Scanning Top Developments in Product Liability News Daily

Endo International Plc has agreed to settle the remaining 22,000 pelvic mesh suits against the company, and has reserved $775 million do so, bringing its total loss reserve to more than $2.6 billion. [8/10/17]

Documents produced in a lawsuit against Monsanto suggest that the company went to great lengths to influence the news media and scientific research concerning the safety of glyphosate, the primary ingredient in its Roundup weed killer. The law firm that made the 75 documents public claimed that “Monsanto’s lawyers made a mistake” by not preserving the confidentiality of the documents, while Monsanto said that the document release violated a standing confidentiality order and that it would seek sanctions for the disclosure. [8/3/17]

The Appellate Division of the New Jersey Superior Court, in an 84-page opinion, revived 2076 lawsuits in which plaintiffs claim that Hoffman-LaRoche, Inc.’s acne drug Accutane caused them to develop Crohn’s disease. The trial court had granted a motion to bar two of plaintiffs’ experts – a statistician and a gastroenterologist – from testifying, among other things, that the epidemiological studies relied upon by Hoffman-LaRoche were flawed and unreliable and that Accutane could cause Crohn’s disease. After striking the experts, the trial court dismissed all 2076 claims with prejudice. The appeals court held that “the trial court went beyond its gatekeeping function” and “improperly determined the weight and credibility of the experts’ testimony.” In particular, the appeals court said that the trial judge  had “inappropriately condemned the experts for relying on relevant scientific evidence other than epidemiological studies, despite their plausible explanations for doing so. [8/3/17]

Drug makers Daiichi Sankyo Inc. and Forest Laboratories, Inc. will pay $300 million to settle all outstanding lawsuits arising from Benicar, Benicar HCT, Azor and Tribenzor blood-pressure drugs. The plaintiffs in those cases alleged that Daiichi knew that the drugs knew could cause abdominal pain, diarrhea, diverticulitis, colitis and nausea, but failed to disclose that information. The settlement is in addition to the $39 million Daiichi paid to the U.S. government to settle charges that it paid illegal kickbacks to prescribing doctors. [8/3/17]

A state court jury in Seattle found that that Olympus Corp. failed to provide adequate warnings and instructions for use of a duodenoscope linked to the infection death of a Seattle patient, but also found that the duodenoscope was not defectively designed. The jury also found that the hospital shared fault in the plaintiff’s death, resulting in a complicated verdict that resulted in a $1 million verdict against the hospital for the patient’s death and a $6.6 million verdict against Olympus for damages suffered by the hospital. [7/27/17]

In a survey published in the Journal of the American Medical Association, a neuropathologist who examined the brains of 111 former NFL players found evidence of chronic traumatic encephalopathy in 110 of them, renewing a debate about the safety of American football. This article breaks down the findings by position. [7/27/17]

A federal jury in Chicago found that AbbVie, Inc. misled an Oregon man about the heart attack risks associated with the company’s AndroGel testosterone booster, but awarded no compensatory damages. The jury then awarded $150 million in punitive damages – an award that is unlikely to stand given the absence of compensatory damages. [7/27/17]

Judge Freda L. Wolfson of the U.S. District Court for the District of New Jersey dismissed a long-running talc class action suit against Johnson & Johnson, finding that plaintiff Mona Estrada did not suffer “an injury-in-fact” and therefore lacked standing to bring the claim. Estrada alleged that J&J knew of a link between talcum powder products and ovarian cancer, and that she would not have Johnson’s Baby Powder had she known of the alleged risk. Crucially, she did not claim any personal injury, but merely claimed monetary losses from purchasing the product. [7/20/17]

The Washington Supreme Court reversed summary judgment in favor of a high school and its unpaid football coach, holding that both could be liable for the death of a football player who suffered a head injury during a game. The state’s high court held that the school and coach could be liable under Washington’s “Lystedt law,” which requires that youth athletes be removed from competition when they exhibit signs of a concussion, and that the coach could also be liable under common law negligence theories. [7/13/17]

Pharmaceutical manufacturer Mallinckrodt LLC, one of the largest manufacturers of generic oxycodone, will pay $35 million to settle Department of Justice claims that it had violated certain provisions of the Controlled Substances Act by failing to detect and notify DEA of suspiciously large orders of oxycodone, one of the drugs at the center of the opioid epidemic. [7/13/17]

