Johnson & Johnson and DePuy Pinnacle Hip Implant Trial Continued Until September 18th Based on Appeal

Johnson & Johnson and DePuy Orthopaedics Latest “Pinnacle Hip Implant Trial” Continued Until September 18th Based on Fifth Circuit Appeal 

  • By Mark A. York (September 15, 2017)

  • Mass Tort Nexus

 

 

 

 

 

The latest bellwether trial in the  DePuy Pinnacle MDL 2244 (see DePuy Pinnacle Hip Implant MDL 2244 Briefcase) litigation has been postponed until September 18th, based on the U.S. Court of Appeals for the Fifth Circuit ruling, just days before the trial was to start, where they cited “grave error” by the sitting US District Court judge, in requesting a trial delay. The trial start date was September 5th, where eight plaintiffs from New York were part of the DePuy Pinnacle MDL 2255 multidistrict litigation, who are now facing jurisdictional issues based on the June 2017 SCOTUS “Plavix Ruling” that restricts jurisdiction over plaintiffs who are residents of another state, SCOTUS Plavix Jurisdictional Ruling Strikes Non-Resident CA Plaintiffs. The Plavix ruling forced thousands of non-California residents to determine if and where they can refile their claims against Bristol-Myers Squibb. DePuy Orthopaedics and it’s parent Johnson & Johnson (J&J) are asserting the Plavix ruling by stating that the New York residents are not subject to jurisdiction of the US District Court ND Texas and the trial should be stopped. This seems to fly in the face of the justification of certain tenants of the Joint Panel on Multidistrict Litigation rules of procedure, which assigned the DePuy Pinnacle Hip Implant cases to the Texas court to consolidate the many thousands of cases across the country.

 J&J Wants To Avoid More Massive Trial Verdicts

J&J are simply using evry legal tool available, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip Implant trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to it’s various other medical device and pharmaceutical product lines.

Appeals Panel Denies Writ of Mandamus Petition

On August 23rd, the Fifth Circuit panel denied Johnson & Johnson’s and DePuy Orthopaedics’ petition for writ of mandamus, which sought to halt the upcoming trial. However, two of the three panel members found that the judge proceeding over the consolidated DePuy Pinnacle litigation in Texas had allowed certain trials to take place before him which a “judicial error” including the one that as scheduled to begin yesterday where plaintiffs were New York residents. On September 1st, U.S. District Court Judge Ed Kinkeade of the Northern District of Texas issued an Order delaying the next DePuy Pinnacle hip replacement trial until September 18, 2017.

DePuy Pinnacle Hip Verdicts

The multidistrict litigation underway in the Northern District of Texas, DePuy Pinnacle MDL 2244, currently involves more than 9,000 hip replacement lawsuits related to the metal-on-metal version of DePuy Orthopedics’ Pinnacle hip system that utilizes the Ultamet liner. Plaintiffs claim that this configuration is defectively designed, as it sheds toxic metals into the joint surround the hip, as well as the blood stream, causing adverse local tissue reactions, metallosis, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the joint.

As of August 2017, MDL 2244 Pinnacle hip litigation has convened three bellwether trials. The first concluded in October 2014, with a verdict for DePuy and Johnson & Johnson.

In March 2016, five plaintiffs were awarded a total of $500 million at the close of the second DePuy Pinnacle trial, where the judge overseeing the case reduced the award to $151 million, in order to comply with Texas law governing punitive damages.

The largest hip implant trial verdict anywhere to date was in the DePuy MDL’s third bellwether trial which ended December 2, 2016, where six Pinnacle implant recipients, who were California residents, were awarded more than $1 billion in punitive damages, see $1 billion DePuy Hip Implant Verdict in MDL 2244, with the judgment later reduced to $543 million, by Judge Kinkeade.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials.  Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the device named in Pinnacle hip replacement lawsuits. According to The New York Times, the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

 

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PA Court Allows Strict Liability Manufacturing Defect Claims Against Stryker

Stryker Gamma 3 Nail System
Stryker Gamma 3 Nail System

A federal judge, ruling on Pennsylvania law, allowed a strict liability manufacturing defect claim to proceed against Howmedica Osteonics Corp. and Stryker Corporation for the complete failure of their hip and leg prosthetic device.

