The Third Circuit recently affirmed a trial court’s granting of a motion for judgment on the pleadings filed by various generic drug manufacturers in a Fosamax suit.  Ninety-one plaintiffs from 28 different states filed suit against Merck and various generic drug manufacturers in Missouri state court, alleging that Fosamax and its generic equivalent (alendronate sodium), used for treating bone conditions such as osteoperosis and Paget’s disease, were defective in labeling, design, et cetera, due to the drug’s propensity to make bones more susceptible to fracture.  The case was removed to federal court and centralized with several other Fosamax-related lawsuits in an MDL in the U.S. District Court for the District of New Jersey.  As mentioned above, the generic drug defendants moved for judgment on the pleadings based on a federal preemption argument, and the trial court granted the motion.

In reaching its decision to affirm dismissal, the Third Circuit relied heavily on Mensing and Bartlett.  The Third Circuit was persuaded by the generic drug defendants’ argument that “they could only avoid liability by taking one of the options that Mensing and Bartlett say they cannot be forced to take: (1) changing alendronate sodium’s labeling, (2) changing the drug’s design, or (3) ceasing sales of the drug altogether.”  In the end, the Third Circuit held that the suit against the generic drug manufacturers was preempted under the doctrine of conflict preemption and affirmed the decision of the trial court.

For more on this opinion, please see this post over at the Drug and Device Law blog.

Two Pennsylvania women brought a state law nuisance claim in federal court against the owner of coal fired power plant that allegedly damaged their property through the emissions of ash, chemicals, and odors.  The power plant, which is owned by GenOn Power, was apparently in compliance with the state and federal environmental regulations that govern the operation of coal power plants.  The lawsuit was initially dismissed by the district court, which held the suit was preempted by the Clean Air Act.   The Third Circuit recently reversed the district court and held that the Clean Air Act is not preemptive.

In its decision, the Third Circuit found that “nothing in the Clean Air Act [indicates] that Congress intended to preempt state common law tort claims.”  The Court further stated that the Clean Air Act is “a regulatory floor, not a ceiling, and expressly held that states are free to impose higher standards on their own sources of pollution, and that state law tort is permissible way of doing so.”  The Third Circuit relied in large part on the Supreme Court’s holding in International Paper Co. v. Ouellette, 479 U.S. 481 (1987),which held that the Clean Water Act did not preempt state law tort claims.

The Third Circuit’s ruling appears to go against strong authority supporting preemption.  In Am. Elec. Power Co., Inc. v. Connecticut, the Supreme Court held that the Clean Air Act preempted federal common law nuisance claims as a means to curb emissions from a power plant. 131 S. Ct. 2527 (2011). In that case, the Supreme Court noted that the EPA has been designated to serve as the emission regulator and is better suited to do so than judges issuing ad hoc injunctions.  Additionally, the Fourth Circuit has held that that state law nuisance claims against power plants are preempted because they threaten the comprehensive regulatory scheme. See N. Carolina, ex rel. Cooper v. Tennessee Valley Auth., 615 F.3d 291, 303 (4th Cir. 2010).

This new ruling is very significant as it opens the door to a potential onslaught of litigation.  It means that residents can pursue property claims against power plants even though they are in compliance with state and federal regulations.  That sound that citizens in Northeast are hearing is the sound of their electricity rates and bills clicking higher.

Earlier this month, on July 12, the Third Circuit upheld a jury’s verdict in favor of a manufacturer of bicycle helmets, and in doing so, affirmed the lower court’s application of a relatively new interpretation of product liability law.  Covell v. Bell Sports, Inc., No. 10–3860, —F.3d—, 2011 WL 2690396 (3d Cir. July 12,  2011). The case was filed by the parents of a 36-year-old schoolteacher who sustained serious brain injuries when he was hit by a car while bicycling to work in 2007.  The parents, in their capacity as guardians, filed suit against the manufacturer of their son’s helmet, alleging that it was defectively designed and lacked adequate warnings.  At trial, over the plaintiffs’ “strident objections,” the court permitted the helmet manufacturer to introduce expert testimony regarding the Consumer Product Safety Commission’s “Safety Standard for Bicycle Helmets.” In turn, the plaintiffs responded with their own expert regarding the CPSC safety standard.  Both experts testified at trial that the CPSC standard forms the “starting point” for any bicycle helmet design, and both agreed that the helmet at issue satisfied CPSC standards in all respects.  At the conclusion of trial, the court instructed the jury that in determining whether the helmet was defective, it could consider evidence of standards in the industry, including the CPSC standards.

