Drug Injury Watch

Infuse Bone Graft: Medtronic-Funded Studies Essentially Ignored Serious Medical Complications And Side Effects Associated With Its Back Surgery Product

2013-05-13T16:25:00-04:00

**A 2009 - 2012 Series Of Investigative Reports Published By The Milwaukee Journal Sentinel Exposed Various "Problems" With How Medtronic Went About Boosting Sales Of Infuse**

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the second part of this Medtronic Infuse series of articles we want to bring to your attention some of the investigative news reports looking into the serious medical complications and side effects associated with the Infuse Bone Graft that were essentially ignored in Medtronic-funded studies.

As may know, we started this series with "Medtronic Infuse Bone Graft Efficacy And Safety Study By Yale: Widely Anticipated Results Are Set To Be Released In June 2013".

Reporter John Fauber, a news reporter for the Milwaukee Journal Sentinel, seems to be the journalist who should be credited most for exposing the several problematic aspects of how Medtronic has marketed its Infuse Bone Graft product over the years.

Here is a list of such investigative reports published by the Milwaukee Journal Sentinel from 2009 to 2012, ranging from the Infuse clinical trials to serious conflicts of interest and more:

Medical device maker paid UW surgeon $19 million

Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin-Madison, raised eyebrows three years ago when it was learned that he had been receiving $400,000 yearly from the medical device company. But yearly payments actually averaged about 10 times that figure.

Journal editor gets royalties as articles favor devices

In 2002, Thomas Zdeblick, a UW orthopedic surgeon who has pocketed millions of dollars in royalties from the spinal device maker Medtronic, took over as editor-in-chief of a medical journal about spinal disorders. It would be the beginning of a beautiful friendship.

Bone-fusion protein raises questions about doctors' financial stakes

The story of BMP-2 raises questions about whether doctors should be allowed to do clinical trial research involving products that might enrich them or the company they work for.

Doctors question journal articles

Over the last decade, a small group of surgeons has been enlisted by Medtronic to do research or write articles about the company's new spine surgery product. This year alone, many of those doctors received payments of hundreds of thousands to millions of dollars each in royalties for a variety of other Medtronic devices.

Researchers get royalties, papers omit sterility link

Since 2002, Medtronic and a group of doctors with financial ties to the medical device company were aware that a new biological agent used in back surgery was linked to sterility in men. But that crucial information was not revealed in medical journal articles written by those doctors.

U.S. Senate panel probes Medtronic

A U.S. Senate committee has launched an investigation into reports that doctors with financial ties to the medical device company Medtronic were aware of serious complications with a lucrative spine surgery product yet failed to reveal those problems in medical journal articles.

Journal: Unreported side effects, disclosure failures with Medtronic back product

The entire issue of a medical journal is devoted to a scientific and financial expose of a product, the practices of the company that markets it and the financially conflicted doctors who tested and promoted it.

Articles leave pain in their wake

Patients' excruciating pain is at the center of a growing controversy surrounding the Medtronic and the spine surgery product Infuse that it markets.

Doctors didn't disclose spine product cancer risk in journal

Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company's spine surgery product in a 2009 paper about results of a large clinical trial. The company and doctors had become aware of information on an additional cancer case, which pushed the concern to a critical level, at least two months before the paper was published, a Journal Sentinel/MedPage Today investigation found.

Medtronic paid millions to influential UW chairman

An orthopedic surgeon at the University of Wisconsin-Madison gets so much money from the medical device firm Medtronic that he is required to meet annually with his department chairman. But the chairman, Thomas Zdeblick, got more than 25 times that amount from Medtronic during the same time.

Senate panel says Medtronic workers ghostwrote papers

Medtronic marketing employees were secretly involved in drafting and editing favorable medical journal articles about the company's lucrative back surgery product, a U.S. Senate investigation reveals.

These Milwaukee Journal Sentinel articles were taken from the Side Effects page of JSOnline.com, the newspaper's web site, where you can find additional resources (such as documents and photos) pertaining to these Medtronic Infuse investigative reports.

