Footing The Bill: California Drug Disposal Law Aimed At Drug Makers Upheld

Who foots the tab for the disposal of prescription drugs that aren’t (improperly) flushed down the drain or thrown into landfill?  One California county believes that such costs should fall to drug companies. Armed with that belief, county officials passed an ordinance in 2012 requiring drug companies to pay for a drug-disposal program.  Last month, the Ninth Circuit upheld Alameda County’s ordinance, which drug industry groups claimed was unconstitutional. The Safe Drug Disposal Ordinance at issue mandates that companies selling or distributing prescription drugs in Alameda County fund a program to ensure safe disposal of unused drugs.  The goal is to remove unused and unwanted drugs from households without contaminating water supplies. Under the law, drug companies must establish drop-off stations for the disposal of unused drugs.

Three trade groups sued Alameda County, alleging that the ordinance violated the the dormant commerce clause. If you don’t remember, the dormant commerce clause prohibits states from passing legislation that improperly burdens or discriminates against interstate commerce. The trade groups alleged that the ordinance would constitute an economic burden in the magnitude of approximately $1 million per year for each drug company required to comply.  Alameda County claimed this cost was exaggerated and argued that any burden would be minimal in comparison to the nearly $1 billion in drugs sales that occurred in their county each year.

The Ninth Circuit agreed with the county and unanimously held that the ordinance did not violate the dormant commerce clause. The court further held that the ordinance treats all manufacturers equally without respect to the geographic location of the manufacturer  Finally, the court held that the plaintiffs presented no evidence that the ordinance would substantially burden the flow of interstate prescription drugs.  In so doing, the court observed that the U.S. Supreme Court is “reluctant to invalidate regulations that touch upon safety.”  As such, it upheld the district court’s dismissal of the case. In concluding the opinion, the court stated:

Opinions vary widely as to whether adoption of the Ordinance was a good idea. We leave that debate to other institutions and the public at large. We needed only to review the Ordinance and determine whether it violates the dormant Commerce Clause of the United States Constitution. We did; it does not.

The case is PRMA, et al. v. County of Alameda, et al.,  No. 13-16833 (9th Circuit Sept. 30, 2014).

The Google Wi-Fi Litigation

Google claims it made an honest mistake in 2010 when its Street View cars were collecting too much data. Instead of just obtaining the bare minimum data needed to map out the locations of Wi-Fi networks, the cars allegedly unintentionally collected “packet” data that contained private user information.  Armed with Google’s admission that it had, at a minimum, made an honest mistake, class-action lawyers pounced, alleging violations of federal anti-wiretapping laws.  According to Reuters, Google’s attempts to have the cases dismissed were recently denied.

Google sought dismissal of the cases on the grounds that the old pre-Internet telephone privacy laws don’t apply. In so doing, Google argued that dismissal was appropriate because data transmitted over a Wi-Fi network is readily accessible to the public. Alternatively, it said the Wi-Fi data could be considered an unencrypted “radio communication,” which means it would not be subject to liability under the wiretapping law.  However, District Judge James Ware disagreed with Google’s contention and held that the cases could move forward.

Google appealed, and the Ninth Circuit ultimately agreed with the district court. The Ninth Circuit found that the data collected by Google didn’t fit into either category; it was neither a “radio communication” nor an “electronic communication”  The ruling also rejected the idea that Wi-Fi data is “readily accessible” because most of the general public lacks the expertise to intercept and decode payload data transmitted over a Wi-Fi network.

The case in question is Joffe v. Google, Inc., — F.3d —-, No. 11–17483 (9th Cir. Sept. 10, 2013), which affirmed In re Google Inc. Street View Electronic Communications Litigation, 794 F. Supp. 2d 1067 (N.D. Cal. 2011).

Ninth Circuit Affirms Exclusion of Two Experts in Products Case in Eight Paragraphs

We here at Abnormal Use adore concise, get-to-the point jurisprudence, which is why we pause today to reflect upon the Ninth Circuit’s recent eight paragraph memorandum opinion in Shalaby v. Newell Rubbermaind, Inc., No. 09-56331 (9th Cir. May 17, 2010) (unpublished) [PDF]. To reduce the disposition of a products liability action to eight paragraphs is sublime.

In that case, the Plaintiffs, apparently from California, filed a products liability action after Mr. Shalabay was allegedly injured “when a handheld, gas-powered torch that he had purchased from a Home Depot store exploded.” Ever so briefly and succinctly, the Ninth Circuit observed that expert testimony is required in products liability matters to establish causation when the theory is “beyond common experience,” and because the Plaintiffs’ two proffered experts had been properly excluded by the trial court, the Plaintiff had no case. Thus, the Ninth Circuit affirmed the ruling of the district court, which had initially excluded both experts.

