After 100,000 Adverse Events, Litigation Against Surgical Staples Are Burgeoning

After being hidden in a secret database for decades, evidence of 100,000 adverse reports for surgical staples are driving a burgeoning number of lawsuits against the manufacturers.

Used to close wounds quickly, the staplers misfire, fail to fire, punch holes in the body without injecting a staple, and insert malformed staples. Staples are more popular with doctors than suturing or stitching incisions.

Injuries are severe, including:

  • Opening of the staple line
  • Infections
  • Organ damage
  • Sepsis
  • Fistula formation
  • Death

“Mishaps like these can be severe or even fatal, especially when a staple is injected into a patient where it should not have been. In many of these cases, a defective stapler or defective staples could have been the root cause of the problem,” says the Shouse Law Group of California.

Nearly 80 percent of surgical staplers and sutures used in American hospitals are manufactured by Johnson & Johnson with its subsidiary Ethicon, and by Medtronic with its subsidiary Covidien.

Other manufacturers include 3M; B. Braun; Cardica; Care Fusion; CONMED; Frankenman; Meril Life Science; Purple Surgical; Smith & Nephew; Stryker; U.S. Surgical; Welfare Medical; Reach Surgical; and Zimmer Biomet.

Secret FDA Database

Now is an opportune time for mass tort lawyers to open a practice involving surgical staple injuries. The litigation is in an early stage, and no multidistrict litigation docket (MDL) has been created by the federal courts.

The adverse news began to show up at the FDA in 2011, recalls began in 2013, and a California jury awarded $80 million in damages in 2015.

The FDA’s MAUDE database (Manufacturer and User Facility Device Experience) has found more than 41,000 adverse event reports filed between January 1, 2011, and March 31, 2018. According to this review, surgical staplers have malfunctioned approximately 32,000 times. There have been 9,000 serious patient injuries. More than 350 patients are known to have died as a result of surgeons employing surgical staplers.

These numbers represent only what the FDA has publicly admitted. On May 30, 2019, Kaiser Health News reported that an additional 56,000 reports had been submitted over the same time period. However, these reports were never disclosed, nor even made available to the public.

The FDA had created an exception for stapler makers to report adverse events in its Alternative Summary Reports database, where it was top secret and not even available to doctors. The program was in effect from 1997 through June 2019, when it was closed.

“It shocks the conscience,” said Chad Tuschman, a lawyer representing Mark Levering, 62, of Toledo, Ohio, who suffered a serious brain injury after a stapler malfunction caused massive bleeding in 2018. The surgeon, hospital and device maker Covidien, a division of Medtronic, have all denied allegations of wrongdoing in an ongoing lawsuit.

Years of recalls

According to the Belluck & Fox law firm, recalls began in 2013:

Manufacturer Year Number Recalled Products Included Reason for Recall
Ethicon 2019 92,496 Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples
Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
Two patients were injured after devices misfired, cutting portions of their rectums.
Medtronic 2019 3,113,280 Endo GIA Articulating Reloads with TriStaple Technology Missing components could affect staple alignment.
Medtronic 2018 171,271 Endo GIA “Auto Suture” Universal Articulating Loading Unit Five people were injured related to missing components that could affect staple alignment.
Ethicon 2015 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads Inspections found certain staplers may not insert a full line of staples when fired.
Ethicon 2013 57,540 ECHELON 60mm Endoscopic Linear Cutter Reloads Black Manufacturer identified a potential for reload damage that would prevent a complete line of staples firing.

These recalls covered manufacturing defects, missing components, and failed staples that all had the ability to cause pain, bleeding, leaks, infection, and sepsis throughout the body. They could also cause the need for permanent ostomy bags, antibiotics, additional imaging studies, and even surgery, as well as life-long nutritional deficiencies and life-long digestive issues.

The FDA finally warned doctors about reported problems in a letter issued in March 2019.

Burgeoning litigation

The FDA’s lack of action and transparency has not held plaintiffs back.

A retired San Jose officer was awarded $80 million over a defective stapler in December 2015. A botched hemorrhoid surgery in 2011 nearly killed Florence Kuhlmann. Experiencing severe pain afterwards, she discovered her bowel had been stapled shut against her rectal wall, closing off her intestine.

“She was diagnosed with an occlusion,” Kuhlmann’s attorney, Nina Shapirshteyn, said. “Her bowel ruptured, causing a major infection and sepsis. She was really close to death.”

It was later determined that the stapler used in the procedure was defective, and the company that manufactured it, Johnson and Johnson subsidiary Ethicon Endo-Surgery, recalled certain models of the device — including the one used on Kuhlmann — later that year.

A $5 million settlement was reached on Sep 29, 2017, against surgical device-maker Covidien, Southern Illinois University School of Medicine and an SIU surgeon. The plaintiff was April Ryan, a 33-year-old Charleston woman who bled to death during an elective surgery in 2013.

Surgeon Dr. Sabha Ganai used a Covidien surgical stapler during the procedure that cut a blood vessel but failed to properly seal the vessel shut. This led to massive blood loss, cardiac arrest related to the blood loss, and death the same day.

Separately, three plaintiffs who say they were seriously injured by Medtronic surgical staplers are sued the company in 2019 for knowingly selling defective devices and intentionally hiding risks from doctors and patients.
The three patients had gastrointestinal surgeries in 2017 that required staples to be precisely placed in organs after surgery. The Medtronic staplers allegedly malfunctioned, for example, by creating holes without leaving behind staples or not properly closing implanted staples.

Adverse effects included severe infections, cardiac problems, corrective surgeries, and hundreds of thousands of dollars in additional medical expenses.