A report issued by the Health Care Industry Cybersecurity Task Force identifies critical risks to patient health and safety associated with the cyber-vulnerability of interconnected medical devices, and outlines specific measures to increase the security of interconnected devices. [7/13/17]

As of July 7, California will list glyphosate – the active chemical in the herbicide Roundup – as a carcinogen under the state’s “Proposition 65” warning law. Companies will have one year in which to include health warnings related to the presence of glyphosate in their products. [6/7/17]

The California Second District Court of Appeal reversed a $48 million damages award and ordered a retrial of the plaintiff’s claims that he developed a skin disease after taking Motrin. The appeals court held that the jury’s finding of a negligent failure to warn was “fatally inconsistent” with its finding of no liability for strict liability failure to warn, and that the special verdict was defective because it failed to ask the jury to decide whether a reasonable manufacturer under the same or similar circumstances would have warned of the danger. The appeals court also concluded that federal law preempted all design defect claims. [7/6/17]

A federal judge in Boston sentenced Barry J. Cadden, the former co-owner of the compounding pharmacy linked to hundreds of meningitis infections and several deaths in 2012, to 9 years in prison. [6/28/17]

The U.S. Supreme Court has further narrowed the scope of personal jurisdiction against companies selling products nationwide. The Court ruled, with only Justice Sotomayor dissenting, that 529 plaintiffs from 33 other states could not join 86 California residents in bringing products liability, negligent misrepresentation, and misleading advertising claims in California State Court against Bristol-Myers Squibb Company regarding the blood-thinning drug Plavix. The California Supreme Court had upheld jurisdiction against Bristol-Myers Squibb – which is incorporated in Delaware, headquartered in New York, and has most of its operations in New York and New Jersey – using a “sliding scale approach to specific jurisdiction,” in which “extensive contacts with California” permitted the exercise of specific jurisdiction “based on a less direct connection between [California] activities and plaintiffs’ claims than might otherwise be required.” The Supreme Court would have none of that, referring to California’s approach as “a loose and spurious form of general jurisdiction.” Although the California courts could exercise jurisdiction over California residents’ claims, the Court noted that the nonresidents – who were not prescribed Plavix in California, did not purchase Plavix in California, and were not injured in California – would have to look elsewhere to file suit. [6/19/17]

A putative class action claims that Poland Spring bottled water is a “colossal fraud” and contains “ordinary groundwater that defendant collects from wells it drilled in saturated plains or valleys where the water table is within a few feet of the earth’s surface.” Nestlé Waters North America, which markets the water, responded that “Poland Spring is 100% spring water” and that the lawsuit claims “are without merit and an obvious attempt to manipulate the legal system for personal gain.” [8/17/17]

Judge Charles Norgle of the U.S. District Court for the Northern District of Illinois dismissed, with prejudice, a putative class action claiming that various Quaker Oats Company oatmeal products were mislabeled as “natural” because they contained trace amounts of glyphosate, a chemical used to aid in the drying of oats. Judge Norgle held that FDA’s role in regulating food labels, as well as a federal statute governing tolerances for pesticide residues, established that Congress intended to preempt state regulation, and therefore barred the action. Judge Norgle also held that, in light of Spokeo, the plaintiffs lacked standing to assert claims with respect to products they did not purchase, no matter how similar the products were to the allegedly purchased products. [8/17/17]

A panel of the U.S. Court of Appeals for the Ninth Circuit vacated a defense verdict in favor of SQM North America Corporation and remanded for a new trial in a case brought by the city of Pomona, California, for the perchlorate contamination of the city’s water supply. The Ninth Circuit held that the District Court abused its discretion in limiting the testimony of one of Pomona’s experts and in failing to make sufficient findings before admitting the testimony of one of SQM’s experts. [8/10/17]

The U.S. Court of Appeals for the Sixth Circuit reversed the dismissal of two cases brought by residents of Flint, Michigan, arising out of the lead contamination of that city’s water supply. The appeals court held that the District Court erred in finding the plaintiffs’ 42 U.S.C. § 1983 claims preempted by the federal Safe Drinking Water Act, holding that “there is no textual indication in the SDWA that Congress expressly chose to preempt § 1983 claims and that the provisions of the remedial scheme do not demonstrate such an intention, we also find that the contours of the rights and protections found in the constitutional claims diverse from those provided by the SDWA such that we infer lack of congressional intention to foreclose § 1983 claims.” Although reversing the District Court with respect to claims against Flint, its former mayor, and its former Emergency Managers, the Sixth Circuit upheld dismissal of claims against the State of Michigan on Eleventh Amendment grounds. [8/3/17]

