In a Big Win, Plaintiffs’ Experts can Testify in Talc-Ovarian Cancer Litigation

A federal judge in New Jersey has ruled that scientific and medical experts proposed by the plaintiffs’ experts are qualified to testify about how genital talc use causes ovarian cancer. The ruling has major implications for ongoing state and federal litigation against Johnson & Johnson.

The ruling paves the way for future bellwether trials that could establish compensatory and punitive damage guidelines for the more than 16,000 cases pending in the MDL.

The ruling is a big win for plaintiffs’ attorneys, who for years have faced accusations from Johnson & Johnson about allowing “junk science” into the courtroom. J&J sought to bar all of the plaintiffs’ experts from testifying, which would have effectively wiped out all the cases before Wolfson.

“These experts report on the growing amount of peer-reviewed medical literature regarding talcum powder and ovarian cancer and represent the increasing number of highly respected researchers and doctors who are standing up to tell the world about the dangers of talcum powder,” said Leigh O’Dell, co-chair of the plaintiffs’ steering committee. “These respected and qualified experts will now testify in trials about the risk factors and causes of ovarian cancer, and the biological links of talcum powder use to this deadly disease.”

The clinical experts initially challenged by the defense but now cleared to testify about the dangers of talcum powder use include:

  • Anne McTiernan, MD, Ph.D. – Research Professor at the University of Washington School of Public Health’s Department of Epidemiology and the University of Washington School of Medicine, and a cancer prevention researcher at the Fred Hutchinson Cancer Research Center.
  • Arch “Chip” Carson, MD, Ph.D. – Associate Professor and Program Director for the Southwest Center for Occupational and Environmental Health at the University of Texas School of Public Health in Houston.
  • Daniel Clarke-Pearson, MD – Professor and recent Chairman in the Department of Obstetrics and Gynecology at the University of North Carolina-Chapel Hill, specializing in gynecologic oncology.
    Judge Wolfson’s ruling allows additional testimony from the following experts:
  • Ghassan Saed MD, Ph.D. – Research Professor in the Departments of Obstetric Gynecology and Oncology at Wayne State University and the Karmanos Cancer Center in Detroit. Dr. Saed will testify about his clinical research demonstrating that talcum powder can cause inflammation and oxidative stress in cells.
  • William Longo, Ph.D. – Material scientist/electron microscopist and founder of Georgia’s Micro Analytical Laboratories, specializing in the analysis of asbestos and mineral fiber-containing materials. Dr. Longo will testify that J&J talcum powder products contain asbestos and fibrous talc, based on his analysis using transmission electron microscopy.

“We are obviously pleased with the court’s ruling and are eager to move forward, said Michelle Parfitt, co-chair of the plaintiffs’ steering committee. “Epidemiologists and gynecologic oncologists will be allowed to testify that talcum powder causes ovarian cancer, including their opinions regarding the contribution of asbestos, fibrous talc, and metals to its carcinogenicity.”

The ruling by Wolfson will allow plaintiffs to present expert testimony that J&J’s talc products can cause cancer-based on epidemiological studies. They will be allowed to testify that the link could be caused by contamination with asbestos and heavy metals.

Wolfson also ruled that the plaintiffs’ experts cannot testify that inhaling talc can travel to the ovaries if inhaled, though they may say that it can reach the ovaries when used vaginally.

The case is In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation (MDL No. 2738). There are 16,594 cases consolidated before Chief US District Judge Freda L. Wolfson.

In 2018 J&J finally complied with discovery requests, which disclosed damning revelations that its own tests have found asbestos in its talc for 60 years and that the company lied to the FDA about it.

Since then plaintiff lawyers have introduced the internal documents into evidence with devastating results at trial. Most of the verdicts have involved plaintiffs with mesothelioma.

  • $4.7 billion awarded in December 2018 to 22 women with ovarian cancer. A Missouri state jury made the award after it heard that Johnson & Johnson has known for decades about the risk of asbestos contamination in its talc.
  • $325 million awarded in May 2019 in New York to Donna Olson, whose mesothelioma was caused asbestos-laced Johnson & Johnson baby powder. The company’s damning internal documents were used as evidence.
  • $117 million awarded by a New Jersey jury in April 2018 to Steven Alonzo, who has mesothelioma.
  • $40.3 million awarded by a California jury in October 2019 to Nancy and Phil Cabibi because the company’s baby powder was tainted with asbestos. In 2017, Nancy was diagnosed with mesothelioma.
  • $37.3 million awarded by a New Jersey jury in September 2019 to four plaintiffs claiming they developed mesothelioma from inhaling asbestos allegedly present in Johnson & Johnson’s cosmetic talc products. The judge actually struck the closing argument by defense lawyer Diane Sullivan for accusing the plaintiffs’ attorneys of creating evidence and being sinister.

The talc litigation may eventually cost the company as much as $10 billion, according to Bloomberg Intelligence.

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Lawsuits Rise Against Allergan for Breast Implant-Caused Cancer

Since Allergan recalled its Biocell textured breast implants in July 2019 for causing a rare form of cancer, hundreds of women who underwent breast implant surgery are finding their cancer were caused by defective Allergan breast implants.

Five months later the Judicial Panel on Multidistrict Litigation consolidated four pending class actions involving Allergan to Federal Court in New Jersey. Since December 2019, some 66 cases are pending before US District Judge Brian R. Martinotti in MDL 2921, IN RE: Allergan Biocell Textured Breast Implant Products Liability Litigation.

Allergan’s textured implants are linked to women developing anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is not breast cancer. The cancerous cells develop in scar tissue and fluid near the implant, and in some cases, it can spread and lead to death. Some symptoms of ALCL include persistent swelling or pain near the breast implant, and development seromas, or fluid pockets.

“We cannot allow women to be unnecessarily harmed while we collect data,” Dr. Eric Swanson wrote in a February 2019 article in the Annals of Plastic Surgery. “The cost of medications and the emotional and financial impact of BIA-ALCL take a heavy toll on affected women, even if the disease is seldom fatal.”

Implants and Cancer

Plaintiffs seek to force Allergan to pay for the costs of surgery, diagnostic testing, and medical monitoring in people who have Biocell implants. For those who choose not to replace their Biocell implants, Allergan has refused to cover the costs of invasive diagnostic testing and medical monitoring.

The FDA has not linked smooth Allergan breast implants to cancer, and these are not involved in the recall.

At the time of the recall, the FDA also indicated that the breast implant cancer problems have resulted in:

  • 573 Breast Implant BIA-ALCL cases reported worldwide.
  • 84% (481) of the cancer cases involved Allergan Breast Implants.
  • 33 deaths from BIA-ALCL have been identified.
  • More than 90% of breast implant cancer deaths where the model is known to involve Allergan devices.