  • Harris County, Texas resident Cynthia Nicholson in her Dec. 20 complaint filed against Medtronic in Hennepin County District Court. Her complaint states, “A reasonable and prudent manufacturer is or should be aware of the risk that if its product is defective, the [surgical] repair it is intended to secure could break loose, causing the contents of an organ undergoing repair to be released into the surrounding area of the body.”
  • Robert Snyder of Gilman, Iowa, sued Medtronic in Hennepin County District Court on Dec. 24 after experiencing years of negative effects following treatment for stomach pain. Snyder contracted infections and required several surgical treatments after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his small bowel, leading to a serious complication called an anastomotic leak, the lawsuit says.
  • Meanwhile, Janet and Randy Adams of Collin County, Texas, filed suit in federal court in the Eastern District of Texas on Dec. 23 alleging that the Medtronic EEA surgical stapler used in a procedure to repair Janet Adams’ surgically created stoma misfired and punctured her intestines without engaging the staples.

“Had these incidents been accurately reported, it is highly likely that public notice, FDA scrutiny, and product recalls would have preceded [Janet Adams’] surgery,” her lawsuit says, “and … the devices would have been appropriately recalled before being used on [Adams] by her unsuspecting surgeons.”

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Drug Manufacturer Mallinckrodt to Pay $1.6 Billion to Settle Opioid Claims

 With executives bailing out and its stock price crashing, opioid maker Mallinckrodt has agreed to pay $1.6 billion in a “settlement framework” as it put the company’s generics unit into Chapter 11 bankruptcy.

The plaintiff’s executive committee negotiated the settlement in MDL 2804 before U.S. District Judge Dan A. Polster in Cleveland, where 2,725 lawsuits are pending in IN RE: National Prescription Opiate Litigation.

Every day, 128 people in the US die after overdosing on opioids. The misuse of prescription pain relievers, heroin, and synthetic opioids like fentanyl—is a national crisis. The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

A total of 47 state and territory attorneys general approved the framework for the agreement.

“Nothing can undo the devastating loss and grief inflicted by the opioid epidemic upon victims and their families, but this settlement with Mallinckrodt is an important step in the process of healing our communities,” California Attorney General Xavier Becerra said in a statement. “While today’s settlement is a step in the right direction, we’ll continue to work to bring more much-needed relief to families throughout California whose lives have been upended by the opioid crisis.”

Under the terms of its proposed agreement, Mallinckrodt would pay the $1.6 billion over eight years:

  • $300 million after the specialty generics business wraps its restructuring.
  • $200 million in anniversary payments for years one and two.
  • $150 million in anniversary payments for years two through eight.
  • The post-restructuring trust would also receive warrant options to purchase up to 19.99% of the company’s stock at $3.15 per share, Mallinckrodt said.

Mallinckrodt plc, which is based in Ireland and has U.S. offices in St. Louis, said the agreement involves subsidiaries Mallinckrodt LLC, SpecGx LLC, and other affiliates. Neither Mallinckrodt plc nor its “specialty brands” subsidiaries would be part of the bankruptcy.

Facing financial doom

Two Ohio counties, Cuyahoga and Summit, reached a $260 million settlement with Mallinckrodt and three other opioid distributors in October, averting an imminent trial. The counties also reached a $20.4 million settlement with Johnson & Johnson.

Facing financial doom, Mallinckrodt changed its severance policy in September to allow for departing executives to receive lump-sum payouts rather than installments.

In June, the Department of Justice filed criminal kickback charges on Mallinckrodt, which acquired Acthar-maker Questcor Pharma in 2014 for $5.6 billion, accusing the company of funneling money through front funds to illegally subsidize Medicare copays and jack up the drug’s list price by 85,000%.

The charges filed in Pittsburgh federal court took place on the same day the drugmaker agreed in principle to a $15.4 million settlement on separate charges tied to two whistleblower kickback suits the DOJ joined in early May.

Mallinckrodt’s announcement came just after more than 20 attorneys general rejected an $18 billion settlement deal proposed by three of the nation’s biggest opioid distributors. Negotiations are ongoing, as are in talks to settle the claims in the Cleveland case.

“In negotiations, our goal — and the goal of the communities we represent — is to create resource streams into localities that long have, and still are, battling the crisis,” the three co-lead plaintiff lawyers in the Cleveland litigation said in a statement. “Our pursuit of corporate accountability against a host of other defendants across the entire drug supply chain will not stop.”

Next month, numerous drug companies are scheduled to go to trial in New York, and later this year, additional cases are scheduled in West Virginia and Cleveland.

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Corporations Gang Up to Make It Harder to Admit Plaintiff Experts

A rogue’s gallery of pharma giants, insurance companies, and carmakers has called on a federal court committee to restrict Federal Rule of Evidence 702 to make it harder for plaintiffs to get their experts admitted.

The blatant move to rig the admission of experts in favor of corporations came from notorious mass tort defendants like Bayer, GlaxoSmithKline, Johnson & Johnson, Medtronic, Merck, Novartis, Pfizer, Teva, and Walgreen.

The brazen attack on Rule 702, or the Daubert rule, was sent on March 2 to the Committee on Rules of Practice and Procedure, Administrative Office of the United States Courts.

“Too often, courts do not fully execute or enforce the “gatekeeping” obligation. Instead, we see courts allowing juries a role in deciding whether an expert’s opinions have the requisite scientific support without first ensuring that the testimony is the product of reliable principles and methods and is reliably applied,” the gang of corporate marauders wrote.

Furthermore, the group wanted the Committee to get rid of the “presumption of admissibility” for experts. The Committee had issued a rule amendment in 2000 stating that “the rejection of expert testimony is the exception rather than the rule.”

