Month: July 2016
EMPLOYER ATTORNEYS: MOHAJERIAN LAWYERS REPRESENT EMPLOYERS THROUGHOUT CALIFORNIA
From July 1, 2016, employers in the City of Los Angeles must allow for at least 48 hours of employee paid sick leave in each year of employment, calendar year, or 12-month period. Accrued unused paid sick leave will roll over to the following year of employment and may be capped at 72 hours. Paid sick leave may be provided in lump sum at the beginning of the year, or accrued at a rate of at least 1 hour per every 30 hours worked which is the same minimum accrual rate as CA law, but with a higher accrual cap. CA has a cap of 48 hours.
Filed Under: Labor & Employment
Revlon paid out $900,000 to settle a class claim over the product line’s name to mislead consumers into believing the foundation, powder, and concealer would alter the genetic code of their skin cells.
Products: DNA Advantage line of three cosmetic products: foundation, powder and concealer
NY Federal District Court:
ANNE ELKIND and SHARON ROSEN, on behalf of themselves and all others similarly situated, Plaintiffs, vs
REVLON CONSUMER PRODUCTS CORPORATION, Defendant. Case No. 2:14-cv-02484-JS-AK
Filed Under: Class Action, Cosmetics
Bayer vs. Belmora: Appeal from the United States District Court for the Eastern District of Virginia, at Alexandria. Gerald Bruce Lee, District Judge. (1:14-cv-00847-GBL-JFA)
In this unfair competition case, the court considered whether the Lanham Act permits the owner of a foreign trademark and its sister company to pursue false association, false advertising, and trademark cancellation claims against the owner of the same mark in the United States. Bayer Consumer Care AG (“BCC”) owns the trademark “FLANAX” in Mexico and has sold naproxen sodium pain relievers under that mark in Mexico (and other parts of Latin America) since the 1970s. Belmora LLC owns the FLANAX trademark in the United States and has used it here since 2004 in the sale of its naproxen sodium pain relievers. BCC and its U.S. sister company Bayer HealthCare LLC (“BHC,” and collectively with BCC, “Bayer”) contend that Belmora used the FLANAX mark to deliberately deceive Mexican-American consumers into thinking they were purchasing BCC’s product. BCC successfully petitioned the U.S. Trademark Trial and Appeal Board (“TTAB”) to cancel Belmora’s registration for the FLANAX mark based on deceptive use. Belmora appealed the TTAB’s decision to the district court. In the meantime, BCC filed a separate complaint for false association against Belmora under § 43 of the Lanham Act, 15 U.S.C. § 1125, and in conjunction with BHC, a claim for false advertising.
After the two cases were consolidated, the district court reversed the TTAB’s cancellation order and dismissed the false association and false advertising claims.
Bayer appeals those decisions. In its decision, the district court focused on a key question related to Bayer’s Lanham Act § 43(a), 15 U.S.C. § 1125(a), claim: “Does the Lanham Act allow the owner of a foreign mark that is not registered in the United States and further has never used the mark in United States commerce to assert priority rights over a mark that is registered in the United States by another party and used in United States commerce?” The district court held that the answer was no, based on the district court’s interpretation of the Supreme Court’s analysis in Lexmark International, Inc. v. Static Control Components, Inc.
The 4th Circuit held the answer was yes. The court found that the plain language of the Lanham Act § 43(a) does not require the plaintiff to possess or have used the trademark in U.S. commerce. The court found that it is not the plaintiff’s use, but rather the defendant’s use in commerce—of an offending “word, term, name, symbol, or device,” or of a “false or misleading description of fact”—that creates injury under the terms of the statute. The court thus held that it was Belmora’s use of FLANAX in commerce that grounded the injury.
AL MOHAJERIAN
Filed Under: Trademark, Unfair Competition
The U.S. Occupational Safety and Health Administration (OSHA) has changed material elements of the 29 Code of Federal Regulation (CFR) 1904 to include electronically submittal of injury and illness data for certain industries. This rule will be phased into effect within a two-year period with certain high-risk employers being targeted for more frequent reporting than their low-risk counterparts. Whereas, employers with high injury rates will have injury records available for workers, job seekers, customers, researchers, and the general public that will affect the way they do business. The rule applies to private sector employers covered by OSHA with more than 10 employees. State and local government employers are covered in states with federally approved state OSHA plans. OSHA does not require employers in industries it considers “low hazard” to keep injury records under the new rule. This category includes educational services (schools, colleges, universities, and libraries), medical and dental clinics and laboratories, and other workplaces where AFSCME members are employed. These employers must still report any workplace incident that results in a death or causes three or more employees to be hospitalized, the same as other employers.
Filed Under: OSHA
Telephone Consumer Protection Act (TCPA) regulates and limit’s retailers’ ability to contact consumers by cell phone, text or prerecorded message. Businesses have serious liabilities for violating TCPA. Developing effective and creative mobile marketing campaigns to promote products and services is the solution to make sure your business TCPA compliant.
