Scanning Top Developments in Product Liability News Daily

A New York Times article describes how some litigation funders and some lawyers contact would-be pelvic mesh plaintiffs and arrange for mesh-removal surgery, whether advisable or not. [4/14/18]

A New Jersey state court jury awarded $23 million in compensatory damages and $35 million in punitive damages to a woman who alleged that C.R. Bard's pelvic mesh products left her with chronic pain, and another $10 million in compensatory damages to the woman's husband.  [4/13/18]

A New Jersey state court jury awarded $80 million in punitive damages to a man who alleged that Johnson & Johnson's talc-based products, including Johnson's Baby Powder, contain asbestos and caused his mesothelioma.  The $80 million is in addition to the $37 million in compensatory damages previously awarded by the jury.  [4/11/18]

A New Jersey state court jury awarded $37 million in compensatory damages to a man who blamed his on years of using Johnson’s Baby Powder made with asbestos-containing talc. The jury found Johnson & Johnson responsible for 70 percent of the damages and its French talc supplier with 30 percent of the damages. The jury will return April 10 to consider punitive damages.  [4/7/18]

The Massachusetts Supreme Judicial Court held that brand name drug manufacturers may be liable to consumers of the drug's generic equivalent for recklessly failing to update the contents of a warning label (which, under law, generic manufacturers must follow) when they know of substantial injury risks.  The court rejected drug maker liability under general product liability or negligence theories.  [3/23/18]

The U.S. Securities and Exchange Commission has charged one-time Silicon Valley darling Elizabeth Holmes, founder and CEO of blood testing startup Theranos; the company's former president, Ramesh “Sunny” Balwani; and Theranos itself with “massive fraud.”  According to the SEC, Theranos and Holmes have agreed to settle the fraud charges, with Holmes agreeing to pay a $500,000 penalty, give up control of Theranos, and not to serve as an officer or director of any public company for 10 years.  [3/14/18]

A federal jury in Indiana awarded $10 million in compensatory damages and $25 million in punitive damages to a woman who claimed that pelvic mesh sold by Johnson & Johnson's Ethicon subsidiary caused debilitating pain.  [3/13/18]

The U.S. Court of Appeals for the Eleventh Circuit affirmed a $5 million compensatory damages award and a $2.5 million punitive damages award in an Engle progeny case brought by a smoker who alleged that cigarettes caused her COPD.  The court of appeals held that the district court did not err in denying a request for a mistrial after the plaintiff suffered a medical incident in front of the jury, finding that the trial judge properly instructed the jury to disregard the incident and individually interviewed the jurors regarding their ability to keep their sympathy related to the incident from influencing their deliberations.  The appeals court also refused to second-guess the district court on instructions given to the jurors during closing arguments and in giving an Allen charge.  [3/11/18]

The U.S. Department of Justice has announced that it will seek reimbursement from manufacturers and distributors of opioid pain medications for the “billions of taxpayer dollars” that the that the federal government—through various federal health programs and law enforcement efforts—has borne as a result of the opioid epidemic. The Justice Department said that it would be filing a Statement of Interest in the multi-district action pending in Cleveland involving several hundred lawsuits against opioid manufacturers and distributors. [3/1/18]

The U.S. Court of Appeals, in a case of first impression, has held that when a medical device is comprised of both Class III components – which are entitled to express federal preemption – and Class I or Class II components – which are not entitled to express preemption – whether state tort claims are preempted is to be analyzed at the component level. As a result, the appeals court found that the plaintiffs’ negligence, strict liability, and breach of implied warranty claims involving deterioration of a metal liner (a Class III device) following a hip replacement were preempted by federal law, notwithstanding the plaintiffs’ claims the entire hip replacement “system” – comprised largely of Class II devices – should be the basis of any preemption analysis. The plaintiffs did not come away empty-handed, however, as the appeals court revived their negligence claim based on alleged off-label promotion of the Class III metal liner as an “option” for hip systems other than the one for which it received FDA approval. [3/2/18]