Plaintiff Gary A. Smith had a Stryker Gamma 3 Nail System implanted on March 2, 2015. X-ray images taken on Sept. 30, 2015, showed that the Stryker nail had broken. As a result on April 26, 2016, Smith had to undergo a left total hip replacement, which became infected causing more medical consequences.

He filed strict liability, negligence, breach of implied warranty claims under Pennsylvania law. Gary A. Smith v. Howmedica Ostonics and Stryker Corporation, No. 17-1174, US District Court for Eastern District of Pennsylvania (April 27, 2017).

“In the absence of a controlling decision by the Pennsylvania Supreme Court, a federal court applying that state’s substantive law must predict how Pennsylvania’s highest court would decide this case,” Judge Wendy Beetlestone wrote.

“This Court predicts that the Pennsylvania Supreme Court would not bar strict liability claims asserting a manufacturing defect against medical device manufacturers under Comment k” to Section 402A of the Restatement (Second) of Torts.

Stryker is a defendant in other litigation including:

Other claims fail

The court, however, dismissed the plaintiffs’ claims for:

  • Strict liability claims asserting a design defect against medical device manufacturers.
  • Negligent failure to warn and to recall against medical device manufacturers.
  • Breach of implied warranty of merchantability.

A strict liability claim generally requires proof “(1) that the product was defective, (2) that the defect existed when it left the hands of the defendant, and (3) that the defect caused the harm.”

“Here, the plaintiffs have plausibly alleged a manufacturing defect strict liability claim. The existence of a manufacturing defect is satisfied by the allegation that the Stryker Gamma 3 Nail System broke down after it was implanted into Mr. Smith, where it was subjected to normal and anticipated use, and that there were no reasonable secondary causes,” the judge said.

“That it existed at the time it left Defendants’ control is plausibly suggested by the allegation that the product was manufactured and shipped by Defendants to Grand View Hospital, where it was ultimately implanted into Mr. Smith.”

“And causation follows from the allegation that the failure of the Stryker Gamma 3 Nail System necessitated a subsequent surgery to remove it, as well as a total hip replacement, which gave rise to a secondary infection. Therefore, the motion to dismiss the strict liability claim insofar as it asserts a manufacturing defect will be denied,” the judge said.

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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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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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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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Bellwether Mediation in Mass Tort Litigation Promotes Settlements

Professor Adam Zimmerman, Loyola Law School, Los Angeles
Professor Adam Zimmerman, Loyola Law School, Los Angeles

Adam Zimmerman, Professor of Law, Loyola Law School, has published his new article “Bellwether Settlements” to SSRN.  The abstract is below:

This article examines the use of bellwether mediation in mass litigation. Bellwether mediations are different from “bellwether trials,” a practice where parties choose a representative sample of cases for trial to decide how to resolve a much larger number of similar cases. In bellwether mediations, the parties instead rely on a representative sample of settlement outcomes overseen by judges and court-appointed mediators.

The hope behind bellwether mediation is that different settlement outcomes, not trials, will offer the parties crucial building blocks to forge a comprehensive global resolution. In so doing, the process attempts to:

  1. Yield important information about claims, remedies, and strategies that parties often would not share in preparation for a high-stakes trial.
  2. Avoid outlier or clustering verdicts that threaten a global resolution for all the claims.
  3. Build trust among counsel in ways that do not usually occur until much later in the litigation process.

“Information-forcing” role

The embrace of such “bellwether settlements” raises new questions about the roles of the judge and jury in mass litigation. What function do courts serve when large cases push judges outside their traditional roles as adjudicators of adverse claims, supervisors of controlled fact-finding, and interpreters of law?

