NJ Designates State Lawsuits over Stryker LFIT V40 Femoral Heads as Multicounty Litigation

LFIT V40 Femoral Head Recall
LFIT V40 Femoral Head

New Jersey’s chief justice on May 16 assigned state lawsuits over the Stryker LFIT Anatomic Cobalt Chromium (CoCr) V40 femoral heads into a multicounty litigation docket.

The court assigned the artificial hip cases to Judge Rachelle Harz of the Bergen County Superior Court, In Re:  Stryker LFIT Anatomic CoCr V40 Femoral Heads Litigation, No. 624, N.J. Superior Court in Bergen County, NJ.

Separately, 36 federal LFIT cases were centralized in April into MDL 2768 in US District Court for the District of Massachusetts.

Chief Justice Judge Harz issued an initial case management order on May 22.  The first trial conference is set for June 21. The multicounty litigation was sought by 25 plaintiffs.

Motion follows recall

The Stryker LFIT was voluntarily recalled in August by Howmedica Osteonics Inc. when some taper locks failed. Plaintiffs allege that the part can fret and corrode, releasing metal particles and posing a risk of metallosis, necrosis, osteolysis and higher levels of cobalt and chromium in the bloodstream.

Howmedica opposed consolidation, saying existing cases are being effectively coordinated by Judge Harz.  It suggested that if cases are consolidated, they be limited to cases involving the recalled LFIT V40 femoral heads that show taper lock failure.

The motion was filed by plaintiff attorney Ellen Relkin of Weitz & Luxenberg in New York.

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Judge Awards $2 Million to Zimmer Hip Implant Plaintiff

Joseph Osborne, Jr., of Osborne & Associates in Boca Raton, Fla
Joseph Osborne, Jr., of Osborne & Associates in Boca Raton, FL.

Medical device manufacturer Zimmer Inc. has been ordered to pay more than $2 million to a New Mexico man for a defective Zimmer hip implant with an “unreasonably dangerous design,” following a two-week bench trial.

“This is the first case we know of that has gone to trial in the country, and a growing number of these are going to court,” said Joseph Osborne, Jr., of Osborne & Associates in Boca Raton, Fla., who represents medical device plaintiffs around the country. Osborne tried the case with Randi McGinn and Allegra Carpenter of McGinn, Carpenter, Montoya & Love, P.A., of Albuquerque, N.M.

The product in question is Zimmer’s dual modular hip implant, the M/L Taper Hip Prosthesis with Kinectiv Technology (“MLTK”) and a cobalt-chromium head.

In a 27-page decision, New Mexico Judge Nan G. Nash ruled that the defective design and insufficient testing caused likely permanent harm to the plaintiff, resulting in “metallosis,” or a buildup of cobalt debris harming the hip joint and contaminating blood.

“It is never appropriate to design a hip implant system that would create an unreasonable risk of injury to the health or safety of a patient,” Nash wrote, ruling for the patient on grounds of strict products liability.

The case is McDonald v. Zimmer Inc. and Zimmer Holdings, Case No. D-202-CV-201304060, Second Judicial District, New Mexico County for Bernalillo.

Separately, Zimmer is facing 466 lawsuits in MDL 2158 supervised by U.S. District Judge Susan D Wigenton in federal court in New Jersey. IN RE: Zimmer Durom Hip Cup Products Liability Litigation.

Two corrective surgeries

In February 2010, Michael Brian McDonald, an Albuquerque economist then in his sixties, was suffering right hip pain that was preventing him from his usual tennis and golf. That June, McDonald received the MTLK implant.

Initial recovery went well, but by May 2011, McDonald suffered from hip and groin pain and loss of flexibility, resulting in two corrective surgeries that October and November, during which the doctor implanted two new prostheses and replaced the cobalt-chromium head with a ceramic head.

After a lengthy recovery, McDonald sued and the case went to bench trial before Judge Nash December 12-23, 2016, in the Second Judicial District Court in Albuquerque.

In her March 31 ruling, Judge Nash wrote that the ordeal has forced McDonald to a permanent course of antibiotics, an end to golf and tennis, and the likelihood of a recurrent infection.

“It is more probable than not that Plaintiff will need a third, more complicated revision surgery in the future,” Nash wrote. “This surgery will cost approximately $250,000 and will involve removal of all of the implant components for a period of 2-3 months to try and kill the infection, during which Plaintiff will be wheelchair bound. If the infection can be successfully eradicated, another hip prosthesis will be implanted, necessitating the same type of physical therapy and recovery period as the first two revision surgeries.”

Product defect

The judge traced the product defect to Zimmer’s testing its components in isolation, but not their interactions together, which would have determined their potential harm.

