Drug Injury Watch

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

(Posted by Tom Lamb at DrugInjuryWatch.com)

The December 28, 2009 edition of "US Morning Meeting Highlights" from UBS Investment Research brought some relatively grim news for patients who have a defibrillator with a Sprint Fidelis lead wire. 

As explained by Thomas Lee for MedCity News in his December 29, 2009 article, "Sprint Fidelis lead woes continue to haunt Medtronic, industry as FDA takes notice":

A report by UBS Investment Research Monday said lead failures could accelerate over time, citing independent studies that predict failure rates could hit 30 percent by four years. Medtronic’s own data suggests a 3 percent failure rate at three years. Leads are wires that doctor snake through veins that connect the battery of an implantable cardioverter defibrillator (ICD) to the heart. An ICD is a device that detects abnormal heart beats and shocks the heart back into rhythm....

Interestingly enough, one study, called Altitude, says healthy patients are more at risk because they live longer and thus more vulnerable to problems like lead failure, making the risk/reward scenario less appealing to patients who receive ICDs....

Earlier this year, Medtronic told doctors that lead failures may have factored into at least 13 deaths. About 260,000 Sprint Fidelis leads have been implanted in patients in the United States, with 143,000 still active.

Here are a couple of our earlier 2009 articles about the "consequences" associated with the October 2007 Sprint Fidelis recall:

March 2009 Update: Sprint Fidelis Heart Device Connected To At Least 13 Deaths

Sprint Fidelis Lead Wire Failures May Be On The Rise According To February 2009 Journal Article By Hauser And Hayes

To our knowledge, the last public communications from Medtronic about the Sprint Fidelis failure problem is their March 13, 2009 "Dear Doctor" letter and their March 13, 2009 "Open Letter to Sprint Fidelis Lead Patients".

Our law firm continues to review possible Sprint Fidelis lawsuits involving incidents of harmful unnecessary shocks in anticipation that the Medical Device Safety Act (MDSA; HR 1346 / S 540) will become law in 2010 and, thereafter, lawsuits can be filed against Medtronic on behalf of those injured patients.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

A New Year's Resolution For The FDA, As Recommended By The GAO

FDA Needs To Restructure Its Staff In Order To Better Monitor Emerging Drug Safety Issues

(Posted by Tom Lamb at DrugInjuryWatch.com)

In mid-December 2009 the Government Accounting Agency (GAO) -- often referred to as the federal government's watchdog agency -- issued a report which was critical of the slow rate of change at the FDA as regards better monitoring of drug safety issues.

In preparing his December 9, 2009 article, "GAO: FDA yet to make safety changes post-Vioxx", Associated Press (AP) reporter Matthew Perrone reviewed a copy of this December 2009 GAO report.

From the December 9 AP article, here are this reporter's observations about some points raised in the GAO's December 2009 FDA report:

• Agency officials have made some changes to drug oversight, according to a Government Accountability Office report, but the FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market.

• The watchdog agency's report calls on the FDA to set a timetable for transferring new responsibilities to the surveillance office.

• The FDA said it intends to give the surveillance office more responsibilities, but only after its nearly 200 employees gain the experience and resources needed to take on those tasks. The Office of New Drugs has more than 900 employees.

• According to the GAO, the number of surveillance staffers would have to double in coming years to accommodate the additional work being assigned to the unit.

As pointed out by Perrone in his article, drug safety experts outside of the FDA contend that emerging drug safety issues should not be handled by the same FDA scientists who were involved with reviewing new drug applications -- that is, those who work in the FDA's Office of New Drugs.

Returning to the December 9 AP article:

"There's this desire on the part of the people who first approved the drug to say, 'We predicted everything and it's fine,'" said Dr. Diana Zuckerman of the National Research Center for Women and Families in Washington.

Zuckerman and others say such decisions should be made with equal input from the FDA's office for monitoring reports of side effects collected from across the country.

The GAO, the Institute of Medicine and other experts have long recommended that the so-called Office of Surveillance and Epidemiology be given equal authority on drug safety with the agency's Office of New Drugs. But GAO investigators report that FDA leaders still have not transferred key responsibilities to surveillance officials.