Chipotle Mexican Grill Inc. said in a regulatory filing that it had received a subpoena from federal prosecutors in California concerning a suspected norovirus outbreak at one of the chain’s restaurants in Sterling, VA, last week. More than 100 diners reported norovirus-like symptoms after eating at the restaurant. The subpoena is apparently connected to prosecutors’ ongoing criminal investigation into E. Coli, salmonella and norovirus outbreaks at Chipotle locations in 2015. [7/27/17]

Judge Todd E. Edelman of the Superior Court for the District of Columbia has denied General Mills, Inc.’s motion to dismiss a “private attorney general” action brought by the Organic Consumers Association alleging that General Mills’s Nature Valley granola products were deceptively labeled as being made with “100% Natural Whole Grain Oats” when the products allegedly contained trace amounts of glyphosate, an herbicide and desiccant. Judge Edelman, following a lengthy discussion, concluded that OCA had standing to pursue claims against the 22 varieties of Nature Valley granola products that it did not purchase, and said that the question was more properly addressed at the class certification stage. The court also rejected General Mills’s primary jurisdiction argument, noting that the question of whether customers had been misled was “within the realm of judicial experience” and did not turn on whether FDA might ultimately weigh in on the question of whether the presence of trace amounts of an agricultural chemical rendered a product “unnatural,” and further noting that the FDA was moving at less than lightning speed in (possibly) addressing the issue. [7/20/17]

Judge Brendan Shannon of the U.S. Bankruptcy Court for the District of Delaware granted airbag inflator manufacturer Takata Corp a 90-day stay on all lawsuits outside the ongoing MDL. Although Judge Shannon said that he was “extremely sensitive” to the plaintiffs in the stayed proceedings, he agreed that a 90 day “breathing spell” would enable Takata to complete a $1.6 billion sale of its viable operations as part of its reorganization and to replace recalled airbag inflators. [8/17/17]

A Tennessee jury awarded a truck fleet owner $10.8 million in actual damages and $20 million in punitive damages over alleged defects in Navistar, Inc.’s MaxxForce engines, which the fleet owner contended were not properly tested before being brought to market. Milan Supply Chain Solutions purchased 243 Navistar tractors equipped with MaxxForce engines, which have been plagued with problems and have been discontinued. At trial, a former Navistar executive colorfully testified that the company “did not test s**t” before selling the engines. [8/17/17]

The U.S. Court of Appeals for the Seventh Circuit slashed the attorneys’ fees award in a class action settlement involving allegedly defective Sears washing machines 44 percent, disagreeing that the “novelty and complexity” of the case warranted a fee multiplier – particularly when the class members received far less than the attorneys. In a brief opinion authored by Judge Richard Posner, the Seventh Circuit said that novelty and complexity didn’t necessarily warrant a multiplier, “because novelty and complexity influence the base fee—the more novel and complex a case, the more hours will be billed and the higher the hourly billing rates will be.” Noting that the total award to class members was likely to be around $900,000, the panel said that the fee award should be $2.7 million – the pre-multiplier award sought by class counsel – and not the $4.8 million awarded by the District Court. [8/17/17]

Fulfilling a vow by Chief Justice Roberts, the Supreme Court today that it would begin requiring parties represented by counsel to submit electronic versions of all documents filed with the Court, which filings would then be made available to the public through the Court’s website. [8/3/17]

President Trump has nominated Ann Marie Buerkle, acting chairwoman of the U.S. Consumer Product Safety Commission, to serve a new, seven-year term as Chairwoman. Her appointment is subject to Senate approval. [7/27/17]

The U.S. Court of Appeals for the Ninth Circuit reversed judgment in favor of Mazda Motor Corporation following a trial in a strict liability action alleging that a car’s seat belt system was defectively designed. The Ninth Circuit held that the district court judge erred by allowing Mazda to present evidence that the plaintiff’s misuse of the passive restraint system – she routed the shoulder belt under her arm – caused her injuries, but in failing to instruct the jury that foreseeable misuse is not a defense to strict liability under Montana law. The appeals court also held that the district court committed reversible error in denying the plaintiff the opportunity to introduce foreseeability evidence. [7/27/17]