We commend this newspaper and reporter John Fauber for developing this Infuse Bone Graft story of apparent corporate misconduct by Medtronic, which is still emerging as we wait for the release of the Yale Infuse Study currently scheduled to be released in June 2013.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Review done by attorney Tom Lamb)

Medtronic Infuse Bone Graft Efficacy And Safety Study By Yale: Widely Anticipated Results Are Set To Be Released In June 2013

2013-04-29T15:58:27-04:00

This Controversial Medtronic Spine Treatment Was Put In The Spotlight By June 2011 Medical Journal Articles About Serious Risks And Problems With Infuse

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Medtronic Infuse Bone Graft product was under some scrutiny even before the June 2011 edition of The Spine Journal, which was a special issue containing articles that challenged earlier published research backing the widespread use of Infuse. Among the various problems revealed in those articles was that several clinical studies of the Infuse failed to report serious complications that arose in the device clinical trials. Further compounding this situation was the somewhat veiled fact that those Infuse clinical trials were conducted by surgeons with strong economic ties to Medtronic.

In response to this special "Infuse issue" of The Spine Journal, Medtronic gave a $2.5 million grant in August 2011 to Yale University to conduct an independent review of all clinical study data that examined the effectiveness and safety of the Infuse Bone Graft product. The plan for this Yale study review was developed by Harlan Krumholz, M.D., a prominent cardiologist who has been outspoken about the need for full disclosure by drug and medical device companies about their products so that doctors and patients can make decisions based on full knowledge of the risks and benefits of those products.

From the Yale School of Medicine web site:

Medtronic Research Grant to Yale University Establishes New Model for Independent Analysis and Dissemination of Industry Data

Medtronic, Inc. has provided a grant to Yale University to apply the YODA Project model in practice for the first time. Yale will lead independent, systematic reviews of the entire body of scientific evidence regarding the safety and effectiveness of Medtronic’s recombinant bone morphogenetic protein-2 (rhBMP-2) product. The reviews will be conducted independently by two academic teams with full access to all Medtronic’s clinical trial, post-marketing and safety data about rhBMP-2. The results of the reviews are anticipated to be released June 2013.

In addition, the grant supports the dissemination of all Medtronic clinical research data on rhBMP-2 to external investigators, which is also expected for June 2013.

But there is much more involved with the Medtronic Infuse Bone Graft safety issue, a subject which we will be focusing on over the next couple of months leading up to the scheduled release of this Yale Infuse study.

As a preview, during this Medtronic Infuse series of articles we will be covering:

Investigative news reports looking into the serious medical complications and side effects associated with the Infuse Bone Graft that were essentially ignored in Medtronic-funded studies;
A U.S. Senate Finance Committee investigation led by Senators Charles Grassley and Max Baucus concerning the revelations made by those press reports as well as The Spine Journal June 2011 edition featuring the Infuse safety issues;
A U.S. Justice Department investigation looking into the reportedly 85% "off-label" use of the Medtronic Infuse Bone Graft product, i.e., its use for procedures beyond those officially approved by the FDA, with an emphasis on the allegation that Medtronic actively promoted off-label use of Infuse; and,
Lawsuits being filed against Medtronic on behalf of patients who have suffered ectopic / excessive / unwanted bone growth, neurological impairment, and other severe side effects of the Infuse Bone Graft product.

In summary, from these several perspectives, during this special series of articles we will examine the serious risks associated with the so-called "blockbuster" Medtronic Infuse Bone Graft product.

Of course, if you have any tips or tidbits about the Infuse Bone Graft which you think deserve more attention, please send them to me by email for consideration to be included in one of these upcoming Infuse articles here on Drug Injury Watch.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Review done by attorney Tom Lamb)

Mirena IUD Migrations And Perforations Requiring Surgical Removals Result In Growing Number Of Lawsuits Against Bayer

2013-04-22T16:15:00-04:00

**First Mirena Case Trial, Baugh v. Bayer, Scheduled To Start May 6, 2013 In South Carolina Federal District Court**

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Plaintiffs granted consolidation in Bayer IUD lawsuits" (Reuters, 4/24/13)

Over opposition from Bayer AG, the U.S. Judicial Panel on Multidistrict Litigation has consolidated more than 40 personal injury lawsuits stemming from the drugmaker's Mirena intrauterine contraceptive.