“In designing the MLTK, Defendants knew that the use of dissimilar metals can result in a higher potential for corrosion and that wear debris from a junction of two dissimilar metals had been documented to be toxic and harmful to the human body,” she wrote.

In determining the damages of $2.027 million, Judge Nash apportioned it into $1 million for past and future pain and suffering, $480,000 for lost enjoyment of life, and the rest for past and future medical expenses, lost household services, and out-of-pocket expenses.

 

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Federal MDL Created for Stryker LFIT Anatomic CoCR V40 Prosthetic Hip

LFIT V40 Femoral Head Recall
LFIT V40 Femoral Head

The Judicial Panel on Multidistrict Litigation (JPMDL) created the new MDL No. 2768 to hear products liability litigation involving the Stryker-branded LFIT Anatomic CoCR V40 femoral heads, a prosthetic hip replacement device.

US District Judge Indira Talwani in Boston will oversee a total of 33 cases from 17 district courts, with at least eight groups competing plaintiffs’ counsel involved, in In re: Stryker LFIT V40 Femoral Head Products Liability Litigation. Defendant HowmedicaOsteonics Corp. of Mahwah, NJ, unsuccessfully opposed centralization and wanted the cases heard in New Jersey or New York federal court.

All the lawsuits involve common factual questions about alleged defects in Howmedica’s Stryker-branded LFIT Anatomic CoCr V40 femoral heads. The federal MDL motion was filed Jan. 13 by attorney Walter Kelley of Kelley Bernheim & Dolinsky LLC in Plymouth, MA.

42,519 defective hips

Howmedica recalled 42,519 of the defective hips on August 29, 2016. The company also issued a letter to orthopedic surgeons advising them of a “higher than expected” incidence of taper lock failure for certain sizes of its LFIT Anatomic CoCr V40 Femoral Heads.

Potential hazards listed in the recall notice included excessive metal debris, disassociation of the head from the stem/failure, trunnion fracture, and corrosion at the femoral head and stem junction.

Simultaneously, the Canadian public health agency issued a recall about the Stryker LFIT V40 and the Australian Government Department of Health published a Hazard Alert about the same devices.

The plaintiffs’ claims focus on the performance of the LFIT V40 cobalt-chromium device, in particular the alleged propensity of the device to cause corrosion at the taper junction when paired with femoral stems made from different alloys (such as Howmedica’s proprietary TMZF, which is an alloy of titanium, molybdenum, zirconium and iron). This corrosion allegedly leads to failure of the implant or other serious health consequences and necessitates surgery to remove and replace the implants.

In addition to the specific causes of the failure of each plaintiff’s device, the cases have common issues about the development, manufacture, testing, regulatory history, promotion, and labeling of the LFIT V40 cobalt-chromium femoral head. “We note, though, that the transferee judge might find it useful, for example, to establish different tracks for the different femoral stems that can be mated with the LFIT device,” the JPMDL said.

New Jersey plaintiffs

A different group of 25 plaintiffs is requesting that the New Jersey state courts create a multi-county litigation docket for the same device.

The New Jersey motion was filed Jan. 26 by attorney Ellen Relkin of Weitz & Luxenberg in New York. She estimates that more than 85 cases over the LFIT V40 Hip have been filed before Judge Rachelle Harz in Bergen County, NJ.

Separately, Stryker is the target 1,800 lawsuits in MDL 2441, supervised by US District Judge Donovan W. Frank in Stryker Rejuvenate in ABG II Hip Implant Products Liability Litigation and in Stryker Trident Hip Implants New Jersey State Court.

 

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11th Circuit Upholds $2.1 Million Verdict by Initially-Confused Jury in Wright Hip Case

The 11th US Circuit Court of Appeals upheld a $2.1 million judgment, excusing the initial confusion by a jury in the first bellwether trial in a multidistrict litigation involving over 500 cases about the Wright Medical Conserve “metal-on-metal” hip replacement device.

U.S. District Judge William S. Duffey Jr. of the Northern District of Georgia corrected the jury form, re-charged the jury, and ordered it to continue deliberating until it reached a final verdict on November 25, 2015, in Robyn Christiansen, v. Wright Medical Technology Inc., Case No. 16-12162.

Wright today faces 585 lawsuits over its metal-on-metal hip replacement in Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation.

A crunching sound

Christiansen received a Wright Conserve Hip Implant System in 2006. Six years later, she “felt and heard a crunching sound and then felt immediate, severe pain in her right hip and groin” while doing yoga. She was diagnosed with a loose and displaced acetabular cup, and forced to undergo revision surgery. During the procedure, her surgeon discovered “a metallosis reaction” in the joint around the implant.

