60 Day Notice 2016-00391

Withdraw Notice Add a Complaint Add a Settlement Add a Judgment

AG Number: 
2016-00391
Notice PDF: 
PDF icon 2016-00391.pdf
Date Filed: 
04/29/2016
Noticing Party: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Alleged Violators: 
Progenex Holdings, LLC
Chemicals: 
Lead and lead compounds
Source: 
Dietary Supplements

60-Day Notice Document

Civil Complaint
AG Number:
2016-00391
Complaint PDF: 
PDF icon 2016-00391C4518.pdf
Date Filed:
12/19/2016
Case Name: 
Environmental Research Center, Inc. v Progenex Holdings, LLC
Court Name: 
Alameda County Superior Court
Court Docket Number: 
RG16842984
Plaintiff: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Defendant: 
Progenex Holdings, LLC
Type of Claim: 
Failure to Warn
Relief Sought: 
Warning
Civil Penalty
Contact Name: 
William F. Wraith
Contact Organization: 
Wraith Law
Email Address:
bill@wraithlaw.com
Address: 
24422 Avenida de la Carlota, Suite 400
City, State, Zip:
Laguna Hills, CA 92653
Phone Number:
(949) 452-1234
Settlement
AG Number:
2016-00391
Settlement PDF: 
PDF icon 2016-00391S5469.pdf
Settlement Date:
12/31/2016
Case Name: 
Environmental Research Center v. Progenex
Court Name: 
Alameda County Superior Court
Court Docket Number: 
RG16842984
Plaintiff: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Defendant: 
Progenex Holdings, LLC
Injunctive Relief: 
Pursuant to Section 3 of the Consent Judgment which provides: 3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning on the Effective Date, PROGENEX shall be permanently enjoined from manufacturing for sale in the State of California, “Distributing into the State of California”, or directly selling in the State of California, any Covered Products which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms of lead per day and/or “Daily Cadmium Exposure Level” of more than 4.10 micrograms of cadmium per day unless it meets the warning requirements under Section 3.2. 3.1.1 As used in this Consent Judgment, the term “Distributing into the State of California” shall mean to directly ship a Covered Product into California for sale in California or to sell a Covered Product to a distributor that PROGENEX knows or has reason to know will sell the Covered Product in California. 3.1.2 For purposes of this Consent Judgment, the “Daily Lead Exposure Level” and “Daily Cadmium Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of lead or cadmium per gram of product, multiplied by grams of product per serving of the product (using the largest serving size appearing on the product label), multiplied by servings of the product per day (using the largest number of servings in a recommended dosage appearing on the product label), which equals micrograms of lead or cadmium exposure per day. 3.2 Clear and Reasonable Warnings If PROGENEX is required to provide a warning pursuant to Section 3.1, the following warning must be utilized (“Warning”): ⚠ WARNING: This product can expose you to chemicals including lead and cadmium which are known to the State of California to cause [cancer and] birth defects or other reproductive harm. For more information got to www.P65Warnings.ca.gov. PROGENEX shall use the phrase “cancer and” in the Warning only if the “Daily Lead Exposure Level” is greater than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4. The Warning shall be securely affixed to or printed upon the container or label of each Covered Product distributed into the State of California as defined in Section 3.1.1. In addition, for any Covered Product sold over the internet, the Warning shall appear on the checkout page when a California delivery address is indicated for any purchase of any Covered Product. An asterisk or other identifying method must be utilized to identify which products on the checkout page are subject to the Warning. The Warning shall be at least the same size as the largest of any other health or safety warnings also appearing on its website or on the label or container of PROGENEX’s product packaging and the word “WARNING” shall be in all capital letters and in bold print. No statements contradicting or conflicting with the Warning shall accompany the Warning. PROGENEX must display the above Warning with such conspicuousness, as compared with other words, statements, design of the label, container, or on its website, as applicable, to render the Warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use of the product. 3.3 Reformulated Covered Products A Reformulated Covered Product is one for which the “Daily Lead Exposure Level” is no greater than 0.5 micrograms of lead per day and/or “Daily Cadmium Exposure Level” is no more than 4.10 micrograms of cadmium per day as determined by the quality control methodology described in Section 3.4. 