Attorney General Jennings Announces Multistate Settlement with Johnson & Johnson, Ethicon, Inc.

Delaware Attorney General Kathleen Jennings announced Thursday a multistate settlement with Johnson & Johnson and its subsidiary, Ethicon, Inc., for their deceptive marketing of transvaginal surgical mesh devices.

A multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use.

“Manufacturers of medical devices must do better than the cavalier and dangerous attitude towards women exhibited here by Johnson and Johnson. Today’s settlement holds Johnson and Johnson accountable for their failures and my office will continue to ensure that Delawarean’s can rely on manufacturer’s assurances as to the safety and effectiveness of medical devices,” said Attorney General Jennings.

Transvaginal surgical mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse.

The multistate investigation found the companies misrepresented or failed to adequately disclose the products’ possible side effects, including the risk of chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations, and vaginal scarring. Evidence shows the companies were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.

The settlement requires J&J and Ethicon to provide full disclosure of the device’s risks and accurate information on promotional material and package inserts.

Among the specific requirements, the companies must:

  • refrain from referring to the mesh as “FDA approved” when that is not the case;
  • refrain from representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone;
  • ensure that any product trainings provided to medical professionals covers the risks associated with the mesh;
  • omit claims that surgical mesh stretches after implantation, that it remains soft after implantation, that foreign body reactions are transient, and that foreign body reactions “may” occur (when in fact they will occur);
  • disclose that mesh risks include: fistula formation, inflammation, mesh extrusion, exposure, and erosion into the vagina and other organs;
  • disclose risks of tissue contraction, pain with intercourse, loss of sexual function, urge incontinence, de novo incontinence, infection following transvaginal implantation, and vaginal scarring; and
  • disclose that revision surgeries may be necessary to treat complications, that revision surgeries may not resolve complications, and that revision surgeries are also associated with a risk of adverse reactions.

Additionally, Johnson & Johnson has agreed to pay a combined $116.86 million to the 41 participating states and District of Columbia. Delaware will receive $1.4 million under the settlement which will go to the state’s Consumer Protection Fund. The Fund pays the investigative costs, consumer outreach activities and operations of Delaware DOJ’s Consumer Protection Unit, with excess amounts returned to the state’s General Fund for allocation by the state legislature and Governor through the normal budgetary process.

Joining Delaware in this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin.

The matter was handled by Assistant Director of Consumer Protection Regina S. Schoenberg.


During Peak Tax Season, Consumer Protection Unit Urges Delawareans to be on Guard Against IRS Scams

With IRS W-2 forms already issued by many employers, the 2019 tax season is underway, and the Department of Justice’s Consumer Protection Unit is cautioning Delaware consumers and employers to be on guard for fake IRS phone call scams and IRS Form W-2 email phishing scams that are targeting Delaware employers, including retail businesses, school districts, nonprofit organizations, and law firms.

IRS Phone Call Scam

In a typical IRS phone scam, a caller pretends to work for the Internal Revenue Service (or sometimes the U.S. Treasury Department), and tells the intended victim that the IRS will imminently be filing suit against the victim, or threatens the intended victim with arrest or some other kind of punishment, and the only way to avoid the lawsuit or arrest is to immediately pay a sum of money, usually via a pre-paid debit card or a money order, or even Amazon or iTunes gift cards.

The IRS says that these scammers often spoof the telephone number to disguise where they are calling from, and they sometimes manipulate the caller ID information so it seems like the call is coming from the IRS. They may even give out a fake IRS badge number, and may even know the last four digits of a victim’s Social Security number and try to use that information to gain a victim’s trust. Many times these scam messages will contain misspellings, unusual phrases, or terminology that is not customary in the U.S. or the area.

As a reminder, the IRS will never reach out to a taxpayer with an initial contact by telephone, email, text message, or social media. The IRS also will never demand credit or debit card payment over the telephone, nor will the IRS demand that you pay a tax bill in a specific manner, such as with a gift or pre-paid card.

The Consumer Protection Unit urges consumers to ignore these calls and not return voicemail messages. Consumers should instead do the following:

  • If you are worried that the call might be real, because you owe federal taxes, or think you might owe federal taxes, hang up and call the IRS directly at 1-800-829-1040. IRS workers there will be able to help you with any payment questions.
  • Report the scam to federal authorities: fill out the “IRS Impersonation scam” form on TIGTA’s website, or call TIGTA at 800-366-4484, and also consider filing a complaint with the Federal Trade Commission at www.ftc.gov (add “IRS Telephone Scam” to the comments in your complaint).

