Drug Injury Watch

An Increase In Complications Due To Surgical Revision Of Defective Sprint Fidelis Leads

Lead Wire Extraction Surgery Might Be More Hazardous Than Once Thought, Including Serious Cardiovascular Injuries And Deaths

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Sprint Fidelis lead wire, a heart defibrillator cable made by Medtronic, was removed from the market in October 2007 due to a defect that caused it to malfunction, which may have resulted in at least five patient deaths.

An April 7, 2009 New York Times news report by Barry Meier, "Removing Medtronic Heart Cables Is Hard Choice", describes what was the then-current thinking about the consequences for patients who had one of these defective Sprint Fidelis leads -- and things have seemingly gotten worse for them since then:

But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country.

In the next few years, thousands of those patients may face risky surgical procedures to remove and replace the electrical cable, which connects a defibrillator to a chamber of the heart.

Medtronic estimates that the cable has failed in a little more than 5 percent of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.

Already, four patients have died during extractions. Experts fear that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of the operations.

“I think we are just seeing the tip of the iceberg,” said Dr. Charles J. Love, a cardiologist at Ohio State University Medical Center in Columbus, who specializes in cable extractions.

As regards how things may be worse now, to begin, I will quickly touch upon the failure rate aspect by referring back to a couple of articles which I posted here in the past:

From December 2009:  "Sprint Fidelis Lead Wire Failure Rate Could Rise To 30 Percent By Four Years" -- About 260,000 Medtronic Sprint Fidelis Leads Were Implanted In US, With Approximately 143,000 Still Active

From February 2010:  "There Is Disagreement Over The Three-Year Failure Rate For Sprint Fidelis Lead Wires"-- Medtronic Says 4.6 Percent Of Leads Failed, While Reports From Some Hospitals Indicate 9.2 Percent Of Sprint Fidelis Wires Failed

We turn next to the surgical complications aspect.  We will start with an April 2010 Medscape article, "Deaths and Cardiovascular Injuries Due to Device-assisted Implantable Cardioverter–Defibrillator and Pacemaker Lead Extraction" (free registration required) by Robert G. Hauser, M.D. -- who has been an active participant in the debate about the consequences of the Sprint Fidelis recall -- and colleagues. From this Dr. Hauser article, we get these points:

• The controversy surrounding the management of patients who have Sprint Fidelis ICD leads and the report of deaths associated with Sprint Fidelis lead extraction prompted us to examine the worldwide adverse events that have been reported by manufacturers, hospitals, and health providers to the US Food and Drug Administration (FDA). The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than available data suggest, and whether procedural safety precautions, including standby cardiothoracic surgery, are effective. [footnotes omitted]
• This study shows that device-assisted lead extraction has resulted in fatal cardiovascular injuries often despite emergency surgical intervention. Moreover, the majority of the reported deaths have occurred in the last 2 years, and most of them were caused by lacerations of major veins during laser or mechanical dilator sheath extractions. This finding is timely and important because more than 100 000 patients have underperforming Sprint Fidelis ICD leads that may require replacement. Medtronic has announced that 4 of the 13 deaths due to fractures of Sprint Fidelis leads were associated with the extraction of the failed lead.
• Conclusion  These findings suggest that device-assisted lead extraction is a high-risk procedure and that serious complications including death may not be mitigated by emergency surgery. However, skilled standby cardiothoracic surgery is essential when performing pacemaker and ICD lead extractions. Although the incidence of these complications is unknown,...

And the last part of that Conclusion, above, makes especially significant this June 2010 article, "Complications Associated With Revision of Sprint Fidelis Leads", published by the medical journal Circulation.  From the Abstract for this article:

Background—  It has been observed that replacement of an implantable cardioverter-defibrillator generator in response to a device advisory may be associated with a substantial rate of complications, including death. The risk of lead revision in response to a lead advisory has not been determined previously.

Methods and Results—  .... As of June 1, 2009, there had been 310 lead failures found in 6237 Sprint Fidelis leads in Canada (4.97%) over a follow-up of 40 months. There were 469 leads to be revised, 66% for confirmed fracture. Of the patients who underwent revision, 95% had a new lead inserted, whereas 4% had a pace/sense lead added. The lead was removed in 248 cases (53%), by simple traction in 61% and by laser lead extraction in 33%. Complications were encountered in 14.5% of the lead revisions; 7.25% of these were major, whereas 7.25% were minor. There were 2 deaths (0.43%). The overall risk of complications (19.8%) was greater in those who underwent lead removal at the time of revision than in those whose leads were abandoned (8.6%; P=0.0008).