3.4 Testing and Quality Control Methodology 3.4.1 Beginning within one year of the Effective Date, PROGENEX shall arrange for lead and/or cadmium testing of the Covered Products at least once a year for a minimum of five consecutive years by arranging for testing of five randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which PROGENEX intends to sell or is manufacturing for sale in California, directly selling to a consumer in California or “Distributing into the State of California.” If tests conducted pursuant to this Section demonstrate that no Warning is required for a Covered Product during each of five consecutive years, then the testing requirements of this Section will no longer be required as to that Covered Product. However, if during or after the five-year testing period, PROGENEX changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, PROGENEX shall test that Covered Product annually for at least four (4) consecutive years after such change is made. 3.4.2 For purposes of measuring the “Daily Lead Exposure Level” and/or “Daily Cadmium Exposure Level,” the highest lead and/or cadmium detection result of the five (5) randomly selected samples of the Covered Products will be controlling. 3.4.3 All testing pursuant to this Consent Judgment shall be performed using a laboratory method that complies with the performance and quality control factors appropriate for the method used, including limit of detection, qualification, accuracy, and precision that meets the following criteria: Inductively Coupled Plasma-Mass Spectrometry (“ICP-MS”) achieving a limit of quantification of less than or equal to 0.010 mg/kg or any other testing method subsequently agreed to in writing by the Parties and approved by the Court through entry of a modified consent judgment. 3.4.4 All testing pursuant to this Consent Judgment shall be performed by an independent third party laboratory certified by the California Environmental Laboratory Accreditation Program or an independent third-party laboratory that is registered with the United States Food & Drug Administration. 3.4.5 Nothing in this Consent Judgment shall limit PROGENEX’s ability to conduct, or require that others conduct, additional testing of the Covered Products, including the raw materials used in their manufacture. 3.4.6 Within thirty (30) days of ERC’s written request, PROGENEX shall deliver lab reports obtained pursuant to Section 3.4 to ERC. PROGENEX shall retain all test results and documentation for a period of five years from the date of each test.
*Non-Contingent Civil Penalty:
$ 48,572.00
Attorney(s) Fees and Costs:
$ 39,999.00
Payment in Lieu of Penalty:
$ 36,429.00  (Pursuant to Section 4 of the Consent Judgment: 4. SETTLEMENT PAYMENT 4.1 In full satisfaction of all potential civil penalties, additional settlement payments, attorney’s fees, and costs, PROGENEX shall make a total payment to ERC of $125,000.00 (“Total Settlement Amount”) in six monthly installments plus 8% simple interest on the balance remaining after the first payment. The Total Settlement Amount including interest shall be paid on the following schedule (“Due Dates”): $20,833.33 due within 5 days of the Effective Date $21,527.77 due within 35 days of the Effective Date $21,388.89 due within 65 days of the Effective Date $21,250.00 due within 95 days of the Effective Date $21,111.11 due within 125 days of the Effective Date $20,972.24 due within 155 days of the Effective Date PROGENEX shall make these payment by wire transfer to ERC’s escrow account, for which ERC will give PROGENEX the necessary account information. The Total Settlement Amount shall be apportioned as follows: 4.2 $48,572.05 shall be considered a civil penalty pursuant to California Health and Safety Code section 25249.7(b)(1). ERC shall remit 75% ($36,429.04) of the civil penalty to the Office of Environmental Health Hazard Assessment (“OEHHA”) for deposit in the Safe Drinking Water and Toxic Enforcement Fund in accordance with California Health and Safety Code section 25249.12(c). ERC will retain the remaining 25% ($12,143.01) of the civil penalty. 4.3 $4,437.80 shall be distributed to ERC as reimbursement to ERC for reasonable costs incurred in bringing this action. 4.4 $ 36,428.97shall be distributed to ERC as an Additional Settlement Payment (“ASP”), pursuant to California Code of Regulations, title 11, sections 3203, subdivision (d) and 3204. ERC will utilize the ASP for activities that address the same public harm as allegedly caused by Defendant in this matter. These activities are detailed below and support ERC’s overarching goal of reducing and/or eliminating hazardous and toxic chemicals in dietary supplement products in California. ERC’s activities have had, and will continue to have, a direct and primary effect within the State of California because California consumers will be benefitted by the reduction and/or elimination of exposure to lead and/or cadmiumin dietary supplements and/or by providing clear and reasonable warnings to California consumers prior to ingestion