According to the FDA, the following products have been removed from the market:

  • Natrelle Saline-Filled breast implants (Styles 168, 163, 363 & 468)
  • Natrelle Silicone-Filled breast implants (Styles 110, 115 & 120)
  • Natrelle Inspira Silicone-Filled breast implants (multiple “T” Styles)
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
  • McGhan Bidimensional Silicone-Filled breast implants (Style 153)
  • McGhan Croissant Shaped Tissue Expander (Style 134)
  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs

The textured implants carried a greater risk of performance failure, pain, rupture, and scar tissue around implant.

The FDA first identified a connection between breast implants and anaplastic large cell lymphoma in 2011. But the agency said there were too few cases at the time to properly gauge the risk. In 2016, the World Health Organization classified the disease as a type of T-cell lymphoma that developed after receiving breast implants.

By 2017, the FDA announced BIA-ALCL was primarily associated with textured implants, which led to the recall.

In an early case, plaintiff Misty Riportella of Santa Clarita, California filed suit against Allergan on November 1, 2019, Case 8:19-cv-02103, in federal court.

Unbeknownst to Ms. Riportella, the FDA released a report on January 26, 2011 finding “[b]ased on the published case studies and epidemiological research, the FDA believes that there is a possible association between breast implants and ALCL.”

Back in March 2000 Riportella was implanted with a Textured Saline Filled 270 cc McGhan® Style 168 breast implant on the left (No. 27-168271 Lot MR7826) and Textured Saline-Filled 270 cc McGhan®Style 168 breast implant on the right (No. 27-168271 Lot MA4827).

At the time the implants were placed into Riportella’s body, she was not advised, nor did she have any independent knowledge, that they were anything other than safe, life-long products. Nor was she advised that the product was associated and/or known to cause BIA-ALCL.

Throughout the years, different physicians discussed diagnoses such as congestive heart failure, COPD, blood flow issues, and numerous other “causes” for how Riportella was feeling. She had multiple imaging studies, x-rays, ultrasounds, CTs, blood work-ups, heart monitoring to name a few of the battery of tests she underwent.

In February 2019, Riportella’s daughter noticed a significant swelling in one of her breasts. She went to the ER and several other doctors until she was diagnosed with BIA-ALCL in June 2019. The implants and one lymph node were removed on July 17, 2019.

“Had the medical community been made aware of the existence of the true frequency, severity and significance of BIA-ALCL caused by the products, medical professionals and providers, including those who advised and served Plaintiff, would not have advised patients, including Plaintiff, to proceed with implantation of the products,” the complaint says.

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After $265M Verdict, Farmers Nationwide Sue Monsanto and BASF over Crop-Killing Dicamba

When drifting clouds of poisonous dicamba herbicide killed 30,000 of his peach trees, a Missouri farmer blamed Monsanto and BASF. A jury agreed that the manufacturers were to blame and awarded him $265 million.
Since then 100 farmers have filed suit in state courts, and in federal court in Missouri where the cases are consolidated before U.S. District Judge Stephen N. Limbaugh, Jr. in MDL 2820, IN RE: Dicamba Herbicides Litigation.

More than 2,000 farmers are likely to become plaintiffs, according to plaintiff lawyer Joseph Peiffer of the Peiffer Wolf Carr & Kane law firm. Federal crop insurance often does not cover their losses.
On top of that, a coalition of farmers and conservationists have sued the US Environmental Protection Agency for approving it in the first place – once in 2016 and again in 2018.

“Pesticide companies, right now, are only being held in check by tort claims and personal injury lawyers,” said Nathan Donley, a senior scientist with the Center for Biological Diversity, who is also suing the EPA. “EPA keeps making horrible decisions, and people are having to seek damages from something that could’ve been avoided in the first place.”

Killing crops

The defect in Monsanto’s XtendiMax and BASF’s Engenia brand of dicamba is “volatility,” which is when an herbicide moves off-target in the hours or days after spraying. Scientists say volatility is the main cause of crop damage from dicamba.

Farmers first plant genetically engineered dicamba-resistant cotton and soybeans. Then they spray dicamba to fight pigweed, but this has destroyed 4.7 million acres of soybeans and crops on neighboring farms, drifting far outside target zones.

Older and newer versions of dicamba have the same volatility flaw, and the damage can take weeks to appear. Arkansas, Kansas, Missouri, and Tennessee have all taken action to restrict dicamba products over a concern with the off-target drift.

The Missouri peach farmer, Bill Bader and his family-owned Bader Farms, filed suit in the MDL. In the first bellwether trial, the jury awarded $15 million in compensatory damages on February 14, 2020. The following day, they added another $250 million in punitive damages to be paid by Bayer AG (Monsanto’s German owner) and BASF. The jury found that Monsanto and BASF conspired in actions that created what Bader’s attorney called an “ecological disaster” designed to increase profits at the expense of farmers such as Bader.

The companies were damned by numerous internal corporate documents discovered in the dicamba litigation that convinced the jury of the company’s liability, according to Bader Farms attorney Bill Randles.

Randles has obtained hundreds of internal Monsanto and BASF corporate records demonstrating the companies were aware of the harm their products would create even as they publicly claimed the opposite. He said one BASF document referred to dicamba damage complaints as a “ticking time bomb” that “has finally exploded.”

EPA ignores its own scientists

BASF and Monsanto conspired together in a dicamba collaboration in 2011. In 2016, the U.S. Environmental Protection Agency approved Monsanto’s dicamba-based herbicide under a conditional two-year registration. Both XtendiMax and Engenia were first sold in the US in 2017.

The companies said their new dicamba herbicides would be less volatile and less prone to drift than old formulations of dicamba. But they refused to allow for independent scientific testing.

By 2018, farmers had filed more than 4,200 official complaints that damage to at least 4.7 million acres of soybeans from the use of dicamba.

Yet the EPA reapproved dicamba for another two years on October 31, 2018.

Four farm and environmental groups – the National Family Farm Coalition, the Center for Food Safety, the Center for Biological Diversity, and the Pesticide Action Network — filed suit against the EPA in 2017. National Family Farm Coalition v. USEPA, No. 17-70196 (9th Cir. 2019)

The groups argue that the federal agency broke the law when it first registered XtendiMax, Engenia, and DuPont’s FeXapan) in 2016, by ignoring key requirements of the Endangered Species Act and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

The Ninth Circuit already heard arguments in August 2018, but the case was mooted out by the EPA’s October 2018 decision to reapprove the herbicide for two years. As a result, the Ninth Circuit expedited the case to ensure it is heard before the EPA makes another registration decision later this year.

In the 2018 re-registration, the EPA found the off-target movement in the 2017 and 2018 growing seasons may have resulted in harm to off-target plants and endangered species of animals. Again, the agency did not reach out to the Fish and Wildlife Service, but decided to take additional mitigation requirements, including an omnidirectional buffer in counties where endangered species habitat exists, the lawsuit alleges.

Documents included as part of the lawsuit show that the EPA ignored its own scientists’ recommendations for a larger buffer zone around fields to protect endangered species and that Monsanto had dozens of off-target incidents during its testing of the herbicide.

More than 2,700 farms have suffered dicamba damage, according to University of Missouri crop science professor Kevin Bradley.

