DePuy Hip Lawyer

Johnson & Johnson is beleaguered with lawsuits about the metal on metal hip replacement products from its medical device subsidiary DePuy Orthopaedics, Inc. In August 2010, Johnson & Johnson launched a massive recall of two of its DePuy ASR hip implants. The DePuy ASR XL Acetabular Hip System and the DePuy XL Hip Resurfacing System were recalled after multiple studies showed that the implants failed at an alarmingly high rate. The DePuy Pinnacle implants were never recalled, but an increasing amount of litigation alleges that the Pinnacle implants suffer from similar potential defects.

Johnson & Johnson's latest Form 10Q filing with the U.S. Securities and Exchange Commission (SEC) shows that the multifaceted corporation faces extensive litigation after the DePuy ASR hip recall and related litigation. The SEC requires public companies like Johnson & Johnson to file a Form 10Q quarterly report every three months. Form 10Q informs the investing public about the operation of the company in comparison to past quarters. In its latest Form 10Q filing, available on its corporate website, Johnson & Johnson admits that the number of personal injury lawsuits "continues to increase."

Johnson & Johnson faces personal injury lawsuits related to both its DePuy ASR and DePuy Pinnacle hip implants. The amount of DePuy ASR hip lawsuits increased significantly after the metal on metal hip implants were recalled. DePuy ASR hip implants have dramatically high failure rates. DePuy cited an unpublished study showing a 13% failure rate, which is more than double the typical rate for medical devices. Independent medical research has found a failure rate as high as 49%. DePuy ASR hip failures are linked to tissue damage, heightened levels of metal in the blood, and excruciating pain. Many patients had to undergo invasive revision surgeries, in which the failed implant may be removed and replaced.

The plaintiffs in DePuy Pinnacle lawsuits allege problems that are similar to the problems caused by DePuy ASR recalled hips. According to Johnson & Johnson's Form 10Q filing, there are 560 pending DePuy Pinnacle lawsuits seeking "substantial compensatory and, where available, punitive damages." Reports indicate that Johnson & Johnson may have quality control issues. Johnson & Johnson has instituted more than 50 product recalls in the past two years. The corporation faces lawsuits from the DePuy hips, as well as several pharmaceutical and medical device products.

Continue reading "Johnson & Johnson SEC Filing Reveals Hundreds of DePuy Pinnacle Lawsuits" »

The DePuy hip replacement recall litigation continues to grow in the United States. More than 2,600 people have filed lawsuits in the American federal court system about the De Puy ASR hip replacements. Some analysts estimate that there are 20 new DePuy hip lawsuits per day. Johnson & Johnson, the corporate parent of DePuy Orthopaedics, may face liability as much as $1 billion because of its metal on metal hip replacement products. More than 37,000 patients in the United States were implanted with DePuy ASR hips.

Litigation against Johnson & Johnson may increase outside the United States as well. Thousands of Australian patients were implanted with DePuy metal on metal hips. Australian patients are now suffering the same complications suffered by American patients as a result of their DePuy hip implants. Scores of Australian patients have already undergone revision surgeries to replace their recalled hip implans. According to reputable Australian newspapers, Johnson & Johnson has "reimbursed" thousands of patients who filed claims about DePuy implants.

Australian news media reports reveal outrage against the country's regulatory process because of the DePuy hip crisis. In Australia, the key regulatory agency for medical devices and drugs is the Therapeutic Goods Administration (TGA). The TGA is the Australian equivalent of the Food & Drug Administration (FDA) in the United States. Media reports indicate that the TGA did not adequately respond to negative information about DePuy implant failures.

Reports show that Johnson & Johnson discussed the "unacceptable" failure rate for its DePuy implants with the TGA, but the TGA did not respond effectively. Specifically, Johnson & Johnson advised the TGA that its DePuy implants had a high revision surgery rate - patients were undergoing surgeries to have their implants replaced much sooner than expected.

The TGA did not remove DePuy hip implants from the Australian medical market after receiving information about the high failure rate. According to records, the TGA failed to even meet for 18 months after receiving the news. The TGA received the information in May 2008 but did not meet again until December 2009. The agency announced that DePuy's implants should be recalled at the December 2009 meeting. At that same meeting, TGA members complained that the agency's response was delayed and ineffective.

