CPSC Finalizes Ban on Certain Children’s Toys and Child Care Articles

On October 27, 2017, the U.S. Consumer Product Safety Commission (“CPSC”) issued a final rule prohibiting children’s toys and child care articles that contain concentrations of more than 0.1 percent of certain phthalates.

What’s Prohibited

The final rule states children’s toys and child care articles containing concentrations of more than 0.1 percent of diisononyl phthalate (“DINP”), diisobutyl phthalate (“DIBP”), di-n-pentyl phthalate (“DPENP”), di-n-hexyl phthalate (“DHEXP”), and dischyclohexyl phthalate (“DCHP”) are prohibited.

Section 108 of the Consumer Product Safety Improvement Act (“CPSIA”) prohibits the manufacture for sale, offer for sale, distribution in commerce, or importation into the U.S. of any children’s toy or child care article that contains these concentrations of certain phthalates.  Children’s toys include consumer products designed or intended by the manufacturer for a child 12 years or younger for use by the child when the child plays.  A child care article is a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.

What Are Phthalates

The most common phthalate, DINP, is added to some plastics to make them flexible and is commonly found in automobile interiors, wire and cable insulation, gloves, tubing, garden hoses, and shoes.  DINP is also found in flexible vinyl materials that are used in the production of bedding, garments, outdoor products such as tents and book binders.  Non-PVC or vinyl products include inks, adhesives, sealants, paints and lacquers.  DINP is also a listed substance known to cause cancer under California’s Proposition 65 and products must provide a warning about exposure.

The CPSC determined that because DIBP, DPENP, DHEXP, and DCHP aren’t widely used, few manufacturers will be impacted and need to reformulate their products.  Examples of products containing these phthalates are coating products, fillers, plasters, binding agents, paints, adhesives,

Who’s Affected

The final rule expanded the interim rule concerning DINP to cover all children’s toys, not just those that can be placed in a child’s mouth.  Children’s toys that can be placed in a child’s mouth and child care articles containing more than 0.1 percent of DINP have been prohibited since 2009.  Manufacturers won’t have to reformulate products in these categories.  Only manufacturers of children’s toys that cannot be placed in a child’s mouth will be affected by the final rule.

The final rule applies to both domestic manufacturers and importers and will not be a barrier to international trade.  The prohibition involving DINP applies regardless of the origin of the DINP or the phthalate formulation used.  Children’s toys and child care articles containing DINP in concentrations greater than 0.1 percent are prohibited even if DINP was not intentionally added.

The final rule becomes effective April 25, 2018 and applies to products manufactured or imported on or after that date.

This post was written by Ayako Hobbs of Squire Patton Boggs (US) LLP., © Copyright 2017
For more legal analysis go to The National Law Review

Sears Seeks to Modify FTC Order on Online Tracking

In 2009, Sears Holding Management settled with the Federal Trade Commission (FTC) over allegations that the company’s online tracking activity exceeded what they told consumers. Now, Sears has submitted a petition requesting that the FTC reopen and modify its settlement order, arguing that changing technology since 2009 has made the order’s definition of “tracking applications” too broad and has put them at a competitive disadvantage.

The 2009 FTC complaint charged that Sears “failed to disclose adequately the scope of consumers’ personal information it collected via a downloadable software application, telling consumers that the software would track their “online browsing,” without telling them that it also collected information from third-party websites consumers visited such as their shopping cart information, online bank statements, and drug prescription records. Sears was required to stop collecting data from participating consumers and to destroy what they’d collected.

Sears now argues that the definition of “tracking application” in the FTC’s order now applies to most software on nearly all platforms, making them “out of step with current market practices without a corresponding benefit in combatting threats to consumer privacy.” The definition of tracking applications is so broad, Sears claims, that it “encompasses all of Sears’ current mobile apps, forcing Sears to handle disclosures differently than other companies with mobile apps and disadvantaging Sears in the marketplace.” Sears claims that modification of the order would allow the retailer to align with current tracking practices used by their competitors.

 This post was written by Sheila A. Millar ,Tracy P. Marshall Nathan A. Cardon of Keller and Heckman LLP.,© 2017
For more legal analysis, go to The National Law Review 

Telemedicine – Are There Increased Risks With Virtual Doctor Visits?