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FDA FINDS NDMA CONTAMINATION IN YET ANOTHER DRUG

MTN previously opined that our research indicates that the current Zantac litigation is just the tip of a much larger iceberg.
It appears our prior opinion may become reality, sooner rather than later.

Nationwide Recalls of Nizatidine, Heart Medicine and Blood Sugar Drugs Due to NDMA Impurity.

On April 15th, 2020 Amneal Pharmaceuticals of Bridgewater, New Jersey announced that it is voluntarily recalling three lots of Nizatidine Oral Solution, a heartburn medicine packaged in 480 ml bottles. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly-owned subsidiary of Amneal Pharmaceuticals.

The reason is that Nizatidine contains the impurity NDMA (N-nitrosodimethylamine), which is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

About 15 million Americans take Proton Pump Inhibitors (PPIs) like Nizatidine each year to treat common conditions such as gastroesophageal reflux disease (GERD).

There is no Nizitadine multi-district litigation docket at this time however, MTN expects numerous cases involving all H2 Blocker Acid Reducers to be filed this year, without regard to the existence of a consolidated litigation (MDL).

In addition to evidence that NDMA is carcinogenic, the literature also supports the conclusion that NDMA causes still births, certain birth defects as well as organ failure in adults.

First FDA Removal Request

Back on April 1, 2020, the FDA requested that all makers of all ranitidine drugs (Zantac and generics) remove their products from the market. This was the first time the FDA requested market withdrawal of all ranitidine products.

Ranitidine works by reducing the amount of acid your stomach produces. It is used to treat and prevent ulcers in the stomach and intestines. It also treats GERD and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

“The FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity,” the agency says.

As of April 15, 229 Ranitidine lawsuits are being overseen by US District Judge Robin L. Rosenberg in MDL 2924, IN RE: Zantac (Ranitidine) Products Liability Litigation.

The FDA has also ordered recalls of entirely different drugs where NDMA impurities were found:

  • Valsartan, Losartan, and Irbesartan, which are Angiotensin II Receptor Blockers (ARBs), which are used to treat high blood pressure and heart failure.
  • Metformin, which is a prescription drug used to control high blood sugar in patients with type 2 diabetes.

Nizatidine, like Ranitidine Hydrochloride (Zantac), is a histamine H2 receptor antagonist that inhibits stomach acid production. Nizatidine was patented in 1980 and approved for medical use in 1988. Eli Lilly developed it, and brand names include Tazac and Axid.

Amneal Pharmaceuticals denied it has received any reports of adverse events that are confirmed to be directly related to the recall. Nizatidine Oral Solution is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can send an email to Inmar Intelligence DrugSafety@amneal.com for further information.

Heartburn Medications Lawsuits in MDL 2789

The first heartburn medication lawsuit was filed in the Western District of Tennessee against AstraZeneca’s Nexium in May 2016. The PPI kidney failure lawsuit alleged that the defendants knew or should have known about the significantly increased risk for kidney injuries and failed to adequately warn consumers.

Multidistrict Litigation (MDL 2789) was finally approved on August 2, 2017, to streamline proceedings. By July 2018, 4,618 kidney failure lawsuits were still pending before U.S. District Judge Claire C. Cecchi in New Jersey.

Today there are 13,432 PPI lawsuits filed in MDL 2789, IN RE: Proton-Pump Inhibitor Products Liability Litigation (No. II)

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6th Circuit Throws Out a Dozen DePuy Hip Cases for Lack of Jurisdiction

After 8 years of litigation in the DePuy hip litigation in MDL 2197 in Ohio, the 6th Circuit Court of Appeals abruptly threw out twelve cases against DePuy Orthopaedics for manufacturing defective hip replacements.

“Here, even though nearly eight years have passed since the plaintiffs sued, all now recognize that the district court lacked diversity jurisdiction from the start. We thus vacate the district court’s judgments,” the court said.

“Federal courts must catch jurisdictional defects at all stages of a case, even when substantial resources have already been invested in it.”

The problem was that the plaintiffs are citizens of either the United Kingdom or Spain. DePuy International is incorporated in the United Kingdom and has its principal place of business there.

“On these facts, the plaintiffs cannot satisfy 28 USC § 1332(a)(2) or (a)(3). Section 1332(a)(2) will not work because citizens of foreign states fall on both sides of the dispute and so complete diversity is lacking,” the court said.

The Case is Linda Boal v. DePuy, Case Nos. 19-3494/3501/3503/3504/3505/3506/3507/3508/3510/3511/3512/3513.

8,500 cases, 12,000 plaintiffs

Since 2010, the federal court for the Northern District of Ohio has been the home of multidistrict litigation involving the DePuy ASR XL Acetabular Hip System, a medical device used in hip-replacement surgeries.
Plaintiffs charge that this device is defective and that the defendants gave inadequate warnings about its risks. At its peak, the multidistrict litigation contained more than 8,500 cases with more than 12,000 plaintiffs.

These plaintiffs sued six defendants:

  • DePuy Orthopaedics, Inc.
  • DePuy, Inc.
  • DePuy International Limited
  • Johnson & Johnson
  • Johnson & Johnson Services, Inc.
  • Johnson & Johnson International

Residents of the United States litigated most of these cases. In late 2013, the defendants entered into a $44 billion agreement with this group of plaintiffs. The district court has since implemented the agreement and appointed an administrator to process thousands of claims.

The trial court dismissed the 12 cases under the non convenes doctrine, a Latin phrase meaning inconvenient forum. The court found that Spanish law likely applied to the claims and that the courts there were an adequate forum for the consumers, the opinion said.

The court reasoned that the plaintiffs were residents of Spain; that their hip-replacement surgeries and follow-up care had occurred there; that the case-specific evidence was located there; and that Spanish law likely applied. It also found that Spanish courts provided an adequate forum for the plaintiffs and that the defendants had not waited too long in filing their motions.

“The plaintiffs thus seek to create jurisdiction by amending their complaints to add a new federal claim. Section 1653’s text and the case law interpreting it show that the statute does not permit this kind of amendment,” the court said.

The plaintiff attorneys on the case included E. Aaron Sprague, Creed & Gowdy, P.A., Jacksonville, Florida, and Jeffrey L. Haberman, Schlesinger Law Offices, P.A., Fort Lauderdale, Florida.
DePuy’s lawyers are Benjamin C. Sassé, Tucker Ellis LLP, Cleveland, Ohio and Benjamin C. Sassé, Kristen L. Mayer, Tucker Ellis LLP, Cleveland, Ohio.

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Hernia Mesh Cases Set for Trial Nationwide

Courthouses will explode with hernia mesh litigation in 2020 as several bellwether cases go to trial in federal and state courts in the sprawling litigation. Already 8,200 cases are filed in three MDLs against several companies, plus thousands of additional cases filed in state courts nationwide.

Millions of surgeries have relied upon the implant, and the failure rate is estimated as high as 12-30%. Many of the plaintiffs did not realize until years after the surgery.