The hip implants were not recalled in the United States until August 2010. The FDA did not force Johnson & Johnson to recall the products. Instead, Johnson & Johnson voluntarily recalled two of its DePuy implants - the DePuy ASR Hip Resurfacing System and the DePuy ASR XL Acetabular Hip System. Johnson & Johnson has not instituted a De Puy Pinnacle recall, but litigation about that medical device is growing as well.

Continue reading "DePuy Hip Failures Wreak Havoc in Australia" »

The medical community is alarmed at the financial relationship between the medical device industry and physician community. Financial payments made to doctors may influence how doctors choose medical devices for their ailing patients. Medical crises like the massive DePuy hip recall and Zimmer hip lawsuits enlarge the concern over potential kickbacks paid to doctors from the medical device industry.

The Archives of Internal Medicine recently published a study by four scientific and medical researchers detailing the shocking number of payments that the medical device industry pays to orthopedic surgeons, the very physicians who advise and operate on patients in dire need of medical implants. Patients entrust orthopedic surgeons with the integrity of their bodies. The medical device industry should not be able to compromise that trust.

The Archives of Internal Medicine study is titled: "Financial Payments by Orthopaedic Device Makers to Orthopaedic Surgeons." The researchers who performed the study were Jason M. Hockenberry, PhD; Paula Weigel, MS; Andrew Auerbach, MD, MPH; Peter Cram, MD, MBA. The researchers were able to uncover the extent of medical payments from medical device makers to orthopedic surgeons by analyzing the data made available by the Department of Justice.

In 2007, the Department of Justice (DOJ) launched a serious investigation of the largest medical device manufacturers in the United States. DePuy Orthopaedics (a subsidiary of Johnson & Johnson), Zimmer, Biomet, and Smith & Nephew were suspected of violating federal anti-kickback laws. Specifically, the DOJ believed that the medical device manufacturers paid doctors to induce them to use that company's medical devices. The companies may have encouraged doctors to prescribe products like DePuy ASR hip replacements based on finances instead of their patient's needs.

The medical device manufacturers involved in the investigation account for more than 90% of the American medical device market. The investigation resulted in a settlement. Under the terms of the settlement, the medical device manufacturers must comply with reporting procedures about payments made to doctors. The companies also agreed to federal oversight and new compliance procedures.

The medical study found that since the 2007 DOJ investigation, the number of payments to doctors from medical device manufacturers increased. Before the settlement, medical device manufacturers made more than 1,000 payments to doctors in a single year. Those payments totaled more than $198 million. After the settlement, the amount of money paid to doctors increased. In a single year, major medical device manufacturers paid $228 million to orthopedic surgeons in one year.

Continue reading "Settlement Forces Hip Implant Manufacturers to Cut Doctor Fees" »

On October 19, 2011, the California Technology Assessment Forum (CTAF) published a new study about metal on metal hip implants. The CTAF study reviews recent medical research on hip implants to determine the benefit they may provide to patients, if any. The CTAF study exemplifies the concern about metal on metal hip implants in the medical community. The concern grows as medical professionals observe their patients suffer the consequences of having DePuy recalled hips. The CTAF concluded that metal on metal hips fail to improve net health outcomes and fail to benefit patients as established alternatives.

Before the massive Depuy ASR recall, Johnson & Johnson and its medical device subsidiary DePuy Orthopaedics advertised metal on metal hips as a better alternative for the physically active. Now, multiple medical studies indicate that metal on metal hips may not be the best option for patients. Several studies have found that metal on metal hips may not improve gait speed, postural balance, or other clinical outcomes. According to the CTAF study and other reports, metal on metal hips failed to help patients more than established, safe implants and treatments.

Additional studies indicate that metal on metal hip implants increase the risk for negative clinical outcomes in patients. DePuy metal on metal hips are linked to an increase in the blood levels of cobalt and chromium ions. DePuy recalled hips have an abnormally high failure rate as well. One clinical trial using metal on metal hip implants had to stop early because so many patients experience early failures.