Conclusions—  The overall rate of major complications that arose from lead revision due to the Sprint Fidelis advisory was significant. This must be taken into account when lead revision is planned in those patients who have not yet demonstrated an abnormality in lead performance.

So the patient who still has a defective Sprint Fidelis lead wire implanted is probably being advised to keep it in place until a break or fracture occurs -- which potentially causes a massive unnecessary shock to the patient's heart, or causes the defibrillator battery to go dead and the implantable heart device fails to deliver a necessary life-saving shock.

If and when the Sprint Fidelis lead wire breaks or fractures, then the patient is faced with a revision surgery which appears to be associated with a significant rate of hazardous, and possibly fatal, complications.

In the end, it seems relatively clear that this is quite an unfortunate situation to be in for any such patient.

P.S.  "Psychological Adjustment in ICD Patients Living With Advisory Fidelis Leads", published early -- August 19, 2010 -- online by The Journal of Cardiovascular Electrophysiology. 

From the Abstract:

• This study focused on the Sprint Fidelis advisory.
• The study had 2 objectives: (1) to examine whether there is adverse psychological adjustment when an ICD is under advisory, and (2) to assess the psychological sequel of advisory ICD component malfunction.
• On one side, the risk of device malfunction and the likely severity of clinical sequelae have to be estimated. This estimate has to be weighed against the risks of surgery to replace the advisory component.

(8/31/10)

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Digitek MDL Federal Court Judge Goodwin Issues Litigation Stay In August 2010

October 2010 Meeting With State Court Judges Is Postponed; Fate Of Digitek Bellwether Trials Uncertain

(Posted by Tom Lamb at DrugInjuryWatch.com)

On August 12, 2010 U.S. District Court Judge Joseph Goodwin issued Pretrial Order #62 (Re: Stay of Litigation) for the In Re Digitek® Product Liability Litigation, MDL No. 1968, which begins with this simple but far-reaching statement:

For reasons appearing to the court, I ORDER that all discovery, motion practice and any scheduled hearings in cases in MDL 1968 are hereby STAYED until October 26, 2010.

The full ramifications of this August 2010 Order are not yet clear, but it is seems relatively certain that Judge Goodwin will not be meeting with the several state courts handling Digitek cases around the country -- namely, Alan Moats of Taylor County, West Virginia, Buddie Hahn of Orange County, Texas; Sandra Moss of Philadelphia, Pennsylvania, and Brian Martinotti of New Jersey -- for a hearing in Philadelphia, PA on October 13 and 14, 2010.  This meeting had been arranged by Judge Goodwin back in back in December 2009, when he issued Pretrial Order #48 for In Re Digitek® Product Liability Litigation, MDL No. 1968, entitled "Joint Hearing to Address Challenges to Scientific and Technical Evidence".

There were approximately 850 lawsuits in the federal court Digitek MDL at the time when this Pretrial Order was issued by Judge Goodwin in August 2010.

Previously, in November 2009, Judge Goodwin issue Pretrial Order #47 by which it was announced that five Digitek federal court cases had been selected for trial.  These cases would serve as the first set of so-called "bellwether", or test cases, for the Digitek MDL.

At the present time, it is unclear what effect Pretrial Order #62 will have on those Digitek bellwether trials.

We will continue to monitor the Digitek litigation and report significant developments here on our Drug Injury Watch blog.

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Popular Seizure And Bipolar Disorder Medication Lamictal Associated With Aseptic Meningitis In August 2010

FDA Working With GlaxoSmithKline To Update Label, Or Package Insert, And Patient Medication Guide To Warn About This Side Effect

(Posted by Tom Lamb at DrugInjuryWatch.com)

On August 12, 2010 the FDA announced that Lamictal (lamotrigine), a medication commonly used for seizures in children two years and older as well as for bipolar disorder in adults, can cause aseptic meningitis.  Lamictal is also sold as Lamictal ODT (an orally disintegrating tablet), Lamictal CD (a chewable, dispersible tablet), and as Lamictal XR (an extended release product).  GlaxoSmithKline -- commonly known as Glaxo and GSK -- is the drug company that manufactures and markets these several Lamictal products.