The judicial panel in Washington on April 8 ruled that overarching commonalities in the cases, which had been filed in federal courts across the country, supported granting consolidation....

(4/25/13)

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The Mirena lawsuit Kelli Baugh v. Bayer Corporation (USDC, District of South Carolina, 4:11-cv-00525) is scheduled for a May 6, 2013 trial date. If this Mirena trial goes forward as currently set, it will be the first Mirena trial in the U.S. for this relatively new and still growing drug / device injury litigation.

In simple terms, the Baugh lawsuit alleges that the design of the Mirena intrauterine device (IUD) allows for the migration of the device through the uterine lining because the way that the Mirena works, essentially, is by thinning the uterine lining.

As a result of this "side effect" happening to Kelli Baugh in South Carolina, this woman in her twenties had to have a total hysterectomy, is now in surgically-induced menopause, and has to take estrogen daily.

Some of the Mirena lawsuits against Defendant Bayer Healthcare Pharmaceuticals, Inc., have been filed in the federal court Mirena MDL -- In Re: Mirena IUD Products Liability Litigation, Multidistrict Litigation No. 2434, United States District Court, Southern District of New York, with Judge Cathy Seibel presiding -- which was commenced by means of an April 8, 2013 Transfer Order.

Most of the other Bayer Mirena drug / device cases have been filed in the New Jersey state court system, as Bayer has a corporate headquarters in New Jersey.

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As background, the Mirena IUD is a plastic device containing a hormone, the drug levonogestrel, which is released slowly over time. With the Mirena, both the drug and the device work to prevent pregnancy. The Mirena IUD was first marketed in the United States in 2000. Since then, however, Bayer has received notices of complications or side effects with the use of the Mirena including embedment in the wall of the uterus and perforation of the wall, then the subsequent need to do surgery in order to retrieve the Mirena IUD device from the abdomen.

In the Mirena lawsuits filed to date it is alleged that the device embedments and IUD-related perforations are caused by the defective design of this Bayer IUD. Further, these Mirena legal cases allege that Defendant Bayer failed to issue sufficient warnings of the risks associated with its Mirena IUD as regards the risks of device migration and perforation.

In some instances a Mirena IUD perforation incident can be discovered with the sudden onset of pain. With other incidents there is no such acute pain and the Mirena migration might be identified by: (1) an ultrasound or x-ray; (2) at the time of 5-year routing removal; or, (3) unexpected pregnancy due to device migration.

If you or a loved one has a possible Mirena legal case, you can use our online Case Evaluation form or send me an email or call me on our toll-free number, 800-426-9535.

We have extensive experience working on legal compensation cases involving unsafe birth control methods such as YAZ / Yasmin / Ocella, the NuvaRing, and Ortho Evra. This past legal and practical experience with these types of cases will serve the interests of our Mirena clients in this relatively new drug injury / device litigation.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Review done by attorney Tom Lamb)

Two Conferences About Big Pharma Conduct: One Past (Selling Sickness 2013), One Future (PharmedOut's 4th Annual Conference)

2013-04-15T15:45:00-04:00

At Their Respective Websites, You Can See What You Have Missed And What You Can Look Forward To In Washington, DC

(Posted by Tom Lamb at DrugInjuryWatch.com)

In February I attended Selling Sickness 2013 - People Before Profits, which was a diverse conference about the pharmaceutical drug industry, with a focus on several different facets of its conduct and practices.

I want to let you know that the materials used by some of the speakers at this Selling Sickness 2013 conference are now available for download at the conference website on its Presentations page. These are organized by day, session, and name. There are missing presentations that will be added as soon as materials are received from the speakers.