Unfortunately, thousands of patients received metal on metal implants before the recalls were enacted. Surgeons implanted 93,000 patients with ASR hips before Johnson & Johnson launched a recall. Johnson & Johnson recalled two of its metal on metal hip products - the ASR XL Acetabular Hip System and the DePuy ASR Hip Resurfacing System. Johnson & Johnson faces more than 1,000 federal and state lawsuits about the harm caused by De Puy recalled hips. Depuy has not instituted a DePuy Pinnacle recall, but faces lawsuits for its Pinnacle hip implants as well. The lawsuits for the products allege similar facts: early hip failures, patients suffering excruciating pain, and revision hip surgeries.

Continue reading "New Medical Study Confirms Dangers of Metal-on-Metal Hips" »

DePuy Orthopaedics is a medical device subsidiary of Johnson & Johnson. DePuy appeared to experience great success for a number of years with its sales of metal-on-metal hip implants. However, medical research began to indicate that DePuy metal-on-metal hip implants were failing at an abnormally high rate. The high failure rate of DePuy hip replacements was serious for patients. Patients felt excruciating pain. Many patients underwent painful revision surgeries, in which a defective implant was removed and replaced. In 2010, Johnson & Johnson initiated a recall of two of its metal-on-metal hip implants - the DePuy ASR XL Acetabular Hip System and the DePuy ASR Hip Resurfacing System. Johnson & Johnson now faces thousands of DePuy ASR hip lawsuits.

The federal court system consolidated all federal DePuy ASR lawsuits consolidated in a process called Multi-District Litigation (MDL). The MDL process combines the pretrial and discovery phases of all related federal cases. The DePuy ASR MDL is called "In re DePuy Orthopaedics Inc. Hip Implant Liability Litigation." The Honorable David A. Katz is overseeing the DePuy ASR MDL in the United States District Court of the Northern District of Ohio,

On October 26, 2011, Judge Katz ordered a new status conference about the DePuy hip implant lawsuits. At an MDL status conference, the judge meets with attorneys to cover what has occurred in the complex litigation. The next status conference is set for the morning of November 22, 2011 at 11:00am. The status conference will be held in the James M. Ashley and Thomas W.L. Ashley Courthouse in Toledo, Ohio.

Since the last status conference, the discovery process has continued. The judge has ordered the plaintiffs to submit Plaintiff Fact Sheets and Medical Records Authorizations. Plaintiff Fact Sheets are used to gather information about the individual plaintiffs during the discovery phase. Plaintiff Fact Sheets play an important role in large scale litigation like the DePuy ASR MDLs. Defendants use the fact sheets to get information about the plaintiff's injuries. In this case, the plaintiffs must indicate whether they received a revision surgery and other important facts.

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DePuy Orthopaedics, the medical device subsidiary of Johnson & Johnson responsible for the DePuy hip recall, recently settled a United States Department of Justice (DOJ). The DOJ lawsuit charged Depuy - and four other artificial hip and knee manufacturers - with paying illegal kickbacks to surgeons. The lawsuit is a matter of public concern, since the manufacturers involved may have increased the use of DePuy defective hips through kickback payments.

DePuy and Styker were able to avoid criminal liability for kickbacks by settling with the DOJ. The settlement requires that the corporations make several changes: (1) the corporations must allow the federal government to review its agreements with doctors; (2) the corporations must show the federal government its current agreements with doctors; (3) the corporations must publish payments to doctors on their web sites; and (4) the corporations must scale back its payments to doctors.

Nearly 1,000 orthopedic surgeons received money from medical device manufacturers. These payments are paid to the surgeons in the form of research grants, consulting fees, and royalty payments. One report shows that American orthopedic surgeons may have received more than $200 million in payments and royalty buyouts.

Kickback payments may exert undue influence on the relationship between doctor and patient. Studies indicate that gifts from medical device corporations may affect how doctors treat their patients. A gift as small as a free lunch may affect the doctor's treatment decisions. Patients should receive medical treatment based solely on their medical needs. The patient is not served well if corporations may affect that treatment for profit. The fight against kickbacks ultimately protects the interest of the patients.

DePuy Orthopaedics, the medical device subsidiary of Johnson & Johnson, has not launched a DePuy Pinnacle hip recall. However, DePuy is facing hundreds of lawsuits asserting that DePuy Pinnacle hip replacements are defective and dangerous.

