The FDA issued a warning to Medtronic, Inc. on Friday, September 29, 2006 regarding the delayed filing of a post market surveillance interim report on the AneuRx Stent Graft System. According to Medtronic, Inc. the letter is not related to the quality, design or manufacture of the product. However, the purpose of the Postmarket study is to make sure the device is appropriately labeled for use in designated patient populations and to confirm the necessary training and experience for users of the device which is used to treat patients suffering from life-threatening Abdominal Aortic Aneurysms. The System was commercially approved in 1999 and the interim postmarket surveillance report, initially issued in 2002, has been filed on an annual basis until now.

The FDA has issued alerts and recalls affecting more than 337,000 defibrillators since 1990. There has been a reduced market for defibrillators since that time and a reported 8% decrease in the last 12 months.

Posted by David P. Hersh at 05:51 PM | Permalink | Comments (0) | TrackBacks (0)

Just eight months after losing the bid for medical-device maker Guidant, Johnson & Johnson is suing Boston Scientific and Abbott Laboratories saying that the two companies intentionally interfered and induced Guidant to breach the deal by leaking confidential information to Abbott to arrange a prepackaged divestiture of Guidant businesses to Abbott.

J&J wanted to purchase Guidant which was one of three companies preparing to put drug-coated stents on the market to give the company entry into the lucrative market for implantable pacemakers and defibrillators.

Posted by David P. Hersh at 05:49 PM | Permalink | Comments (0) | TrackBacks (0)

Less than two weeks after the FDA alert about an outbreak of E. coli, 183 cases of illness due to E. coli infection after eating suspected contaminated prepackaged spinach have been reported to the Centers for Disease Control and Prevention (CDC). The reported cases include 29 cases of Hemolytic Uremic Syndrome (HUS), 95 hospitalizations and one death.

Symptoms of illness may include diarrhea with bloody stools; a form of kidney failure called Hemolytic Uremic Syndrome (HUS) may also occur but is more likely in young children and the elderly. Serious kidney damage may result in death.

The 26 affected states are: Arizona (7), California (1), Colorado (1), Connecticut (3) Idaho (4), Illinois (1), Indiana (9), Kentucky (8), Maine (3), Maryland (3), Michigan (4), Minnesota (2), Nebraska (9), Nevada (1), New Mexico (5), New York (11), Ohio (24), Oregon (6), Pennsylvania (8), Tennessee (1), Utah (18), Virginia (2), Washington (3), West Virginia (1), Wisconsin (47), and Wyoming (1).

Wisconsin health authorities reported the E. coli fatality was a 77-year-old woman from Manitowoc who died September 7.

Posted by Michael S. Burg at 05:38 PM | Permalink | Comments (0) | TrackBacks (0)

As everyone knows, an out-break of e-coli contamination has caused spinach to be taken off menus around the country. Grocery stores removed all spinach-containing products from their shelves. Restaurants were compelled to find alternatives for their customers.

At least 183 people in 26 states have become ill during the outbreak. One woman in Wisconsin died and officials are looking at two other deaths, a 2-year-old in Idaho and an elderly Maryland woman, that also may be linked to consumption of spinach contaminated with E. coli.

While school children everywhere may be rejoicing over meals free from spinach, adults are struggling to properly balance the nutritional needs of the family against the risk of ingesting fresh spinach . Businesses have also modified their offerings to limit their potential liability.

Spinach lovers got the green light Tuesday to start eating the leafy vegetable again as long as it is not from certain California fields. In statements Monday and Tuesday, the FDA announced that it traced spinach tainted with E. coli bacteria to three California counties and reassured consumers that spinach grown elsewhere is safe.

Providers of spinach-containing products are fearful of lawsuits if a consumer is injured. Consumers are concerned about their health. Growers and suppliers of spinach are concerned about their economic well-being and survival.

At least one suit has been filed, and others are sure to follow. The parents of a Bowling Green, Ohio-area toddler who became critically ill after eating fresh spinach filed a lawsuit yesterday in U.S. District Court in Toledo against a California grower that has been linked to the nationwide E. coli outbreak.

Losses could total $50 million to $100 million, which includes destroying spinach already on the market and plowing under unharvested fields, in addition to the negative financial impact on farm workers, truckers, restaurants, and grocery stores. Growers from Colorado to Texas to Florida could also be affected, but California, which supplies 75 percent of the US market, will be hit the hardest. At the same time, several factors are mitigating such losses. Spinach is a fast-growing crop - about 28 days from plant to harvest on average - so many farmers can plant something besides spinach. By contrast, many other crops, such as some fruit, take at least nine months to grow. Thus, the recovery from one lost spinach crop could take less time.

Posted by David P. Hersh at 06:04 PM | Permalink | Comments (0) | TrackBacks (0)

According to the latest news from the FDA, Ortho and FDA notified healthcare professionals and patients about
changes to the available prescribing information to inform them of the results of two separate epidemiology studies evaluating the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different oral contraceptive.

The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho
Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate.

In the second study, the increased risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen was nearly double. The results of the second study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.

Prescribing information for Ortho Evra continues to recommend that women with concerns or risk factors for thromboemboli disease talk with their healthcare professionals about using Ortho Evra versus other contraceptive options.

Posted by Seth A. Katz at 04:12 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA reports that, to date, 102 cases of illness due to E. coli infection have been reported to the Centers for Disease Control and Prevention (CDC), including 16 cases of Hemolytic Uremic Syndrome (HUS) and one death. Illnesses continue to be reported to CDC.

