Judge Rules that Invokana Litigation Should Stay in Federal Court

invokana-warning kidney-damage
US District Judge Mitchell Goldberg ruled that the federal court will retain jurisdiction over 106 Invokana lawsuits that were filed last year in the Philadelphia Court of Common Pleas.

The ruling did not address whether the 106 cases will remain in US District Court for Eastern District of Pennsylvania or be rolled into MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in New Jersey.

Invokana is a prescription drug used to treat Type 2 Diabetes. Plaintiffs describe a variety of ailments, including kidney failure and diabetic ketoacidosis. The case is Arthur Portnoff v. Janssen Pharmaceuticals, Inc., Case No. 16-5955.

Class Action Fairness Act

Defendants removed all 106 cases to US District Court on Nov. 9, 2016, asserting federal jurisdiction as a “mass action” pursuant to the Class Action Fairness Act (“CAFA”). The plaintiffs contested removal and filed a motion to remand arguing that Defendants’ attempt to remove those cases was untimely, and that the federal Court lacked jurisdiction under CAFA.

To remove a mass action under CAFA, there must be 100 or more plaintiffs. The initial consolidation petition was filed on September 23, 2016, but was later withdrawn on October 11, 2016. On the same day, a second petition was filed.

The plaintiffs argued unsuccessfully that a 30-day time clock started running on Sept. 23. But Judge Goldberg ruled that the first petition was “legally inoperable.” The defendants filed within the time limit starting from the Oct. 11 petition.

The plaintiffs also argued that the Second Petition contemplated consolidation for pretrial proceedings only and that the single mention of a joint trial in the Second Petition’s conclusion was a “scrivener’s error.” Plaintiff’s counsel explained that she used a previously filed petition as a template for the Second Petition and that the proposal for a joint trial contained therein was a scrivener’s error.

However, 5 other plaintiff lawyers approved the document and failed to comment on the scrivener’s error, undermining their argument.

“So long as CAFA’s other jurisdictional requirements are met, federal district courts have jurisdiction over: any civil action . . . in which monetary relief claims of 100 or more persons are proposed to be tried jointly on the ground that the plaintiffs’ claims involve common questions of law or fact, except that jurisdiction shall exist only over those plaintiffs whose claims in a mass action satisfy the jurisdictional amount requirements . . . .,” the court said.

 

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Parties Agree To Reschedule Xarelto Bellwether Trials to April

xarelto internal-bleedingThe four lawsuits that were to be tried first in the federal Xarelto products liability MDL No. 2592 were pushed back another month at the request of both plaintiffs and defendants.

The four Xarelto bellwether trials were initially set to begin this month in Louisiana’s Eastern District. They were rescheduled to begin in March after the NBA All-Star Games were moved to New Orleans in response to North Carolina’s controversial “bathroom bill.”

At both parties’ request, the bellwethers were delayed again and the first trial will now begin in April. The second, third, and fourth trials are scheduled to begin in the following months.

District Judge Eldon E. Fallon issued Case Management Order 2D on Jan. 30, laying out the bellwether trial schedule as follows:

  • First trial — April 24, 2017 in the Eastern District of Louisiana
  • Second trial — May 30, 2017 in the Eastern District of Louisiana
  • Third trial — To Be Set in June 2017 in the Southern District of Mississippi
  • Fourth trial — To Be Set in July 2017 in the Northern District of Texas

Four cases were chosen as bellwethers:

  1. Boudreaux, Jr. et al v. Janssen Research & Development LLC et al (2:14-cv-02720)
  2. Orr et al v. Janssen Research & Development LLC et al (2:15-cv-03708)
  3. Mingo v. Janssen Research & Development LLC et al (2:15-cv-03469)
  4. Henry v. Jansen Research & Development LLC et al (2:15-cv-00224)

Uncontrollable bleeding

There are 15,291 lawsuits consolidated in the massive Xarelto MDL as of Feb. 15.

The lawsuits stem from allegations that the anticoagulant Xarelto could cause uncontrollable bleeding in some people. They accuse the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — of failing to warn about Xarelto’s potential risks.

