FDA (Food and Drug Administration) Declines Courts’ Requests to Define “Natural” with respect to GMO (Genetically-Modified Organisms) Foods

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The FDA recently issued a letter to three federal district court judges declining the courts’ requests to adopt a definition of “natural” or to state whether the terms “natural” or “all natural” can be used to refer to foods containing genetically-modified organisms (GMOs) to help resolve pending consumer class actions over the term. The FDA cited three reasons for its decision not to define the term(s): (1) it would prefer to use a public, administrative process than to define the term in the context of private litigation; (2) the definition implicates other agencies, most notably, the USDA; and, (3) the FDA has limited resources and other matters currently take priority.

As noted in our August 2013 Alert on the issue, Judge Yvonne Gonzalez Rogers of theNorthern District of California started the trend in Cox v. Gruma Corp., a case in which the plaintiff alleges that Gruma’s use of “all natural” on its tortilla shells violates various consumer protection laws because they contain genetically-modified corn. In Van Atta v. General Mills, pending in Colorado and involving GMOs in granola products, a magistrate judge agreed with Judge Rogers and recommended a stay of proceedings in the case pending the FDA’s response to Judge Rogers’s request. Most recently, in Barnes v. Campbell Soup Co., also pending in the Northern District of California and involving GMOs in various soups, a different judge also stayed the case pending the FDA’s response.

These cases are potentially quite important because there are many pending consumer class actions, particularly in California, over whether the use of some variant of the term “all natural” is proper in light of one or more ingredients in the food at issue. Indeed, some quip that food labeling litigation has replaced tobacco and asbestos as the favorite category of suit for the plaintiffs’ bar. Thus, the FDA’s response to the request by these courts, and the courts’ further actions based on the response, could resolve or guide the resolution of many of these cases.

In a related development, the Grocery Manufacturers’ Association has recently filed a citizen’s petition asking FDA to state that GMO foods may be labeled “natural.” The FDA alluded to the possible filing of this petition in its letter, but did not state whether it is willing to take up the issue using that procedure, which does allow for public comment.

A copy of the FDA’s letter can be found here.

Article by:

Of:

Barnes & Thornburg LLP

Hey Wait, What About North Carolina's Fancy New Quasi-Judicial Statute?

Poyner Spruill

 

In 2009, the North Carolina General Assembly adopted Senate Bill 44, an act that codified the case law regarding quasi-judicial land use proceedings, including the proper standards and procedures for judicial review. See N.C. Gen. Stat. § 160A-393. Quasi-judicial land use decisions include, among other things, decisions involving variances, special and conditional use permits, and appeals of administrative decisions. See N.C. Gen. Stat. § 160A-393(b)(3).  The adoption of this new statute took the effort of many accomplished land use attorneys and interested stakeholders.  In fact, discussions regarding the need for this legislation originated before my legal career even began. So, when I read a recent Court of Appeals decision involving the denial of a special use permit by a quasi-judicial body, I was befuddled as to why the opinion did not contain a single citation to G.S. § 160A-393.

In Blair Investments, LLC v. Roanoke Rapids City Council, et al. (filed December 17, 2013), the petitioner sought a special use permit to construct a cell phone tower.  After considering the evidence presented by the applicant, planning department and concerned neighbors, the Roanoke Rapids City Council denied the special use permit on the grounds that the proposed tower would “endanger the public or safety” and would “not be in harmony with the surrounding area.”  The Superior Court affirmed the Council’s decision.  On appeal, however, the Court of Appeals reversed the Council’s decision on the grounds that the applicant had met its burden of making a prima facie showing of entitlement to the special use permit and the testimony of the concerned neighbors were speculative opinions, unsupported by any documentary or testimonial evidence.  Therefore, the Court held the Council’s decision was not supported by substantial, competent, and material evidence and remanded the case with instructions that the special use permit be granted.  