of the products. Based on a review of past years’ actual budgets, ERC is providing the following list of activities ERC engages in to protect California consumers through Proposition 65 citizen enforcement, along with a breakdown of how ASP funds will be utilized to facilitate those activities: (1) ENFORCEMENT (65-80%): obtaining, shipping, analyzing, and testing dietary supplement products that may contain lead and/or cadmium and are sold to California consumers. This work includes continued monitoring and enforcement of past consent judgments and settlements to ensure companies are in compliance with their obligations thereunder, with a specific focus on those judgments and settlements concerning lead and/or cadmium. This work also includes investigation of new companies that ERC does not obtain any recovery through settlement or judgment; (2) VOLUNTARY COMPLIANCE PROGRAM (10-25%): maintaining ERC’s Voluntary Compliance Program by acquiring products from companies, developing and maintaining a case file, testing products from these companies, providing the test results and supporting documentation to the companies, and offering guidance in warning or implementing a self-testing program for lead and/or cadmiumin dietary supplement products; and (3) “GOT LEAD” PROGRAM (up to 5%): maintaining ERC’s “Got Lead?” Program which reduces the numbers of contaminated products that reach California consumers by providing access to free testing for lead in dietary supplement products (Products submitted to the program are screened for ingredients which are suspected to be contaminated, and then may be purchased by ERC, catalogued, sent to a qualified laboratory for testing, and the results shared with the consumer that submitted the product). ERC shall be fully accountable in that it will maintain adequate records to document and will be able to demonstrate how the ASP funds will be spent and can assure that the funds are being spent only for the proper, designated purposes described in this Consent Judgment. ERC shall provide the Attorney General, within thirty days of any request, copies of documentation demonstrating how such funds have been spent. 4.5 $10,045.00 shall be distributed to William F. Wraith as reimbursement of ERC’s attorney’s fees, while $25,516.18 shall be distributed to ERC for its in-house legal fees. Except as explicitly provided herein, each Party shall bear its own fees and costs. 4.6 In the event that PROGENEX fails to remit the Total Settlement Payment owed under Section 4 of this Consent Judgment on or before the Due Date, PROGENEX shall be deemed to be in material breach of its obligations under this Consent Judgment. ERC shall provide written notice of the delinquency to PROGENEX via electronic mail. If PROGENEX fails to deliver the Total Settlement Payment within ten (10) days from the written notice, the Total Settlement Payment shall accrue interest at the statutory judgment interest rate provided in the Code of Civil Procedure section 685.010. Additionally, PROGENEX agrees to pay ERC’s reasonable attorney’s fees and costs for any efforts to collect the payment due under this Consent Judgment. )
Total Payments:
$ 125,000.00
Will settlement be submitted to court?
Yes
Contact Name: 
William F. Wraith
Contact Organization: 
Wraith Law
Email Address:
bill@wraithlaw.com
Address: 
24422 Avenida de la Carlota, Suite 400
City, State, Zip:
Laguna Hills, CA 92653
Phone Number:
(949) 452-1234
Judgment
AG Number:
2016-00391
Judgment PDF: 
PDF icon 2016-00391J3470.pdf
Judgment Date:
04/21/2017
Settlement reported to AG: 
Sat, 12/31/2016
Case Name: 
Environmental Research Center v. Progenex Holdings, LLC
Court Name: 
Alameda County Superior Court
Court Docket Number: 
RG16842984
Plaintiff: 
Environmental Research Center, Inc.
Plaintiff Attorney: 
William F. Wraith
Defendant: 
Progenex Holdings, LLC
Injunctive Relief: 
Pursuant to Section 3 of the Consent Judgment which provides: 3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning on the Effective Date, PROGENEX shall be permanently enjoined from manufacturing for sale in the State of California, “Distributing into the State of California”, or directly selling in the State of California, any Covered Products which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms of lead per day and/or “Daily Cadmium Exposure Level” of more than 4.10 micrograms of cadmium per day unless it meets the warning requirements under Section 3.2. 3.1.1 As used in this Consent Judgment, the term “Distributing into the State of California” shall mean to directly ship a Covered Product into California for sale in California or to sell a Covered Product to a distributor that PROGENEX knows or has reason to know will sell the Covered Product in California. 