The first bellwether trial involves a Louisiana man with atrial fibrillation, who took Xarelto and suffered life-threatening gastrointestinal bleeding according to the Schmidt National Law Group in in San Diego.  Joseph Boudreaux Jr. took Xarelto for just under one month in 2014 before he was hospitalized for severe internal bleeding, according to the lawsuit.

He needed several blood transfusions and was hospitalized for five days as a result of his Xarelto bleeding episode. He then required follow-up medical treatment following his stay in the hospital.

Boudreaux filed a Xarelto lawsuit against Janssen and Bayer in December 2014, accusing the two manufacturers of concealing their knowledge of Xarelto’s defects from physicians and patients like himself.

His attorneys are set to square off against defendants Janssen and Bayer on April 24, 2017 in New Orleans.

 

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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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Alarm: H.R. 985 is an Attempt to Undermine Multidistrict Litigation

Howard M. Erichson, Professor of Law, Fordham University
Howard M. Erichson, Professor of Law, Fordham University

Several law professors, including Fordham Law Professor Howard Erichson, are ringing alarm bells about a new bill that just passed the House Judiciary Committee that “is a crass attempt to undermine any effort by plaintiffs to seek justice in mass disputes.”

The bill, H.R. 985, the “Fairness in Class Action Litigation Act of 2017,” seeks to reduce defendants’ exposure to liability for mass harms by:

  • Tightening the standard for class certification
  • Imposing an ascertainably requirement
  • Delaying the payment of class counsel fees
  • Limiting the use of issue class actions
  • Expanding diversity jurisdiction
  • Mandating Lone Pine orders in MDL
  • Banning trials in an MDL
  • Capping MDL personal injury attorneys’ fees at 20%

As Beth Burch noted, the bill does not make things fairer for those who have been wronged.

“The abuses in class actions and non-class mass litigation happen mostly in settlement, not litigation and adjudication,” Erichson says. “But that is not what this bill would address. Instead, its provisions are aimed mostly at protecting defendants from the kinds of class actions and mass litigation that actually empower consumers, employees, citizens, and others to fight corporate and government wrongdoing.

“Even where the bill aims at real problems, it goes too far, failing to match its solution to the problem of magnet jurisdiction in nationwide mass disputes,” he says. “In my letter to Congressional leaders, I attempt to explain which of the provisions of H.R. 985 are especially problematic, and why.”

Click to download Erichson’s HR985 letter

Following is a round-up of the commentary thus far according to the Mass Tort Litigation Blog.

John Coffee (Columbia):   Download Coffee – How Not to Write a Class Action “Reform” Bill _ CLS Blue Sky Blog

Myriam Gilles (Cardozo):  Download Gilles Letter to James Park on HR 985

Elizabeth Chamblee Burch (Georgia):  Download Burch Final Comments on Fairness in Class Action Litigation Act

For those of you who like up to the minute commentary, several academics and reporters keep very active twitter accounts that track the bill: @adam_zimmerman, @elizabethcburch, @HowardErichson@PerryECooper

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Johnson & Johnson’s Risperdal Behind Massive Spike in Mass Tort Litigation

Risperdal-V2-headerBy Anjelica Cappellino. This article is reprinted from The Expert Institute.

There has been a huge spike in mass tort litigation due to the Johnson & Johnson medication, Risperdal, an anti-psychotic drug used to treat schizophrenia and other psychiatric disorders. Risperdal has been the center of litigation for years due to allegations that the drug causes breast tissue growth in young men, a condition called gynecomastia. This past year, however, Risperdal has accounted for over a third of all mass tort lawsuits pending in the Philadelphia Complex Litigation Center. Mostly comprised of individual suits rather than class actions, the verdicts may differ greatly, depending upon the evidence presented in each case. Due to the scientific and medical nature of the drug’s effects, experts in the field may strongly impact the verdict.