There are 19 confirmed states (versus 20 reported yesterday). The case originally attributed to Tennessee was, in fact, in Kentucky. States reporting illnesses include: California, Connecticut, Idaho, Indiana, Kentucky, Maine, Michigan, Minnesota, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, Utah, Virginia, Washington, Wisconsin, and Wyoming.

FDA advises consumers to not eat fresh spinach or fresh spinach-containing products until further notice.

Natural Selection Foods, LLC, of San Juan Bautista, California, is recalling all of its products containing spinach in all brands they pack with "Best if Used by Dates" of August 17, 2006 through October 1, 2006. These products include spinach and any salad with spinach in a blend.

Natural Selection Foods, LLC brands include: Natural Selection Foods, Pride of San Juan, Earthbound Farm, Bellissima, Dole, Rave Spinach, Emeril, Sysco, O Organic, Fresh Point, River Ranch, Superior, Nature's Basket, Pro-Mark, Compliments, Trader Joe's, Ready Pac, Jansal Valley, Cheney Brothers, Coastline, D'Arrigo Brothers, Green Harvest, Mann, Mills Family Farm, Premium Fresh, Snoboy, The Farmer's Market, Tanimura & Antle, President's Choice, Cross Valley, and Riverside Farms.

The affected products were also distributed to Canada and Mexico.

Posted by Michael S. Burg at 09:28 PM | Permalink | Comments (0) | TrackBacks (0)

The U.S. Food and Drug Administration now reports that one person has died, 14 suffered kidney failure and at least 94 in 20 states were ill after eating suspected contaminated pre-packaged spinach, at least some of it packed by California-based Natural Selection Foods LLC/Earthbound Farm.

Additional cases have been reported expanding the number of states to include California, Indiana, Idaho, Kentucky, Maine, Michigan, Minnesota, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Utah, Virginia, Washington, Wisconsin and Wyoming.

Wisconsin health authorities reported the E. coli fatality was a 77-year-old woman from Manitowoc who died September 7; 29 cases of E. coli were reported to the Centers of Disease Control in Wisconsin alone.

Posted by Michael S. Burg at 12:03 AM | Permalink | Comments (0) | TrackBacks (0)

On September 14 2006, an alert was issued by the Food and Drug Administration because of an outbreak of E. coli in several states. The source of the outbreak is believed to be bagged fresh spinach and consumers are being warned to not eat bagged fresh spinach at this time. Symptoms of illness may include diarrhea with bloody stools; a form of kidney failure called Hemolytic Uremic Syndrome (HUS) may also occur but is more likely in young children and the elderly. Serious kidney damage may result in death.

50 cases of illness have been reported including 8 cases of HUS and one death.

States reporting illness to date include Connecticut, Idaho, Indiana, Michigan, New Mexico, Oregon, Utah and Wisconsin.

Posted by Michael S. Burg at 11:09 PM | Permalink | Comments (0) | TrackBacks (0)

There is new case law in Colorado regarding the stacking of underinsured motorist insurance (UIM). Per the Supreme Court case holding (No. 05SA369, In Re State Farm Mutual Auto. Ins. Co. v. Progressive Mutual Ins. Co. - Automobile Insurance - Underinsured Motorist - Uninsured Motorist Stacking - Limits of Liability), insureds who are insured persons under multiple UIM policies can stack those polices to determine whether the tortfeasor was underinsured. Until now, conventional thought was that the tortfeasor coverage was measured against an individual UIM policy, not the sum of multiple policies, to see if the tortfeasor was underinsured

For example, if tortfeasor has $100K in liability coverage, and the insured victim has two UIM policies of $100K each ($200K total), (1) the driver is underinsured as a matter of law, and (2) the tort victim can recover the $200k less an offset of $100K paid by tortfeasor's insurance, for a net recovery of $100K to be shared equally by the two UIM insurers.

Before this decision, insurers were uniformly denying any UIM coverage when tortfeasor's coverage was equal to or less than the individual UIM policy limits. Plaintiff's attorneys should be able to use this decision to their client's advantage. If you have an auto accident case you should search high and low for all UIM coverages in which your client would or may be an insured person, such as resident relative status with persons who have personal auto policies. Holly knows how to do this as well as anyone I have known.

Incidentally, Colorado may be the only state in which this type of stacking is allowed. The decision is based on statutory language, C.R.S 10-4-609, which is distinct and different in each state for UM/UIM coverage.

Opinions of the Colorado Supreme Court are available to the public and can be accessed through the Court's homepage.

Posted by Peter W. Burg at 05:59 PM | Permalink | Comments (0) | TrackBacks (0)

About 85,000 Taxus stents are being recalled voluntarily by Boston Scientific because of possible defects. Of the 42 complaints received, 30 systems showed actual performance flaws generally thought to be the result of excess heat being applied during the laser welding stage during the manufacture of the product. 200 Taxus stents were recalled earlier this month.

In a meeting with the FDA in early August, Boston Scientific reported finding a slightly higher risk of blood clotting in paitients with the new drug-coated stents compared with bare-metal versions and at the World Cardiology Congress in Barcelona, Spain, recent study findings were released indicating a higher risk of rare instances of potentially fatal blood clots. The September 6, 2006 edition of the Wall Street Jounal reported on the study.

While bare-metal stents allow cells to naturally grow to cover the stent after surgery the drug-coated versions like Taxus can prevent tissue growth which helps prevent blockages but leaves exposed metal that can act as a magnet for clots.

Posted by Seth A. Katz at 09:58 PM | Permalink | Comments (0) | TrackBacks (0)