From the August 2010 "FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine)":

Meningitis is an inflammation of the protective membranes (the meninges) that cover the brain and spinal cord. Aseptic meningitis is generally diagnosed when tests of a patient with signs and symptoms of meningitis do not detect bacteria. Causes of aseptic meningitis include viruses and other non-bacterial infections, toxic agents, some vaccines, malignancy, and certain medications, including Lamictal.

Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light. In cases of meningitis, it is important to rapidly diagnose the underlying cause so that treatment can be promptly initiated.

From the related August 12 press release, "FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal":

“Aseptic meningitis is a rare but serious side effect of Lamictal use,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Patients that experience symptoms should consult their health care professional immediately.”

The FDA became aware of the association between Lamictal and aseptic meningitis through routine adverse event monitoring and communications with the drug’s manufacturer [GSK]....

The Data Summary section of this August 2010 FDA Drug Safety Communication about Lamictal provides more information about how this link with aseptic meningitis was found:

The decision to revise the Warnings and Precautions section of the Lamictal label and patient Medication Guide is based on FDA's review of adverse event reports submitted to the agency from December 1994 (when the drug was approved) through November 2009. A total of 40 cases of aseptic meningitis occurring in pediatric and adult patients taking Lamictal were identified.

In the 40 cases, headache, fever, nausea, vomiting, nuchal rigidity, rash, photophobia and myalgias were noted. Symptoms occurred 1 to 42 days after starting Lamictal (mean of 16 days). There was one reported death, although the death was not thought to be the result of aseptic meningitis. Thirty-five of the 40 patients required hospitalization. In the majority of cases, symptoms resolved after Lamictal was discontinued. Fifteen cases reported a rapid return of symptoms following re-initiation of Lamictal; symptoms recurred within 30 minutes to 24 hours following re-initiation of Lamictal (mean of 5 hours). In these rechallenge cases, symptoms were frequently more severe after re-exposure.

In addition to the items referenced above, the agency has issued an "FDA Drug Safety Podcast for Healthcare Professionals: Aseptic meningitis associated with use of Lamictal (lamotrigine)", which includes a written transcript.

It remains to be seen whether Glaxo will be sending a so-called "Dear Doctor" letter out to warn about the apparent link between Lamictal and aseptic meningitis.

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August 2010 Status Update For The Yaz / Yasmin / Ocella Federal Court MDL Litigation

More Than 2600 Lawsuits Have Been Filed To Date; First Trial May Be As Soon As September 2011

(Posted by Tom Lamb at DrugInjuryWatch.com)

On August 11, 2010 Judge David R. Herndon held a Status Conference for the Yaz / Yasmin / Ocella federal court multi-district litigation (MDL) -- IN RE YASMIN AND YAZ (DROSPIRENONE) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION, MDL No. 2100.

Quickly, before we get to some of the significant developments that were discussed at this August 2010 Status Conference, we want to report that the official web site for the Yaz / Yasmin / Ocella federal court MDL litigation shows 2621 lawsuits have been filed as of August 12, 2010.  This is more than double the number (1100) of cases that Bayer said previously had been filed as of mid-February 2010.

Please note this new case number does not include any of the lawsuits that have been filed in the New Jersey state court "mass tort" consolidation for Yaz / Yasmin / Ocella personal injury and wrongful death cases (426 cases as of August 12, 2010) nor the lawsuits that have been filed in the Pennsylvania state court system. As background, NJ and PA are the two primary "alternative" jurisdictions for this particular drug injury litigation.

As for some of the more interesting points discussed at the August 2010 federal court Yaz / Yasmin / Ocella MDL Status Conference:

• The Plaintiffs Steering Committee has served additional sets of discovery on a number of topics, including requests for additional information concerning Angeliq and Natazia, which are two other birth control pills made by Bayer.  Angeliq contains the progestin drospirenone (DRSP) which is found also in the Yaz, Yasmin, Ocella, and Gianvi oral contraceptives.  Natazia does not contain drosperinone, but has a different progestin called dienogest;

• An attorney for the drug company Defendants told Judge Herndon that over 30 million pages of materials plus a variety of other discovery responses have been provided to the Plaintiffs attorneys to date; and,

• The lawyers representing the Plaintiffs and the Defendants seemed to agree that this litigation is progressing such that the first Yaz / Yasmin / Ocella trial in the federal court MDL could start in September 2011. For the differences between the parties on the first MDL trials, we provide this excerpt from the official MINUTES OF STATUS CONFERENCE:

Regarding trial scheduling... [the plaintiffs] proposed to defendants a schedule that would get things done and setting trials by next September. They agreed on general timing and how cases will be selected but from plaintiffs’ perspective, plaintiffs should be able to pick cases to present to juries. Counsel to discuss this and their goal is to have a program in place where depositions will take place and experts disclosed to shoot for early trial in September 2011. [The drug company attorney] agrees cases need to proceed but disagree in the process. They believe in Bellwether type of process where defendants should also have input on what cases are tried.... They will address this further at the next conference [which is scheduled for September 16, 2010].