Risperdal’s Litigation History and Current Lawsuits

Risperdal has received a significant amount of attention dating back to 1994, when the drug first went on the market and Johnson & Johnson was accused of illegal marketing activities. In one of the largest health care fraud settlements in United States history, Johnson & Johnson was forced to pay more than $2 billion in penalties and settlements to state and government entities as a result of lawsuits relating to Risperdal and two other drugs, as well as civil and criminal complaints about their use. The Department of Justice stated Risperdal and two other Johnson & Johnson drugs were promoted for dementia patients, when Risperdal was approved only to treat schizophrenia. The Food and Drug Administration did not approve this use as safe and effective.

Deceptive marking actions are not the only claims against Risperdal.  The largest cause of action against the drug is that it causes men to develop gynecomastia. This breast development can have devastating and long-term effects on young men. At least 13,000 product liability claims involving Risperdal have been filed in courts around the United States, alleging that Johnson & Johnson was aware that the medication could cause gynecomastia, but concealed that information to the public.

Most of the current litigation is pending in the Los Angeles Superior Court and the Philadelphia Court of Common Pleas in Pennsylvania, where a small group of cases went to trial as part of a bellwether trial process. In February 2015, in one of the first cases to go to trial, a Pennsylvania jury awarded $2.5 million in damages to a 20-year old male plaintiff who had been using Risperdal since he was eight years old. A month later at the second trial, the plaintiff was not awarded any damages after a jury concluded that there was insufficient evidence that Risperdal caused his breast growth. However, the jury did find that the company provided inadequate safety warnings. In November of that same year, a separate jury in the same court awarded $1.75 million to another Risperdal user who developed breasts after taking the drug since age five. In July 2016, the largest award in Philadelphia Risperdal litigation was reached. A jury awarded a Tennessee teenager $70 million in damages after finding that Johnson & Johnson officials failed to warn the young man and his family that the drug could cause him to grow breasts. Most recently, in January 2017, Johnson & Johnson entered into a pre-trial settlement days before another Philadelphia trial, a case which would have been the seventh trial about Risperdal’s link to gynecomastia.

With more than 2,000 cases pending in the Complex Litigation Center of the Philadelphia Court of Common Pleas, and another 300 cases pending in Los Angeles Superior Court, litigation is far from over. The total number of mass tort cases pending in Philadelphia’s Complex Litigation Center at the beginning of 2017 has risen to its highest level in more than five years. Risperdal accounts for the second largest percentage of cases, making up more than 31 percent of Philadelphia’s mass tort docket. In 2016, there were 550 pending Risperdal cases, a 40 percent increase from the previous year.

How Have the Experts Weighed in?

Since the inception of the first lawsuit, expert witnesses were vital to the outcome of the case. David Kessler, a pediatrician and former Food and Drug Administration Commissioner, has been a vocal expert witness in the Risperdal litigation. Since 2012, Kessler has offered his expert services to plaintiffs as both a pediatrician and failure-to-warn expert, writing detailed reports about Johnson & Johnson’s promotion of Risperdal for non-approved uses in children. In 2015, Kessler testified in a Philadelphia trial that Johnson & Johnson knew as early as 2001 that Risperdal could cause gynecomastia in boys, five years before the company adding a warning about such a side effect on its label. The crux of most Risperdal cases is whether the company adequately warned the plaintiff of the drug’s side effects. Therefore, expert testimony like Kessler’s is indispensable in establishing that Risperdal did not contain adequate warnings of its possible side effects.

As plaintiffs often begin taking Risperdal in their youth, pediatricians have served as vital expert witnesses in explaining the effects of the drug on young males. Pediatric neurologists and endocrinologists have testified to explain how the drug affects the hormone levels and nervous system. Specifically, the drug stimulates the pituitary gland and elevates levels of prolactin, a hormone that is related to female breast development and lactation in nursing mothers.

In addition to Risperdal’s long-term effects on young men, the causal link between Risperdal and gynecomastia must also be established. As David Kessler previously testified in January 2015, he concludes that there is a connection. Kessler has pointed to a clinical trial, funded by Johnson & Johnson, that showed 3.8% of young males using Risperdal developed breasts. Kessler testified that the medication “probably or very likely” triggered the condition. Because gynecomastia is caused by elevated amounts of prolactin, experts have testified that if children’s levels of prolactin are monitored while on the medication, the development of gynecomastia can be more easily recognized, opposed to incorrectly attributing the side effects to weight gain.