This article argues that, as in other areas of aggregate litigation, courts can play a vital “information-forcing” role in bellwether settlement practice. Even in a system dominated by settlement, judges can help parties set ground rules, open lines of communication, and, in the process, make more reasoned trade-offs. In so doing, courts protect the procedural, substantive, and rule-of-law values that aggregate settlements may threaten.

Following is the introduction:

A curious thing happened in a Bergen County court in New Jersey. In a case involving thousands of people with defective hip implants, the parties reached a $1 billion global settlement in record time through an unprecedented series of “bellwether settlements.”

For years, courts have relied on “bellwether trials” to resolve large numbers of similar lawsuits. In a bellwether trial, the parties select a small group of cases for jury trial out of a larger pool of similar claims. Steering committees of plaintiff and defense lawyers then use information gleaned from those trials to resolve the remaining cases. Bellwether trials have been used in many high-profile cases—most famously in the Vioxx litigation— and, most recently, in General Motors’s litigation over its defective ignition switches. As multidistrict proceedings begin to take up a larger portion of the federal docket, the use of bellwether trials will only grow.

But instead of bellwether trials, the Bergen County court organized a system of bellwether mediations. In a bellwether mediations, no jury decides the merits or value of the case. Rather, the parties—supervised by the court—rely on a structured sample of mediated settlements involving representative plaintiffs. The different settlement outcomes, much like a series of bellwether trials, are intended to offer the parties crucial “building blocks” of information to globally resolve the remaining cases.

Judge Brian R. Martinotti, the New Jersey state court judge designated to handle the selected cases, was incredibly successful. Following forty representative mediations, the parties resolved more than 2,000 lawsuits in New Jersey state court and a similar number of pending lawsuits in a parallel federal multidistrict litigation in Minnesota—all in one fell swoop. In the end, over 95 percent of the potential plaintiffs accepted settlement offers based on the global agreement.

The court’s complete embrace of a bellwether settlement scheme raises new questions for juries and judges. What do bellwether settlements mean when the procedures and outcomes lack any connection with a jury trial? By dispensing with the jury entirely, the parties arguably give up procedures that are thought to (1) encourage vigorous advocacy before neutral fact-finders, (2) promote fidelity to law by ensuring that settlements correspond to the merits of the dispute, and (3) provide a democratic bulwark against unelected judges who may harbor biases about what makes for a fair outcome.

Zimmerman, Adam S., The Bellwether Settlement (March 15, 2017). Fordham Law Review, Vol. 85 (forthcoming 2017). Available at SSRN.

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Motion Filed to Create MDL for Smith & Nephew Birmingham Hip Litigation

Smith & Nephew's Birmingham hip
Smith & Nephew’s Birmingham hip resurfacing medical device

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.

There are now 31 cases involving the BHR and R3 devices pending in 22 US district courts, with 32 different law firms involved. Most cases were filed in the last 12 months.

The BHR and the R3 are components in “metal-on-metal” hip implant systems made by Smith & Nephew, Inc. Similar metal-on-metal hip systems have been the subject of widespread mass tort litigation in recent years.

Toxic levels of metal

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 pain, adverse local tissue reaction, pseudotumor, bone and tissue necrosis, metallosis, and other symptoms leading to revision surgery. The lawsuits charge failure to warn patients and doctors, suppressing important information, defective design, and illegal marketing practices.

The JPMDL previously granted motions to transfer cases involving six other metal-on-metal hips:

  • MDL 2158, In re: Zimmer Durom Hip Cup Products Liability Litigation
  • MDL 2197, In Re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation
  • MDL 2144, In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation
  • MDL 2329, In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation
  • MDL 2391, In re: Biomet M2a Magnum Hip Implant Products Liability Litigation
  • MDL 2441, In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation.

The BHR consists of a femoral head component and a hemispherical acetabular cup made in a range of 12 sizes. The cup fits into the patient’s hip socket, or acetabulum, and then rubs against the femoral head during articulation (movement) of the patient’s hip joint. Both components are made of cobalt and chromium metal alloys.