And if you want to learn more about the intended subject of any of these presentations you can also view the Official Program for Selling Sickness 2013.

For those of you interested in this past conference about Big Pharma conduct, I want to let you know about a somewhat related conference which is coming up in the relatively short-term future.

PharmedOut, a Georgetown University Medical Center project that advances evidence-based prescribing and educates health care providers about industry marketing practices, is taking place June 6-7, 2013 at Georgetown University. The project is directed by Adriane Fugh-Berman MD, who recently moderated the Corruption panel at the Selling Sickness 2013 conference.

The theme or title for this year's PharmedOut's 4th Annual Conference is "Medical Behavior in a Commercial World: Who Is Responsible?". From the PharmedOutweb page for this upcoming conference:

This year's conference will explore the ethical responsibilities of health care providers, medical journals, industry, and payers on therapeutic choices, as well as the effects on public health at large.

At that PharmedOut 2013 conference page you will also access the current schedule by using this Conference At-A-Glance (pdf) link.

From the email announcement which I received earlier today from the PharmedOut Project Manager for this June 2013 conference:

PharmedOut's past conferences have been highly acclaimed by participants, who tend to be physicians, policymakers, and other professionals and students in a range of disciplines and perspectives that don't typically get to converge....

Among our many speakers:

- A former pharmaceutical executive will speak for the first time on ethical conflicts within industry
- Former editor-in-chief of New England Journal of Medicine Marcia Angell MD, chief editor of PLOS Medicine Virginia Barbour MD, and clinical editor at British Medical Journal Elizabeth Loder MD will speak about how medical journal advertising and editorial policies affect public health
- Carl Elliott MD PhD, author of White Coat, Black Hat and Professor at the University of Minnesota’s Center for Bioethics, will discuss industry-funded trials at academic medical centers
- Charles Ornstein of ProPublica will speak about how lessons learned from the Dollars for Docs database will apply to the Physician Payments Sunshine Act;
- A medical ghostwriter will reveal how he helped sell Low Testosterone syndrome (Low-T) to consumers

Sounds like this one will be another high quality and interesting event concerning the conduct of Big Pharma, as was Selling Sickness 2013.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Review done by attorney Tom Lamb)

Second Fosamax - Femur Fracture Lawsuit Trial Starts In New Jersey, This One In The Federal Court MDL With Judge Pisano Presiding

2013-04-08T15:33:00-04:00

**Still Waiting For The First Jury Verdict In A Fosamax Bellwether Trial Involving Femur Fractures, After The Su v. Merck Case Ended Suddenly In A Mistrial**

(Posted by Tom Lamb at DrugInjuryWatch.com)
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UPDATE: "Verdict for Merck in Suit Alleging Fosamax Causes Femur Fractures" (New Jersey Law Journal, 5/1/13)

Jurors answered "no" to the first question on the verdict sheet, which was, "did Bernadette Glynn prove by the preponderance of the evidence that she experienced an atypical femur fracture in April 2009?"

Their answer of "no" meant they did not proceed to questions on adequacy of Merck's warning and the proper amount of compensation.

The verdict was reached after 15 days of trial before U.S. District Judge Joel Pisano.

(5/3/13)

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UPDATE: "Merck Wins First Femur-Related Fosamax Suit" (Law360, 4/29/13)

Merck & Co. on Monday triumphed in a New Jersey bellwether trial over femur fractures allegedly caused by its bone drug Fosamax, after a jury ruled that the nature of the plaintiff’s injury ruled out Fosamax as a potential cause.

A New Jersey federal jury found for the drugmaker, deciding plaintiff Bernadette Glynn’s femur fracture could not have been caused by Fosamax, a drug prescribed to treat diminished bone density, agreeing that Glynn’s fracture was consistent with a traumatic injury rather than compromised bone health....

(4/30/13)

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UPDATE: "Jury rules in Merck's favor in Fosamax trial" (Bloomberg, 4/29/13)

(4/30/13)

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UPDATE: "Statement on FOSAMAX® (alendronate sodium) Product Liability Trial":

... In Glynn v. Merck, the plaintiff alleges she used FOSAMAX and sustained an atypical femur fracture.

