We have carefully reviewed your questions and the recent promotion for your program on the ABC website.

Transcription

1 23 May 2014 Mr P Cronau Senior Producer, Four Corners, The ABC, GPO Box 9994, Sydney NSW Dear Mr Cronau, We have carefully reviewed your questions and the recent promotion for your program on the ABC website. As you are aware, the ASR Hip System is the subject of a dispute pending in Federal Court, NSW, and it appears that you have prejudged the matter and condemned the company based on a selective presentation of only a small portion of the evidence. The proper venue for the complexities of the science and facts on these issues is the federal hearing where all the appropriate evidence will be considered. Indeed, the lawyers representing ASR Hip System patients believe that a full exposition of all the issues will require a 16 week hearing. In light of the pending lawsuit, it would be inappropriate for the company to engage in an extensive debate outside the appropriate legal setting. We are also concerned that the tenor of your questions and the selective nature of the information that appears to be the focus of the program could be a disservice to patients who need accurate information to make the proper medical choices in consultation with their doctors. In the interests of ensuring that the public is made aware that the allegations made by Four Corners are disputed, and subject to constraints identified above, we provide the attached response. We ask that you publish this information in full during your broadcast and on your website. Yours sincerely, Mindy Tinsley 1

2 COMPANY STATEMENT We firmly believe that DePuy acted properly and responsibly with the information it had and that the full history of the ASR Hip System shows DePuy is a company that takes action when necessary and is standing by patients today. More than 10 years ago, DePuy scientists, working with expert surgeons, set out to design an improved metal hip implant as an option for the increasing number of younger, active patients who needed hip replacement surgery. That is our mission at DePuy: to develop products that meet the needs of patients. Following years of design and testing, the ASR Hip System was cleared for sale through the regulatory processes of various countries around the world. After the system was on the market, DePuy continued to study the device and closely watched how it was performing. The company looked at data from a variety of sources around the world and sponsored studies in which doctors monitored patients and reported data about the ASR Hip System. The company openly and rigorously evaluated the data on the device and shared information with surgeons and regulators. In late 2009, DePuy made the business decision to discontinue the ASR Hip System worldwide because of declining demand and to allow the company to focus on developing the next generation hip technologies to better meet the needs of patients and surgeons. In Australia, the decision to discontinue ASR Hip System sales was announced in letters to customers in late 2009 and was communicated in writing to the Therapeutic Goods Association (TGA) in early December There was no recall in Australia, or anywhere in the world, until August In August 2010, DePuy issued a worldwide recall of the ASR Hip System after new data indicated patients were undergoing a second hip replacement surgery, called revision surgery, sooner than expected. We immediately recalled the product in every country where it was sold. Until mid-2010, the totality of the data available to the company showed the ASR Hip System was performing consistent with the class of monoblock metal-on-metal hip implants. We understand the worldwide, voluntary 2010 recall has been concerning for ASR Hip System patients and health care providers. Within days of the recall, the company set up a Help Line for patients that is available in dozens of countries and has served tens of thousands of callers. In Australia, over four thousand ASR Hip System patients have registered for support, and, so far, many thousands of payments have been made to such patients for testing, treatment, and other out-of-pocket expenses. We encourage ASR Hip System patients in Australia who have not registered with the reimbursement program to call: In Australia, DePuy also established a Compensation Programme. The Compensation Programme allows eligible patients to make a claim for compensation directly from DePuy for pain and suffering and, if applicable, future costs, out-of-pocket expenses and/or loss of earnings related to their ASR Hip System following revision surgery. Regarding the class action proceeding, the company will defend itself against the allegations raised, and DePuy believes the evidence will show the company acted appropriately and responsibly. 2

