Medical Device MDL & Recall Status

The following is the status of pending multidistrict litigation (MDL) and recalls among the major global manufacturers of medical devices:


2158 IN RE: Zimmer Durom Hip Cup Products Liability Litigation
District of New Jersey (Hon. Susan D. Wigenton)

In 2016, Zimmer Inc. reached a binding settlement agreement to resolve claims of patients who underwent revision surgery for a Durom Acetabular Component hip (Durom Cup). Only plaintiffs who had “qualified revision surgery” less than nine years after the date of implantation would be eligible for either a base award of $175,000 subject to enhancement or reduction, or a fixed award of $25,000. Claimants who rejected the award were required to request mediation to be schedule by February 28, 2017. Zimmer will not make any payment unless 67 percent of eligible claimants accept the award offer by September 29, 2017.

2197 IN RE: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation
Northern District of Ohio (Hon. Jeffrey J. Helmick)

Still pending notwithstanding settlement whereby DePuy agreed to pay $2.5 billion to settle approximately 8,000 lawsuits by United States patients who had hip revision surgery as of August 31, 2013. The ASR Settlement has been extended to cover people implanted with the Depuy ASR hip who received a revision surgery between January 31, 2015 and February 15, 2017. The deadline to enroll is now June 19, 2017.

2244 IN RE: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation
Northern District of Texas (Hon. James Edgar Kinkeade)

On December 1, 2016, in the third set of bellwether trials, a Texas federal jury awarded $40 million in compensatory damages and more than $1 billion in punitive damages to six plaintiffs who alleged that DePuy Orthopaedics Inc.’s Pinnacle metal-on-metal hip implants were defectively designed and that the company failed to warn doctors and consumers about complications possible from the device, which included pain and subsequent revision surgeries. Johnson & Johnson prevailed in the first bellwether trial in 2014, and the second bellwether trial in March 2016 yielded a $500 million jury award to five plaintiffs. The court ordered that $140 million would be applied to collective compensatory damages with $360 million being awarded in punitive damages. After the trial, Judge Kinkeade reduced the $360,000,000.00 punitive damages award to $9,646,256.00 pursuant to a Texas statute capping punitive damages. DePuy Orthopaedics and Johnson & Johnson appealed the decision and the plaintiffs filed their brief in response. Defendants also recently filed a reply brief supporting their motion for a protective order, maintaining that the plaintiffs are seeking a deposition that is not proportional to the needs of the lawsuits. A fourth bellwether trial, which will involve 10 patients, is scheduled for September 2017.

2272 IN RE: Zimmer NexGen Knee Implant Products Liability Litigation
Northern District of Illinois (Hon. Rebecca R. Pallmeyer)

At least 5,900 product liability lawsuits have been consolidated. In late January 2017, Zimmer won its third bellwether trial. In the first bellwether trial in November 2015, the jury found for Zimmer given that the plaintiff failed to prove defective design and failure to warn claims. Zimmer also won its second bellwether trial in late 2016 on summary judgment when the judge found that the plaintiff failed to prove that a design defect caused the knee implant to fail. That case is on appeal. Zimmer prevailed again in January 2017 in the third NexGen knee bellwether trial.

2329 IN RE: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation
Northern District of Georgia (Hon. William S. Duffey)

In November 2016, Wright Medical Group announced a $240 million settlement on behalf of its wholly-owned subsidiary, Wright Medical Technology, which ended five years of litigation brought by 1,300 claimants. Under the terms of the settlement, Wright will pay $170,000 to each claimant who were implanted with its Conserve Cup device, and $120,000 to each claimant who received either a Dynasty or Lineage replacement hip. Wright also established a fund to reimburse patients who suffered “extraordinary injury” resulting from the failure of their hip implants. The settlement applied to patients with lawsuits pending in the multidistrict litigation as well as those included in proceeding in California Superior Court in Los Angeles. On April 10th, Wright petitioned the 11th Circuit U.S. Court of Appeals for an en banc rehearing of the panel’s March 20th affirmation of a $2.1 million verdict in the first Conserve hip trial. The court has scheduled a May 19th status conference, indicating its intent to discuss the timetable for remand briefing in those cases that are not included in the recent settlement.

2391 IN RE: Biomet M2a Magnum Hip Implant Products Liability Litigation
Northern District of Indiana (Hon. Robert L. Miller)

A settlement program between was announced in early 2014 in which certain patients implanted with Biomet’s defective M2a Magnum hip implant system were to receive up to $200,000. Recently, Judge Miller released an order disclosing that 93 lawsuits were settled in October 2016. Despite this settlement, depositions are ongoing and the admissibility of expert testimony and reports will be litigated through August 2017, with bellwether trials most likely taking place in late 2017 or early 2018.