... Merck believes the evidence will show that the plaintiff did not sustain an atypical femur fracture, that FOSAMAX did not cause plaintiff’s fracture, and that the company acted responsibly in researching and developing FOSAMAX and in monitoring the medicine ever since it has been on the market.

Merck Press Release, 4/9/13

(4/11/13)

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UPDATE: "At Fosamax trial, attorney charges Merck knew drug increased risk of fractures":

Merck & Co. was aware its Fosamax osteoporosis drug might cause bone brittleness and increase fracture risks years before it was made available to the public, a lawyer told a jury today at the start of a lawsuit trial....

Bloomberg News, 4/9/13

(4/9/13)

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In mid-March 2013 the Su v. Merck trial started but was stopped, i.e., mistrial declared, before the second week of testimony began due to an unfortunate medical development concerning the plaintiff.

Today, April 8, 2013, the trial for this so-called "bellwether", or test, case, Glynn v. Merck Co., 3:11-cv-05304, U.S. District Court, District of New Jersey, begins in Trenton, NJ, with Judge Joel Pisano presiding.

This second Fosamax - femur fracture bellwether case concerns a broken femur suffered by New York resident Bernadette Glynn in April 2009, after she had been using Fosamax regularly over a period of seven years, starting in 2002.

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Strictly Confidential, No Obligation.

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As regards some of the evidence that the jury will hear during the Glynn trial, from an April 8, 2013 Bloomberg news report, "Merck Starts Fresh Trial on Fosamax Broken-Leg Claims":

In preparation for the [Glynn v. Merck] trial, [Judge] Pisano ruled on March 8 [2013] that Merck couldn’t block testimony or evidence about the short-term effectiveness of Fosamax. [Judge Pisano] granted [Merck's] bid to block evidence about e-mails containing opinions of non-Merck employees regarding the drug’s effectiveness, calling them “inadmissible hearsay.”

In the same ruling, [Judge] Pisano said [attorneys for Plaintiffs Richard and Bernadette] Glynn could only use so-called adverse event reports -- formal descriptions of similar injuries suffered by other people -- to show whether Merck had been properly notified of a possible connection between Fosamax and [atypcial, low-stess femur fractures].

We will be monitoring this April 2013 Glynn v. Merck Fosamax trial, which is expected to last about three weeks, and will report the jury verdict here when it becomes available.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Review done by attorney Tom Lamb)

Fate Of Affymax Anemia Drug Omontys Remains Uncertain As FDA And Drug Company Continue To Study Cause Of Drug Reactions

2013-04-01T17:15:00-04:00

Fresenius Dialysis Clinics Decided To Stop Using Omontys Before FDA Warning Came Out Due To Five Adverse Event Reports From One Day In February 2013

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Omontys (peginesatide) injection had been used in more than 25,000 patients since it was approved by the FDA in March 2012 to treat kidney dialysis patients for anemia stemming from chronic kidney disease. Omontys was generally more convenient than other anemia drugs in that it can be infused once month, while other anemia drugs generally are given a dozen or more times a month.

Less than a year after Omontys was FDA-approved, however, all lots of this apparently unsafe drug were recalled by its manufacturer, Affymax Inc., as we reported in this article, "Kidney Dialysis Anemia Drug Recall: Omontys: Hypersensitivity / Allergic Reactions And Anaphylaxis; Serious Side Effects With Some Being Fatal".

Now, a new Wall Street Journal (WSJ) piece by reporter Thomas M. Burton provides some interesting background information about the Omontys safety signals that started to emerge back in August 2012 and were finally detected in February 2013.

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From this March 29, 2012 WSJ news report, "Anemia Drug Had Early Side Effects":

A total of 98 "adverse events" tied to the drug were reported to the FDA by Feb. 22 of this year, the day before the recall. There were 12 deaths among the reports to the FDA, but the cause of death wasn't specified, and the patients getting dialysis and Omontys are by definition already very sick. Takeda said there were five deaths that the companies considered in deciding to recall Omontys lots on Feb. 23....