The BHR may be used as part of a hip resurfacing, or it may be combined with a femoral stem in a total hip arthroplasty. The U.S. Food and Drug Administration approved the BHR for sale in the U.S. on May 9, 2006, through the Premarket Approval (“PMA”) process for Class III medical devices.

High failure rates

The R3 system consists of a femoral head and cup, with a metal acetabular liner separating the two components. These two devices share a similar mechanism of failure, and the FDA initially approved the R3 to be used as part of the BHR system. Smith & Nephew recalled the R3 in June 2012 due to high failure rates. The company later withdrew the BHR device from the U.S. market in June 2015 due to similar high failure rates, particularly in women and in patients with smaller hip joints.

The problems associated with the BHR and the R3 liner are similar to the injuries caused by other metal-on-metal hip devices, which have been well documented starting with the August 2010 recall of the DePuy ASR device. Data compiled by the National Joint Registry of England and Wales show the BHR has a seven-year revision rate of 11.76 percent, well above the normal acceptable failure rate for a device of this type. Similar data compiled by the National Joint Replacement Registry of Australia in 2015 show the BHR has a ten-year revision rate of 14.5 percent for women. Other studies place the failure rate for women as high as 26 percent.

Smith & Nephew continued selling its metal-on-metal hips for years even after most of its competitors recalled or withdrew similar devices from the U.S. market in 2010 and 2011.

Warnings about BHR system

Smith & Nephew issued an urgent field safety notice in 2015 updating the instructions for use of its Birmingham Hip Resurfacing System. The notice reveals that certain groups of patients are more likely to require revision surgery after receiving a Birmingham Hip Resurfacing System implant. These groups include women, men aged 65 or older, and patients who require an implant head equal to or smaller than 48mm.

This was followed in May 2016 with a new hazard alert issued by the Australian government, also applying to women, men aged 65 or older, and patients who require an implant head equal to or smaller than 48mm.

“Consolidation of other metal-on-metal hip cases has proven to be an efficient and cost-effective tool to resolve products liability litigation where a single manufacturer is connected to hundreds or even thousands of similar claims,” the motion states.

“For example, there are currently 1,452 actions pending in MDL 2197 for the DePuy ASR device, compared to 9,929 total actions historically. Likewise, there are 455 actions pending in MDL 2391 involving Biomet metal hips, compared to 2,642 total actions historically. Finally, there are 1,794 actions pending in MDL 2441 involving Stryker metal hips, compared to 3,356 historically.”

The plaintiff’s nominated Judge Catherine C. Blake, who is familiar with key issues related to Smith & Nephew’s metal-on-metal hip devices. Notably, she evaluated and ruled upon PMA preemption issues in Williams in August 2015 and she recently accepted a second BHR case.  Judge Blake has been an Article III judge for more than two decades, and she has presided over at least two other MDLs. She recently presided over MDL 2294, a patent infringement case filed in 2011 that appears to have been resolved as of June 2016.

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New MDLs Requested for Farxiga, Mirena, Hip Implants and Sorin 3T Heater

farxiga320x320The US Judicial Panel on Multidistrict Litigation (JPMDL) will hear argument on March 30 on whether to create new multi-district litigation docket (MDL) No. 2776 for Farxiga and Xigudo diabetes medicines.

Oral argument is scheduled starting in the morning at the US Courthouse in Phoenix, Arizona. In addition, oral arguments will be held to create the following MDLs:

Ketoacidosis and kidney failure

Plaintiff’s attorney Holly Dolejsi of Robins Kaplan L.L.P. in Minneapolis moved to transfer currently filed Faxiga and Xigduo cases to either the Southern District of New York before Judge Lorna G. Schofield, the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel, who all have Farxiga cases assigned to them.

The motion involves 18 pending cases in 6 district courts, with 13 of the 18 filed in New York. The Defendants The Defendants in these cases are Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, and AstraZeneca PLC.

