Butkiewicz v. Bayer Corporation
- John Tunheim
- 0:19-cv-01602
- U.S. District Court · District of Minnesota
- 30
In Butkiewicz v. Bayer, Judge Tunheim granted in part and denied in part Bayer’s dismissal motion, dismissing four claims with prejudice while allowing the others to proceed.
David Butkiewicz’s claims against Bayer Corporation, Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma A.G., and Bayer A.G. Four claims were dismissed with prejudice, while his negligence, negligent-misrepresentation, fraud, fraudulent-concealment, and Illinois consumer-protection claims remained.
What happened
In Butkiewicz v. Bayer, David Butkiewicz alleged that he developed irreversible peripheral neuropathy after taking generic ciprofloxacin. He claimed Bayer’s warning label failed to adequately disclose that risk, and that he and his prescribing physician relied on the label.
The court ruled that Butkiewicz could not pursue strict-liability, product-liability failure-to-warn, or express- and implied-warranty claims against the brand-name manufacturers because they did not manufacture or distribute the generic drug and were not in a contractual relationship with him. But the court allowed his negligence, negligent-misrepresentation, fraud, fraudulent-concealment, and Illinois consumer-protection claims to proceed because they concerned reliance on Bayer’s warning label.
Judge Tunheim granted in part and denied in part the defendants’ motion to dismiss. He dismissed Counts I, II, IV, and V with prejudice and denied the motion as to all other counts.
The detailed version
- Butkiewicz v. Bayer Corporation · No. 0:19-cv-01602
- John Tunheim
- Feb. 4, 2021
Background
David Butkiewicz alleged that he used generic ciprofloxacin from February through June 2013 and developed irreversible peripheral neuropathy. He alleged that Bayer Corporation, Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma A.G., and Bayer A.G. created the warning label used for both brand-name Cipro and generic ciprofloxacin. According to the allegations, the label did not adequately warn about the risk of rapid-onset, irreversible peripheral neuropathy. Butkiewicz claimed that he and his prescribing physician relied on the label and therefore did not recognize his symptoms as a drug side effect.
Butkiewicz asserted claims for strict liability, product-liability failure to warn, negligence, express warranty, implied warranty, fraud, negligent misrepresentation, fraudulent concealment, and violation of the Illinois Consumer Fraud and Deceptive Business Practices Act. The defendants moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint states a legally sufficient claim for relief.
Court’s Analysis
The court explained that federal law requires generic-drug labels to match the corresponding brand-name label, while brand-name manufacturers may revise their labels. The court concluded that federal law did not preempt Butkiewicz’s claims against the brand-name manufacturers.
The court predicted that Illinois law would treat claims based on faulty product information as distinct from claims based on the condition of the product itself. It held that Butkiewicz’s negligence, negligent-misrepresentation, fraud, fraudulent-concealment, and consumer-protection claims were based on Bayer’s conduct in creating and disseminating the warning label, not simply on Bayer’s manufacture or distribution of the drug. The court further held that Bayer owed a limited duty to generic consumers who foreseeably relied on its warning label. That duty extended only to injuries caused by deficiencies in the label.
The court rejected the defendants’ argument that an Illinois decision concerning unidentified drug manufacturers barred the claims. The court found that Butkiewicz identified the entities allegedly responsible for the warning-label conduct, so the case did not involve uncertainty about which manufacturer caused the injury.
Individual Claims
The court held that the strict-liability claim failed because strict liability applies to entities in the product’s distribution chain, and the defendants did not manufacture or distribute the generic ciprofloxacin.
The product-liability failure-to-warn claim also failed. The court treated that claim as a negligent product-liability claim requiring an analysis of the condition of the product. Because the defendants were outside the distribution chain for generic ciprofloxacin, the claim could not proceed.
The express-warranty and implied-warranty claims failed because Illinois law generally requires a contractual relationship, or privity, between the parties. The court found no such relationship between Butkiewicz and the defendants, and found that the defendants did not sell the ciprofloxacin to him.
The court found the negligence and negligent-misrepresentation claims plausibly alleged. It accepted, at this stage, the allegations that the defendants knew about the risk, failed to disclose it adequately, and caused injury through Butkiewicz’s reliance on the warning label.
The court also found that the fraud and fraudulent-concealment claims were adequately pleaded. It concluded that the complaint provided sufficiently specific allegations about the alleged false statements, their timing and contents, the people involved, and the defendants’ knowledge of the risks. Finally, the court found that the allegations plausibly stated a claim under the Illinois Consumer Fraud and Deceptive Business Practices Act.
Disposition
The order granted the defendants’ motion to dismiss as to Counts I, II, IV, and V, and those counts were dismissed with prejudice. The order denied the motion as to all other counts. The remaining counts were negligence, negligent misrepresentation, fraud, fraudulent concealment, and violation of Illinois consumer-protection law.
Read the full 30-page opinion on CourtListener, the free public archive maintained by the Free Law Project.