Fresenius Medical Care AG, which operates 1,800 dialysis facilities in the U.S., said it has used Omontys in over 18,000 patients.

It said that shortly after it expanded use of the drug in February, on Feb. 11 "five adverse event reports of allergic type reactions were received," according to a company spokesman. Soon after, Fresenius decided to "pause" in its use of Omontys, the spokesman said.

We are currently investigating what appears to be one of those February 11, 2013 adverse events at a Fresenius dialysis clinic. Our case involves a woman in Florida who suffered a life-threatening anaphylactic reaction for which she was hospitalized three days.

Generally, anaphylactic reactions, or anaphylaxis, are acute allergic reactions in which the patient's airway constricts making it a struggle to breathe, with blood pressure plummeting and the heart beating erratically such that it might not be able to pump enough blood.

According to the March 2013 WSJ article about Omontys, the FDA is currently "evaluating various factors" in its determination about whether Omontys will be sold again, or not, in the U.S.

We are actively monitoring the Omontys recall situation and investigating possible products liability lawsuits for serious side effects involving hypersensitivity reactions such as anaphylaxis, which can be fatal and result in the patient's death.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Review done by attorney Tom Lamb)

NuvaRing Update 2013: More NuvaRing Lawsuits Filed According To Merck Report; First NuvaRing Trial Dates Moved Back (Again)

2013-03-25T16:30:00-04:00

March 2013 Rulings By New Jersey Judge Martinotti And NuvaRing MDL Judge Sippel On Expert Witness Testimony Issues All Go In Favor Of Plaintiffs

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to the Merck 2012 Annual Report / Form 10-K, at page 110, there were approximately 1,315 NuvaRing cases filed against Organon, Schering-Plough, and Merck at the start of January 2013, with about 1,105 of those NuvaRing lawsuits being part of the federal court NuvaRing MDL.

As background, about a year ago we posted this article, "950 NuvaRing Lawsuits Pending As Of December 31, 2011 According To Merck Annual Report", which was an update to our earlier article, "730 NuvaRing Lawsuits Filed As Of December 31, 2010 Per Merck Annual Report".

On March 5, 2013 Judge Brian Martinotti moved the first New Jersey state court NuvaRing trial date from May 6, 2013 to June 17, 2013 at the request of the defense attorneys.

It is anticipated that, in turn, Judge Rodney Sippel will move back the start date for the first federal court NuvaRing MDL trial from July 2013 to August 2013. (Note: Back in April 2010 Judge Sippel had scheduled the first NuvaRing MDL to start in June 2011.)

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Also in March 2013, both Judge Martinotti and Judge Sippel issued some significant rulings having to do with expert witnesses and expert testimony at trial. Those NuvaRing experts rulings which were in favor of the plaintiffs should be most helpful with the presentation of evidence against the drug companies at the upcoming NuvaRing trials later this year.

We will continue to report significant developments in the NuvaRing drug injury litigation.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Review done by attorney Tom Lamb)

Emerging Drug Safety Issue: Possible Increased Risk Of Pancreatic Cancer With Byetta, Januvia, And Victoza -- Little Is Known About Long-Term Effects

2013-03-18T15:50:00-04:00

As "Pancreatitis Is On The Pathway Toward Pancreatic Cancer", Medical Studies Needed To Determine If GLP-1 Diabetes Medications Linked To Cancers Or Malignancies Involving Pancreas

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type 2 diabetes" (EMA Press Release, 3/26/13)

(3/26/13)

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We last wrote about the relatively new and increasingly popular diabetes medications Byetta and Januvia back in November 2011: "Byetta And Januvia: More Debate About The Possible Increased Risk Of Pancreatitis, Pancreatic Cancer, And Thyroid Cancer".

And our last report about Victoza was in November 2012: "The Drug-Induced Pancreatitis Safety Problem That Hangs Around Victoza Gets Another Look".

