Scanning Top Developments in Product Liability News Daily

The judge presiding over the first trial against Johnson & Johnson alleging that the company's talcum powder products cause mesothelioma has granted a mistrial after the plaintiff referenced a connection between talcum powder and ovarian cancer -- a topic prohibited by a pre-trial ruling.  A new jury will be selected, with opening statements in the new trial expected to begin next week.  [10/11/12]

The U.S. Supreme Court Monday declined drug maker GlaxoSmithKline LLC's petition to review a ruling by the Illinois Appellate Court, First District, upholding jurisdiction over claims brought by six out-of-state mothers and their children in Illinois claiming that the antidepressant Paxil caused birth defects. [10/3/17]

AmerisourceBergen Specialty Group pleaded guilty to selling misbranded drugs and agreed to pay $260 million in penalties.  In court documents, the company admitted that a former subsidiary had packaged syringes of cancer drugs at a facility no registered with the U.S. Food and Drug Administration, that it filled syringes in excess of safe doses, and that it dispensed syringes based on prescriptions not signed by medical practitioners.  Federal prosecutors also alleged that the subsidiary prepared syringes by pooling single-use glass vials in a non-sterile environment.  [9/28/17]

An Alaska union benefits plan has filed a putative class action alleging that St. Jude Medical, now owned by Abbott Laboratories, knew that the lithium ion batteries in certain St. Jude defibrillators could short out and run down as early as 2011, but sold over 250,000 defibrillators with the defective batteries before initiating a recall.  [9/22/17]

A divided panel of the U.S. Court of Appeals for the Eighth Circuit has revived a qui tam action against Bayer Healthcare, finding that the District Court erred in concluding that it lacked jurisdiction because the plaintiff was not “the original source of the information” as required by the False Claim Act, but rather relied on information previously disclosed in lawsuits, news articles, public filings and medical literature. The panel majority held, however, that, under circuit precedent, a relator “does not have to have personal knowledge of all elements of a cause of action;” rather, the majority said, “[a]s long as the relator has ‘direct knowledge of the true state of the facts,’ she can be an original source even though her ‘knowledge of the misrepresentation is not first-hand.’”

Novo Nordisk Inc. will pay $58.65 million to resolve federal claims that the company violated the False Claims Act by failing to comply with the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza. The government claimed that some Novo Nordisk sales representatives gave information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant. The complaint further alleges that Novo Nordisk failed to comply with the REMS by creating the false or misleading impression about the Victoza REMS-required risk message that violated provisions of the FDCA and led some physicians to be unaware of the potential risks when prescribing Victoza. [9/7/17]

The U.S. Food and Drug Administration said in a warning letter that Pfizer subsidiary Meridian Medical Technologies, which makes the EpiPen self-injection epinephrine pen, had received 171 complaints about EpiPens that failed to activate between 2014 and 2017, but did not disassemble "the vast majority" of the defective EpiPens to investigate. [9/8/17]

A state court jury in Philadelphia Thursday awarded $57.1 million in damages – of which punitive damages accounted for $50 million -- to a 51-year-old Pennsylvania woman who claimed that pelvic mesh implants sold by Johnson & Johnson subsidiary Ethicon caused her to be chronically incontinent and in constant pain. The verdict is the largest awarded in a pelvic mesh suit. [9/7/17]

The U.S. Food and Drug Administration has approved a firmware update to address cybersecurity vulnerabilities in St. Jude Medical (now Abbott) RF-enabled implantable cardiac pacemakers.  In an announcement, the FDA said that it had confirmed the existence of cyber vulnerabilities in the pacemakers and that the vulnerabilities, "if exploited, could allow an unauthorized user (i.e., someone other than the patient's physician) to access a patient's device" and to "modify programming commands to the implanted pacemaker, which could result in patient harm." [8/31/17]

A state court jury in Los Angeles found Johnson & Johnson liable for failing to warn of the cancer risks of its talcum products, and awarded $417-million to a 63-year-old woman diagnosed with terminal ovarian cancer. The award was the largest to date among lawsuits claiming that the company’s talcum products cause ovarian cancer. [8/24/17]