The exclusion of an expert witness can cause the dismissal of a mass tort case. For example, Pfizer knocked out more than 300 birth defect lawsuits over the medication Zoloft simply by having expert witnesses disqualified.

Plaintiffs reject changing Rule 702

The corporations, who banded under the misleading name, “Lawyers for Civil Justice,” are making bids to gain a structural advantage for its members.

AAJ Senior Director of Policy and Senior Counsel Sue Steinman said, “Taken together, they are all designed to make it harder and more time consuming for people who are injured to get justice in courts. And in some cases, it would also add more time and burden to the judges who work on these cases,”

Rule 702 grew out of the 1993 Supreme Court ruling Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), which overturned the Frye standard for admitting experts, saying “that the rule incorporated a flexible reliability standard instead.”

Rule 702 of the Federal Rules of Evidence provides in part: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise…

Bayer, which makes the cancer-causing Roundup weed killer, and Johnson & Johnson, which makes cancer-causing baby powder and talc products, constantly argue that plaintiff experts are offering “junk science.”

The giant corporations have failed to persuaded juries, so they are running an end-around with the Court Committee.

Bayer faces 3,000 federal lawsuits over Roundup in MDL 2741, overseen by U.S. District Judge Vince Chhabria in California, IN RE: Roundup Products Liability Litigation. It faces another 10,000 cases in state courts. Recently a state court jury in Oakland in May found that the plaintiff’s use of glyphosate-based herbicide for over 30 years caused them to contract non-Hodgkin’s lymphoma. The judge cut a $2 billion verdict to $86.7 million.

Johnson & Johnson faces 15,299 cases nationwide in federal court, but all of the action so far has been in state courts. The federal cases are consolidated before Chief US District Judge Freda L. Wolfson in MDL 2738 in New Jersey, IN RE: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation.

Many state juries have awarded 7- and 8-figure verdicts against J&J after it was proven that the company knew for decades about the risk of cancer-causing asbestos contamination in its talc products. For example, a jury awarded $4.7 billion against J&J in December 2018 to 22 women with ovarian cancer.

Many of the corporations seeking to restrict Rule 702 are insurance companies, along with:

  • AT&T
  • Benjamin Moore
  • Comcast
  • Dow Inc.
  • Electrolux
  • Ford Motor
  • Google
  • Hyundai
  • Microsoft
  • Smith + Nephew
  • Toyota
  • Whirlpool

The next meeting of the Committee is May 8.

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Yet Another Zantac Recall as Litigation Mounts

American Health Packaging announced yet another recall of 150 milligram Zantac pills because the heartburn drug has high amounts of the cancer-causing impurity NDMA.

Several recalls were made earlier by Appco Pharma LLC, Aurobindo Pharma USA, Sanofi, GlaxoSmithKline, Glenmark Pharmaceutical Inc., Novartis, Dr. Reddy’s Laboratories, Perrigo, Novitium Pharma, and Lannett Company.

Walmart, Walgreens, CVS, and Rite Aid also pulled prescription and over-the-counter varieties of the drug from their shelves.

Zantac (Ranitidine) provides heartburn relief for acid in the stomach and has been sold in the US for more than 30 years. The recalled batches of the drug contained high levels of N-Nitrosodimethylamine (NDMA).

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. According to the Environmental Protection Agency, animals exposed to the chemical have developed tumors in the liver, blood vessels, kidneys, and respiratory tract.

Plaintiffs have filed 140 federal lawsuits against Zantac drug makers, as of February 19, 2020. They are consolidated in MDL 2924 before US District Judge Robin L. Rosenberg in West Palm Beach, Florida, IN RE: Zantac (Ranitidine) Products Liability Litigation.

The defendants include:

  • Boehringer Ingelheim Pharmaceuticals, Inc.
  • GlaxoSmithKline LLC
  • Pfizer Inc.
  • Sanofi-Aventis U.S. LLC
  • Sanofi US Services Inc.
  • Chattem, Inc.

Many lawsuits to come

The Plaintiffs have cancer of the bladder, kidney, colon, and stomach, and charge that the manufacturers, sellers, and distributors of Zantac knew that it contained NDMA and that the defendants concealed the NDMA-associated dangers posed to consumers.

Plaintiffs argue that NDMA is inherent to the drug’s molecular structure. Also, in a January 2, 2020 letter to the FDA, the Emery Pharma lab said that prolonged heat exposure can increase NDMA to unsafe levels in ranitidine. “This was concerning since significantly elevated temperatures can occur within closed vehicles during transportation and during storage of the drug,” the company.

Plaintiff attorney Robert Hilliard of Hilliard Martinez Gonzales said that his firm has already been hired by 15,000 consumers.

“Zantac will ultimately be one of the biggest consumer frauds ever perpetrated by Big Pharma,” Hilliard said. He believes consumer claims are backed by strong scientific evidence.

Concerns over Zantac began in 2019 when Valisure, an online pharmacy, discovered NDMA in batches of ranitidine during routine independent testing.

Valisure reported in a Sept. 9, 2019, FDA citizens petition letter that it detected extremely high levels of the chemical in every lot it tested across multiple manufacturers. The company said one tablet of Zantac may contain amounts of NDMA several thousand times higher than acceptable FDA limits.

The FDA announced on Sept. 13, 2019, that trace amounts of NDMA were found in Zantac.


Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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Defendants’ Distortion of the Fosamax Ruling Fails to Impress the Court

The Supreme Court handed down its ruling in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (2019 on May 20, 2019.

