Pharma Companies Argue the Proton Pump Litigation Too Complex for an MDL

nexium-b-1Vehemently opposing a motion to create a new MDL for proton-pump inhibitor litigation (PPI), pharmaceutical companies argue that there are too many disparate issues involving drugs, companies and plaintiffs to centralize the cases.

So far, plaintiffs have filed 27 cases in federal court. They requested that the Judicial Panel on Multidistrict Litigation create a new MDL 2757 in Louisiana to consolidate all the cases.

They allege that as a result of ingesting a PPI for gastric acid-related conditions, they have been diagnosed with kidney injuries including acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure, also known as end-stage renal disease (ESRD).

Hodge-podge

But the primary defendant AstraZeneca Pharmaceuticals LP asserts, “Movants seek to create an unwieldy MDL with a hodge-podge of divergent defendants, medications (prescription and OTC), and alleged injuries.  More than 40 companies manufacturing and/or selling nearly 30 different PPIs (brand and generic) spanning nearly three decades may be implicated.”

The three primary drugs are Prilosec, Nexium, and Prevacid. The primary defendants are AstraZeneca, Takeda, and McKesson. But the defense says this is making things too simple.

“More than 40 companies manufacturing and/or selling nearly 30 different PPIs (brand and generic) spanning nearly three decades may be implicated,” AstraZeneca argues.

With so many different products, parties, and alleged injuries, individualized issues will eclipse any purported common ones, and MDL efficiency tools, such as a Master Complaint and bellwether trials, will be, at best, cumbersome and, at worst, unfeasible, and in all likelihood ineffective at efficiently narrowing claims and issues.”

AstraZeneca argues that the injuries cited are common among aging Americans and that the complaints focus on one of the most commonly prescribed classes of medications.

However if the JPMDL does create an MDL, AstraZeneca requested US District Judge Dale S. Fisher of the Central District of California. He presided over Nexium product liability litigation in 2012.

Enzyme Inhibitor

PPIs are a group of drugs containing Omeprazole that are intended to act as hydrogen potassium ATPase (“H+/K+ ATPase”) enzyme inhibitor to block the production of gastric acid. The FDA approved PPIs in 1989 and on Oct. 31, 2014 required PPIs to carry a warning label:

Acute interstitial nephritis has been observed in patients taking PPIs including [Brand]. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue [Brand] if acute interstitial nephritis develops.

The plaintiff’s brief cites several studied supporting their arguments:

  • In October 1992, researchers from the University of Arizona Health Sciences Center led by Stephen Ruffenach published the first article associating PPI usage with kidney injuries in The American Journal of Medicine.
  • In 2006, researchers at the Yale School of Medicine conducted a case series published in the International Society of Nephrology’s Kidney International finding that PPI use, by way of AIN, left most patients “with some level of chronic kidney disease.”
  • On August 23, 2011, Public Citizen, a consumer advocacy group, filed a petition with the FDA to add black box warnings and other safety information about several risks associated with PPIs including AIN.
  • In January 2016, a study published in the Journal of the American Medical Association found that PPI use was independently associated with a 20 – 50% higher risk of CKD.

The plaintiffs recommended the MDL be created in the federal Middle District of Louisiana in Baton Rouge before Chief Judge Brian A. Jackson, Judge Shelly D. Dick, Judge John W. deGravelles or Senior Judge James Joseph Brady.

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Court: California Can Label Roundup as Cancer Threat

WHO-says-Roundup-probably-causes-cancerFresno County Superior Court Judge Kristi Kapetan ruled that California can require Monsanto to label its herbicide Roundup as a possible cancer threat.

California would be the first state to order such labeling for the weed-killer, which is used by farmers and home gardeners worldwide.

Separately, U.S. District Judge Vince Chhabria is supervising Roundup Products Liability Litigation, MDL No. 2741 in San Francisco. Since the MDL was created in October, it has attracted 46 lawsuits, Case No. Case 3:16-md-02741-VC.

