Butkiewicz v. Bayer Corp. (In re Fluoroquinolone Prods. Liab. Litig.)
| Decision Date | 04 February 2021 |
| Docket Number | Master Docket Case No. 0:15-md-02642,MDL No. 2642 (JRT),Case No. 0:19-cv-01602-JRT. |
| Court | U.S. District Court — District of Minnesota |
| Parties | IN RE: FLUOROQUINOLONE PRODUCTS LIABILITY LITIGATION This Document Relates to: David Butkiewicz v. Bayer Corp., Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma A.G., and Bayer, A.G. |
Patrick Francis Bradley, CLIFFORD LAW OFFICES, 120 North LaSalle Street, Suite 3100, Chicago, IL 60602, for plaintiff.
Andrew Keith Solow, ARNOLD AND PORTER KAY SCHOLER LLP, 250 West 55th Street, New York, NY 10019, for defendants.
Defendants, manufacturers of the brand-name drug Cipro
, filed a Motion to Dismiss, asserting that each of Plaintiff David Butkiewicz's claims alleged only injuries related to his use of ciprofloxacin, the generic equivalent of Cipro, which Defendants did not manufacture, market, or distribute.
Butkiewicz, a resident of Illinois, contends that he and his prescribing physician relied on the ciprofloxacin
label created by Defendants, as required by federal law, which failed to adequately warn of the risk of peripheral neuropathy as a side effect of the drug. Therefore, Butkiewicz argues that Defendants breached their duty to him under Illinois common law, and that he was injured by their negligent and fraudulent labeling. Defendants disagree and urge the Court to reject Butkiewicz's theory of liability. Defendants posit that, although the Illinois Supreme Court has not addressed whether brand-name manufacturers may be liable for injuries caused by their warning labels when the label is affixed to a generic version of the drug, it would likely find that such claims are not viable.
Defendants are correct that Butkiewicz's strict liability and product liability – failure to warn claims fail as a matter of law because Defendants did not manufacture or distribute ciprofloxacin, and Butkiewicz's warranty claims fail because the parties were not in privity. Yet Butkiewicz may assert that Defendants are liable for his reliance-related injuries under theories of negligence, misrepresentation, and fraud with respect to their ciprofloxacin warning label. Under Illinois law, claims related to injuries caused by information about a product are distinct from product liability claims, and Defendants have a duty to all consumers who foreseeably rely on their warning label, irrespective of whether the consumer uses the brand name or generic form of the drug.
Accordingly, the Court will grant Defendants’ Motion to Dismiss as it relates to Butkiewicz's strict liability, product liability – failure to warn, and breach of express and implied warranty claims, but will deny Defendants’ Motion as it relates to Butkiewicz's remaining claims because they are cognizable and plausibly alleged.
Plaintiff David Butkiewicz was prescribed ciprofloxacin
, a fluoroquinolone antibiotic, and used it as directed, (Compl. ("Individual Complaint") ¶¶ 30, 34, June 4 2019, Docket No. 1), from February to June 2013, .1 Butkiewicz developed irreversible peripheral neuropathy. (Individual Compl. ¶ 3.) Due to misrepresentations by Bayer Corporation, Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, and Bayer AG (collectively, "Defendants") in the ciprofloxacin warning label, Butkiewicz and his physicians did not recognize that he was suffering from permanent peripheral neuropathy caused by ciprofloxacin. (Id. ¶¶ 61–62.)
Butkiewicz alleges that Defendants failed to appropriately and adequately inform consumers and their physicians of the serious and dangerous risks of irreversible peripheral neuropathy
associated with the use of Cipro and ciprofloxacin. . The ciprofloxacin label used from September 2004 to August 2013 indicated that only "rare" cases of peripheral neuropathy
had been reported in patients receiving quinolones, and the label did not explicitly include ciprofloxacin as among the drugs posing a risk of peripheral neuropathy. (MDL Master Compl. ¶ 89.) Because of the inadequate label, patients received fluoroquinolones, such as ciprofloxacin, instead of acceptable and adequate non-fluoroquinolone antibiotics. (Id. ¶¶ 96–97.)
On August 15, 2013, an updated warning label and accompanying safety information was issued for ciprofloxacin
, which included a warning about the risk of rapid onset, irreversible peripheral neuropathy. (Id. ¶ 90.)