The day after the Supreme Court Ruled Mass Tort Nexus published our take on the ruling in an article entitled: Fosamax Ruling: “A Small Win for Defense, A Big Win for Plaintiffs

It has been apparent that the defense bars takeaway from the Fosamax ruling differed from that of MTN in that almost every defendant in every current pharmaceutical MDL, has threatened to raise a defense sounding in the Supreme Courts ruling in Fosamax, despite the fact that they can not allege that they actually sought approval from the FDA to make a specific change to their warning label, and were the requested permission from the FDA. It appears that the defense bar has interpreted the Fosamax ruling as green lighting future implied impossibility or possibility of impossibility defenses, versus foreclosing on these defenses. It was MTN’s take on the ruling that the Court foreclosed on any theory sounding in implied impossibility or possibility of impossibility defense versus green lighting these defenses for application in other cases.

We are happy to report that at least one Circuit Court, faced with a motion sounding in the defense bars take on the Fosamax ruling, interpreted the SCOTUS jurisprudence in the same manner MTN interpreted the ruling the day after the Supreme Court ruled.

Crockett v. LUITPOLD PHARMACEUTICALS, INC., Dist. Court, ED Pennsylvania 2020
Hypertext the link below to the above
https://scholar.google.com/scholar_case?case=972595979562724211&q=avandia+adequacy+of+warning&hl=en&scisbd=2&as_sdt=40006

In deciding whether impossibility preemption requires the dismissal of a claim, the judge must evaluate the evidence presented and “simply ask … whether the relevant federal and state laws `irreconcilably conflict.'” Merck, 139 S. Ct. at 1679 (quoting Rice v. Norman Williams Co., 458 U.S. 654, 659 (1982)). To put the Court in a position to conduct this evaluation, Defendants must identify the state law at issue (e.g. the requirement that drug manufacturers warn about particular risks of a drug) and the federal law with which it conflicts irreconcilably. To “show[] that federal law prohibited [a] drug manufacturer from adding a warning that would satisfy state law,” the drug manufacturer must demonstrate that (1) “the drug manufacturer fully informed the FDA of the justifications for the warning required by state law” by “submitt[ing] all material information to the FDA[,]” and (2) the FDA “informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Id. at 1678. Such demonstration must be made with “clear evidence,” i.e., “evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Id. at 1672.

In making a preemption argument, it is not sufficient for the proponent to contend that if it had submitted a new label—with additional warnings—to the FDA, the FDA would have rejected the warning. See PLIVA, 564 U.S. at 624 n.8 (noting that the “possibility of impossibility” is not enough for preemption). In other words, the conflict must be real—”[t]he existence of a hypothetical or potential conflict is insufficient to warrant the pre-emption of the state statute.” See Merck, 139 S. Ct. at 1679 (quoting Rice, 458 U.S. at 659).


Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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37 State AGs Object to Fee Structure in Opioid MDL

A group of 37 state attorneys general filed a motion objecting to a fee payment plan for private lawyers working in the national opioid litigation. U.S. District Judge Dan A. Polster is overseeing 2,725 lawsuits in MDL 2804, IN RE: National Prescription Opiate Litigation.

The payment plan submitted on January 28 by the Plaintiff’s Executive Committee proposes a “common benefit fund” to award attorney fees and litigation costs, with funding from the cities private lawyers represent, but also the sates – over which the court lacks jurisdiction.

The AGs said that the Plaintiff’s Committee plan to establish a common benefit fund “goes well beyond what is necessary to ensure fair compensation for private counsel. The proposed order violates state sovereignty, including by purporting to apply to some aspects of State Attorney General settlements and to other state court actions over which this Court lacks jurisdiction.
Their objection came in a letter and motion on February 24 to Judge Polster, whose court is in Cleveland.

The proposed plan “would require local governments to pay more in attorneys’ fees rather than simply reallocate fees among attorneys with cases in the MDL, as common benefit fees are typically intended to do.”

“Moreover, if entered, the proposed order will disrupt – perhaps irreparably so – the substantial progress that has been made to negotiate a large national settlement with several defendants.”
The settlement negotiations are produced no results. More than 20 state attorneys general on February 14 rejected an $18 billion settlement offer from three major drug wholesalers meant to end litigation against their role in the opioid crisis.

The states are seeking between $22 billion and $32 billion.
The distributors — McKesson Corp., AmerisourceBergen Corp., and Cardinal Health Inc. — had reportedly been discussing the settlement since October, and had offered to pay $18 billion over 18 years.

Head of negotiation class dies

In related news, the architect of the Opioid MDL “negotiation class” died on February 24. Francis McGovern, age 75, died from a fall at his home.

Under the negotiation class concept, attorneys for the class would try to reach nationwide settlements with individual drug companies. Any settlement would be put to a vote and require approval by 75% of voting governments by number, by population and by the allocation of settlement funds.

No replacement for McGovern has been named.

Seeking a fair common benefit fund

Nearly every state and more than 2,727 cities, tribes and municipalities have filed suits against opioid manufacturers, distributors, and pharmacies over their roles in the opioid epidemic.
The distributors – McKesson, AmerisourceBergen, and Cardinal Health — have so far paid hundreds of millions of dollars in settlements and fines for failing to monitor suspicious orders of opioids. In October, they reached a $215 million settlement in Ohio just an hour before a landmark trial was set to begin.

Every day, 128 people in the US die after overdosing on opioids. The misuse of prescription pain relievers, heroin, and synthetic opioids like fentanyl—is a national. The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

The letter from the 37 AGs said the attorneys general were ready to find a “reasonable and equitable way” for everyone who devoted time and resources to the litigation to be “fairly compensated.”

But it must be “done in a way that is fair to all parties, does not risk disrupting a nationwide settlement, and does not divert vital resources from going to address the opioid crisis effectively,” the attorneys general added.