To be clear, I take no issue with the Court’s ultimate decision in Blair.  The Court appropriately reviewed the record and made the correct determination based on the facts and evidence that were before the Council.  I also take no issue with the overall legal principles and case law cited by the Court in Blair.  I do find it perplexing, however, that in discussing the appeal procedure, scope of review and its ultimate disposition of the case, the Court cited to a number of cases decided prior to the adoption of G.S. § 160A-393, but did not cite to or discuss 160A-393 at all.  As already discussed, the purpose of adopting 160A-393 was to codify prior case law and establish the black letter law governing the review of quasi-judicial decisions.  Perhaps the failure to recognize or cite to 160A-393 was an oversight by the lawyers who argued the case or perhaps it simply slipped by the law clerks working on the opinion.  I can’t imagine, however, the statutory framework for reviewing quasi-judicial decisions was completely ignored by the Court intentionally.

Many might consider this article to be a technical assault on an otherwise good appellate opinion.  While I believe it to be a substantive omission, my true reason for writing this article is to hopefully ensure that this fancy new statute at least gets dropped in a future footnote. Too many people worked too hard for it not to.

Article by:

Chad W. Essick

Of:

Poyner Spruill LLP

Comment Period Almost Over for OSHA (Occupational Safety and Health Administration) Crystalline Silica Proposal

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In August 2013, the Occupational Safety and Health Administration (“OSHA”) announced a proposed rule regarding workplace exposure to crystalline silica. The proposal includes two separate standards – one for general industry and maritime employment, and one for construction.

If you do not know what crystalline silica is, chances are you are not in an industry that has exposure to it. Crystalline silica is minute, respirable particles that are generated from operations involving stone, rock, concrete, brick, block, mortar and industrial sand. Workers who encounter these materials are in a broad range of industries, including mining, oil and gas, foundries, masonries, pottery manufacturing, and sand blasting.

OSHA’s proposal seeks to limit routine occupational exposure to the so-called “deadly dust.” Inhalation of the particles causes silicosis, an incurable lung disease. Workers are also at risk for developing lung cancer, chronic obstructive pulmonary disease, and kidney disease.  OSHA estimates that its proposal will save 700 lives each year and prevent 1,600 cases of silicosis annually. There are already established permissible exposure limits (“PEL”) for silica, but they were established in 1971 – new research reflects that more stringent standards are needed. The new PEL, 50 micrograms per cubic meter of air, would apply to all the regulated industries (though OSHA plans to create distinct standards for the construction industry). In addition to the PEL, the rule also calls for medical surveillance, worker training, recordkeeping, and exposure assessments.

Initially, the deadline to submit written comments and testimony to OSHA was December 11, 2013. That deadline, however, was extended by an additional 47 days to allow for additional public input. The new cut-off is January 27, 2014. Public hearings on the issue are scheduled to begin in March and will likely continue for several weeks due to the significant impact the rule will have on so many industries. Millions of American workers encounter crystalline silica in their day-to-day work operations.

The proposal will directly affect many small businesses and OSHA is specifically interested in receiving input from these entities. Be sure to check back on Wednesday with some tips on what employers can do now to protect workers (and potentially limit their liability for future silica-related claims).

Article by:

Cynthia L. Effinger

Of:

McBrayer, McGinnis, Leslie and Kirkland, PLLC

PTO Litigation Center Report – January 14, 2014

Sterne Kessler Goldstein Fox

Listed below are all new filings before PTAB of requests for inter partes review (IPR) and covered business methods review (CBM).  Since the last report, no new requests for ex parte reexamination at the USPTO have been posted.  This listing is current as of 9:30 AM on Tuesday, January 14, 2014.

New IPR Requests

Trial Number – IPR2014-00346
Filing Date – 1/13/2014
Patent # – 8,364,295
Title – INTERACTIVE SOUND REPRODUCING
Assignee – BOSE CORPORATION
Petitioner – SDI TECHNOLOGIES, INC.
Status – Pending
Tech Center – 2600

Trial Number – IPR2014-00347
Filing Date – 1/13/2014
Patent # – 8,504,631
Title – METHOD APPARATUS AND BUSINESS SYSTEM FOR ONLINE COMMUNICATIONS WITH ONLINE AND OFFLINE RECIPIENTS
Assignee – EVERYMD.COM LLC
Petitioner – GOOGLE INC. and TWITTER, INC.
Status – Pending
Tech Center – 2400

New CBM Review Requests

There have been no new requests for CBM review since the last report.

