Philips’ Objections Over CPAP Lawsuits and Another Obstacle

Santa Clara, CAAs Philips attempts to toss or trim its CPAP defective breathing machine claims, another recent recall affecting 72,000Trilogy Evo ventilators has left the company reeling. And as it scrambles to make up for the CPAP shortage, the medical device competition moves in.

In a Pennsylvania federal court on July 10, Philips’ attorneys in their motion to dismiss argued that claims in the “master complaint” for a multidistrict litigation (MDL) regarding its recalled breathing machines are either:

• Preempted by federal law;
• Part of state consumer protection laws;
• Couldn't be independent claims in states that don't recognize them;
• The check-box "short form complaints" filed by hundreds of plaintiffs joining the case were insufficiently detailed;
• Weren't allowed as independent causes of action in dozens of states that plaintiffs hailed from.

According to Law360, numerous arguments involved whether the motion to dismiss was even the right time in the litigation process to bring up the above objections or if the court needed more time to decide which states’ laws were relevant, or if a decision was reached before the cases are transferred back to their originating states. 

In October 2021 many complaints were consolidated into an MDL based in Pittsburgh, home of Philips Respironics U.S. offices and manufacturing facilities. In June 2022, a master complaint for personal injury plaintiffs was first filed—one year after its recall of its CPAP, Bi-Level PAP and mechanical ventilators containing polyester-based polyurethane sound abatement foam. Then in October an amended version was filed. Philips filed a motion to dismiss in December.

Phillips’ attorney told Judge Thomas I. Vanaskie, (who is retired but now sitting as a "special master" for motions in the case) that the plaintiffs' consolidated complaint relied on the federal Food, Drug and Cosmetic Act and how Philips allegedly violated that law, but attempted to turn those violations into state law claims for things like negligence, strict liability and fraud. He argued that these claims were preempted by the federal law and fell under the FDA’s jurisdiction to enforce, not private plaintiffs. “State law claims must be dismissed where federal enactments are the critical element in the state law claim,” he said, and reported by Law360.

But one of the plaintiffs’ attorneys quipped that “preemption would only apply if the state-law claims sought relief contradictory to what was allowed under federal law, and they would not interfere with the FDA's ongoing investigation into the recall. And because the plaintiffs' claims were looking back in their argument that Philips had delayed and botched its recall and the FDA's work was focused on whether the recall followed the law going forward, the lawsuit “was not stepping on the FDA's toes”.

As for the "short-form complaints" issue, Phillips attorneys said plaintiffs can simply fill in blanks for their names and home districts on the forms then check off boxes for the defendants, the type of recalled machine they used and the injuries they suffered, but one key element was missing: any causal link between Philips' products and the injuries suffered. In other words, the form doesn’t include detailing any of the specific facts necessary to sustain a complaint. Plaintiffs’ attorneys answered: Details connecting the alleged injuries to the recalled devices were being put into supplemental fact sheets for each plaintiff, which could be weighed later in discovery or when the court is selecting bellwether cases for trial.

The case is In re: Philips Recalled CPAP, Bi-Level PAP and Mechanical Ventilator Products Litigation, case number 2:21-mc-01230, in the U.S. District Court for the Western District of Pennsylvania.

Another Recall

Phillips is in more trouble, this time involving a recall of 73,000 Trilogy Evo ventilators. These machines are mainly used in hospitals for pediatric and adult patients who are on life support, like so many Covid patients who couldn’t breathe without a machine. A buildup of dirt in the device’s air path could block oxygen, leading to serious injury or death. The FDA’s MAUDE adverse event database reported that indeed a patient died in March 2022 while using the Trilogy Evo machine. The device’s alarm system indicated the patient’s dropping blood oxygen levels. CPR couldn’t save the patient.

When Philips evaluated the device, it found that the filter had not been installed, which allowed significant amounts of dirt to seep in. Is Phillips trying to shift the blame, like it did with the soundproofing foam in CPAP machines? (In October 2021 SoClean filed a lawsuit against Philips for trying to blame ozone cleaning machines for the faulty design and poorly chosen sound abatement foam in millions of CPAP, BiPAP and ventilator recalls.)

Experts say this March 2023 recall is another obstacle to regaining consumer and regulator confidence for the company. And more than two years after the June 2021 recall, hundreds of thousands of patients are still waiting for CPAP, BiPAP and ventilator machine replacements, and they could wait until later this year. Meanwhile, Philips’ competitor, ResMed, has opened new manufacturing facilities to increase production.

Phillips reported to the FDA in April 2023 that it had shipped 2.46 million replacement devices, but the number of patients who received the machines was far less. The following month Phillips said about 2,830,000 of those new devices and repair kits are in the U.S. and about 2,360,000 have been received by American patients and medical providers.