In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation
Docket: MDL No. 2:14-mn-02502-RMG
Court: District Court, D. South Carolina; January 2, 2017; Federal District Court
CASE MANAGEMENT ORDER NO. 100 addresses the Defendant’s Omnibus Motion for Summary Judgment, which has been partially granted. Background includes the creation of a Multidistrict Litigation (MDL) on February 18, 2014, centralizing cases in which female plaintiffs claim to have developed type 2 diabetes from Pfizer’s Lipitor due to inadequate warnings about associated risks. The Court conducted initial and subsequent status conferences, leading to the establishment of a discovery plan under CMO 4, which mandated document production, interrogatories, and depositions of Pfizer employees. CMO 5 required Plaintiffs to provide Fact Sheets and mandatory disclosures.
In June 2014, under Amended CMO 6, Plaintiffs’ Steering Committee and Defendant selected seven cases each for a Discovery Pool, leading to detailed case-specific discovery in the fall of 2014. On January 30, 2015, the Court selected the first bellwether trials from the Discovery Pool, with Daniels v. Pfizer and Hempstead v. Pfizer being the first two cases chosen. The parties agreed that Plaintiffs must prove both general and specific causation, with general causation determining if Lipitor can cause diabetes and specific causation assessing whether it caused the diabetes of individual plaintiffs.
Expert disclosures for general causation were served in March and April 2015, with the Court allowing supplemental disclosures in May 2015 to enhance information for Daubert motions. Specific causation expert disclosures followed in the bellwether cases in May and June 2015.
The Court permitted Plaintiffs to present a rebuttal report from a specific expert despite Defendant's objections. Following comprehensive discovery, Defendant moved to exclude both general and specific causation expert testimony from Plaintiffs in two bellwether cases. The Court ruled to exclude general causation expert testimony for dosages under 80 mg of Lipitor, which applies to the Plaintiffs in question. Additionally, the Court excluded specific causation testimony from experts Dr. David Handshoe and Dr. Elizabeth Murphy, as their opinions relied solely on increased risk and temporal association.
Despite these exclusions, Plaintiffs cited the SPARCL study, suggesting that individuals taking 80 mg of Lipitor had a relative risk ratio for diabetes greater than 2.0, potentially allowing for a valid specific causation opinion under certain circumstances. The Court initiated a scheduling order for cases that fit this profile; however, during a January 22, 2016 hearing, Plaintiffs' Lead Counsel indicated that no MDL plaintiffs met the necessary criteria.
The Court then inquired whether a bellwether case involving lower dosages could yield a survivable specific causation claim, to which Plaintiffs' counsel confirmed that, based on the Court's previous rulings, no such cases existed. The discussion shifted towards procedural options, with Defendant’s counsel suggesting an order to show cause to identify any unique cases, followed by a potential summary judgment for all cases if no distinctions were presented. This approach aims to streamline litigation and facilitate an appeal to the Fourth Circuit.
Mr. Hahn, the Plaintiffs’ Lead Counsel, expressed concerns about potential misconduct involving Mark during proceedings, suggesting he may have been cheating by reading from Hahn's notes. The Court issued CMO 65, which emphasized a critical deadline for Plaintiffs. During a January 22, 2016, conference, Lead Counsel communicated that if the Court's decision to exclude Dr. Elizabeth Murphy's expert testimony (CMO 55) was upheld, no pending cases in the MDL would likely survive summary judgment on specific causation. Any Plaintiff contesting this ruling had to notify the Court within 15 days, detailing how their case differed from CMO 55. This order did not require evidence gathering but merely notification of intent to proceed. Despite this, no Plaintiff responded or requested an extension by the January 25, 2016, deadline. Nearly eleven months later, the Court noted that not a single Plaintiff had come forward.
During a Status Conference on June 9, 2016, Plaintiffs’ counsel first mentioned that some cases might survive summary judgment despite the Daubert rulings. Mr. Hahn argued that certain plaintiffs, particularly from states like New Mexico, might not need expert testimony to advance their claims. However, the Court reiterated that any Plaintiff disputing the Lead Counsel's position needed to identify their case and expert witnesses by a designated date to facilitate discovery. The Court acknowledged the existence of states without expert testimony requirements but affirmed that Plaintiffs must still meet legal standards to establish causation. Consequently, a schedule for briefing on summary judgment was established (CMO 79), allowing Plaintiffs to present evidence under this new argument.
