with the qualifications to comment on adverse cardiovascular events. At most, Schwartz is knowledgeable about cardiovascular pharmacology. Schwartz has performed research in cardiovascular pharmacology and served as the research director of the Cardiovascular Research Center at Baylor College of Medicine. Schwartz is a fellow for the American College of Cardiology, American Heart Association, and International Heart Failure Society. This background, while impressive, does not qualify Schwartz to give expert testimony best suited for a cardiologist. Therefore, while Schwartz is qualified to testify regarding how Meridia acts on the body and its systems (including the cardiac system), he cannot testify regarding whether a particular level of injury will result from a certain level of blood pressure increase, or whether a certain likelihood of death will attend certain increases in heart rate. Schwartz also is not qualified to testify as an obesity expert. Schwartz’ involvement with obesity is fairly limited; he has attended symposia on weight loss and lectured regarding obesity. As part of his work for the United States Air Force, Schwartz worked with a team that made decisions concerning whether to prescribe weight loss medication and which medication to prescribe. Nevertheless, Plaintiffs make no showing that Schwartz is specially qualified to testify regarding the effects of certain levels of weight loss on one’s health. Thus, the Court does not allow Schwartz to testify regarding whether any “benefits” from a certain level of weight loss outweigh “risks” accompanying the use of a weight loss medication. In regard to the substance of Schwartz’ testimony, Schwartz does not give foundation as to how he reaches his conclusions with regard to causation. As described above, Schwartz opines that no-repinephrine crosses the blood brain barrier and causes increased blood pressure and heart rate. When attempting to explain his conclusion, Schwartz often resorted to circular logic: “I think it’s generally agreed that when blood pressure and heart rate are increased by reuptake inhibitors, of norepinephrine now, neorepinephrine, it occurs all over the body.” (Schwartz dep. at 221). Thus, Schwartz first starts with the conclusion that Meridia causes high blood pressure then hypothesizes about the mechanisms of how the drug caused that result. Such analysis cannot be used as evidence of causation. Further, Schwartz himself acknowledges that he is unsure about the exact amount of Meridia which is distributed throughout the human body: “The drug is in fact distributed all over the body ... but how much in the human is not known.” (Schwartz rep. at 6). Instead, Schwartz expresses concern “with any drug, but specifically Meridia, that effects norepinephrine.” (PI. opposition at 34). Such vague assertions, without sufficient explanation as to how Meri-dia causes increased blood pressure and heart rate, render Schwartz’ testimony on this point unreliable. See Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193, 1207-08 (10th Cir.2002) (holding that the district court did not abuse its discretion in excluding experts’ theory of causation based on the pharmacological properties a drug, without ample explanation as to how that drug caused negative health effects). As described, Schwartz posits that Meri-dia raises blood pressure. However, the scientific community has yet to reach a consensus on this issue. In a systematic review of clinical trials published on this issue, the authors found that not enough strong data exists to draw any strong conclusions regarding Meridia’s effect on blood pressure. David E. Arterburn, Paul K. Crane, & David Veenstra, The Efficacy and Safety of Sibutramine for Weight Loss: A Systematic Review, 164 Arch. Intern. Med. 994, 1000 (2004) [hereinafter, Arterburn, et al., The Efficacy and Safety of Sibutramine ]. One study found that users of Meridia showed a mean systolic increase in blood pressure of 4.4 mm Hg and a diastolic increase of 3.3 mm Hg. But does this minimal increase result in health consequences? Schwartz shows no training or experience allowing him to answer this question. Restating, Schwartz is qualified to render opinion on certain pharmacological effects of Meridia, but he is not qualified to testify regarding whether these effects are capable of causing com-pensable injury. Thus, Schwartz’ testimony is not competent for purposes of general causation. Plaintiffs attempt to defend Schwartz’ vague assertions by pointing out that Schwartz bases his opinion on “his education, training, and experience.” (PI. opposition to Def. motion to exclude pi. expert witness testimony at 