Subject: Summary Judgement

Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

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Zofran (ondansetron) has often been used to combat nausea during pregnancy.  It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks – for example, a recent systematic review and meta-analysis concluded that use of ondansetron during pregnancy was associated with a reduced incidence of miscarriage but “was not associated with abnormal pregnancy outcomes,” including a variety of birth defects.  Nevertheless, plaintiffs have alleged that Zofran causes birth defects and that the warnings accompanying the drug should have said so.  Those claims were dismissed in 2021 when the district court held them preempted, and the First Circuit recently affirmed that decision in In re Zofran (Ondansetron) Products Liability Litigation, — F.4th —, 2023 WL 128570 (1st Cir. Jan. 9, 2023).

Plaintiffs in the Zofran MDL alleged, among other things, that the defendants failed to warn of birth defects observed in certain animal studies.  Because such claims implicate the warnings accompanying an FDA-approved drug, they are preempted unless the manufacturer could have unilaterally amended the label through the Changes Being Effected (CBE) regulation.  The CBE regulation permits a manufacturer to amend a product’s labeling without prior FDA approval “to reflect newly acquired information” and thereby “add or strengthen” the warnings where there is “evidence of a causal association” between the drug and the subject on which the warnings are being amended.

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Expert’s Failure to Identify Product Defect in Pressure Cooker or Inadequacy in Warnings Leads to Summary Judgment

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It is axiomatic that a plaintiff must offer evidentiary support for each element of her claim in order to survive summary judgment. And a ubiquitous feature of product liability actions is the use of expert witnesses by both sides. These principles are, of course, related – the plaintiff usually must offer expert testimony in order to make a prima facie case, and the defense then attacks that prima facie case through expert testimony. But sometimes a plaintiff loses sight of the connection and, despite retaining an expert, fails to elicit the opinions she needs to make her case. As a recent decision from the Western District of Wisconsin illustrates, it pays for a defendant to carefully evaluate whether a plaintiff has checked all of the necessary boxes.

In Moore v. National Presto Industries, Inc., 2022 WL 1555875 (W.D. Wis. May 17, 2022), Plaintiff alleged that she was injured when she opened her pressure cooker while it was still pressurized, ejecting its contents onto her arm, causing burns. Plaintiff sued the cooker’s manufacturer, asserting strict liability claims for design defect and failure to warn as well as a claim for negligence. Defendant moved for summary judgment on each of these claims.

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It’s not what happened, but why: First Circuit rejects conclusory, unsupported expert opinions

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It is not uncommon for an opposing expert to opine that the existence of injury alone implies negligence, nor is it unusual to find that such opinions are supported only by general reliance on “literature” with no discernible connection to the issue at hand. Certainly, Federal Rule of Civil Procedure 26(a)(2)(B) requires an expert’s report to contain “a complete statement of all opinions the witness will express and the basis and reasons for them.” And, Federal Rule of Evidence 702 requires that an expert not only base an opinion on sufficient facts or data but also reliably apply his or her methodology to those facts or data. Yet all too often, courts decline to hold an expert to task and instead find that these deficiencies go to the weight, but not the admissibility, of an expert’s opinion. But, as recently observed by the First Circuit, an expert must do more than merely cite the existence of an injury if a res ipsa loquitur argument is not available. And regardless, an expert’s failure to link the literature cited to the opinions offered is not a matter of insufficiency, but rather of unreliability.

In López-Ramírez v. Toledo-González, — F.4th —, 2022 WL 1261299 (1st Cir. 2022), Plaintiff experienced hearing loss, facial paralysis and loss of balance following a neurosurgical procedure performed by the defendant neurosurgeon. Plaintiff sued the physician and the hospital, alleging that the defendant neurosurgeon’s failure to properly evaluate, treat and monitor her condition during the surgery amounted to medical malpractice. In support of that claim, Plaintiff disclosed a neurology expert who opined that the defendant neurosurgeon deviated from the standard of care and included with his report articles from the medical literature that he felt “may be helpful” in understanding his opinions.

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Plaintiff Shoots an Airball Against Nike in Design Defect Case

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In the wake of March Madness, it is only appropriate to call attention to an opinion laced with pithy basketball puns. In Nachimovsky v. Nike, Inc. et al., 2022 WL 943421 (E.D.N.Y. Mar. 29, 2022), Plaintiff injured his knee during a recreational basketball game. Blaming this injury on his new sneakers, he called foul and brought claims for negligence and products liability—specifically design defect—against Nike, which designed and manufactured the sneakers, and Shoe Fitters, which sold the sneakers.

To support his claims, Plaintiff proffered two one-page letters from a podiatrist who concluded that the sneakers were defective and a “major contributing factor” to Plaintiff’s injury. Nike (and Shoe Fitters, by incorporation) responded with a full-court press, seeking to exclude the podiatrist’s opinions under Federal Rule of Evidence 702, arguing that they were not reliable and he was not qualified to offer them.

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The Culpable Co-Defendant Problem: How to Preserve Your Client’s Defenses After a Culpable Co-Defendant Files a Motion for Summary Judgment in California State Court

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Defense attorneys involved in California multi-defendant product liability lawsuits are familiar with the challenge of properly balancing the need to preserve their clients’ defenses with the strategic importance of maintaining cooperation among co-defendants.  In many cases, co-defendants’ interests are aligned, and they find the strategic benefits of cooperation outweigh any benefits of finger-pointing amongst one another.  Indeed, co-defendant infighting is risky on several fronts—it can help the plaintiffs, increase defense costs, create animosity among possible business partners, and chill future cooperation with defendants who regularly blame their co-defendants.  Inevitably, however, cases arise that involve a culpable co-defendant and a client wants to preserve its ability to attribute fault to the co-defendant at trial.  This issue becomes complex and the specific language of California Code of Civil Procedure Section 437c(l) comes into play when the co-defendant seeks no-fault summary judgment.

Section 437c(l) operates to limit the extent to which defendants can attribute legal fault at trial to defendants who were dismissed through no-fault summary judgment.  Specifically, Section 437c(l) provides that “if a motion for summary judgment is granted on the basis that the defendant was without fault, no other defendant during trial, over plaintiff’s objection, may attempt to attribute fault to, or comment on, the absence or involvement of the defendant who was granted the motion.”  Cal. Civ. Proc. Code § 437c(l).  In other words, remaining defendants cannot assert the empty chair defense to attribute legal fault to co-defendants who obtained summary judgment.

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Treating Physician’s Informed Consent Process and Decision-Making in Device Selection Lead to Partial Summary Judgment for Device Manufacturer

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A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively prune a plaintiff’s ambitious product defect claims. Conn v. C.R. Bard, Inc., No. 4:14-CV-298.

In 2006, plaintiff’s physicians discovered a blood clot in his inferior vena cava. An IVC filter was inserted to prevent the blood clot from causing potentially fatal further injury. Because of plaintiff’s young age, the physician chose a removable filter. Plaintiff reported abdominal pain just four days after the IVC filter was placed. The blood clot was found to have moved and extended through and above the recently placed filter, and the physicians initiated anticoagulant therapy.

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