“Telemedicine” or “Telehealth” are the terms most often used when referring to clinical diagnosis and monitoring that is delivered by technology. Telemedicine encompasses healthcare provided via real time two-way video conferencing; file sharing, including transmission of health history, x-rays, films, or photos; remote patient monitoring; and consumer mobile health apps on smart phones, tablets, and devices that collect data and transmit it to a healthcare provider. Telemedicine is increasingly being used for everything from diagnosing common viruses to monitoring patients with serious long-term health issues.

The American Telemedicine Association reports that majority of hospitals now use some form of telemedicine. Two years ago, there were approximately 20 million telemedicine video consultations; that number is expected to increase to about 160 million by 2020. An estimated one-third of employer group plans already cover some type of telehealth.

Telemedicine implicates legal and regulatory issues as licensing, prescribing, credentialing, and cybersecurity. Pennsylvania recently passed legislation joining the Interstate Medical Licensing Compact, an agreement whereby licensed physicians can qualify to practice medicine across state lines within the Compact if they meet the eligibility requirements. The Compact enables physicians to obtain licenses to practice in multiple states, while strengthening public protection through the sharing of investigative and disciplinary information.

Federal and state laws and regulations may differ in their definitions and regulation of telemedicine. New Jersey recently passed legislation authorizing health care providers to engage in telemedicine and telehealth. The law establishes telemedicine practice standards, requirements for health care providers, and telehealth coverage requirements for various types of health insurance plans. Earlier this year, Texas became the last state to abolish the requirement that patient-physician relationships must first be established during an in-person patient/doctor visit before a telemedicine visit.

As telemedicine use increases, there will likely be an increase in related professional liability claims. One legal issue that arises in the context of telemedicine involves the standard of care that applies. The New Jersey statute states that the doctor is held to the same standard of care as applies to in-person settings. If that is not possible, the health care provider is required direct the patient to seek in-person care. However, the standard of care for telemedicine is neither clear nor uniform across the states.

Another issue that arises in the context of telemedicine is informed consent, especially in terms of communication, and keeping in mind that the Pennsylvania Supreme Court recently held that only the doctor, and not staff members, can obtain informed consent from patients. Miscommunication between a healthcare provider and patient is often an underlying cause of medical malpractice allegations in terms of whether informed consent was obtained.

In addition, equipment deficiencies or malfunctions can mask symptoms that would be evident during an in-person examination or result in the failure to transmit data accurately or timely, affecting the diagnosis or treatment of the patient.

Some of these issues will likely ultimately be addressed by legislative or regulatory bodies but others may end up in the courts. According to one medical malpractice insurer, claims relating to telemedicine have resulted from situations involving the remote reading of x-rays and fetal monitor strips by physicians, attempts to diagnose a patient via telemedicine, delays in treatment, and failure to order medication.

recent Pennsylvania case illustrates how telemedicine may also impact the way medical malpractice claims are treated in the courts. In Pennsylvania, a medical malpractice lawsuit must be filed in the county where the alleged malpractice occurred. Transferring venue back to Philadelphia County, the Superior Court in Pennsylvania found that alleged medical malpractice occurred in Philadelphia — where the physician and staff failed to timely transmit the physician’s interpretation of an infant’s echocardiogram to the hospital in another county where the infant was being treated.

The use of telemedicine will likely have wide-reaching implications for health care and health care law, including medical malpractice.

This post was written by Michael C. Ksiazek of STARK & STARK, COPYRIGHT ©
2017
For more Health Care legal analysis, go to The National Law Review 