Plaintiffs in a mass tort action against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, presented sufficient evidence that Janssen's drug, Risperdal, caused gynecomastia -- a condition in which female breast tissue grows in males, the Superior Court of Pennsylvania has ruled.  [2/22/18]

The U.S. Court of Appeals for the Fourth Circuit has rejected Boston Scientific Corporation's appeal from $18.5 million in damages awarded by a jury in four pelvic mesh cases consolidated for trial.  The appeals court found no merit in Boston Scientific's claims that it was unfairly prejudiced by consolidation, by the admission of the manufacturer's warning on the MSDS for the polypropylene used in the mesh products, or by the exclusion of evidence concerning the product's 510(k) approval.  [2/8/18]

Glenn Chin, the former supervisory pharmacist at the New England Compounding Center -- the Boston-area pharmacy that made and sold mold-contaminated steroid injections -- received an eight year jail sentence for his role in the 2012 meningitis outbreak that killed nearly 80 people.  [2/3/18]

The United States Court of Appeals for the Seventh Circuit upheld a district court ruling that the more than one thousand failure-to-warn claims in multidistrict litigation against Pfizer Inc. for its Depo-T testosterone replacement drug were preempted by federal law.  [1/24/18]

A panel of the Pennsylvania Superior Court ruled January 8 that plaintiffs asserting claims against Johnson & Johnson's Janssen Pharmaceuticals unit over the drug Risperdal could seek punitive damages if their home states allowed such damages.  Previous rulings had prevented plaintiffs in the several thousand lawsuits pending in the Keystone State from seeking punitive damages because the law of New Jersey, where Johnson & Johnson is based, does not allow such damages.  [1/12/18]

Deoleo, Inc., the seller of Bertolli olive oil products, has agreed to pay $7 million and to change its labeling to settle a putative class action alleging that the company marketed and sold the products as being "Imported from Italy" although most of the oil came from countries other than Italy, and that the oil degraded to the point that it did not meet the "extra virgin" standard through the "best by" date on bottles. [4/6/18]

Two courts came to differing conclusions this week regarding the effect of ingredient labels on plaintiffs’ ability to establish the reliance element in false labeling cases. Judge Edward J. Davila of the U.S. District Court for the Northern District of California held that no reasonable consumer could conclude that Pepsi beverages were free of artificial ingredients – a claim Pepsi did not make – when the label specifically listed “phosphoric acid,” “citric acid” and “caramel color” as ingredients. On the other hand, Judge Staci M. Yandle of the U.S. District Court for the Southern District of Illinois held that dismissal of false labeling claims concerning “Wish-Bone® E.V.O.O. Dressing- Made With Extra Virgin Olive Oil” was not warranted even though the product did contain extra virgin olive oil because whether a “reasonable consumer would believe that all of the oil in the product is extra virgin olive oil instead of an admixture with water and soybean oil” could not be determined as a matter of law. [3/30/18]

Judge Alison J. Nathan of the U.S. District Court for the Southern District of New York sided with the Ninth Circuit rather than the Third Circuit in holding that federal labeling regulations do not preempt claims that the labels on Johnson & Johnson’ Benecol Spread claiming “no trans fats” are misleading because the spread contains partially hydrogenated soybean oil, which contains trans fats. [3/30/18]

A putative class action alleging that Chipotle Mexican Grill, Inc.'s alleged failure to disclose details and risks of its produce processing and food safety procedures caused the company's shareholders to suffer losses when Chipotle's stock plunged after a series of food borne illness incidents in 2014 and 2015 fails to state a claim of securities fraud, Judge Katherine Polk Failla of the U.S. District Court for the Southern District of New York has ruled.  [3/24/18]