The mesh can adhere through tissue ingrowth to vital organs and twist around the patient’s bowels and other internal organs, which can cause the patient to suffer bowel obstruction, and necrosis of the organ tissue. Moreover, it can be impossible for surgeons to remove the mesh without also removing large portions of the patient’s bowel, causing infection to develop, leading the patient to suffer peritonitis, sepsis, organ failure, or death.

There are four major makers of hernia mesh in the U.S:

  • C.R. Bard
  • Johnson & Johnson’s Ethicon subsidiary
  • Atrium Medical Corp.
  • Medtronic’s Covidien subsidiary.

There are 3 MDLs for the federal litigation.

Davol, Inc./C.R. Bard, Inc. polypropylene hernia mesh products liability litigation is consolidated before Chief District Court Judge Edmund A. Sargus, Jr. in Ohio. MDL 2846 currently has 3,569 cases.

Lawsuits over Bard Davol’s Kugel Patch formed an earlier MDL that ended in a $184 million settlement in 2011 for 2,600 Kugel Patch lawsuits. So far, this has been the largest settlement amount in any hernia mesh litigation.

Bard first recalled the patch in 2005 after the company said it could cause bowel perforations and fistulas. The first lawsuits followed soon after.

In 2007, a federal panel combined the first 150 Kugel Patch lawsuits into an MDL in a Rhode Island federal court. Eventually, plaintiffs filed more than 3,000 cases against C.R. Bard, Inc.

Two bellwether trials took place in 2010. Bard won the first, but a jury awarded $1.5 million to the plaintiffs in the second trial.

In the second trial, jurors heard the case of Christopher and Laure Thorpe of North Carolina. Christopher Thorpe underwent hernia repair with a Kugel Patch in 2005. Between 2007 and 2008, he underwent multiple surgeries to remove infection and a fistula resulting from the repair.

There are thousands of cases in state litigation in Rhode Island about Ventralex and Composix E/X.

Ethicon Physiomesh Flexible composite hernia mesh products are consolidated before Sr. District Judge Richard W. Story in Georgia. MDL 2782 has 2,664 cases. Johnson & Johnson subsidiary Ethicon, and it pulled a version of Physiomesh off the market in 2016 because high failure rates led to hernias recurring.

The FDA approved Physiomesh in 2010 through its 510(k) process, and it started receiving reports of Physiomesh failures shortly after the approval, including recurring hernias, adhesions, and infections.

The New Jersey Supreme Court consolidated 107 Physiomesh lawsuits into multicounty litigation in August 2018.

Atrium Medical Corp. C-Qur mesh products liability litigation is before U.S. District Judge Landya B. McCafferty in New Hampshire. MDL 2753 has 1,975 cases.

Atrium manufactures C-QUR, Vitamesh, Proloop, Prolite and Prolite Ultra brands of hernia mesh. Atrium recalled its C-QUR Edge mesh in 2013, 2015 and 2018.

There were also FDA injunctions against the manufacturer for failure to address complaints regarding the product as well as a Class II recall.

Covidien hernia mesh is manufactured by Medtronic, including three brands: Parietex Surgical Mesh, Parietex Composite Mesh, and Parietex ProGrip Mesh.

There is no MDL in the Covidien litigation so there is no readily available number of cases. Most cases are being filed in state court using state law claims. For example, there was a new lawsuit filed by a California man in state court in August 2019. There have been no recent settlements or verdicts to report.

Plaintiffs formulate cases

Plaintiff cases allege strict product liability-defective design, strict product liability – failure to warn, strict product liability – manufacturing defect, negligence, gross negligence and violations of state consumer protection laws.
There are more than 20 brands of hernia mesh:

  1. 3DMax Mesh
  2. 3DMax Light Mesh
  3. Bard (Marlex) Mesh Dart
  4. Bard Mesh
  5. Bard Soft Mesh
  6. Composix
  7. Composix E/X
  8. Composix Kugel Hernia Patch
  9. Composix L/P
  10. Kugel Hernia Patch
  11. Marlex
  12. Modified Kugel Hernia Patch
  13. Perfix Light Plug
  14. PerFix Plug
  15. Sepramesh IP
  16. Sperma-Tex
  17. Ventralex Hernia Patch
  18. Ventralex ST Patch
  19. Ventralight ST
  20. Ventrio Patch
  21. Ventrio ST
  22. Visilex

Donna Jager’s Mesh Nightmare

In an illustrative case, Donna Jager of Apple Valley, CA, was left with a gaping hole in her abdomen from multiple surgeries to remove infected mesh. She sued Davol Inc. and C.R. Bard in federal court in 2016 in central California, Case No. 16-cv-01424-JGB-KK.

On October 4, 2004, Jager underwent a hernia repair procedure during which a Bard Composix Kugel hernia mesh was implanted. The company told doctors that the Patch was safe, cost effective and suitable for hernia repair.

But by April 3, 2015, Jager had a hernia mesh infection, requiring her to undergo an exploratory laparotomy, open ventral hernia repair, and an appendectomy.

The surgeon noted “[g]ross purulent drainage was present with [the] previous mesh involved.” Further, he observed, “[d]ense adhesions of the appendix was noted to the inferior edge of the mesh on the abdominal wall.”
Additionally, “[f]urther inspection revealed the tract of the fistula emanating from the tip of the appendix. In that area the ring from the Bard mesh had fractured and was poking into the tip of [her] appendix.” This required the surgeon to excise the fistula tract and detach Plaintiff’s appendix from her abdominal wall.

She spent more than a month in a hospital and was finally discharged on May 5, 2015. As a further result of her infected Kugel Patch, she was required to undergo a wound VAC as well as intensive home wound care for the gaping hole in her abdomen.

Jager alleges that Davol and Bard knew, prior to the recalls of the Kugel Patch, that it was not properly developed, manufactured, inspected, marketed, and sold; that the Patch was not suitable for the purpose it was intended; and it was unreasonably dangerous and likely to injure patients implanted with it.

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FDA REQUEST RECALL OF ALL ZANTAC/ RANTIDINE PRODUCTS. IS THIS THE TIP OF A MUCH LARGER ICEBERG? By JOHN RAY

On 04/01/2020, the FDA requested that all makers of all ranitidine drugs (Zantac and generics) remove their products from the market. The reasoning citied by the FDA “The FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity”. See entire press release at this link.

The reason the FDA has requested that all ranitidine (Zantac et.al) products be removed from the market go far beyond the reasons currently stated in the FDA press release.