Herbicide found in popular foods

Roundup’s main ingredient, glyphosate, has no color or smell. Recently, the independent food safety testing done by Food Democracy found extremely high levels of the herbicide glyphosate — the active ingredient in Monsanto’s Roundup — in America’s most popular food products.

Monsanto introduced the chemical in 1974 as an effective way of killing weeds while leaving crops and plants intact. It’s sold in more than 160 countries, and farmers in California use it on 250 types of crops.

  • The chemical is not restricted by the U.S. Environmental Protection Agency, which says it has ‘low toxicity’ and recommends people avoid entering a field for 12 hours after it has been applied.
  • But the International Agency for Research on Cancer, a Lyon, France-based branch of the U.N. World Health Organization, classified the chemical as a ‘probable human carcinogen.’

Shortly afterward, California took its first step in 2015 to require the warning labels.

Attorneys for California consider the International Agency for Research on Cancer the ‘gold standard’ for identifying carcinogens, and they rely on its findings along with several states, the federal government and other countries, court papers say.

 

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Join us March 10-13 for the “Four Days to Mass Tort Success Course” in Fort Lauderdale

 
Contact Barbara Capasso at (954) 383-3932 
or barbara@masstortnexus.com for more information. 

The upcoming year promises to create more opportunities  than ever  for Plaintiff Attorneys who currently practice Mass Torts, or are interested in adding Mass Torts to their current practice.

Mass Tort Nexus is currently tracking  and researching over 300 potential Mass Tort cases, many of which may reach the litigation phase in 2017. 

Over 250 attorneys have already attended the Mass Tort Nexus Four Days to Mass Tort Success Course. We only accept 20 attorneys per course and the March Course has just 4 seats remaining.

It’s your turn to gain inside knowledge of the only practice area that provides true economies of scale and the opportunity to work smarter, not harder.

Whether you are a Mass Tort pro, dabbled in Mass Torts, or are new to the practice area, the “Four Day Mass Tort Success Course” will help you avoid common mistakes, while giving you a road map to success in Mass Torts.  We teach you a step- by-step process to ensure you understand the methods and metrics of this practice area.

In addition to the hands-on, how-to instruction attendees will receive,  our panel of experts will be presenting real world case studies related to emerging and ongoing litigations.

NEW HOT EMERGING LITIGATIONS 

Liva Nova Stockert 3T System – Potentially Deadly Infections
Fortify and Quadra Assura Litigation Stemming From FDA Recall
Mirena Intra Cranial Pressure  (New Mirena Litigation)
Atrium C-Qur Hernia Mesh
Ethicon Physiomesh  Hernia Mesh
 

NEW AND ONGOING HIP LITIGATIONS 

Tandem Bipolar Hip System
 Profemur Hip  System
LFIT V 40 Acetabular  Cup
New Information on Metalosis 

 VITAL UPDATES ON IMPORTANT CURRENT  LITIGATIONS

Taxotere – Permanent Hair Loss      
Proton Pump Inhibitors – Kidney Damage
Xarelto – Bleeding and Ishemic Stroke            
 Pradaxa – State Court Consolidations
All IVC  Filters – not just Bard and Cook                 
Abilify- Compulsive Behavior
Fluoroquinolones –  more than peripheral neuropathy 

Our Panel of Expert Speakers

Attorney James Onder
 
James (Jim) Onder is well known for his multiple  fifty million dollar plus Talcum Powder Ovarian Cancer verdicts. Jim’s vastexperience in numerous Mass Tort litigations makes him an invaluable resource.
Jim and other members of his firm, have served as co-lead counsel and in various leadership positions on numerous MDLs. The opportunity to hear James speak about a difficult litigation, that he and his co-counsel firms managed to achieve massive jury awards will be an opportunity you won’t want to miss.
 