33). However, “[i]f the witness is relying solely or primarily on experience, then the witness must explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the fact.” Advisory Committee Note to Fed. R. Evid. 702. In the matter sub judice, Schwartz does not provide this Court with more than conclusory statements regarding his opinions. Schwartz’s testimony calls upon this Court to rely solely on his subjective judgments. However, the more subjective an expert’s inquiry, the more likely the testimony should be excluded as unreliable. See, e.g., O’Conner v. Commonwealth Edison Co., 13 F.3d 1090 (7th Cir.1994). “We’ve been presented with only the experts’ qualifications, their conclusions and their assurances of reliability. Under Daubert, that’s not enough.” Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1319 (9th Cir.1995). See also Samarah v. Danek Med., Inc., 70 F.Supp.2d 1196, 1206 (D.Kan.1999) (“Indeed, there is nothing in Dr. Armani’s notes to indicate ... how he arrived at the conclusion that defendants’ bone screws caused the injuries for which plaintiff presently seeks damages.”). For the aforementioned reasons, the Court grants-in part-Defendants’ motion to exclude the expert testimony of Schwartz. As a result, Schwartz does not assist the Meridia Plaintiffs in creating a material dispute of fact with regard to causation. C. Proportional Reporting Rate Analysis Plaintiffs next attempt to create an issue of material fact based on a “proportional reporting rate analysis” performed by Keith Altman. Altman collects and analyzes adverse event data on file with pharmaceutical companies and the Food and Drug Administration (“FDA”). The adverse event drug experience reports, which form the basis of Altman’s data, were prepared by consumers, physicians, or nurses and sent to the pharmaceutical companies, who then forwarded them to the FDA. Federal regulations require that all domestic adverse experiences with a marketed drug be reported to the manufacturer who, in turn, must report the adverse events to the FDA. Additionally, consumers may directly inform the FDA of alleged adverse reactions and experiences. FDA regulations call for reports of adverse events following usage of drugs whether or not there is any belief of a causal relationship. See 21 C.F.R. § 314.80(c). In the matter sub judice, Altman compiled statistics regarding adverse events for Meridia and juxtaposed the results with the results of other drugs-Xenical (Orlistat), Effexor, and Ultran. Altman’s charts and graphs, contained in Exhibits C and D, represent the percentages of different types of adverse events associated with Meridia and Xenical, one of Meridia’s competitors. It is notable that the charts do not depict raw numbers. Of particular importance, Altman examines the total number of reports of adverse cardiovascular events for both Meridia and Xenical. He then compares the percentages of reports from cardiovascular events for each drug. From these calculations, Plaintiffs conclude that “incidences of [various] cardiovascular injuries dramatically exceed and are more than twice as likely to [be] reported in connection with Meridia usage than in connection with Xenical usage[.]” (PI. br. at 35). Plaintiffs attempt to offer Altman’s data as evidence of general causation. Even readers with only a casual understanding of statistics can recognize that this evidence does not speak to the issue of causation, and therefore cannot create a genuine issue of material fact. Indeed, proportional reporting rate analy-ses are incomplete and often misleading because they do not show the total distribution of reports. The following example illustrates this flaw: Suppose that 10,000 people received Meridia and an additional 10,000 received Xenical. Suppose further that 100 people from each group developed hypertension and that an additional 100 from the Xenical group experienced severe stomach pains. Under a proportional reporting rate analysis, Meridia would have a hypertension rate of 100%, whereas Xenical’s hypertension rate would be only 50%. This analysis conveys the impression that people taking Meridia are twice as likely to develop hypertension than are people taking Xenieal, even though the condition occurred with the same frequency in both groups in the above hypothetical. Clearly, such evidence conceals too much to speak directly to the issue of causation. For this reason, the Court rejects Plaintiffs’ proportional reporting rate analysis and holds that such evidence is insufficient to create a genuine issue of material fact regarding general causation. The Court further notes that this determination is consistent with other courts’ conclusions