Jessica Alba’s Honest Co. will pay $7.35 million and will stop labeling its products as “all natural” and “100% natural” as part of a settlement of class action claims that the company falsely labeled its products, according to a motion for preliminary approval of class action settlement filed in the U.S. District Court for the Southern District of New York. The proposed settlement is in addition to the $1.55 million the company agreed to pay last week to settle a federal lawsuit in Los Angeles in which the plaintiffs claimed that Honest Co. had sold laundry detergent, dish soap and multipurpose cleaner containing a skin irritant that that company said it avoided using. [7/6/17]

Plaintiffs who brought a putative class action against Microsoft alleging design defects in Xbox video-game consoles faced this choice when the District Court denied class certification and the Ninth Circuit denied a petition for interlocutory review of that order under Rule 23(f): plaintiffs could have proceeded to litigate the case to a final judgment and then appealed from the certification ruling, they could have settled the individual claims, or they could have proceeded to litigate the case and hope that the District Court later certified the proposed class. Instead, plaintiffs dismissed all claims with prejudice and then appealed the order striking their class allegations. Reversing the Ninth Circuit, which held that it had jurisdiction to consider the appeal, the U.S. Supreme Court held that 28 U.S.C. §1291 did not support appellate jurisdiction to review an interlocutory order after a voluntary dismissal. [6/15/17]

Kawasaki Heavy Industries, Ltd. and its US affiliates have agreed to pay a $5.2 million civil penalty to settle charges brought by the U.S. Consumer Product Safety Commission that the companies failed timely to report hazardous defects in 2012-2016 model year recreational off-highway vehicles and that the companies, when they did ultimately report, noted only a single incident and did not identify more than 400 similar incidents. [6/8/17]

Honest Company, actress Jessica Alba’s brand of non-toxic products, has entered into a $1.55 million settlement to resolve claims that it misled consumers into thinking that its laundry detergent, dish soap and surface cleaner did not contain the skin irritant sodium lauryl sulfate, when, in fact, the products used sodium coco sulfate, of which sodium lauryl sulfate is a component. As part of the settlement, Honest Company will not use either ingredient in its products. [6/8/17]

At a hearing this week, Commissioners of the U.S. Consumer Product Safety Commission expressed differing views about the wisdom of adopting a proprietary “flesh sensing” technology as a product standard for table saws. This NPR report discusses the long history of the proposed standard. [8/10/17]

The government of the United Kingdom has published a guidance document on August 6 concerning cybersecurity in connected and automated vehicles. The guidance is grouped around eight primary principles. [8/10/17]

Researchers from the University of Washington have demonstrated that it’s possible to encode malicious software into physical strands of DNA, so that when a gene sequencer analyzes the DNA, the resulting data corrupts the gene-sequencing software and ultimately takes over the underlying computer. [8/10/17]

The U.S. Court of Appeals for the District of Columbia  Circuit has reversed dismissal of a putative class action brought against health insurer CareFirst, Inc. in connection with a 2014 cyberattack. The District Court had dismissed the case on the grounds that the plaintiff CareFirst customers had “not demonstrated a sufficiently substantial risk of future harm stemming from the breach” and therefore lacked standing. The D.C. Circuit disagreed, on multiple grounds.  First, the appeals court disagreed with the District Court’s conclusion that the complaint did not allege the theft of social security and credit card numbers; in fact, the complaint specifically alleged that the cyberattack gained access to “patient credit card . . . and social security numbers.”  With this information, the D.C. Circuit concluded that the plaintiffs faced a substantial risk of identity theft. Moreover, the D.C. Circuit noted that the complaint alleged the theft of subscriber ID numbers and other information that made a substantial risk of identify fraud – including “medical identity theft” and inaccurate medical record entries that could result in improper medical care, insurance ineligibility, or depleted health insurance. Finally, the D.C. Circuit dismissively rejected CareFirst’s argument that the plaintiffs’ injury was only “fairly traceable” to the data thief.  The court noted that “Article III standing does not require that the defendant be the most immediate cause, or even a proximate cause, of the plaintiffs’ injuries; it requires only that those injuries be ‘fairly traceable’ to the defendant” – which the plaintiffs adequately pleaded by alleging that CareFirst failed properly to secure patient data. [8/3/17]