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]

Judge Charles A. Pannell, Jr. of the U.S. District Court for the Northern District of Georgia has imposed $40.1 million in contempt sanctions against Hi-Tech Pharmaceuticals, Inc. and three of its executives for violating injunctions against advertising the company's weight loss products with unsubstantiated claims.  This is the second time the court has imposed such a sanction on the company and the executives in this long-running litigation brought by the Federal Trade Commission; the U.S. Court of Appeals for the Eleventh Circuit vacated an earlier contempt sanction on the basis that the trial court misapplied collateral estoppel in excluding certain evidence regarding the defendants' compliance with the injunctions.  [10/12/17]

Judge Philip S. Gutierrez of the U.S. District Court for the Central District of California has dismissed consolidated class actions alleging that the labeling and packaging of Quaker Oats Company's Maple & Brown Sugar instant oatmeal is false and misleading because the product does not contain maple syrup.  Judge Gutierrez held that the federal Food, Drug and Cosmetics Act and the Nutritional Labeling and Education Act preempted plaintiffs' claims. [10/12/17]

A recently unsealed indictment accuses Hi-Tech Pharmaceuticals, Inc. and two of its senior executives of wire fraud, money laundering, introducing misbranded drugs into interstate commerce and manufacturing and distributing controlled substances.  Among other things, the indictment alleges that the company and its executives forged FDA Certificates of Free Sale and created bogus Good Manufacturing Practice certificates and audit reports.  The indictment also alleges that at least five of the company's “prohormone” supplements contain anabolic steroids, which are   controlled substances. [10/11/17]

The U.S. Supreme Court declined to hear an appeal brought by Conagra Brands, Inc. challenging the Ninth Circuit's view that Rule 23 does not require plaintiffs to establish an administratively feasible way to identify members of a putative class in order to have a class certified.  The ruling makes it likely that the Ninth Circuit -- and, in particular, the U.S. District Court for the Northern District of California -- will continue to be plaintiffs' forum of choice in food and consumer goods litigation. [10/11/17]

Frito-Lay North America, Inc. will drop "Made with All Natural Ingredients" and other "natural" labels from various Tostitos, SunChips, and Fritos Bean Dip products as part of a settlement of class action litigation asserting that the company's labels were deceptive.  [10/5/17]

The U.S. Court of Appeals for the Eleventh Circuit affirmed the grant of summary judgment in favor of Chipotle Mexican Grill, Inc. in a putative class action alleging that Chipotle's menu panels and window clings stating "Farewell to GMOs" and "all of our food is non-GMO" were deceptive because Chipotle served meat from animals feed GMO feed (a fact disclosed on Chipotle's website).  The circuit court upheld the district court's ruling that the named plaintiff lacked standing to sue as a class representative because she could not establish actual damages:  she admitted that she paid the same amount for Chipotle burritos before and after the company launched its non-GMO advertising campaign. [10/5/17]

Japanese steelmaker Kobe Steel, Ltd. acknowledged that it had falsely certified that it aluminum, copper, steel and steel powder products met quality standards.  Because the company's metals are used in automobiles, airplanes and other industrial products, the quality and safety of a number of end products is now in question.  Lawsuits are undoubtedly on the horizon. [10/12/17]

Judge William M. Conley of the U.S. District Court for the Western District of Wisconsin ordered consumer products distributor Spectrum Brands Inc. to pay $1.9 million in civil penalties for failing timely to inform the Consumer Product Safety Commission of customer reports about handles on Black & Decker SpaceMaker coffee carafes that suddenly broke or separated from carafes of hot coffee, and for continuing to distribute the carafes following a recall.