No Plaintiff submitted evidence opposing the summary judgment deadline, merely speculating about the potential existence of unidentified circumstantial evidence. Plaintiffs conceded that any individual who could provide a viable differential diagnosis should have responded under CMO 65. They requested permission to present non-expert testimony post-remand. The Court offered a third chance for Plaintiffs to present evidence, issuing CMO 81, which required them to detail their claims, specify applicable state law, and provide evidence against summary judgment within 15 days. If additional discovery was needed, Plaintiffs were instructed to comply with Fed. R. Civ. P. 56(d). Despite this, no Plaintiffs presented evidence or individual Rule 56(d) requests, instead filing a collective response asserting that only bellwether Plaintiffs had developed their cases. They claimed that others lacked opportunities for expert engagement, despite CMO 65 providing such opportunities. In their Rule 56(d) affidavit, Plaintiffs requested various forms of evidence and expert opinions but did not elaborate further. CMO 82 was subsequently issued, affirming that the time for Plaintiffs to argue for expert testimony had elapsed, and noting that no Plaintiff had come forward in the preceding seven months to demonstrate their ability to meet expert evidentiary standards outlined in prior orders.
Plaintiffs were required to present expert evidence on specific causation in response to CMO 65, following the exclusion of Dr. Murphy under Rule 702 and Daubert standards. Despite understanding the directive, no Plaintiff submitted such evidence, leading to the conclusion that their claim of lacking opportunity for expert testimony is unfounded, resulting in a waiver of that argument. The Court provided a final opportunity for Plaintiffs to present non-expert evidence, extending the deadline by 60 days in response to their concerns about time constraints. Plaintiffs indicated that they needed to gather information from their treating physicians and medical records, without requesting further discovery from Defendants or third parties. The Court deemed this additional time adequate.
In response to CMO 82, no Plaintiff filed a Rule 56(d) motion, confirming the sufficiency of the 60 days. The Plaintiffs’ Steering Committee submitted omnibus responses, while 34 Plaintiffs from the Hayes Law Firm provided fact sheets and medical records, asserting that they were not diabetic prior to taking Lipitor. The Douglas, London Plaintiffs did not initially submit evidence but argued that their health histories and existing records supported their case against summary judgment. The Court ordered these Plaintiffs to submit any evidence for consideration, leading to an influx of disorganized documents submitted without clear indication of their relevance to the summary judgment issue.
The Court reviewed numerous documents, most of which were deemed irrelevant, including medical images and results unrelated to the case. During oral arguments on November 1, 2016, the Court addressed motions regarding expert witness testimonies, particularly focusing on the general causation of diabetes linked to Lipitor, which is available in four doses: 10 mg, 20 mg, 40 mg, and 80 mg. Plaintiffs' experts initially claimed that Lipitor could cause diabetes without specifying a particular dose at which this risk begins, attributing any risk found in studies to all doses. Pfizer contested this by emphasizing the necessity of dosage in establishing causation and argued that plaintiffs lacked reliable evidence for diabetes risk at doses below 80 mg.
The Court expressed concerns about the adequacy of facts and data supporting the plaintiffs' claims across all doses and noted that some experts hesitated to comment on lower doses due to insufficient studies. Many plaintiffs’ experts acknowledged a dose-response relationship, asserting that the risk of diabetes increased with higher doses of Lipitor, leading the Court to order supplemental briefing on the matter.
On October 22, 2015, the Court ruled that expert testimony must establish that Lipitor can cause diabetes at specific dosages, asserting that dose is a significant factor. Despite opposition from the Defendant, the Court allowed for re-opening expert discovery, granting plaintiffs extra time to provide additional reports on causation at various dosages. After further expert analysis and additional oral arguments in early 2016, the Court issued a ruling on March 30, 2016, excluding most of the plaintiffs' expert opinions on general causation, with the exception of Dr. Singh’s opinion that Lipitor 80 mg causes diabetes. The Court found Dr. Singh's analysis for the 10 mg dosage lacked sufficient evidence and failed to reliably apply the required epidemiological methods due to the absence of statistically significant studies at that dosage.
Dr. Singh's opinion on Lipitor 80 mg is the only admissible testimony on general causation, as his opinions on Lipitor 20 mg and 40 mg depend on the admissibility of his opinion regarding Lipitor 10 mg, which was excluded. The Court also excluded the testimonies of Dr. Quon, who selectively reviewed literature, Dr. Roberts, who misapplied epidemiological methods and failed to analyze specific dosages, and Dr. Gale, who similarly did not analyze dosages and inaccurately generalized risks from Lipitor 80 mg to all dosages.