2441 IN RE: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation
District of Minnesota (Hon. Donovan W. Frank)

In November 2014, Stryker settled approximately 3,000 Rejuvenate Hip Stem and ABG II Modular Hip Stem lawsuits in New Jersey’s Bergen County Superior Court, the 17th Judicial Circuit Court of Florida, the 15th Judicial Circuit Court of Florida, and the MDL. Pursuant to the settlement, Stryker agreed to pay hip implant patients a base award of $300,000 for each revised hip, with additional compensation for patients who had complications during revision surgery to remove the hip implant. On December 19, 2016, Judge Frank ordered that individuals who had initial implant surgery and revision surgery by December 19, 2016 were eligible to participate in the settlement. Further, hip implant patients who were eligible for the settlement in November 2014 but did not enroll were deemed still eligible to participate in the settlement. Plaintiffs with unresolved claims remaining on the docket were required to respond to the Settlement Oversight Committee’s requests for information regarding their claims last month.

2666 IN RE: Bair Hugger Forced Air Warming Products Liability Litigation
District of Minnesota (Hon. Joan N. Erickson)

Pursuant to Pretrial Order No. 17, plaintiffs and defendants have each nominated 16 federally-filed Bair Hugger lawsuits from a group of 150 cases randomly selected by the Court earlier this year. As their selections overlapped, the bellwether candidate list submitted to the Court consists of 31 lawsuits. Each side also selected two Bair Hugger cases from the docket pending in Minnesota’s Ramsay County District Court. As one of those cases also overlapped, a total of three selections were submitted to the Court. Upon completion of case-specific discovery, the parties will choose eight representative cases from this list for a Final Bellwether Trial Pool. The first Bair Hugger trial will be convened on February 8, 2018, once bellwether case discovery, challenges to the admissibility of expert witness testimony and any dispositive motions have been completed. Judge Erickson recently has held that the plaintiffs are not entitled to documents concerning another patient-warming system because it uses a different type of heating technology than the Bair Hugger and is therefore a “substantially different product”. As such, the documents sought by plaintiffs are not relevant to their allegations that a safer alternative design existed for the Bair Hugger.

2768 IN RE: Stryker LFIT V40 Femoral Head Products Liability Litigation
District of Massachusetts (Hon. Indira Talwani)

On April 5th, the United States Judicial Panel on Multidistrict Litigation (JPML) ordered the transfer of 33 pending federal lawsuits from 17 district courts, along with all future claims, asserting injury caused by HowmedicaOsteonics Corp.’s Stryker-branded LFIT Anatomic CoCR V40 femoral heads, a prosthetic hip replacement device, to the United States District Court for the District of Massachusetts to the court so that they can be coordinated before U.S. District Judge Indira Talwani. In an April 21st order, Judge Talwani scheduled an initial status conference for May 16th and asked counsel in the lawsuits to file a status report identifying pending motions, including those to remand or dismiss.

2775 IN RE: Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation
District of Maryland (Hon. Catherine C. Blake)

On April 5th, the JPML also created this MDL. United States District Judge Catherine C. Blake in the District of Maryland will hear 28 actions pending in 19 districts, plus 11 related actions pending in 11 other district courts related to the premature failure of the Smith & Nephew Birmingham Hip Resurfacing (BHR) System and R3 Acetabular System.

Recent Recalls

Zimmer Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340

In February 2017, the United States Food & Drug Administration (FDA) released information on a Class 1 recall of Zimmer Biomet‘s Comprehensive Reverse Shoulder System. Zimmer Biomet’s Comprehensive Reverse Shoulder system is a shoulder replacement device designed to be surgically implanted to restore arm movement in patients with rotator cuff tears who have developed artropathy and have failed shoulder joint replacements. Zimmer Biomet recalled a total of 3,662 devices with product codes KWS and PAO and all lots with part number 115340 manufactured between August 25, 2008 and September 27, 2011, and distributed between October 2008 and September 2015.

DePuy Synthes Radial Head Prosthesis System

In December 2016, DePuy Synthes, a division of Johnson & Johnson, issued an “Urgent Notice: Medical Device Field Safety Notification” to inform patients that the Synthes Radial Head Prosthesis System was being voluntarily removed from the worldwide market given that the radial stem (the component that anchors the implant in the arm’s radius bone) could loosen at the stem-bone interface following implantation. The DePuy elbow implant recall involved 50,311 units distributed throughout the United States.

Modular SMF and Modular Redapt Femoral Hip Systems Recall

In November 2016, Smith & Nephew recalled its Modular SMF and Modular Redapt hip implants “due to a higher than anticipated complaint and adverse event trend” with the modular necks used in the devices. Smith & Nephew also recalled the corresponding hip stem components.

Tandem Bipolar Hip System Recall

On August 29, 2016, Smith & Nephew recalled certain batches of its Tandem Bipolar Hip System in the United States due to a retainer groove that is out of specifications that can cause the artificial hip joint to disassmeble, usually within the first few weeks of surgery. This necessitates painful revision surgery to remove and replace the defective artificial joint and treat injuries caused by the implant failure. Smith & Nephew stated that the defect will be discovered before the device is implanted in most cases as surgeons will notice that the device did not assemble properly. All unused units have been recalled.

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