PRIMARY TOPICS COVERED IN THIS ARTICLE

  1. The FDA may (and arguably should) demand the recall of all ‘histamine H2-receptor antagonists’ (227 approved products in total) as the “contamination issue” is not the primary defect or danger presented by these drugs. In more simple terms, these drugs most likely cause the production of high levels of N-Nitroso compounds when introduced in the human body, especially in individuals with higher than normal levels of acid in their stomach or GI tract. Why? ‘Histamine H2-receptor antagonists are nitrosatable.Nitrosatable: Capable of being converted into nitroso compounds also referred to as n-nitroso compounds. (See list of n-nitroso compounds in appendix A below)Nitrosatable Drug: Drugs Capable of being converted into nitroso compound also referred to as n- nitroso compounds.) Generally, the conversion to or production of the n- nitroso compound occurs when the drug interacts with the acidic compounds found in the stomach and gastrointestinal tract.
  2. The litigation resulting from the current ranitidine requested recall may dramatically increase in scope over the next year, to include all ‘histamine H2-receptor antagonists without regard to whether an individual consumed a product known to have been contaminated.
  3. The litigation will be complex as under certain scenarios cases involved ANDA approved products (generics) may be foreclosed on by Pliva v. Mensing, while under other circumstances Pliva v. Mensing may not foreclose on claims involving generics (this subject will be more thoroughly covered in future articles).
  4. The injuries or adverse events caused by the n-nitroso compounds, whether through contamination in the production process, aggravated by heat or due to the inherent nitrosatable properties of Histamine H2-receptor antagonists are not limited to cancer, the n-nitroso compounds produced by consumption of these drugs (without regard to contamination, not only are believed to cause cancer. The n-nitroso compounds in question are also known to cause major organ failure, still births and birth defects. The fact that pregnant women often have issues with stomach acidity and consume ‘histamine H2-receptor antagonists” to mitigate the pain associated with this ailment, is of significant concern to this researcher. (this subject will be more thoroughly covered in future articles)

THE ELEPHANT IN THE ROOM

The FDAs reasoning behind the requested recall of all ranitidine products being that the level or amount of the N-Nitroso impurity (contamination) increases when exposed to heat higher than room temperatures begs the following question:

Why is the FDA only requesting the removal of ranitidine products and not other products such as the various blood pressure medications (ie. Valsartan) that have also been found to be contaminated with N-Nitroso compounds?

There may be a simple answer to the question posed. Ranitidine like all other ‘histamine H2-receptor antagonists’ are nitrosatable while Valsartan et.al. drugs are not nitrosatable.

Histamine H2-Receptor Antagonists
Histamine H2-Receptor Antagonists also known as H2 blockers are a group of medicines that reduce the amount of acid produced by the cells in the lining of the stomach. They include cimetidine, famotidine, nizatidine and ranitidine, and have various brand names, including Zantac. (See Appendix B1, a list of all FDA approved ranitidine and Appendix B2 for a list of all other FDA approved ‘histamine H2-receptor antagonists’ (141 products)

Individuals take H2-receptor antagonists due to pain caused lower than normal PH Levels (more acidic) stomach and gastrointestinal “juices” than normal. The lining of the stomach and other structures in the gastrointestinal tract are not designed to resist degradation by acids with lower PH (more acidic) than the normal levels found in healthy individuals.

The scientific literature supports the conclusion that the introduction of a Nitrosatable Drug in a patient with lower than normal (more acidic) PH levels in their Stomach and GI tract, produces higher levels of as n-nitroso compounds than are produced with that same drug is introduced into the body of an individual with normal PH levels (normal acid levels) in their Stomach and GI tract see:

See: N-Nitrosamines in gastric juice of patients with gastric ulcer before and during treatment with histamine H2-receptor antagonists: https://link.springer.com/article/10.1007/BF02776810

REASONABLE CONCLUSION

Reasonable Conclusion: A Nitrosatable Drug designed to treat individuals known to have lower than normal PH levels in their Stomach and GI tract, is defective in concept and design in that the drug will arguably create higher levels of n- nitroso compounds in the group of individuals that the drug is intended to treat, versus a nitrosatable Drug designed to treat individuals not known to have lower than normal PH levels in their Stomach and GI tract (such as Valsartan). More simply stated, the drugs are intended to treat individuals with pre-existing conditions that make these individuals more susceptible to the significant adverse events that can result from consumption of the drug.

THE TIP OF A VERY LARGE ICEBERG

The issue arising from contamination certain lots of Valsartan and certain Ranitidine products was first brought to the attention of the FDA by a small company relatively young company Valisure, LLC (founded in 2015) operating out of New Haven Connecticut. See the record of communications between Valisure, LLC and the FDA at this link.

Valisure’s Harvard- and Yale-trained scientists have developed laser-based technology to analyze the chemical properties and ingredients of pharmaceutical products. The novel technology employs laser-induced, quantum shift emissions to address the variability and quality problems that pervade many pharmaceutical products throughout the US.

On an unrelated note that might be of interest to investors, Valisure, currently a privately held company, filed the required documents to make a public stock offering in 2019 see documents at this link.

Shortly after Valisure filed its first petition related to its findings of NDMA and other n-nitroso compounds found in certain lots of blood pressure drugs (Valsartan et.al.) and antacid drugs (Zantac et.al) the FDA began a rapid-fire succession of actions designed to remove certain lots of these products from the market. See the relevant FDA actions at this link.

The fact that the FDA has now requested the removal of all ranitidine drugs from the market, (without regard to specific lot contamination) while not requesting the same of those non-nitrosatable drugs (Valsartan) for which contaminated lots have been discovered, lead this researcher to the conclusion that the issue with the ranitidine and other H2 blockers, goes far beyond the fact that a limited number of lots were found to be contaminated with the same harmful compounds the drug produces when introduced into the human body, without regard to additional contamination during the manufacturing process.

APENDIX A
LIST OF N-NITOROS COMPOUNDS

NAA N-nitrosoamino acids
NDBA N-nitrosodibutylamine
NDBZA N-nitrosodibenzylamine
NDEA N-Nitrosodiethylamine
NDMA N-Nitrosodimethylamine
NDPA N-Nitrosodipropylamine
NHMT N-nitroso-2-(hydroxymethyl)thiazolidine
NHMTCA N-nitroso-2-hydroxymethylthiazolidine-4-carboxylic acid
NHPRO N-nitroso-4-hydroxyproline
NMAMBA N-nitroso-N-(1-methylacetonyl)-3-methylbutylamine
NMEA N-Methyl-N-ethylnitrosamine
NMOCA N-nitroso-5-methyloxazolidine-4-carboxylic acid
NMOR N-nitrosomorpholine
NMTCA N-nitroso-2-methylthiazolidine-4-carboxylic acid
NPIP N-nitrosopiperidine
NPYR N-nitrosopyrrolidine
NPRO N-nitrosoproline
NSAR N-nitrososarcosine
NTCA N-nitrosothiazolidine-4-carboxylic acid
NTHZ N-nitrosothiazolidine
NTHZCA N-nitrosothiazolidine carboxylic acid and related homologues
N03 Nitrate
NO2 Nitrite

APPENDIX B1
LIST OF ALL FDA APPROVED H2 RECEPTOR ANTAGONIST CONTAINING RANITINIDINE or RANITINIDINE HYRDROCHLORIDE ( 86 Products)