Now, with a couple of developments in the first part of 2013, it seems that the pancreatic cancer risk is becoming the real drug safety issue as regards Byetta, Januvia, Victoza, and the other incretin mimetic drugs for type 2 diabetes.

In the last few weeks there has been an FDA alert about these diabetes drugs as well as a new significant medical journal article about a study concerning Byetta and Januvia which both have to do, in part, with the possible association between pancreatic cancer and the use of Victoza, Januvia, Byetta, etc.

First, from the March 14, 2013 "FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes":

The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.

Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

This March 2013 drug safety alert points out that "FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics."

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Diabetes drugs in the incretin mimetic class -- and their manufacturers --include:

Byetta, Bydureon (Exenatide / injection) -- Amylin, which was acquired by Bristol Myers Squibb (BMS), which co-markets with Astra-Zeneca (AZ);

Victoza (Liraglutide / injection) -- Novo Nordisk;

Januvia, Janumet, Janumet XR, Juvisync (Sitagliptin / tablets) -- Merck;

Onglyza, Kombiglyze XR (Saxagliptin / tablets) -- BMS / AZ;

Nesina, Kazano, Oseni (Alogliptin / tablets) -- Takeda; and,

Tradjenta, Jentadueto (Linagliptin / tablets) -- Boehringer Ingelheim

Next we move to the most recent medical article to raise the possible link between pancreatic cancer and these newer diabetes drugs, "Glucagonlike Peptide 1–Based Therapies and Risk of Hospitalization for Acute Pancreatitis in Type 2 Diabetes Mellitus: A Population-Based Matched Case-Control Study", published online by JAMA Internal Medicine in late February 2013.

From a February 26 Medscape.com report about this JAMA medical journal article, "GLP-1 Mimetics Double Pancreatitis Risk in Diabetics":

But most important, said [Sonal Singh, MD, from Johns Hopkins University School of Medicine, Baltimore, Maryland], the study should raise a red flag because "pancreatitis is on the pathway toward pancreatic cancer." Writing in an accompanying commentary, Belinda Gier, PhD, and Peter Butler, MD, from the Larry L. Hillblom Islet Research Center, University of California, Los Angeles, agree, calling the issue of pancreatic cancer "the real crux of the controversy with regard to the safety of GLP-1–based treatment."

"At present, the GLP-1 class of drugs is heavily promoted (and prescribed) as having purported advantages that outweigh its risks. Singh and colleagues provide a timely reminder that, despite large numbers of underpowered studies claiming the contrary from marketing companies, little is yet known about long-term adverse effects of the GLP-1 class of drugs on the exocrine pancreas," they observe.

We will look for future announcements or drug safety alerts from FDA about the safety of Byetta, Januvia, and Victoza, as well as monitor the leading medical journals for long-term studies examining the development of pancreatic cancer in diabetic patients using these newer diabetes medications.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Review done by attorney Tom Lamb)

March 2013 Fosamax Product Liability Litigation Update: Femur Fracture Cases Against Merck

2013-03-11T14:30:00-04:00

December 31, 2012 Totals: 2,075 New Jersey (NJ) State Court Lawsuits, With 820 Cases Pending In Federal Court Fosamax MDL And 420 California Claims

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Second Fosamax - Femur Fracture Lawsuit Trial Starts In New Jersey, This One In The Federal Court MDL With Judge Pisano Presiding"

(4/8/13)

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The first Fosamax - femur fracture trial, Su v. Merck, starts today (March 11, 2013) in a New Jersey (NJ) state court.

From the Merck 2012 Annual Report / Form 10-K (PDF) we get this information about the NJ state court Fosamax litigation:

As of December 31, 2012, approximately 2,075 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. The parties have selected an initial group of 30 cases to be reviewed through fact discovery.

The federal court Fosamax multidistrict (MDL) for femur fracture cases was created in May 2011 and the first trial in that litigation is currently scheduled to start in April 2013.

