Drug Injury Watch

Original "First" Vioxx Trial Will Be Nation's Fourth: Garza v. Merck, et.al.

Next Vioxx Case Goes to Court Late January 2006 In Starr County, Texas

The nation’s fourth Vioxx trial against Merck & Co. concerning its recalled painkiller Vioxx is reportedly set to begin, with jury selection, on January 24, 2006, in a Texas state court located in Starr County.  This Vioxx wrongful death lawsuit was originally set for trial in February 2005, which would have made it the first Vioxx trial in the U.S.  Various procedural developments and tactics, however, got that trial delayed.

The family of 71-year-old Leonel Garza, who resided in Rio Grande City, Texas, alleges in their lawsuit that his fatal heart attack is the result of using Vioxx for one month.  A 12-member jury in Starr County, Texas will hear competing evidence presented by lawyers for the respective parties, and then determine whether Merck and/or two McAllen, Texas doctors and/or a Harlingen, Texas medical clinic -- all of whom have been named as defendants in the case -- should be held legally liable for Mr. Garza's heart attack and death.

In more detail, the Garza Vioxx trial will take place in the Texas state court system's 259th judicial district, with State District Court Judge Alex Gabert presiding.  Observers estimate that jury selection and presentation of evidence in the Garza case could take a month, such that there would not be a jury verdict until about March 1, 2006.

Meanwhile, during the expected course of the Garza trial, two other Vioxx cases will begin.  The first, a re-trial of the federal court MDL Irvin / Plunkett case, is set to start in New Orleans on February 6, 2006.  The second is a New Jersey state court consolidation of two Vioxx personal injury cases, Cona and McDarby, scheduled to begin in Atlantic County, NJ on February 27, 2006.

These next three Vioxx trials will, no doubt, be closely watched by all persons with any interest in the Vioxx litigation.

(Posted by: Tom Lamb)

Global Vioxx Settlement "Unacceptable" To Merck CEO Richard Clark

With Three Vioxx Trials Under Its Belt, Merck Sticks To Its Guns

On January 3, 2006 Merck & Co.'s Chief Executive Officer Richard Clark told a Morgan Stanley pharmaceutical conference audience that Merck will defend itself against each and every Vioxx lawsuit filed against the drug company.  By rejecting the notion of any "global" settlement of Vioxx cases, Mr. Clark reiterated the the position taken earlier by Merck's General Counsel, Kenneth Frazier.

At this Morgan Stanley conference, which was held in New York, Mr. Clark commented:

• "Thinking about a global settlement or trying to put this behind us is totally unacceptable."
• "We've had three cases, and as you know, at least to date, we haven't written a check."

At the time of Mr. Clark's remarks, of the more than 9,000 Vioxx lawsuits that had been filed, three cases had gone to trial with Merck losing the first, winning the second, and getting a "draw" by mistrial in the third.

Overall, most of the Vioxx cases filed thus far allege that Vioxx caused serious cardiovascular side effects such as heart attacks and strokes.

(Posted by: Tom Lamb)

Scios Says Two Deaths In Natrecor Trial Were Not Reported To FDA

Latest Natrecor News Increases Safety Concerns About J&J Heart Failure Drug

The Scios unit of Johnson & Johnson (J&J) did not immediately report to the FDA two deaths from a clinical trial, or study, intended to determine the safety of Natrecor, its heart failure drug, according to several news reports published in early January 2006.  In addition, the deaths of these two patient using Natrecor were omitted from a report of this Natrecor study that was published in the October 2005 edition Journal of Emergency Medicine.

In more detail, the October 2005 study article reported five deaths of patients within 30 days of their using Natrecor in hospital emergency rooms in 2001 and early 2002.  Of the 237 patient covered by this Natrecor study, there was one additional death following the use of some other heart failure treatment. The two new deaths now divulged by Scios involved patients who had used Natrecor, which raises the total to seven deaths among Natrecor patients in the subject clinical trial. 

According to a January 4, 2006 story in The New York Times (NYT):

"Neither Scios nor Dr. W. Franklin Peacock 4th of the Cleveland Clinic, the principal investigator in the study, disclosed yesterday how the deaths had been omitted from the results, but said they had learned only recently that the deaths occurred within the 30-day study period. A final analysis of the results is under way and will be submitted to the Food and Drug Administration, said Mark Wolfe, a Scios spokesman. He said he did not yet know the causes of the two additional deaths."