GM Labeling Update: Ingredient Disclosure Debate

  • As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018. On June 28, 2017, USDA’s Agricultural Marketing Service (AMS) posted a list of 30 questions to obtain stakeholder input to facilitate the drafting of mandatory disclosure requirements to implement the National Bioengineered Food Disclosure Law. One of those questions is:
    • “Will AMS require disclosure for food that contains highly refined products, such as oils or sugars derived from bioengineered crops?”
  • USDA has not yet posted the comments it has received, which were due by August 25, 2017; however, several organizations have posted the comments they submitted in response to the questions. Among the organizations supporting disclosure were the Grocery Manufacturers Assn. (GMA), the International Dairy Foods Assn. (IDFA)and the Consumers Union. Noting that excluding highly refined ingredients (HRI) from the scope of the mandatory disclosure standard would result in roughly 80% fewer products being subject to the disclosure requirements under the federal law, GMA wrote, “A clear, simple, and consistent mandatory disclosure standard that includes HRI will assist manufacturers in educating consumers about biotechnology as a safe and beneficial method of plant breeding.”
  • In contrast, the Information Technology & Innovation Foundation (ITIF) and The Biotechnology Innovation Organization (BIO) are opposed to mandatory disclosure of HRI. ITIF suggested that some refined products do not contain residual DNA sequences and that “[t]here are not analytical methods that would allow such products to be identified as coming from ‘GM’ plants or animals vs. others.”
  • While USDA develops mandatory disclosure requirements for bio-engineered foods, a number of class action laws suit have been filed suggesting that products containing GM ingredients are falsely labeled as natural. For example, last week, the U.S. Supreme Court refused to hear a bid by Conagra Brands Inc. to avoid a class-action lawsuit concerning cooking oil labeled 100% natural that contains GM ingredients (see S. News). And earlier this month, Frito-Lay North America agreed to not make any non-GMO claims on certain products “unless the claim is certified by an independent third-party certification organization”(see Food Navigator).
  • We will continue to monitor developments on the National Bioengineered Food Disclosure Standard and report them to you here.
This post was written by the Food and Drug Law at Keller and Heckman of Keller and Heckman LLP., © 2017
For more Biotech, Food & Drug legal analysis, go to The National Law Review

So…Everyone’s Been Compromised? What To Do In The Wake of the Equifax Breach

By now, you’ve probably heard that over 143 million records containing highly sensitive personal information have been compromised in the Equifax data breach. With numbers exceeding 40% of the population of the United States at risk, chances are good that you or someone you know – or more precisely, many people you know – will be affected. But until you know for certain, you are probably wondering what to do until you find out.

To be sure, there has been a lot of confusion. Many feel there was an unreasonable delay in reporting the breach. And now that it has been reported, some have suggested that people who sign up with the Equifax website to determine if they were in the breach might be bound to an arbitration clause and thereby waive their right to file suit if necessary later (although Equifax has since said that is not the case). Others have reported that the “personal identification number” (PIN) provided by Equifax for those who do register with the site is nothing more than a date and time stamp, which could be subject to a brute-force attack, which is not necessarily reassuring when dealing with personal information. Still others have reported that the site itself is subject to vulnerabilities such as cross-site scripting (XSS), which could give hackers another mechanism to steal personal information. And some have even questioned the validity of the responses provided by Equifax when people query to see if they might have been impacted.

In all the chaos, it’s hard to know how to best proceed. Fortunately, you have options other than using Equifax’s website.

1. Place a Credit Freeze

Know that if you are a victim of the breach, you will be notified by Equifax eventually. In the meantime, consider placing a credit freeze on your accounts with the three major credit reporting bureaus. All three major credit reporting bureaus allow consumers to freeze their credit reports for a small fee, and you will need to place a freeze with each credit bureau. If you are the victim of identity fraud, or if your state’s law mandates, a credit freeze can be implemented without charge. In some states, you may incur a small fee. Lists of fees for residents of various states can be found at the TransUnionExperian, and Equifax websites. Placing a freeze on your credit reports will restrict access to your information and make it more difficult for identity thieves to open accounts in your name. This will not affect your credit score but there may be a second fee associated with lifting a credit freeze, so it is important to research your options before proceeding. Also, know that you will likely face a delay period before a freeze can be lifted, so spur-of-the-moment credit opportunities might suffer.

Here is information for freezing your credit with each credit bureau:

Equifax Credit Freeze

  • You may do a credit freeze online or by certified mail (return receipt requested) to:

            Equifax Security Freeze

            P.O. Box 105788

            Atlanta, GA 30348

  • To unfreeze, you must do a temporary thaw by regular mail, online or by calling 1-800-685-1111 (for New York residents call 1-800-349-9960).