At the trial, the jury initially filled out Question 1A incorrectly on the jury verdict form saying that the hip device was not defectively designed. Then it inconsistently awarded $662,500 in compensatory damages and $2.5 million in punitive damages. The judge told the jury to go back into the jury room and “please carefully read the instructions.”

Minutes later the jury returned and said it did not understand the verdict sheet. This time the judge added to the verdict sheet instructions: “If you answered NO to Question 1A, stop [regarding defective design]. Do not complete the remainder of the form.”

Half a day later the jury said one juror was refusing to deliberate. The judge interviewed the recalcitrant juror in open court, decided that the juror was unwilling to follow the instructions, and dismissed him or her. The seven remaining jurors returned to the jury room and reached the final verdict in 30 minutes:

  • The hip device was defectively designed and unreasonably dangerous.
  • It caused the plaintiff’s harm.
  • Wright did not meet its burden to prove that the device could not be made safe.
  • Wright made a negligent misrepresentation about the device.
  • Wright’s conduct was “willful and malicious,” “intentionally fraudulent,” or “manifested a knowing and reckless indifference towards, and a disregard of, the rights of others, including Ms. Christiansen.”
  • $1.1 million in compensatory damages.
  • $10 million in punitive damages, which the judge later reduced to $1.1 million.

Wright wanted judgment

On appeal Wright argued that the court failed to grant it judgment as a matter of law based on the jury’s first verdict sheet.

The 11th Circuit rejected the idea, because under Rule 49 of the Federal Rules of Civil Procedure the district court has authority enter judgment, order further deliberations, or order a new trial.

“From a review of the record, the district court acted in a neutral and non-biased manner in acknowledging and addressing the inconsistent verdict,” the appeals court said.

In November 2016 Wright agreed to settle 1,292 claims in consolidated litigation in Georgia federal court and California state court for $240 million, putting an end to the majority of the suits over the implants.

Patients who had revision surgery within eight years of their original Conserve, Lineage or Dynasty hip implant are eligible for the settlement.

  • Those implanted with the Conserve Cup —  the device with the most frequent failures — can receive $170,000.
  • Those who had the metal-liner Dynasty and Lineage devices can recoup $120,000, according to a statement from the plaintiffs’ leadership counsel.

Meanwhile, Wright also faces 74 lawsuits involving fractures of its Profemur long titanium modular neck hip device. It has been marketed by MicroPort Orthopedics, Inc. of Arlington, TN, since 2013.

On June 21, 2016, MicroPort recalled its Conserve Shell, Dynasty® Metal Liner, Procotyl® Metal Liner and Lineage® Metal Liner because of “an increasing overall trend in revisions from 2009 to present, and it was found that there was a specific hazard/harm for “suspected tissue reaction to metal debris.” The potential for a patient reaction when implanted with Metal on Metal THA is a known risk for this product technology. The typical impairment of tissue reaction is reversed by revision surgery to remove the old device and replace it with a new device.”

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New Group of Plaintiffs Seek Stryker LFIT Hip MDL in New Jersey State Court

LFIT V40 Femoral Head Recall
LFIT V40 Femoral Head Device

As the federal courts weigh creating an MDL for litigation involving the Stryker LFIT V40 Hip Device, a different group of 25 plaintiffs is requesting that the New Jersey state courts create a multi-county litigation docket for the same device.

  • The New Jersey motion was filed Jan. 26 by attorney Ellen Relkin of Weitz & Luxenberg in New York. She estimates that more than 85 cases over the LFIT V40 Hip have been filed before Judge Rachelle Harz in Bergen County, NJ.
  • The federal MDL motion was filed Jan. 13 by attorney Walter Kelley of Kelley Bernheim & Dolinsky LLC in Plymouth, MA, requesting MDL No. 2768 be created in federal court in Massachusetts. The Judicial Panel on Multidistrict Litigation (JPMDL) will hear this motion on March 30 in Phoenix, AZ.

Separately, Stryker is the target 1,800 lawsuits in MDL 2441, supervised by US District Judge Donovan W. Frank in Stryker Rejuvenate in ABG II Hip Implant Products Liability Litigation and in Stryker Trident Hip Implants New Jersy State Court.

Defective hips

Defendant Stryker Howmedica Osteonics Corp. of Mahwah, NJ, recalled 42,519 of the defective hips on August 29, 2016. The company also issued a letter to orthopedic surgeons advising them of a “higher than expected” incidence of taper lock failure for certain sizes of its LFIT Anatomic CoCr V40 Femoral Heads.

Simultaneously, the Canadian public health agency issued a recall about the Stryker LFIT V40 and the Australian Government Department of Health published a Hazard Alert about the same devices.

