As a defense lawyer, I dream about preemption; it can bar a staggeringly wide range of claims. The plaintiffs in Gelber v. Stryker, — F.Supp.2d —-, No. 09-CIV-1322, 2010 WL 4740432 (S.D.N.Y. Sept. 14, 2010), however, do not view preemption so fondly. After Jeannette Gelber’s hip was replaced with a Stryker Trident hip, she began to have pain and noticed a squeaking sound when she walked. She was told the artificial hip was defective, and thereafter, filed suit. The defendants filed a motion to dismiss, and the plaintiff conceded the dismissal of claims based on failure to warn, improper labeling, improper or misleading marketing and/or defective design. Therefore, the only claims remaining in the defendants’ motion to dismiss were those of negligence, strict liability and breach of warranty claims based on alleged violations of the FDA’s manufacturing requirements.

And then, the defendants dropped the atom bomb: federal preemption based on the rigorous review the FDA had used in approving the Trident hip for use and distribution; in fact, as a so-called “Class III” device, the Trident hip had been subject to the “rigorous regime” of premarket approval (“PMA“) within the FDA, a process under which only 1% of devices were scrutinized in 2005:

The PMA process is lengthy-it takes over 1,200 hours to review each application-and involves the submission of volumes of comprehensive information on the device. The FDA only grants premarket approval if it finds there is a reasonable assurance of the device’s safety and effectiveness. After approval, the FDA still retains regulatory control over the device. The manufacturer is prohibited from changing “design specification, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness” without first obtaining FDA’s approval.

There is a way around federal preemption, and the plaintiffs tried it in this case: the plaintiffs claimed that the defendants violated FDA manufacturing requirements, a so-called “parallel” claim. Here’s how a parallel claim would work, in the Court’s opinion

Riegel [v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008)] specifically found that claims of strict liability, negligence and breach of implied warranty were expressly preempted. However, there is an absence of Supreme Court guidance on whether the [Medical Device Amendments of 1976] preempts state requirements of general applicability that only incidentally regulate medical devices, e.g., Uniform Commercial Code or unfair trade practice laws, since Riegel refrained from analyzing the exception provided by 21 U.S .C. § 808.1(d)(1). Riegel, 552 U.S. at 328-29 (” § 808.1(d)(1) can add nothing to our analysis but confusion…. Neither accepting nor rejecting the FDA’s distinction between general requirements that directly regulate and those that regulate only incidentally[,] the regulation fails to alter … the outcome of this case”). Post-Riegel, courts have struggled to determine whether state-law claims that only incidentally regulate medical devices are still available insofar as they are “parallel” to federal requirements. . . . This Court finds it persuasive that since the Supreme Court did not carve out a safe harbor for state laws that only incidentally regulate medical devices, the same preemption analysis applies and only those claims that are parallel to federal requirements are permissible.

(internal citations omitted). This might have been a great argument for the plaintiffs, except that the court held that they did not sufficiently plead claims “grounded in violations of federal law and/or requirements.” The pleadings didn’t provide the requisite amount of factual detail and specificity to survive the defendants’ motion to dismiss and, therefore, the remaining claims of the plaintiffs were dismissed. Pesky pleadings. However, the Court stated that “because courts have only recently articulated how a plaintiff can successfully plead a parallel claim,” the plaintiffs would be allowed to replead.

Jury instructions served as the basis for appeal in Kokins v. Teleflex, Inc., 621 F.3d 1290 (10th Cir. 2010) (PDF). This suit arose out of an accident involving a city park ranger, who was thrown from a boat after the boat’s steering cable snapped and sustained a permanent injury to her ankle. She sued the manufacturer of the steering cable, alleging that it was defectively designed and unreasonably dangerous. During discovery, the parties determined and agreed that the reason the cable snapped was because water had somehow entered the core of the cable and caused it to rust. The parties could not agree on how the water got there. The plaintiff alleged that the cable was defectively designed and that a simple fix to the design could have prevented the water from entering into the cable’s core. Teleflex, however, provided evidence at trial that the cable was improperly installed, and had not undergone routine maintenance.

Fellow blog The Hot Dish had an interesting post recently about a diner suing a restaurant owned by the Hillstone Restaurant Group because he was not properly instructed on how to eat an artichoke. Mr. Carvajal, the diner in question, ate the actual leaves of the artichoke, leading him to experience severe abdominal pain due to the leaves being lodged in his small bowel.