Experian Credit Freeze

  • You may do a credit freeze online, by calling 1-888-EXPERIAN (1-888-397-3742) or by certified mail (return receipt requested) to:

            Experian

            P.O. Box 9554

            Allen, TX 75013

  • To unfreeze, you must do a temporary thaw online or by calling 1-888-397-3742.

TransUnion Credit Freeze

  • You may do a credit freeze online, by phone (1-888-909-8872) or by certified mail (return receipt requested) to:

            TransUnion LLC

            P.O. Box 2000

            Chester, PA 19016

  • To unfreeze, you must do a temporary thaw online or by calling 1-888-909-8872.

After you complete a freeze, make sure you have a pen and paper handy because you will be given a PIN code to keep in a safe place.

2. Obtain a Free Copy of Your Credit Report

Consider setting up a schedule to obtain a copy of your free annual credit report from each of the reporting bureaus on a staggered basis. By obtaining and reviewing a report from one of the credit reporting bureaus every three or four months, you can better position yourself to respond to unusual or fraudulent activity more frequently. Admittedly, there is a chance that one of the reporting bureaus might miss an account that is reported by the other two but the benefit offsets the risk.

3. Notify Law Enforcement and Obtain a Police Report

If you find you are the victim of identity fraud (that is, actual fraudulent activity – not just being a member of the class of affected persons), notify your local law enforcement agency to file a police report. Having a police report will help you to challenge fraudulent activity, will provide you with verification of the fraud to provide to credit companies’ fraud investigators, and will be beneficial if future fraud occurs. To that end, be aware that additional fraud may arise closer to the federal tax filing deadline and having a police report already on file can help you resolve identity fraud problems with the Internal Revenue Service if false tax returns are filed under your identity.

4. Obtain an IRS IP PIN

Given the nature of the information involved in the breach, an additional option for individuals residing in Florida, Georgia, and Washington, D.C. is to obtain an IRS IP PIN, which is a 6-digit number assigned to eligible taxpayers to help prevent the misuse of Social Security numbers in federal tax filings. An IP PIN helps the IRS verify a taxpayer’s identity and accept their electronic or paper tax return. When a taxpayer has an IP PIN, it prevents someone else from filing a tax return with the taxpayer’s SSN.

If a return is e-filed with a taxpayer’s SSN and an incorrect or missing IP PIN, the IRS’s system will reject it until the taxpayer submits it with the correct IP PIN or the taxpayer files on paper. If the same conditions occur on a paper filed return, the IRS will delay its processing and any refund the taxpayer may be due for the taxpayer’s protection while the IRS determines if it is truly the taxpayer’s.

Information regarding eligibility for an IRS IP PIN and instructions is available here and to access the IRS’s FAQs on the issue, please go here.

Conclusion

Clearly, the Equifax breach raises many issues about which many individuals need to be concerned – and the pathway forward is uncertain at the moment. But by being proactive, being cautious, and taking appropriate remedial measures available to everyone, you can better position yourself to avoid fraud, protect your rights, and mitigate future fraud that might arise.

 This post was written by Justin L. Root Sara H. Jodka of Dickinson Wright PLLC © Copyright 2017
For more legal news go to The National Law Review

Trump Administration Issues New Guidance for Automated Driving Systems

The National Highway Traffic Safety Administration (NHTSA) announced yesterday the Trump administration’s first significant guidance concerning autonomous vehicles and Automated Driving Systems (ADS).

The new voluntary guidelines, titled Automated Driving Systems: A Vision for Safety, are intended to encourage innovation in the industry and are being touted as the administration’s “new, non-regulatory approach to promoting the safe testing and development of automated vehicles.” One of the most important aspects of these guidelines is the NHTSA’s clarification of its view of the delineation between the roles of the states and the federal government with respect to ADS technology.

The new guidelines replace the Federal Automated Vehicle Policy (FAVP), which was released by the Obama administration in 2016A Vision for Safety comprises voluntary guidance for vehicle manufacturers, best practices for state legislatures when drafting ADS legislation, and a request for further comment.