As a result of ingesting Farxiga, the plaintiffs have suffered sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels), and/or acute renal failure, and/or pyelonephritis (kidney infection) and/or urosepsis and continue to suffer from the sequelae of these injuries. Farxiga (dapagliflozin) is a pharmaceutical drug used to treat Type 2 Diabetes. All of these injuries were the subject of recent FDA safety advisories. On January 8, 2014, the FDA approved Farxiga for use in

On January 8, 2014, the FDA approved Farxiga for use in treatment of type 2 diabetics.2 Farxiga is a part of the gliflozin drug class. The gliflozin class is referred to generally as SGLT2 (short for “Sodium Glucose Cotransporter 2”) inhibitors. Xigduo XR was (dapagliflozin combined with metformin) designed and made by the same defendants as Farxiga, and is an extension of the Farxiga product line. Xigduo XR was approved shortly after Farxiga, on October 29, 2014.

FDA safety warning

On December 4, 2015 the FDA issued a safety communication disclosing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization due to ketoacidosis-related to SGLT2 inhibitors. The FDA noted adverse event reports “include only reports submitted to FDA, so there are likely additional cases about which we are unaware.”

The same safety communication also warned of “life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis). In light of the data disclosed in the December 4, 2015 safety communication, the FDA changed the label for Farxiga and Xigduo XR to include a warning “about the risks of too much acid in the blood” and urged patients taking SGLT2 inhibitors to stop taking the drug and seek immediate medical attention if they have any symptoms of ketoacidosis. The FDA also required a label change to warn of urosepsis and pyelonephritis. On June 14, 2016, the FDA issued a safety announcement which advised that the existing warning about the risk of acute kidney injury on the Farxiga and Xigduo labels would be strengthened.

While a cross-motion to include Farxiga cases with Invokana MDL No. 2750 was raised, considered and ultimately denied by the Panel following the hearing in Charlotte, North Carolina, that request was opposed by both the Invokana Plaintiffs’ counsel and Defendants who claimed that the litigations were sufficiently different such that a joint SGLT2 MDL was improvident.

A total of 100 lawsuits have been filed in the MDL since the courts created it in December.

 

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FDA Recalls 32,000 More Smith & Nephew Hip Replacements

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

The Food and Drug Administration has recalled 31,936 hip replacement systems made by Smith & Nephew because of the “higher than anticipated complaint and adverse event trend.”

This follows the FDA’s Class 2 recall of the company’s Tandem Bipolar hip on November 3, 2016, because “some Bipolar shells were manufactured with an out-of-specification retainer groove.”

Three new Class 2 recall, dated January 4, 2017, covers Smith & Nephew hip systems distributed worldwide:

  • 6,266 units of the Modular Redapt Hip Systems. It received FDA 510(k) premarket approval on October 15, 2012.
  • 11,999 units of the Modular SMF Hip System. It received FDA 510(k) approval on July 31, 2008.
  • 13,671 units of Modular Necks. It received FDA 510(k) approval on January 10, 2008.

Growing litigation

The FDA grants clearance to market a medical device under the 510(k) shortcut if it is substantially equivalent to a pre-existing, approved device. A Class 2 recall is a situation in which use of a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Smith & Nephew is a UK company with an office in Memphis, TN. As hip litigation builds against the company, the Judical Panel on Multidistrict Litigation (JPMDL) is considering the creation of MDL No. 2775 for Smith & Nephew Hip Implant Products Liability Litigation. Eight plaintiffs who had the Birmingham Hip Resurfacing (“BHR”) and R3 metal-on-metal liner (“R3”) implanted filed the motion.

The devices were approved by the FDA in 2006, but Smith & Nephew recalled the R3 in June 2012 and withdrew the BHR device in June 2015 due to similar high failure rates. Data shows that the devices have a 10-year revision rate of 14.5 percent.