The Hot Dish asks the right question: “To what extent should restaurants be liable for the foods they serve?” For instance, should diners be warned not to eat the bones of barbecue ribs?

Other blogs have also provided commentary on this case; a post in the Miami New Times points out that Mr. Carvajal is a doctor originally from Cuba, and suggests that perhaps, he should have known better. Word of Mouth also posted on the suit, commenting that it raises questions about the balance between “helpfulness and over-familiarity” by servers. But perhaps the best commentary on the case from a legal standpoint comes from a post by On Point, which analyzes the negligence case Mr. Carvajal will be attempting to make against the restaurant as follows:

Florida, like other states, uses a “reasonable expectation” test in unfit food cases. A preparer of food “has the duty of ordinary care to eliminate or remove in the preparation of the food he serves such harmful substances as the consumer of the food, as served, would not ordinarily anticipate and guard against,” the Florida Court of Appeals said in Zabner v. Howard Johnson’s, 201 So.2d 824 (1967).

Carvajal, though, can’t recover damages for unfit food since there was nothing harmful per se in the artichoke he was served. It is not what he ate that allegedly caused his injury, but how he ate it.

***

Carvajal would have a better case if his server had given him incorrect instructions on how to eat an artichoke. As the case stands now, it would expose a restaurant to liability any time a server does not explain to a customer how to eat a lobster, relieving the customer of responsibility for asking the simple question, “How do I eat this?”

While I agree with this analysis as a whole from a public policy standpoint, I’m not sure it isn’t what Mr. Carvajal ate that wasn’t the problem–he ate the entire leaf of the vegetable, instead of just the meat inside it. For my part, that’s a what and not a how as On Point describes it. But to burden restaurants and servers with explaining to each diner how to eat his food–from shrimp to ribs to bone-in steak–would be to expand the concept of duty in a negligence action far beyond the scope that the law–and common sense–ever intended.

The Associated Press recently reported that if you use your laptop for too long while it sits on your lap, you could develop “toasted skin syndrome,” also known as erythema ab igne. This is a gross-sounding skin condition characterized by darkening or discoloration caused by long term exposure to relatively moderate heat levels – say from a heating pad, or a hot water bottle.

Fact: Technology is moving faster than many of us can fathom. This is, of course, news to no one. The laptop I bought just one year ago is now a “dinosaur,” and I could probably buy a brand new one with the same specs for roughly half of what I paid last year.

Fact: The law has not kept up with the quick pace of technology. This is also news to no one. Privacy concepts have been turned on their heads by the Facebook/MySpace/Twitter social media explosion. Entirely new concepts of law have also developed over the past few years; “e-discovery” has raised the stakes – and the cost – of litigation dramatically.

The ABA Journal provided another example of technology outpacing law in its newsletter last week: the driverless car, citing a recent New York Times article on the same subject. Apparently, Google has developed technology that can drive a car with minimal human input. In fact, the only accident that occurred during testing of the vehicle was caused by human, not car, error. This is a huge jump even from the Lexus LS460 that can park itself.

As both the ABA Journal and the New York Times point out, the obvious question is this: Who is liable for an accident caused by a car that is driving itself – the person sitting in the driver’s seat of the car who isn’t actually driving, or the manufacturer of the driverless car itself?

We don’t have an answer yet, because it’s all hypothetical at this point, and “the law” hates hypotheticals. But my point is this: Do we really want “the law” to keep pace with technology?

Technology always asks “Can we?”, but in my experience, sometimes fails to consider the better question of “Should we?” For my part, I’m not sure a driverless car is a good idea. Thus, I disagree with Kenneth Anderson of The Volokh Conspiracy, who recently opined that “[t]he idea of robotic cars that drive themselves is a good one, I think, and one whose time is rapidly coming.” But the law is different. It must always ask, what “should” the law be? And if that means that it moves slowly, even glacially, while it considers the answer to that question in a new situation, then that’s okay. Or maybe I’m just old [fashioned].

For my part, I’m still waiting for someone to sell me my own personal Rosie.

Someday.

The dangerous instrumentality doctrine is nothing new in products law. What is different about Florida’s doctrine, however, is that “it is the only state to have adopted this rule by judicial decree,” as noted by the recent case Salsbury v. Kapka, 41 So. 3d 1103 (Fla. Ct. App. 2010). Other states have held that the issue is one for the jury to decide.

One of the more interesting problems in products law is how to handle the middle man. If the retailer does not design or manufacture a product, but merely stocks its shelves, can he be liable to a plaintiff who is injured by the product? Different states handle the question differently.