3.1.2 For purposes of this Consent Judgment, the “Daily Lead Exposure Level” and “Daily Cadmium Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of lead or cadmium per gram of product, multiplied by grams of product per serving of the product (using the largest serving size appearing on the product label), multiplied by servings of the product per day (using the largest number of servings in a recommended dosage appearing on the product label), which equals micrograms of lead or cadmium exposure per day. 3.2 Clear and Reasonable Warnings If PROGENEX is required to provide a warning pursuant to Section 3.1, the following warning must be utilized (“Warning”): ⚠ WARNING: This product can expose you to chemicals including lead and cadmium which are known to the State of California to cause [cancer and] birth defects or other reproductive harm. For more information got to www.P65Warnings.ca.gov. PROGENEX shall use the phrase “cancer and” in the Warning only if the “Daily Lead Exposure Level” is greater than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4. The Warning shall be securely affixed to or printed upon the container or label of each Covered Product distributed into the State of California as defined in Section 3.1.1. In addition, for any Covered Product sold over the internet, the Warning shall appear on the checkout page when a California delivery address is indicated for any purchase of any Covered Product. An asterisk or other identifying method must be utilized to identify which products on the checkout page are subject to the Warning. The Warning shall be at least the same size as the largest of any other health or safety warnings also appearing on its website or on the label or container of PROGENEX’s product packaging and the word “WARNING” shall be in all capital letters and in bold print. No statements contradicting or conflicting with the Warning shall accompany the Warning. PROGENEX must display the above Warning with such conspicuousness, as compared with other words,statements, design of the label, container, or on its website, as applicable, to render the Warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use of the product. 3.3 Reformulated Covered Products A Reformulated Covered Product is one for which the “Daily Lead Exposure Level” is no greater than 0.5 micrograms of lead per day and/or “Daily Cadmium Exposure Level” is no more than 4.10 micrograms of cadmium per day as determined by the quality control methodology described in Section 3.4. 3.4 Testing and Quality Control Methodology 3.4.1 Beginning within one year of the Effective Date, PROGENEX shall arrange for lead and/or cadmium testing of the Covered Products at least once a year for a minimum of five consecutive years by arranging for testing of five randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which PROGENEX intends to sell or is manufacturing for sale in California, directly selling to a consumer in California or “Distributing into the State of California.” If tests conducted pursuant to this Section demonstrate that no Warning is required for a Covered Product during each of five consecutive years, then the testing requirements of this Section will no longer be required as to that Covered Product. However, if during or after the five-year testing period, PROGENEX changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, PROGENEX shall test that Covered Product annually for at least four (4) consecutive years after such change is made. 3.4.2 For purposes of measuring the “Daily Lead Exposure Level” and/or “Daily Cadmium Exposure Level,” the highest lead and/or cadmium detection result of the five (5) randomly selected samples of the Covered Products will be controlling. 3.4.3 All testing pursuant to this Consent Judgment shall be performed using a laboratory method that complies with the performance and quality control factors appropriate for the method used, including limit of detection, qualification, accuracy, and precision that meets the following criteria: Inductively Coupled Plasma-Mass Spectrometry (“ICP-MS”) achieving a limit of quantification of less than or equal to 0.010 mg/kg or any other testing method subsequently agreed to in writing by the Parties and approved by the Court through entry of a modified consent judgment. 3.4.4 All testing pursuant to this Consent Judgment shall be performed by an independent third party laboratory certified by the California Environmental Laboratory Accreditation Program or an independent third-party laboratory that is registered with the United States Food & Drug Administration. 3.4.5 Nothing in this Consent Judgment shall limit PROGENEX’s ability to conduct, or require that others conduct, additional testing of the Covered Products, including the raw materials used in their manufacture. 3.4.6 Within thirty (30) days of ERC’s written request, PROGENEX shall deliver lab reports obtained pursuant to Section 3.4 to ERC. PROGENEX shall retain all test results and documentation for a period of five years from the date of each test.