Wal-Mart Stores Inc. announced plans to reduce hazardous chemicals in such products as household cleaners, cosmetics and skin care products 10 percent by by 2022.  [9/29/17]

The U.S. Court of Appeals for the Eleventh Circuit upheld a Florida jury's finding that claims that R.J. Reynolds Tobacco Company had negligently and fraudulently concealed information about the harms of cigarette smoking were barred by the relevant statute of limitations.  The plaintiff claimed that the trial court's jury instructions constituted an "improper comment on the evidence" because it informed the jury that a medical diagnosis was not required for the jury to find that the plaintiff knew or should have known that he had COPD before the limitations deadline.  The court of appeals rejected that argument, noting that the instruction was not a comment on the evidence, but rather necessary background to assist the jury in deciding the issue at hand.  [9/28/17]

A panel of the U.S. Court of Appeals for the Third Circuit has affirmed a district court's finding that a high school football coach enjoys qualified immunity from Section 1983 claims that the coach violated a brain-injured former player's Fourth Amendment due process rights to bodily integrity by allowing the player to continue practicing after exhibiting signs of a concussion.  The appeals court held that the player's parents had presented sufficient evidence to go to a jury on the question of whether the coach violated the player's constitutional rights, but held that a football player's constitutional right to be held out of practice after experiencing a violent hit and showing signs of a concussion had not been established prior to November 2011, when the plaintiffs' son was injured.  The court left open the possibility that football coaches could be found to have violated players' constitutional rights in such situations at an unspecified later date. [9/22/17]

The U.S. Court of Appeals for the Seventh Circuit has tossed a settlement in class action litigation over the length of Subway "foot long" sandwiches, holding that because the settlement resulted in $525,000 in fees for class counsel but yielded "zero benefits for the class," the class "should not have been certified and the settlement should not have been approved."  Repeating its observation in In re Walgreen, the court said that a settlement that results in fees for counsel but no meaningful benefit for the class "is no better than a racket." [8/31/17]

Home Depot U.S.A. Inc. will pay a $5.7 million civil penalty and implement a compliance program to settle charges by the U.S. Consumer Product Safety Commission that the company knowingly sold and distributed 2,816 recalled products  from August 2012 through November 2016. [8/31/17]

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]

Israeli intelligence found that Russian government hackers were able to steal American intelligence secrets using antivirus software made by Kaspersky Lab.  Although the U.S. government is in the process of removing Kaspersky software from computers at more than 20 government agencies, the software is used by 400 million people worldwide. [10/11/17]

A security firm says that Apple Inc.'s so-called extensible firmware interface – a critical element of the firmware in Mac computers that could potentially corrupt everything on the device – is not being updated, either because updates pushed out by Apple are silently failing or because Apple is not issuing firmware updates.

The U.S. Department of Transportation released voluntary guidance regarding the development of autonomous vehicles. The guidance steered clear of regulating the nascent self-driving vehicle industry, but, by leaving the industry largely to regulate itself, left the door open to conflicting state regulations.  [9/14/17]

An internet security company has identified a malware attack method by which the Bluetooth signals from more than 5.3 billion devices can be used to spread a virus to other Bluetooth-enabled devices, without the users being aware of the infection. This new type of malware attack is “highly infectious,” according to researchers, because it can spread to any nearby devices with Bluetooth turned on.  [9/12/17]

The U.S. House of Representatives, with bipartisan support, passed the SELF DRIVE Act, which is intended to establish a federal regulatory regime for autonomous vehicles. The legislation is intended to preempt state regulation – currently, there are at least 21 different state regulatory schemes for self-driving vehicles – and to encourage the development of autonomous vehicles, particularly with an eye to reducing traffic deaths.  The bill now moves to the Senate.  [9/8/17]

Security researchers have identified a new flaw in the electronic architecture of automobiles that could allow hackers to shut off safety systems without being detected. [8/24/17]

The U.S. Court of Appeals for the Seventh Circuit has reversed dismissal of a putative class action against Volvo Cars of North America arising from alleged false representations regarding electric-only range of Volvo XC 90 T8 plug-in hybrid automobiles, finding that a rejected offer of settlement did not strip a putative plaintiff of standing. [7/24/17]

Judge Michael J. Reagan of the U.S. District Court for the Southern District of Illinois dismissed a variety of claims related to the cyber vulnerabilities of certain Chrysler vehicles, as exposed by a 2015 Wired magazine article, but allowed the plaintiffs to proceed with loss of value, unjust enrichment and contract claims related to the alleged security flaws. [8/24/17]

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]