The LFIT femoral head has been marketed fo ruse with a variety of femoral stems. Some medical literature says the problem arises when stems made of titanium or TMZF titanium alloy are combined with cobalt-chromium alloy femoral head and taper devices.

The problem involves fretting and corrosion in the junction where the femoral head connects to the femoral stem. Corrosion at this junction has led to the systematic release of metal particles into the surrounding tissue and bone, putting patients are risk of toxic metallosis, tissue death, bone death and elevated levels of cobalt and chromium in the blood.

Adverse events include loss of mobility pain, inflammation, adverse local tissue reaction, disassociation of the femoral head, dislocation, joint instability, broken bones and the need for revision surgery.

Furthermore, excessive corrosion at the head-neck junction causes the femoral head to break off the from neck, become loose in the body, and depart from the acetabular cup where it is supported to move.

Revision surgery

Adverse events include loss of mobility pain, inflammation, adverse local tissue reaction, disassociation of the femoral head, dislocation, joint instability, broken bones and the need for revision surgery. Many of the New Jersey cases involve patients who have needed revision surgery.

All the cases allege design defect, failure to warn, breach of warranty and manufacturing defect.

Judge Harz is presiding over the LFIT litigation, as well as the Stryker Rejuvenate and ABG II litigation, which involves similar issues.  “It is both logical and fair to the litigants for these cases to remain in Bergen County before Judge Harz,” attorney Relkin argues. She speculates that if a federal MDL were created in New Jersey, then “seamless coordination could occur between the federal MDL and state MCL litigation.”

The New Jersey Multicounty Litigation Center centralizes litigation over Accutane, Benicar, Talcum Powder, Stryker Hip/ABG II, DePuy ASR Hip Implant, Mirena, Pelvic Mesh, Stryker Implant, Yaz/Yasmin/Ocella, Asbestos, AlloDerm, Fosamax, Levaquin, Propecia, Reglan and Risperdal / Seroquel / Zyprexa.

A global settlement was announced December 19, 2015 regarding the Stryker Hip/ABG II litigation.

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Admitting Hip Replacements Cause Metallosis, Smith & Nephew Issues Urgent Recall

Smith & Nephew Modular SMF hip implant
Smith & Nephew Modular SMF hip implant

Admitting for the first time that its Modular SMF and Modular REDAPT femoral replacement hip systems cause toxic metallosis in patients, Smith & Nephew has issued an urgent field safety notice recalling thousands of the defective medical devices.

The recall affects 6,266 SMF and REDAPT hip systems in commerce, plus 13,671 modular neck hip prostheses in commerce — shipped from October 2008 through July 2016.

Based in Memphis, TN, Smith & Nephew has sold the Modular SMF and REDAPT implants for almost a decade. In its letter to doctors, the company admitted that “Smith & Nephew considers that patients implanted with the modular neck hip prostheses may be at greater risk of revision surgery than with comparable monolithic products.”

Metal-Related Adverse Events

The letter states, “We observed a rate of complaints higher than comparable monolithic hip prostheses. Metal-related complaints are trending upward year-on-year with an overall complaint rate (number of complaints/total implantations) of 0.527% for Modular SMF and 0.25% for Modular REDAPT Revision Femoral Hip Systems. Overall, the metal-related Adverse Events accounted for the highest category of complaints in both products.

“For patients that exhibit these symptoms, physicians may consider additional clinical follow-up which includes the following:

  • Cobalt/Chromium metal-ion level measurements in whole blood – metal ion levels in excess of 7ppb may indicate the potential for soft tissue reaction; and
  • Where appropriate and subject to the clinician’s assessment, further active evaluation of the potential soft tissue reactions either through ultrasound or cross-sectional imaging might be indicated.”

Hip litigation

In related litigation, plaintiffs who were injured by Smith & Nephew’s Birmingham Hip Resurfacing (“BHR”) system and R3 metal-on-metal liner (“R3”) have filed a motion with the Judicial Panel on Multidistrict Litigation to create new MDL No. 2775 in the US District Court for the District of Maryland.

The plaintiffs allege that the BHR and R3 devices have caused toxic levels of cobalt and chromium in the bodies of patients implanted with the devices, and caused other symptoms including metallosis, pain, adverse local tissue reaction, pseudotumor, bone and tissue necrosis, and other symptoms leading to revision surgery.

Modular femoral stems have been a big problem in orthopedics for years. Stryker Orthopedics had to recall two of its modular stems in 2012 because of very high failure rates. A total of 1,807 cases have been filed in MDL 2441 against Stryker before Sr. US District JudgeDonovan W. Frank in Minnesota.

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