*Non-Contingent Civil Penalty:
$ 48,572.00
Attorney(s) Fees and Costs:
$ 39,999.00
Payment in Lieu of Penalty:
$ 36,429.00  (Pursuant to Section 4 of the Consent Judgment: 4. SETTLEMENT PAYMENT 4.1 In full satisfaction of all potential civil penalties, additional settlement payments, attorney’s fees, and costs, PROGENEX shall make a total payment to ERC of $125,000.00 (“Total Settlement Amount”) in six monthly installments plus 8% simple interest on the balance remaining after the first payment. The Total Settlement Amount including interest shall be paid on the following schedule (“Due Dates”): $20,833.33 due within 5 days of the Effective Date $21,527.77 due within 35 days of the Effective Date $21,388.89 due within 65 days of the Effective Date $21,250.00 due within 95 days of the Effective Date $21,111.11 due within 125 days of the Effective Date $20,972.24 due within 155 days of the Effective Date PROGENEX shall make these payment by wire transfer to ERC’s escrow account, for which ERC will give PROGENEX the necessary account information. The Total Settlement Amount shall be apportioned as follows: 4.2 $48,572.05 shall be considered a civil penalty pursuant to California Health and Safety Code section 25249.7(b)(1). ERC shall remit 75% ($36,429.04) of the civil penalty to the Office of Environmental Health Hazard Assessment (“OEHHA”) for deposit in the Safe Drinking Water and Toxic Enforcement Fund in accordance with California Health and Safety Code section 25249.12(c). ERC will retain the remaining 25% ($12,143.01) of the civil penalty. 4.3 $4,437.80 shall be distributed to ERC as reimbursement to ERC for reasonable costs incurred in bringing this action. 4.4 $ 36,428.97shall be distributed to ERC as an Additional Settlement Payment (“ASP”), pursuant to California Code of Regulations, title 11, sections 3203, subdivision (d) and 3204. ERC will utilize the ASP for activities that address the same public harm as allegedly caused by Defendant in this matter. These activities are detailed below and support ERC’s overarching goal of reducing and/or eliminating hazardous and toxic chemicals in dietary supplement products in California. ERC’s activities have had, and will continue to have, a direct and primary effect within the State of California because California consumers will be benefitted by the reduction and/or elimination of exposure to lead and/or cadmiumin dietary supplements and/or by providing clear and reasonable warnings to California consumers prior to ingestion of the products. Based on a review of past years’ actual budgets, ERC is providing the following list of activities ERC engages in to protect California consumers through Proposition 65 citizen enforcement, along with a breakdown of how ASP funds will be utilized to facilitate those activities: (1) ENFORCEMENT (65-80%): obtaining, shipping, analyzing, and testing dietary supplement products that may contain lead and/or cadmium and are sold to California consumers. This work includes continued monitoring and enforcement of past consent judgments and settlements to ensure companies are in compliance with their obligations thereunder, with a specific focus on those judgments and settlements concerning lead and/or cadmium. This work also includes investigationof new companies that ERC does not obtain any recovery through settlement or judgment; (2) VOLUNTARY COMPLIANCE PROGRAM (10-25%): maintaining ERC’s Voluntary Compliance Program by acquiring products from companies, developing and maintaining a case file, testing products from these companies, providing the test results and supporting documentation to the companies, and offering guidance in warning or implementing a self-testing program for lead and/or cadmiumin dietary supplement products; and (3) “GOT LEAD” PROGRAM (up to 5%): maintaining ERC’s “Got Lead?” Program which reduces the numbers of contaminated products that reach California consumers by providing access to free testing for lead in dietary supplement products (Products submitted to the program are screened for ingredients which are suspected to be contaminated, and then may be purchased by ERC, catalogued, sent to a qualified laboratory for testing, and the results shared with the consumer that submitted the product). ERC shall be fully accountable in that it will maintain adequate records to document and will be able to demonstrate how the ASP funds will be spent and can assure that the funds are being spent only for the proper, designated purposes described in this Consent Judgment. ERC shall provide the Attorney General, within thirty days of any request, copies of documentation demonstrating how such funds have been spent. 4.5 $10,045.00 shall be distributed to William F. Wraith as reimbursement of ERC’s attorney’s fees, while $25,516.18 shall be distributed to ERC for its in-house legal fees. Except as explicitly provided herein, each Party shall bear its own fees and costs. 4.6 In the event that PROGENEX fails to remit the Total Settlement Payment owed under Section 4 of this Consent Judgment on or before the Due Date, PROGENEX shall be deemed to be in material breach of its obligations under this Consent Judgment. ERC shall provide written notice of the delinquency to PROGENEX via electronic mail. If PROGENEX fails to deliver the Total Settlement Payment within ten (10) days from the written notice, the Total Settlement Payment shall accrue interest at the statutory judgment interest rate provided in the Code of Civil Procedure section 685.010. Additionally, PROGENEX agrees to pay ERC’s reasonable attorney’s fees and costs for any efforts to collect the payment due under this Consent Judgment.)
Total Payments:
$ 125,000.00
Is Judgment Pursuant to Settlement?
Yes
Contact Name: 
William F. Wraith
Contact Organization: 
Wraith Law
Email Address:
wraithlaw@earthlink.net
Address: 
24422 Avenida de la Carlota, Suite 400
City, State, Zip:
Laguna Hills, CA 92653
Phone Number:
(949) 452-1234

* A non-contingent civil penalty is the civil penalty that must be paid pursuant to the settlement, regardless of future events or actions of the defendant. If a settlement includes a contingent penalty, the plaintiff should report the additional penalty amount when it becomes due.