The DePuy Pinnacle hip lawsuits allege that the metal-on-metal hip implants were manufactured defectively, designed defectively, and that the manufacturer's failed to warn of the hip implants dangers. A substantial proportion of the plaintiffs assert that they underwent painful revision surgeries because of DePuy Pinnacle hip defects. Many lawsuits additionally allege that Johnson & Johnson was aware of the dangers posed to patients by the DePuy Pinnacle hip implants, but waited to recall the products.

The United States Judicial Panel on Multidistrict Litigation ordered that all federal DePuy Pinnacle lawsuits be consolidated in a Multi-District Litigation (MDL). MDL is a process in which the pretrial and discovery phases of multiple federal lawsuits against a single defendant are transferred to a single district court. The purpose of MDLs is to increase judicial efficiency. A single judge in a single district court oversees a single discovery process for a single defendant, instead of multiple judges around the country completing discovery of the same information.

In May 2011, the DePuy Pinnacle MDL consolidated three federal lawsuits against Johnson & Johnson and transferred them to the Northern District of Texas. By August, 213 Pinnacle lawsuits were a part of the MDL. As of October 6, 2011, more than 530 lawsuits were involved in the DePuy Pinnacle MDL.

The DePuy Pinnacle MDL does not represent all the metal-on-metal hip implant litigation that Johnson & Johnson faces. MDLs are a strictly federal process. DePuy Pinnacle lawsuits filed and kept in state courts are not involved in the DePuy Pinnacle MDL. Johnson & Johnson also faces more than 1,000 lawsuits after the DePuy ASR hip replacement recall. Johnson & Johnson initiated a recall of two hip implants in 2010 - the ASR XL Acetabular Hip System and the ASR Hip Resurfacing System. The metal-on-metal hip replacements were implanted in more than 93,000 patients before the recall.

Continue reading "DePuy Pinnacle MDL Cases Double in Two Months" »

Penny Brown was a poster-woman for the DePuy ASR hip metal-on-metal hip implants. The former gymnast appeared in promotional materials for DePuy Orthopaedics, a medical device subsidiary of Johnson & Johnson. Ms. Brown even launched DePuy's metal-on-metal product line on stage in exotic Monte Carlo. Ms. Brown was heavily featured in Johnson & Johnson's promotions for a five year period.

Now Ms. Brown joins hundreds of other United Kingdom (UK) patients who are suing Johnson & Johnson because of DePuy recalled hips. Like many other DePuy hip implant patients, she began to suffer severe pain related to her metal-on-metal hip implants. For years, she endured constant pain. Her walking ability was hampered. Eventually, she underwent surgery to have her DePuy metal-on-metal hip implants removed.

The DePuy recalled hips were implanted in more than 90,000 patients around the world before Johnson & Johnson launched a massive recall of the product in 2010. Many of these patients lived in the United States and the UK. Litigation against Johnson & Johnson in those countries is intensifying.

A "group action" lawsuit (similar to an American class action lawsuit) is developing in the UK Ms. Brown will join roughly 300 DePuy hip plaintiffs in suing Johnson & Johnson for compensation. According to reports, another 500 cases are under evaluation.

In the United States, Johnson & Johnson faces more than 1,000 lawsuits. American plaintiffs allege that their injuries and the DePuy hip recall were caused by manufacturing defects, design defects, failure to warn of risks, and other causes of action. Most importantly, the DePuy hip lawsuits claim that DePuy hips fail at an abnormally high rate. DePuy failed hip replacements may cause excruciating pain. Patients may experience pseudotumors caused by metal debris created by the failure of metal hip implants. The damage caused by defective hip implants has the ability to severely interfere with a patient's quality of life.

Continue reading "DePuy Hip Poster Woman Sues after Pain, Revision Surgery" »

According to reports, the Food & Drug Administration (FDA) recalled yet another metal-on-metal (MoM) hip implant. The Zimmer Trabecular Metal Modular Acetabular System was recalled on September 27, 2011. The Zimmer hip recall is the latest in a string of strong indications that MoM hip implants pose a serious risk to patients.

The Zimmer hip implant in question replaces hip sockets in total hip arthroplasty operations. The device is made of a shell, a locking ring, and a line. The hip implant may come with optional screws. Reports indicate that the locking ring groove is not appropriately deep. The inappropriate groove depth may prevent the liner from fitting into the shell.

