Monthly Archives: December 2009

Medtronic Hasn’t Put Sprint Fidelis Leads Behind It

While the medical device company has already suffered revenue loss, market share, and some confidence of the industry, Medtronic has not seen the end of its Sprint Fidelis defibrillator lead woes. A new report by UBS Investment Research stated that lead failures could accelerate over time. In citing an independent analysis, UBS noted that defibrillator lead failure rates could hit 30% at four years. Medtronic’s numbers suggest a much more modes 3% failure rate at 3 years.
When Medtronic first introduced its newer Sprint Fidelis defibrillator leads, they were praised by the company as the newest breakthrough in medical device technology, far superior to the older Sprint Quattro models. However, the new models have been prone to fracture causing erratic and painful jolts of electricity to the heart. Further exacerbating the problem is the fact that patients who’ve suffered fractured defibrillator leads face the unpleasant choice of having the leads extracted and replaced. There is considerable risk involved in such procedures and at least 3 deaths have been attributed to defibrillator lead extraction.
The Supreme Court has ruled that Medtronic can not be held liable for a device that had previously met the FDA standards. But that may change if Congress passes the Medical Device Safety Act. The bill has received bipartisan support and President Obama has indicated his approval of the measure.

Links Between Irish Priest Abuse Scandal and United States

A lay group that has spent the better part of this decade documenting cases of Catholic priest abuse in the United States now claims there’s a significant link between what has occurred in the US Catholic Church and the ongoing Irish priest abuse scandal. BishopAccountability.org has documented more than 70 cases of Irish priests emigrating to the United States where they’ve abused in the United States as well. We blogged on the topic and the disturbing connection back on August 14th in a post entitled “Irish Priest Abuse Has US Connections”.
It’s a well-known fact that in the 19th century and the early part of the 20th century, the United States was considered missionary territory and many foreign born Irish priests came to the United States to serve in US dioceses across the country. The full extent of the connection is still under investigation and may take years for the depth of the relationship to be uncovered. However, we do know that a number of these priests are now documented sexual abusers of the young and innocent in this country.
In studying this relationship, Irish Central, a periodical targeting Irish-Americans, has quoted the founder of Bishop Accountability in exploring this issue.
“Bishops in Ireland just like bishops here have been moving accused priests around even though they know they are dangerous,” said Terence McKiernan, founder of BishopAccountability.org. “Unfortunately the places where they put them include our own backyard. So the Irish crisis, basically has become our crisis, too.”
In the 19th and 20th centuries, American bishops often took trips to Ireland to recruit seminarians and priests for service in the United States. Because of the scarcity of priests, these bishops were more often concerned with staffing their parishes with priests without doing any type of background checks on these men. As we’ve learned from the documents discovered in the litigation process, some of these men were problems in their home dioceses and the bishops were only too happy to send them elsewhere, even the United States.

Zicam Lawsuit Alleges Fraud

A new Zicam shareholder lawsuit filed last week in U.S. District Court in Phoenix Arizona claims Matrixx Initiatives’ executives withheld adverse safety reports from its shareholders as company executives dumped shares of Matrixx stock just prior to the FDA recall of some Zicam intranasal products. The lawsuit claims that company officials have known as far back as 1999 that the nasal products had safety issues.
Since the product recall, Matrixx has faced lawsuits claiming Zicam users have contracted anosmia, a loss of the sense of smell. The company has denied those claims and has been successful in fighting those claims in several federal court cases. However, a new study now links some Zicam products with anosmia.
The shareholder lawsuit claims that Matrixx CEO William Hemelt sold $379,000 in company stock while Timothy Clarot, vice president of research and development, sold $2,000,000 in stocks. According to the lawsuit, the two company executives sold the stock using knowledge of non-public information about Zicam.

Boston Scientific to Pay $22 Million in Kickback Scheme

US attorneys have announced that Boston Scientific has agreed to pay a $22 million relating to charges that its Guidant medical device division paid doctors to use their cardiac devices. The US Department of Justice, which coordinated the investigation, found that in 2003 and 2004 Guidant targeted cardiologists who were using competitors’ medical devices and offered to pay them between $1,000 and $1,500 to participate in studies designed to increase Guidant sales of company pacemakers and defibrillators.
“This important settlement emphasizes the government’s continued efforts to assure accountability and transparency in the health care industry,” said Lewis Morris, chief counsel for the Office of Inspector General of the U.S. Department of Health and Human Services, in a statement.
Last month, Boston Scientfic announced that it would pay $296 million as well as plead guilty to a misdemeanor charge connected to a defibrillator recall in 2005.
Boston Scientific purchased Guidant in 2006. The agreement does not include any admission of guilt from the medical device company. However, the settlement does require that the medical device company disclose on its website any payments to doctors and healthcare professionals.
Last month, Boston Scientific agreed to pay $296 million and plead guilty to two misdemeanor charges in connection with a 2005 defibrillator recall which sparked the federal probed into Boston Scientific’s marketing practices.

Yaz Class Action Lawsuits Making Progess

Yaz and Yasmin birth control lawsuits are making steady progress in the multi district litigation established to handle the consolidated lawsuits. It’s been less than 90 days since a U.S. Judicial Panel on Multidistrict Litigation ordered all Yaz and Yasmin lawsuits be consolidated and coordinated in U.S. District Court for the Southern District of Illinois.
Thus far, approximately 300 lawsuits have been filed against Bayer Pharmaceuticals alleging that the pharmaceutical company failed to warn women about the increased risk of developing heart attacks, strokes, blood clots, and gall bladder disease. More Yaz and Yasmin lawsuits are expected against Bayer Pharmaceuticals.
The MDL judge overseeing the cases is pleased with the progress of litigation.
The Court would like this case to move along efficiently and effectively,” indicated Judge Herndon in minutes from the December 17 hearing. “Both sides are working diligent and in good faith to move this litigation at a fast pace and court is encouraged by that. Court has had to intervene very little.”