In light of the growing mass tort litigation, the Philadelphia Court of Common Pleas is scheduled to convene a meeting on March 9, 2017 concerning its centralized docket of Risperdal claims. Although several plaintiffs have reached confidential settlements prior to trial thus far, there are thousands of cases that are still pending and there are no signs that litigation will slow down in 2017.

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Biomet Pays $350,000 to Settle Defective Shoulder Replacement Case

Defective Biomet replacement shoulder, showing the fractured baseplate and snapped of trunnion.
Defective Biomet replacement shoulder, showing the fractured baseplate and snapped of trunnion.

Biomet, Inc. agreed to pay $350,000 to a Denver man who had both shoulders replaced with defective Comprehensive Reverse Shoulder prostheses, only to have double revision surgeries after they both snapped and broke inside his body.

Plaintiff Alfonso A. Alarid accepted the settlement on Feb. 4, 2016, from defendants Biomet Inc., Biomet Orthopedics LLC and Biomet Manufacturing LLC, all based in Indiana. The case is Alarid v. Biomet,  Case No. 1:14-cv-02667-REB-NYW, US District Court for the District of Colorado.

The settlement was negotiated by plaintiff’s attorneys Jennifer E. Bisset, Bisset Law Firm of Denver, CO, and Gregory A. Hall, Law Office of Gregory A. Hall of Denver, CO.

On September 13, 2010 Biomet issued a recall notice for the defective Comprehensive Reverse Shoulder, including the two Comprehensive Reverse Shoulder devices that were implanted into the plaintiff’s left shoulder in 2009 and his right shoulder in 2010. According to Biomet, it issued the recall notice due to complaints it received about fracturing of the device at the joint between the trunnion and the baseplate.

Biomet’s Comprehensive® Reverse Shoulder is a Class II medical device, approved in 2008 pursuant to the FDA short-cut 510(K) process, instead of the more rigorous FDA “Premarket Approval” process. By September 2010 Biomet had received multiple adverse reports about the defective Reverse Shoulder and recalled it.

Alarid filed suit on July 20, 2014, alleging strict products liability, breach of express warranty, breach of implied warranty of merchantability and negligence.

Left shoulder replaced

His doctor told him on October 21, 2008, that he would need a left shoulder replacement because of a massive rotator cuff tear. Reverse shoulder replacement, or RTSA, is a surgical procedure that reverses the anatomy of the shoulder. It is designed so that the ball is attached to the shoulder blade (scapula) and the socket is placed on top of the upper-arm bone (humerus). By reversing the normal anatomy, the deltoid muscle, one of the stronger shoulder muscles and the only abducting muscle remaining in the shoulder, is given control to raise the arm.

Alarid had the left shoulder replaced on September 24, 2009. On July 30, 2012 Plaintiff was simply participating in physical therapy when he felt a clicking sensation in his left arm followed by immediate pain. A CT scan on August 6, 2012 showed that the humeral baseplate tray and trunnion of the Biomet Comprehensive® Reverse Shoulder had separated. On October 11, 2012, Dr. Schneider performed revision surgery to remove and replace the Biomet shoulder prosthesis.

A visual inspection confirmed that the device fractured at the joint between the trunnion and the baseplate.

Right shoulder replaced

On May 12, 2010 an MRI of Plaintiff’s right shoulder showed severe glenohumeral joint arthritis with labral tearing and irregularity with a large paralabral cyst along the posterior glenoid. On July 22, 2010, Plaintiff underwent surgery on his right shoulder, during which Dr. Schneider performed a reverse right total shoulder arthroplasty and implanted the second Biomet Comprehensive® Reverse Shoulder device.

On March 22, 2013, the plaintiff was simply getting up off the floor when he experienced right shoulder pain. On April 17, 2013, Dr. Schneider performed revision surgery on the right shoulder to remove and replace the defective Comprehensive® Reverse Shoulder prosthesis.