Hopefully, the FDA will adopt this drug safety-related recommendation from the GAO and others as its New Year's resolution for 2010.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

FDA Finds It Unlikely That Vytorin Or Zetia Increases Risk Of Cancer, But Such A Link Is Possible

December 2009 Update From FDA For Its August 2008 Early Communication About Safety Review of Ezetimibe / Simvastatin (Vytorin) And Ezetimibe (Zetia)

(Posted by Tom Lamb at DrugInjuryWatch.com)

On December 22, 2009 the FDA issued an update about its August 2008 Early Communication which described a possible association between the use of Vytorin – a combination of simvastatin (Zocor) and ezetimibe (Zetia) – and an increased risk of cancer and cancer-related death compared to placebo.

As you may recall, that August 2008 Early Communication was based on preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial.

From the December 2009 safety update about Vytorin and Zetia, which is titled "Follow-Up to the August 2008 Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) - FDA Investigates a Report from the SEAS Trial":

FDA has now completed its review of the data from the SEAS trial as well as a review of interim data from two large-scale ongoing cardiovascular trials with Vytorin - the SHARP and IMPROVE-IT trials. Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out....  [footnotes omitted]

The SHARP trial is placebo-controlled, but uses a lower dose of Vytorin (10/20 mg) than was used in the SEAS trial. The IMPROVE-IT trial compares Vytorin 10/40 mg to simvastatin 40 mg. An interim analysis of the cancer data from these two trials, which includes a total of 20,617 patients, did not show an increased risk of cancer with Vytorin. There was an increase in the number of cancer-related deaths, with 97 deaths in the Vytorin groups compared to 72 deaths in the control groups, but this finding was not statistically significant.

When completed, the SHARP and IMPROVE-IT trials will provide additional data to further assess cancer risk with simvastatin and ezetimibe. The SHARP trial is expected to be completed in 2010 and IMPROVE-IT in 2012.

As for other serious side effects which have been associated with Vytorin and Zetia, back in September 2008 we reported about two medical journal articles which described a case of liver disease involving Zeita and a case of liver failure possibly linked to Vytorin.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Digitek Federal Court MDL Judge Sets Joint Hearing To Address Scientific And Technical Issues For October 2010

Judge Goodwin Will Be Joined By State Court Judges Overseeing Digitek Consolidations In New Jersey, Pennsylvania, Texas, And West Virginia At This Daubert Hearing

(Posted by Tom Lamb at DrugInjuryWatch.com)

On December 18, 2009 Joseph F. Goodwin, Chief Judge for the United States District Court, Southern District of West Virginia, 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".

Therein, Judge Goodwin set for hearing on October 13-14, 2010 the disposition of all issues related to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).  Essentially, this Daubert opinion sets forth the federal court standard for the admissibility of expert witness testimony at trial.

Further, Judge Goodwin announced that the so-called Daubert hearing in October 2010 will include the four state court judges who are overseeing the Digitek case consolidations that have been established in New Jersey, Pennsylvania, Texas, And West Virginia.

From Pretrial Order #48:

In the spirit of cooperation and collegiality evident since the inception of this MDL, several distinguished state judicial officers presiding over certain consolidated Digitek actions have graciously agreed to conduct, with the undersigned, a joint hearing to address the scientific and technical issues presented in this litigation for resolution pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and its federal and state progeny. Those issues are best addressed through coordinated proceedings, albeit with each presiding judicial officer giving separate and individualized attention, and disposition, to the evidence and arguments as they relate to his or her assigned consolidated civil actions.

The Honorable Sandra Mazer Moss of Pennsylvania, the Honorable Brian R. Martinotti of New Jersey, the Honorable Alan D. Moats of West Virginia and the Honorable Buddie J. Hahn of Texas will sit jointly with the undersigned and hear evidence on these issues....

A bit earlier, on November 20, 2009, Judge Goodwin entered Pretrial Order #47 by which it is was ordered that the following five Digitek federal court cases have been selected for trial:

• David Kelch et al., v. Actavis Totowa, LLC et al., 2:08-cv-01282;
• William J. Young et al., v. Actavis Totowa, LLC et al., 2:09-cv-00498;
• Jacquelyn K. Fox et al., v. Actavis Totowa, LLC et al., 2:09-cv-00389;
• Karen Sheahan, et al., v. Actavis Group, et al., 2:08-cv-01051;
• Scottie Vega et al., v. Actavis Group hf., et al., 2:09-cv-00768.

Interestingly, no starting dates for these first five Digitek MDL trials were included in Pretrial Order #47.  It appears, however, that the earliest trial date for the first federal court Digitek case would be some time in early 2011.

