Sunday, October 20, 2013

Johnson & Johnson settles another DePuy ASR lawsuit

October 15, 2013 by Brad Perriello

Mass Device
 
 
Johnson & Johnson (NYSE:JNJ) settled another of the thousands of lawsuits it's facing over its recalled DePuy ASR metal-on-metal hip implant, according to court records.
The lawsuit, MacDonald et al v. DePuy Orthopaedics Inc. et al, filed in the Bergen County division of the New Jersey Superior Court, is slated to be dismissed once the court receives formal notice from both sides, according to the records.
The case "has been resolved," Judge Brian Martinotti wrote, according to court documents.

 

"All pending motions are withdrawn, the complaint will be dismissed with prejudice upon receipt of a fully executed stipulation signed by all counsel," Martinotti wrote, according to the documents.

Sunday, October 13, 2013

Metal-on-Metal Bearing: Is This the End of the Line? We Do Not Think So.


2012 Oct;8(3):262-269. Epub 2012 Sep 11.

Metal-on-Metal Bearing: Is This the End of the Line? We Do Not Think So.

Source

Department of Orthopedic Surgery, Roger Salengro Hospital, University of Lille, 2 Av Oscar Lambret, 59037 Lille Cedex, France ; Orthopaedics Department, University of Lille, 2 avenue Oscar Lambret, 59037 Lille Cedex, France.

Abstract

BACKGROUND:

Recent studies have recommended the discontinuation of metal-on-metal (MoM) components in total hip arthroplasty (THA) because of adverse effects reported with large-diameter MoM THA. This is despite favorable long-term results observed with 28 and 32 mm MoM bearings.

QUESTIONS/PURPOSES:

The aim of this study was to assess the value of calls for an end to MoM bearings as THA components. Specifically, we wish to address the risks associated with MoM bearings including adverse soft tissue reactions, metal ion release, and carcinogenic risk.

METHODS:

The study evaluates the arguments in the literature reporting on MoM (adverse soft tissue reactions, metal ion release, and carcinogenic risk) and the experience of the current authors who re-introduced these bearings in 1995. They are balanced by a benefit-risk review of the literature and the authors' experience with MoM use.

RESULTS:

Adverse reactions to metallic debris as well as metal ion release are predictable and can be prevented by adequate design (arc of coverage, clearance), metallurgy (forged instead of cast alloy, high-carbide content), and appropriate component orientation. There is no scientific evidence that carcinogenicity is increased in subjects with MoM hip prostheses. MoM articulations appear to be attractive allowing safe hip resurfacing, decreasing the risk of THA revision in active patients, and providing secure THA fixation with cement in cages in severely deformed hips. MoM bearings in women of child-bearing age are controversial, but long-term data on metallic devices in adolescents undergoing spinal surgery seem reassuring.

DISCUSSION:

Adequate selection of MoM articulations ensures their safe use. These articulations are sensitive to orientation. Fifteen years of safe experience with 28- and 32-mm bearings of forged alloy and high-carbide content is the main reason for retaining them in primary and revision THA.

Over 150 Cases Added to Federal DePuy Pinnacle Lawsuit Litigation in September, More Than 5,000 Metal Hip Claims Now Pending in Texas Federal Court

PR Web
Oct 6th

More than 150 DePuy Pinnacle lawsuit (http://www.depuypinnacle-lawsuit.com/) claims have been added in less than a month to a fast-growing federal hip replacement litigation currently pending in the U.S. District Court, Northern District of Texas, Bernstein Liebhard LLP reports.
According to a Master Case List update on October 1st, a total of 5,037 cases have now been filed in the proceeding over a version of the DePuy Pinnacle Hip Replacement System that includes a metal Ultamet liner. Approximately 4,880 cases alleging injuries caused by the artificial hip were pending in the litigation as of September 3rd. (In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Product Liability Litigation, MDL No. 2244; N.D. Texas)

Update on the first MDL litigation in Cleveland

The case was originally scheduled for trial on September 9, 2013 in Cleveland, Ohio, and then rescheduled to Sept. 24, 2013.

"After conferring at length with the trial attorneys handling this matter, the Court has determined that because of the initial continuance of this trial as aforesaid the scheduling of expert witnesses by both parties has become an extremely difficult task," wrote U.S. District Judge David A. Katz in his reschedule notice.

"Additionally, issues remain with regard to scheduling of additional depositions and pretrial discovery which are necessary for the thorough preparation and presentation of this bellwether case. In the interests of justice, judicial economy and to protect the interests of the parties in this case, the adjourned trial date of September 24, 2013 is set aside and continued to the call of the Court, trial to be set to commence within ninety (90) days."