Newly-Posted Reexam Requests

Control # – 90/013,118
Date – 1/13/2014
Patent # – 6,435,450
Inventor –  SHIELDS, John et al.
Assignee –  SASCO
Title – MULTI-COMPARTMENT PARALLELING REEL HAVING INDEPENDENT COMPARTMENTS
Co-pending Litigation – SASCO v. Weber Electric Mfg. Co., Case No. 8:13-cv-00022-CJC-JPR, CD Cal.

 

Article by:

PTO Litigation Center

Of:

Sterne, Kessler, Goldstein & Fox P.L.L.C.

New Jersey Governor Publicly Signs DREAM Act, Calls Undocumented Students 'An Inspiration'

GT Law

 

On January 7, 2014, the Governor of New Jersey publicly signed the state’s DREAM Act,which provides in-state tuition benefits at public colleges and universities to undocumented graduates of New Jersey high schools. The legislation, which the Governor privately signed last month, emerged from a bipartisan compromise after legislators agreed to remove a provision that would have extended financial aid eligibility to undocumented students. The Governor previously said he would veto the bill if the financial aid provision remained.

Explaining his support for the law, the Governor stated, “Our job I believe as a government is to give every one of these children, who we have already invested hundreds of thousands of dollars in, an opportunity to maximize that investment for their own benefit, for the benefit of their families, and for the benefit of our state and our country.” The Governor also urged students who stand to benefit from the legislation to “make the most of the opportunity,” while a U.S. Senator for New Jersey released a statement describing New Jersey as “a more welcoming and inclusive state for immigrants and their families” due to the new law.

Article by:

Nataliya Binshteyn

Of:

Greenberg Traurig, LLP

Updates from the January 2014 Visa Bulletin

GT Law

 

The Department of State (“DOS”) recently released the January 2014 Visa Bulletin, which contains some very interesting developments that affect foreign workers in the Employment-Based 2nd and 3rd categories, particularly those who are citizens of China. The Visa Bulletin is issued by the DOS on a monthly basis and informs applicants when they are eligible to apply for U.S. Permanent Residence (commonly referred to as “Green Card”). Each fiscal year, each country is issued an equal number of immigrant visa numbers. However, as there are more applicants seeking green cards from certain countries (i.e. India, China, Mexico and Philippines) than there are numbers available, the citizens of affected countries experience significant delays in getting their green cards. This is known as visa retrogression. Affected applicants cannot adjust their statuses to green card holders until the priority dates on their respective cases become current. Each month the DOS publishes the Visa Bulletin, which indicates what priority dates are current and who is eligible to apply for the final stage of the green card process. Wait times published in the Visa Bulletin range from a few months to 10 or more years.

The January 2014 Visa Bulletin is unusual because the EB-3 category is moving faster than the EB-2 category for Chinese citizens. (To qualify for the EB-2 category, the offered position must require a Master’s degree or Bachelor’s degree and five years of experience; EB-3 requires a Bachelor’s degree.) For example, a Chinese national whose EB-3 PERM application was filed on or before March 31, 2012 is now eligible to adjust status, whereas a Chinese national whose EB-2 PERM application was filed on the same date is not. Historically, China EB-2 has moved faster than China EB-3, which is why this month’s visa bulletin is unique. As a result, many employers may see an increase in requests from employees for an EB-3 green card process. If the employee already has an approved EB-2 I-140 (second phase of the employment based green card process), the company can consider filing an amended I-140 and request EB-3 classification while retaining the priority date. If the amended I-140 will make the applicant’s priority date current, the applicant is eligible to concurrently file an Adjustment of Status application (the final phase of the green card process). We’ll continue to monitor Chinese EB-3 movement on this blog. Unfortunately, for Indian nationals we saw no change from the December 2013 to January 2014 Visa Bulletin. The February Visa Bulletin is expected to be released in the next 12 -14 days, and we will report on any pertinent developments.

Employment-Based Visa Bulletin Predictions

The Department of State also issued predictions in Visa Bulletin movement for the next few months. For the EB-2 category, the Department of State predicted no forward movement for India EB-2, slight movement of 3-5 weeks for EB-2 China, and Worldwide will remain current.