IRS Form W-2 Phishing Scam

The Consumer Protection Unit also warns Delawareans about a dangerous email scam that has been circulating nationwide and is targeting a wide variety of public and private-sector employers, including retail businesses, universities, secondary school districts, nonprofit organizations, hospitals, and law firms.

Typically, the scammer sends a “spoofing” email posing as an internal executive or official within the organization, requesting employee payroll data, including IRS W-2 forms that contain Social Security numbers and other personally identifiable information. If these cybercriminals are successful in tricking payroll and human resource officials into disclosing that data, they can use the data to file fraudulent tax returns for refunds and commit other forms of identity theft.

According to the IRS, these are examples of the details that may be contained in some of these emails:

  • “Kindly send me the individual [2018] W-2 (PDF) and earnings summary of all W-2 of our company staff for a quick review.”
  • “Can you send me the updated list of employees with full details (Name, Social Security Number, Date of Birth, Home Address, Salary).”
  • “I want you to send me the list of W-2 copy of employee wage and tax statement for [2018], I need them in PDF file type, you can send it as an attachment. Kindly prepare the lists and email them to me asap.”

The IRS has also established a process that will allow employers and payroll service providers to quickly report any data losses related to this W-2 scam: https://www.irs.gov/individuals/form-w2-ssn-data-theft-information-for-businesses-and-payroll-service-providers. The IRS has established a dedicated email address for employers to report W-2 scams and data thefts: dataloss@irs.gov. According to the IRS, if notified in time the IRS can take steps to prevent employees from being victimized by identity thieves filing fraudulent returns in their names. There is also information about how to report receiving the scam email even if an employer did not fall victim to the scam.

The Consumer Protection Unit also reminds employers that if they are victimized by this scam, they have suffered a data breach and may need to give notice to affected individuals under Delaware’s data breach notification law (Title 6, Chapter 12B of the Delaware Code), and may also need to give notice under other applicable state or federal law. Employers who suffer a data breach are encouraged consult with legal counsel to ensure compliance with all applicable data breach notification laws.


DOJ Consumer Protection Unit Warns Delawareans About Scam Utility Calls

The Department of Justice’s Consumer Protection Unit (CPU) warns Delawareans to be wary of threatening collection calls purporting to be from Delmarva Power. The callers allege that the consumer has an overdue balance and threaten to have utility services shut off within minutes if large sums of money are not provided. The callers demand these large payments in MoneyPak cards, iTunes gift cards, or other prepaid card products. The callers may also attempt to obtain certain personal or financial information from consumers as well.

Delaware utility consumers should be cautious of any phone call where the caller employs threats to immediately turn off utility services. Current customers of Delmarva Power, or other authorized utility providers, should ask the caller to provide information that legitimate employees of actual utility providers should have readily available – including the utility account number, property address, and account holder’s name – in order to verify their identity. Consumers should terminate the call if the caller cannot provide this basic information.

In addition, consumers should inform callers that they will check recent billing statements and payment records and call back at the telephone number listed on their billing statements. If the caller provides a different number or directs the consumer to take another action, it is likely a scam.

The CPU is aware of these scam phone calls and Attorney General Jennings cautions all consumers to be diligent before disclosing any personal information, payment information, or account information to any callers. More importantly, consumers should verify the amounts claimed due with their own records before remitting any money. Some tips to protect personal information include:

  • Asking callers pointed questions to verify that they are who they say they are;
  • Reviewing monthly bills for any information about amounts due;
  • Asking callers for time to review records before agreeing to pay any amounts – legitimate collection calls will allow time to verify the balance due;
  • Wariness of any calls where a caller employs a threat of any kind to try to compel immediate financial action; and
  • Declining to answer calls from unfamiliar numbers or callers, or hanging up if the caller pressures the consumer.

The CPU Unit encourages consumers who believe they may have been scammed to call its toll-free Consumer Hotline at (800) 220-5424 or email consumer.protection@delaware.gov. Consumers who have lost money to scam calls should make a report to their local police agency.


Wells Fargo Consumer Redress Review Program Mandated By National Settlement With AGs Starts

Program allows consumers, who have not been made whole through other remediation programs, to have inquiry reviewed by escalation team

Wells Fargo has begun a consumer redress review program through which consumers who have not yet been made whole through other remediation programs already in place can seek to have their inquiry or complaint reviewed by a Wells Fargo escalation team for possible relief, Attorney General Kathleen Jennings and other AGs announced Wednesday.