Paul T. Farrell Jr., Paul J. Hanly Jr. and Joe Rice — the co-leads of the plaintiffs’ executive committee — said in a joint statement that the concerns of the attorneys general stemmed from a “lack of understanding on how common benefit fees are paid.”

The letter was signed by the attorneys general of North Carolina, Alaska, Arkansas, Colorado, Idaho, Indiana, Kansas, Maine, Michigan, Mississippi, Nevada, New Jersey, New York, Oklahoma, Pennsylvania, Vermont, Wisconsin, Texas, Arizona, California, Hawaii, Illinois, Iowa, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Mexico, North Dakota, Oregon, Tennessee, Virginia, the District of Columbia, Guam and the Northern Mariana Islands.

The second bellwether case in the MDL is set for October 2002. Cuyahoga and Summit counties from Ohio are next in line for their day in court.

The trial is tentatively set for October 7, 2020, to begin jury selection with opening statements beginning October 13, 2020.

Meanwhile, Ex-Insys CEO Michael Babich was sentenced to 30 months in prison in the Insys opioid fraud case.

Babich was accused of arranging bribes for doctors to prescribe more prescription opioid drugs.

Many of the opioid drugmaker defendants involved in the opioid multi-district litigation have sued doctors across Ohio claiming that physicians are the true culprits in the nation’s opioid crisis.

Major chains such as CVS, Walgreen CO., Walmart, Rite Aid, and others claim that opioid prescribers, aka physicians, bear the burden of responsibility for the opioid epidemic although the physicians are not set to defend themselves in trial this coming October against Summit and Cuyahoga counties.


Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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13,000 Kidney Patients Await Trial Over Deadly Proton Pump Inhibitors

The invidious aspect of heartburn medicines called “proton pump inhibitors” (PPIs) is that there are no specific symptoms of the kidney damage that they cause.

Victims take the medicine for years and suffer general symptoms such as decreased urine output, tiredness, difficulty concentrating, problems sleeping, loss of appetite and dry, itchy skin. Only when they visit their doctor do they discover – to their shock — that they have deadly kidney disease.

The patients unwittingly took PPIs for acid reflux, GERD, dyspepsia, and peptic or stomach ulcers. Little did they know that the “little purple pill” and other PPIs were giving them chronic kidney disease, acute kidney failure, acute interstitial nephritis, and end-stage renal disease.

Now they faced agonizing dialysis, a kidney transplant or death.

“You can treat and hopefully cure infections. Fractures can heal, though they can be catastrophic events for older people, but chronic kidney disease doesn’t go away,” Dr. Adam Schoenfeld, an internal medicine resident at the University of California, San Francisco, told The New York Times in 2016.

The patients charge in 13,338 federal lawsuits that multiple drug makers knew that PPIs caused kidney damage but they failed to warn doctors and patients. The cases are consolidated in MDL 2789 before US District Judge Claire C. Cecchi in Newark, New Jersey, IN RE: Proton-Pump Inhibitor Products Liability Litigation (No. II).

More than 15 million Americans are taking PPIs, including the biggest PPI brand names in the U.S. market:

  • Nexium (esomeprazole)
  • Prilosec (omeprazole)
  • Prevacid (lansoprazole)
  • Protonix (pantoprazole)
  • Dexilant (dexlansoprazole)
  • Zegerid (omeprazole and sodium bicarbonate)
  • AcipHex (rabeprazole)
  • Vimovo (esomeprazole and naproxen)

Reducing stomach acid

Stomach acid is essential for proper digestion, but it’s also highly corrosive. It’s as powerful as battery acid and potent enough to dissolve metal or to eat a hole through wood.

When your body produces too much gastric acid, it can eat through the protective stomach lining. This leads to a painful ulcer. If the valve that keeps the stomach acid from rising up from the stomach and into your esophagus doesn’t work, that acid can damage your esophagus.

Stomach acid is produced by glands — proton pumps — in the stomach’s lining. PPIs inhibit the amount of acid they produce.

The root of the litigation started in 1989 when the FDA approved Prilosec (Omeprazole) as a heartburn drug, sold in prescription-strength capsules and over the counter forms. Quickly, many PPI’s were approved for the market, and total sales skyrocketed to $14 billion by 2016.

However, researchers began documenting problems with PPIs shortly after the first drug hit the market. Patients had no idea there was a connection between their heartburn medication and kidney failure.

In 1992, just three years after Prilosec got FDA approval, an article appeared in The American Journal of Medicine detailing the first case of acute interstitial nephritis caused by a PPI.

Some Prilosec lawsuits allege that AstraZeneca knew of the risk of kidney damage since 2004 before warning the public.

  • In 2004, researchers writing in the journal Nephrology, Dialysis, and Transplantation concluded Prilosec and Prevacid are the “drugs most commonly associated with interstitial nephritis.”
  • In 2007, other researchers writing in Clinical Nephrology identified an “ever-increasing number of cases of acute interstitial nephritis associated with PPI therapy” and that “all PPIs have been documented to cause AIN [acute interstitial nephritis].”

Despite numerous studies finding a connection between drugs and acute interstitial nephritis, the FDA did not require manufacturers to add acute interstitial nephritis warnings to labels until December 2014.

In 2015, a study in CMAJ Open found that those who started PPI therapy had an increased risk of acute kidney injury and acute interstitial nephritis.

A 2016 study in the Journal of American Nephrology found long-term users were 28 percent more likely to suffer from chronic kidney disease. They were also 95 percent more likely to experience kidney failure. This is also called end-stage renal disease.

A different 2016 study in the journal JAMA Internal Medicine associated long-term use with a 20 to 50 percent higher chance for developing chronic kidney disease.

