Share |

J&J to Pay NJ $1 Million to Settle Claims Over Contaminated Meds

$33 Million Settlement Involves Quality Control at PA & Puerto Rico Facilities
Chris Porrino
NJ Attorney General Chris Porrino Charlie Kratovil

TRENTON, NJ–New Jersey Attorney General Christopher S. Porrino announced on May 24 that the State will receive $1.04 million from a 42-state civil settlement with Johnson & Johnson.

The Garden State participated in the settlement to resolve allegations that J&J's McNeil-PPC unit "made false or misleading representations about its over-the-counter [OTC] products," while also distributing products that were "adulterated as a matter of federal law," according to Porrino. 

“This is an important settlement for New Jersey consumers, because it imposes requirements on the company designed to prevent similar misconduct going forward,” Porrino said in a statement, noting that the case focused on "well-known [medications] commonly found in people's medicine cabinets."

“It’s essential that people who buy and consume these products be able to do so with confidence, and without fear that they may be tainted in some way, or manufactured in substandard facilities," Porrino added.

Under terms of the multi-state settlement, McNeil will pay a total of $33 million to NJ and 41 other participating states, plus the District of Columbia.

The pharma giant operated a plant in Fort Washington, Pennsylvania, where it made hundreds of millions of packaged drugs between 2009 to 2011.

But J&J recalled nearly 2,000 lots, according to Porrino. Together with nine other states, NJ investigated claims that McNeil engaged in wrongful distribution and promotion of the drugs.

The complaint also says that "McNeil violated state consumer protection laws by (1) misrepresenting the quality and compliance level of their [OTC] drugs and (2) falsely representing that the products at issue had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities or qualities they did not have."

More than 1,800 drugs were recalled due to the possibility of poor quality during their production. They included various lots of:

  • Tylenol
  • Motrin
  • Benadryl
  • St. Joseph Aspirin
  • Sudafed
  • Pepcid
  • Mylanta
  • Rolaids
  • Zyrtec
  • Zyrtec Eye Drops

The settlement resolves allegations that McNeil and J&J falsely promoted the products as having met federal standards.

However, between 2009 and 2011, the Food and Drug Administration (FDA) cited some McNeil facilities for failing to meet a federal standard known as current Good Manufacturing Practices (cGMP).

Three J&J factories where the medications were made were flagged in FDA inspections involving multiple violations of the cGMP standard.

According to the Consent Judgement filed on May 24, McNeil will no longer be able to market and promote the drugs unlawfully. Two of the facilities were in Pennsylvania, while another one was in Puerto Rico. 

J&J is pleased to finalize the settlement agreement and noted that the recalls between 2009 to 20011 were voluntary, according to spokesman, Marc Boston. 

"[The] recalls were precautionary and not undertaken on the basis of any health or safety risks to consumers," said Boston. "We remain committed to providing consumers with safe and effective over-the-counter medicines."

According to court papers, McNeil can no longer: 

  • Represent on its Web sites that McNeil’s over-the-counter drug product facilities meet the current good Manufacturing Practice standards as outlined by the FDA if McNeil has had a Class I or Class II recall of over-the-counter drug products within the prior 12 months. (A Class I recall involves a situation in which there is a reasonable probability that the use of, or exposure to, a violative product would cause serious adverse health consequences or death. A Class II recall involves a situation 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).
  • Fail to follow its internal standard operating policies regarding whether to open a Corrective Action/Preventive Action plan during the manufacture of an over-the-counter drug
  • Fail to provide information to participating Attorneys General within 60 day of a written request regarding the identity of wholesalers or warehouses to which any over-the-counter drugs that were subject to a recall were distributed in their state.

Deputy Attorney General Patricia A. Schiripo, Assistant Section Chief of the Division of Law’s Consumer Fraud Prosecution Section, handled the Johnson & Johnson matter on behalf of the State.

The parties have agreed to settle under the umbrella of consumer protection laws found in individual states, but McNeil is not admitting any wrongdoing. On the contrary, it denies wrongdoing, according to the final consent judgement. 

However, McNeil can still make representations permitted by the Food and Drug Administration (FDA), if they are true.

Though New Brunswick is the home of J&J's corporate headquarters, Pennsylvania's Attorney General took credit for leading the effort to hold the corporation accountable.

“We’re proud Pennsylvania helped lead this national effort to ensure health care companies are held accountable when they mislead consumers about the quality of the products they put into the marketplace,” said Attorney General Josh Shapiro of Pennslyvania.

“It’s particularly troubling that many of the drugs that were found to be contaminated in this case were designed for infants and children,” added Shapiro.

The acceptance of the judgement by McNeil "shall not be deemed approval by the Plaintiffs of any of McNeil's advertising or business practices," reads the final consent judgement. Nor should it be implied that the State of NJ has "approved or sanctioned" McNeil's advertising. 

McNeil was previously investigated by the US Department of Justice over quality control problems, according to reports.

But it pled guilty and paid the government $25 million. McNeil also defended itself in federal multidistrict litigation initiated by consumers who feel Tylenol has the capacity to damage the liver.

Though the court cases concluded with a settlement earlier this year, the amount of the pay out has not been made public.