Filed Under: TCPA
The Labor Code Private Attorneys General Act (PAGA) authorizes aggrieved employees to file lawsuits to recover civil penalties on behalf of themselves, other employees, and the State of California for Labor Code violations. PAGA cases must follow the requirements specified in Labor Code Sections 2698 – 2699.5. SB 836 became effective on June 27, 2016. It made important changes in PAGA requirements. These requirements apply prospectively to all pending PAGA cases as well as new ones.
- All new PAGA claim notices must be filed online, with a copy sent by certified mail to the employer.
- All employer cure notices or other responses to a PAGA claim must be filed online, with a copy sent by certified mail to the aggrieved employee or aggrieved employee’s representative.
- A filing fee of $75 is required for a new PAGA claim notice and any initial employer response [cure or other response] to a new PAGA claim notice.
- The filing fee may be waived if the party on whose behalf the notice or response is filed is entitled to in forma pauperis status.
- The time for the Labor and Workforce Development Agency (LWDA) to review a notice under Labor Code § 2699.3(a) has been extended from 30 to 60 days.
- When filing a new PAGA lawsuit in court, a filed-stamped copy of the complaint must be provided to LWDA. (Applies only to cases in which the initial PAGA claim notice was filed on or after July 1, 2016.)
- Any settlement of a PAGA action must be approved by the court, whether or not the settlement includes an award of PAGA penalties.
- A copy of a proposed settlement must be provided to LWDA at the same time that it is submitted to the court.
- A copy of the court’s judgment and any other order that awards or denies PAGA penalties must be provided to LWDA.
All items that are required to be provided to the LWDA must be submitted online. All PAGA related notices and documents are no longer required to be submitted to LWDA by certified mail.
MOHAJERIAN LAWYERS REPRESENT EMPLOYERS THROUGHOUT CALIFORNIA
Filed Under: Labor & Employment, Litigation, PAGA
The Defend Trade Secrets Act of 2016 (“DTSA”), enacted on May 11, 2016, represents the significant trade secret reform legislation in years. The DTSA amends the Economic Espionage Act of 1996, providing for federal criminal penalties for foreign economic espionage and trade secret theft and adds new federal civil trade secret protections. The Act creates a new cause of action which became effective immediately – for trade secret misappropriation. The Federal Courts take jurisdiction and provide remedies. The plaintiff has a choice of Federal or State remedies. There is whistleblower protection and employment contracts require disclosure about the whistleblower protection and immunity provisions in employee contract “that governs the use of a trade secret or other confidential information” that is “entered into or updated after” May 11, 2016. The failure to provide notice will bar exemplary damages or attorney fees against an employee who did not receive notice.
Filed Under: Litigation, Trade Secrets
Employers of 26 or more employees need to update their handbooks and revise their HR policies. They need to provide wage increases to their minimum wage employees effective July 1, 2016, adopting both minimum wage rules and paid sick leave benefits applicable to all employees who perform at least two hours of work in a particular week within the boundaries of the City of Los Angeles.
Filed Under: Labor & Employment
Under the FDA rules, the answer is yes:
21 U.S.C. 353b provides, inter alia,
“(d)(4)(A) The term “outsourcing facility” means a facility at one geographic location or address that–
(i) is engaged in the compounding of sterile drugs;
(ii) has elected to register as an outsourcing facility; and
(iii) complies with all of the requirements of this section.
(B) An outsourcing facility is not required to be a licensed pharmacy.
(C) An outsourcing facility may or may not obtain prescriptions for identified individual patients. (emphasis added)”
“….Section 503(b) establishes ‘Outsourcing Facilities.’ Outsourcing facilities can provide compounded sterile drugs without patient-specific prescriptions. “Outsourcing facilities can provide patient-specific and non-patient-specific medications.”1
“Section 503(a) applies to pharmacies that compound patient-specific prescriptions, such as patient-specific intrathecal medications…. Pharmacies that practice under this business model are regulated by their respective State Boards of Pharmacy2.
“State regulations can also complicate the definition of whether pharmacies are in compliance with “patient-specific” only when compounding for one patient…” 3”
Last in February 2015, in the California legislature, Senator Mike Morell introduced
Senate Bill 619, which was sponsored by the California Board of Pharmacy. This Senate Bill has not been enacted into law. On February 1, 2016, Senate Bill 619 was returned to the Secretary of the Senate, pursuant to Joint Rule 56.4 If it had been enacted, it would have prevented a 503(b) pharmacy from preparing patient specific medications.
Senate Bill 619 has passed the California Senate but it has not been enacted into law. The Bill stated: “California licensing requirements for a new category of prescription drug compounding entity called an outsourcing facility. This bill will prohibit a licensed outsourcing facility from filling patient specific prescriptions. This bill will create new licensure requirements, specific to the state of California, for in state and out of state outsourcing facilities doing business within and across state lines. These new requirements will prohibit an outsourcing facility to be located in the same licensed premises as a pharmacy, therefore only allowing outsourcing facilities to distribute compounded drugs for non-patient specific prescriptions. Since the FDA has yet to release specific federal requirements for outsourcing facilities, this bill anticipates future federal requirements and creates California specific standards by which licensed outsourcing facilities must comply.5”
Although this Senate Bill is not enacted into law, it could be enacted soon.