Attorney John Dalimonte 
 
John Dalimonte currently serves on the Steering Committee of the Cook Medical IVC Filter Litigation and the Bard IVC Filter Litigation. He will be speaking about  the Cook and Bard IVC Filter Litigations, as well as other ongoing and emerging IVC Filter Litigations, which involve additional IVC manufacturers.  John has served in leadership positions on a number of MDLs and was Co-Lead Counsel in the Vioxx Product Liability Litigation.
The IVC Filter Litigation may be one of the largest mass product liability litigation’s of all time, with respect to the number of plaintiffs and payouts. This litigation puts the “complex” in complex litigation and the opportunity to interact with one of the leading attorneys in this case is invaluable.
Attorney Ryan Thompson
 
  Not yet forty years old, Ryan has already has an impressive record of achievements, that most lawyers would consider a stellar lifetime career. He served as Co-Lead Counsel on the Incretin Memetics Litigation, as well as in leadership positions on numerous MDLs. Ryan is often involved in emerging litigations in a major way. His grasp of the science involved in pharmaceutical and medical device litigation and his willingness to take risks, have resulted in his incredible rise in the world of Mass Tort litigation.
 
One of Ryan’s early victories involved taking on a major credit reporting agency and collecting 28 Million dollars, in a litigation other firms had overlooked. Ryan brings a unique perspective to Mass Torts. It is a privilege to hear Ryan speak and even more of a privilege to get to know him.
 
 Attorney Darin Schanker
Darin  has over a decade of experience in Mass Tort litigation. Darrin and his law partner, Kyle Bachus were the driving force behind the current Taxotere litigation.  Darin and Kyle were responsible for the voluminous research and work that led to the discovery of the devastating effects of Taxotere.
 
Although many attorneys have represented clients in mass tort litigation’s, few have “discovered” the cause of action and developed the first client case for a new litigation. The opportunity to hear Darrin speak should not be missed. 

Attorney Greg Rueb

Greg has tried over 75 Jury Trials with only one loss. He has established himself as an elite trial attorney and hard nosed negotiator. Greg currently serves in leadership positions on a number of ongoing Mass Tort litigations. Having taken and defended over 750 depositions, he has developed a unique perspective and an ability to unearth the facts defendants most want to keep hidden. He is a major force in Mass Tort litigation as well as an extremely informative speaker.
Contact Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com
for information and to book your seat for the March Course.

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Court in Roundup MDL Orders Briefs on Cancer Studies

roundup-cancerU.S. District Judge Vince Chhabria ordered the parties in Roundup Products Liability Litigation, MDL No. 2741 to submit briefs on alleged flaws and biases in federal and United Nations research linking the herbicide to cancer.

Since the MDL was created in October, it has attracted 46 lawsuits, Case No. Case 3:16-md-02741-VC.

In March 2015, leading cancer experts from the World Health Organization’s International Agency for Research on Cancer (IARC) declared that glyphosate is a “probable human carcinogen.” IARC reached its decision based on the research of 17 top cancer experts from 11 countries, who met to assess the carcinogenicity of 5 pesticides. The IARC review of glyphosate has led to the European Parliament calling for a complete ban on non-commercial public use of glyphosate and serious restrictions on agricultural use.

In contrast, on Sept. 12, 2016, the EPA’s Office of Pesticide Programs (“OPP”) issued a 227-page evaluation of glyphosate’s carcinogenic potential, concluding that “[t]he strongest support is for [the description] ‘not likely to be carcinogenic to humans’ at doses relevant to human health risk assessment.” See Glyphosate Issue Paper: Evaluation of Carcinogenic Potential.

EPA vs. IARC

In pretrial order No. 8, the judge wrote, “It appears the plaintiffs are preparing to argue that the EPA’s conclusions about the carcinogenicity of glyphosate are flawed and/or biased. It appears Monsanto is preparing to argue the same with respect to IARC. It’s not obvious how directly relevant these arguments are to the questions the Court must consider during the general-causation phase of this case.”

Briefs must be filed by February 8.

An Illinois plaintiff who contracted non-Hodgkin’s lymphoma (cancer of the lymph nodes) after using the herbicide Roundup, charges in a new lawsuit filed in federal court that Monsanto knew of the cancer risks since the 1980s, but covered it up.