Concerning the reference to "Bellwether type of process" in the excerpt above, to start (as some of you may already know), the word "bellwether" is a noun meaning "a male sheep that leads the flock; it normally wears a bell."

To give you some understanding about the significance of these early trials in large drug injury product liability mass tort cases like this Yaz / Yasmin / Ocella MDL litigation, here are some comments and observations from a defense lawyer who was writing a couple of years back about bellwether cases, generally:

"On the one hand, a bellwether trial in an MDL (or statewide coordinated) proceeding isn't very informative. Trying one or two cases out of a collection of hundreds, or thousands, certainly doesn't give any statistical information about the value of the cases. The one or two cases are not a statistically significant cross-section of the mass of litigation.

"Moreover, the many pending cases (at least in the product liability field) probably differ from each other in ways that make their settlement values vary. Trying one case may not say much about the value of the next. And the performances of witnesses, trial counsel, and judges, and the make-up of juries, will vary across trials, too, so a few early trial results aren't particularly meaningful.

"On the other hand.... bellwether trials do provide some information. They force plaintiffs' counsel to do the work needed to prepare their standard trial package, and the early trials give some sense of how sound that package is. The bellwether trials force the court to resolve legal questions that arise only as a trial actually approaches and witnesses begin to take the stand. And the bellwether trials test the expert witnesses and give both parties a sense of how much it costs to try a case."

Of course, we will continue to monitor the Yaz / Yasmin / Ocella litigation -- not only the federal court MDL but also the New Jersey "mass tort" consolidation and the lawsuits that have been filed in the Pennsylvania state court system -- for significant developments, which we will report here on our Drug Injury Watch blog.

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Mixed Signals About The Safety Of Acne Medication Accutane (Isotretinoin) Continue To Emerge In Summer 2010

FDA Says Accutane Was Not Withdrawn Because Unsafe Drug, While Medical Journal Article Finds Link Between Isotretinoin Therapy And Ulcerative Colitis

(Posted by Tom Lamb at DrugInjuryWatch.com)

When we last wrote about the acne medication Accutane (isotretinoin), it seemed that there was some momentum growing as regards the idea that Accutane was an unsafe drug, as can seen by this headline:

April 2010 Accutane Update: More Medical Evidence Follows A Large Trial Verdict For Drug Injury Victim -- New Study Finds Increased Risk Of Developing Ulcerative Colitis; New Jersey Jury Decides Accutane Caused Man's Inflammatory Bowel Disease

In the few months which followed, however, the safety debate about Accutane -- which actually is no longer available; in June 2009 the drug company Roche Holding AG announced that Accutane will no longer be available to American patients -- and isotretinoin, its generic equivalent -- which is still available by prescription in the U.S. -- continues, and the tide may be turning.

First, we learn from this August 6, 2010 article by Bloomberg reporter Jef Feeley, "Roche Wins Reversal of $10.5 Million Accutane Verdict in New Jersey Case", that in early August 2010 a New Jersey appellate court reversed on legal grounds the 2008 verdict in favor of Kamie Kendall, a Utah woman who developed inflammatory bowel disease (IBD) after using Accutane.

Next, in early July 2007 the FDA published this Notice (the title of which speaks for itself) in The Federal Register:

Determination That ACCUTANE (Isotretinoin) Capsules, 10 Milligrams, 20 Milligrams, and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

But a relatively recent medical journal article found an apparent association between Accutane and ulcerative colitis (UC), one type of inflammatory bowel disease (IBD).  From the Abstract for "Isotretinoin Use and the Risk of Inflammatory Bowel Disease: A Case–Control Study", which was initially published online by The American Journal of Gastroenterology back in late March 2010:

OBJECTIVES: Isotretinoin is commonly prescribed for the treatment of severe acne. Although cases of inflammatory bowel disease (IBD) have been reported in isotretinoin users, a causal association remains unproven....