3 ADDITIONAL INFORMATION COMPANY CONDUCT Many of your questions relate to DePuy s conduct before the recall decision was made. We believe we made the appropriate decision to recall the ASR Hip System at the appropriate time given the available information. It appears some of your questions rely on documents that were presented during two ASR Hip System trials in the United States in The juries for these two trials, one in Los Angeles, California, and one in Chicago, Illinois, considered all of the evidence drawn from the more than 55 million pages of documents produced in this litigation. Neither jury found the company acted in the manner portrayed by Four Corners. We believe the totality of the evidence, not selected documents or s out of millions, supports the juries conclusions on these issues. The Chicago trial resulted in a verdict in favor of DePuy, and we are appealing the judgment rendered in the Los Angeles trial. ASR HIP SYSTEM PERFORMANCE MONITORING Following years of testing, the ASR Hip System was cleared for sale by regulators in various countries around the world. After the ASR Hip System was on the market, DePuy continued studying and closely watching how the device was performing, as we do with all our devices. At all times, the company was looking out for patient interests, analyzing data, participating in a dialogue with surgeons and appropriately communicating with regulators about the ASR Hip System. We received information about the ASR Hip System from many sources including from joint registries, surgeons, clinical performance data, and our company tracking system. No individual piece of data is determinative; all data has to be considered; and none of it can be ignored. Our obligation is to consider all the data available to us at a given time, and that is what we did. The Australian Orthopaedic Association National Joint Replacement Registry (AOA NJRR) data you cite were not consistent with the global data at that time, which spurred discussion and a thorough analysis by the company. We did what a responsible company would do: we were in regular contact with regulatory authorities and surgeons to try to understand the data and patient experience with the product. This included putting in place an ASR Hip System training and education program in Australia to address feedback received on the implant. DePuy also sponsored five post-marketing clinical studies involving the ASR and ASR XL, and several investigator-initiated studies were sponsored by DePuy, in which the investigators owned the data. AUGUST 2010 RECALL The totality of the data showed that up until mid-2010, the ASR Hip System was performing in line with other large diameter metal-on-metal monoblock and resurfacing hip devices. Ultimately, after receiving the new 2010 UK National Joint Registry data, the company decided that it was in the best interests of patients to voluntarily recall the ASR Hip System worldwide. This data showed a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System, which was higher than expected and not in line with data previously reported in that registry. 3

4 CORRECTION You state that the ASR Hip System was recalled in Australia in There was no recall in Australia or in any country until August In 2009, the company made the business decision to discontinue ASR Hip Systems worldwide because of declining demand and to allow the company to focus on developing next generation hip technologies to better meet the needs of patients and surgeons. In Australia, the decision to discontinue ASR Hip System sales was announced in letters to customers in late 2009 and was communicated in writing to the Therapeutic Goods Association (TGA) in early December The decision was made for commercial reasons; use of the products at that time in Australia was limited. August 2010 HHE The ASR Hip System is not a defective device. Let us provide some context. One part of DePuy s overall product evaluation system is called the Health Hazard Evaluation (HHE) process, which is considered best practice in the industry. The process includes a review of product data and consideration of the product s potential hazard or risk. From beginning to end, the process is rigorous, thorough and designed to protect the interests of patients. The HHE form completed by the company in August 2010 about the ASR Hip System included a box checked by the term defective product. The term defective product on the HHE form did not relate in any way to a legal definition of defectiveness, and it simply reflected the company position that the product had a higher than expected revision rate. The ASR Hip System continues to function well for some patients; not all ASR Hip System patients will require revision surgery as a result of the recall. India The August 2010 recall was carried out at the same time in every country where the ASR Hip System was sold around the world. In India, as with every other country where the ASR Hip System was sold, the recall was implemented according to the practices and regulations of the country. At the time of the recall in 2010, DePuy informed the Drugs Controller General of India (DCGI) of the recall, and we have continued to cooperate with them to help patients ever since. Additionally, from the moment of the recall, we supported ASR Hip System patients in India with a reimbursement program (now in its fourth year) for their medical costs, including revision surgery where necessary. We have worked with surgeons to help them identify and contact their ASR Hip System patients. We encourage all ASR Hip System patients in India to register with this program ( for TATA subscribers; for Airtel subscribers; or ). Our goal is to make sure as many ASR Hip System patients in India as possible are aware of the recall and understand the support available to them. REASONS FOR REVISION You refer multiple times to health problems associated with the ASR Hip System, and it is unclear to what this phrase is referring. The reasons for revision identified for the ASR Hip System in national joint registries include component loosening, component misalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain. These reasons for revision are common to all metal-on-metal hip implants. If you are referencing the effects of wear debris from metal-on-metal hip implants, let us provide some information. It is well documented that all hip implants, no matter what materials are used, experience 4