Judge William H. Orrick of the U.S. District Court for the Northern District of California rejected Post Foods, LLC's attempt to knock out, on First Amendment grounds, claims in a putative class action that the health and wellness claims made on a variety of Post's cereal boxes were false and misleading because of the amount of sugar contained in the cereals.  Seizing on the Ninth Circuit's opinion in American Beverage Assn. v. City and County of San Francisco, which struck down an ordinance requiring health warnings on soda advertisements, Post argued that its health and wellness claims were protected by the First Amendment because the health effects of sugar remains in dispute.  Judge Orrick found American Beverage Assn. both non-precedential (the Ninth Circuit has voted to rehear the case en banc) and inapposite:  whereas American Beverage Assn. concerned compelled disclosure of "unqualified" health statements, the Post plaintiffs had adequately pleaded adverse health effects of overconsumption of sugar to support their misleading labeling claims.  [3/23/18]

The omnibus spending bill passed by Congress contained a paragraph referencing a House agriculture appropriations subcommittee report directing the U.S. Food and Drug Administration to develop a standard of identify for dairy products derived from animals.  Dairy producers hailed the action, but plant based "milk" producers saw little significance in the action.  [3/23/18]

A divided panel of the U.S. Court of Appeals for the Fourth Circuit held that a “citizen suit” may be brought under the Clean Water Act even when a pipeline – the original source of the pollution – is repaired, as long as the pollutants continue to be “added” to navigable waters. In doing so, it reversed a district court’s dismissal of a suit brought against Kinder Morgan Energy Partners LP in connection with a 2014 spill of several hundred thousand gallons of gasoline from a pipeline in South Carolina. Whereas the district court focused on whether pollution continued to be discharged from the original point source, the Fourth Circuit panel held that the discharge of those same pollutants from ground water into navigable waters could constitute an ongoing violation of the Act. [4/13/18]

Wisconsin Governor Scott Walker signed into law Wisconsin Act 235, making the Badger State the first in the country to require disclosure of litigation funding agreements.  [4/5/18]

Polaris Industries Inc. will pay a $27.25 million civil penalty to settle charges by the U.S. Consumer Product Safety Commission that Polaris failed to report immediately defects in certain of its recreational off-road vehicles that could cause them to catch fire while being driven. CPSC alleged that, by the time Polaris reported the defect, it had received reports of 150 fires, including one that resulted in the death of a 15-year old passenger; 11 reports of burn injuries; and a fire that consumed ten acres of land.  [4/3/18]

In a case involving a 2004 oil spill in the Delaware River, the U.S. Court of Appeals for the Third Circuit affirmed a $71.5 million judgment in favor of the owner of an oil tanker against CITGO, and reversed a district court finding that the United States could recover only 50 percent of its roughly $72 million in cleanup costs. The District Court found that CITGO, as charterer of the ship, had breached a contractual “safe berth warranty” because the ship struck an abandoned anchor as it was being maneuvered into port. CITGO appealed, arguing that the ship must have had a draft exceeding 37 feet – the depth below which the warranty would not apply – and that the District Court erred in failing to explain how the abandoned anchor could have moved from a horizontal position suggested by pre-incident sonar data to the upright position necessary for it to have damaged the ship at a draft less than 37 feet. The court of appeals held that the District Court did not need to provide a specific mechanism for the change in the anchor’s position, because ample evidence supported the finding that the ship’s draft was less than 37 feet. The court of appeals also found that CITGO had failed to establish an equitable recoupment defense, and held that the United States could recover the full amount of its cleanup costs from CITGO. [3/30/18]

The U.S. Court of Appeals for the Ninth Circuit revived a putative class action alleging that carbon ceramic brakes on BMW vehicles were defective and therefore breached the car maker's express warranty and the implied warranty of merchantability.  The trial court had dismissed the action on the grounds that because all of BMW's carbon ceramic brakes exhibited the defect, the problem could not be a manufacturing defect.  The appeals court, however, held that "under California law a manufacturing defect encompasses instances where products differ, even uniformly, from a manufacturer's intended result or design."  [3/23/18]

