The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of

Johnson and Johnson Johnson & Johnson (J&J) is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company i ...

, recalled its ASR XL Acetabular metal-on-metal

hip replacement Hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant, that is, a hip prosthesis. Hip replacement surgery can be performed as a total replacement or a hemi (half) replacement. Such joint replacement o ...

system on August 24, 2010.

Background

The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment,

infection An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dis ...

, fracture of the bone,

dislocation In materials science, a dislocation or Taylor's dislocation is a linear crystallographic defect or irregularity within a crystal structure that contains an abrupt change in the arrangement of atoms. The movement of dislocations allow atoms to s ...

, metal sensitivity and pain. Additional complications from the hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis, swelling,

nerve damage Nerve injury is an injury to nervous tissue. There is no single classification system that can describe all the many variations of nerve injuries. In 1941, Seddon introduced a classification of nerve injuries based on three main types of nerve f ...

, tissue damage and/or muscle damage. At the beginning of 2011, DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australian implant registry. In March 2011, ''

The New York Times ''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid d ...

'' reported that DePuy issued its first warning to doctors and patients about the high early failure rate. However, at this point, they still had not issued a recall of the product. In fact, they claimed any statements referencing a recall were false.

Lawsuits

About 93,000 persons worldwide received an ASR implant. The first lawsuit in the United States against DePuy Orthopaedics was filed on June 15, 2010.

Shine Lawyers Shine Lawyers is an Australian law firm specialising in personal injury compensation law, operating on a no win no fee basis. The firm has expanded into providing professional negligence, coal seam gas and aviation law legal services through a ...

commenced an Australian class action in the Federal Court of Australia on September 27, 2011, against DePuy International Pty Ltd and Johnson and Johnson Medical Pty Ltd. Both lawsuits claimed that the DePuy ASR hip replacement was defectively designed, that DePuy knew that there were problems with the implant early on but did not do anything to let patients or their surgeons know about the possible problems. The United States

Judicial Panel on Multidistrict Litigation The United States Judicial Panel on Multidistrict Litigation (J.P.M.L. or the Panel) is a special body within the United States federal court system which manages multidistrict litigation. It was established by Congress in 1968 by , and has th ...

filed a ruling on December 7, 2010 that determined the fate of the thousands of lawsuits regarding DePuy Hip Recalls in the United States. Its ruling stated that all cases filed across the country, "are transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable David A. Katz for coordinated or consolidated pretrial proceedings." On January 26, 2011, Judge Katz entered an order in the

multidistrict litigation In United States law, multidistrict litigation (MDL) refers to a special federal legal procedure designed to speed the process of handling complex cases, such as air disaster litigation or complex product liability suits. Description MDL cases ...

naming the leadership counsel for both the plaintiffs and the defendants. Ben Gordon, Eric Kennedy,

Ellen Relkin Ellen is a female given name, a diminutive of Elizabeth, Eleanor, Elena and Helen. Ellen was the 609th most popular name in the U.S. and the 17th in Sweden in 2004. People named Ellen include: *Ellen Adarna (born 1988), Filipino actress *Ellen ...

, Mark Robinson, Christopher Seeger, and

Steven Skikos Stephen or Steven is a common English first name. It is particularly significant to Christians, as it belonged to Saint Stephen ( grc-gre, Στέφανος ), an early disciple and deacon who, according to the Book of Acts, was stoned to death; ...

were named on the plaintiffs' Executive Committee. Robert Tucker and Susan Sharko were named as defendants' Co-Lead Counsel. Discovery of documents from Johnson & Johnson and DePuy Orthopaedics has commenced. In 2014, Johnson & Johnson announced it would not withdraw a $2.5 billion global settlement. Settlements began at a base of $250,000. Johnson & Johnson continued to deny culpability. On March 17, 2016, United States District Judge Ed Kinkeade, after receiving the juries verdict, signed final judgment for Case# MDL Docket No. 3:11-MD-2244-K. The jury awarded five plaintiffs (3:13-cv-1071, 3:14-cv-1994,3:12-cv-1672,3:11-cv-2800, & 3:11-cv-1941) a combined award of $120 million against DePuy Orthorpaedics Inc, and a combined award $240 million against Johnson & Johnson.United States District Court Northern District of Texas Dallas Division Web-Site

India

Of the total number of people receiving the implants, about 4,700 were in India. As of 2018, J&J committed to working with the Indian government to support all Indian ASR patients. In late 2018, an Indian government report, the accuracy of which has been disputed by J&J, proposed that each patient who had a faulty implant should receive a lump sum payment of (). J&J had previously provided to cover diagnostic and surgical costs to patients with defective implants, but the Indian government was concerned that these monies included no compensatory funds.

References

{{Reflist

External links

ASR Hip Replacement Recall site
DePuy Hip Recall Product recalls Johnson & Johnson

Background

Lawsuits

India

References

Further reading

External links