5 wear over time and generate wear debris. The U.S. Food and Drug Administration, in providing information on metal-on-metal hip implants, explains: All artificial hips require one component to slide against another component and it is inevitable that material at the surfaces will wear as they interact. 1 Metal-on-metal wear can result in the release of ions that can be measured through medical tests. Although there has been theoretical concern over metal ion release from metal-on-metal implants, no definitive data establishes that the level of metal ion release has clinical significance. The U.S. FDA has stated that there is insufficient evidence to correlate the presence of localized lesions, clinical outcomes, and/or the need for revision with specific metal ion levels for individual patients. 2 The U.K. Medicines and Healthcare products Regulatory Agency (MHRA), in releasing updated treatment guidelines for metal-on-metal hips, stated: The majority of patients implanted with MoM hip replacements have well-functioning hips and are thought to be at a low risk of developing serious problems. A small number of patients implanted with these hips may, however, develop progressive soft tissue reactions to the wear debris associated with MoM articulations. 3 Chromium and cobalt, from which the ASR Hip System was made, are biomaterials that are naturally occurring in the body. Hip implants made from these materials have been thoroughly tested for years and are considered safe for such implants. Regarding your questions about internal discussions related to ions, it is inappropriate to draw conclusions based on individual documents out of the millions that have been turned over to plaintiffs attorneys as part of the litigation. The fact is the company was continuing to appropriately investigate metal ions with regard to the ASR Hip System, and DePuy engineers presented research on ions at medical conferences. This is an example of a company openly and transparently working to advance the medical and scientific understanding related to ions. The company tests and studies did not suggest a reason to recall the device at the time those tests and studies were being done. Given your questions about health problems, we would also like your viewers to know that, based on numerous clinical studies conducted to date, there is at this time no proven connection between metal-onmetal devices such as the ASR Hip System and any form of cancer. The British Orthopaedic Association/British Hip Society, in response to the media attention generated by media references to metal-on-metal hip implants and cancer risks, stated that, Currently there is no verified evidence that having a metal on metal hip replacement increases cancer risk. The BOA/BHS went on to warn that, It would be unwise to suggest removing these joint replacements and taking additional risks of surgery just on the possible cancer risk. ENGAGEMENT WITH SURGEONS DePuy actively investigated alleged issues with the ASR Hip System, and it remained responsive to surgeon feedback. DePuy carefully considered complaints about its ASR Hip System through its Health 1 FDA Website on Metal-on-Metal Hip Implants, Information for Patients Considering a Metal-on-Metal Hip Implant System: htm 2 FDA Website on Metal-on-Metal Hip Implants, Information for All Health Care Professionals Who Provide Treatment to Patients with a Metal-on-Metal Hip Implant System: htm 3 5

6 Hazard Evaluation ( HHE ) process, an intensive process in which the company s Quality Department brings together a cross-functional team to investigate an issue and determine what action, if any, needs to be taken. DePuy engaged with surgeons about their general feedback on the ASR Hip System. DePuy also hired an outside bioengineering consultant to assist in independently investigating surgeon complaints by analyzing explanted devices. DePuy s marketing department was part of a coordinated and thorough effort to receive surgeon feedback and address surgeon questions; the marketing department did not control or manage scientific issues. Design Surgeons It is critical and responsible to have practicing orthopaedic surgeons who conduct frequent surgeries and follow patients daily in the clinic give input and advice on the practical aspects of implant use and design. It is industry practice for design surgeons to be compensated for their work. Advertising The ad you mention in the Journal of Bone and Joint Surgery was calculated from data from the National Joint Registry of England and Wales (UK NJR). The practice of using national joint registry data in advertising is common in the industry, as is the practice of using ads for the purpose of describing products and initiating conversations with surgeons. Surgeons use many sources of data in the selection and recommendation of implants for their patients. Importantly, surgeons use their medical judgment and knowledge of their patients medical needs when making a decision to use a device, and do not simply rely on company advertising. MANUFACTURING DePuy has a robust quality control system for all of its products. We are not aware of any evidence that an ASR Hip System device did not meet manufacturing specifications. Further, it appears the sources of this claim are paid witnesses in litigation against the company. LITIGATION DePuy is committed to the well-being of ASR Hip System patients globally. Your comparison of the Australian Compensation Programme to the U.S. Settlement Program is inaccurate and misleading. The U.S. settlement program has no bearing on legal proceedings or ongoing support of ASR Hip System patients in other countries. It is consistent with the U.S. legal system and takes into account patient claims filed in the U.S. by U.S. citizens and residents only. The Australian Compensation Programme allowed eligible patients to make a claim for compensation directly from DePuy for pain and suffering and, if applicable, future costs, out-of-pocket expenses and/or loss of earnings related to their ASR Hip System implant following revision surgery. In countries outside the United States where ASR Hip System litigation is pending, the company will continue to appropriately address the litigation in a manner that is consistent with that country s legal system. Regarding the class action proceeding in Australia, the company will defend itself against the allegations raised, and DePuy believes the evidence will show the company acted appropriately and responsibly. 6