http://health.usnews.com/health-news/articles/2014/09/29/medical-implant-devices-skate-through-review-process-studies-claim
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http://online.wsj.com/articles/medical-devices-lack-safety-evidence-study-finds-1412017201?mod=WSJ_hp_LEFTTopStories
Last week, the remainder of Dr. Nargol’s video deposition was played following the conclusion of Dr. Fisher’s testimony.
On Monday, September 22nd, Dr. Henrik Malchau, an orthopedic surgeon and professor at Harvard, took the stand. He performed two of the plaintiff’s revision surgeries. The jury watched a video of one of the revisions. Dr. Malchau described the surgery from the stand. He mentioned pervasive metal stained tissue and grossly abnormal fluid. His testimony continued, and subsequently concluded, on Tuesday, September 23rd. The jury then watched a video from the index surgeon, Dr. Allmacher. Kathy Paoli, the plaintiff, took the stand on Wednesday, September 24th. Afterwards, Dan Bagwell, a Certified Life Care Planner and Certified Disability Management Specialist, took the stand. On Thursday, September 25th, Mr. Bagwell’s testimony concluded. His testimony was followed by Dr. Altwell, a Neurologist, and Rehabilitation and Life Care Planning expert, Scott Bayley, a CPA, and John Paoli, the plaintiff’s husband. On September 14th, the defendants filed a Motion for Mistrial concerning Dr. Nargol’s testimony. The plaintiffs filed their response on September 15th. The court then denied the Motion for Mistrial and request to disregard Dr. Nargol’s testimony. Subsequently, Pam Plouhar, DePuy V.P. of Clinical Research, took the stand. Ms. Plouhar’s testimony continued on Tuesday, September 16th. Wednesday, September 17th was Plouhar’s third day on the stand. She was examined by both plaintiffs and defendants. She was dismissed that same day, and will not return for further questioning.
On Thursday, September 18th, Dr. John Fisher, defense tribologist, took the stand (a tribologist studies the science of rubbing surfaces). He has strong ties with J&J and DePuy. His testimony occupied the entire day. Many individuals are implanted with various bearing surfaces in their hip implants- metal on metal hips, ceramic on ceramic, and advanced plastics. Often times, people are unsure of the name and model of their hip implant. There are various ways to acquire this information:
1) Contact your orthopedic surgeon's office directly with a phone call or email, and request your medical records. 2) Request a copy of your medical records in writing from your orthopedic surgeon's office or the hospital where your surgery was performed. Once you have access to your medical records*: After receiving your medical records, establish which hip prosthesis was implanted into your body. There are generally two places where this is found. First, look for a document titled “operative report.” An operative report describes your hip operation in detail. Typically, the operative report lists the name and model of the prosthetic hip used in your surgery. Look for the “product ID stickers" if the operative report does not state the name and model. The hip implant components come in a box with a detachable product ID sticker affixed to it. The sticker has a bar code and identifies the name, model, and serial number for the enclosed parts. Many surgeons detach the stickers from the box and then simply attach them to a piece of paper inserted into the patient’s medical records. *By law, your doctor and the admitting hospital are required to provide you with your medical records. Kershaw|Talley LLP understands individuals implanted with the DePuy Pinnacle are legitimately concerned about the various side effects associated with these devices. Metallosis is one major side effect. Metallosis is the accumulation of metal debris in the soft tissues of the body. Symptoms of metallosis include metal toxicity, bone deterioration, pain, swelling and inflammation, pseudotumors (fluid-filled collection within periprosthetic tissues), and loosening, dislocation or fracture of the implant. Metal joint implants, such as the DePuy Pinnacle, significantly increased the incidence of metallosis in the last 40 years. Metallosis may involve hip, knee, shoulder, elbow or wrist joint replacements. Metal toxicity (cobalt-chromium toxicity) is another common side effect. Metal toxicity occurs when metal components of the hip implant grind together and release metal particles into the blood stream. There is potential for long term health problems associated with metal toxicity. Blood metal analysis tests for elevated blood levels of cobalt and chromium. Individuals with the DePuy Pinnacle should request ongoing, consistent monitoring of their blood metal levels. Side effects from metal toxicity include:
We recommend anyone implanted with the DePuy Pinnacle undergo a MARS MRI, or a Metal Artifact Reduction Sequence MRI. A MARS MRI is an imaging technique which minimizes metal artifact (i.e. parts of the implant) while maintaining image quality. It is utilized to detect adverse local tissue reactions (ALTRs) and adverse reaction to metal debris (ARMD). Mayo Clinic describes ARMD as, "Implant-specific local and systemic adverse effects related to sensitivity to the metal or due to the wear of the metal surfaces themselves...serum chromium and cobalt concentrations correlate with ARMD." Side effects from adverse reaction to metal debris (ARMD) include:
 Property of Mayo Clinic: Mayo Medical Laboratories http://www.reuters.com/article/2014/09/16/johnson-johnson-hips-trial-idUSL1N0RG2KG20140916
On Monday, September 8th, Polly Cary, Product Director of Marketing, took the stand via video deposition. Matt Reimink, a manager of the hip project division group, followed with his video deposition which continued on Tuesday, September 9th.
September 9th also included Paul Berman, former Marketing Director of DePuy, provided his deposition via video and Dr.Thomas Schmalzried who took the stand in the afternoon. Dr.Schmalzried is an orthopedic design surgeon who entered a consulting agreement with DePuy in 1996. Dr. Schmalzried’s testimony continued throughout the day on Wednesday, September 10th. The first portion of Mark Lanier’s examination of Dr. Scmalzried ended on September 10th. Schmalzried has not been dismissed as a witness, and he will return to trial at a later time in order for Lanier to complete his examination. The defense will then begin their examination of Schmalzried. The jury viewed Dr. Antoni Nargol’s video deposition on Thursday, September 11th. Dr. Nargol is an orthopedic surgeon, specializing in hip surgery, from England. His testimony occupied the entire day. Tuesday, September 2, 2014 marked the first bellwether trial regarding the Johnson & Johnson (J&J) DePuy Pinnacle metal on metal hip implant.
Jury selection occurred on September 2nd. The trial proceeded with a nine member jury composed of five women and four men, including an attorney and a PhD pharmacist. Mark Lanier is the lead plaintiff’s attorney. On Wednesday, September 3, opening statements occupied the morning. In the afternoon, Andrew Ekdahl, ex-DePuy President, took the stand. He was head of marketing during key periods in question. Currently, he is chairman of DePuy Synthes unit’s global orthopedic business. Ekdahl implies this is a promotion from his previous position. His testimony monopolized all of Wednesday afternoon as well as Thursday, September 4. Trial is not held on Fridays. The trial is anticipated to last approximately 6-8 weeks. |
Kershaw, Cook & Talley PCWe are product liability lawyers based in Sacramento, CA serving clients nationwide. Happy with our updates? Please take a moment to review your experience with us. Your feedback not only helps us but also helps other potential clients. Thank you!
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