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.

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.

Forty-three states, including Delaware, have reached a settlement with Johnson & Johnson Consumer Inc. and Johnson & Johnson over allegations that the manufacturers inaccurately promoted their over-the-counter (OTC) drugs as complying with federally mandated current Good Manufacturing Practices despite some manufacturing facilities did not comply.

The state alleged that between 2009 and 2011, McNeil Consumer Healthcare Division, now a division of Johnson & Johnson Consumer Inc., violated state consumer protection laws by misrepresenting the current Good Manufacturing Practices (cGMP) compliance and the quality of their OTC drugs, and represented that these OTC drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities that they did not have.

McNeil’s alleged quality control lapses resulted in recalls of drugs manufactured between 2009 to 2011including Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec, and Zyrtec Eye Drops, several of which are indicated for pediatric use.

The consent judgment entered into by the states and McNeil require that marketing and promotional practices do not unlawfully promote OTC drug products. Specifically, McNeil:

• Shall not represent on its websites that McNeil’s OTC Drug Product facilities meet cGMP as outlined by the FDA if McNeil has had a Class I or Class II Recall of OTC drug products within the prior 12 months. Class I recalls involve situations in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recalls involve situations in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote;

• Shall not fail to follow its internal standard operating polices regarding whether to open a Corrective Action/Preventive Action plan (CAPA) during the manufacture of an OTC drug; and

• Shall not fail to provide information to participating Attorneys General within sixty (60) days of a written request regarding the identity of wholesalers or warehouses to which any OTC drugs that were subject to a recall were distributed in their State.

The settlement also requires Johnson & Johnson to pay $629,569.51 to the Delaware Consumer Protection Fund, which funds work on consumer fraud and deceptive trade practice matters and other consumer-oriented investigations and legal actions. Johnson & Johnson will pay a total of $33 million to states as part of the settlement.

Delaware sat on the executive committee of the multi-state group that investigated the allegations and reached the settlement.

Deputy Attorney General Christian Wright led Delaware’s efforts in the investigation.

Delaware Attorney General also announces that legislation championed by his office will significantly increase state’s share of future settlements

Dover – Attorney General Beau Biden announced today that the state will be paid $2 million by Johnson & Johnson as part of national settlement to resolve allegations that the New Jersey-based pharmaceutical manufacturer fraudulently marketed the antipsychotic drugs Risperdal and Invega.

Of this payment, secured for Delaware by the Attorney General’s Medicaid Fraud Control Unit (MFCU), the Delaware Medicaid and Medical Assistance program will directly recoup $943,821 in civil restitution and fines.  Since 2008, Biden’s office has been involved in this ongoing litigation, assisting the national team with data retrieval and other investigative and litigation requests.  The successful resolution of this investigation is another example of the efforts by the Delaware MFCU to recover state and federal funds lost to unscrupulous providers who attempt to defraud the state healthcare system.

“Pharmaceutical companies that do not follow the rules and pitch their product to the public for purposes that have not been approved will be held accountable,” Biden said.

Nationwide, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., will pay state and federal governments $1.2 billion over charges that the companies promoted and marketed Risperdal and Invega for uses that were not approved by the Food and Drug Administration and for uses that were not medically indicated, made false and misleading statements about the safety of the two drugs, and paid illegal kickbacks to healthcare professionals and long-term care pharmacy providers to induce them to promote or prescribe Risperdal to children, adolescents and the elderly. The companies faced both civil and criminal charges.  As part of the settlement, Janssen Pharmaceuticals, Inc. will plead guilty in the United States District Court in Pennsylvania to a criminal misdemeanor charge of misbranding Risperdal in violation of the Food, Drug, and Cosmetic Act and pay an additional $400 million fine.

Going forward, Delaware will receive an additional 10 percent bonus in its share of future settlements in cases like this under the Delaware False Claims and Reporting Act thanks to legislation Biden and the Medicaid Fraud Control Unit proposed to the General Assembly and enacted earlier this year – Senate Bill 146, sponsored by Sen. Robert Marshall and Rep. Michael Barbieri.  Earning a 10 percent bonus in shares of future false claims settlements is expected to generate hundreds of thousands of additional dollars in recoveries for Delaware and the Delaware Medicaid and Medical Assistance program.

# # #