"Given the fact that there are thousands of similar cases and this is a bellwether case in this litigation it is important that both parties receive a fair trial and the judge has expressed his concerns,"

DePuy ASR Hip Metallosis Lawsuits Heading to Settlement?

The Legal Examiner

According to sources, Johnson & Johnson (J&J), and its subsidiary DePuy, are in active discussions to attempt a global settlement of their defective ASR metal on metal artificial hips.

J&J Potential Settlement North of $3 Billion 
Apparently J&J has discussed paying more than $3 billion to settle lawsuits over its recalled hip implants.  J&J is exposed to over 11,500 product liability lawsuits in the U.S. and is considering paying more than $300,000 per case.

According to experts, such a global settlement would surpass $3 billion if most plaintiffs accept the proposed terms, this valuation is 50% larger than previously proposed.  Still, according to industry watchers, a $3 Billion is a drop in the ocean for the profits that J&J has generated from the sale of the recalled devices.

Settlement is Dependent on Trial Outcomes 
Any settlement would be subjected to the outcome of 7 product-liability trials between September and January 2014.

J&J’s DePuy unit recalled 93,000 implants worldwide in 2010, including 37,000 in the U.S. The failure rate that patients and doctors were seeing dwarfed the official company failure rate

7 Bellwether Trials Scheduled
7 other trials are set for later in the year, the first is scheduled to begin September 9 in Cleveland. The plaintiff is Ann McCracken, 58, from New York, who needed two replacement surgeries or revisions after her ASR implant.

Trials also are scheduled in state courts in San Francisco in October; in Hackensack, New Jersey, in October and January; in West Palm Beach, Florida, in November; in Chicago in December; and in Los Angeles in January.

Federal Multidistrict Litigation 
There are about 8,000 federal cases consolidated in the multidistrict litigation or MDL, in the Northern District of Ohio, for the pre-trial consideration.

About 2,000 cases are pending in the California Judicial Council Coordinated Proceeding before Judge Richard Kramer in San Francisco.

DePuy ASR Hip Lawsuit News: Settlement Reached in California Hip Case, Rottenstein Law Group LLP Reports

Digital Journal

Johnson & Johnson subsidiary DePuy Orthopaedics has agreed to settle a DePuy ASR hip lawsuit before what would have been the first bellwether trial in a California state court consolidation of ASR cases
Robert Eugene Ottman had alleged that his metal-on-metal ASR hip implant caused him to suffer from several alleged side effects, including the need for revision surgery because of device failure. Ottman's case was to be the first trial in the state consolidation of ASR cases, set to begin in a couple weeks, according to court documents (DePuy ASR Hip System Cases; CJC-10-004649, San Francisco Superior Court, Calif.). Settlement details were not available at press time.

“A settlement is encouraging,” said Rochelle Rottenstein, principal of the Rottenstein Law Group. “If DePuy and J&J are interested in settling these cases, and they are offering reasonable settlement amounts, then victims might see money to compensate them for injuries much sooner than if each person has to take his or her case to trial.”


Tuesday, October 1, 2013

DePuy Pinnacle Lawsuits Stayed in Federal Litigation Pending Completion of First Bellwether Trials, Bernstein Liebhard LLP Reports

Digital Journal
 
New York, New York (PRWEB) October 01, 2013
 
DePuy Pinnacle lawsuits (http://www.consumerinjurylawyers.com/depuy-pinnacle/lawsuit) involving a metal-on-metal version of the DePuy Pinnacle Hip Replacement System continue to move towards trial in a multidistrict litigation now underway in U.S. District Court, Northern District of Texas, Bernstein Liebhard LLP reports. According to an Order dated September 30, 2013, the Court has stayed all Pinnacle hip lawsuits filed in the proceeding, with the exception of those selected for its bellwether trials, pending the completion of those trials. Court documents indicate that federal Pinnacle hip lawsuits will begin going before juries in September 2014. (In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Product Liability Litigation, MDL No. 2244; N.D. Texas)

“Our Firm is looking forward to the commencement of bellwether trials in this litigation, as it is likely that their outcomes will provide some insight into how juries might rule in similar DePuy Pinnacle lawsuits,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. Jeffrey S. Grand, a partner with the Firm, serves on the Plaintiffs’ Steering Committee for federally-filed Pinnacle hip lawsuits. Bernstein Liebhard LLP continues to offer free legal evaluations to alleged victims of serious complications associated with the all-metal DePuy Pinnacle Hip Replacement System.