Specific causation in diabetes cases is complicated due to multiple contributing factors such as genetics, diet, exercise, age, and weight. Plaintiffs' experts could not establish a causal link between Lipitor and individual cases of diabetes, lacking methodologies to differentiate between Lipitor-induced diabetes and other risk factors. None of the plaintiffs’ experts diagnosed Lipitor-induced diabetes outside this litigation, and they acknowledged their inability to determine causation in individual cases. Previous cases, such as Guinn v. AstraZeneca Pharm. LP and Haller v. AstraZeneca Pharm. LP, demonstrated similar challenges in proving causation, where reliance on temporal proximity and generalized risk factors was deemed legally insufficient. The issues identified with the plaintiffs' specific causation experts reflect these past rulings.
Plaintiff Daniels presented Dr. David Handshoe's testimony on specific causation, while Plaintiff Hempstead included both Dr. Handshoe and Dr. Murphy. Pfizer moved to exclude both experts' testimonies, leading to two days of oral arguments in October and December 2015. On December 11, 2015, the Court issued CMO 55, excluding Dr. Murphy's testimony. Dr. Murphy calculated a relative risk ratio of 1.6 for diabetes development linked to Lipitor, concluding that 37% of Lipitor users who developed diabetes did so due to the drug. However, Dr. Murphy's assessment of Plaintiff Hempstead relied on factors like BMI, weight gain, family history, age, and hypertension, without adequately explaining why these factors alone were not solely responsible for her diabetes. Consequently, the Court deemed Dr. Murphy's methodology insufficient under Rule 702 and excluded his testimony, later denying a motion to reconsider.
On May 11, 2016, the Court issued CMO 76, excluding Dr. Handshoe's testimony for both cases. He estimated a relative risk ratio of 1.25, suggesting that 20% of those who developed diabetes while on Lipitor did so because of the drug. However, Dr. Handshoe acknowledged he could not distinguish between statin-induced and non-statin-induced diabetes in patients. He deemed Hempstead's overweight BMI as not clinically significant and was uncertain if weight gain affected diabetes risk, while also acknowledging that her ethnicity and age increased her risk but dismissed these factors based on his clinical judgment.
Dr. Handshoe failed to consider various independent risk factors for diabetes, including hypertension and lipid levels, despite previously testifying that diabetes risk factors are additive. In a prior case, he suggested multiple risk factors could collectively influence diabetes onset, but in his deposition in this case, he asserted that Lipitor was the sole cause of Ms. Hempstead’s diabetes, dismissing all other factors as insignificant. His reasoning was based solely on the temporal relationship between taking Lipitor and developing diabetes. The Court deemed Dr. Handshoe's testimony unreliable and excluded it.
In response to a summary judgment motion, Plaintiffs argued they could survive without expert testimony, claiming the Defendant admitted Lipitor can cause Type 2 diabetes at doses below 80 mg, which they considered competent evidence of general causation. For specific causation, they contended that non-expert evidence could suffice and requested the Court to remand cases for further consideration. The Court then outlined the legal standard for summary judgment, noting it is appropriate when there is no genuine dispute over material facts.
Defendant's motion for summary judgment was based on Plaintiffs’ lack of evidence for essential elements of their claims—general and specific causation. The Court clarified that Plaintiffs must present evidence that Lipitor can cause diabetes at dosages below 80 mg, and that it caused individual Plaintiffs' diabetes, but noted that expert testimony on general causation related to such dosages had been excluded. Consequently, Plaintiffs lacked admissible expert testimony to support their claims regarding general causation in this context.
Plaintiffs contend that certain admissions by Defendant are adequate to prevent summary judgment, specifically arguing that four pieces of evidence demonstrate that Lipitor can cause diabetes at dosages under 80 mg. These pieces of evidence include: 1) an email from Senior Vice President David DeMicco, 2) the U.S. Lipitor label indicating reported increases in HbA1c and fasting serum glucose levels from statins, 3) data from Parke-Davis’s New Drug Application showing Lipitor's association with increased blood glucose levels, and 4) statements from the official Lipitor website regarding elevated blood sugar levels. Pfizer does not contest the admissibility of these pieces of evidence, except for the Japanese label, but challenges their sufficiency to withstand summary judgment without expert testimony.
Plaintiffs argue that state substantive law determines whether expert causation evidence is necessary in products liability cases, while also asserting that if the evidence in question constitutes a party opponent admission under Rule 801(d)(2), federal Rule 56 governs and mandates denial of summary judgment. The court finds that Plaintiffs cannot simultaneously assert that Rule 56 supersedes state law and that state law governs the necessity of expert testimony.
The court establishes that in diversity cases, federal procedural standards apply to evidence sufficiency regarding jury issues, while substantive elements of state claims, including causation and the applicable standard of care, are governed by state law. Numerous federal courts have held that the requirement for admissible expert testimony on medical causation in complex products liability cases is a substantive state law issue.
