United States: New Jersey Gives PMA Medical Device Case The Cold Shoulder

It's cold in New Jersey now. At the time this post hits the blog, it will be about 20 degrees, real feel 15 degrees in most of New Jersey. That's too cold for this blogger. That's an extra-large cup of coffee for the ride to work. That's two-layers of clothing to walk the dog. That's dry skin, chapped lips, runny nose, stinging eyes kind of cold. It can also be sit by a fire with a good book or curl up with a blanket and one of those Oscar-nominated movies you haven't gotten around to watching yet type of weather. Or, if you are one of those people who actually like winter, let's just say we'll agree to disagree and leave it at that.

But it doesn't have to be cold outside to get left out in the cold. That's what happened to plaintiff in Gomez v. Bayer Corp., 2020 N.J. Super. Unpub. LEXIS 92 (N.J. Super. App. Div. Jan. 14, 2020). And deservedly so. Plaintiff's claims either did not exist under New Jersey law or were preempted. Plaintiff underwent implantation of a pre-market approved (PMA) permanent birth control device manufactured by defendant. Plaintiff suffered serious side effects after implantation that ultimately led to her having a hysterectomy. Id. at *9. Plaintiff's complaint alleged causes of action against the manufacturer of the device for: negligence, breach of express and implied warranties, gross negligence, strict liability, failure to warn, fraud and misrepresentation, and violation of the New Jersey Consumer Fraud Act (NJCFA). Id. And that was plaintiff's first mistake. With the exception of breach of express warranty, New Jersey recognizes only one products liability cause of action. All products liability claims are subsumed under the New Jersey Products Liability Act (NJPLA). So, the appellate court upheld the dismissal of plaintiff's negligence, implied warranty, gross negligence, fraud and misrepresentation, and violation of the NJCFA claims simply because they don't exist in New Jersey. The court did carve out of this section of the decision plaintiff's negligent training claim, but it didn't get a warmer reception under the preemption analysis.

The Gomez opinion contains a very thorough discussion of the regulatory framework that serves as the basis for PMA preemption. Id. at *2-7. We think you probably all know it, but to summarize – because of the MDA's express preemption provision and that the PMA process establishes product-specific regulations and requirements, a common law product liability claim is preempted where it would impose a requirement that is different from or in addition to those imposed by the FDA. When applied to plaintiff's remaining claims, none made the cut.

The court started with plaintiff's failure to warn claim – the sum total of which was an allegation that the product "failed to contain adequate warnings or instructions." Id. at *24. Because a device's labeling and instructions are part of its pre-market approval, any finding that they were inadequate or deficient would be different from FDA's requirements and therefore must be preempted. In New Jersey, there is another rub. The NJPLA provides:

N.J.S.A. 2A:58C-4. Courts have held that this rebuttable presumption of adequacy creates stricter pleading requirements for failure to warn claims. Gomez, at *18. To state a claim, the "plaintiff must plead specific facts alleging deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process." Id. (citation omitted). As noted above, plaintiff's single, unsupported assertion that defendant's warnings were inadequate fall far below this heightened standard. Id. at *24.

Plaintiff's express warranty claim suffered from a similar problem. When the claim is based on information in the FDA approved labeling, it too is preempted. Id. at *24-25. Therefore, under New Jersey law the only breach of express warranty claim that would survive PMA preemption is one based on voluntary statements by defendant that were not approved by the FDA. Id. at *25-26. Because plaintiff's complaint didn't contain such allegations, this claim was also dismissed.

The court moved on to the negligent training claim. Here, plaintiff's allegations were again sparse and very generalized that defendant failed to properly train and screen healthcare providers. Id. at *28-29. From this the court could not determine whether plaintiff was alleging a preempted claim. Plaintiff's allegations did not include whether defendant departed from any FDA requirement or how. Moreover, plaintiff failed to allege how the negligent training, whatever it was, caused plaintiff's injury. Id. at *29. This claim failed both on preemption and causation.

Finally, the court read plaintiff's strict liability claim as a manufacturing defect claim – which also was insufficiently pleaded. PMA devices have manufacturing regulations with which manufacturers are required to comply. Plaintiff failed to allege which FDA manufacturing requirements defendant violated, let alone how defendant violated them. Id. at *31. Once again. Plaintiff also failed to allege how any purported violation caused her injury. Id. at *32.

At oral argument, plaintiff admitted to having no additional facts she could plead to support her allegations. That coupled with New Jersey's heightened pleading standards for PMA-device claims led the appellate court to affirm dismissal of all claims with prejudice. There may be only 58 days until spring, but plaintiffs bringing PMA device claims in New Jersey are looking at an extended wintery forecast.

This article is presented for informational purposes only and is not intended to constitute legal advice.