The consumer redress review program was a key component of the December 2018 settlement with the attorneys general of all 50 states and the District of Columbia to resolve claims that the bank violated state consumer protection laws by (1) opening millions of unauthorized accounts and enrolling customers into online banking services without their knowledge or consent, (2) improperly referring customers for enrollment in third-party renters and life insurance policies, (3) improperly charging auto loan customers for force-placed and unnecessary collateral protection insurance, (4) failing to ensure that customers received refunds of unearned premiums on certain optional auto finance guaranteed asset/auto protection (“GAP”) products, and (5) incorrectly charging customers for mortgage rate lock extension fees.

As part of the program, Wells Fargo will maintain a website that contains information regarding consumers’ eligibility for redress. Wells Fargo’s website describes the issues covered by the settlement agreement and provides escalation phone numbers consumers may use to request review. In addition, Wells Fargo will provide periodic reports to the states about ongoing remediation efforts.

Wells Fargo’s consumer redress review website may be accessed at https://www.wellsfargo.com/commitment/redress/.

Consumers with questions or concerns may call the following Wells Fargo escalation phone numbers:
Unauthorized Accounts / Improper Retail Sales Practices: 1-844-931-2273
Improper Renters and Life Insurance Referrals: 1-855-853-9638
Force-Placed Collateral Protection Auto Insurance (“CPI”): 1-888-228-9735
Guaranteed Asset/Auto Protection (“GAP”) Refunds: 1-844-860-6962
Mortgage Interest Rate Lock Extension Fees: 1-866-385-5008

Details of the states’ settlement with Wells Fargo can be found here.


Delaware Joins 44 Other States and District of Columbia in Settlement Over Misleading Information Regarding Hip Implants

Delaware Attorney General Kathy Jennings announced Friday that she and 45 other Attorneys General reached a settlement with Johnson & Johnson and its subsidiary DePuy Orthopaedics, Inc., to resolve allegations that DePuy unlawfully promoted two of its metal-on-metal hip implant devices.

Attorneys General allege that DePuy engaged in deceptive practices in its promotion of the ASR XL and Pinnacle Ultamet hip implant devices by making misleading claims as to their longevity, also known as survivorship. DePuy advertised that the ASR XL hip implant had a survivorship of 99.2 percent at three years when the National Joint Registry of England and Wales reported a 7 percent revision rate at three years. Similarly, DePuy promoted the Pinnacle Ultamet as having a survivorship of 99.8 percent and 99.9 percent survivorship at five years when the National Joint Registry of England and Wales reported a 2.2 percent three-year revision rate in 2009 increasing to a 4.28 percent five-year revision rate in 2012.

Some patients who required hip implant revision surgery to replace a failed ASR XL or Pinnacle Ultamet implant experienced persistent groin pain, allergic reactions, tissue necrosis, and a build-up of metal ions in the blood. The ASR XL was recalled from the market in 2010. DePuy discontinued its sale of the Pinnacle Ultamet in 2013.

“Accurate and up to date information for both doctors and patients is critical to effective health care,” said Attorney General Jennings. “This settlement helps ensure that doctors can continue making the most informed, medically appropriate decisions they can about patient care.”

As part of the settlement, DePuy has agreed to the entry of a cease-and-desist order that requires the company to reform how it markets and promotes its hip implants in Delaware. Under the order, DePuy shall:

  • Base claims of survivorship, stability or dislocations on scientific information and the most recent dataset available from a registry for any DePuy hip implant device.
  • Maintain a post market surveillance program and complaint handling program.
  • Update and maintain internal product complaint handling operating procedures including training of complaint reviewers.
  • Update and maintain processes and procedures to track and analyze product complaints that do not meet the definition of Medical Device Reportable Events.
  • Maintain a quality assurance program that includes an audit procedure for tracking complaints regarding DePuy Products that do not rise to the level of a Medical Device Reportable Event but that may indicate a device-related serious injury or malfunction.
  • Perform quarterly reviews of complaints and if a subgroup of patients is identified that has a higher incidence of adverse events than the full patient population, determine the cause and alter promotional practices as appropriate.

The total value of the settlement is $120 million. Delaware will receive $1.3 million, with the money going to the state’s Consumer Protection Fund, which funds consumer protections investigations and activities.

Deputy Attorney General David Weinstein of the Consumer Protection Unit led Delaware’s efforts on this matter.

The complete cease-and-desist order can be found here.

The investigation was led by the Attorneys General of Texas and South Carolina with an Executive Committee consisting of the Attorneys General of Florida, Indiana, North Carolina, Ohio, Pennsylvania, and Washington. Also participating in the settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, and Wisconsin.