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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Stryker Hip Settlement Extended to Cover 2014 to 2016

Stryker Rejuvenate Hip-Replacement-5US District Judge Donovan W. Frank in pretrial order No. 36 expanded a 2014 settlement program for US patients who underwent surgery to replace their metal-on-metal Stryker Rejuvenate Modular-Neck hip stem or their ABGII Modular-Neck hip stem up to Dec. 19, 2016.

The judge is overseeing 1,800 lawsuits in Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation, MDL 2441 in Minneapolis, MN.

“In order for this Court, the cooperating New Jersey Multicounty Litigation (Master Docket No. BER-L-936-13), and any other cooperating courts to manage this litigation, as well as to assist the parties to effectuate the provisions of the private Settlement Agreement, it is necessary to continue to identify and update all remaining, unresolved filed and unfiled claims,” the judge said.

No dollar value was placed on the expanded settlement. Stryker said it expects most payments to be made by the end of 2017. About 20,000 people were implanted in the US with the Rejuvenate and ABG II hip replacement.

$1 billion settlement

Stryker recalled the Rejuvenate and ABGII hips in 2012.  Plaintiffs allege that the metal-on-metal design of the hip joint components caused premature failure and resulted in metal debris causing pain, infection, tissue and bone death and difficult revision surgery.

The parties reached a $1 billion settlement in 2014. Eligible claimants will receive a base award of $300,000 for each revised hip. Unrepresented claimants are eligible for 71% of the base award, or $213,000. Reductions will be made for obesity, smoking and age, according to the settlement. Settlements may be increased up to $550,000 under an enhanced benefit program, for re-revision surgery, related additional surgery,  dislocation of the femoral head of the hip, infections, inability to lift the front part of the foot, and pulmonary embolism or deep vein thrombosis during hospitalization.

Plaintiffs’ lead counsel are Peter J. Flowers of Meyers & Flower in Chicago; Annesley H. DeGaris of the DeGaris Law Group in Birmingham, Ala.; Wendy Fleischman of Lieff, Cabraser, Heimann & Bernstein in New York; Ben W. Gordon Jr. of Levin Papantonio in Pensacola, Fla.; Eric Kennedy of Weisman, Kennedy & Berris in Cleveland; Genevieve M. Zimmerman of Meshbesher & Spence in Minneapolis; and Charles S. Zimmerman of Zimmerman Reed in Minneapolis.

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Jury Returns Defense Verdict in Zimmer NexGen Knee Trial

Zimmer NexGen Flex knee implant
Zimmer NexGen Flex knee implant

A Chicago jury returned a defense verdict for Zimmer Inc. in the third NexGen knee bellwether trial.

The verdict was returned on Jan. 26 in Beverly Jemma Goldin v. Zimmer, Inc., et al., No. 12-2048, N.D. Ill., Eastern Div.

Goldin argued unsuccessfully that the implant was defective because Zimmer failed to warn her orthopedic surgeon, Dr. Russell Windsor, that a patient’s obesity or morbid obesity was a risk factor that could increase the likelihood of an implant loosening for the NexGen knee implant.

Zimmer’s defense prevailed, contending that the warnings provided adequately informed surgeons like Dr. Windsor of the risks relating to a patient’s weight, and that Dr. Windsor independently knew about those risks.

A medical device manufacturer has a duty to warn of all potential dangers in its prescription devices that it knew, or, in the exercise of reasonable care should have known to exist. Reasonable care means that degree of care which a reasonably prudent person would use under the same circumstances.

500 lawsuits

There are 500 lawsuits filed against Zimmer in MDL No. 2272 in the Northern District of Illinois, supervised by US District Judge Rebecca R. Pallmeyer.  Separately, Zimmer is facing 463 lawsuits in IN RE: Zimmer Durom Hip Cup Products Liability Litigation in MDL 2158 before U.S. District Judge Susan D. Wigenton in the District of New Jersey.

doctors-Bal_Bhajanjit
Dr. Bhajanjit Sonny Bal, MD, JD, MBA, a Professor of Orthopaedic Surgery at the University of Missouri.

Goldin had her right knee replaced in 2009 with a NexGen Flex knee made by Zimmer, after exhausting all non-surgical options — but it loosened and collapsed in 2011, when she had it replaced. Total knee replacements usually last for a period of 10 to 15 years or longer.