The excerpt addresses the legal issue of whether admissions made by a defendant can replace expert testimony regarding causation in products liability cases. It emphasizes that, under substantive products liability law, expert testimony is typically required for complex issues beyond the understanding of average jurors. The defendant argues against conflating federal procedural law about expert testimony admissibility with Texas substantive law concerning causation proof in toxic torts. The court must consider whether state laws, which may impose stricter requirements for proving claims (like the necessity of expert testimony), should govern even in federal diversity cases. Various cases highlight that state law can define the sufficiency of evidence needed for recovery, particularly in medical malpractice claims. The excerpt concludes with the observation that the notion of substituting party-opponent admissions for expert evidence is a recent development in multi-district litigations, which state courts have yet to address, requiring the court to predict how state supreme courts would rule on this issue.
A federal court exercising diversity jurisdiction should cautiously predict state court decisions on novel state law issues, as emphasized by the Fourth Circuit. In the matter of whether expert testimony is required under state substantive law, Plaintiffs argue that state law presents a spectrum of rules regarding this requirement. However, it is established that all jurisdictions necessitate expert testimony in cases involving medically complex issues beyond common understanding. Cases cited illustrate that expert testimony is essential to establish causation when the nature and origin of injuries are not comprehensible to laypersons. For instance, Alabama law mandates expert testimony for causation in complex medical cases, while Alaska and Arizona courts require it unless a causal relationship is readily apparent. Similarly, Arkansas law stipulates that expert testimony is necessary when the alleged negligence involves complicated medical determinations. California law reinforces that causation in personal injury cases must be proven with competent expert testimony, even though juries may typically resolve causation issues without expert guidance. Overall, expert testimony is crucial to establish causation in complex medical injury claims across various jurisdictions.
Causation issues that exceed laymen's understanding necessitate expert testimony, as established in Howell v. Centric Grp. LLC, and further supported by various Colorado and federal cases. While circumstantial evidence may sometimes infer causation, complex or technical matters, particularly in products liability or negligence claims, require expert input under Colorado law. If ordinary experience does not clarify the case, expert testimony becomes essential to establish a prima facie case, as emphasized in cases like White v. Mazda Motor of Am. Inc. and Roache v. Charney. In personal injury claims, a competent medical expert must provide direct testimony linking the defendant's negligence to the alleged injury. Expert testimony is mandatory when the issues fall solely within the expertise realm, as indicated in Lasley v. Georgetown Univ. and similar rulings from other jurisdictions. However, expert testimony is unnecessary if causation can be established through common knowledge, as noted in Baltimore v. B.F. Goodrich Co. and other cases. In conclusion, while certain straightforward negligence claims may not require expert evidence, medically complex questions still demand specialized testimony to establish legal causation, as recognized in Barbee v. Queen’s Med. Ctr. and other relevant decisions, although Hawaii allows a 'common knowledge' exception for expert testimony in causation.
Expert testimony is generally required in personal injury cases where causation involves complex medical factors that lay jurors are unlikely to understand. Courts across multiple jurisdictions, including Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, and Maryland, have emphasized that when the relationship between an injury and an event necessitates specialized knowledge, expert testimony must be presented. This requirement is rooted in the understanding that laypersons lack the necessary experience to evaluate complicated technical data or medical causation.
Exceptions exist where causation is evident and within the common knowledge of laypersons, such as when the harmful results of negligence are obvious. However, for cases involving medical issues that are not readily apparent, expert testimony is mandatory to draw proper conclusions. The doctrine of res ipsa loquitur may apply in limited circumstances, but generally, the intricate nature of medical causation requires expert insight to ensure jurors can make informed decisions.
Expert testimony is essential when the subject matter involves specialized knowledge beyond the understanding of an average layperson, particularly in cases involving medical causation. Under Maryland law, expert testimony is necessary for technical medical questions that laypersons cannot comprehend. This principle is reinforced across various jurisdictions, indicating that understanding medical causation often requires expert input due to the complex nature of injuries and the lack of obvious connections between exposure and harm. In numerous cases, courts have ruled that expert testimony is mandatory when the issues presented exceed common knowledge and experience. Specifically, in situations involving sophisticated injuries or those requiring advanced medical techniques for diagnosis, expert testimony becomes imperative. This requirement is consistent across multiple states, where courts have held that lay jurors lack the necessary experience or knowledge to make informed decisions without the assistance of expert testimony. In less complex cases where causation can be discerned through common sense, lay testimony may suffice; however, medically complicated injuries necessitate expert evidence to establish causation.