The Zimmer hip replacement recall is not the only ongoing MoM hip replacement recall. In August 2010, Johnson & Johnson subsidiary DePuy Orthopaedics recalled two MoM hip replacement models: the ASR XL Acetabular Hip System and the DePuy ASR Hip Resurfacing System. Johnson & Johnson recalled the MoM hip implants after medical researchers found an abnormally high failure rate for the devices. Zimmer launched a Durom Cup recall as well.

Hip replacement failure may be a horrifying occurrence for a patient. The hip replacements are surgically implanted into the patient's body. Any defects in a MoM in a hip implant may result in serious pain for the patient. For example, DePuy defective hip patients report pain resulting from the grinding of the metal parts of the implant. Patients have also reported difficulty walking.

The FDA has received thousands of complaints from MoM hip implant patients. According to national news agencies, the FDA has received more MoM implant complaints in the past year than in the previous four years combine. Patients who have received a MoM hip implant from Zimmer or DePuy would be advised to contact a skilled hip recall lawyer to learn about their legal rights.

Johnson & Johnson recently recalled hundreds of thousands of syringes filled with an anemia drug. The anemia drug recall affects the retail and wholesale levels. According to national reports, the recall will affect 17 countries. Most of the recalled drug syringes have been used by patients. However, more than 6,000 syringes may still be on the market.

Johnson & Johnson loses roughly $900,000 in sales because of the numerous products each year. The barrage of product recalls has caused some analysts to say that the healthcare corporation may have serious quality control issues. Johnson & Johnson's reputation may be permanently sullied by the volume of product recalls initiated in the past two years.

The drug syringe recall is one of many product recalls that Johnson & Johnson has instituted in the past two years. In March, the Ethicon unit of Johnson & Johnson recalled more than 300,000 surgical-wound draining products because of concerns about their sterility. Johnson & Johnson recalled more than half a million surgical sutures. Notably, Johnson & Johnson's Depuy unit launched a massive DePuy hip replacement recall in August 2010.

Johnson & Johnson did not institute the DePuy hip recall until after the hip replacements were implanted in roughly 93,000 patients worldwide. The corporation recalled two models - the DePuy ASR XL Acetabular Hip System and the DePuy ASR Hip Resurfacing System. Johnson & Johnson recalled the hips after they began failing at an abnormally high rate. DePuy cited a 12-13% failure rate. However, later reports have shown an even higher rate.

Independent medical research has uncovered shockingly high failure rates for the hip implants. The National Joint Registry of England and Wales found that 29% of DePuy defective hips had to be replaced after six years. The British Hip Society and the British Orthopaedic Society published a report that found a failure rate as high as 49% for DePuy hip recall implants. The overall failure rate for metal-on-metal hip implants is only 9.5%.

According to an investigation into a U.K. medical registry, DePuy recall hips failed nearly in nearly 30% of British patients. The U.K. study adds to mounting evidence that the metal-on-metal hip implants recalled by healthcare giant Johnson & Johnson are defective.

In August 2010, Johnson & Johnson recalled two of its metal-on-metal hip replacements: the DePuy ASR XL Acetabular Hip System and the DePuy ASR Hip Resurfacing System. Johnson & Johnson cited an unpublished study showing a failure rate of 12-13%, which is dramatically higher than the 2-3% failure rate for medical devices overall.

Recently, the National Joint Registry of England and Wales reviewed revision rates for DePuy hip replacements to determine whether the metal-on-metal hip replacements from Johnson & Johnson failed at an abnormally high rate. The registry discovered that DePuy's hips had to be removed or replaced in 29% of patients after six years. The rate for DePuy's hip implants is significantly higher than the 9.5% failure rate for metal-on-metal hip implants.

The failure rate evidenced by the medical registry is abnormally high. However, previous British research pointed to an even higher failure rate for DePuy recalled hips. The British Hip Society and the British Orthopaedic released a report that found a 49% failure rate for DePuy's metal-on-metal hip implants.

The heightened failure rate for De Puy defective hips is tragic for the 93,000 patients who were implanted with the metal-on-metal hip implants. Patients with failed hip implants often suffer severe pain and decreased mobility. Patients with failed hips also undergo painful revision surgeries in which the defective hip implant is removed and replaced.

