Drug Injury Watch

May 2011: Defense Verdict In Fourth Zometa Trial, Hogan v. Novartis

Jury Considered Causation Issue And Label Warning About Osteonecrosis Of The Jaw (ONJ)

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late May 2011 a federal court jury sitting in New York City found in favor of the drug company Novartis in a products liability lawsuit concerning the company's bisphosphonate medication Zometa.  The case is Hogan v. Novartis Pharmaceuticals Corp, which was pending in the U.S. District Court for the Eastern District of New York.

According to a May 25, 2011 Bloomberg article, "Novartis Properly Warned About Bone Drug Zometa’s Risks, Lawyer Tells Jury", in closing arguments, a defense lawyer representing Novartis argued that the drug company had done nothing wrong.  In particular, the lawyer for Novartis asserted the company had properly warned about the osteonecrosis of the jaw (ONJ) side effect that has been associated with intravenous bisphosphonate medications like Zometa and Aredia as well as oral forms of the medication like Fosamax and Boniva.

A May 26, 2011 Reuters article, "U.S. jury finds Novartis not liable for jaw disease", provided some additional key facts about this Zometa lawsuit:

According to documents presented in Brooklyn federal court, Hogan was prescribed Zometa in 2003 after being diagnosed with multiple myeloma, a type of cancer that affects blood plasma cells.

In 2004, a dental surgeon discovered Hogan had developed osteonecrosis of the jaw, which causes bones in the jaw to deteriorate. The surgeon suggested a link between Zometa and the disease, the lawsuit stated.

Hogan's widow said Novartis knew about the risks of Zometa but failed to inform physicians until late 2004. As a result, she said, Hogan developed the bone disease, which left him debilitated in his final years, the lawsuit alleged.

Novartis defended itself by pointing to testimony from the physician who prescribed Zometa to Hogan, who said the potential benefits of Zometa outweighed its risks. Further testimony from Hogan's dentist indicated that he had numerous dental problems when he first came in for treatment.

Mr. Hogan died from multiple myeloma in 2005, the year before this so-called "survival action" personal injury claim was filed on his behalf by his wife.

For some information about the three earlier Zometa lawsuits that have gone to trial, see these articles:

First Zometa-ONJ Personal Injury Lawsuit Against Novartis Goes To Jury This Week (October 20, 2009)

Aredia / Zometa Jaw Injury Lawsuit In New Jersey Ends In Defense Verdict For Novartis (October 7, 2010)

North Carolina Aredia / Zometa Product Liability Federal Court Trial Jury Verdict Coming Soon (November 19, 2010)

We will continue to monitor the hundreds of Zometa and Aredia lawsuits filed against Novartis.

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Two New Books About Drug Injury Lawsuits, "All The Justice Money Can Buy" and "The Trial"

First Covers One Of The Early Vioxx Cases, Second Is Legal Thriller Fiction With Parallels To Ketek Fiasco

(Posted by Tom Lamb at DrugInjuryWatch.com)

As the summer reading season draws near, we take a break from our usual reporting to let you know about two new books which provide insights to the world of pharmaceutical drug litigation concerning serious side effects, commonly referred to as drug injury law.

The first new book, which comes out June 7, 2011, is "All the Justice Money Can Buy -- Corporate Greed on Trial", by Snigdha Prakash, an investigative journalist who was a reporter for NPR from 1998 to 2007 where she developed a deep knowledge of the pharmaceutical industry and product liability litigation.

Here is part of the publisher's description (accessed 5/23/11) of this non-fiction work about the Vioxx debacle:

All the Justice Money Can Buy is the true-life story of a courtroom showdown between the man many consider the best trial lawyer of his generation and one of the nation’s richest and most-respected corporations.

Journalist Snigdha Prakash is embedded with the plaintiffs’ team for the seven-week trial, and takes us into the trenches of the tough—and dirty—battle between corporate interests and the individual that plays out in the courts. From early mornings when Lanier works in his hotel suite, to the daily post-mortems after court, and late nights in the plaintiffs’ “war room,” Prakash shadows Lanier and his team.

With its bird’s-eye view of the strategic thinking and meticulous planning that undergird Lanier’s seemingly unrehearsed performances in court, and of the well-oiled machine of lawyers and assistants that backs his every move, All the Justice Money Can Buy is a fast-paced, often funny journey behind the front-lines of a high-stakes, 21st century legal trial. Along the way, Prakash renders a piercing portrait of the challenges that await those who would take on corporate interests.

Part corporate expose´ and part legal thriller, All the Justice Money Can Buy is a gripping—and topical—read for our scandal-plagued times.

The second book, “The Trial”, by Texas attorney Larry D. Thompson, raises serious issues about the pharmaceutical industry's conduct and the FDA’s drug safety oversight.  Released in March 2011, this work of fiction will bring to mind the Ketek fiasco, for those familiar with that hard-to-believe real life story. 