An injury is generally considered a subjective condition that necessitates expert testimony to establish a causal link between the incident and the resulting injury or disability, unless the nature and effect of the injury are readily apparent. In cases where the causal connection between negligence and injury is not obvious, expert testimony is essential. This requirement is supported by various jurisdictions, including Nevada, where medical expert testimony is needed to establish causation, particularly for less apparent causes of death. Similarly, in New Jersey, expert testimony is mandated for causation issues that are complex and beyond the understanding of lay jurors.
Expert testimony is required in scenarios where the matter is so specialized that it exceeds common knowledge, whereas it may not be necessary when the injury's relationship to the disability is evident and can be understood by an average layperson. In New Mexico, expert testimony is mandated when the issue of causation involves complexities not within common knowledge, distinguishing between testimony needed to establish claims and that which merely enhances juror understanding. New York law follows a similar principle, requiring expert testimony for topics outside the ordinary juror’s knowledge and experience. Ultimately, the use of expert medical testimony is determined by the trial court's discretion to inform jurors adequately on the relevant issues.
Under New York law, when determining causation for an illness or injury that is not within common knowledge, expert opinion evidence is necessary. Due to the complexities of medical science, particularly regarding diagnosis and causation, only experts can provide competent evidence on the cause of such injuries. This principle extends to other jurisdictions, such as North Dakota, Oklahoma, and Oregon, where expert testimony is required for complex medical questions or when the issue is outside ordinary experience. Various cases affirm that unless causation is evident to laypersons, plaintiffs must present medical expert testimony to establish the causal link between a negligent act and the injury. This necessity for expert evidence is consistent across multiple jurisdictions, emphasizing that questions of causation often require specialized knowledge that exceeds common understanding.
Expert testimony is essential in legal cases to establish facts that are beyond the understanding of a layperson, particularly in matters not generally known or obvious to a jury. In South Carolina, expert testimony is required when issues exceed common knowledge, especially for medical causation in product liability cases. Tennessee law mandates that plaintiffs provide expert testimony for both causation and product defect in product liability claims, particularly for complex medical devices. In Utah, expert testimony is necessary for establishing causation involving medical conditions that are obscure or complex, and only in clear-cut cases may a plaintiff avoid this requirement. Similarly, in Virginia, expert testimony is needed for proving causation in toxic torts and product liability due to the intricate nature of causation. Overall, whenever the causal connection between an alleged defect and claimed injuries is not apparent to an average juror, expert testimony is crucial to substantiate the claims.
Proving that an alleged defect caused an injury necessitates qualified expert testimony on specific causation, similar to requirements in medical malpractice cases in the Virgin Islands. Expert testimony is mandated when injuries involve obscure medical factors, as laypersons would otherwise be left to speculate. Courts have consistently held that expert testimony is essential when the injury's effects are not readily ascertainable or within common knowledge. This principle applies across various jurisdictions, including Virginia and Wisconsin, where causation-related issues often require expert input due to their technical nature. While there are exceptions where expert testimony is unnecessary—such as when causation can be inferred from common knowledge or when symptoms immediately follow an accident—these circumstances do not apply in every case. For instance, cases involving immediate symptoms or the absence of alternative causes may not require expert testimony, as illustrated by various precedents. However, in instances where the origin of the injury is obscure or multiple probable causes exist, expert testimony remains essential to avoid speculative conclusions by jurors.
In Pitts v. Wingate At Brighton, Inc., the court determined that lay jurors do not require expert testimony to understand that a nursing home patient falling could result in injury, such as a broken bone. This principle is supported by cases like Dodge-Farrar, where the causal connection between a fall and immediate physical symptoms is deemed within the common experience of average individuals. Conversely, expert testimony is essential for understanding complex medical issues, such as the effects of drugs or the causation of diseases like diabetes, as established in cases like Hollander and Sullivan. In pharmaceutical product liability cases, courts consistently require expert testimony for both general and specific causation due to the intricate nature of medical causation that lay jurors cannot grasp. Examples include Phelps, where expert testimony is necessary to connect drug effects to injuries, and Hinkle, where causation regarding drug-related deaths must be established by experts. Additionally, cases like Mills and Ellis illustrate the necessity of expert evidence to establish causation related to medication and environmental toxins, respectively. Failure to provide such expert testimony can result in summary judgment for defendants.