Patients have filed scores of administrative and legal complaints against Johnson & Johnson because of failed hip implants. Patients have filed more than 5,000 complaints with the Food & Drug Administration (FDA) about the DePuy hip replacement recall. More than 2,000 lawsuits have been filed against Johnson & Johnson as well. Analysts predict that Johnson & Johnson may face $1 billion in liability.

Continue reading "DePuy Hip Recall Products Failed for Nearly 30% of Patients" »

According to national reports, many orthopedic surgeons are refusing to implant metal-on-metal hip replacements. Surgeons are abandoning metal-on-metal hip implants in reaction to the rising number hip replacement complaints filed with the federal Food & Drug Administration (FDA). Two widely used metal-on-metal hip implants were subject to Johnson & Johnson massive DePuy hip implant recall after the implants failed in thousands of patients.

According to national news reports, more than 5,000 patients have filed FDA complaints in 2011 alone. More complaints are expected by the conclusion of the year. Most of the DePuy defective hip implant complaints show that the metal-on-metal hip implants failed in just a few years. Hip replacements usually last at least 15 years.

The complaints may increase as DePuy defective hips continue to fail. More than 93,000 patients worldwide received Johnson & Johnson's DePuy metal-on-metal hip implants before they were recalled in August 2010. According to a review of FDA hip complaints conducted by the New York Times, Johnson & Johnson's DePuy hips accounted for roughly 75% of FDA hip complaints. Patients with DePuy defective hip implants may experience debilitating pain or crippling tissue damage. Some hip implant patients have additionally reported difficulty walking after their hip implants failed.

Patients with defective hip implants may have to undergo revision surgeries. In a revision surgery, a defective hip implant is removed and replaced with another model. Surgical complications are an inherent risk in revision surgeries. Patients are more likely to suffer from surgical complications in a revision surgery than in the initial implant surgery. Even if the revision surgery is without complications, patients have to experience the pain of surgical interventions. Patients lose time from their daily lives to physically recover from a revision surgery as well.

Since the DePuy defective hip recall, many surgeons have avoided using any metal-on-metal hip implants. Given the dangers that metal-on-metal implants pose to patients, doctors now prefer models that include plastic or ceramic components. Metal-on-metal hip implants used to occupy a substantial portion of the American hip implant market. Now those devices only account for 5% of the domestic hip implant market.

According to one New York orthopedic surgeon, using metal-on-metal hip implants is "like playing Russian roulette."

Continue reading "Surgeons Abandon Metal-on-Metal Hip Implants as FDA Complaints Rise" »

In March, Johnson & Johnson announced the resignation of David K. Floyd, the president of its DePuy Orthopaedics medical device subsidiary. Floyd was the head of DePuy Orhopaedics for years while the subsidiary sold and marketed DePuy defective hips.

Two of DePuy's metal-on-metal hip replacement models - the DePuy ASR Hip Resurfacing System and the DePuy ASR XL Acetabular Hip System - were the subject of a massive product recall. Johnson & Johnson launched its massive DePuy Orthopaedics hip recall after studies found abnormally high failures rates for the implants. The failing implants left patients with serious injuries. Many patients had to undergo painful and costly revision surgeries. Floyd resigned as the DePuy hip lawsuits began to increase.

Now, Floyd will act as a Chief Executive Officer for OrthoWorx. OrthoWorx is an orthopedics industry initiative based in Warsaw, Indiana. Indiana is home to a substantial portion of the worldwide orthopedics medical device industry. OrthoWorx aims to help Indiana maintain its position as a major player in the orthopedics device industry.

OrthoWorx cited Floyd's experience as the president of DePuy Orthopaedics as a factor in its decision to hired Floyd. OrthoWorx hired Floyd because of his experience at DePuy, despite the injuries called by the DePuy hip recall. More than 1,000 lawsuits have been filed against Johnson & Johnson since the recall began. DePuy Orthopaedics is headquartered in Warsaw, Indiana.

Floyd became President of DePuy Orthopaedics in September 2007. Floyd also served in leadership positions for several other medical device companies: he was the President of Centerpulse Orthopedics, the President of Abbott Spine, and the President and CEO of AxioMed Spine Corporation. Floyd was also a founding board member of OrthoWorx.