John Cushman of Effingham County, IL, sprayed Roundup on a regular basis for decades. He filed suit in US District Count for the Southern District of Illinois, alleging that the maker, Monsanto Company of St. Louis, MO, pressured the EPA not to label the herbicide as carcinogenic, and aggressively marketed it as “safer than table salt.” Cushman v. Monsanto, Case No. 16 cv 1042.\

“Any firm would be wise to get younger lawyers involved because this will be a long, hard fight,” said John Ray, a mass tort expert speaking in a recent webinar. Click to see the Slides & Recording for NTL Webinar: Mass Torts Update for Plaintiff Attorneys.

“This chemical interferes with the metabolic process, as a method for killing plants. There is no reason to believe it wouldn’t have the same effect on people,” Ray said. “The question is how much exposure is necessary to cause problems. Non-Hodgkin’s lymphoma is the tip of the iceberg. This chemical could affect the future of our species. It will be decades before we know everything that it did.”

 

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New Study Suggests Genital Talc Use Increases Ovarian Cancer Risk by 20%

talcum powder cancerYet another study has found a possible link between the genital use of talcum powder and an increased risk of ovarian cancer. The research, which was published this month in the European Journal of Cancer Prevention, consisted of a meta-analysis of 24 previously published statistical analyses and several prospective studies involving more than 300,000 ovarian cancer patients.

Overall, women who used talc had about a 20% increased risk for ovarian cancer compared to those who did not. The report’s authors characterized the findings as “statistically significant.”

“The publication of this research comes as thousands of ovarian cancer victims and their families pursue talcum powder lawsuits against Johnson & Johnson. The findings only add to the growing body of evidence suggesting that the regular and repeated use of talc-based powders for feminine hygiene purposes may contribute to the development of the disease,” says attorney Sandy A. Liebhard of Bernstein Liebhard LLP in New York.

Nationwide Talcum Powder Litigation

Johnson & Johnson is a defendant in more than 2,000 talcum powder lawsuits pending in courts around the country. All were filed on behalf of women diagnosed with ovarian cancer following long-term use of Baby Powder or Shower-to-Shower for feminine hygiene purposes. Plaintiffs allege that since the 1970s, a growing number of studies have pointed to a link between genital talc use and an increased risk of ovarian cancer. They further assert that Johnson & Johnson has long been aware of this research, but placed profits before consumer safety by withholding information and warnings from the public.

One of the country’s largest talcum powder litigations is now underway in Missouri’s 22nd Circuit Court for St. Louis, where three trials were convened last year. All three juries delivered verdicts in favor of plaintiffs, ordering Johnson & Johnson to pay compensatory and punitive damage awards totaling $55 million, $72 million and $70 million. Jury selection for the litigation’s fourth trial is scheduled to begin on January 30th.

In addition to the cases pending in Missouri, nearly 100 talcum powder lawsuits filed against Johnson & Johnson have been centralized in a federal multidistrict litigation now underway in the U.S. District Court, District of New Jersey. (In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation – MDL No.2738)

An additional 224 cases are pending in a multicounty litigation established in New Jersey’s Atlantic County Superior Court. (In Re: Talc-Based Powder Products – Case No. 300).

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Court Names Plaintiff’s Steering Committee for Invokana MDL

invokana-warning kidney-damageUS District Judge Brian Martinotti appointed the plaintiff’s steering committee for MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in New Jersey in Case Management Order #2. A total of 100 lawsuits have been filed in the MDL since the courts created it in December.

The attorneys compose “an array of highly skilled counsel with diverse backgrounds and experience which will provide the Court with an effective committee to advance this litigation in an efficient and just manner,” the judge said. They include:

Christopher A. Seeger (Co-Lead Counsel)
Seeger Weiss LLP
77 Water Street, 26th Fl.
New York, New York 10005
Phone: (212) 584-0700
Fax: (212) 584-0799
Email: cseeger@seegerweiss.com

Michael A. London (Co-Lead Counsel)
Douglas & London, P.C.
59 Maiden Lane, 6th Fl.
New York, New York 10038
Phone: (212) 566-7500
Fax: (212) 566-7501
Email: mlondon@douglasandlondon.com