The money paragraphs were:

The court excluded the testimony of one of those witnesses, Dr. Anderson, a metallurgy expert, as unreliable and irrelevant. To support his theory that a design defect in the torch caused the explosion, Dr. Anderson conducted two tests on exemplar torches to demonstrate the flaw. The district court concluded that because Dr. Anderson had performed only two non-standardized tests, on torches that may have been different from the one here at issue, and did not adequately explain the results of or discuss the possible rate of error for such tests, his testimony would be unreliable. It would also be unreliable because he did not address certain contradictory evidence. Finally, he did not present adequate evidence that the design flaw caused Shalaby’s injuries, rendering his testimony irrelevant.

The district court excluded the testimony of the other witness, Dr. Vredenburgh, because she was not a qualified expert and, even if she were, her testimony was unreliable and irrelevant. Dr. Vredenburgh’s field of expertise was not torches; she had some experience in the formulation of warning instructions for various devices. When asked whether a different or larger warning would have helped in Shalaby’s case, Dr. Vredenbugh testified that “I don’t know why [the torch] failed, so I don’t know that a warning would have helped.” She stated that she had never operated a handheld torch and had not seen one operated in seventeen years. She had not spoken to any users of handheld torches in many years, and she had incorrectly testified about how such a torch is used. Dr. Vredenburgh admitted that she did not collect any empirical data, did not conduct any testing, did not conduct any surveys, did not seek data from manufacturers, did not review any peer-reviewed literature, did not conduct any other kind of research prior to forming her opinion, and did not follow her own typical process for developing product warnings.

Sure, maybe the conclusion was so easily reached that it only merited an eight paragraph opinion. But it’s nice to see such a case given short shrift.

Ninth Circuit Reverses Exclusion of Plaintiff’s Expert in Medical Device Case

You know you’re in trouble as defense counsel when the appellate court’s opinion starts with the sentence: “[The Plaintiff] has suffered a miserable ordeal since she had elbow surgery. ” That can only suggest that reading the court’s ruling will be a miserable ordeal for the defendant. So begins the opinion in last week’s Primiano v. Cook, — F.3d —-, 2010 WL 788906 (9th Cir. March 10, 2010) [PDF]. Analyzing the admissibility of expert medical testimony at the summary judgment stage, the Ninth Circuit reversed the ruling of the trial court, which had excluded the Plaintiff’s medical expert and granted the defendants’ motion for summary judgment.

The Plaintiff, a 36 year old woman, suffered a fall in her kitchen, broke her right elbow, and ultimately required elbow replacement surgery. Her surgeon used an artificial elbow manufactured by the Howmedica Osteonics Corporation. Apparently, during the surgery, the surgeon realized that one of the component parts of the artificial elbow was intended to be used for a left elbow, not a right elbow. He then contacted a representative of Howmedica, who indicated that the component part was symmetrical, equally functional, and thus, able to be used for the surgery on the Plaintiff’s right elbow with only minor modifications. Following the surgery, all seemed to be well initially, but the Plaintiff ultimately experienced difficulties with the elbow replacement and required four additional surgeries, including the removal and replacement of the original artificial joint. Subsequent analysis revealed that the original artificial elbow had excessive wear. She then sued Howmedica, as the manufacturer of the device, its parent company, a Howmedica sales representative, and her surgeon under various theories of recovery, including products liability (the only cause of action at issue on the appeal). The suit was heard by the Honorable James C. Mahan of the U.S. District Court for the District of Nevada.

Noting that the prosthesis had been “malaligned,” the defense experts also argued that the life of the device would be limited due to the Plaintiff’s relative youth, level of activity, and her pre-existing rheumatoid arthritis. (Young people wear out artificial joints more quickly than older people, they said.). The district court excluded the testimony of the Plaintiff’s expert, Dr. Arnold-Peter Weiss, who had opined that “the polyethylene bushing had worn through in less than eight months, ‘not a usual or expected circumstance.'” The district court appeared concerned by the fact that Dr. Weiss had neither seen nor spoken with the Plaintiff as well as the fact that he could testify that the device failed but not why it did so. With no expert testimony supporting the Plaintiff’s case, the court granted the defendants’ motion for summary judgment. On appeal, the Ninth Circuit addressed the application of Federal Rule of Evidence 702 and Daubert to the testimony of expert physician witnesses. Analyzing the background, qualifications, and testimony of Dr. Weiss, the Ninth Circuit noted that they “[left] room for only one conclusion regarding its admissibility. It had to be admitted.” In so doing, the court noted:

