The Court investigates Johnson's ex-charges for fraud in hip prostheses

The National Court investigates three former senior officials of the company Johnson & Johnson SA for an alleged fraud in the commercialization of defective hip prostheses. The criminal investigation, which started secretly in August 2017, was opened as a result of the complaint filed by 64 affected in Spain for the product, which was withdrawn from the European market in mid-2010 due to the risks involved.

The criminal proceeding began after eight years of litigation in the civil jurisdiction and following indications that the multinational had prior knowledge that the prostheses distributed had failures and therefore implied a risk of health hazard. The complainants, who claim that there is evidence that the danger was known before 2005, accuse senior officials of the company of the commission of crimes of fraud, continued injuries, against public health and fraud of pharmaceutical or medicinal substances.

As specified by a car to which El Confidencial has had access, the indications are based on the statement of a key witness, the doctor Anthony Nargol, "that could prove the knowledge of the defects and their very serious consequences on the part of those responsible in Spain for their importation and distribution as executives of the Johnson & Johnson SA entity ".

Click to enlarge.

According to the claim of the complainants, the extensive placement of these prostheses over time, despite the health problems they caused, was possible thanks to the circumvention of new medical controls by an artifice consisting in the modification of the initial device that had already overcome them. The physical damages caused reside as much in the manufacturing defects as in the composition of the product.

The secret of the proceedings, which they already consist of four volumes, was lifted on May 6 and, as El Confidencial has been able to know by legal sources, the Central Court of Instruction 6 cited shortly before those dates to Enrique Álvarez López, Margarida Neves Y Ángel Ignacio Cano, the three with management positions leading the Spanish division of the company. His current legal representative was also cited, Pablo Arias Sanjuán. All of them refused to testify until they knew the content of the procedure.

In August, the company acknowledged that it has received "thousands" of complaints from patients around the world who lament "acute pains"

The sources cited suggest that they will be relocated to appear in the National Court at the end of this month, after the rise of the secret. Those affected in Spain, to whom the firm represents Emilio Ortiz Abogados, have also asked to investigate the engineer responsible for the design of the prosthesis, Graham Isaak. The complainants request that the former vice president be also investigated for regulatory matters of the company's global division Shally Katherin. In statements made in the civil process, this responsible said that the prostheses were classified as class A, ie, likely to cause harm to the health of people, even before 2005, they say.

Click to enlarge.

These two people and two others linked to the company could not be located at the moment. The same happens with two former legal representatives of Johnson. The complainants do not rule out asking that proceed to its international search and capture. The legal representation of those affected has contributed Internal documents of the multinational parent company and emails that, according to their defense, accredit prior knowledge of the risk. The contributed papers have been used in disputes at international level, in particular in Australia, USA, Ireland or United Kingdom. The National Court has also heard the statements of several witnesses. Under the focus is also the manufacturer of the prosthesis: the American brand Depuy.

The health alert jumped in October 2010 when, allegedly voluntarily, Depuy, a subsidiary of Johnson & Johnson, requested the surveillance and removal of nearly 93,000 hip prostheses and titanium metal bones implanted worldwide, due to "serious failures" of the material. Defective prostheses, specifically the ASR XL Acetabular System and ASR XL Hip Resurfacing System models, were on the market from 2004 and 2003, respectively.

The alert jumped in October 2010, when Depuy, a subsidiary of Johnson & Johnson, requested the surveillance and removal of about 93,000 hip replacements.

The defective products caused a symptomatology of pain, inflammation or difficulty walking. They also presented a danger of transfer of metals such as chromium and cobalt to tissues surrounding the prosthesis. The products were distributed in some 70 centers of all the autonomous communities, except Aragón, Cantabria, Ceuta, Extremadura, Melilla, Navarra and La Rioja.

The company then issued an appeal in which it demanded that patients from all over the world consult with their doctor and warn that a replacement intervention was recommended. The decision comes after last August the company announced that it has received "thousands" of complaints from patients around the world who lamented "acute pains" and of "huge difficulties to move"