The Third Circuit recognized the “core conflict” that exists within provisions of the “strict liability regime” of the Restatement (Second) of Torts: that courts are to ignore evidence that the seller “exercised all possible care in the preparation and sale of his product,” yet imposes liability only for products that are “unreasonably dangerous.”  It is, of course, often impossible for a jury to determine whether a product is “unreasonably dangerous” without referencing evidence that the seller did or did not exercise “care in the preparation” of its product. Ultimately, the court held that federal courts applying Pennsylvania law are to use the Restatement (Third) of Torts to guide both their decisions regarding the admittance of evidence and in their usage of jury instructions.  In this regard, it allows for a more negligence-friendly products liability regime than previously recognized in Pennsylvania, where juries may properly consider industry standards and government regulations.  This is certainly a defense-friendly analysis and decision.  Short of doing away with strict liability laws in their entirety, incorporating more negligence-type concepts into the analysis of manufacturer liability is a positive approach.

Emily Pincow of the Product Liability Monitor blog has additional thoughts on the case here.

Recently, the Third Circuit affirmed the dismissal of a plaintiff’s complaint seeking damages for injuries as a result of cell phone usage on the ground that his claims were preempted by Federal Communications Commission (“FCC”) regulations. Farina v. Nokia, Inc., No. 08-4034, 2010 WL 4138502 (3d Cir. Oct. 22, 2010) [PDF]. In that case, the Plaintiff, Francis Farina (“Farina”), brought a class action against numerous cell phone manufacturers and retailers. Farina asserted that cell phones were unsafe to be operated without headsets because, without a headset, the user is exposed to dangerous amounts of radio frequency (“RF”) radiation and current marketing of cell phones as safe violated state law. The FCC regulations at issue adopted a maximum absorption rate that measured the amount of energy absorbed in human tissue.

In reviewing the decision of the District Court, the Third Circuit discussed the three types of federal preemption of state law — express preemption, field preemption, and conflict preemption. First, the Third Circuit found no express preemption by 47 U.S.C. Section 332(c)(7)(B)(iv) that provided the following: “No State or local government or instrumentality thereof may regulate the placement, construction, and modification of personal wireless service facilities on the basis of the environmental effect of radio frequency emissions to the extent that such facilities comply with the Commission’s regulations concerning such emissions.” (emphasis added). Defendants argued that the term “facilities” included alternations to cell phones. The Third Circuit disagreed finding that “facilities” related to infrastructures and not transient cell phones, concluding no express preemption.

Next, the Third Circuit found no field preemption stating that “[w]hile the FCC may have ‘primacy over the areas of technical standard and competitive market structure for cellular service . . . neither Congress nor the FCC has evinced an intent to occupy the entire field.”

Finally, however, the Third Circuit found conflict preemption accepting Defendants’ argument that “Farina’s suit would erect an obstacle to the accomplishment of the objectives of Congress.” Farina’s claims were based on alleged false and misleading statements that cell phones were safe to use without a headset. The Third Circuit pointed out that in order to establish his claims, “Farina must show that [the FCC] standards are inadequate that they are insufficiently protective of public health and safety.” That said, the Third Circuit was tasked with determining “whether suits challenging the adequacy of the FCC’s RF regulations are preempted.” Defendants argued that Farina’s suit conflicts with the FCC regulations because a finding of liability would “upset the FCC’s delicate balancing of efficiency and uniformity with the health and safety of the public.” Permitting a jury to find that cell phones that meet the FCC standards are nevertheless unreasonably dangerous would upset its objectives and balance, and thus the Third Circuit decided such suits are preempted.

The Drug and Device Law blog offers an interesting discussion and analysis of the decision here. It appears that this is another in a series of cases in which the courts try to make sense of conflict preemption in the wake of Wyeth v. Levine, 129 S. Ct. 1187 (2009).