Goldin’s causation expert was Dr. Sonny Bal.  Bal is a board-certified orthopedic surgeon and a professor of orthopedic surgery at the University of Missouri Health Care hospital in Columbia, Mo.

The plaintiff is 5-feet one-inch tall and weighs 241 pounds, giving her a body mass index of 45.5, considered morbidly obese. The package inserts warned about the failure of the knee prosthesis for “heavy patients,” which Dr. Bal said is vague. In his opinion, Zimmer had the knowledge, resources, and ability to conduct tests, and to warn, about the NexGen Flex’s risks when implanted in morbidly obese patients.  There is no mention of weight or obesity in the “contraindications,” “warnings,” or “precautions” sections of the package insert.

The first bellwether trial resulted in a defense verdict, and Zimmer obained summary judgment in the second bellwether case, which is now on appeal.

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Litigation Building Over Smith & Nephew Tandem Bipolar Hip

Smith & Nephew Tandem Bipolar Hip System
Smith & Nephew Tandem Bipolar Hip System

In the wake of recalls in the US and Australia, litigation is building against Smith & Nephew over its Tandem Bipolar Hip System, which can detach after surgery.

The firm issued a recall on August 29, 2016, to return any stock product. The FDA followed up with a Class 2 device recall for the Tandem Bipolar hip on November 3, 2016, because “some Bipolar shells were manufactured with an out-of-specification retainer groove.”

The Australian Department of Health issued a hazard alert on Sept. 12, warning patients and health professionals that the manufacturing defect, “could lead to three potential failures, including the device not assembling properly and the head being too tight and not moving freely. Both of these failures would be identified during preparation before the implantation surgery.”

“The third potential failure is the device may appear to be assembled properly during the implantation surgery, but parts become detached at a later time. If the third failure occurs, it could result in adverse events and require revision surgery,” it says.

5,000+ units distributed

The device is a partial hip replacement, which is used to replace half of the hip joint (also known as hemiarthroplasty) in which only the femoral head or “ball” of the damaged hip is replaced, according to attorney Michael E. Schmidt of The Schmidt Law Firm of Dallas.

So far 5,806 units were distributed nationwide and in 23 developed nations. Signs of the hip failure include unexpected pain, limited mobility or loss of range-of-motion.

According to attorney Collen A. Clark of The Clark Firm in Dallas, “The surgeon should hear a “click” when the components are assembled properly. If the surgeon implants a device that is not assembled properly, it could detach suddenly. This will probably occur within the first few weeks after the operation.”

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Corrupt Congressman Invests in Zimmer Biomet, Then Sponsors Bill to Make Stock Price Go Up

Georgia Republican Congressman Tom Price
Georgia Republican Congressman Tom Price

According to CNN, Rep. Tom Price last year bought shares in a defective medical device manufacturer days before introducing legislation that would have directly benefited the company, raising new ethics concerns for President-elect Donald Trump’s nominee for Health and Human Services secretary.

Price bought between $1,001 to $15,000 worth of shares last March in Zimmer Biomet, according to House records reviewed by CNN.
Less than a week after the transaction, Price introduced the HIP Act, legislation that would have delayed until 2018 a Centers for Medicare and Medicaid Services regulation that industry analysts warned would significantly hurt Zimmer Biomet financially once fully implemented.
Zimmer Biomet, one of the world’s leading manufacturers of knee and hip implants, was one of two companies that would have been hit the hardest by the new CMS regulation that directly impacts the payments for such procedures, according to press reports and congressional sources.
Zimmer is facing nationwide litigation against it:
  • MDL 2158 Zimmer Durom Hip Cup Products Liability Litigation, where 463 cases are consolidated before U.S. District Judge Susan D. Wigenton in New Jersey. The plaintiffs charge the replacement hip was defectively designed or manufactured, and that Zimmer failed to provide adequate warnings about it.
  • MDL 2272 Zimmer NexGen Knee  Product Liability Litigation, where 501 cases are consolidated before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois. Four cases have been scheduled for bellwether trials, where plaintiffs suffered loosening of the replacement knee or had to have it removed and replaced.

After Price offered his bill to provide Zimmer Biomet and other companies relief from the CMS regulation, the company’s political action committee donated to the congressman’s reelection campaign, records show.