For the EB-3 category, the Worldwide category has experienced rapid movement forward, which is expected to end in February 2014. China and Mexico will likely continue to match the Worldwide dates. No forward movement is estimated for India, and the Philippines is projected to have slight movement forward of 3-6 weeks.

EB-1 is expected to remain current.

EB-3 Worldwide, China, and Mexico applicants with a current priority date should consider filing their Adjustment of Status applicants now as EB-3 priority dates may retrogress in the next few months.

December Visa Bulletin (includes DOS projections for upcoming months): http://travel.state.gov/visa/bulletin/bulletin_6211.html

January Visa Bulletin: http://www.travel.state.gov/visa/bulletin/bulletin_6228.html

Article by:

Emily R. Liss

Of:

Greenberg Traurig, LLP

Employers’ Immigration Update – No. 12 December 2013

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H-2B Employers Using Temporary Foreign Workers Not Required to Pay Supplemental Prevailing Wages

In a significant decision likely to have a major impact on H-2B employers, the Department of Labor’s Board of Alien Labor Certification Appeals (BALCA) has rejected the DOL’s attempt to apply supplemental prevailing wage determinations (PWDs) retroactively on employers who use H-2B temporary foreign labor. The action came in an Appeals Board Decision rendered on December 3.

Ninth Circuit Requires Reimbursement of H-2A Expenses

In the latest in a series of decisions addressing the proper allocation of travel and immigration fee expenses between employers and employees utilizing the H-2A agricultural guest worker program, the U.S. Court of Appeals for the Ninth Circuit, in San Francisco, has ruled that an employer must reimburse an H-2A worker for the employee’s travel and immigration expenses in the initial week of employment.

Health History Can Block Entry to U.S.

A disturbing trend appears to have developed in the last few years in admissions review at the Canadian border. U.S. border guards reportedly are barring entry to anyone they deem a threat to themselves, others or their property based on the person’s personal health history. The Information and Privacy Commissioner of Ontario will “look into the matter to ensure that personal health information isn’t compromised.” One 2011 report states, “More than a dozen Canadians have told the Psychiatric Patient Advocate Office in Toronto within the past year that they were blocked from entering the United States after their records of mental illness were shared with the U.S. Department of Homeland Security.”

New E-Verify MOU to be Released

New Memorandums of Understanding (MOUs) for E-Verify will be released on December 8, 2013, according to USCIS. Current E-Verify users will not be required to execute a new MOU, but they are bound by any and all enhancements to the E-Verify program, including the new or revised MOU that applies to their access method; therefore, they should become familiar with the new or revised MOU that applies to their access method. Employers who join the E-Verify program on or after December 8, 2013, will execute a new or revised MOU (Revision Date 06/01/2013) during enrollment.

Restaurant Manager Indicted on Harboring Charges

The manager of a restaurant who failed to complete I-9s and provide housing for his workers has been indicted on harboring charges. The manager faces a maximum penalty of 10 years in federal prison and a fine of up to $250,000 for each count in the indictment. These charges illustrate that ICE techniques for worksite enforcement are not limited to I-9 inspections and fines.

 

Article by:

Of:

Jackson Lewis P.C.

 

The Top Ten Things You Should Know About The Innovation Act of 2013 (For Now)

Andrews Kurth

 

Companies that find themselves either defending against patent infringement lawsuits or enforcing their own patent infringement claims should pay close attention to the Innovation Act of 2013 (H.R. 2639). The Innovation Act (“the Act”), which was introduced by Representative Bob Goodlatte (R-VA), made it out of committee and has now been passed by the House, is aimed squarely at non-practicing entities (“NPEs”), i.e., companies that own patents but that do not sell any products or provide any services themselves. While NPEs may be the primary target, the Innovation Act, if passed, will impact all patent litigation, not just NPE efforts. Likewise, while primarily having a potentially negative impact on plaintiffs, the Act will also have potentially negative impacts on defendants. With bipartisan support and the backing of the White House, the Innovation Act may be the first such legislation to pass.