There are 31 cases involving the BHR and R3 devices pending in 22 different districts, with 32 different law firms involved. Plaintiff’s attorneys Jasper D. Ward IV and Alex C. Davis of Jones Ward in Louisville, KY, requested the cases be consolidated in the US District Court of Maryland.

The JPMDL previously created MDLs involving six other metal-on-metal hips:

  • MDL 2158, In re: Zimmer Durom Hip Cup Products Liability Litigation
  • MDL 2197, In Re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation
  • MDL 2144, In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation
  • MDL 2329, In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation
  • MDL 2391, In re: Biomet M2a Magnum Hip Implant Products Liability Litigation
  • MDL 2441, In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation.

There are 719,000 total knee replacements and 332,000 hip replacements performed annually in the U.S. (data from the Centers for Disease Control and Prevention (CDC). This number will grow exponentially with a more active and aging population.)

  • More than 7 million people in the U.S. have had a knee or hip replacement surgery
  • Hip and knee devices account for more than 85% of the joint reconstruction and replacement market
  • Joint registries demonstrate up to a 50% reduction in revision rates after registry initiation and identification of best practices

 

 

 

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Plaintiff Seeks MDL for Stryker LFIT V40 Hip Device

LFIT V40 Femoral Head
Stryker LFIT V40 Anatomic Femoral Head device

A Massachusetts hip replacement patient has requested that the Judicial Panel on Multidistrict Litigation (JPMDL) consolidate litigation against Stryker Orthopaedics over its defective LFIT V40 Anatomic Femoral Head devices, of which more than 100,000 units have been implanted into patients.

The new wave of litigation arises after Stryker Corporation issued an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

At the moment, six product liability actions over the LFIT device are pending in three jurisdictions, prosecuted by at least 10 different law firms. Plaintiff attorney Walter Kelley of Kelley Bernheim & Dolinsky LLC in Plymouth, MA, proposed that new MDL. No 2768 be located in federal court in Massachusetts before Judge Joseph L. Tauro, Judge Patti B. Saris, Judge Richard Saylor or Judge Indira Talwani.

The JPMDL has created MDLs in the court in Boston for litigation over GranuFlo/NaturaLyte, Zofran, Nexium, Neurontin, Celexa and Lexapro.

1,800 lawsuits

Stryker is already 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.

The prosthetic hip used in a total hip arthroplasty, more commonly known as total hip replacement, generally consists of several components – a femoral stem, a femoral head or ball, and an acetabular cup with liner. The Stryker LFIT V 40 Anatomic Femoral Head represents one part of a hip prosthesis and can be used across many hip replacement femoral hip stems manufactured and marketed by Stryker.

Stryker explains in its marketing materials that the “LFIT Anatomic CoCr Femoral Heads are compatible with Accolade TMZF, Secur-Fit Max, Citation TMZF, Hipstar, and most commercially available Stryker femoral hip stems.”

During hip replacement surgery, the femoral head is impacted onto the taper, in this case a V 40 taper, where it is supposed to lock in place. The failure of that taper lock causes excessive movement between the femoral head and the stem and ultimately leads to product failure.

On August 29, 2016, Stryker sent an “Urgent Medical Device Recall Notification” letter to surgeons that implanted or reported problems with certain Stryker LFIT V40 femoral heads manufactured prior to 2011. The letter explained that Stryker had received a higher than expected number of complaints involving taper lock failure of the recalled femoral heads.

In the letter, Stryker outlined the failure of the Stryker LFIT V40 femoral head and enumerated the reported problems associated with the device:

  • Dislocation of the femoral head from the hip stem
  • Hip stem fractures
  • Excessive metallic corrosion leading to cobalt and/ or chromium poisoning
  • Insufficient range of motion
  • Loss of implant/bone fixation strength
  • Excessive wear debris
  • Noise

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

The plaintiffs contend that Stryker knew for years that the LFIT V 40 femoral heads were defective and dangerous but instead chose to downplay the risk of using such device and failed to properly warn the hundreds of physicians implanting these devices

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