As you may recall, in late April 2008 the FDA announced that Digitek (digoxin tablets) was the subject of a nationwide Class I recall because of the possibility that some tablets were manufactured such that they contain twice the approved level of active ingredient.

We will continue to monitor the federal court Digitek MDL as well as the Digitek state court consolidations in New Jersey, Pennsylvania, Texas, and West Virginia.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Bisphosphonates Such As Fosamax And Femur Fractures: Some Recent 2009 Medical Journal Articles

Atypical Low-Energy Femoral Fractures Associated With Long-Term Use Of Fosamax And Other Bisphosphonates

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Journal Watch General Medicine (JW Gen Med) published December 15, 2009 included an article, "Atypical Fractures in Long-Term Bisphosphonate Users" (subscription required), by Allan S. Brett, MD.

In this brief article, Dr. Brett reviewed the following two recent medical journal articles about Fosamax (alendronate) or other bisphosphonates and femur fractures, also known as femoral fractures:

"Bilateral low-energy simultaneous or sequential femoral fractures in patients on long-term alendronate therapy" (J Bone Joint Surg Am 2009 Nov; 91:2556); and,

"Association of low-energy femoral fractures with prolonged bisphosphonate use: A case control study" (Osteoporos Int 2009 Aug; 20:1353)

As regards those two medical articles, here is what Dr. Brett observed:

Comment: These reports, and several others (e.g., JW Gen Med Apr 5 2005), suggest that a small subgroup of women could be susceptible to atypical femoral fractures after prolonged bisphosphonate use; suppression of bone turnover and accumulation of microdamage is a postulated mechanism. Prospective studies are needed to prove a causal relation; if causality is demonstrated, we'll need to determine whether the incidence of this complication is appreciable and whether at-risk patients can be identified.

Following my review of those two medical articles about low-energy femoral fractures in patients using bisphosphonates such as Fosamax, I collected several other recent articles from various medical journals, which are listed below:

"Bisphosphonate-associated femoral fracture: implications for management in patients with malignancies" (J Bone Joint Surg Am 2009 Nov 91:2556);

"Low-energy femoral fractures associated with the long-term use of bisphosphonates: a case series from a Swiss university hospital" (Drug Saf. 2009;32(9):775-85);

"Subtrochanteric and diaphyseal femur fractures in patients treated with alendronate: a register-based national cohort study" (J Bone Miner Res. 2009 Jun;24(6):1095-102);

"Atraumatic bilateral femur fracture in long-term bisphosphonate use" (Orthopedics. 2009 Aug;32(8)); and,

"Bilateral low-energy simultaneous or sequential femoral fractures in patients on long-term alendronate therapy" (J Bone Joint Surg Am. 2009 Nov;91(11):2556-61).

Moving from the medical realm to the legal arena, there have been product liability lawsuits filed on behalf on people who have suffered femur fractures during or following their use of Fosamax and other bisphosphonates.

We will continue to watch and periodically report about this emerging drug injury topic.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

December 2009: Voltaren Gel And Other Products Containing Diclofenc Sodium Linked To Liver Problems

"Dear Doctor" Letter From Endo And Novartis Offers Information About Prevention And Diagnosis Of Drug-Induced Liver Injury (DILI)

(Posted by Tom Lamb at DrugInjuryWatch.com)

On December 4, 2009 the FDA issued this MedWatch alert, "Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes", which provided news about an emerging drug safety issue concerning all products containing diclofenac sodium, including Voltaren Gel.  From the FDA MedWatch alert, in relevant part:

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of  these reported cases resulted in fatalities or liver transplantation.

This December 2009 FDA MedWatch alert also provided links to:  (1) "Prescribing Information" -- also known as the package insert or label -- for Voltaren Gel; and, (2)  a "Dear Healthcare Professional Letter" -- commonly called a "Dear Doctor" letter -- from Endo Pharmaceuticals Inc. and Novartis Consumer Health, Inc., the companies responsible for Voltaren Gel in the U.S.

On December 5, 2009 Medscape published an article, "Diclofenac Linked to Liver Failure, Death", about these developments which included a summary of the Voltaren Gel Dear Doctor letter:

Physicians should discontinue diclofenac treatment immediately if patients continue to have abnormal or worsening liver test results, if liver disease symptoms develop, or if systemic manifestations occur, such as eosinophilia, rash, abdominal pain, diarrhea, or dark urine, according to a letter from Endo and Novartis to healthcare professionals.