Expert testimony is essential in cases involving complex medical questions, such as whether the drug Lipitor can cause diabetes, which exceeds the understanding of lay jurors. The plaintiffs have not provided any legal authority suggesting that party opponent admissions can replace the need for expert testimony. The court examined relevant county cases, notably the Meridia MDL, which established that admissions in a drug's label can sometimes suffice to survive summary judgment on general causation but emphasized that mere associations do not equate to causation. Specifically, the Meridia court found the label's claim that the drug “substantially increases blood pressure” was sufficient for general causation claims, while statements associating the drug with other medical conditions were inadequate. Consequently, the court granted summary judgment for the defendants concerning all claims except those related to increased blood pressure. The Sixth Circuit affirmed this decision, underscoring the importance of specific language in determining causation. Additionally, the Mirena MDL court noted that while it might be conceivable for party opponent statements to substitute for expert testimony, such instances would be exceedingly rare, particularly in pharmaceutical or medical contexts.
Clear, unambiguous, and concrete admissions could potentially substitute for expert testimony in complex cases requiring causation proof under state law. However, speculation about the meaning of such admissions is insufficient. The Mirena court emphasized that unlike the Meridia court, it recognized state law requirements for expert testimony regarding causation. The Mirena court deemed this distinction critical, ruling that no court has accepted admissions as a substitute for requisite expert testimony, as doing so would undermine the purpose of such requirements and leave jurors to speculate. This could hinder open discussions among drug and device manufacturers and lead to less informative warnings, ultimately harming public health.
The court also noted that manufacturers may provide warnings out of caution or to avoid litigation, but such labels should not replace expert testimony, as they would provide a speculative basis for causation. Previous cases have either dismissed the issue summarily or relied on the understanding that correlation does not imply causation. Instances cited, such as PLIVA and Haggerty v. Upjohn Co., illustrate that reports of potential side effects do not establish causation. The plaintiffs' key piece of evidence is a one-sentence email from Pfizer VP Dr. DeMicco, highlighting the inadequacy of relying solely on such communications for establishing causation.
On September 25, 2009, Dr. DeMicco communicated with Dr. David Waters regarding statistical analyses of diabetes occurrence in the SPARCL study. Dr. Waters noted that the SPARCL data aligns with findings from the TNT study, concluding that atorvastatin increases diabetes risk, with similar risks at 10 mg and 80 mg doses. He highlighted that fasting blood sugar levels and metabolic syndrome features are strong diabetes predictors in both studies. Dr. DeMicco agreed with Waters' assessment, but clarified that their emails demonstrate an association, not causation. He emphasized the distinction between association and causation, noting that while an increase in statistical risk (e.g., a hazard ratio of 1.37) indicates a correlation, it does not establish causal relationships. The plaintiffs misinterpret "increases the risk" as synonymous with "causes," reflecting a common misunderstanding. Statistical analyses can show increased risk but do not objectively prove causation, as the definitions of risk and increased risk pertain solely to probabilities of events occurring, not to direct cause-and-effect relationships.
Establishing an association between Lipitor and diabetes does not confirm that Lipitor caused diabetes in individual plaintiffs. The Reference Manual on Scientific Evidence clarifies that association reflects a statistical relationship, not necessarily causation. An example highlights how herpes was associated with cervical cancer risk but later research identified HPV as the actual cause, illustrating that correlation does not imply causation. Dr. DeMicco's agreement with Dr. Waters on the SPARCL data indicates a higher risk of diabetes with Lipitor use, but this remains an association and does not create a factual dispute regarding causation. Furthermore, a single email from Dr. DeMicco suggesting Lipitor caused diabetes lacks the substantiation required by state law for expert testimony, which is necessary for proving general causation. The court contrasts this weak statement with more definitive language from the Meridia case, which met the threshold for causation. The court emphasizes the need to adhere to state law requirements for expert testimony and declines to accept a single email as sufficient evidence of causation. Additionally, the next pieces of evidence mentioned involve only associations or pertain to blood glucose rather than diabetes itself.
The U.S. Lipitor label notes that increases in HbA1c and fasting serum glucose levels have been reported with statins, including Lipitor, but does not mention diabetes, indicating a distinction between elevated blood glucose levels and diabetes itself. The phrase “have been reported” suggests a temporal association rather than causation, failing to establish a genuine issue of material fact regarding whether Lipitor causes diabetes, particularly at dosages below 80 mg. Plaintiffs' references to NDA data and the Lipitor website also highlight increased blood glucose levels without establishing a causal link to diabetes.
The Japanese label for Lipitor acknowledges that hyperglycemia and diabetes mellitus may occur but does not assert that Lipitor causes diabetes, reflecting a possible association instead. This label change was based on 30 adverse event reports, deemed insufficient to demonstrate association due to the lack of a comparison group. Additionally, the label change was mandated by Japan’s Ministry of Health, Labor, and Welfare (MHLW) without input from Pfizer, who opposed the change. Therefore, this label is not an admission of causation by Pfizer.