ZANTAC 150 (RANITIDINE HYDROCHLORIDE) | NDA #018703 | TABLET;ORAL | GLAXO GRP LTD
ZANTAC 150 (RANITIDINE HYDROCHLORIDE) | NDA #020251 | TABLET, EFFERVESCENT;ORAL | GLAXO   GRP LTD
ZANTAC (RANITIDINE HYDROCHLORIDE) | NDA #019090 | INJECTABLE;INJECTION | TELIGENT
ZANTAC (RANITIDINE HYDROCHLORIDE) | NDA #019675 | SYRUP;ORAL | GLAXO GRP LTD
ZANTAC 25 (RANITIDINE HYDROCHLORIDE) | NDA #020251 | TABLET, EFFERVESCENT;ORAL | GLAXO GRP LTD
ZANTAC 300 (RANITIDINE HYDROCHLORIDE) | NDA #020095 | CAPSULE;ORAL | GLAXOSMITHKLINE
ZANTAC 300 (RANITIDINE HYDROCHLORIDE) | NDA #018703 | TABLET;ORAL | GLAXO GRP LTD
ZANTAC 75 (RANITIDINE HYDROCHLORIDE) | NDA #020520 | TABLET;ORAL | SANOFI US
ZANTAC 75 (RANITIDINE HYDROCHLORIDE) | NDA #020745 | TABLET, EFFERVESCENT;ORAL | SANOFI US
   ZANTAC IN PLASTIC CONTAINER (RANITIDINE HYDROCHLORIDE) | NDA #019593 | INJECTABLE;INJECTION | TELIGENT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074864 | TABLET;ORAL | WATSON LABS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075000 | TABLET;ORAL | RANBAXY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075094 | TABLET;ORAL | CONTRACT PHARMACAL
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075132 | TABLET;ORAL | SUN PHARM INDS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075165 | TABLET;ORAL | HERITAGE PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075167 | TABLET;ORAL | APOTEX INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075180 | TABLET;ORAL | PAR PHARM
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075208 | TABLET;ORAL | WOCKHARDT LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075212 | TABLET;ORAL | ANI PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075254 | TABLET;ORAL | RANBAXY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075294 | TABLET;ORAL | DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075296 | TABLET;ORAL | ANI PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075439 | TABLET;ORAL | SUN PHARM INDS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075497 | TABLET;ORAL | MYLAN
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075519 | TABLET;ORAL | SANDOZ
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075557 | CAPSULE;ORAL | TEVA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075564 | CAPSULE;ORAL | MYLAN
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #075742 | CAPSULE;ORAL | DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074023 | TABLET;ORAL | MYLAN
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074467 | TABLET;ORAL | SANDOZ
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074488 | TABLET;ORAL | ANI PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074552 | TABLET;ORAL | MYLAN
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074655 | CAPSULE;ORAL | SANDOZ
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074662 | TABLET;ORAL | BOEHRINGER INGELHEIM
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074680 | TABLET;ORAL | APOTEX
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074764 | INJECTABLE;INJECTION | BEDFORD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #074777 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #076705 | TABLET;ORAL | DR REDDYS LABS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #076760 | TABLET;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #076195 | TABLET;ORAL | PERRIGO
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #076124 | SYRUP;ORAL | ACTAVIS MID ATLANTIC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077405 | SYRUP;ORAL | PHARM ASSOC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077458 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077476 | SYRUP;ORAL | TARO
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077426 | TABLET;ORAL | ANI PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078192 | TABLET;ORAL | DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077824 | TABLET;ORAL | AMNEAL PHARMS NY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078701 | TABLET;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078684 | SYRUP;ORAL | BRECKENRIDGE
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #077602 | SYRUP;ORAL | APOTEX INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078312 | SYRUP;ORAL | AMNEAL PHARMS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078448 | SYRUP;ORAL | RANBAXY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078542 | TABLET;ORAL | GLENMARK PHARMS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078653 | TABLET;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078884 | TABLET;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #078890 | SYRUP;ORAL | LANNETT CO INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #090054 | SYRUP;ORAL | ANDA REPOSITORY
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #090102 | SYRUP;ORAL | TORRENT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #079076 | INJECTABLE;INJECTION | MYLAN LABS LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #079211 | SYRUP;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #079212 | SYRUP;ORAL | WOCKHARDT
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #200536 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #201745 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091288 | SYRUP;ORAL | LANNETT CO INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091534 | INJECTABLE;INJECTION | ZYDUS PHARMS USA INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091078 | SYRUP;ORAL | HI TECH PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091091 | SYRUP;ORAL | NOSTRUM LABS INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #090623 | SYRUP;ORAL | AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #091429 | TABLET;ORAL | PERRIGO R AND D
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #200172 | TABLET;ORAL | APOTEX INC
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #203694 | TABLET;ORAL | ACIC PHARMS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #205512 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #211893 | CAPSULE;ORAL | APPCO
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210228 | TABLET;ORAL | UNIQUE PHARM LABS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210243 | TABLET;ORAL | GRANULES INDIA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210250 | TABLET;ORAL | UNIQUE PHARM LABS
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #209859 | CAPSULE;ORAL | AJANTA PHARMA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210010 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #210681 | CAPSULE;ORAL | NOVITIUM PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #211058 | CAPSULE;ORAL | AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #211289 | TABLET;ORAL | VKT PHARMA PVT LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #209160 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #209161 | TABLET;ORAL | STRIDES PHARMA
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #207578 | TABLET;ORAL | AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE) | ANDA #207579 | TABLET;ORAL | AUROBINDO PHARMA LTD
    RANITIDINE (RANITIDINE) | ANDA #074794 | SOLUTION; ORAL | ACTAVIS ELIZABETH

APPENDIX B2
LIST OF ALL FDA APPROVED H2 RECEPTOR ANTAGONIST (141 Products)