A report issued by Lloyds of London and Cyence, a risk modeling company, concludes that industry is hugely underinsured against a major global cyberattack. In one attack scenario examined in the report, “hacktivists” make a malicious modification to a hypervisor that controls the cloud infrastructure, causing numerous cloud-based servers to fail. In the second scenario, criminals use system exploits to attack multiple businesses using versions of a common operating system in a “mass vulnerability attack.” In the first scenario, the report projects losses are between $4.6 billion for a large event to $53.1 billion for an extreme event, with only 17% of the economic losses covered by insurance – an uninsured gap of up to $45 billion. In the second scenario, losses could range from $15.6 billion to $121.4 billion – with as little as 7% of economic losses covered by insurance. [7/20/17]

Judge Manish S. Shah of the U.S. District Court dismissed claims brought against an affiliate of toy maker VTech Electronics North American, LLC alleging damages from a data breach that allowed a hacker access to personally identifiable information submitted through the company’s electronic toys. Judge Shah first determined that the plaintiffs had standing to pursue their claims that the toys were worth less than the purchase price because of the cyber-vulnerability, but did not have standing to claim future harm and mitigation expenses as a result of the breach. Judge Shah then turned to the breach of contract claim, which was based on security promises in the online services’ Privacy Policy. The court ruled that purchase contract pertained only to the physical toys, and not to the available online services. Consequently, Judge Shah, held, the plaintiffs “did not enter into an online service contract at the time of purchase,” dooming their contract claims. [7/6/17]

The Petya (or Petrwrap) ransomware attack that has affected Ukrainian infrastructure, the law firm DLA Piper, shipping company Maersk, and Russian oil giant Rosnoft utilizes the same NSA-developed EternalBlue hacking tool as last month’s WannaCry attack. The latest version of Petya, however, does not include the kill switch that stifled the spread of WannaCry. The spread of Petya suggests that many computer uses have yet to install critical security patches. [6/28/17]

Congress and the White House are working on legislation and regulations for driverless cars, as the technology advances faster than expected and as climbing vehicular deaths spur interest in the potential safety benefits of autonomous vehicles. [6/22/17]

The National Transportation Safety Board Monday released more than 500 pages of documents concerning the fatal 2016 highway crash involving a Tesla Model S operating in “Autopilot mode” and a tractor-semitrailer truck near Williston, Florida. NTSB investigators say that, prior to the collision, the car audibly warned the driver six times to keep his hands on the steering wheel and provided seven visual warnings on the car’s dashboard. [6/22/17]

Security researchers have identified the malware used in a cyberattack on Ukraine’s power grid and warn that it threatens power grids and industrial control systems worldwide. Called “Crash Override” and “Industroyer,” the malware represents the second known instance of malicious code purpose-built to disrupt physical systems, such as industrial control systems. (The first was Stuxnet, which was used to destroy centrifuges in an Iranian nuclear enrichment facility in 2009.) [6/15/17]

A putative class-action lawsuit filed in federal court in Detroit claims that General Motors employed software to cheat emissions tests on its Chevy Silverado and GMC Sierra heavy-duty pickups. [6/1/17]

The U.S. Department of Justice has filed suit against Fiat Chrysler Automobiles in federal court in Detroit, Michigan, alleging that the company equipped nearly 104,000 light duty diesel vehicles with “defeat device“ software that allowed the vehicles to cheat on emissions control tests. [5/25/17]

Fiat Chrysler Automobiles will recall more than one million pickup trucks to fix faulty software that could disable computer modules in Ram pickups if the underbody of a truck was struck, causing side airbags and seatbelt tension devices to shut off. The flaw has been linked to one death and two injuries. [5/12/17]

Last week, a security researcher discovered a vulnerability (since patched) in the billion-plus devices that have Windows Defender installed that would have allowed a hacker to create havoc merely by sending a bug by email. Why? Because the bug targeted the security program’s expansive permissions and exploited the antivirus software’s automatic inspection of incoming files. [5/11/17]

Security researchers have demonstrated the numerous security vulnerabilities in internet-connected industrial robots that would allow hackers to wreak havoc on manufacturing operations. [5/4/17]