The court concludes that even if state courts allowed certain admissions to substitute for expert testimony, the foreign label’s statement does not meet this standard, thus granting summary judgment due to the lack of a genuine issue of material fact regarding general causation. Furthermore, specific causation requires expert testimony, as the complexities of drug effects on the human body and the causation of diseases like diabetes exceed common knowledge.
Expert testimony is essential to establish the effects of the drug Parlodel and its potential link to plaintiffs' injuries, as the scientific complexities involved exceed common understanding. The need for expert input is underscored by cases indicating that personal injury claims concerning pharmaceuticals necessitate specialized knowledge for accurate causation assessments, particularly in complex medical conditions like diabetes. The plaintiffs’ general causation experts have been unable to determine if diabetes was due to Lipitor or other factors, highlighting the inadequacy of layperson judgment in such matters.
While some jurisdictions allow a combination of specific causation expert testimony with non-expert evidence to establish causation, this principle does not apply in the current context. Non-expert evidence must be probative and supportive of a causal connection, which can help infer causation alongside expert opinions. Cases are cited where non-expert testimony, when corroborated by expert suggestions of possible causes, has been deemed sufficient for jury consideration without falling into speculation.
An expert's opinion indicated that a collision was a "possible" cause of a plaintiff's constant menstrual bleeding, which changed to uncontrollable bleeding immediately after the accident and was not a symptom prior to the collision. This evidence was deemed sufficient to survive summary judgment regarding whether the accident caused the bleeding. In similar cases, expert testimonies linking injuries to accidents, absent prior trauma, have also been deemed sufficient. However, in the current case, the plaintiffs failed to produce any expert evidence linking Lipitor to diabetes. Attempting to rely on relative risk estimates from undisclosed experts was unsuccessful, as the court had excluded their testimony. The plaintiffs' assertion that the MDL included patients without a diabetes history before taking Lipitor was countered by the impossibility of establishing causation if diabetes developed before exposure to the drug. Although a temporal relationship between drug exposure and disease onset can suggest causation, mere correlation is not sufficient. The court highlighted that without expert evidence or probative non-expert evidence, causation could not be inferred merely from the timing of events.
A temporal relationship between exposure to a substance and the onset of symptoms can suggest causation, but this is insufficient when substantial risk factors and significant time gaps exist, as seen in the case of Lipitor and diabetes. The court previously determined that the temporal connection presented by the plaintiffs does not meet the reliability standards set forth in Daubert, leading to the conclusion that there is no genuine issue of material fact regarding causation. The Hayes Law Firm plaintiffs asserted they were not diabetic before taking Lipitor and were diagnosed afterward; however, this sequence does not establish causation, resulting in summary judgment granted in their favor. The Douglas and London plaintiffs failed to provide relevant evidence to contest summary judgment, merely submitting extensive but mostly irrelevant documentation. As a result, summary judgment was also granted for these plaintiffs. The court concluded that there is no need to suggest remand in this matter.
The PSC and certain Plaintiffs assert that the Court has exceeded its authority as an MDL court by engaging in specific causation analysis, referencing previous MDL cases that avoided such intricate, case-specific legal issues. They argue that MDL courts possess the discretion to suggest remand instead of resolving these complex matters. While MDL transferee judges are not required to complete all pretrial proceedings, they do have the authority to rule on motions for summary judgment and dispose of cases on the merits. Historical cases have affirmed that MDL courts can enter dispositive orders, including summary judgments, even on state law doctrines. The Supreme Court has acknowledged that Congress intended for some actions to be resolved during pretrial proceedings, which should be remanded unless previously terminated. The Lexecon ruling clarified that while MDL courts can conduct pretrial proceedings, including dispositive motions, they must ultimately remand cases when pretrial proceedings conclude. The Court's decision to rule on motions prior to remand aligns with Section 1407’s objectives of reducing duplication, avoiding conflicting rulings, and promoting efficient litigation. Addressing common issues, such as the need for expert testimony on specific causation, through an omnibus summary judgment motion is seen as consistent with the coordinated pretrial proceedings envisioned by Section 1407.
The MDL court is positioned to rule on summary judgment motions that address issues common to all cases within its jurisdiction, as it can handle the scientific and legal complexities more efficiently than multiple courts. Remand is generally considered only if further coordinated proceedings in the MDL are deemed beneficial. In this instance, since no plaintiff can present a viable expert on specific causation that meets Daubert standards, remanding the cases would be inefficient and contrary to the statute's purpose. The court declines to disregard the ongoing MDL process and dismisses plaintiffs' claims listed in Appendix 1 with prejudice, partially granting the Defendant's Omnibus Motion for Summary Judgment. The order specifically pertains to plaintiffs who ingested less than 80 mg of Lipitor and notes that claims involving other dosages are addressed in a separate case management order.