James E. Cecchi (Liaison Counsel)
Carella, Byrne, Cecchi, Olstein, Brody & Agnello
5 Becker Farm Road
Roseland, New Jersey 07068
Phone: (973)994-1700
Fax: (973)994-1744
Email: jcecchi@carellabyrne.com

Ellen Relkin (Executive Committee)
Weitz & Luxenberg, P.C.
700 Broadway
New York, New York 10003
Phone: (212) 558-5500
Fax: (212) 344-5461
Email: erelkin@weitzlux.com

Hunter J. Shkolnik (Executive Committee)
Napoli Shkolnik, PLLC
360 Lexington Avenue, 11th Fl.
New York, New York 10017
Phone: (212) 397-1000
Fax: (646) 843-7603
Email: hunter@napolilaw.com

Timothy O’Brien (Executive Committee)
Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.
316 South Baylen Street
Pensacola, Florida 32502
Phone: (850) 435-7084
Fax: (850) 436-6084
Email: tobrien@levinlaw.com

Ashley Brittain-Landers
Schlicter Bogard & Denton, LLP
100 South Fourth Street, Ste. 1200
St. Louis, Missouri 63102
Phone: (314) 621-6115
Fax: (314) 621-7151
Email: abrittain@uselaws.com

John Gomez
Gomez Law Firm
655 West Broadway, Ste. 1700
San Diego, California 92101
Phone: (619) 237-3490
Fax: (619) 237-3496
Email: john@thegomezfirm.com

Anthony D. Irpino
Irpino, Avin & Hawkins
2216 Magazine Street
New Orleans, Louisiana 70130
Phone: (504) 525-1500
Fax: (504) 525-1501
Email: airpino@irpinolaw.com

Holly H. Dolejsi
Robins Kaplan, LLP
800 LaSalle Avenue, Ste. 2800
Minneapolis, Minnesota 55402
Phone: (612) 349-8500
Fax: (612) 339-4181
Email: hdolejsi@robinskaplan.com

Danielle Ward Mason
Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.
218 Commerce Street
Montgomery, Alabama 36104
Phone: (800) 898-2034
Fax: (334) 954-7555
Email: danielle.mason@beasleyallen.com

Frank M. Petosa
Morgan & Morgan, P.A.
600 North Island Road, Ste. 400
Plantation, Florida 33324
Phone: (954) 318-0268
Fax: (954) 327-3018
Email: foetosa@forthepeople.com

Jason C. Webster
The Webster Law Firm
6200 Savoy Drive, Ste. 150
Houston, Texas 77036
Phone: (713) 396-5197
Fax: (713) 581-3907
Email: jwebster@thewebsterlawfirm.com

David S. Stellings
Lieff Cabraser Heimann & Bernstein, LLP
250 Hudson Street, 8th Floor
New York, New York 10013
Phone: (212) 355-9500
Fax: (212) 355-9592
Email: dstellings@lchb.com

The Court also appointed as Co-Lead Counsel, Christopher Seeger and Michael London, and as Liaison Counsel, James Cecchi. Together, and along with Ellen Relkin, Hunter Shkolnik, and Timothy O’Brien, they comprise the PSC Executive Committee. It is the Executive Committee’s duty to coordinate the responsibilities of the PSC, schedule PSC meetings, keep minutes or transcripts of these meetings, appear at periodic court noticed status conferences, perform other necessary administrative or logistic functions of the PSC.

The Invokana litigation involves allegations that Invokana causes diabetic ketoacidosis and kidney damage, and that defendant Janssen Pharmaceuticals, Inc., which developed and manufactured the drug, failed to adequately test the drug and warn of its risks.

The JPMDL declined to include other SLGT2 inhibitors in the litigation, such as Farxiga (dapagliflozin) and Jardiance (empagliflozin). Farxiga is marketed and distributed by AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, AstraZeneca PLC, and Bristol-Myers Squibb Co., and Jardiance is marketed and distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, and Lilly USA, LLC.

Invokana went on sale in 2013 to treat type 2 diabetes by inhibiting renal glucose reabsorption with the goal of lowering blood glucose. Canagliflozin is a member of the gliflozin class of pharmaceuticals, also known as sodium glucose cotransporter 2 (“SGLT2”) inhibitors.