Have you ever thought that traveling in a vehicle going above 65 miles per hour could cause cancer? One Pennsylvania resident, Ted McCracken (“McCracken”), thought so and asked the Eastern District of Pennsylvania to award him damages as a result of such alleged injury. Pro se Plaintiff McCracken filed an action against Ford Motor Company asserting that he contracted thyroid cancer as a result of the insufficient protection Ford windshields provided from ambient radiation in the air that increases to dangerous levels inside a cabin when a vehicle travels at speeds in excess of 65 miles an hour. McCracken v. Ford Motor Co., No. 09-3995, 2010 WL 3010304 (3d Cir. Aug. 3, 2010) [PDF]. McCracken asserted eight causes of action, including strict products liability and defective design.

Ford filed a motion to dismiss on a number of grounds and the District Court of Pennsylvania dismissed all McCracken’s claims, except for strict products liability and defective design, and entered a scheduling order. Pursuant to this scheduling order, McCracken’s expert report was due on April 6, 2009. After this deadline had passed, McCracken filed a motion for an extension of time to retain an expert and a motion for the appointment of an expert under Fed. R. Evid. 706. The District Court denied his motions and Ford moved for summary judgment based upon McCracken’s lack of expert testimony. The District Court granted summary judgment in favor of Ford and McCracken appealed.

On appeal, McCracken asserted that he submitted sufficient evidence to survive summary judgment even without the testimony of an expert. This evidence included data regarding environmental radiation, a list of books and articles on radiation, the deposition testimony of a representative of the Pennsylvania Department of Environmental Protection, and affidavits from him and his mother stating that they observed increased readings on a Geiger meter when the vehicle accelerated. The Third Circuit found that this “evidence” was not enough to withstand summary judgment on the cause of McCracken’s cancer or the defective design of Ford’s windshields.

McCracken’s second argument on appeal is that the District Court erred in not appointing him an expert. The Third Circuit agreed with the District Court that “the purpose of Rule 706 is not to provide ‘litigation assistance’ to a party unable to retain an expert on its own.” The Third Circuit found no error by the District Court. McCracken asserted four more arguments on appeal, all not worth discussing here, which were all rejected by the Third Circuit.

This case is another example of a Plaintiff asking our Courts to buy into his or her theory of injury based on “because I said so.” The Third Circuit correctly found that Ford was entitled to summary judgement where plaintiff either could not find an expert to support his theory or he disregarded the court’s instructions by failing to find such an expert within their deadlines.

As a side note, this is McCracken’s thirteenth lawsuit asserting this general ambient radiation theory. He has sued numerous defendants including other automobile manufacturers, manufacturers of other types of vehicles that can travel in excess of 65 miles per hour, nuclear power plants, and energy companies. See McCracken v. R.E. Ginna Nuclear Power Plan, LLC, No. 08-cv-6217L, 2010 WL 1404115, at *4 (W.D.N.Y. Mar. 31, 2010).

In 1999, Robert Jacobson (“Jacobson”) went to do errands with his two sons, Ryan and Christopher, in his BMW 325i. Jacobson stopped at a convenience store, parked, placed the gear shift in park, turned off the engine, engaged the emergency brake, removed the keys from the ignition, and exited the vehicle, leaving his sons inside. Ryan, playing with the gear shift, placed the vehicle in reverse or neutral and the vehicle began to roll. Christopher exited the vehicle without injury. However, Ryan sustained severe injuries as a result of his exit from the vehicle. Thereafter, Jacobson filed a action against BMW alleging that it should have had a device in place that would have prevented the car from shifting out of park.

Under Pennsylvania law, “a manufacturer can be deemed liable only for harm that occurs in connection with a product’s intended use by an intended user.” On appeal Jacobson cited to two Third Circuit opinions, Pacheco v. The Coats Co., 26 F.3d 418, 422 (3d Cir. 1994) and Sheldon v. West Bend Equipment Corp., 718 F.2d 603, 608 (3d Cir. 1983) for the proposition that “intended use” under Pennsylvania law includes all uses “reasonably foreseeable by the manufacturer.” The Court disagreed and held that this proposition had been expressly rejected by the Pennsylvania Supreme Court in Pa. Dep’t of Gen. Servs. v. U.S. Mineral Prods. Co., 898 A.2d 590 (Pa. 2006). The Court found no error in the underlying court’s decision to omit “foreseeability” from its jury instruction on “intended use.”