Litigation begins

The first PPI lawsuit was filed against AstraZeneca’s Nexium in May 2016 in federal court in Tennessee. According to the complaint, Charles Bowers took Nexium from 2003 to 2008, when he was diagnosed with acute interstitial nephritis. As a result of his condition, Mr. Bowers was forced to undergo dialysis three times a week and is awaiting a kidney transplant.

In February 2017, the Judicial Panel of Multidistrict Litigation denied a motion to combine 39 PPI cases into centralized proceedings, because it said the cases were too different. By the summer of 2017, there were more than 160 lawsuits filed against five PPI manufacturers.

Due to the huge number of similar cases, MDL 2789 was finally approved on August 2, 2017 to streamline proceedings for more than 60 early lawsuits. A “science day” was held in May 2018, where the parties made presentations about their cases.

The first bellwether trial is scheduled for November 15, 2020.

People who took these drugs and got kidney disease have filed lawsuits against a who’s who of 26 corporate defendants:

  1. Abbott Laboratories
  2. AstraZeneca Pharmaceuticals LP
  3. AstraZeneca LP
  4. GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  5. GlaxoSmithKline Consumer Healthcare LP
  6. GlaxoSmithKline Consumer Healthcare Holdings (US) IP LLC
  7. Merck & Co. Inc. d/b/a Merck, Sharp & Dohme Corporation
  8. Novartis Corporation
  9. Novartis Pharmaceutical Corporation
  10. Novartis Vaccines and Diagnostics, Inc.
  11. Novartis Institutes for Biomedical Research, Inc.
  12. Novartis Consumer Health, Inc.
  13. Pfizer, Inc.
  14. The Procter & Gamble Company
  15. Procter & Gamble Manufacturing Company
  16. Takeda Pharmaceuticals USA, Inc.
  17. Takeda Pharmaceuticals America, Inc.
  18. Takeda Pharmaceuticals LLC
  19. Takeda Pharmaceuticals International, Inc.
  20. Takeda California, Inc.
  21. Takeda Development Center Americas, Inc. f/k/a Takeda Global Research & Development Center, Inc.
  22. Takeda Pharmaceutical Company Limited
  23. TAP Pharmaceutical Products, Inc. f/k/a TAP Holdings Inc.
  24. Wyeth Pharmaceuticals, Inc.
  25. Wyeth-Ayerst Laboratories
  26. Wyeth LLC

Penelope Costamagna of California suffered kidney failure and required a kidney transplant after taking Prilosec for “multiple years.” She sued Procter & Gamble and AstraZeneca in February 2017.

Costamagna stopped taking the medication in November 2016, when doctors discovered she had a kidney injury. Her complaint said she was unaware of any risk to her kidney health until doctors diagnosed her injury.

“It is statistically likely that Plaintiff Penelope Costamagna will require another kidney transplant in her lifetime, or will die as a result of not having such a transplant available,” her complaint said.

The court-approved plaintiff’s short-form complaint allows the following claims:

  • Strict Product Liability
  • Strict Product Liability – Design Defect
  • Strict Product Liability – Failure to Warn
  • Negligence
  • Negligence Per Se
  • Breach of Express Warranty
  • Breach of Implied Warranty
  • Negligent Misrepresentation
  • Fraud and Fraudulent Misrepresentation
  • Fraudulent Concealment
  • Violation of State Consumer Protection Laws
  • Loss of Consortium
  • Wrongful Death
  • Survival Action

AstraZeneca is the worst defendant

By far the worst corporate actor is AstraZeneca, headquartered in Gaithersburg, MD. In 2015 the company paid millions in fines and settlements over illegal kickbacks, a “pay for delay” scheme, shortchanging Medicaid and ripping off consumers.

In 2015, AstraZeneca agreed to pay the U.S. government $7.9 million to resolve kickback allegations involving Nexium. The government charged AstraZeneca worked with another company to boost sales.

AstraZeneca had paid pharmacy-benefit manager Medco Health Solutions to maintain Nexium’s “sole and exclusive” status on certain Medco lists. AstraZeneca provided the payment to Medco through price concessions on drugs including Prilosec, Toprol XL, and Plendil.

“Hidden financial agreements between drug manufacturers and pharmacy benefit managers can improperly influence which drugs are available to patients and the price paid for drugs,” Joyce R. Branda, the Acting Assistant Attorney General, said at the time.

In 2015, AstraZeneca was accused in a class action of participating in a pay-for-delay scheme, which is when a pharmaceutical company pays another drug manufacturer to hold off on selling a generic version of a particular drug.

The Nexium class-action lawsuit claimed the company paid off Teva Pharmaceuticals to delay its release of a generic version of Nexium. Teva paid a $24 million settlement to the U.S. government, freeing itself from the case.

Also, in 2015, AstraZeneca agreed to pay the U.S. government and several states $26.7 million to settle claims that its underpaid rebates owed under the Medicaid Drug Rebate Program.
In February 2015, AstraZeneca agreed to pay $20 million to consumers in a Prilosec and Nexium class-action lawsuit that had lasted for 10 years.

The class action claimed the company spent $260 million on an advertising campaign to mislead consumers into buying more expensive medicine. It accused AstraZeneca of attempting to keep market share as a patent expired.

According to the lawsuit, AstraZeneca’s patent on Prilosec was about to expire, so the company pushed Nexium to replace it. The two drugs were almost chemically identical, but Nexium was far more expensive than Prilosec.