regarding proportional reporting rate analyses. See Rider v. Sandoz Pharms. Corp., 295 F.3d 1194, 1199 (11th Cir.2002) (noting that “case reports alone cannot prove causation”); Glastetter v. Novartis Pharms. Corp., 252 F.3d 986, 989-90 (8th Cir.2001) (noting that case reports do not screen out alternative causes for the adverse event and often lack analysis; con-eluding that the temporal correlation upon which they are based is not scientifically valid proof of causation); Dunn v. Sandoz Pharms. Corp., 275 F.Supp.2d 672 (M.D.N.C. 2003) (noting that one of the plaintiffs own witnesses “acknowledgefd] that adverse drug reaction case reports are of limited value in determining causation”). Given that Altman’s data is irrelevant to establish a material issue of fact at the summary judgment stage, the Court denies as moot Defendant’s motion to strike Altman’s affidavit. D. Defendants’ Alleged Admissions Ultimately, Plaintiffs’ primary argument in support of summary judgment is that the Meridia label and internal company documents reveal Defendants’ recognition that Meridia has the capacity to cause injury. This is a novel argument, and it creates an issue of first impression for this Court. Plaintiffs argue that Abbott’s own records constitute an admission that Meridia is capable of causing injury. Plaintiffs’ witness Altman compiled evidence obtained from electronic discovery, including data from an adverse events database that Abbott maintained. According to Altman, the database contained the company’s determinations of whether “Meridia was causally related to” particular adverse events. (Altman Afft ¶ 26). Exhibit F to Altman’s affidavit charts all serious adverse event reports in which either the reporter (the patient or medical professional who filed the report) or Abbott allegedly concluded that there was a probable causal relationship between the drug and the adverse event. According to Altman’s chart, Abbott found a “probable” relationship between Meridia and the following adverse events: unwanted pregnancy, blood pressure increase, psychotic disorder, non-accidental overdose, angina pectoris (two instances), hypertensive crisis, illusion, panic reaction, peripheral coldness, sweating increased, suicide attempt, tachycardia NOS (two instances), hypertension NOS (two instances), anaemia NOS, dyspnea NOS (two instances), hepatic disorder NOS, hypokalaemia, pyre-xia, hepatomegaly, liver function tests NOS abnormal, and enteritis haemor-rhagic (two instances). Altman Afft, Exh. F. Additionally, according to the chart, Abbott noted a “probable” causal relationship between Meridia and a longer list of adverse events, ranging from insomnia to dyspepsia to renal failure. Id. However, in deposition, Abbott’s former director of post-marketing safety testified that the internal company documents do not reflect attempts to determine causation. Instead, members of the post-marketing safety team examine the adverse event reports “for a ... potential signal,” meaning “a particular pattern of events that might have a specific characteristic signature or symptom complex, similar temporal relationship... [or] some biological plausibility for the event.” (Carlson Dep. at 150). She further testified that the final reports to the regulatory agencies, not the internal company documents, represent the company’s conclusions regarding the adverse event reports. Id. at 153. Because the internal, documents do not represent conclusions, Defendants say they cannot constitute admissions Plaintiffs also argue that the fact sheets that Abbott provided as package inserts with Meridia constitute admissions of general causation. Abbott supplied fact sheets to both physicians and patients. These inserts contain detailed product information on Meridia. Both the physician sheet and the patient sheet are relevant to determining whether Abbott admitted that Meridia is capable of causing injury. The product information provided to physicians is extensive. It describes the chemical makeup of Meridia, its mode of operation, and the results of various studies. In its “Warnings” section, the fact sheet states in bold letters: “MERIDIA SUBSTANTIALLY INCREASES BLOOD PRESSURE IN SOME PATIENTS. REGULAR MONITORING OF BLOOD PRESSURE IS REQUIRED WHEN PRESCRIBING MERIDIA.” The sheet also lists adverse reactions that patients taking Meridia experienced both in clinical trials and in post-marketing reports. These adverse events ranged from the mundane (e.g., increased salivation, yawning, and acne) to the severe (e.g., congestive heart failure, sudden unexplained death, and heart arrest). The product insert provided to patients offers information in a Q & A format. It notes, “In studies the most common side effects were: dry mouth, constipation, loss of appetite, and insomnia (inability to fall asleep). Other side effects that may occur include: headache, increased sweating, an increase in blood pressure, and an increase in heart rate.” Shortly thereafter, the insert states in bold letters: “MERIDIA SUBSTANTIALLY INCREASES BLOOD PRESSURE IN SOME PATIENTS. REGULAR MONITORING OF BLOOD PRESSURE IS REQUIRED WHEN TAKING MERIDIA.” Finally, the insert notes that certain diet drugs have been associated with pulmonary hypertension (PPH), which it describes as “a rare but sometimes fatal disease” and cardiac valve dysfunction. However, the insert states that it is unknown whether Meridia may cause either condition. Reading the product inserts to both physicians and patients in the light most favorable to the Plaintiffs, as the Court must at this stage, the Court concludes that the inserts constitute admissions of Meridia’s potential to cause substantial increases in blood pressure in some patients. The insert lists the other conditions as being “associated” with Meri-dia. Such admissions of temporal associations (or reports of temporal associations) are insufficient to create admissions of causation. Therefore, Plaintiffs have met their burden of showing a genuine issue of material fact only with respect to Meridia’s capacity to cause substantial increases in blood pressure. For all other conditions, Plaintiffs have not met their burden. The Court therefore GRANTS Defendants’ motion for summary judgment with regard to all tort claims involving harms not related to increased blood pressure. Nevertheless, the remaining product liability claims will prove insufficient for plaintiffs to recover. II. Strict Product Liability Section 402A of the Restatement (Second) of Torts provides for strict product liability in tort for sellers of “any product in a defective condition unreasonably dangerous to the user or consumer.” Plaintiffs allege product liability claims under three separate theories — inadequate warning, defective design, and manufacturing defect. The Court addresses these claims in turn. A. Failure to Instruct and Warn First, Plaintiffs allege claims based on the inadequate warning theory. Under this theory, a product is “in a defective condition unreasonably dangerous” when it is not accompanied by warnings sufficient to allow users to avoid risks inherent in the product. According to Plaintiffs, Defendants have a duty to both warn and to instruct consumers. In support of this argument, Plaintiffs focus on the conjunctive language of statutes and case law. For instance, they note that under Ohio’s products liability statute, a prescription drug is not defective “if the manufacturer ... provides adequate warning and instruction ....” Ohio Rev.Code § 2307.75(D) (emphasis added). Additionally, they cite Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254 (5th Cir.2002), for the proposition that Louisiana’s products liability statute contains a definition of “adequate warning” that encompasses instructions as well as warnings. Id. at 269-70. The Court notes that a textual reading of the Restatement (Third) of Torts supports this conclusion. Subsection 2(c) of the Restatement states that a product may be “defective because of inadequate instructions or warnings.” Restatement (Third) Of Torts: Prod. Liab. § 2(c) (1998) (emphasis added). Therefore, the Court must examine both defendants’ warnings and their instructions and assess the adequacy of each. Defendants argue that Plaintiffs have failed to set forth a genuine issue of material fact with regard to their failure to instruct and warn claims. According to Defendants, the learned intermediary doctrine shields them from liability. Under the learned intermediary doctrine, manufacturers of prescription drugs escape liability for failure to instruct and warn consumers so long as they adequately instruct and warn physicians responsible for prescribing the medication. See Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn.1994). The underlying premise of this doctrine is that patients rely on their doctors’ expert judgment-not any materials included on the label or in the drug packaging-when deciding which drugs to use and how to use them. See, e.g., Seley v. G.D. Searle & Co., 67 Ohio St.2d 192, 202-03, 423 N.E.2d 831 (1981) (stating that under the learned intermediary doctrine, “[t]he patient is expected to place primary reliance upon the physician’s judgment, and to follow his advice and instructions as to use of the drug.”). Drug manufacturers may reasonably rely on physicians to transmit their warnings