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Federal Judge Joins Plaintiff Cases in Wright Profemur Hip Litigation

wright PROFEMUR-R1 hipAt the plaintiff’s request, US District Judge Christina A. Snyder in California combined two cases against Wright Medical Technology, Inc. in litigation over the defective Profemur Total Hip System. In both cases the hip implant broke during normal daily use.

The cases are Richard B. Sarafian and Kristin Biorn, new case No. 2:15-cv-07102-CAS, US District Court for the Central District of California in Los Angeles. The cases were already proceeding with joint discovery.

Separately, 575 hip implant lawsuits against Wright are pending in Georgia in MDL 2329 before U.S. District Judge William S. Duffey, Jr. IN RE: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation.

Recalled in 2015

The Profemur hip was designed in 1985 and has been implanted in more than 50,000 patients. Wright received a short-cut 501(k) FDA approval in 2000 to sell the device base on an earlier hip replacement. The FDA recalled the device in August 2015.

Sarafian had his left his replaced in 2012 and the implant’s neck broke 37 months later. Biorn had her left hip replaced in 2013 and it broke after 20 months. Both were performing the “normal and expected activity of daily living.” The revision surgeries were done as emergency procedures.

Wright objected to combining the cases, arguing that it would allow evidence in one case that may not have been allowed otherwise in the other. It also argued that having multiple plaintiffs would make it look inherently guilty.

Both actions appear to share common issues of fact and law,” the judge wrote. “On balance, plaintiffs have the stronger argument.”

Sarafian and Biorn are represented by Helen Zukin, Paul R. Kiesel, D. Bryan Garcia and Cherisse H. Cleofe of Kiesel Law LLP.

 

 

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Plaintiffs in DePuy Hip Cases Ask 5th Circuit to Hear Appeals Together

depuy-asr-hip-replacementEight successful plaintiffs in In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation have called on the Fifth US Circuit Court of Appeals to consolidate all the appeals from two jointly-tried cases where juries found that the company knowingly sold a defective hip replacement.

Citing Fed. R. App. P. 3(b)(2) allowing appeals to be joined, the plaintiffs point out that the cases have the same MDL, defendants, lawyers, plaintiff injuries, evidence and witnesses. The appeals arise out of the second and third bellwether trials in MDL 2244 before US District Judge James Edgar Kinkeade in the Northern District of Texas. A total of 8,707 lawsuits are pending against DePuy in case No. 3:11-md-02244.

  • J&J prevailed in the first Pinnacle hip case to go to trial in October 2014.
  • In the second bellwether trial, a jury awarded $502 million to five of the patients in March 2016. The court cut the award to $150 million.
  • In the third bellwether trial, a jury awarded $1.04 billion in December 2016. The judge cut the punitive damages portion of the award in half.

The only difference is that the law of Texas governed the second trial, and the law of California governed the third.

Design flaws

The plaintiffs were implanted with the hip devices and experienced tissue death, bone erosion and other injuries they attributed to design flaws. Plaintiffs claimed the companies promoted the devices as lasting longer than devices that include ceramic or plastic materials.

The evidence demonstrated that:

(i) the Pinnacle Ultamet was defectively designed and marketed by Defendants.

(ii) Defendants failed to provide adequate warnings for the device.

(iii) Defendants failed to test the device in people before putting it on the market.

(iv) Defendants knew or should have known of the dangers of metal-on-metal hip implants.

(v) Defendants misrepresented or concealed material facts about the device.

(vi) Defendants polluted the scientific literature with fraudulent studies and biased doctors.

(vii) Defendants routinely used improper consulting agreements to induce orthopedic surgeons to use and market their products.

(viii) Defendants routinely prioritized marketing and sales over product safety.

The motion was filed by Kenneth W. Starr; The Lanier Law Firm, PC (W. Mark Lanier, Kevin Parker, M. Michelle Carreras); Fisher, Boyd, Johnson & Huguenard, LLP (Wayne Fisher, Justin Presnal); Neblett, Beard & Arsenault (Richard J. Arsenault, Jennifer M. Hoekstra); Simmons Hanly Conroy (Jayne Conroy, Andrea Bierstein), counsel for Plaintiffs-Appellees.

 

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