A visual inspection confirmed the device fractured at the joint between the trunnion and the baseplate, and that the trunnion had snapped off.

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Physio-Control Recalls Lifepak15 Defibrillator for Failure to Deliver Electrical Shock

LIFEPAK15 Monitor/DefibrillatorThe FDA has issued a Class I recall, the most serious type of recall, for The Physio-Control Lifepak 15 Monitor/Defibrillator (LP15). Use of these devices may cause serious injuries or death.

Recalled Product

  • Distribution Dates: September 13, 2014, to July 4, 2016
  • Manufacturing Dates: September 3, 2014 to June 30, 2016
  • Devices Recalled in the U.S.: 139 nationwide

The LIFEPAK 15 Monitor/Defibrillator is used to deliver life-saving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the defibrillator to help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The LIFEPAK 15 monitor displays the patient’s heart rhythm in waves so the health care provider can study the heart’s electrical activity.

Physio-Control is recalling the LIFEPAK Monitor/Defibrillator due to an electrical problem which may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. If the electrical shock is not delivered, the monitor will indicate “Abnormal Energy Delivery” on the display.

A delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.

Who May be Affected

  • Health care providers and first responders using this monitor/defibrillator
  • Patients who may need this defibrillation to restore normal heart rhythm

On January 12, 2017, Physio-Control sent an “Urgent Medical Device Correction” letter to all affected customers. The letter asked customers to:

  • Review the safety notice and make sure appropriate staff is aware of the notice.
  • Follow the instructions on the “Confirmation Sheet” for each serial number listed in the facility’s possession, and return the completed Confirmation Sheet to Physio-Control.
  • Perform the “User Test” every day, as instructed in the LIFEPAK 15 Operating Instructions, page 10-4. If the device fails the “User Test”, as described in the notice, contact Physio-Control immediately to arrange for correction of the device.
  • Continue to perform the User Test as outlined in the Daily Operator’s Checklist within the LIFEPAK 15 Operating Instructions.

Contact Information

Health care professionals and consumers with questions are instructed to contact Physio Control at 1-800-442-1142 with any questions related to this recall.

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Woman Sues Ethicon After Intestines Push Through Hernia Mesh

Ethicon PhysiomeshA Georgia woman filed a products liability suit against Johnson & Johnson and Ethicon when loops of her intestines protruded through multi-layer Physiomesh hernia mesh, causing an intestinal obstruction and severe pain.

She and her husband charge the companies with defective design, failure to warn, negligence and loss of consortium in Connie Franklin and Marvin Franklin v. Johnson & Johnson, No. 4:17-cv-00031, Feb. 2, 2017, US District Court, Middle District of Georgia

As many as 300,000 people may have been implanted with Physiomesh since the FDA approved the product via the 510(k) process in 2010. Ethicon issued an urgent field safety notice on May 25, 2016 related to its hernia repair product Ethicon Physiomesh Flexible Composite Mesh.

  • On the same day, Health Canada, (the Canadian FDA) issued a recall of the Physiomesh products as well.
  • The Australian Therapeutic Goods administration followed suit in June issuing a hazard alert.

See MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation

Cannot remove Physiomesh

Connie Franklin was implanted with a 20 cm by 25 cm section of Physiomesh to repair an incisional hernia. After suffering pain, nausea and vomiting, she had surgery again on August 1, 2016 for a hernia recurrence.

“The central portion of the Physiomesh device was not incorporated into the abdominal wall and loops of Ms. Franklin’s intestines were protruding through the ruptured central portion of the mesh, and she suffered an intestinal obstruction. The mesh was densely adhered to the loops of Ms. Franklin’s intestines,” the complaint says.

“Ms. Franklin underwent a prolonged surgical procedure to attempt to remove the Physiomesh from her intestines and to remove the mesh that failed to incorporate into the abdominal facsia. Portions of the Physiomesh could not be removed, and remain in Ms. Franklin’s body.”