Judge Vince Chhabria of the U.S. District Court for the Northern District of California called a UCLA epidemiologist's testimony that glyphosate -- the active chemical in Roundup herbicide -- causes cancer "shaky" and "dubious," but nonetheless appeared to let the epidemiology testify to a jury in multistate litigation involving the claims of hundreds of farmers and landscapers that the chemical caused them to develop non-Hodgkins lymphoma.  [3/16/18]

The U.S. Consumer Product Safety Commission has sued Britax Child Safety, Inc., alleging that certain models of the company's jogging strollers contain a defect that causes wheels to detach.  The CPSC says that the defect has caused injuries to children including a concussion, injuries to the head and face requiring stitches, dental injuries, contusions and abrasions; and adult injuries including a torn labrum, fractured bones and torn ligaments, contusions and abrasions.  CPSC says that Britax declined to recall or repair the strollers.  [2/23/18]

Walgreen Co. will pay $2,250,000 to settle a civil suit brought by four California counties alleging that the retailer did not remove infant formula, baby food and over-the-counter drugs from its shelves as of the products' expiration dates and charged consumers more than the lowest posted price for certain products.  [2/3/18]

The California Court of Appeal for the Fourth Appellate District vacated a class certification order in a case alleging damage from a defective power button on Apple Inc.'s iPhone 4, 4S and 5 smartphones.  The appellate court held that the trial court erred in failing to determine the admissibility of expert opinions proffered by the plaintiffs in seeking class certification, explaining that the standard for admissibility of expert testimony set forth in Sargon Enterprises, Inc. v. Univ. of Southern California applied at the class certification stage as well as at trial.  Had the lower court exercised its gatekeeper responsibilities, the appellate court concluded, "there is a reasonable chance the court would have denied plaintiffs' motion for class certification," because the expert testimony in support of a class-wide damages model, as well as the expert opinions used t determine the size of the proposed class, were suspect.  [2/3/18]

By failing to conduct a choice-of-law analysis to determine whether the consumer-protection laws of the various states represented by class members varied in material ways, a divided panel of the U.S. Court of Appeals for the Ninth Circuit held that a federal district court erred in certifying a nationwide settlement class involving claims that Hyundai Motor America, Inc. and Kia Motors, Inc. overstated the fuel efficiency of their vehicles.  The Ninth Circuit ruled that the lower court erred in concluding that the settlement context relieved it from ensuring that the putative class met all of the prerequisites of Rule 23.  In vacating class certification, the appeals court also held that "because the record does not support the presumption that used car owners were exposed to and relied on misleading advertising, the district court had an obligation to define the relevant class 'in such a way as to include only members who were exposed to advertising that is alleged to be materially misleading.'" [1/24/18]

An Uber self-driving car struck and killed a pedestrian in Tempe, Ariz., Sunday night.  Uber announced that, as a result of the incident, it was suspending all self-driving vehicle operations in Pittsburgh, Tempe, San Francisco and Toronto.  The car was operating in autonomous mode at the time of the accident, but had a human safety driver in the car as well.  [3/19/18]

Researchers at security firm Kaspersky reported an apparently state-sponsored hacking program that uses routers as the entry point to deploy spywear deeper into a network. Unlike past attacks on routers, which came in the form of distributed-denial-of-service attacks or eavesdropping on the routers, the new method uses routers to infect other computers within a network with spywear. [3/12/18]

Judge Jack B. Weinstein of the U.S. District Court for the Eastern District of New York issued a preliminary injunction against CabbageTech Corp. in connection with the purchase and trading of "virtual currencies" Bitcoin and Litecoin.  In doing so, Judge Weinstein concluded that cryptocurrencies are commodities subject to CFTC oversight.  [3/9/18]