Here is what the Literary Guild had to say about "The Trial": 

A pharmaceutical giant’s disregard for human life spurs to action a small-town lawyer in Larry D. Thompson’s stunning courtroom drama, The Trial. Luke Vaughn’s rage stems from the fact that, unbeknownst to him, his daughter, a rebellious teenager, volunteered for a clinical drug trial that’s left her in desperate need of a liver transplant—and he can’t afford it. So Luke decides to make the culprits pay, and he chooses to do so in the venue he knows best…the courtroom. When Luke discovers what he suspected all along—that the drug company and the FDA knew the pill carried potentially lethal side effects—he thinks the case is won. But his adversary’s prescription for silencing the opposition calls for bribery, kidnapping…and murder.

I thoroughly enjoyed my time with the "The Trial", and I look forward to reading "All The Justice Money Can Buy", soon.

Depending on your preference, fiction or investigative reporting, you will certainly get some insights to the world of drug injury litigation from reading either one of these new books.

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Yasmin / YAZ MDL: First Trial Moved From September 2011 To January 2012 Per Plaintiffs' Request

A Pulmonary Embolism Case Is Selected By Judge Herndon; More Than 6600 Lawsuits Filed Against Bayer As Of May 2011

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  The January 9, 2012 Sims v. Bayer "bellwether", or test, trial has been postponed indefintely, and Judge David Herndon has ordered mediation for the entire Yasmin and YAZ MDL litigation in order to see if some or all of these federal court lawsuits can be settled. 

See:  CASE MANAGEMENT ORDER NUMBER 53 -- Regarding Bellwether Plan

(1/4/12)

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In May 2011 federal court Judge David R. Herndon announced that the first trial in MDL 2100 -- Yasmin and YAZ (Drospirenone) Marketing, Sales Practices and Products Liability Litigation -- will start in January 2012 and that it will be a pulmonary embolism case.  At the time, there were more than 6600 YAZ / Yasmin / Ocella lawsuits filed in the MDL on behalf of more than 8000 plaintiffs.

In more detail, in mid-March 2011 the Yasmin / YAZ federal court MDL Plaintiffs Steering Committee (PSC) filed a motion to modify the Amended Case Management Order 24.  This PSC motion began as follows:

The PSC respectfully moves the Court to modify Amended Case Management Order 24
(CM/ECF Doc. 1329) by modifying the Bellwether Trial Selection Plan. As will be outlined in detail below, good cause exists for this motion. The volume and complexity of discovery that needs to be completed before the expert disclosure deadline in the PE case (currently May 2, 2011), despite the parties’ best efforts to move expeditiously, make the current schedule unrealistic....

The PSC concluded their motion by suggesting to Judge Herndon a January 9, 2012 trial of the first pulmonary embolism (PE) "bellwether", or test, case.
 
In turn, at an April 12, 2011 Status Conference, Judge Herndon vacated the September 12, 2011 trial date for the first MDL trial and then, the following day, issued Case Management Order No. 32, in which he set forth a modified plan for the selection of a set of possible bellwether cases from which the judge would pick the lawsuit that would be the subject of the first Yasmin / YAZ MDL trial.

Finally, in the second week of May 2011 Judge Herndon announced that the first MDL trial would be a pulmonary embolism case which is expected to start in January 2012 -- about four months after the original first trial date of September 12, 2011.

We will continue to monitor developments in the Yasmin / YAZ MDL concerning the first bellwether trial date.

Meanwhile, we continue to hear from women who have suffered deep vein thrombosis (DVT) and/or pulmonary embolism (PE) or needed to have their gallbladder removed after using one of the following birth control pills that contains the progestin drospirenone (DRSP): YAZ, Yasmin, and Ocella as well as Gianvi, Zarah, Beyaz, and Safyral.

Free Case Evaluation:  YAZ / Yasmin / Ocella / Gianvi / Zarah / Loryna / Syeda / Beyaz / Safyral
Strictly Confidential, No Obligation.

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Fosamax: Femur Fractures And Osteonecrosis Of Jaw: Medical Journal Articles: May 2011 Update

One Sees Mixed Findings About These Fosamax Side Effects From Various Research Reports And Case Studies

(Posted by Tom Lamb at DrugInjuryWatch.com)

Last month we wrote about the status of the thousands of Fosamax lawsuits that have been filed against Merck alleging that the use of this bisphosphonate drug by osteoporosis patients resulted in either atypical low-stress femur fractures or osteonecrosis of the jaw, commonly called ONJ.

In this article we provide an overview of the medical articles about these Fosamax side effects that have been published in the first part of 2011.  As you will see, there is some difference of opinion found in these several research reports and case studies.

We begin with two recent articles about femur fractures, which is the common term for the atypical subtrochanteric femoral shaft fractures that are the subject of an increasing number of Fosamax cases filed against Merck:

(1) "Oral bisphosphonates and risk of subtrochanteric or diaphyseal femur fractures in a population-based cohort", published by Journal of Bone and Mineral Research in May 2011

From the Abstract: "There was no evidence of an increased risk of subtrochanteric or diaphyseal femur fractures in bisphosphonate users compared with raloxifene/calcitonin users. However, this study cannot exclude the possibility that long-term bisphosphonate use may increase the risk of these fractures."