AXID (NIZATIDINE) | NDA #021494 | SOLUTION;ORAL | BRAINTREE
AXID (NIZATIDINE) | NDA #019508 | CAPSULE;ORAL | SMITHKLINE BEECHAM
AXID AR (NIZATIDINE) | NDA #020555 | TABLET;ORAL | GLAXOSMITHKLINE
NIZATIDINE (NIZATIDINE) | ANDA #075934 | CAPSULE;ORAL | MYLAN PHARMS INC
NIZATIDINE (NIZATIDINE) | ANDA #075616 | CAPSULE;ORAL | WATSON LABS
NIZATIDINE (NIZATIDINE) | ANDA #075668 | CAPSULE;ORAL | ANI PHARMS INC
NIZATIDINE (NIZATIDINE) | ANDA #075806 | CAPSULE;ORAL | MYLAN PHARMS INC
NIZATIDINE (NIZATIDINE) | ANDA #075461 | CAPSULE;ORAL | ANI PHARMS INC
NIZATIDINE (NIZATIDINE) | ANDA #076383 | CAPSULE;ORAL | APOTEX INC
NIZATIDINE (NIZATIDINE) | ANDA #076178 | CAPSULE;ORAL | SANDOZ
NIZATIDINE (NIZATIDINE) | ANDA #090576 | SOLUTION;ORAL | AMNEAL PHARMS
NIZATIDINE (NIZATIDINE) | ANDA #090618 | CAPSULE;ORAL | GLENMARK GENERICS
NIZATIDINE (NIZATIDINE) | ANDA #077314 | CAPSULE;ORAL | DR REDDYS LABS LTD
TAGAMET (CIMETIDINE) | NDA #017920 | TABLET;ORAL | GLAXOSMITHKLINE
TAGAMET (CIMETIDINE HYDROCHLORIDE) | NDA #017924 | SOLUTION;ORAL | GLAXOSMITHKLINE
TAGAMET (CIMETIDINE HYDROCHLORIDE) | NDA #017939 | INJECTABLE;INJECTION | GLAXOSMITHKLINE
TAGAMET HB (CIMETIDINE) | NDA #020238 | TABLET;ORAL | MEDTECH PRODUCTS
TAGAMET HB 200 (CIMETIDINE) | NDA #020951 | SUSPENSION;ORAL | GLAXOSMITHKLINE
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (CIMETIDINE HYDROCHLORIDE) | NDA #019434 | INJECTABLE;INJECTION | GLAXOSMITHKLINE
CIMETIDINE (CIMETIDINE) | ANDA #074890 | TABLET;ORAL | HIKMA
CIMETIDINE (CIMETIDINE) | ANDA #074948 | TABLET;ORAL | APOTEX
CIMETIDINE (CIMETIDINE) | ANDA #074972 | TABLET;ORAL | PERRIGO
CIMETIDINE (CIMETIDINE) | ANDA #074961 | TABLET;ORAL | CONTRACT PHARMACAL
CIMETIDINE (CIMETIDINE) | ANDA #074963 | TABLET;ORAL | CONTRACT PHARMACAL
CIMETIDINE (CIMETIDINE) | ANDA #075122 | TABLET;ORAL | SANDOZ INC
CIMETIDINE (CIMETIDINE) | ANDA #075285 | TABLET;ORAL | L PERRIGO CO
CIMETIDINE (CIMETIDINE) | ANDA #075345 | TABLET;ORAL | IVAX SUB TEVA PHARMS
CIMETIDINE (CIMETIDINE) | ANDA #075425 | TABLET;ORAL | WATSON LABS TEVA
CIMETIDINE (CIMETIDINE) | ANDA #074316 | TABLET;ORAL | WATSON LABS INC
CIMETIDINE (CIMETIDINE) | ANDA #074329 | TABLET;ORAL | CHARTWELL MOLECULES
CIMETIDINE (CIMETIDINE) | ANDA #074151 | TABLET;ORAL | TEVA
CIMETIDINE (CIMETIDINE) | ANDA #074246 | TABLET;ORAL | MYLAN
CIMETIDINE (CIMETIDINE) | ANDA #074250 | TABLET;ORAL | SANDOZ INC
CIMETIDINE (CIMETIDINE) | ANDA #074100 | TABLET;ORAL | YAOPHARMA CO LTD
CIMETIDINE (CIMETIDINE) | ANDA #074566 | TABLET;ORAL | PLIVA
CIMETIDINE (CIMETIDINE) | ANDA #074568 | TABLET;ORAL | PLIVA
CIMETIDINE (CIMETIDINE) | ANDA #074361 | TABLET;ORAL | CYCLE PHARMS LTD
CIMETIDINE (CIMETIDINE) | ANDA #074463 | TABLET;ORAL | TEVA
CIMETIDINE (CIMETIDINE) | ANDA #074349 | TABLET;ORAL | WATSON LABS INC
CIMETIDINE (CIMETIDINE) | ANDA #074339 | TABLET;ORAL | DAVA PHARMS INC
CIMETIDINE (CIMETIDINE) | ANDA #074340 | TABLET;ORAL | DAVA PHARMS INC
CIMETIDINE (CIMETIDINE) | ANDA #074401 | TABLET;ORAL | IVAX SUB TEVA PHARMS
CIMETIDINE (CIMETIDINE) | ANDA #074402 | TABLET;ORAL | IVAX SUB TEVA PHARMS
CIMETIDINE (CIMETIDINE) | ANDA #074365 | TABLET;ORAL | TEVA
CIMETIDINE (CIMETIDINE) | ANDA #074371 | TABLET;ORAL | CYCLE PHARMS LTD
CIMETIDINE (CIMETIDINE) | ANDA #074506 | TABLET;ORAL | UPSHER SMITH LABS
CIMETIDINE (CIMETIDINE) | ANDA #074424 | TABLET;ORAL | IVAX SUB TEVA PHARMS
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074428 | INJECTABLE;INJECTION | DAVA PHARMS INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074344 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074345 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074353 | INJECTABLE;INJECTION | LUITPOLD
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074412 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074422 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074541 | SOLUTION;ORAL | CYCLE PHARMS LTD
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074553 | SOLUTION;ORAL | PHARM ASSOC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074610 | SOLUTION;ORAL | ANI PHARMS INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074664 | SOLUTION;ORAL | HI TECH PHARMA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074005 | INJECTABLE;INJECTION | VINTAGE PHARMS LLC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074251 | SOLUTION;ORAL | LANNETT CO INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074252 | INJECTABLE;INJECTION | TEVA PARENTERAL
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074176 | SOLUTION;ORAL | G AND W LABS INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074296 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #075560 | SOLUTION;ORAL | PHARM ASSOC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #075110 | SOLUTION;ORAL | ANI PHARMS INC
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074757 | SOLUTION;ORAL | WOCKHARDT BIO AG
CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE) | ANDA #074859 | SOLUTION;ORAL | ANI PHARMS INC
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (CIMETIDINE HYDROCHLORIDE) | ANDA #074269 | INJECTABLE;INJECTION | HOSPIRA
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (CIMETIDINE HYDROCHLORIDE) | ANDA #074468 | INJECTABLE;INJECTION | HOSPIRA
PEPCID (FAMOTIDINE) | NDA #019462 | TABLET;ORAL | VALEANT PHARMS NORTH
PEPCID (FAMOTIDINE) | NDA #019510 | INJECTABLE;INJECTION | MERCK
PEPCID (FAMOTIDINE) | NDA #019527 | FOR SUSPENSION;ORAL | SALIX PHARMS
PEPCID AC (FAMOTIDINE) | NDA #020902 | TABLET;ORAL | J AND J CONSUMER INC
PEPCID AC (FAMOTIDINE) | NDA #020801 | TABLET, CHEWABLE;ORAL | J AND J CONSUMER INC
PEPCID AC (FAMOTIDINE) | NDA #020325 | TABLET;ORAL | J AND J CONSUMER INC
