950 F.3d 423
7th Cir.2020Background
- Antrim (ANDA holder for escitalopram) contracted with Bio‑Pharm to manufacture the generic drug; no signed written contract replaced an earlier, expired term sheet.
- Bio‑Pharm manufactured escitalopram but did not deliver it to Antrim; parties dispute whether they had an oral contract or whether Bio‑Pharm relied on promises of equity (promissory estoppel).
- Antrim sued for breach of contract; Bio‑Pharm counterclaimed for promissory estoppel (or breach in the alternative) and later sought lost‑profits relief as an alternative remedy.
- Pretrial: Antrim moved to exclude expert Schwartz (former FDA lawyer) on FDA practices; Bio‑Pharm moved to exclude portions of Antrim expert Brynjelsen on industry practice and lost‑enterprise value; the court issued mixed rulings.
- Trial: court used a general verdict form; jury found for Bio‑Pharm on Antrim’s breach claim and for Antrim on Bio‑Pharm’s counterclaim; no damages awarded to either party. Antrim appealed several evidentiary and instruction rulings.
Issues
| Issue | Antrim's Argument | Bio‑Pharm's Argument | Held |
|---|---|---|---|
| Jury instruction (ANDA ownership) | Court should have instructed jury that FDA treats ANDA holder as owner of the product | ANDA ownership is irrelevant to ownership of manufactured product | Rejected Antrim; ANDA ownership does not determine product ownership; instruction would have been misleading |
| Admissibility of Schwartz (FDA practices) | Exclude Schwartz because his testimony on ANDA ownership is legally wrong and invades the court’s role | Adduce Schwartz to explain regulatory framework and FDA inferences | Affirmed admission; expert could explain complex regulatory framework and that ANDA ownership does not resolve product ownership |
| Preclusion of Brynjelsen on industry practices | Brynjelsen would show industry norms that contract manufacturers do not own product, supporting Antrim’s position | His general industry testimony lacked specific knowledge of the parties’ agreement | Affirmed exclusion; testimony was irrelevant without specific knowledge of the parties’ deal |
| Exclusion of Brynjelsen’s lost enterprise‑value damages | Damages based on lost enterprise value are recoverable; expert should be allowed to quantify | Expert’s multiplier and assumptions were speculative and lacked foundation | Affirmed exclusion; Illinois law bars speculative damages and expert’s valuation rested on conjecture |
| Allowing Bio‑Pharm to seek lost profits (late Rule 26 disclosure) | Late disclosure should bar lost‑profits remedy | Disclosure violation was harmless; Antrim knew of counterclaim and would not have acted differently | Affirmed; district court found harmless violation and no reversible error (also Antrim cannot appeal Rule 37 ruling after prevailing on counterclaim) |
Key Cases Cited
- Jimenez v. City of Chicago, 732 F.3d 710 (7th Cir. 2013) (instructional error standard and prejudice requirement)
- United States v. Beavers, 756 F.3d 1044 (7th Cir. 2014) (legal accuracy review of jury instructions)
- United States v. Caputo, 517 F.3d 935 (7th Cir. 2008) (experts may not testify on pure questions of law)
- Bammerlin v. Navistar Int'l Transp. Corp., 30 F.3d 898 (7th Cir. 1994) (district court decides legal meaning of statutes/regulations)
- Platinum Tech., Inc. v. Fed. Ins. Co., 282 F.3d 927 (7th Cir. 2002) (Illinois law bars speculative damages; need reasonable certainty)
- Freeman v. Chicago Park Dist., 189 F.3d 613 (7th Cir. 1999) (effect of general verdicts on appellate review)
- Unitherm Food Sys., Inc. v. Swift‑Eckrich, Inc., 546 U.S. 394 (2006) (Rule 50(b) preserves sufficiency challenges)