Pinnacle Hip Lawsuits
According to court documents, the DePuy Pinnacle hip at the center of the federal litigation underway in Texas is a metal-on-metal device that utilizes the Ultamet liner. Plaintiffs in Pinnacle hip lawsuits claim that this design allows the hip to shed dangerous amounts of toxic metal debris into a recipient’s tissue and the blood stream, resulting in metallosis, pain, swelling, premature failure of the implant, and need for revision surgery. Plaintiffs also assert that the all-metal Pinnacle is similar in design to the ASR hip, which DePuy Orthopaedics recalled in 2010. They question whether or not this version of the Pinnacle should have been removed from the market as well. Court records indicate that more than 4,800 DePuy Pinnacle lawsuits are now pending in the federal litigation.
On May 17th, The New York Times reported that DePuy Orthopaedics had decided to phase out sales of all-metal hips, including the metal-on-metal version of the Pinnacle, due in part to the recent actions taken by the U.S. Food & Drug Administration (FDA).* DePuy’s decision followed an FDA announcement in January regarding a new regulatory proposal that, if adopted, would require the manufacturers of metal-on-metal hips currently on the market to conduct post-market safety studies of those products in order to keep selling them.


Read more: http://www.digitaljournal.com/pr/1501650#ixzz2gWI3OBBP

The influence of stem design on critical squeaking friction with ceramic bearings.


J Orthop Res. 2013 Oct;31(10):1627-32. doi: 10.1002/jor.22413. Epub 2013 Jun 27.
The influence of stem design on critical squeaking friction with ceramic bearings.
Fan NMorlock MMBishop NEHuber GHoffmann NCiavarella MChen GXHothan AWitt F.
Source
Tribology Research Institute, Southwest Jiaotong University, Chengdu, 610031, China; Biomechanics Section, TUHH Hamburg University of Technology, Hamburg, 21073, Germany.

Abstract
Ceramic-on-ceramic hip joints have been reported to squeak, a phenomenon that may occur in compromised lubrication conditions. One factor related to the incidence of in vivo squeaking is the stem design. However, it has not yet been possible to relate stem design to squeaking in deteriorating lubrication conditions. The purpose of this study was to determine critical friction factors for different stem designs. A hip simulator was used to measure the friction factor of a ceramic bearing with different stem designs and gradually deteriorating lubrication represented by evaporation of a volatile fluid lubricant. The critical squeaking friction factor was measured at the onset of squeaking for each stem. Critical friction was higher for the long cobalt chrome (0.32 ± 0.02) and short titanium stems (0.39 ± 0.02) in comparison with a long titanium stem (0.29 ± 0.02). The onset of squeaking occurred at a friction factor lower than that measured for dry conditions, in which squeaking is usually investigated experimentally. The results suggest that shorter or heavier stems might limit the possibility of squeaking as lubrication deteriorates. The method developed can be used to investigate the influence of design parameters on squeaking probability. © 2013 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 31:1627-1632, 2013.
Copyright © 2013 Orthopaedic Research Society.

Stryker Hip Recall Update: FDA Announces Launch of New Medical Device Identification System to Better Target Recalls, Improve Patient Safety

The Digital Journal
 
New York, NY (PRWEB) September 29, 2013


The U.S. Food and Drug Administration (FDA) is launching a new system for identifying high-risk medical devices, like those affected by the Stryker hip recall (http://www.strykerhiprecall.net/) that it says will target product problems more quickly and improve patient safety, Bernstein Liebhard LLP reports.

According to an update issued September 20th on the FDA’s website, the agency has announced its plans to phase in a new unique device identification system (UDI) that will require each medical device on the market to be labeled with a unique number indicating its model, expiration date and manufacturing date.* The FDA will primarily focus on high-risk medical devices, which may include metal hip implants similar to the now-recalled Stryker Rejuvenate and ABG II modular-neck hip stems, in its program launch. The new system will allow federal regulators to efficiently identify medical devices and improve the accuracy of adverse event reports indicating possible issues with each one, the agency’s notification states.

Meanwhile, recent court records show that over 600 Stryker hip lawsuits brought by individuals who allegedly suffered pain, swelling, metallosis and other debilitating early device failure complications caused by the Rejuvenate and ABG II metal hip implants have been filed in the U.S. These devices were recalled by Stryker Orthopaedics on July 6, 2012.