Meanwhile, a J&J spokesman said the drug company will look again at the results of this Natrecor study, taking into account the two "new" deaths.  It seems that, by means of this study, J&J was seeking to establish support for its contention that Natrecor does not cause a higher risk of death in the first 30 days following a patient's use of the drug. As background, some earlier studies concerning Natrecor had suggested that patients using this J&J heart-failure drug had an increased incidence of kidney problems and mortality.

In addition, according to a January 3, 2006 article published online by Reuters, Scios is conducting further analysis of the Natrecor trial data in order to "evaluate all-cause mortality through 180 days following treatment with Natrecor or placebo", and a final report on this "expanded analysis" should be submitted to the FDA by the first quarter of 2006.

Returning to the January 4, 2006 NYT article, the paper's Stephanie Saul reported that "a spokeswoman for the Cleveland Clinic, Eileen Sheil, said that Dr. Peacock strongly believed that the deaths had been accidental and not related to problems with Natrecor."

Natrecor was approved in August 2001 by the FDA for isolated use in acutely ill heart-failure patients, and only in a hospital setting.  Over time, however, there was increasing "off-label" use of Natrecor to treat less severely ill patients who had breathing difficulties caused by congestive heart failure, which treatment was done on a regular, i.e., repeated, basis in outpatient clinics or in cardiologists' offices.

Away from the safety issue, the U.S. Justice Department is investigating whether Scios wrongfully promoted the off-label prescribing and use of Natrecor.  More recently, it was announced that Medicare and Medicaid will no longer cover the costs of outpatient Natrecor use.

(Posted by: Tom Lamb)

"iPLEDGE" Registry for Accutane Patients Is Mandatory Starting In 2006

Primary Aim Is To Reduce Number Of Accutane-related Birth Defects

Enrollment in the "iPLEDGE' national registry for the anti-acne drug Accutane is mandatory starting January 1, 2006.

This "iPLEDGE" registry concerns any and all doctors, patients, and pharmacists involved with Accutane (isotretinoin), or the three generic versions of the drug, which are known as Amnesteem, Claravis, and Sotret.

About 100,000 Americans a month use Accutane and its generic versions (hereinafter, collectively referred to as Accutane). If a woman uses Accutane during pregnancy -- or becomes pregnant within a month of taking Accutane -- her baby runs a significant risk of suffering brain and heart defects or mental retardation.

According to Dr. Paul Seligman, director of the FDA office responsible for post-marketing drug surveillance, although the FDA has tried for more than 20 years to limit the exposure of fetuses to Accutane, anywhere from 100 to 140 pregnancies a year are still being reported in women using Accutane. "We hope [iPLEDGE] will be the program that ensures that we can get as close to the goal of the least pregnancy exposures as possible," Seligman said.

All Accutane users must enroll by telephone at (866) 495-0654 or through the Internet at http://www.ipledgeprogram.com in order to receive the drug after January 1, 2006.

Furthermore, each Accutane user must sign a document informing them of serious side effect risks associated with Accutane, including the possibility that the anti-acne drug contributes to depression or suicidal thoughts.

In addition, all female patients of childbearing age who plan to use Accutane must:

• undergo two pregnancy tests before the initial Accutane prescription can be filled;
• have a monthly follow-up pregnancy test before each Accutane refill;
• use two different forms of birth control at the same time or agree not to have sexual intercourse for one month before starting Accutane, during the entire course of Accutane treatment, and for one month after her Accutane treatment has ended.

Accutane is approved by the FDA for treatment of only the most severe acne, but the drug is widely prescribed "off-label" for more minor cases of acne.

The FDA has received reports of more than 2,000 pregnancies among Accutane users since it was introduced to the U.S. market in 1982. Of those pregnancies, most ended in abortion or miscarriage, but the FDA has received reports of more than 160 babies born with Accutane-related birth defects. 

It is generally thought that less than ten percent of adverse drug reactions and serious side effects in the U.S. are ever reported to the FDA, so the number of birth defects caused by Accutane over the years is most likely significantly higher than 160. 

Visit the FDA's dedicated web page for more information about Accutane.

(Posted by: Tom Lamb)