Scanning Top Developments in Product Liability News Daily

The West Virginia Supreme Court, answering a question certified by the U.S. Court of Appeals for the Fourth Circuit, held that "there is no cause of action in West Virginia for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug ingested was produced by a generic drug manufacturer."  [5/12/18]

The U.S. Court of Appeals for the Fifth Circuit had harsh words for noted plaintiffs’ attorney Mark Lanier in reversing a $151.6 million judgment against DePuy Orthopaedics, Inc. and its parent, Johnson & Johnson, in a hip replacement bellwether trial. The appeals court first held that the trial court had erred in admitting evidence of a Deferred Prosecution Agreement in which Johnson & Johnson admitted that a non-party affiliate had paid bribes to the Iraqi government – which Lanier told the jury could be used to infer Johnson & Johnson’s wrongdoing with respect to artificial hips – and hearsay allegations of race discrimination contained in a former DePuy employee’s resignation letter – which Lanier told the jury was further evidence of Johnson & Johnson’s knowledge of the artificial hip’s design flaws. The court then turned to two orthopedic surgeons called as expert witnesses at trail by Lanier, and whom Lanier had characterized as non-retained expert witnesses in pre-trial disclosures. Lanier told the jury that it should contrast these experts, whom Lanier characterized as unpaid, voluntary witnesses, with the defendants’ experts’ “bought testimony.” What Lanier failed to mention was that he had paid $10,000 to a charity designated by one of the experts five weeks before trial, and paid the experts $35,000 and $30,000, respectively, after trial. Despite noting the “heavy burden” on the defendants of showing by clear and convincing evidence that Lanier’s misrepresentations prevented defendants from fully and fairly presenting their case, the court found that this was “the rare case in which counsel’s deceptions were sufficiently obvious, egregious, and impactful to penetrate the layers of deference that would ordinarily shield against reversal.” Of Lanier’s deceptions, the court said: “The pre-trial donation check, Morrey Jr.’s expectation of compensation, and the post-trial payments to both doctors are individually troubling, collectively devastating.” [4/30/18]

The U.S. Food and Drug Administration released its Medical Device Safety Action Plan, which sets forth FDA's vision for improving the safety of medical devices.  Among the topics covered are improved medical device cybersecurity and exploration of regulatory options for more timely implementation of post-market mitigations.  [4/18/18]

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]

Judge Jeffrey Alker Meyer of the U.S. District Court for the District of Connecticut dismissed a putative class action alleging that Nestlé Waters North America defrauded consumers by passing off groundwater and surface water as Poland Spring spring water.  In his order, Judge Meyer noted that the federal Food, Drug and Cosmetic Act exclusively governs the "standard of identity" for spring water, and that the Act provides that only the federal government -- not private parties -- may enforce the FDCA.  Because the state law claims asserted by plaintiffs were based entirely on alleged violations of the FDCA, Judge Meyer found the claims preempted.  [5/19/18]

Judge Paul A. Engelmayer of the U.S. District Court for the Southern District of New York dismissed a putative class action against the Pepsi-Cola Company alleging that the use of the term "diet" in marketing Diet Pepsi deludes consumers into believing that consuming the beverage will cause them to lose weight.  Judge Engelmayer held that the term "diet" in the context of a diet soda merely connotes that Diet Pepsi has fewer calories than regular Pepsi, and that the studies cited by the plaintiffs' for the proposition that diet beverages caused weight gain did not support such a conclusion.  [5/19/18]

The U.S. Court of Appeals for the Ninth Circuit reversed dismissal of a putative class action alleging that the statement "Helps Maintain a Healthy Heart" on labels of Pharmavite, LLC's "Nature Made" Vitamin E dietary supplements was false and misleading.  The appeals court held that federal law did not preempt the plaintiff's claims under California law because plaintiff claimed to understand from the labeling both that the Vitamin E would prevent heart disease (a "disease claim" preempted by federal law) and would maintain his heart health (a non-preempted "structure/function claim").  The court also held that the district court erred is denying class certification and in awarding the cost of a consumer survey to Pharmavite.  [5/19/18]

Ferrara Candy Co. has agreed to pay $2.5 million to settle a putative class action alleging that Ferrara's boxes of such candies as Jujyfruits, RedHots, and Chuckles -- sold at movie theaters and retail outlets -- contained excessive nonfunctional empty space that led purchasers to believe that they were purchasing more candy than they actually received.  Ferrara also agreed to modify its filling procedures to reduce slack-fill.  [5/12/18]

The California Second District Court of Appeal has upheld dismissal of a putative class action brought against a group of winemakers by plaintiffs who claimed that trace levels of naturally occurring, inorganic arsenic in wine required a specific warning under California’s Proposition 65. The appeals court, however, agreed with the district court that the winemakers’ use of a “safe harbor” Proposition 65 warning for wine (intended to warn of the dangers of alcohol) rendered an additional arsenic warning unnecessary. The court noted that the administrative body that drafted the “safe harbor” warning for wine specifically decided against requiring identification of the specific chemicals that triggered a Proposition 65 warning requirement.  [5/11/18]

Judge Jon S. Tigar of the U.S. District Court for the Northern District of California dismissed a proposed class action claiming that the addition of DHA -- an omega-3 fatty acid -- to Danone North America's Horizon Organic milk rendered the milk's organic label misleading.  Judge Tigar held that the federal Organic Foods Production Act preempted the claims, and also held that the plaintiff lacked standing because the label prominently disclosed the presence of DHA.  [5/4/18]

Judge Amit P. Mehta of the U.S. District Court for the District of Columbia upheld the U.S. Food and Drug Administration's rule imposing health warning requirements for cigar packaging and advertising and assessing a user fee on cigar and pipe tobacco products.  [5/18/18]

The Minnesota Supreme Court adopted the Restatement (Third) of Torts rule concerning post-sale duties to warn of safety hazards, finding that the rule promoted consistency, avoided perverse incentives to forego warnings of known dangers, and provided guidance to courts regarding the duties of various entities in a product's chain of distribution. [5/12/18]

An indictment unsealed May 3 charges Martin Winterkorn, the former Chief Executive Officer of Volkswagen AG, with conspiracy and wire fraud in connection with the automaker’s “defeat device” emissions cheating scandal. The indictment alleges that Winterkorn, along with other VW executives, not only knew about the “defeat devices,” but actively concealed VW’s cheating from federal regulators. [5/4/18]

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]

Facebook Inc. quietly changed its terms of service to make 1.5 billion users who currently are subject to Irish law subject to U.S. law instead, moving them out of the ambit of the European Unions General Data Protection Regulation, which goes into effect May 25.  [4/20/18]

The Federal Bureau of Investigation, the Department of Homeland Security, and the UK's National Cyber Security Centre issued an alert warning of a Russian state-sponsored cyber exploit that compromises routers and other network equipment and uses the network equipment to monitor, modify, and deny traffic.  [4/17/18]

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]