Meridia May Increase Risk for Heart Attack and Stroke

Abbott Laboratories weight loss pill Meridia is being investigated for a potential increase in heart attacks and strokes. The European Medicines Agency is reviewing clinical data from the SCOUT trial involving 10,000 patients over six years. Meridia, known by its chemical name sibutramine, is no stranger to investigations. In 2005, the FDA looked into the same risk factors after a public safety advocacy called for its outright ban in the United States. The prescription drug Meridia does include a warning label that cautions healthcare professionals from prescribing the weight loss drug to those who have a history of cardiovascular problems.
Earlier this month, Public Citizen, a watchdog group, called on the FDA to remove the weight loss drug from the market. Abbott officials responded to the latest study by stating that 90% of those who participated in the SCOUT study were ineligible because of prior cardiac history.

Retiring Archbishop Says Sorry for Priest Abuse

Outgoing Cincinnati Archbishop Daniel Pilarczyk told parishioners at St. Peter in Chains Catholic Church that he’s sorry for his “inadequate” decisions concerning the priest abuse scandal in the Archdiocese of Cincinnati. While the statement of sorrow didn’t include any admission of wrongdoing, it came years after the beleaguered Archbishop had come under fire for covering up for those accused of priest abuse in the Archdiocese. Pilarczyk wasn’t that much different from most other bishops in the United States who clumsily fumbled the abuse crisis from the outset.
The more important question remains-will the apology from the retiring Archbishop mean a new way of operating in the Archdiocese? Will Archbishop Schnurr, a former Bishop of Duluth and US Conference of Catholic Bishops’ bureaucrat, treat those who’ve been abused by clergy differently than his predecessor? Only time will tell.

Generic Drug Makers Can Be Liable for Harmful Drugs

The manufacturers of generic drugs can not be protected by a preemption defense in product liability suits against the generic drug manufacturer, according to the 8th District Court.
The case involved a Minnesota woman who sued the generic drug manufacturers for failure to warn her concerning dangerous side effects associated with metoclopramide, the generic version of Reglan. Both the generic and brand name drugs have been linked to a severe movement disorder, tardive dyskinesia.
Gladys Mensing developed tardive dyskinesia after taking metoclopramide for four years to treat a stomach disorder. She sued Wyeth and other generic manufacturers of metoclopramide for understating the risks associated with the drug.
The 8th District Court’s ruling allows those who’ve been injured by generic drugs to bring claims against the manufacturer of those drugs for failure to warn the public about potentially dangerous side effects. Causes of action based on a failure to warn are not preempted by the Food, Drug and Cosmetic Act.
“The regulatory framework makes clear that a generic manufacturer must take steps to warn its customers when it learns it may be marketing an unsafe drug,” Judge Diana Murphy wrote.
Federal law “does not permit generic manufacturers passively to accept the inadequacy of their drug’s label as they market and profit from it,” Murphy added. “If Mensing’s injuries resulted from their failure to take steps to warn their customers sufficiently of the risks from taking their drugs, they may be held liable.”

Certain Anti-Depressants May Increase Stroke Risk in Post Menopausal Women

Certain anti-depressants may increase the stroke risk in post-menopausal women. The particular antidepressants which may lead to such an increase belong to the family of anti-depressants known as selective serotonin reuptake inhibitors (SSRI). They are sold as Paxil, Prozac, Zoloft, Lexapro, and Celexa.
The findings were published in the December 14th edition of the Archives of Internal Medicine. The study included 136,000 women as part of the Women’s Health Initiative. The participants were not taking antidepressants when enrolled in the study. The research found that women taking SSRI’s had a 45% increase in risk of a stroke.
More study is necessary since it’s still not clear whether the increased risk of stroke resulted in the ingestion of an SSRI or the depression. Post-menopausal women are thought to be more susceptible to depression and depression has been linked to an increase in cardiovascular issues.

Zicam Lawsuits

Zicam lawsuits have been consolidated in multidistrict litigation in United States District Court for the District of Arizona. The multidistrict litigation or MDL means that there are similar fact patterns in all the lawsuits. Those who’ve filed Zicam lawsuits complain of a loss of the sense of smell after using the homeopathic cold remedy. The Zicam lawsuits generally focus on nasal sprays or gels manufactured by Matrixx Initiatives and were sold under the following names:
Zicam Allergy Relief Nasal Gel
Zicam Cold Remedy Nasal Gel
Zicam Cold Remedy Swabs
Zicam Extreme Congestion Relief
Zicam Kids Size Cold Remedy Swab
Zicam Nasal Moisturizer
Since the active ingredient in these products was a zinc derivative, namely, zinc gluconate, they did not require pre-market approval from the FDA. However, medical studies dating back to the 1930′s point to problems with products containing high levels of zinc, especially with the nasal passages. In June 2009, the FDA issued a warning to consumers to halt use of some of these Zicam products. The warning was prompted by 130 reports to the FDA of a loss of the sense of smell (anosmia).
Zicam Sinus Relief

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