The companies also recommend that physicians advise their patients receiving diclofenac of the signs and symptoms of hepatotoxicity, including nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and flulike symptoms, and what to do if these signs and symptoms appear.

To reduce the risk for hepatotoxicity in patients receiving diclofenac sodium, the lowest effective dose should be used for the shortest time possible.

To supplement this "Dear Doctor" letter information from Endo and Novartis, for those who are interested in learning more, we offer a relatively recent article from the medical journal Gut, "Diagnosis, management and prevention of drug-induced liver injury".

If you are aware of a case of drug-induced liver injury involving any product containing diclofenac sodium, including Voltaren Gel, you are encouraged to report that adverse event to the FDA through its MedWatch program.  Your report can be made by the following means:

• by telephone at 1-800-FDA-1088;
• by fax at 1-800-FDA-0178;
• online at http://www.fda.gov/medwatch; or,
• by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

We will continue to monitor this emerging drug safety issue involving Voltaren Gel and other diclofenac products.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Medical Journal Report: Adverse Drug Reactions And Pulmonary Embolism Are Often Difficult For Doctors To Diagnose

These Commonly Missed Diagnoses Are Particularly Relevant To Women Using YAZ, Yasmin, And Ocella, As Well As NuvaRing And Ortho Evra

(Posted by Tom Lamb at DrugInjuryWatch.com)

The November 9, 2009 issue of the Archives of Internal Medicine included an article, "Diagnostic Error in Medicine -- Analysis of 583 Physician-Reported Errors", which should be of particular interest to women using the following birth control products: YAZ / Yasmin / Ocella; NuvaRing; and, Ortho Evra.

The reason for their likely interest, or concern, involves the combination of two facts.

First, this survey of doctors found that adverse drug reactions and pulmonary embolism are the two most common diagnostic errors committed or observed by those doctors.

Second, thromboembolic events such as pulmonary embolism (PE) and deep vein thrombosis (DVT) are adverse reactions that have been associated with these several birth control methods.

To learn more about the adverse drug reactions aspect of this matter -- in particular, the increased risk developing of blood clots that can cause a pulmonary embolism -- we offer these resources:

How And Why YAZ, Yasmin, And Ocella Pills Might Cause A Higher Rate Of Blood Clots In Women

NuvaRing Birth Control Device Use Can Cause Blood Clots and Related Serious Side Effects

Ortho Evra Birth Control Patch: September 2006 Warning About Serious Blood Clot Risks

To learn more about the pulmonary embolism aspect of this matter, we offer this resource:

Pulmonary Embolism And Deep Vein Thrombosis: Symptoms, Treatment, and Recovery

For a complete collection of our articles about these birth control methods as well as selected news reports, see the following:

Focus On Yaz, Yasmin, And Ocella

Focus On NuvaRing

Our law firm is currently handling personal injury claims for women who have suffered a serious side effect while using YAZ, Yasmin, and Ocella, as well as NuvaRing and Ortho Evra.  We also represent the families of women who have died while using one of these birth control methods in wrongful death lawsuits.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

November 2009: Osteonecrosis Of The Jaw (ONJ) And Fosamax: Four Recent Medical Journal Articles

This List Of Abstracts Provides Various Perspectives About ONJ, A Jaw Bone Side Effect Caused By Bisphosphonates

(Posted by Tom Lamb at DrugInjuryWatch.com)

In this brief article we provide a quick round-up of medical journal articles published in November 2009 that address different aspects of how osteonecrosis of the jaw (ONJ) can develop in patients using bisphosphonates, a class of drugs which includes Fosamax.

Osteonecrosis of the Jaw Correlated to Bisphosphonate Therapy in Non-oncologic Patients: Clinicopathological Features of 24 Patients.
The Journal of Rheumatology, November 2, 2009

Bisphosphonates and Time to Osteonecrosis Development
The Oncologist, November 8, 2009

Bisphosphonate (zoledronic acid)-induced osteonecrosis of the jaw
Scandinavian Journal of Urology and Nephrology, November 10, 2009

Bisphosphonate-related Osteonecrosis of the Jaw: A Pictorial Review
RadioGraphics, November 2009

We will continue to watch for new medical journal articles about how and when Fosamax might cause osteonecrosis of the jaw (ONJ).

If you are aware of a recent article about Fosamax or one of the other bisphosphonates being associated with ONJ -- or osteomyelitis involving the jaw bone -- now or going forward, please let us know about it by submitting a Comment, below.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects