323 F. Supp. 3d 837
United States District Court2018Background
- Plaintiff Knight sued Boehringer Ingelheim (BI) alleging Pradaxa's warnings were inadequate and caused a fatal bleed; most summary-judgment issues were resolved May 31, 2018, leaving five in limine/Daubert/spoliation motions.
- Remaining motions addressed: (1) BI's omnibus Daubert motion to exclude plaintiffs' general experts; (2) BI's motion to exclude financial-metrics evidence; (3) plaintiffs' omnibus in limine (good acts, "FDA label," FDA determinations); (4) BI's motion to exclude spoliation-related evidence; (5) plaintiffs' motion for spoliation adverse-inference jury instruction.
- Plaintiffs rely on multiple experts (Baruch, Plunkett, Chertow, Gosselin) for opinions on monitoring, labeling, pharmacokinetics, and testing; plaintiffs also have case-specific experts and treating-physician testimony tying warnings to injury.
- BI argues experts are unreliable or irrelevant, financial evidence is prejudicial and irrelevant, FDA statements are binding/clearing, and prior MDL discovery problems should be excluded; plaintiffs seek sanction (adverse inference) based on lost ESI in the MDL (Dr. Lehr files and lost emails).
- The Court applied Daubert / Rule 702 and amended Rule 37(e) standards and held evidentiary hearings before ruling.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of experts' monitoring opinions | Experts may opine that BI should have recommended monitoring/therapeutic ranges; combined expert testimony plus case-specific evidence shows relevance | Monitoring opinions are irrelevant to Knight and unreliable (no single therapeutic range, unpublished, ipse dixit) | Admissible: court denied exclusion of monitoring opinions; experts may testify. Experts need not each connect every factual link; reliability and sources (BI trials, peer-reviewed literature) suffice. |
| Labeling opinions (experts) | Baruch, Chertow, Gosselin may opine that label failed to warn clinicians/patients and identify/testing info | BI contends experts lack regulatory/labeling qualifications and unreliable methodology | Admissible: court permits labeling opinions (but not regulatory-law opinions). Non-regulatory expert critiques of label content are allowed. |
| Experts' use of BI internal documents / testimony about BI intent | Plaintiffs argue experts may interpret BI documents to explain what BI knew and communicated | BI argues experts cannot opine on motive/intent and cherry-pick documents | Partially granted: experts may interpret internal documents for technical/knowledge issues, but may not testify as to BI's intent or motive; cherry-picking goes to weight, not admissibility. |
| Financial-metrics evidence | Plaintiffs: BI's internal documents show financial motives; financials relevant to motive and punitive damages | BI: company finances/sales/profits are irrelevant and unfairly prejudicial | Denied as to all Pradaxa-related economic evidence: BI financial information tied to Pradaxa development/sales is admissible; general corporate profitability requires leave and may be bifurcated for punitive phase. |
| Plaintiffs' omnibus in limine (good acts; "FDA label"; FDA determinations) | Exclude evidence of BI's unrelated good reputation; prevent calling label the "FDA label"; prevent BI from saying FDA determined monitoring/dose adjustment unnecessary | BI wants to describe regulatory approval history and reference FDA communications | Mixed: bar unrelated "good company" evidence and bar BI from asserting the FDA made a binding determination that monitoring/dose-adjustment was unnecessary; use of term "FDA label" not precluded generically—trial objections permitted. |
| Spoliation / Sanctions (Dr. Lehr files, lost emails) | Plaintiffs seek adverse inference for ESI loss in MDL and other sanctions, claiming prejudice from lost custodial files/emails | BI argues losses were inadvertent/transitional and MDL issues are not grounds for adverse inference here; exclusion of prior discovery rulings should be ordered | Sanctions denied: court found no sufficient showing of prejudice or intent to deprive under amended Rule 37(e); excluded prior MDL discovery findings/sanctions from trial as more prejudicial than probative. |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (expert testimony must be reliable and helpful to the trier of fact)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (district courts have broad latitude in assessing expert reliability)
- Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997) (court may exclude expert opinion if there is too great an analytical gap from data to opinion)
- Silvestri v. General Motors Corp., 271 F.3d 583 (4th Cir. 2001) (spoliation and courts' sanctioning authority to protect judicial integrity)
- Wyeth v. Levine, 555 U.S. 555 (2009) (manufacturer bears responsibility for label content despite FDA approval)
- Nease v. Ford Motor Co., 848 F.3d 219 (4th Cir. 2017) (factors for evaluating expert reliability and use of tested theories)
- PBM Prods., LLC v. Mead Johnson & Co., 639 F.3d 111 (4th Cir. 2011) (expert testimony can be powerful but misleading; gatekeeping role essential)