PEPCID COMPLETE (CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE) | NDA #020958 | TABLET, CHEWABLE;ORAL | J AND J CONSUMER INC
PEPCID PRESERVATIVE FREE (FAMOTIDINE) | NDA #019510 | INJECTABLE;INJECTION | MERCK
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER (FAMOTIDINE) | NDA #020249 | INJECTABLE;INJECTION | MERCK SHARP DOHME
PEPCID RPD (FAMOTIDINE) | NDA #020752 | TABLET, ORALLY DISINTEGRATING;ORAL | MERCK
FAMOTIDINE (FAMOTIDINE) | ANDA #201695 | FOR SUSPENSION;ORAL | NOVEL LABS INC
FAMOTIDINE (FAMOTIDINE) | ANDA #201995 | FOR SUSPENSION;ORAL | HI-TECH PHARMA CO
FAMOTIDINE (FAMOTIDINE) | ANDA #206530 | TABLET;ORAL | AUROBINDO PHARMA LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #206531 | TABLET;ORAL | AUROBINDO PHARMA LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #077146 | TABLET;ORAL | WOCKHARDT
FAMOTIDINE (FAMOTIDINE) | ANDA #077351 | TABLET;ORAL | PERRIGO R AND D
FAMOTIDINE (FAMOTIDINE) | ANDA #077352 | TABLET;ORAL | PERRIGO R AND D
FAMOTIDINE (FAMOTIDINE) | ANDA #077367 | TABLET;ORAL | DR REDDYS LABS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #075942 | INJECTABLE;INJECTION | APOTEX INC
FAMOTIDINE (FAMOTIDINE) | ANDA #076101 | TABLET;ORAL | SANDOZ
FAMOTIDINE (FAMOTIDINE) | ANDA #078641 | INJECTABLE;INJECTION | MYLAN LABS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #078916 | TABLET;ORAL | ALEMBIC PHARMS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #091020 | FOR SUSPENSION;ORAL | NAVINTA LLC
FAMOTIDINE (FAMOTIDINE) | ANDA #090283 | TABLET;ORAL | SUN PHARM INDS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #090837 | TABLET;ORAL | WOCKHARDT
FAMOTIDINE (FAMOTIDINE) | ANDA #090440 | FOR SUSPENSION;ORAL | LUPIN LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #075062 | TABLET;ORAL | WATSON LABS
FAMOTIDINE (FAMOTIDINE) | ANDA #075192 | INJECTABLE; INJECTION | MARSAM PHARMS LLC
FAMOTIDINE (FAMOTIDINE) | ANDA #075193 | INJECTABLE; INJECTION | MARSAM PHARMS LLC
FAMOTIDINE (FAMOTIDINE) | ANDA #075194 | INJECTABLE; INJECTION | MARSAM PHARMS LLC
FAMOTIDINE (FAMOTIDINE) | ANDA #075302 | TABLET;ORAL | PLD ACQUISITIONS
FAMOTIDINE (FAMOTIDINE) | ANDA #075311 | TABLET;ORAL | TEVA
FAMOTIDINE (FAMOTIDINE) | ANDA #075312 | TABLET;ORAL | TEVA
FAMOTIDINE (FAMOTIDINE) | ANDA #075400 | TABLET;ORAL | PERRIGO
FAMOTIDINE (FAMOTIDINE) | ANDA #075404 | TABLET;ORAL | WATSON LABS
FAMOTIDINE (FAMOTIDINE) | ANDA #075457 | TABLET;ORAL | MYLAN PHARMS INC
FAMOTIDINE (FAMOTIDINE) | ANDA #075511 | TABLET;ORAL | IVAX SUB TEVA PHARMS
FAMOTIDINE (FAMOTIDINE) | ANDA #075512 | TABLET;ORAL | P AND L
FAMOTIDINE (FAMOTIDINE) | ANDA #075607 | TABLET;ORAL | SANDOZ
FAMOTIDINE (FAMOTIDINE) | ANDA #075610 | TABLET;ORAL | APOTEX
FAMOTIDINE (FAMOTIDINE) | ANDA #075611 | TABLET;ORAL | APOTEX
FAMOTIDINE (FAMOTIDINE) | ANDA #075639 | TABLET;ORAL | SUN PHARM INDUSTRIES
FAMOTIDINE (FAMOTIDINE) | ANDA #075650 | TABLET;ORAL | ACTAVIS ELIZABETH
FAMOTIDINE (FAMOTIDINE) | ANDA #075651 | INJECTABLE;INJECTION | ATHENEX INC
FAMOTIDINE (FAMOTIDINE) | ANDA #075488 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
FAMOTIDINE (FAMOTIDINE) | ANDA #075674 | TABLET;ORAL | MYLAN
FAMOTIDINE (FAMOTIDINE) | ANDA #075684 | INJECTABLE;INJECTION | ATHENEX INC
FAMOTIDINE (FAMOTIDINE) | ANDA #075704 | TABLET;ORAL | MYLAN
FAMOTIDINE (FAMOTIDINE) | ANDA #075705 | INJECTABLE;INJECTION | HOSPIRA
FAMOTIDINE (FAMOTIDINE) | ANDA #075707 | INJECTABLE;INJECTION | APOTHECON
FAMOTIDINE (FAMOTIDINE) | ANDA #075709 | INJECTABLE;INJECTION | FRESENIUS KABI USA
FAMOTIDINE (FAMOTIDINE) | ANDA #075715 | TABLET, CHEWABLE;ORAL | PERRIGO
FAMOTIDINE (FAMOTIDINE) | ANDA #075718 | TABLET;ORAL | DR REDDYS LABS LTD
FAMOTIDINE (FAMOTIDINE) | ANDA #075793 | TABLET;ORAL | SANDOZ
FAMOTIDINE (FAMOTIDINE) | ANDA #075799 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
FAMOTIDINE (FAMOTIDINE) | ANDA #075805 | TABLET;ORAL | CARLSBAD
FAMOTIDINE (FAMOTIDINE) | ANDA #075786 | TABLET;ORAL | CELLTRION
FAMOTIDINE (FAMOTIDINE) | ANDA #075870 | INJECTABLE;INJECTION | HOSPIRA
FAMOTIDINE (FAMOTIDINE) | ANDA #075905 | INJECTABLE;INJECTION | HOSPIRA
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075813 | INJECTABLE;INJECTION | FRESENIUS KABI USA
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075825 | INJECTABLE;INJECTION | ATHENEX INC
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075708 | INJECTABLE;INJECTION | APOTHECON
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075669 | INJECTABLE;INJECTION | HOSPIRA
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075622 | INJECTABLE;INJECTION | ATHENEX INC
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075486 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #078642 | INJECTABLE;INJECTION | MYLAN LABS LTD
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #075789 | INJECTABLE;INJECTION | WEST-WARD PHARMS INT
FAMOTIDINE PRESERVATIVE FREE (FAMOTIDINE) | ANDA #076324 | INJECTABLE;INJECTION | APOTEX INC
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK) (FAMOTIDINE) | ANDA #076322 | INJECTABLE;INJECTION | APOTEX INC
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER (FAMOTIDINE) | ANDA #075591 | INJECTABLE;INJECTION | BAXTER HLTHCARE
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER (FAMOTIDINE) | ANDA #075729 | INJECTABLE;INJECTION | ABBVIE
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE (CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE) | ANDA #077355 | TABLET, CHEWABLE;ORAL | PERRIGO R AND D
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE (CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE) | ANDA #204782 | TABLET, CHEWABLE;ORAL | PERRIGO R AND D

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