Autonomous-vehicle manufacturers are asked to undertake a voluntary self-assessment addressing 12 safety elements discussed in the new guidance. That is a slight departure from the FAVP, which detailed a 15-point safety assessment. The safety self-assessment remains voluntary, and NHTSA emphasizes that there is no mechanism to compel manufacturers to participate. The agency also stated that the testing or deployment of new ADS technologies need not be delayed to complete a self-assessment.

In what may be the most significant component of the guidance, NHTSA made clear its role as the primary regulator of ADS technology by “strongly encourage[ing] States not to codify th[e] Voluntary Guidance . . . as a legal requirement for any phases of development, testing, or deployment of ADSs.”

Further acknowledging the potential problems associated with a patchwork of state laws, the agency expressed its belief that “[a]llowing NHTSA alone to regulate the safety design and performance aspects of ADS technology will help avoid conflicting Federal and State laws and regulations that could impede deployment.” States are instead tasked by A Vision for Safety with regulating licensing of human drivers, motor vehicle registration, traffic laws, safety inspections, and insurance.

The new guidance comes just one week after the House of Representatives passed the SELF-DRIVE Act designed to eliminate legal obstacles that could interfere with the deployment of autonomous vehicles. However, as NHTSA and Congress are seeking to speed up ADS development by removing regulatory and legal impediments, it is noteworthy that on the same day NHTSA announced A Vision for Safety, the National Transportation Safety Board (NTSB) called for NHTSA to require automakers to install “system safeguards to limit the use of automated vehicle systems to those conditions for which they were designed.”

In an abstract of its forthcoming final report on the 2016 fatal crash involving a Tesla Model S operating in semi-autonomous mode, the NTSB concluded that “operational limitations” in the Tesla’s system played a major role in the fatal crash and that the vehicle’s semi-autonomous system lacked the safeguards necessary to ensure that the system was not misused. These recent developments only underscore the uncertainty facing the industry as regulators attempt to keep pace with fast-developing technology.

This post was written by Neal Walters and Casey G. Watkins of  Ballard Spahr LLP Copyright ©
For more legal analysis go to The National Law Review

Court Orders Monsanto Roundup Safety Documents to be Disclosed

Monsanto is catching a lot of heat now that a court has unsealed documents that cast the company in a negative light and suggest that it was responsible for providing false assertions to the government and public regarding the safety of Roundup. As the most popular herbicide in the world, Roundup and similar products produced by Monsanto are used across the globe for the elimination of pests from lawns, crops, gardens and nurseries. It has provided research that opposes the belief Roundup’s main active ingredient can cause cancer, but the documents unsealed by the court show that these accounts were misleading and, in some cases, false.

Ghostwritten Research

The research that was presented to defend the safety of its products was in fact, ghostwritten and attributed to academics. It also claimed that a senior EPA official attempted to dismiss a report from the United States Department of Health and Human Services that the product could in fact be linked to the deaths of numerous people who suffered from non-Hodgkin’s lymphoma. The evidence tells a story of arguments within the Environmental Protection Agency and conflicting beliefs over whether Roundup and similar products were safe to use.

Emails between Monsanto executives and Jess Rowland of the EPA discuss an effort to disrupt the efforts of the Department of Health and Human Services to make its own determination and review of the product. Rowland states in the emails that he should receive a medal if he is able to succeed in his interference.

World Health Organization Classifies Products as Carcinogenic

The growing litigation over Roundup was sparked off by the classification of Roundup as a carcinogen, due to the discovery of a link between glyphosate and cancer in animals and the destruction of DNA and chromosomes in human cells. Despite the research provided by the WHO, Monsanto went to great lengths to continue the defense of its product and to assert that it was as safe to consume as salt.

While Monsanto claims that glyphosate is safe, those who have come forward with claims against the company allege that Monsanto has repeatedly falsified research and information in order to fool the government and the public. In its defense, Monsanto has claimed that the unsealed documents are being presented out of context and that they provide isolated information. Numerous health agencies around the world have presented conflicting arguments over the safety of these products, so the science has not been settled just yet.

This post was written by Jonathan Rosenfeld of Rosenfeld Injury Lawyers, Copyright © 2017
For more legal analysis go to The National Law Review