Important Case Involving FDA Pre-Market Medical Device Review Evidence Reaches the NJ Supreme Court
When a consumer suffers injury from a product that malfunctions or is defective in New Jersey, they have the option to sue the product manufacturer and any other person or business that contributed to the defective product reaching and injuring the plaintiff. A product may be defective in its design, manufacturing, or warning. To prove a product’s faulty design, a plaintiff must show that while using the product as intended, the product poses a danger. With manufacturing defects, the negligent production of one or several out of a batch of products may be defective. The plaintiff must prove the product that caused the injury was defective when it left the manufacturer. They may also assert that the manufacturer gave no warnings or insufficient warnings of the product’s dangers, another version of product liability often referred to as “failure to warn.”
At trial, the manufacturer of a defective product must defend itself by showing the product’s safety, the misuse by the consumer, or other evidence of the product’s intended use and safety. Some product liability defendants wish to present evidence that their product went through sufficient testing through the FDA before it approved their product. However, judges have disallowed proof of the FDA’s testing to reach jurors in an important case involving one medical device.
Under Consideration: the Admissibility of FDA Review Process-Related Evidence
Now, the New Jersey Supreme Court will hear an appeal by two defendants who produce vaginal meshes used in surgical repairs of the uterus and other pelvic organs. They seek a favorable ruling on the issue of admitting FDA approval process-related evidence. Both companies, divisions of Johnson and Johnson, lost at trial and were ordered to pay multimillion dollar compensatory and punitive damages awards to the plaintiffs.
In Hrymoc v. Ethicon, the Supreme Court will consider Ethicon’s appeal regarding the evidentiary issue. The trial court did not allow evidence of the FDA’s review of the product, known as a 510k review, before its release to the market. The Appellate Court overturned the trial court’s ruling on the inadmissibility of the 510k review. Recently, the New Jersey Supreme Court agreed to hear the appeal.
Examining Both Sides of the Issue
Under consideration will be both sides of the issue. Plaintiffs’ attorneys claim that the Supreme Court should overturn the appellate court’s ruling, and the trial court correctly excluded the 510k review evidence, as it is irrelevant and misleading. The defense attorneys claim that the evidence is essential to their client’s defense in demonstrating that they complied with each of the actions that the government required to bring their product to market.
The Food and Drug Administration is responsible for ensuring public safety regarding products, including medical devices, that humans and animals ingest or otherwise interact with by application or emission. A 510k review process allows manufacturers of medical devices to have their products approved for public sale in a shorter time frame when they can show that their product is significantly like another approved device that is already sold to consumers. And yet, just because the FDA reviewed a product this way does not mean it is safe, according to the plaintiffs. By extension, a plaintiffs’ attorney would take the position that introducing such evidence is confusing and misleading to a jury. On the other hand, defense attorneys claim that precluding such evidence disadvantages the defense. They cannot show the entire saga of their great lengths to follow governmental rules and regulations to ensure product safety.
A Critical Evidentiary Issue Crossing State Lines
This evidentiary issue is not new. Other courts in various jurisdictions have ruled against allowing such evidence to reach a jury. Presently, the New Jersey Supreme Court is taking up the issue, which could ultimately reach the United States Supreme Court if other state Supreme Courts make conflicting decisions on the subject. The New Jersey Supreme Court will consider the trial court’s ruling and reasoning, as well as the Appellate Court’s ruling. The Appellate Court reasoned that the FDA premarket review evidence might help a jury consider whether the defendants acted appropriately in creating and marketing their product. A question that the court may consider is the abbreviated FDA approval process in contrast to the complete approval process, which is always an option for medical device manufacturing companies. Another important consideration is whether medical device manufacturers like those in this case are unable to defend themselves fully against the allegations that their product is unsafe.
Why this Case Matters in New Jersey
Whichever decision the court makes, all product liability defendants of FDA-approved products stand to gain or lose. First, a plaintiff in a product liability lawsuit must prove their theory of defective design, manufacturing negligence, or failure to warn by a preponderance of the evidence. That means that when considering all the evidence, it is more likely than not that the defendant’s product was defective, poorly made, or required a warning which it did not have. Then, they must further prove that the defect, error, or omission caused the plaintiff’s injury. In this context, if the defendant manufacturer can sway a jury that FDA review is evidence that their product is safe, they might successfully implicate the user as the cause of injury in misusing the product. Alternatively, they might assert that others were responsible for the injury, such as the surgeon who installed the medical device in this case.
When a judge decides to exclude evidence, they weigh the probative value, meaning the weight of the evidence to prove a point by either party, against the unfair prejudice the evidence may create. As such, if the evidence is confusing, misleading, or time-wasting, a judge can exclude the evidence, and a party cannot introduce the evidence to the jury. If the New Jersey Supreme Court affirms the Appellate Court’s decision, plaintiffs’ attorneys must then educate a jury about the FDA process. They must explain the option for a full product safety review and the abbreviated review as a false representation of its safety. Clearly, the court’s decision extends far beyond the singular focus of this case, spelling long-term implications for plaintiffs and defendants in product liability actions throughout New Jersey as they seek to secure their desired results.