RESULTS: ... [Ulcerative colitis (UC)] was strongly associated with previous isotretinoin exposure (odds ratio (OR) 4.36, 95% confidence interval (CI): 1.97, 9.66). However, there was no apparent association between isotretinoin and [Crohn disease (CD)] (OR 0.68, 95% CI: 0.28, 1.68).

CONCLUSIONS: UC but not CD is associated with previous isotretinoin exposure. Higher dose of isotretinoin seems to augment this risk. Although the absolute risk of developing UC after taking isotretinoin is likely quite small, clinicians prescribing isotretinoin as well as prospective patients should be aware of this possible association.

We will continue to monitor the legal realm, the regulatory realm, and the medical realm for further developments as regards the issue of whether Accutane and isotretinoin are safe to use, or not.

Our readers can engage in this Accutane safety debate by leaving a Comment below.

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More Evidence That The Stop-Smoking Drug Chantix Is Linked To Agitation, Aggression, And Violence

New Medical Journal Article Looks At 78 Adverse Event Reports Made To FDA Involving Chantix / Champix (Varenicline)

(Posted by Tom Lamb at DrugInjuryWatch.com)

We last wrote about the relatively popular smoking cessation drug varenicline -- trade name Chantix in the USA and Champix in Europe and other countries, marketed by Pfizer -- about a year ago, when we reported that it was getting a "black-box" warning about the risk of serious neuropsychiatric symptoms including agitation, depression, suicidal thoughts, and attempted suicide.

Now, in the September 2010 edition of The Annals of Pharmacotherapy there appears an article, "Thoughts and Acts of Aggression/Violence Toward Others Reported in Association with Varenicline", by Thomas J. Moore, Joseph Glenmullen, and Curt D. Furberg, which provides more evidence that seems to link the use of Chantix / Champix to agitation, aggression, and violence.

The authors of this September 2010 medical journal article looked at information on 78 adverse event (AE) reports involving Chantix that had been received by the FDA as well as four other cases reported in clinical trials and three other Chantix AE case reports from the published literature.

From the July 27, 2010 WebMD Health News story, "Stop-Smoking Aid Chantix Sparks Safety Concerns", we get this overview of what the authors found:

The drug is so potentially dangerous that its use should be restricted to exclude police, military, and similar occupations in which workers carry weapons, says Thomas J. Moore, senior scientist for drug safety and policy at the Institute for Safe Medication Practices....

"My colleagues and I have been concerned about the safety profile of [Chantix] since our first report [warning of adverse events] in 2008," Moore tells WebMD....

The researchers used assessment tools to home in on 26 of the cases to look at more closely. Of these 26:

10 involved assault

9 involved homicidal thoughts
 
7 cases included other thoughts or acts of aggression or violence

In a sampling of the cases, the researchers reported that:

A 24-year-old woman on the drug woke up her boyfriend and started beating him, then attempted to kill herself.

A 21-year-old woman threatened her mother with a shotgun.

A 46-year-old man reported he had ''crazy thoughts'' of killing himself and his parents.

A 42-year-old man punched a stranger while at a bowling alley.

The symptoms typically began soon after starting the drug, Moore and his colleagues say, occurring a median of two days after starting.

They found that when the drug was stopped, the symptoms and other adverse effects resolved in most all cases.

But, as reported by this same WebMD story, Pfizer "disagreed strongly" with the September 2010 medical journal article by Moore, Glenmullen, and Furberg:

MacKay Jimeson, a spokesman for Pfizer, issued this statement: “Pfizer takes the safety of all of its medicines seriously. All post-marketing reports of adverse events are reviewed by Pfizer, and reported to regulators, including FDA. The currently approved Chantix label contains a boxed warning regarding reports of serious neuropsychiatric events reported in some patients. If these neuropsychiatric symptoms are observed by the physician, patient or caregiver, patients should stop taking Chantix and notify their healthcare provider immediately. There is no reliable scientific evidence demonstrating that Chantix causes these events."

Clinical studies are under way, he says, "to help us further characterize the benefit risk profile of Chantix in different smokers. As studies complete, the results will be published.”

We will continue to monitor the safety profile of Chantix / Champix.  Of course, anyone with knowledge about an adverse event involving these smoking cessation drugs can share that with us by submitting a Comment, below.

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