Nevada law establishes that “those products are defective which are dangerous because they fail to perform in the manner reasonably to be expected in light of their nature and intended function.” In Nevada, a plaintiff need not “produce direct evidence of a specific product defect [or] negate any alternative causes of the accident.” An “unexpected, dangerous malfunction” suffices. Since Dr. Weiss, with a sufficient basis in education and experience, testified that the artificial joint “fail[ed] to perform in the manner reasonably to be expected in light of [its] nature and intended function,” that was enough to assist the trier of fact. He did not have to know why it failed.

The district court’s other concerns, that Dr. Weiss never saw or talked to Ms. Primiano, and there was no publication supporting his opinion that the device failed extraordinarily early, might be useful to the jury as impeachment, but neither furnished an adequate basis for excluding his opinion. What he most needed to see was what was inside her arm, not outside it, and he did. He saw the x-rays. He also saw the polyethylene from the implant installed in Primiano’s first surgery. As for lack of a publication backing his opinion up, Daubert offers several reasons why an opinion unsupported by peer-reviewed publication may be admissible, and Dr. Weiss furnished another one: that the phenomenon is so extraordinary that the specialists who publish articles do not see it in their practices.

(Emphasis added).

The Ninth Circuit then reversed the trial court’s granting of the defendants’ motion for summary judgment. An interesting result, as the opinion suggests that an expert who has never examined – or presumably even met – an injured Plaintiff can create a fact issue on summary judgment in a products liability action by claiming that a medical device failed too early without articulating why it did so. The district court had noted that evidence of rapid wear did not necessarily make the device defective. The defense experts did offer an explanation for the wear of the device, namely that devices tend to wear far more quickly when placed in the joints of younger – and presumably, more active – patients. Further, the defense pointed to the fact that this Plaintiff suffered from rheumatoid arthritis which further contributed to the wear. Thus, while the defense posited a specific reason for the rapid wear of the device, the Plaintiff’s expert simply offered the conclusion that the device should have lasted longer than it did. That is now enough to defeat summary judgment. (Interestingly, the Plaintiff did not sue the surgeon for malpractice but only as an agent of the manufacturer of the artificial elbow).

Apple Wins, Always?

Apple wins, always. In Birdsong v. Apple, Inc., No. 08-16641, 2009 WL 5125776 (9th Cir. Dec. 30, 2009) [PDF], the Ninth Circuit affirmed the dismissal of a complaint alleging that Apple’s iPods are defective because it is possible to listen to music at an unsafe volume, and, therefore, they pose an “unreasonable risk of noise-induced hearing loss.”

The plaintiffs planned to represent a nationwide class of iPod users, but the Court rebuffed the plaintiffs’ two main arguments. First, the Court stated that the plaintiffs had alleged no facts that could support a breach of the implied warranty of merchantability. Second, plaintiffs had no standing to assert a claim under California’s unfair competition law.

The plaintiffs alleged that the iPod could be made safer, by the use of some noise-reduction technology or software that could relay the volume in decibels to the iPod user. Simply because a product could be used in a risky manner, however, is not enough to prevail on a warranty of merchantability claim. Put simply, the iPod performs exactly as intended, and there is no breach of the warranty of merchantability.

In addition, the plaintiffs’ claims under the unfair competition law were not supported by an injury, and, therefore, plaintiffs had no standing to assert their claims. First, the plaintiffs did not claim any actual hearing loss as a result of their iPod use, ostensibly because they were not, at any time, actually injured by their iPod. Neither did they assert that such harm was “actual or imminent.” The court observed as follows:

[T]he plaintiffs’ third amended complaint reveals the conjectural and hypothetical nature of the alleged injury as the plaintiffs merely assert that some iPods have the “capability” of producing unsafe levels of sound and that consumers “may” listen to their iPods at unsafe levels combined with an “ability” to listen for long periods of time.

. Finally, plaintiffs’ contention that the iPods’ lack of safety diminished their value to the plaintiffs could not satisfy the injury-in-fact requirement, and the Court noted the plaintiffs’ admission that “Apple provided a warning against listening to music at loud volumes.”

What remains to be seen is where a similar case could go if there were actual injury. Such an injury could support an unfair competition claim as well as additional negligence claims.