Eight months after the NotPetya worm attacked Ukraine, then spread to companies and governments around the world, causing billions of dollars in damage worldwide, the White House has fingered Russia as the source of the cyberattack.  In a brief statement, the White House said that, "In June 2017, the Russian military launched the most destructive and costly cyberattack in history."  The statement added that NotPetya "quickly spread worldwide, causing billions of dollars in damage across Europe, Asia, and the Americas. It was part of the Kremlin’s ongoing effort to destabilize Ukraine, and demonstrates ever more clearly Russia’s involvement in the ongoing conflict. This was also a reckless and indiscriminate cyberattack that will be met with international consequences."  [2/17/18]

The U.S. Department of Justice has taken down an online black market forum known as Infraud and unsealed indictments against 36 people for trading in stolen credit card numbers, Social Security numbers, compromised accounts, and materials to create counterfeit cards, as well as money laundering and "bulletproof" hosting services used to host other illegal online operations.  Infraud allegedly has been in operation for seven years, and has caused $530 million dollars in damage. [2/8/18]

Fresenius Medical Care North America, a major provider of services for people with kidney failure, will pay $3.5 million to the U.S. Department of Health and Human Services, and will implement a corrective action plan, to settle claims of HIPAA violations in connection with five data breach incidents. [2/8/18]

VTech Electronics Ltd. will pay $650,000 to settle charges brought by the U.S. Federal Trade Commission that its electronic toys and associated app collected the personal information of hundreds of thousands of children without notice to or consent from parents, and that the company had inadequate security to protect the information. [1/10/18]

Only days after the disclosure of security flaws in the microprocessors that power computers and handheld devices, purchasers of computers containing Intel chips filed a putative class action against the company.  [1/5/18]

The revelation this week of security flaws in the microprocessors that power computers and hand-held electronic devices points to a huge and long-lasting problem for the computing industry. [1/5/18]

Security firm FireEye has revealed the existence of TRITON malware, which it says targeted industrial processes in the Middle East.  TRITO appears to work by reprogramming the controllers of a Safety Instrumented System so that a malevolent actor can either shut down an industrial process by tricking the SIS into erroneously thinking something is wrong with an industrial system, or can damage or destroy an industrial process by causing the process to operate in an unsafe way without triggering a shutdown or warning. [12/14/17]

In a letter to Facebook CEO Mark Zuckerburg, Senators Richard Blumenthal (D-Conn.) and Edward Markey (D-Mass.) expressed concern over the handling of sensitive information collected through Facebook’s new “Messenger Kids” app, which is designed specifically for children 12 and under.  [12/7/17]

EU Cybersecurity Agency ENISA has issued its recommendations for improved security in the Internet of Things, recommending a “strong holistic approach” aimed at promoting harmonization of IoT security initiatives and regulations; raising awareness of the need for IoT cybersecurity; defining secure software and hardware development lifecycle guidelines for IoT; achieving consensus on interoperability across the IoT ecosystem; fostering economic and administrative incentives for IoT security; establishing secure IoT product/service lifecycle management; and clarifying liability among IoT stakeholders. [12/7/17]

A new type of microprocessor under development may be the key to securing IoT peripheral devices, which currently are fair game for botnets and hacking. [12/7/17]

The call for greater transparency as to how the government uses and when it discloses software vulnerabilities to industry – which reached a crescendo after Shadow Brokers leaked National Security Agency attack tools and exploits last year – has led the White house to release a Vulnerability Equities Policy and Process document explaining the process used by the government in determining whether to notify a manufacturer about a security flaw in its products or whether to remain silent and to exploit the vulnerability for intelligence purposes or otherwise. [11/16/17]

A lawsuit brought by anti-malware software provider Enigma claiming that river anti-malware software provider Malwarebytes violated New York law by selling software that identified Enigma’s software as a potential threat has been dismissed. Judge Edward J. Davila of the U.S. District Court for the Northern District of California held that the immunity provisions of § 230(c)(2) of the Communications Decency Act precluded Enigma’s claims, noting that Congress enacted the provisions “to encourage the development of technologies which maximize user control over what information is received by individuals, families, and schools who use the Internet” and to encourage “development and utilization of blocking and filtering technologies.” [11/10/17]