In separate heartburn litigation involving Zantac, US District Judge Robin L. Rosenberg in West Palm Beach, FL, is presiding over the new MDL No. 2924. Some 126 lawsuits over a cancer-causing impurity in the heartburn medication Zantac before the federal court. Plaintiffs in all the actions allege that Zantac—and its active ingredient ranitidine—breaks down to form a carcinogen known as N-Nitrosodimethylamine (NDMA).

The Plaintiffs have cancer of the bladder, kidney, colon, and stomach, and they charge that the manufacturers, sellers, and distributors of Zantac and other Ranitidine medications knew or should have known that these medications exposed consumers to NDMA, and that defendants concealed the NDMA-associated dangers posed to consumers.

The defendants include Boehringer Ingelheim Pharmaceuticals, Inc.; GlaxoSmithKline LLC; Pfizer Inc.; Sanofi-Aventis U.S. LLC; Sanofi US Services Inc.; and Chattem, Inc.


Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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Unexpectedly, J&J Settles Talc-Mesothelioma Case at Start of Trial

In a highly unusual move, Johnson & Johnson abruptly settled the case of a woman with malignant mesothelioma who charged in her state court lawsuit that she got cancer from using the company’s talcum powder.

New York Supreme Court Justice Barbara Jaffe in Manhattan had just finished instructing the jury before opening statements were to begin. Shortly afterwards, attorneys for J&J and plaintiff Laura Shanahan, age 62, met with the judge in chambers. Moments later they emerged and the judge told the jury the case was over.

The amount of the settlement is secret.

It was the latest trial against Johnson & Johnson over claims its Baby Powder and Shower to Shower talcum powders were contaminated with cancer-causing asbestos.

The company faces 15,299 cases nationwide in separate federal litigation in MDL 2738 before Chief United States District Judge Freda Wolfson in New Jersey, IN RE: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation.

So far, all the action has been in state courts. Jerome Block and Amber Long of Levy Konigsberg represent plaintiff Shanahan.

J&J’s lawyers were John Ewald of King & Spalding, Thomas Kurland of Patterson Belknap, and Shasha Zou and Matthew Bush of Orrick Herrington & Sutcliffe.

Johnson & Johnson has known about cancer-causing asbestos in its talc products since 1957. But in a deny-and-attack litigation strategy, the company has lied about it to consumers and the government, has faked research, has covered up its own findings about asbestos in talc, has bullied independent researchers and has stonewalled litigants.

The U.S. Justice Department started a criminal investigation in July 2019 into whether Johnson & Johnson lied to the public about the possible cancer risks of its talcum powder. A grand jury in Washington, DC, is examining documents related to what company officials knew about any carcinogens in their products.

The FDA announced on October 18, 2019, that over 33,000 bottles of Johnson’s Baby Powder were voluntarily recalled after testing positive for asbestos. Johnson & Johnson voluntarily recalled one lot of baby powder, after a sample tested positive for asbestos.

Juries in state courts have held J&J liable for failing to warn consumers that its talc products cause fatal ovarian cancer and mesothelioma.

Through it all, J&J implausibly contends that its baby powder and talcum powder is “safe” – a claim that has been proven wrong.

For a summary of J&J’s win-loss record in court, visit https://www.masstortnexus.com/News/5416/Attacking-and-Lying-Johnson-And-Johnson-is-Battered-by-Talcum-Powder–Cancer-Litigation

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Taxotere Victim: ‘I’d rather have lost my breasts than my hair’

The damage caused by the breast cancer drug Taxotere is personal and traumatic. Breast cancer patient Shirley Ledlie, 56, wasn’t told the drug causes total, permanent hair loss. When the drug destroyed her appearance, she wished she had lost her breasts rather than her hair.

“I couldn’t believe it. I felt like a complete freak,” she said. “I just couldn’t accept I would spend the rest of my life without my hair. It was the one part of me everyone complimented me on.”

She’s not the only one. Taxotere patient Christine wrote on the online support group A Head of Our Time, about “the horror of the loss of our hair.”

“I will never forget leaving the dermatologist’s rooms after being told that my lack of hair growth was due to my particular cocktail of chemo drugs, the likely culprit being Taxotere. I was utterly devastated as I felt I had lost my femininity and aged another 20 years, all at once. It was so much worse than losing a breast to cancer,” she wrote.

Four years into the mass tort litigation against Taxotere maker Sanofi, thousands of plaintiffs are still waiting for a verdict or settlement for their damages.

There are 12,658 federal lawsuits pending in MDL 2740, created in 2016, before US District Judge Kurt D. Engelhardt of the Eastern District of Louisiana, IN RE: Taxotere (Docetaxel) Products Liability Litigation.

Meanwhile, there are 350 state Taxotere lawsuits in a multicounty litigation (MCL) docket before Superior Court Judge James F. Hyland in New Brunswick, NJ.

The defendants include a dozen Taxotere manufacturers and distributors:

  1. Sanofi US Services Inc. f/k/a Sanofi-Aventis U.S. Inc.
  2. Sanofi-Aventis U.S. LLC
  3. Sandoz Inc.
  4. Accord Healthcare, Inc.
  5. McKesson Corporation d/b/a McKesson Packaging
  6. Hospira Worldwide, LLC f/k/a Hospira Worldwide, Inc.
  7. Hospira, Inc.
  8. Sun Pharma Global FZE
  9. Sun Pharmaceutical Industries, Inc. f/k/a Caraco Pharmaceutical Laboratories Ltd.
  10. Pfizer Inc.
  11. Actavis LLC f/k/a Actavis Inc.
  12. Actavis Pharma, Inc.

The plaintiffs charge that the companies knew Taxotere could cause permanent hair loss, failed to warn doctors and patients about it, and falsely marketed Taxotere.