to the end-users— patients. The overwhelming majority of states have adopted the learned intermediary doctrine. Therefore, this Court properly undertakes this analysis and applies the learned intermediary doctrine to Plaintiffs’ claims. The learned intermediary doctrine does not necessarily bar all failure to warn claims against drug manufacturers. For instance, it does not shield drug manufacturers from liability if the warnings they provided to physicians would not permit the physicians to adequately advise their patients. See Amore v. G.D. Searle & Co., 748 F.Supp. 845, 850 (S.D.Fla.1990). Therefore, the threshold issue for the Court is whether the warnings Defendants provided to physicians were adequate to permit the physicians to properly prescribe Meridia and to properly instruct patients how to use it. Generally, whether a particular warning is “adequate” is a question of fact to be resolved by a jury. However, “where the warning is accurate, clear, and unambiguous,” it is a question of law. Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 853 (10th Cir.2003) (citing Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 105 (Fla.1989)). To be considered adequate, a warning concerning a prescription drug generally must “contain a full and complete disclosure of the potential adverse reactions to the drug.” Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn.1994). Put differently, “a warning is ‘adequate’ ... where, under all the circumstances, it reasonably discloses to the medical profession all risks inherent in the use of the drug which the manufacturer knew or should have known to exist.” Seley, 67 Ohio St.2d at 198, 423 N.E.2d 831. Merely mentioning a possible injury or adverse effect is not necessarily adequate. Stahl v. Novartis Pharms. Corp., 283 F.3d 254, 267 (5th Cir.2002). Instead, at least five factors are relevant in determining whether a warning is adequate as a matter of law: 1. The warning must adequately indicate the scope of the danger 2. The warning must reasonably communicate the extent or seriousness of the harm that could result from misuse of the drug; 3. The physical aspects of the warning must be adequate to alert a reasonably prudent person to the danger; 4. A simple directive warning may be inadequate when it fails to indicate the consequences that might result from the failure to follow it; and 5. The means to convey the warning must be adequate. Thom, 353 F.3d at 853 (citing Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn.1994)). Defendants included the following warning on product inserts available to physicians: “MERIDIA SUBSTANTIALLY INCREASES BLOOD PRESSURE IN SOME PATIENTS. REGULAR MONITORING OF BLOOD PRESSURE IS REQUIRED WHEN PRESCRIBING MERIDIA.” In assessing the adequacy of the warning, the Court must bear in mind the intended audience-physicians. Because physicians are highly trained and able to make much better medical judgments than the consumer, warnings that might not be adequate to average consumers may very well be adequate to physicians. Regarding the first factor, the proffered warning does not detail the scope of the danger. However, because it is directed at physicians, it need not. Physicians are well aware of the scope of the risks associated with increased blood pressure and do not need specifics regarding the possible consequences of blood pressure increases. The same analysis applies to the second and fourth factors. Physicians understand the effects of high blood pressure and the seriousness of the harm that can result from continuing Meridia treatment with patients who have already experienced elevations in blood pressure. The third factor also indicates that the warning is adequate. The warning is printed in bold capital letters just under the heading, “Warnings.” The physical aspects of the warning are therefore sufficient. Finally, considering the fifth factor indicates that the warning is adequate. Defendants conveyed the warning on a product insert-something that one may reasonably assume that physicians will read. See, e.g., Restatement (Seoond) Of ToRts, § 402A cmt. j (“Where a warning is given, the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning, which is safe for use if it is followed, is not in defective condition, nor is it unreasonably dangerous.”). After all, if physicians fail to read the insert, they may well fall below their duty of care to patients. Plaintiffs attempt to salvage their failure to warn claims with testimony from their experts, but to no avail. Dr. Schwartz, for instance, says that if doctors gave Meridia to patients with high blood pressure or to patients who do not respond within four weeks, they