In fact, in the past two weeks, on April 6, 2010 and April 13, 2010, the Eastern District of Pennsylvania and Third Circuit, respectively, upheld the decisions by the settlement trust to deny benefits. In re Diet Drugs Products Liability Litigation, No. 99-20593, 2010 WL 1404624 (E.D. Pa. Apr. 6, 2010); In re Diet Drugs Products Liability Litigation, No. 09-2424, 2010 WL 1473752 (3d Cir. Apr. 14, 2010).

The Court found that Brown-Riddle merely disagreed with the reviewing physician’s determination that she lacked a medical basis for her claim. She failed to identify or substantiate any specific errors and rested on her physician’s “check-the-box diagnoses.” The Court affirmed the decision of the trust denying benefits.

These decisions by the the Eastern District of Pennsylvania and the Third Circuit show that even when a mass class action is settled, litigation continues and our courts are continually asked to evaluate expert evidence as it would in a case of traditional posture. Plaintiffs in these types of cases are not off the hook of providing expert testimony. It will be interesting to note when litigation surrounding this class settlement ends — 10 more years, maybe 20.

The procedural posture of this case would likely bore you and create a lot of extra reading to get the important lesson from this case across to you. That said, I will only briefly recite the basic underlying facts of this case. Dammann is a producer of raw foods, including vanilla beans. Dammann sold IFF vanilla beans, by written contract, for incorporation into IFF’s food and beverage flavoring. IFF incorporated Dammann’s beans into its vanilla extract only later to find out that the beans were contaminated with mercury. As a result, IFF filed claims against Dammann for breach of express warranty, breach of implied warranty, and product liability.

The Court found that there were two schools of thought resolving this question. The majority employs some variation of the following test:

On the other hand, the minority test differentiates between damage to the product itself and other property. The Court held that the New Jersey Supreme Court would likely join the majority and apply the economic loss doctrine to bar IFF’s claim. The Court reasoned this way because New Jersey precedent consistently held that “contract law [was] better suited to resolve disputes between parties where a plaintiff alleges direct and consequential losses that were within the contemplation of sophisticated business entities with equal bargaining power and that could have been the subject of their negotiations.” Further, the Court found that IFF alleged damages, including scrapping of contaminated finished flavoring, claims from customers, testing costs, plant cleaning costs, and lost profits were purely economic damages.

Practitioners should be aware of both the majority and minority rules on this issue and be on the look out to see if the New Jersey Supreme Court resolves this issue as the Third Circuit predicted it would rule in this matter.

In Mracek v. Bryn Mawr Hospital, No. 09-2042, 2010 WL 318372 (3d Cir. Jan. 28, 2010) [PDF], Plaintiff Ronland Mracek was diagnosed with prostate cancer and underwent a prostatectomy. Mracek was told by his surgeon that he intended to use the da Vinci robot to assist in the surgery. However, during Mracek’s surgery, the da Vinci robot became nonoperational and merely displayed error messages. As a result, Mracek’s surgeon used laparoscopic equipment instead.

Mracek appealed to the Third Circuit solely on his strict malfunction liability claim. While a plaintiff can prove a defect using circumstantial evidence under the malfunction theory of liability, the plaintiff must still produce “evidence of the occurrence of a malfunction and . . . evidence eliminating abnormal use or reasonable, secondary causes for the malfunction.” Id. at *1 (internal citations omitted). Further, even if a plaintiff is able to prove the existence of a defect in this manner, he or she still has the burden of proving the defect caused the plaintiff’s injury and that the defect existed when it left the manufacturer’s control.

This opinion again demonstrates the importance of expert testimony in products liability actions. It instructs that merely coming to court and stating that a product malfunctioned is insufficient. Plaintiffs who fail to prove proximate cause should have their claims dismissed.