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From the Merck 2012 Annual Report here is what the drug company reports about this federal court MDL Fosamax litigation:

[A]pproximately 820 cases were pending in the Fosamax Femur Fracture MDL as of December 31, 2012. A Case Management Order has been entered that requires the parties to review 40 cases (later reduced to 33 cases). Judge Joel Pisano has selected four cases from that group to be tried as the initial bellwether cases in the Fosamax Femur Fracture MDL and has set an April 8, 2013 trial date for the first bellwether case, which will be Glynn v. Merck. The Zessin v. Merck case is set to be tried in September 2013; the Young v. Merck case is set to be tried in January 2014; and the Johnson v. Merck case is set to be tried in May 2014.

Lastly, out west, at the end of December 2012 there were 420 California state court lawsuits alleging femur fractures caused by Fosamax use. The consolidated proceedings for those California cases is situated in Orange County, with Judge Steven Perk presiding.

Be assured that we are watching for the Su v. Merck trial jury verdict in New Jersey and we will continue to monitor each of the three Fosamax litigations -- NJ, MDL, and CA.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

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As Bayer Settlements For YAZ, Yasmin, Ocella, And Gianvi Continue In 2013, Total Payments Will Go Over The $1 Billion Level

2013-03-04T17:20:00-05:00

According To Bayer 2012 Annual Report, More Than 3200 Blood Clot Claims Remain Unsettled And Additional Lawsuits Are Anticipated By Drug Company

(Posted by Tom Lamb at DrugInjuryWatch.com)

To start, by my review, there is only one single mention of "Beyaz" in the entire Bayer 2012 Annual Report and none of "Safyral", although these are two of the drug company's newer drospirenone-containing oral contraceptive pills.

A close read of that corporate Form 10-K SEC filing, however, suggests that Bayer apparently is, in fact, counting Beyaz and Safyral lawsuits among the 10,000 pending filed lawsuits and the 1,200 asserted claims that have not been filed (probably its tolling-agreement cases total) as of February 12, 2013.

From the Yasmin™ / YAZ™ part of the Product-Related Litigation section of the drug company's most recent Annual Report, which was filed in late February 2013:

Claimants allege that they have suffered personal injuries, some of them fatal, from the use of Bayer’s drospirenone-containing oral contraceptive products such as Yasmin™ and / or YAZ™ or from the use of Ocella™ and / or Gianvi™, generic versions of Yasmin™ and YAZ™, respectively, marketed by Barr Laboratories, Inc. in the United States. Claimants seek compensatory and punitive damages, claiming, in particular, that Bayer knew, or should have known, of the alleged risks and should be held liable for having failed to disclose them or adequately warn users. [emphasis added]

Stepping back from that specific issue, let's take a look at the so-called Bayer settlement program which began in early 2012. Bayer has thus far acknowledged the existence of about 8000 claims for blood clot-related side effects -- e.g., deep vein thrombosis (DVT) and/or pulmonary embolism (PE) -- arising from the use of its drospirenone (DRSP) birth control pills, with about 60 percent of those cases having been settled by the drug company to date.

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Again, from the Bayer 2012 Annual Report:

As of February 12, 2013, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 4,800 claimants in the U.S. for a total amount of about US$1 billion. Bayer is only settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case-specific analysis of medical records on a rolling basis. Such injuries are alleged by about 3,200 of the pending unsettled claimants.

Concerning how far Bayer has come with its YAZ / Yasmin settlement program, as we reported in our article last year about the Bayer 2011 Annual Report, there were settlement agreements in just 70 cases as of mid-February 2012.

But as pointed out by the drug company in both its 2011 and 2012 Annual Reports, "Additional lawsuits are anticipated." And some of those newly filed cases will include DVT and PE cases involving women using Beyaz or Safyral.

In the end, we expect that those Beyaz and Safyral blood clot claims will be settled by Bayer eventually -- even if those particular DRSP birth control cases are not being mentioned by the drug company to the same extent that the YAZ, Yasmin, Ocella, and Gianvi claims have been to this point in time.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential (Review done by attorney Tom Lamb)