did so because they were not properly educated. (Schwartz Dep. at 283). Yet, Dr. Schwartz says nothing to support this conclusory statement. He provides no reasons why their doing so could be due to negligence or a failure to read the warnings that Defendants provided. Similarly, Schwartz implies that the label’s insistence on “adjusting] the dose” is not adequate because it should say “discontinue the drug.” (Schwartz Dep. at 279). Again, Schwartz does not explain the foundation for his opinion that doctors should discontinue Meridia treatment, rather than lessen the dose, once patients fail to respond in four weeks. Plaintiffs, however, assert that even if the warnings were adequate, Defendants are still liable for failing to provide adequate instructions to physicians. Plaintiffs support this argument with the deposition testimony of Dr. Samuels, who states that the label does not give enough guidance to doctors regarding at what point they should discontinue the drug or how frequently they must monitor patients’ blood pressure. (Samuels Dep. at 190). Dr. Samuels’ point is well-taken, but it overlooks the fact that such judgments are often better left to the doctors’ discretion. Doctors are in a unique position to determine how best to treat their patients-a much better position than that of a faraway official in a pharmaceutical company, whose job is merely to write warnings. The law does not mandate that pharmaceutical manufacturers and marketers provide such specific instructions that they leave little room for doctors’ reasonable medical judgment. Plaintiffs include a hodgepodge of other arguments allegedly in support of their failure to instruct and warn claims. For instance, Plaintiffs argue that Defendants over-promoted Meridia, and thereby nullified the effect of any warnings they may have provided. In support of this argument, Plaintiffs cite to two cases, both at least thirty years old and only sparsely cited since they were decided. The cases are Whitley v. Cubberly, 24 N.C.App. 204, 210 S.E.2d 289 (1974), and Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 107 Cal.Rptr. 45, 507 P.2d 653, 661 (1973). Aside from being so stale that their legitimacy as legal authority is questionable, these cases are doctrinally distinguishable. Both Whitley and Stevens involved claims of negligence based upon defendants’ over promotion of drugs; neither involved the strict liability theory for which they are presently offered. More importantly, however, the cases are factually distinguishable. The pharmaceutical company in both cases knew that the relevant drug (Chloromycetin) was very risky. Contrariwise, Plaintiffs here have produced a mere scintilla of evidence that Meridia is harmful. Had they come forth with evidence that using Meridia poses substantial risks of harm, then their claims that overpromotion nullified the defendants’ warnings might have been sufficient. Given the paucity of evidence that Meridia is harmful, however, the Court must reject this claim. Additionally, Plaintiffs argue that Defendants failed to timely submit adverse event reports to the FDA and mischaracterized some of the events contained in the reports. Try as it might, the Court cannot figure out what this argument has to do with Plaintiffs’ failure to instruct and warn claim. Perhaps the Plaintiffs believe that had the Defendants submitted the information on time and accurately, then the FDA would have required that Defendants place this information on the labels, and no one would have had those adverse effects in the future. This logic is far-fetched. The main problem here is materiality-a missed deadline doth not a failure to warn make without some evidence that the missed deadline caused a failure to warn and a consequent harm. Plaintiffs have failed to generate any such evidence, so the Court rejects this argument as well. For the foregoing reasons, the Court concludes that the warnings that defendants provided to physicians were adequate. Therefore, the learned intermediary doctrine shields defendants from liability for plaintiffs’ claims for failure to instruct and warn. For those states that have not adopted the learned intermediary doctrine, the Court concludes that Defendants’ warnings to consumers are adequate. The Meridia product insert aimed at consumers includes the same warning, in the same capital boldface type, as the physicians’ insert. This warning adequately indicates the scope of the danger, and its physical aspects and placement are adequate to sufficiently warn consumers. Although the warning does not detail the potential consequences of increased blood pressure, it need not, for common knowledg