The Innovation Act makes numerous amendments to Title 35, the section of U.S. Code embodying U.S. patent law. These changes include introducing a discovery delay and other discovery changes, fee shifting, customer suit staying and party-of-interest transparency, heightening pleading requirements and expanding post-grant review. If nothing else, NPEs and their targets should know the following about these changes and the Innovation Act:

Discovery: Perhaps the most expensive and intrusive aspect of any U.S. patent litigation is the discovery process. Indeed, the expense and process of discovery is often the most effective tool used by plaintiffs to bring defendants to settlement, as the process can begin early in the case before any substantial determinations regarding the merits are decided. As a result, defendants are often forced to spend up to hundreds of thousands of dollars going through the discovery process before having any idea whether infringement is a substantial risk or not. The Innovation Act significantly neuters this tool and makes other significant changes to discovery in patent cases:

1. The Act limits discovery to only matters relevant to interpreting the claims until such time as the claims are actually interpreted. Claim interpretation is often dispositive of the merits of the case. Consequently, defendants would be able to dispose of frivolous cases before the expensive discovery process or make settlement decisions more fully informed of the risks; and

2. The Act seeks to better balance discovery costs between the parties, ordering the Judiciary Conference to address the presumably unfair burden placed on defendants and place a higher burden of costs on plaintiffs.

Fee Shifting: Another area in which U.S. patent litigation, indeed U.S. litigation as a whole, differs from foreign litigation is that, except in extreme cases, each party bears its own litigation costs. Currently, NPEs often file suit against multiple defendants. Each defendant is often offered a settlement for an amount much less than that defendant’s anticipated litigation costs. As defendants settle, the settlement price typically is increased for other defendants, further encouraging early settlement. Consequently, many defendants that otherwise believe they have a strong non-infringement case will settle because the cost of achieving victory is substantially higher than settling. This strategy would not work in most foreign countries since, in those countries, the losing party pays the winning party’s fees and costs. The Innovation Act would align U.S. patent litigation with this practice and eliminate the strategy of leveraging high litigation costs for early settlement.

3. In other words, under the Act the Court can force the losing party to pay the winning party’s attorney fees and costs. If passed, this would have a dramatic effect on patent litigation defendants’ decision making process and the typical enforcement strategy of many NPEs. By allowing Courts to shift the litigation costs to the losing side, defendants may be significantly motivated to litigate when they have a strong case even if the price of settlement is relatively low. Combined with the discovery delay described above, defendants will have considerable incentive to remain in the case at least through claim interpretation and to fight infringement claims if the claim interpretation is favorable…

4. …but, by allowing Courts to shift litigation costs to the losing side, defendants’ potential exposure may also be much higher. If the defendant ultimately loses a case, the Court presumably could order them to pay the plaintiff’s litigation costs, particularly if it was apparent that they should have settled. Consequently, the Act’s changes will necessitate defendants making smart decisions about their risk exposure. Fortunately, the discovery delay will enable defendants to economically make more effective decisions by delaying significant discovery costs until after claim interpretation.

5. The Act’s fee-shifting provisions also allows for the limited joinder of parties (such as those covered by transparency provisions described below) to satisfy the award of litigation costs. In principle, this provision could be used against defendants as well as plaintiffs.

The other changes mentioned above may also cast a chill on the NPE business and other patent plaintiffs.

Customer Suit Staying

6. The Innovation Act requires the staying of patent lawsuits against a defendant’s customer. Plaintiffs often sue a defendant’s customers in order to pressure the defendant into settling, often on terms less favorable than the defendant’s actual liability would dictate. Under the Act, an action against a customer may be stayed if the customer agrees to be bound by the results of a suit against the manufacturer. Consequently, customer suit staying takes away another pressure point for plaintiffs.

Post-Grant Review Expansion

7. The Innovation Act expands the post-grant review available against covered business methods (“CBMs”), making CBM review a more effective tool to fight back against patent lawsuits. Specifically, the Act makes the CBM review program permanent and codifies the broad interpretation of what is a CBM.

Heightened Pleading Requirements

8. Currently, many plaintiffs merely name the patents infringed and, in some cases, the products or services infringing. Heightened pleading requirements require more detailed initial pleading by plaintiffs, including greater details describing how a defendant’s products or services infringe the asserted patent claims.