Physiomesh has a unique design incorporating five distinct layers: two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS”), which in turn coat a polypropylene mesh. This design is not used in any other hernia repair product sold in the United States.

“The multi-layer coating was represented and promoted by the Defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation of the mesh into the body, but it did not,” the complaint says.

The defective design causes delayed wound healing, inflammation, foreign body response, rejection, infection, and other complications. When the Physiomesh degrades, the polypropylene mesh is exposed to the adjoining tissue and becomes adhered to organs, causing bowel perforation or erosion, fistula formation, bowel strangulation, hernia incarceration and other injuries.

The plaintiffs argue that neither they nor their physician was adequately warned about the defective and dangerous condition of the product.

Attorneys for the plaintiffs are Henry G. Garrard, III, James B. Matthews, III, Andrew J. Hill III, Josh B. Wages and Patrick H. Garrard of Blasingame, Burch, Garrard & Ashley in Athens, GA.

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High Fracture Rate Causes FDA Recall of Zimmer Biomet Shoulder Replacement

Photo of Zimmer Biomet Comprehensive Reverse Shoulder deviceThe FDA has issued a Class I recall, the most serious type of recall, for more than 3,600 shoulder replacement devices — the Biomet Comprehensive Reverse Shoulder Humeral Tray Model 115340. Use of these devices may cause serious injuries or death.

  • Product Description: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
  • Product Code: KWS, PAO
  • Lot Numbers: All lots with part number 115340
  • Distribution Dates: October, 2008 to September, 2015
  • Manufacturing Dates: August 25, 2008 to September 27, 2011
  • Devices Recalled: 3,662

High fracture rate

The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.

Biomet Manufacturing Corp., based in Warsaw, IN, is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.

No safety review

The FDA gave Bioment clearance to market the shoulder device through the short-cut 510(k) process, based on its similarity to a previously-approved device — but not a review of its safety or efficacy as would happen in a rigororous premarket approval application (PMA):

  • The Biomet Comprehensive® Reverse Shoulder – Mini-Baseplate got 510(k) clearance on January 13, 2012.
  • The Comprehensive Reverse Shoulder – Titanium Glenosphere got 510(k) clearance on August 27, 2013.
  • The Comprehensive® RS Shoulder System got 510(k) clearance on September 28, 2007.

The previous devices were marketed before the May 28, 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.

Biomet Settles Comprehensive Lawsuit for $350,000

Biomet agreed to settle a lawsuit involving its Comprehensive Reverse Shoulder System for $350,000 in February 2016 according to the Schmidt National Law Group.

The lawsuit was filed in the U.S. District Court for the District of Colorado by a man who was implanted with two Biomet Comprehensive systems. The devices later fractured and the man had to undergo additional surgeries to remove and replace the failed systems.

The plaintiff sued Biomet for product liability in 2014, and the company agreed to settle those allegations roughly two years later in February 2016.

More than 50,000 Americans undergo shoulder replacement surgery each year to relieve joint pain. There are several types of shoulder replacement surgery, including conventional and reverse shoulder replacement.

Reverse shoulder replacement is performed in patients who have completely torn rotator cuffs or previously failed replacement surgeries. Reverse implants rely on different muscles to move the arm than traditional implants and can help restore some motion to these patients who have lost mobility in their shoulders due to severe pain.

Merely three years after Biomet’s Comprehensive reverse shoulder hit the market, the company initiated a recall of certain components of the system.

In a September 2010 Urgent Medical Device Recall Notice, Biomet said it was pulling at least 45 humeral tray and 45 locking ring components in distribution in eight states. The company said it initiated the recall after receiving complaints that the device was fracturing after being implanted.

The FDA posted the recall in December 2010 and labeled it as class II, meaning use of the device could cause temporary or reversible adverse health consequences. The agency terminated the recall in July 2011, but the FDA-determined cause remains pending on the agency’s website.

The humeral tray and locking ring components were recalled from at least eight states in the U.S., including New York, Virginia, Maryland, Alabama, Colorado, South Dakota, Texas and Oklahoma.

 

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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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