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 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.”

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.

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.

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 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 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

Another dietary supplement has been recalled after an FDA analysis of the product found it had Sulfoaildenafil, an FDA-approved substance to treat male erectile dysfunction. Atlas Operations Inc. has announced it is recalling the following lot numbers of its product: 494, 520C, 520B, 520A, 520, 521, 705, 706, 779, and 807. The product is sold under the following names: Rock Hard T12-705-09, R52-705-09, 72 hrs B54-708-09, Stamin It R2-705-08, Finally On Demand R26-706-09, R27-706-09, Sexual Surge H49-705-09, Staminil T25,705-09, Virect T29-705-09.
As with other recalled dietary supplements, the active ingredient which prompted the recall was not listed on the product label. Dietary supplements have come under increased federal scrutiny due to misinformation or lack of information on the product label. Such dietary supplements are not regulated by the FDA prior to market approval. The FDA will investigate these products if there are complaints or other issues raised after the supplements have reached the marketplace.

Avandia, manufactured by Glaxo, is the subject of multidistrict lititgation for its dangerous side effects which include serious cardiovascular problems. The judge in the MDL, the Honorable Cynthia M. Rufe of the United States District Court for the Eastern District of Pennsylvania, has ordered Glaxo to release dozens of documents that Glaxo had argued were subject to attorney-client privilege. In Judge Rufe’s opinion, she noted ““attorney-client privilege does not shield documents merely because they were transferred or routed through an attorney,” and that “documents prepared by a corporation as part of efforts to ensure compliance with federal regulatory agencies or maintain a positive public image for its products, and not because of possible litigation, are not protected by [the] work-product doctrine.”
In November 2007, Avandia received a black box warning from the FDA concerning Avandia’s connection with myocardial ischemia. A Cleveland Clinic study that same year found Avandia users to be 43% more susceptible to heart attacks. Since that time, thousands of Avandia patients have filed Avandia lawsuits.

Medtronic has received subpoenas from the Department of Health and Human Services concerning its heart rhythm devices. The subpoenas requested information about the company’s revenue, marketing, reimbursement programs, and scientific studies. Medical device companies including Medtronic and Boston Scientific have come under more scrutiny after investigations into the company’s relationships with doctors as well as their marketing programs.
In the last few years, the federal government has been investigating medical device company’s transparency as well as the manner in which their medical device products are approved for market use.