Party-of-Interest Transparency

9. The actual parties of interest are often not discernible from patent complaints. Many NPEs are shell companies that serve the purpose of hiding the actual party asserting the patent. The Innovation Act requires detailed descriptions of the plaintiff’s business and identification of the real party or parties-of-interest behind the asserting plaintiff. Such transparency makes next to impossible for plaintiff’s to hide their true identity and may impact litigation strategies currently used by NPEs and other plaintiffs.

10. Additionally, the party-of-interest transparency provisions of the Act also permit possible joinder of the real party or parties-of-interest behind the asserting plaintiff. This provision gives real teeth to the Fee Shifting provisions of the Act as it may prevent a real party-of-interest from hiding behind a shell company with limited or no resources and avoiding the consequences of the Fee Shifting provisions.

Keep in mind that the Innovation Act will not just affect the Act’s main target, NPEs. Indeed, the Innovation Act has the potential to affect others. Defendants that choose to fight a patent lawsuit rather than settle could find themselves on the losing end of the fee-shifting provisions. Also, the Act may encourage a delay in sharing sales numbers until after claim interpretation, with the result that defendants that may have previously settled for reasonable amounts may find themselves paying much higher amounts if the claim interpretation goes poorly. On a different front, the amounts NPEs and others are willing to pay for patents may be reduced because of the greater risks and costs involved in enforcement. This could reduce the market for patents that provide additional sources of revenue for many patent owners. This in turn could reduce the overall value of patents, the amount companies are willing to spend on patenting and result in an overall chilling effect on research and development and ultimately innovation. As the Innovation Act evolves through the legislative process, some or all of the points above may vary, but the clear direction of the Act, the limitation of patent litigation by NPEs, will remain.

Article by:

Sean S. Wooden

Of:

Andrews Kurth LLP

USDA (U.S. Department of Agriculture) Finalizes Import Regulations for “Mad Cow Disease”

Varnum LLP

 

In November, the USDA announced a final rule that will align the Agency’s import regulations for bovine spongiform encephalopathy (BSE or “mad cow disease”)with international standards. According to a USDA November news release, the final regulation will allow for the safe trade of bovines and bovine product, while still protecting the U.S. from the introduction of BSE.

Michigan Senator Debbie Stabenow praised the new rule by stating, “I applaud USDA’s actions to make sure that American’s beef producers have access to new export markets…This effort is crucial to breaking down other countries’ unfounded trade barriers, and re-opening trade markets that are closed to U.S. beef. American agriculture has long set the gold standard food production. [These] actions will ensure U.S. beef producers can operate on a more level playing field and help grow our agriculture economy.”

 

Article by:

Aaron M. Phelps

Of:

Varnum LLP

The Christmas Conundrum Re: Employee Time Off

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The holidays are a joyous time of year, but many employers face the season with a certain sense of trepidation as their employees inevitably request time off work.  As the holiday season kicks into full gear, now is a good time for employers to refresh themselves on basic guidelines for granting and denying employees’ vacation requests.

As a starting point, the availability of time off is typically dependent on a number of factors, including the employer’s formal policies, employment contracts, or a collective bargaining agreement. While there are no express state or federal laws requiring private employers to provide time off to celebrate holidays like Christmas, Hanukkah or Kwanzaa, Title VII of the Civil Rights Act of 1964 does require employers to ”reasonably accommodate” an employee’s religious practices, so long as it does not impose an “undue hardship” on the employer. Allowing an employee time off to observe a recognized religious holiday is normally a reasonable accommodation that should be made, if requested, without an undue burden.

Although some employers voluntarily reward employees with at least some time off during the holidays, employers must be careful to recognize that some employees may observe holidays that are not reflected in the employer’s office calendar. For example, if employees are given time off for Christmas day but not for Ramadan, employees observing the Muslim holiday may claim discrimination. Such situations can typically be avoided by utilizing “floating holidays” which allow time off for religious days that do not appear on a company’s official schedule. In addition, employers can include in the company policy that any holiday not appearing on the calendar can be requested and granted subject to review.

Article by:

W. Chapman Hopkins

Of:

McBrayer, McGinnis, Leslie and Kirkland, PLLC