Category: Design Defect

Software Liability: Why a Michigan Federal Court Decision is Relevant to Product Manufacturers Nationwide

Share

Numerous products in our day-to-day lives incorporate or consist of software. The legal system, however, has been hesitant (at best) to bring software within traditional product liability regimes. Courts have grappled with whether to consider software a product and have largely found that it is not. However, a recent decision in the Western District of Michigan holds that software is a product—Holbrook v. Prodomax Automation Ltd., No. 1:17-cv-219, 2021 U.S. Dist. LEXIS 178325 (W.D. Mich. Sept. 20, 2021). While Holbrook may be an outlier, it is significant. It bucks the trend, and potential defendants should be aware of it.

Background: Holbrook involved a wrongful death suit arising out of an accident on a robotic assembly line. The decedent’s estate (Plaintiff) brought a common-law negligence claim against multiple defendants, including the manufacturer who designed, built, and installed the assembly line. Plaintiff’s claim was based, among other things, on the software controlling the robots.

Continue reading “Software Liability: Why a Michigan Federal Court Decision is Relevant to Product Manufacturers Nationwide”

Northern District of Illinois Excludes Engineering Expert’s Testimony and Grants Partial Summary Judgment, Fulfilling its Responsibility as Gatekeeper

Share

For over two decades, dating back to Daubert and the ensuing amendments to Rule 702, federal district courts have been charged to act “as gatekeepers to exclude unreliable expert testimony.” Fed. R. Evid. 702 advisory committee’s note to 2000 amendments. However, some courts have not embraced that role, letting jurors weigh questions about an expert’s qualifications or methodology as though they go to credibility rather than admissibility. Indeed, the Advisory Committee on Evidence Rules proposed an amendment to Rule 702 to address the “pervasive problem” of courts holding that issues of admissibility are questions “of weight for the jury.” See, Sardis v. Overhead Door Corp., 10 F.4th 268, 282-84 (4th Cir. 2021). (quoting Advisory Comm. on Evidence Rules, Agenda for Committee Meeting (Apr. 30, 2021)).

A recent decision out of the Northern District of Illinois, however, provides an excellent example of a court discharging its duty to preclude inadmissible expert opinions. The Plaintiff in Pessman v. Trek Bicycle Corporation, 2021 WL 5769530 (N.D. Ill. Dec. 6, 2021) was injured in a bicycle accident. Plaintiff’s engineering expert opined that the cause of the accident was a crack in the carbon fiber frame of Plaintiff’s Trek bicycle attributable to a design defect. The engineer claimed that carbon fiber frames are prone to cracking and that the crack was mistaken for simple paint chipping by a dealer who had inspected the bicycle several days before the accident, allegedly due to Trek’s failure to train the dealer properly.

Continue reading “Northern District of Illinois Excludes Engineering Expert’s Testimony and Grants Partial Summary Judgment, Fulfilling its Responsibility as Gatekeeper”

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

Share

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.

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

Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review

Share

A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.

On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer.  Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”).   Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.

Continue reading “Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review”

Preemption Torpedoes State Law Claims against Generics Makers in Zantac MDL

Share

A judge in the United States District Court for the Southern District of Florida presiding over the In Re: Zantac (Ranitidine) Products Liability Litigation multidistrict litigation, MDL No. 2924, has held that state labeling and design defect claims against the makers, re-packagers, retailers, and distributors of generic forms for the popular heartburn medication Zantac were preempted by federal law.  The court subsequently dismissed these claims against 32 such Zantac generics makers and distributors.

The Zantac MDL was created by the United States Judicial Panel on Multidistrict Litigation on February 6, 2020.  The plaintiffs allege that ranitidine, the active ingredient in Zantac and its generic forms, breaks down into N-nitrosodimethylamine (“NDMA”), which is part of a group of compounds that have been shown to increase the risk of cancer. The plaintiffs allege a variety of product liability and related claims against the makers and distributors of Zantac and its generic forms under federal and state laws.

Continue reading “Preemption Torpedoes State Law Claims against Generics Makers in Zantac MDL”

Florida Appellate Court Authorizes the Use of the Risk-Utility Test in Complex Medical Device Cases

Share

On October 7, 2020, Florida’s Fourth District Court of Appeal affirmed a defense verdict in favor of a medical device manufacturer and in doing so approved of the trial court’s use of the risk-utility test and not the consumer expectations test in the jury instructions. Cavanaugh v. Stryker Corp., — So. 2d —, 2020 WL 5937405 (Fla. 4th DCA Oct. 7, 2020). The wrongful death lawsuit was filed against multiple defendants, including the manufacturer of a medical device used to remove blood and clear the surgical field, following the death of a patient during lung removal surgery. The claims against the medical device manufacturer included strict liability design defect, strict liability failure to warn, and negligence.

The plaintiff settled with several health care professionals and only the claims against the manufacturer proceeded to trial. At trial, the plaintiff proposed a jury instruction where the jury could find that the product was unreasonably dangerous if the plaintiff established either the consumer expectations test (which determines liability based on whether the product fails to perform as safely as an ordinary consumer would expect when used as intended or when used in a manner reasonably foreseeable by the manufacturer) or the risk-utility test (which determines liability based on whether the risk of danger in the design outweighs the benefit). The defendant manufacturer, however, proposed that the jury instruction include only the risk-utility test (a product is unreasonably dangerous if the risk of danger in the design outweighs the benefit). The trial court rejected the plaintiff’s proposed instruction and adopted the defendant’s risk-utility instruction.

Continue reading “Florida Appellate Court Authorizes the Use of the Risk-Utility Test in Complex Medical Device Cases”