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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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C-Qur Hernia Mesh Judge Pauses Discovery in New MDL

U.S. District Judge Landya B. McCafferty stayed all discovery proceedings in Pretrial Order No. 1, until an initial case management conference is held on February 24 in Atrium Medical Corp. C-Qur Mesh Products Liability Litigation.

At the conference, attorneys can express interest in the roles of lead counsel. The judge appointed Robert Bonsignore of Bonsignore Trial Lawyers PLLC of Las Vegas, NV, as temporary lead counsel.

Introductory briefs in the case, MDL Docket No. 16-md-2753-LM in the US District Court of New Hampshire, are due February 17 concerning the parties’ views on the appointment of a plaintiffs’ steering committee, the nature of the action and principal defenses, whether a consolidated complaint should be filed, and a list of all prior settlement discussions.

Inflammatory bowel response

Since the Judicial Panel on Multi-district Litigation created MDL 2753 on December 1, a total of 21 actions have been filed.

The litigation involves allegations that defects in defendants’ C-Qur mesh products incite an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications.

The company announced a worldwide market withdrawal of the product on May 25, 2016, after unpublished registry data indicated that Physiomesh was associated with higher recurrence and revision rates after laparoscopic ventral hernia repair compared to another set of mesh. A Physiomesh lawsuit pending in the U.S. District Court, Southern District of Illinois, will likely be the first case to go to trial, with jury selection scheduled to begin on January 22, 2018. (Case No. 3:16-cv-00368-JPG-PMF).

Atrium, which is headquartered in New Hampshire promotes the C-Qur line of surgical mesh products for permanent abdominal wall reinforcement in hernia surgeries, claiming that the C-Qur Mesh’s proprietary Omega-3 barrier coating reduces scar tissue formation between the mesh and the patient’s intestines (clinically known as “adhesions”) while promoting permanent fixation of the mesh to the abdominal wall.

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Litigation Started Against Sorin Stöckert 3T Heart Surgery Medical Device

Stockert 3T Heater-Cooler System manufactured by LivaNova PLC
Sorin Group Stöckert 3T Heater-Cooler System manufactured by LivaNova PLC

Following damning reports from the FDA and the Centers for Disease Control and Prevention, the first lawsuit against the Sorin Stöckert 3T Heater-Cooler medical device for open-heart surgery has been filed in US District Court in South Carolina.

Thomas Fowler of Greenville, SC, had a coronary artery bypass grafting procedure during which the Sorin Group Stöckert 3T Heater-Cooler System caused a bacterial infection, according to Thomas Fowler and Roseann Fowler vs. LivaNova PLC, Sorin Group Deutschland GMBH and Sorin Group USA Inc., Docket No. 6:16-cv-02307-BHH, US District Court, South Carolina, Greenville Division.

The defective medical devices, made by LivaNova in Munich, Germany, were contaminated with Mycobacterium chimaera. Two months after Fowler had the cardiac bypass procedure on April 2, 2014, doctors discovered the infection at the surgical wound site. He had to undergo many more surgeries and antibiotic therapy.

The lawsuit filed by attorneys Ashlee Edwards Winkler, Mackenzie Brooke Archenhold, and Robert W. Jones of Parham Smith & Archenhold in Greenville, SC, alleges negligence, breach of express warranty, breach of implied warranties, negligent misrepresentation, misrepresentation by omission, violation of South Carolina Unfair Trade Practices and loss of consortium.

Damning evidence

More than 250,000 heart bypass procedures using heater-cooler devices are performed in the US every year. Approximately 60 percent of heart bypass procedures performed in the U.S. use the Sorin Group Stöckert 3T heater-cooler devices.

The devices regulate a patient’s body temperature. Scientists believe that some of the systems have contaminated water that evaporates into the air, exits the machine through a vent, and enters the patient’s lungs or open chest cavity. The infection can take days, weeks, or months to develop and must be treated with a one-to-two year round of antibiotics.