(2) "Bisphosphonate use and atypical fractures of the femoral shaft", published by The New England Journal of Medicine in May 2011

A large Swedish cohort study found that the use of bisphosphonates for osteoporosis like Fosamax (alendronate) increased the risk of femoral shaft fractures by nearly 50-times; the absolute risk of developing a femur fracture, however, remained very small.

As for recent medical research regarding bisphosphonate-related osteonecrosis of the jaw (BRONJ), we direct you to these articles:

(3) March 2011 Medscape article about International Association of Dental Research (IADR) 89th General Session and Exhibition: Abstract 890 (free registration required)

Oral bisphosphonates like Fosamax do not increase the risk for osteonecrosis of the jaw but study did find a six-times increased risk for ONJ in patients getting intravenous (IV) bisphosphonates.

(4) "ONJ in Two Dental Practice-Based Research Network Regions", published by the Journal of Dental Research in February 2011.

ONJ has been associated with all of the bisphosphonates, including Fosamax (alendronate); patients who had used oral bisphosphonates were 15.5 times more likely to have ONJ than those who had not -- albeit the absolute risk for ONJ from oral bisphosphonates is low.

We will continue to monitor the medical literature for developments concerning the association between Fosamax and low-stress femur fractures as well as Fosamax and the ONJ jaw injury.

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Medical Journal Withdraws Article About Januvia And Byetta After It Gets Letters From Two Drug Companies

April 2011 Edition Of BMJ Breaks News And Provides Insight From One Who Saw An Increased Risk Of Pancreatitis 

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to a news item published April 11, 2011 by The British Medical Journal (BMJ), letters written by Merck and Novo Nordisk to Anil Rustgi, the editor-in-chief of Gastroenterology, resulted in that journal withdrawing an article which it had posted on its website about how Januvia (sitagliptin) and Byetta (exenatide) have been associated with an increased risk of pancreatitis as well as several cancers.

From this April 2011 BMJ piece, "Journal withdraws article after complaints from drug manufacturers":

In the disputed paper the team responsible... used the FDA database of adverse events from 2004 to 2009 to compare the number of cases of disease reported by users of the two drugs with the number reported by users of four other antidiabetes drugs.

They concluded that the risk of pancreatitis was increased by 6.8 times in users of sitagliptin (95% confidence interval 4.7 to 10.2) and by 11.8 times (8.5 to 16.6) in users of exenatide. For pancreatic cancer the risk ratios were 2.4 and 2.0, respectively, and for thyroid cancer 3.4 and 7.6....

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The "disputed paper" was put on the Gastroenterlogy journal's web site on or about February 21, 2011.  About two weeks later, the two drug companies took their actions which resulted in getting this article removed:

The companies wrote letters to Anil Rustgi, the journal’s editor in chief, after the paper appeared online. They expressed concern that the analysis, which used data derived from the US Food and Drug Administration’s adverse event reporting system, reached conclusions that could not be justified. Merck warned that the paper could have a negative effect on the care of patients, while Novo Nordisk claimed that it could spark an unnecessary health scare.

One of the authors of the paper, Peter Butler, of the David Geffen School of Medicine at the University of California at Los Angeles (UCLA), said that the drug companies wanted the paper deleted. Gastroenterology’s website initially recorded the paper as “retracted,” which might imply that the authors themselves had chosen to remove it. This was not the case, Dr Butler said: the decision had been taken by the editors. The journal has since changed the paper’s status from “retracted” to “withdrawn.”... 

Dr Butler said he was pleased that the two drug companies had not achieved “complete deletion” of the paper.

We have been monitoring developments concerning the pancreatitis issue for Januvia since 2009, when we wrote these two articles:

• FDA Wants Merck To Change Januvia Label With Increased Warning About Pancreatitis Risk
• A Review Of Recent Research On Issue Of Whether Januvia Can Cause Pancreatitis
  

As for the link between Byetta and pancreatitis, our first articles were written back in 2008:

• More Information About Reports Of Byetta Use Being Linked To Acute Pancreatitis
• August 2008: Byetta Associated With Hemorrhagic Pancreatitis And Necrotizing Pancreatitis

We will continue to watch for reports of pancreatitis that may have been caused by Januvia or Byetta.

If you are aware of such a case, you may want to share your information by leaving a Comment below or, if interested in a possible legal case, by you can submit a Byetta Case Evalution form.

 

P.S.  The diabetes drug Januvia is marketed by Merck.

Byetta is marketed by Amylin Pharmaceuticals and Eli Lilly.

Novo Nordisk has a relatively new diabetes drug, Victoza (approved by FDA in 2010), which is in the same class of drugs as Byetta.  Victoza (liraglutide) has been linked to pancreatitis, also.  See "Acute Pancreatitis Associated with Liraglutide", The Annals of Pharmacotherapy, April 2011.

(5/3/11)

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