Potential plaintiffs are breast cancer survivors who were prescribed Taxotere before December 2015 and suffered permanent baldness, otherwise known as alopecia.

Permanent alopecia is a disfiguring condition, especially for women. Women who have experienced disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including loss of work or inability to work due to significant psychological damage.

The federal short form complaint allows plaintiffs to allege strict products liability – failure to warn, negligence, negligent misrepresentation, fraudulent misrepresentation, fraudulent concealment, and fraud and deceit.

Defense Verdict in First Trial

The first bellwether trial for plaintiff Barbara Earnest resulted in a defense verdict on September 26, 2019. She was diagnosed with breast cancer in 2011 and was prescribed Taxotere. She lost her hair permanently.

Attorney Karen Barth Menzies of the Gibbs Law Group in Los Angeles, said, “We are certainly disappointed with the verdict. However, the trial was littered with evidentiary violations by the defense from opening statement on. These were highly prejudicial, so much so that the court had to give the jury curative instructions on three separate occasions, and we were compelled to move for a mistrial before closing arguments. Mrs. Earnest intends to seek appropriate post-trial relief.”

The jury did not believe that Barbara Earnest had permanent chemotherapy-induced alopecia caused by Taxotere.

Mrs. Earnest’s additional attorneys were Darin Schanker of Bachus & Schanker in Denver, Rand Nolen of Fleming Nolen Jez in Houston, Christopher Coffin of Pendley, Baudin & Coffin in New Orleans, and David Miceli of Miceli Law in Carrollton, Georgia.

The trial was especially contentious, with Sanofi seeking to delay the trial, filing multiple failed motions to dismiss, and attempting to get information on outside funding for the litigation. The company’s lawyers included Hildy Sastre of Shook, Hardy & Bacon, and lawyers from the New Orleans firm Irwin Fritchie Urquhart & Moore.

No Warnings About Hair Loss

The FDA approved Taxotere in 1996 as a treatment for breast cancer. According to the lawsuits, Sanofi misled the public by falsely assuring them that hair would grow back after chemotherapy. Sanofi falsely assured patients that their hair would grow back.

In 2010, Sanofi-Aventis reported that Taxotere had been used worldwide to treat more than 1.5 million patients and annual sales of Taxotere were $3.1 billion.

According to a 2015 lawsuit filed by one of Sanofi’s former employees, the company engaged in illegal payment of kickbacks to health care professionals to prescribe the drug.

Also, in 2015, the FDA warned that there was a potential for permanent hair loss for users of Taxotere as cases of permanent alopecia had been reported, and required an update to the warning on Taxotere.

Despite informing patients in other countries, Sanofi for years did not warn women in the U.S. of this risk. The words “permanent hair loss” or “alopecia” did not appear in any information published in the U.S., lawsuits say.

Studies the company should have been aware of include:

  • Sanofi sponsored a study 1998 called GEICAM 9805. By 2005, the company knew that the results of this trial revealed 9.2 percent of women who used the chemo drug suffered permanent alopecia.
  • Dr. Scot Sedlacek of the Rocky Mountain Cancer Centers conducted a study in 2006 that revealed Taxotere could cause more than 6 percent of women to suffer permanent alopecia.
  • J. Lemieux et al. published a 2008 review of 38 articles analyzing the impact of hair loss on women with breast cancer. Results showed that “hair loss consistently ranked amongst the most troublesome side effects, was described as distressing, and may affect the body image.”

Going Forward

The next action in the federal MDL litigation is a general status conferences and show cause hearing on March 24, 2020. The second bellwether trial originally set for March 23 has been continued.

Plaintiffs’ Liaison Counsel are Dawn Barrios of Barrios, Kingsdorf & Casteix, LLP in New Orleans, and Palmer Lambert of Gainsburgh Benjamin David Meunier & Warshauer, LLC, also in New Orleans.


Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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Pharmaceuticals Potentially Contaminated with The Deadly Toxin Diethylene Glycol

Apparently the FDAs crackdown on foreign outsource drug manufacturers arising from the revelation that certain pharmaceutical products found to be contaminated with NDMA, NDEA and other N-Nitro’s made offshore and sold in the United States, has led to the discovery that other pharmaceutical products produced by offshore manufacturers are also potentially contaminated with Diethylene Glycol (DEG), a lethal toxin.

Thus far, three offshore pharmaceutical contract manufacturers have received warning letters from the FDA related to DEG found in lots of product. All three of these manufacturers are major importers to the United States to whom many U.S. drug makers outsource production of various prescription as well as over the counter drugs.

It is safe to assume that more recalls like those that have recently been issued related to products contaminated with NDMA, NDEA and other N-Nitro Substances (Valsartan and Zantac et.al.) will be forthcoming soon related to DEG Contamination.

Company/Individual Product/Issue Issue Date
Sunstar Guangzhou Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 1/22/2020
Dental-Kosmetik GmbH & Co. KG

CGMP/Finished Pharmaceuticals/Adulterated 1/16/2020
Huaian Zongheng Bio-Tech Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

What Is Diethylene Glycol?

Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O. It is a colorless, practically odorless, poisonous, hygroscopic liquid with a sweetish taste. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used in antifreeze solutions and as a solvent.

DEG is produced by the partial hydrolysis of ethylene oxide. Depending on the conditions, varying amounts of DEG and related glycols are produced. The resulting product is two ethylene glycol molecules joined by an ether bond, Diethylene glycol is derived as a co-product with ethylene glycol and triethylene glycol.

DEG is highly toxic to humans as well as other animals.

Injuries Associated with Diethylene Glycol

Acute kidney injury often leading to death

Liver Failure

Heart Damage including Heart Failure

Lung Damage

Neurological Damage Brain Damage

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