Plaintiffs diagnosed with diabetes prior to using Lipitor cannot attribute their condition to the drug, leading the Court to grant summary judgment. The Court emphasized that Plaintiffs failed to clarify a timeline for gathering evidence related to causation. In prior cases, it has been established that expert testimony is necessary to prove causation in medical matters outside the common knowledge of jurors, with several case references supporting this requirement under various state laws. The Court noted that if Plaintiffs assert that federal rules supersede state law concerning evidence for summary judgment, then expert testimony would still be necessary. The ruling points out that expert testimony must establish both general causation (the drug's potential to cause harm) and specific causation (the drug's role in the plaintiff's particular injury). Although Plaintiffs cited a New Mexico case to support their position, the Court found it inapplicable to their situation.
Abscesses at the injection site of the deceased animals developed to the extent that the legs "rotted off." An expert pathologist attributed the abscesses to bacteria but did not confirm that the vaccine itself was contaminated. A veterinarian testified that if the vaccine had been bacteria-infected, abscesses could develop within two weeks, ruling out other potential causes like malignant edema or blackleg, and suggesting that the purchased lambs were healthy prior to injection. The court concluded that it was reasonable for a jury to find that the vaccines were contaminated and caused the lambs' deaths. In the case of Meridia, the court assumed, for argument's sake, that no state laws require expert testimony for general causation, indicating that such state laws would also dictate the admissibility of alleged admissions as substitutes for expert testimony. The court contrasted this with Westberry v. Gislaved Gummi AB, where the admissibility of expert testimony was evaluated, emphasizing that a Material Safety Data Sheet (MSDS) alone does not fulfill the requirement for expert testimony needed to overcome summary judgment. Lastly, in Lewis v. Johnson & Johnson, the Fourth Circuit held that expert testimony is essential for establishing causation in complex medical issues, noting that the plaintiff failed to provide such testimony to support her claims. The plaintiffs misinterpreted a statement from Lewis, believing it indicated that admissions from the defendant's employees could serve as proof of general causation.
Lewis noted that the plaintiff did not raise a specific issue, thereby not requiring further consideration. The SPARCL clinical trial evaluated the efficacy of Lipitor in reducing stroke incidence among patients with a history of stroke or TIA, with participants assigned to either 80 mg of Lipitor or a placebo. Although diabetes was not a primary endpoint, adverse event data was collected, leading Pfizer to conduct a post hoc analysis, which revealed a significant increase in diabetes risk among those taking Lipitor compared to the placebo group.
The analysis considered several factors for establishing causation, including strength and specificity of the association, temporal relationships, dose-response relationships, biological plausibility, and consistency with existing knowledge. The Court later clarified that Dr. Murphy's opinion linked Lipitor to an increased diabetes risk and that Ms. Hempstead's diabetes developed post-Lipitor use; however, this only addressed general causation, not specific causation. The Court emphasized that viewing the evidence favorably for the plaintiff does not equate association with causation.
Judicial precedent stipulates that a plaintiff must demonstrate both general causation (the substance increases injury risk) and specific causation (the substance caused the individual's injury). Establishing an association is merely the first step in demonstrating general causation, and it is recognized that association alone does not suffice to prove causation. The parties concurred that establishing association is only the initial phase of a two-step process for general causation. Moreover, the plaintiffs acknowledged that the language in the U.S. label might not robustly support their case, and the interpretation of the data remains contested.
The Court presumes, for this motion, that the NDA data shows a link between Lipitor use and elevated blood glucose levels. It argues that if pharmaceutical liability cases could proceed without expert testimony on causation, it would undermine the judicial process. Plaintiffs fail to cite any precedent allowing similar cases to survive summary judgment. They reference Pennsylvania, where expert evidence of “increased risk of harm” can support a jury trial in medical malpractice, as established in Hamil v. Bashline. However, this ruling is limited to cases involving medical services to prevent injury, as outlined in Section 323 of the Restatement of Torts. Pennsylvania courts have never applied this section to negligence-based products liability cases, which do not involve direct service to individuals. The Court agrees not to extend Hamil to products liability claims. Additionally, each plaintiff has presented multiple risk factors for diabetes, with discrepancies between their claims and medical records. The Court retains discretion in these matters, noting that some MDL courts address specific causation issues in summary judgment motions before considering remand.