Stryker Hip Recall
Court documents issued in September indicate that Stryker lawsuits are continuing to pile up in both the federal and state proceedings established in the U.S. In a multicounty litigation currently underway in New Jersey’s Bergen County Superior Court, a total of 382 cases alleging injuries caused by the Stryker hip recall have been filed. The lawyers at Bernstein Liebhard LLP are actively filing cases alleging metallosis, necrosis, osteolysis and other artificial hip injuries in this litigation. (In Re Stryker Rejuvenate Hip Stem and the ABG II Modular Hip Stem Litigation, No. 296)
A total of 290 Stryker lawsuits are also pending in a federal proceeding underway in the U.S. District Court, District of Minnesota, which similarly allege that the Stryker Rejuvenate and ABG II hip stems were defectively designed by Stryker Orthopaedics, given the potential for their metal components to fret and corrode at the modular-neck junction. The next status conference in this litigation has been scheduled for November 21st at 9:00 a.m. (In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation, MDL No. 2441)

Plaintiffs involved in in both of these proceedings were allegedly forced to undergo revision surgery to remove the metal hip after it failed prematurely.

The Stryker hip recall was announced by the manufacturer on July 6, 2012 after post-market surveillance data revealed the potential for the metal components of the Stryker Rejuvenate and ABG II hip stems to fail early. In the wake of the recall, Stryker Orthopaedics has advised all recipients of these devices to undergo routine medical screening to monitor for the high metal levels in the blood, whether or not they are experiencing symptoms.**


Read more: http://www.digitaljournal.com/pr/1495295#ixzz2gWETcsG4

Metal allergies realized after stainless steel replacements used for knee, hip

The Gadsden Times

By Anne Shumaker
Times Correspondent

Published: Wednesday, September 25, 2013 at 1:43 p.m.
 
ALEXIS --- Patricia Harton had been a strong, energetic woman all her life.
The talented pianist had served many years as church pianist at several churches in the county. She also had presented one-woman recitals for many organizations.
 
In addition, she was frequently called to play for weddings, funerals and special community events.
In 2006, Harton fell and broke her hip. She had surgery and seemed to make good progress. A short time later, she had a knee replacement. Complications arose. She had to have revisions and repairs on the joints and replacements.
 
She seemed to regress every day. In fact, she got to the point that she had to have help with simple tasks such as eating and dressing herself. Her muscles became increasingly weak and nerves seemed to lie dormant. She could no longer play her beloved piano.
She consulted several physicians and obtained various differing diagnoses. She was even given a cardiac pacemaker.
 
One physician even diagnosed her problem as ALS, a neurological disease that usually takes victims’ lives within a couple of years.
 
Because the problems appeared only after Harton received her joint replacements, daughter Christa Davis was curious and concerned enough to do research into the literature relating to muscle and nerve damage and possible metal allergies.
 
Davis had some background in medical topics. She had a bachelor’s degree in anatomy and physiology from Jacksonville State University and had worked at both Floyd and Redmond medical centers in Rome, Ga.
 
She also had been the marketing director at what was then Coosa Valley Technical College, now Georgia Northwestern.
 
Through the Internet, she found some European and Asian physicians who had done some work on metal allergies. She consulted with those doctors, plus a neurologist at UAB.
 
After Davis’ months of study and scores of medical tests on Harton, it was determined that Harton did indeed have a severe allergy to the cobalt and nickel in her stainless steel joint replacements.
After Harton’s joints were replaced with titanium, she slowly but steadily began to improve.
 
Titanium has a much lower rate of allergic reactions than some of the components of stainless steel. Some studies show that as many as 20 percent of people may have cobalt and nickel allergies to a certain degree.
 
Harton’s muscle strength has now progressed to the point that she was able to play one of her own compositions for a recent gathering of the Young at Heart organization in Centre.
Davis has written a book about her mother’s experiences. As Davis does book signings and presentations, she encourages people facing joint replacement surgery to ask the type of replacements the surgeons plan to use.
 
If the surgeons say “stainless,”
 
Davis urges the patient to insist on titanium, and if the surgeon downplays the possible allergy or refuses to use titanium, she recommends finding another surgeon.
 
Christa has presented her findings to the nursing students at Judson College and at an international medical conference in Dallas.
 
She has several other pending presentations to medical groups.
 
Davis has spoken to many groups of senior citizens and other organizations.
Many medical and media personnel are now joining the band in regard to the reality of allergies from metals within the body. Some allergists are now even discussing alloy posts in dental implants.
Davis urges everyone to take charge of his or her own health.
 
Paperback copies of “Steel Standing” are available at the Cherokee Museum in Centre. The book in e-form may be ordered through Amazon.com.
 
Davis has a second version of the book now available through Amazon.com. “Steel Standing: Surviving Metal Allergies” has more medical information than the first version of the book. The book is endorsed by a research neurologist and by the developer of testing for metal allergies.
 
Additional information is available through the “Steel Standing” website: steelstandingbook.com.