PA Court Allows Strict Liability Manufacturing Defect Claims Against Stryker

Stryker Gamma 3 Nail System
Stryker Gamma 3 Nail System

A federal judge, ruling on Pennsylvania law, allowed a strict liability manufacturing defect claim to proceed against Howmedica Osteonics Corp. and Stryker Corporation for the complete failure of their hip and leg prosthetic device.

Plaintiff Gary A. Smith had a Stryker Gamma 3 Nail System implanted on March 2, 2015. X-ray images taken on Sept. 30, 2015, showed that the Stryker nail had broken. As a result on April 26, 2016, Smith had to undergo a left total hip replacement, which became infected causing more medical consequences.

He filed strict liability, negligence, breach of implied warranty claims under Pennsylvania law. Gary A. Smith v. Howmedica Ostonics and Stryker Corporation, No. 17-1174, US District Court for Eastern District of Pennsylvania (April 27, 2017).

“In the absence of a controlling decision by the Pennsylvania Supreme Court, a federal court applying that state’s substantive law must predict how Pennsylvania’s highest court would decide this case,” Judge Wendy Beetlestone wrote.

“This Court predicts that the Pennsylvania Supreme Court would not bar strict liability claims asserting a manufacturing defect against medical device manufacturers under Comment k” to Section 402A of the Restatement (Second) of Torts.

Stryker is a defendant in other litigation including:

Other claims fail

The court, however, dismissed the plaintiffs’ claims for:

  • Strict liability claims asserting a design defect against medical device manufacturers.
  • Negligent failure to warn and to recall against medical device manufacturers.
  • Breach of implied warranty of merchantability.

A strict liability claim generally requires proof “(1) that the product was defective, (2) that the defect existed when it left the hands of the defendant, and (3) that the defect caused the harm.”

“Here, the plaintiffs have plausibly alleged a manufacturing defect strict liability claim. The existence of a manufacturing defect is satisfied by the allegation that the Stryker Gamma 3 Nail System broke down after it was implanted into Mr. Smith, where it was subjected to normal and anticipated use, and that there were no reasonable secondary causes,” the judge said.

“That it existed at the time it left Defendants’ control is plausibly suggested by the allegation that the product was manufactured and shipped by Defendants to Grand View Hospital, where it was ultimately implanted into Mr. Smith.”

“And causation follows from the allegation that the failure of the Stryker Gamma 3 Nail System necessitated a subsequent surgery to remove it, as well as a total hip replacement, which gave rise to a secondary infection. Therefore, the motion to dismiss the strict liability claim insofar as it asserts a manufacturing defect will be denied,” the judge said.

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FDA Publishes New Medical Device Reporting for Manufacturers

The FDA issued a new Medical Device Reporting for Manufacturers, describing its current regulation on reporting and record keeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.

These requirements are contained in its Medical Device Reporting (MDR) regulation at Title 21, Code of Federal Regulations (CFR), Part 803, as authorized by section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations.

The MDR regulation provides a mechanism that allows the FDA to identify and monitor adverse events (deaths and serious injuries) and certain malfunctions involving medical devices. The goal is to detect and correct problems in a timely manner. The requirements of the MDR regulation are enforced under the authority of the FD&C Act. The enforcement mechanisms include seizure, injunction, civil money penalties, and criminal prosecution.

The MDR regulation also includes adverse event reporting and record keeping requirements for medical device user facilities (e.g., a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, outpatient treatment facility), importers of medical devices, and medical device distributors.

Basic requirements

Manufacturers, including foreign manufacturers, of legally marketed medical devices in the United States are required to:

  • Submit reports of MDR reportable events involving their medical devices [21 CFR 803.10(c) and 803.50];
  • Develop, maintain, and implement written procedures for the identification and evaluation of all medical device events (e.g., malfunctions, serious injuries and deaths) to determine whether the event is an MDR reportable event.
  • Establish and maintain complete files for all complaints concerning medical device events.

For manufacturers, “MDR reportable events” are events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur .

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