The Board of Pharmacy in California will continue to seek to regulate outsourcing facilities or 503(b) facilities.
In conclusion, 503(b) pharmacies or outsourcing facilities may under the FDA rules legally prepare patient specific medications. Consult with our firm or your counsel before making any decisions as the law in this field keeps changing. This article is designed for general information only. The information presented should not be construed to be formal legal advice nor the formation of a lawyer/client relationship
1 Hartley Medical, “Revisiting HR3204: the Drug Quality and Security Act of 2013”, William Stuart.
2 Hartley Medical, “Revisiting HR3204: the Drug Quality and Security Act of 2013”, William Stuart.
3 Pharmaceutical North America, Inc. “What is Patient-Specific Compounding? The Gray Areas may Surprise Pharmacists, February 16, 2016.
4 Joint Rules of the Senate and Assembly, 2015-2016 Regular Session,4 Joint Rule 56 states: “Bills introduced in the first year of the regular session and passed by the house of origin on or before the January 31st constitutional deadline are ‘carryover bills.”” Immediately after January 31, bills introduced in the first year of the regular session that do not become “carryover bills” shall be returned to the Chief Clerk of the Assembly or Secretary of the Senate, respectively. Notwithstanding Rule 4, as used in this rule “bills” does not include constitutional amendments,” Joint Rule 4 states: “Whenever the word “bill” is used in these rules, it includes any constitutional amendment, any resolution ratifying a proposed amendment to the United States Constitution, and any resolution calling for a constitutional convention.”
5 Senate Bill 619 on outsourcing facilities.
Filed Under: FDA, Healthcare, Pharmaceuticals
The Nutrition Labeling and Education Act of 1990 (NLEA) amended Food, Drug & Cosmetic Act, requiring food and dietary supplements to have nutrition labeling.
Dietary Supplement Health and Education Act (DSHEA) of 1994, defined Dietary Supplement and added specific labeling requirements for dietary supplements.
In 1997, several key regulations for statement of identity, nutrition labeling, ingredient labeling, nutrition content and health claims for dietary supplements were implemented.[1]
The 1997 Food and Drug Administration Modernization Act authorizes health claims based on an authoritative statement of a scientific body of the U.S. government with official responsibility for public health protection or research directly related to human nutrition, or the National Academy of Sciences. Such claims may be used after submission of a health claim notification to FDA.
Dietary supplements are classified as food products, but DSHEA stipulates that such products must be labeled as “dietary supplements” and be sold in the form of pills, capsules, tablets, gelcaps, liquids, powders, or other forms, and not be represented for use as conventional foods. Supplements also cannot be marketed as the only item in a meal or diet.
As of March 1999, dietary supplement packages must bear a “Supplement Facts” panel, similar to the “Nutrition Facts” panel mandated for food labels by the Nutrition Labeling and Education Act (NLEA) of 1990. The purpose of this labeling is to provide information about nutrients and other dietary ingredients. The label must list all dietary ingredients and the Daily Values (DV) of the amounts contained in a serving. If no DV has been established for a dietary ingredient, this must be indicated. [2]
If a blend of ingredients is proprietary, the total quantity of ingredients per serving must be stated rather than the amount of each individual ingredient in the blend. If an ingredient is an herbal product, the part of the plant (such as the root or leaf) from which the ingredient is derived must be identified. The common name of the botanical as listed in Herbs of Commerce (American Herbal Products Association, Silver Spring, Md.) may be used; if a botanical is not listed in the book, the Latin binomial name (e.g., Echinacea augustifolia DC) must be used. The following information also must appear on the label: statement of identity, which identifies the contents of the product; net quantity of contents; ingredient list (in descending order by weight); and the name and address of the manufacturer, packer, or distributor (FDA, 1997c). [3]
Under DSHEA, however, dietary supplement ingredients may be sold without undergoing a formal FDA approval process. Although the supplement manufacturer is not required to provide rigorous scientific evidence of safety or efficacy, the manufacturer should be able to provide information to support any labeling claims.[4]
Under the law, claims that are allowed to be used on food and dietary supplement labels fall into three categories: nutrient content claims, health claims and structure/function claims. Disease-related claims are generally not permitted for dietary supplements.
[1] See FDA website, Guidance for Industry, Food, Guidance and Regulation, Guidance Documents and Regulatory Information by Topic, A Dietary Supplement Labeling Guide.
[2] IFT Network, Dietary Supplements: Nutritional and Legal Considerations, July 1, 1999.
[3] IFT Network, Dietary Supplements: Nutritional and Legal Considerations, July 1, 1999
[4] IFT Network, Dietary Supplements: Nutritional and Legal Considerations, July 1, 1999.
By Al Mohajerian | Published April 1, 2016 | Posted in FDA |
Filed Under: Dietary Supplements, FDA (Food), Healthcare