Continue reading "Former DePuy Hip Recall CEO Heads Orthopedic Initiative" »

DePuy Orthopaedics is a Johnson & Johnson subsidiary that focuses on producing and marketing medical devices. The subsidiary has been struggling for a year since it launched the DePuy hip recall. DePuy recalled its ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System. The recalled DePuy hips became available in July 2003.

The DePuy metal-on-metal hip implants continued to be sold worldwide, despite indications that the implants were failing at an abnormally high rate. When Johnson & Johnson announced the DePuy defective hip recall, the corporation cited a failure rate of 12-13%. The failure rate cited by Johnson & Johnson is more than triple the failure rate for the medical device industry as a whole. Independent medical research in England found a rate as high as 49% for the defective DePuy hips.

When a defective hip implant fails, the patient must undergo a painful and costly revision surgery. In revision surgeries, surgeons remove the defective implant and replace it with a different model. Patients are at an increased risk of surgical complications during an implant revision surgery as compared to their original implant surgery. Many patients try to make a claim with their doctors to cover out-of-pocket expense. Now national reports indicate that Johnson & Johnson has hired a third-party corporation to process these claims.

Earlier this week, reports indicate that Johnson & Johnson has hired Broadspire Services, Inc. to process claims from patients. Broadspire is a corporation that specializes in processing medical claims for employers and insurance claims. Broadspire will administrate patient claims for out-of-pocket expenses related to DePuy defective hips. Some analysts suspect that Johnson & Johnson is using Broadspire to collect information on potential DePuy hip lawsuit plaintiffs.

Doctors evaluate patient claims for Broadspire. When doctors evaluate cases concerning DePuy defective hips, Johnson & Johnson pays them directly. The DePuy Orthopaedics unit has reportedly offered doctors $50 for each set of forms, giving doctors an incentive to obtain information from their patients. Health consumer advocates are concerned that DePuy is essentially paying doctors to gain access to the medical records of potential plaintiffs who have yet to file a DePuy hip lawsuit.

Continue reading "Johnson & Johnson Uses Corporation to Find Potential DePuy Hip Plaintiffs" »

The Food & Drug Administration's 510(k) medical device approval process used to clear DePuy recalled hips has come under fire in the medical community. The New England Journal of Medicine recently published a forceful editorial calling for an end to the federal medical device approval process that led to the entrance of defective De Puy hips into the American market. The editorial followed a report released by the Institute of Medicine (IOM) entitled "Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years."

The Medical Device Amendments, passed by Congress in 1976, govern the regulatory framework used to approve medical devices for sale in the United States. Congress updated the regulatory framework in 1990 and 1997, but has not changed it substantially since then. Under this framework, federal law requires that new medical devices are reviewed by the FDA before entering the market if the device is deemed "high risk." Manufacturers must show that a high risk device is safe and effective before being able to sell that device to the public at large.

Moderate risk devices do not have to undergo extensive review and testing to garner FDA approval. Rather, manufacturers only have to show that a new medical device is substantially equivalent to another device that was sold in the United States. If the manufacturer shows that the medical device is similar enough to another device that was sold before, the device receives FDA 510(k) approval. One may think that the 510(k) approval process indicates that the FDA found the device safe and effective, but that is not the case. The FDA stated that 510(k) substantial equivalence is not a determination of safety or effectiveness. The United States Supreme Court ruled on the issue in Medtronic, Inc. v. Lohr. The Supreme Court agreed that substantial equivalence is not an FDA finding that a moderately risky medical device is safe and effective.

Roughly 33% of all medical devices receive FDA approval through the 510(k) approval process, including DePuy defective hips. The DePuy defective hips received 510(k) FDA clearance for sale in the United States. The metal-on-metal hip implants were widely marketed. Surgeons implanted more than 93,000 DePuy ASR hip replacements into patients before the DePuy hip recall in August 2010. Many patients underwent invasive, painful revision surgeries to have the defective hips removed. Litigation allows these injured patients to receive compensation for their injuries, but some analysts now believe the FDA should have never cleared these implants in the first place.

Continue reading "Medical Journal Demands End to FDA 510(k) Approval Process Used for DePuy" »