We slipped our summer vacation in just before summer slipped away. Last week, we walked the rocky shores of Cape Cod, ate lobstah rolls the size of trolley cars, and navigated our way through the traffic catastrophes charmingly known in New England as “rotaries.” On our last day in the Bay State, the temperature plunged. Many fellow strollers on the sand donned down jackets. Summer in Massachusetts has a way of vanishing suddenly.
On our six and half hour drive back home, we dreamed up an outline for a short story entitled “Thoreau in the Passenger Seat.” Odds are we’ll never follow through, so here’s a sketch.
While we ogled the beautiful red-and-white Nauset Lighthouse in Eastham, a scruffy, bearded guy sidled up close to us (not much social distancing) and described the lighthouse’s history. Then he held forth about the power and majesty of the surf below. Many waves were 20 feet high. They crashed with fury. His words climbed above the din, and were poetic and precise. This shore saw scores of shipwrecks. Sharks had been spotted throughout the season. According to this strangely intense guy, who told us his name was Henry, the only comparable beach in the northeastern quadrant of the country was said to be the vast expanse on Long Beach Island in New Jersey, which he had never actually laid eyes on, but fervently hoped to someday.
It so happened that we would be driving down in that direction the next morning, and we said we’d be happy to give our new friend a lift. Deal. So at 10 am sharp on Saturday, we picked Henry up at the Dunkin’ Donuts in Mashpee, drove across the Bourne Bridge, and proceeded southwest. Through New Bedford and Fall River, Henry’s conversation was interesting enough, though his pro-whaling and pro-Lizzy Borden positions struck us as a bit off-key. We also noticed a hygiene deficiency; he gave off a slight whiff of pond scum. Then he started fiddling with the radio stations. Our usual rule is that the driver calls the tune. If Casey Kasem’s America Top 40 keeps us calm and steady in the middle lane, that should suffice. Yes, the time period of this particular Top 40 show, September 1978, was a particularly putrid moment for popular music. The Grease soundtrack dominated the charts. The number one song was “Boogie Oogie Oogie.” But Henry wanted to play the Hair Nation station. We demurred. A dose of Great White, Ratt, and Poison would prompt us to drive into a pylon. After we slapped Henry’s hand away from the dial, he stewed sullenly for a half hour.
The silence was tense, but was preferable to the way it ended – Henry started jibbering about the local flora and fauna, and none of what he said seemed remotely plausible. We’re pretty sure that the trees outside Providence, Rhode Island do not leak jello, and we doubt that salmon sing in the streets of Stamford, Connecticut. By the time we crossed the George Washington Bridge, we had grown quietly desperate to get away from this guy. If there was an ejection seat button, we’d have pushed it. The gas gauge was nearing the E, so we pulled into the first service station in New Jersey. Filling the tank cost almost $50. We eyed Henry expectantly. He never once reached for his wallet. Instead, he acidly observed that the namesake for the Turnpike Plaza, Vince Lombardi, couldn’t hold a Yankee candle to Bill Belichick’s record with the New England Patriots. We seethed. Then Henry said he needed to visit the men’s room and the Popeye’s chicken stand. Why couldn’t he have done that while we gassed up, especially since he wasn’t going to chip in at all? We sighed, pulled around, dropped him off, and waited. We waited about sixty seconds. That was just enough time to wrestle with our conscience, accelerate onto the ramp, and get back into the highway.
In his book on Cape Cod, Thoreau wrote that a man could stand on the great beach on Eastham and “put all America behind him.” At the Vince Lombardi rest stop on the New Jersey Turnpike, we decided to put Henry behind us. All the way down to the Philly suburbs, we didn’t look at our rearview mirror once.
Today we will look at our rearview mirror. It is worthwhile to reflect upon Webb v. Mentor Worldwide LLC et al., 2020 WL 1685323 (N.D.N.Y. April 7. 2020), because it adds to the consensus that breast implant litigation is severely circumscribed by express preemption. Breast implants are class III medical devices. They go through the Premarket Approval (PMA) process and are subject to the Medical Device Amendments (MDA) of 1976 provision, 21 USC section 360k, which preempts any safety-related state rule regarding medical devices that is different from or in addition to federal requirements.
In Webb, the plaintiff claimed that her breast implants caused her to suffer many serious physical ailments. Her lawsuit included the usual panoply of causes of action for manufacturing defect, design defect, failure to warn, and breach of warranty. The court held that all were preempted.
The failure to warn, design defect, and warranty claims were clearly preempted. Any additional warning or different design would necessarily be different from or in addition to the federal scheme. Why do plaintiff lawyers even bother to include these claims anymore?
As usual, the real action resided in the manufacturing defect claim. As usual, the plaintiff argued for the narrow parallel claim exception, meaning that the claims were premised on violations that implicated both federal and state law. Also as usual, all the plaintiff could cite in the way of federal law were generic Quality System Regulations and Current Good Manufacturing Practices (CGMP). The plaintiff never specified how the defendant violated those regulations. The Webb court correctly held that any action premised on vague, overboard violations of general regulations would necessarily subject a defendant to standards different from or in addition to the MDA provisions.
There are some courts out there that permitted manufacturing defect claims based on vague CGMP violations to elude preemption. Those decisions are in the minority and are poorly reasoned. With the Webb decision in the books, that minority rule is even more in the minority, and the poor reasoning behind it is now even more obviously poor.
There are two other aspects of the Webb decision that the defense bar might find an opportunity to employ. First, the court rejected the plaintiff’s effort to include the manufacturer’s parent company as a defendant. The conclusory allegations of alter ego status could not survive a motion to dismiss. Second, the court denied the plaintiff’s request to amend her complaint. The plaintiff had not offered to amend her complaint after being served with the defendant’s pre-motion letter, and did not include a proposed amendment when she ultimately did seek permission to amend.
Thoreau ended Walden by announcing that “There is more day to dawn.” Not for the Webb complaint. Not for breast implant claims.