Evidence is mounting against the device:

  • The CDC warned healthcare providers and patients on October 13, 2016 about the potential risk of infection from the Stöckert 3T.
  • The Greenville Health System Hospital on July 21, 2014 outlined safety measures for a “cardioplegia machine” connected to a rare non-tuberculosis mycobacterium infection that infected 14 patients during open heart surgeries. GHS indicated that there had been four deaths resulting from the same infection.
  • On July 15, 2015, the FDA issued a Class II Recall of the Sorin 3T System due to the “potential colonization of organisms, including Mycobacteria” in Sorin Heater Cooler Devices.
  • On December 29, 2015, the FDA issued a Warning Letter to the defendants, which indicated that its inspection of Sorin’s Germany and Colorado facilities revealed that the Sorin 3T System devices had been “adulterated.”

Not surprisingly, the device was approved in a short-cut 510(k) application by the FDA on June 6, 2006, which means it did not go through clinical trials because it was “equivalent” to a predicate device.

“Despite Defendants’ knowledge of the catastrophic injuries, conditions, and complications caused by the Sorin 3T System, in violation of Federal and State requirements, it continued to manufacture, market, provide inadequate instructions for use, and sell the Sorin 3T System, and also failed to adequately warn, label, instruct, and disseminate information with regard to Defendants’ Sorin 3T System both prior toand after the marketing and sale of the System,” the complaint states.

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Mirena IUD Plaintiffs Seek 2d MDL for Intracranial Hypertension Claims

mirena-side-effectsTen plaintiffs who have filed suit against Bayer over its Mirena hormone-coated birth control device have asked the Judicial Panel on Multi-District Litigation (JPMDL) to set up a new MDL focusing on injuries caused by increased intracranial pressure.

In November, the JPMDL reopened MDL 2434 in the Southern District of New York for product liability claims involving migration of the IUD in the uterus. It does not include any claims that the synthetic levonorgestrel hormone coating causes intracranial pressure or hypertension.

The new MDL No. 2767 would consolidate 166 “substantially similar” cases in 17 jurisdictions. The plaintiffs requested that US District Chief Judge Louis Guirola, Jr.,  of the Southern District of Mississippi, Southern Division, supervise the new MDL. The defendants include Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG and Bayer Oy.

IH in the skull

Medical literature identifies the condition by various names, such as Intracranial Hypertension (“IH”), Pseudotumor Cerebri (“IH”), Benign Intracranial Hypertension (“BIH”), Secondary Intracranial Hypertension (“SIH”), Medication-Induced Intracranial Hypertension (“MIH”), or Idiopathic Intracranial Hypertension (“IIH”).

IH is a condition that develops in the skull when a person’s cerebrospinal fluid level becomes elevated, causing increased intracranial pressure. Fluid builds up in the skull and is not released and absorbed at the proper rate.

Symptoms of IH include severe headache, nausea, ringing in the ears, blurred or dimmed vision, double vision, and neck, shoulder or back pain. This condition can also cause swelling of the optic nerves, leading to temporary or permanent blindness.

The FDA approved Mirena in 2000 and more than 15 million women worldwide have used Mirena. However, the association between IH and levonorgestrel has been known since 1991, when Wyeth began selling Norplant, a birth control system that released the same hormone. Norplant’s drug label warned about IH and added, “NORPLANT SYSTEM should be removed from patients experiencing this disorder.”

The plaintiff’s motion says, “In light of the pharmaceutical industry’s experience with the Norplant® System, as well as Bayer’s specific involvement as the manufacturer of the Norplant® System, Bayer knew or should have known of the association between levonorgestrel and IH at the time it put Mirena on the market.”

“However, the product label for the Mirena® LNG-IUS has never contained any warning relating to the risk of IH. To this day, Bayer does not warn patients or physicians of the association between the Mirena® LNG-IUS and IH, despite the fact that another of its levonorgestrel-releasing contraceptive implants, Jadelle®, contains such a warning.”

Plaintiff attorney Trevor B. Rockstad of Davis & Crump, P.C. in Gulfport, Mississippi, said he expects to file more than 100 lawsuits for individuals injured by Mirena and is aware of several hundred more unfiled cases.

 

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