However, Defendants knew peripheral neuropathy
and related symptoms were among the most common side effects of fluoroquinolones, including ciprofloxacin, for more than a decade prior to the August 2013 label change. (Id. ¶¶ 120, 123, 139.) Despite this knowledge, Butkiewicz alleges, Defendants recklessly and intentionally misled patients and physicians from September 2004 through August 2013, (id. ¶¶ 152, 156), by aggressively marketing fluoroquinolones and concealing the risks through misrepresentations and omissions, (id. ¶¶ 126–27.)
Defendants, through paid medical consultants, allegedly "fraudulently and intentionally polluted the scientific literature related to the safety and efficacy" of ciprofloxacin
. (Id. ¶ 231 ().) For example, a consultant named Peter Ball stated that, "Ciprofloxacin is well tolerated; the incidence of adverse events is low and serious adverse events are rare." (Id. ) In 2001, Defendants, through Glenn Tillotson, a Bayer director and co-developer of Cipro, also allegedly sought to downplay the significance of the first major study finding peripheral neuropathy to be a permanent side effect of Cipro. (Id. ¶ 232.)
Butkiewicz asserts that Defendants intended consumers and physicians to rely on the misinformation in the ciprofloxacin warning label, (id. ¶ 164), and that he and his physician did so rely, (Individual Compl. ¶¶ 61–62.) Butkiewicz therefore alleges that his injuries were the direct and proximate result of Defendants’ negligence, misrepresentations, and fraud in creating the ciprofloxacin warning label. (See, e.g. , MDL Master Compl. ¶¶ 212, 246, 254, 263.)
Butkiewicz filed a Complaint against Defendants in the Northern District of Illinois on June 4, 2019. (Individual Compl.) On June 18, 2019, Butkiewicz's case was transferred to the District of Minnesota for pretrial proceedings as part of Multidistrict Litigation ("MDL") No. 2642. (Conditional Transfer Order, June 18, 2019, Docket No. 4.) Butkiewicz completed the individual MDL Short Form Complaint on April 13, 2020. (Am. Compl., Apr. 13, 2020, Docket No. 26.)
On April 27, 2020, Butkiewicz filed an Amended MDL Short Form Complaint, clarifying that he used generic ciprofloxacin. (Am. MDL Short Form Compl. ¶¶ 8–9.) Butkiewicz identified Illinois law as supporting his generics-related claims against the brand-name manufacturers.2 (Id. ¶ 9.) Butkiewicz asserts claims for Strict Liability, Product Liability – Failure to Warn, Negligence, Breach of Express Warranty, Breach of Implied Warranty, Fraud, Negligent Misrepresentation, Fraudulent Concealment, and Violation of Consumer Protection/Consumer Fraud Law. (Id. ¶ 17.)
On August 14, 2020, Defendants filed a Motion to Dismiss Butkiewicz's Amended MDL Short Form Complaint pursuant to Rule 12(b)(6), arguing Butkiewicz failed to state a claim against Defendants under Illinois law. (Mot. Dismiss, Aug. 14, 2020, Docket No. 34.)
In reviewing a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), the Court considers all facts alleged in the complaint as true to determine if the complaint states a "claim to relief that is plausible on its face." Braden v. Wal-Mart Stores, Inc. , 588 F.3d 585, 594 (8th Cir. 2009) (quoting Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal , 556 U.S. at 678, 129 S.Ct. 1937. Although the Court accepts the complaint's factual allegations as true and construes the complaint in a light most favorable to the plaintiff, it is "not bound to accept as true a legal conclusion couched as a factual allegation." Papasan v. Allain , 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986). In other words, a complaint "does not need detailed factual allegations," but it must include more "than labels and conclusions, and a formulaic recitation of a cause of action's elements" to meet the plausibility standard. Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007).
The obligations and limitations of brand-name and generic drug manufacturers are set by federal law. Most important here, the Hatch-Waxman Amendments streamlined the approval process for generic equivalents of brand-name drugs that had already been approved by the FDA. See PLIVA, Inc. v. Mensing , 564 U.S. 604, 612–13, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) (citing 21 U.S.C. § 355 ). The simplified generics approval process requires the generic drug's design and warning label to be identical to the brand-name version at the time of approval. Id. at 613, 131 S.Ct. 2567.
In Mensing , the Supreme Court addressed whether generic manufacturers may change their labels after initial FDA approval. Id. The Supreme Court held that, unlike brand-name drugs, generic drug manufacturers cannot unilaterally change their warning labels after initial approval, since federal law requires that generic drug labels be the same as the corresponding brand-name drug label at all times. Id. at 618, ...
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