Emerging Products & Technology

On December 8, 2015, researchers at Harvard University announced that they had examined a small sample of flavored e-cigarette products and found that some contained diacetyl, a chemical suspected of causing respiratory illness. In the wake of this announcement, some news organizations reported that the Harvard paper established a “link” between e-cigarettes and bronchiolitis obliterans, a disease associated with diacetyl exposure.

But the Harvard study did not discuss any connection between diacetyl in e-cigarettes and respiratory illness. The researchers merely noted the presence of diacetyl in e-cigarettes and that diacetyl has been associated with respiratory disease in the industrial context. The study drew no conclusions about the possible health risks that vaping poses to consumers. Instead, the study’s authors recommended that this new potential source of exposure to diacetyl be further evaluated. Continue Reading Researchers Turn Their Attention to Diacetyl in E-Cigarettes

Millions of Americans rely on implantable medical devices to stay alive. These battery-operated devices communicate through wireless transmissions — and can be hacked like any other wireless device. For example, a wireless pacemaker regulates a person’s heartbeat and records the heart’s activity, and then transmits this information to doctors who can reprogram the pacemaker. The interconnectivity between medical devices and clinical systems leaves wireless medical devices vulnerable to security breaches. Continue Reading Hacking Health Care: When Cybersecurity Can Mean Life or Death

Two partners from Schiff Hardin LLP’s Product Liability & Mass Torts Practice Group spoke about the future of mass tort litigation in the United States at the Lloyd’s Old Library in London on October 20, 2015.  Paul A. Scrudato and Edward Casmere discussed the state of mass tort litigation and its future with a group of London-based insurance professionals in the historic Old Library at Lloyds on Lime Street in London.  The topics included nanotechnology, pharmaceuticals and medical devices, e-cigarettes, wearable technology, and fracking.

Continue Reading Schiff Hardin Partners Present on the Future of Mass Tort Litigation at Lloyd’s Old Library in London

Less than 1% of the population suffers from the serious gluten allergy known as celiac disease. Yet every time this writer goes out to dinner at least one dining companion passes on bread and pasta, claiming a self-diagnosed “gluten sensitivity” that manifests as a collection of nondescript symptoms, the major one being “fatigue.” The odd thing is that our obsession with gluten – present in a staple food for millennia – has only recently become the bad actor in all sorts of physical and mental maladies in celiac-free individuals. Continue Reading Electromagnetic Hypersensitivity (EHS): Fad Allergy, Debilitating Disease, or What?

For those of you who are fans of Michael McKean of This is Spinal Tap (lead singer David St. Hubbins…remember?), you know that he has a recurring role as Saul Goodman’s brother Chuck, on AMC’s hit show Better Call Saul.  Chuck is an x-Big Law partner who is convinced he has electromagnetic sensitivity. So he says in a dark, electricity free house wrapped in a big foil space blanket.  Art does, however, imitate fiction, as there are folks who live in communes in the US and Europe that are totally removed from any electromagnetic radiation from things like cell phones, garage door openers, and wifi. Continue Reading Suffer From Electromagnetic Hypersensitivity? Better Call . . .

As regulatory clouds continue to gather over the electronic cigarette industry, public health researchers have set their sights on the potential risks these products pose to non-users. A study published this month in conjunction with the FDA’s second public workshop on e-cigarettes claimed that bystanders may be exposed to aerosol particles smaller than 1,000 nanometers, similar in size to tobacco smoke and diesel engine exhaust. The aerosol, according to the study’s authors, contains nicotine, glycerin/glycols, artificial flavorings, and preservatives.

Continue Reading Regulators and Researchers Focus on Secondhand Exposure to E-Cigarette Emissions

The Federal Aviation Administration (FAA) has finally announced its proposed rules governing the commercial use of drones.  The proposed rules, which have been long-awaited by members of the emerging multi-billion dollar unmanned aerial vehicle industry, pave the way for the commercial use of drones in the United States.  The proposed rules, released on February 15, 2015, are applicable to all commercial drones under 55 pounds.  The rules would require such drones to operate only in daylight hours below a 500 foot altitude ceiling and under a 100 mph airspeed limit.

The proposed rule would also prohibit the operation of commercial drones in the vicinity of other aircraft or known flight paths and, significantly, would prohibit the operation of drones above any people not involved in the operation of the drone.  One restriction in particular is likely to receive significant attention during the upcoming comment section for the proposed rule.  That proposal requires that drones only be operated within the unaided visual-line-of-site of their operators. Such a limitation, combined with a proposed prohibition of dropping any objects from a drone, is certain to impact various publicized plans for commercial drone delivery services. Continue Reading FAA Clears Way for Commercial Drone Use

Researchers, academics, public health advocates, and other stakeholders in the e-cigarette industry participated in the FDA’s first public workshop on e-cigarettes over two days in December 2014.  The workshop on e-cigarettes and other vapor products (sometimes referred to as Electronic Nicotine Delivery Systems, or ENDS) suggested that ongoing efforts to regulate these devices are aligning some players while at the same time exposing some divisions within the industry.

Several common themes emerged from tobacco industry representatives, FDA-affiliated presenters, and public health presenters at the workshop: product uniformity, material quality standards, and concerns about user-modified products. Some participants expressed concern that user-modified devices allow for greater inhalation, as well as increased fire risk from more powerful batteries.  FDA chemist Michael Trehy pointed out the presence of impurities in e-cigarettes, as well as variations between claimed and actual nicotine content of certain products.  It was suggested that a push against user-modified products may disadvantage smaller players in the market, who specialize in customizable “open systems,” and that regulations may give large traditional tobacco manufacturers an edge over smaller competitors.

Continue Reading First FDA E-Cigarette Workshop Highlights Divisions in the Industry

E-cigarettes continue to come under fire from numerous groups, as shown by several events in the last week. Scientists from Portland State University, in a January 22 letter to the New England Journal of Medicine, contend that e-cigarette use may carry a risk of cancer 5 to 15 times greater than the risk associated with traditional cigarettes. That conclusion is based on data showing e-cigarette vapers may inhale formaldehyde-releasing agents. The researchers conceded that “[h]ow formaldehyde-releasing agents behave in the respiratory tract is unknown.” However, they estimated a vaper’s daily exposure to formaldehyde could be more than 4.5 times that of a pack-a-day cigarette smoker. This study relates exclusively to e-cigarettes used on high voltage settings – at lower voltages, the scientists detected no formaldehyde.  And the study extrapolated the results from a single test without considering real-world vaping habits, which have not been studied well to date.

Continue Reading Cancer Concerns, Proposed New Regulations Dog E-Cigarette Industry

On Thursday, January 22, 2015, Transportation Secretary Anthony Foxx announced that the National Highway Traffic Safety Administration plans to change its safety ratings program for passenger vehicles by adding two automatic emergency braking systems to the agency’s recommended advanced safety features. NHTSA’s New Car Assessment Program currently awards up to five stars to vehicles based on safety features.  Under the proposed change, the two automatic emergency braking systems – crash imminent braking (CIB) and dynamic brake support (DBS) – would be considered by NHTSA when deciding a vehicle’s safety rating.  The proposed change to NHTSA’s safety ratings program is currently in a 60-day public comment period. Continue Reading NHTSA To Change Safety Rating Program