Drug Injury Watch

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

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)

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UPDATE: "Medtronic bone graft has limited benefit, may cause harm: reviews"  (6/17/13, Reuters)

"Reviewers: Medtronic's controversial Infuse offers little to no benefit"  (6/17/13, Minnesota Public Radio)

(6/18/13)

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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.

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Free Infuse Bone Graft Case Evaluation 

Strictly Confidential, No Obligation.

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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

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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Free Mirena Case Evaluation 

Strictly Confidential, No Obligation.

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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)

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

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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Free Fosamax Case Evaluation 

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

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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Free Omontys Case Evaluation 

Strictly Confidential, No Obligation.

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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)