Sunday, November 30, 2008

Starcaps FDA Recall Notice

Balanced Health Products, Inc. Conducts Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient

FOR IMMEDIATE RELEASE -- November 26, 2008--- Balanced Health Products, Inc. is voluntarily recalling STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot 12/2011 – 84810, sold in 30 capsule plastic bottles.

The recall is effective immediately and is being undertaken because this lot of STARCAPS contains an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Bumetanide is also not listed on the product label as an ingredient in this product.

Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Bumetanide has been detected in STARCAPS at a level of 0.8mg per capsule. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide.

The company has received no reports of illness associated with this product.

To date, this recall only applies to Lot 12/2011 – 84810. The company is in the process of testing other lots and will notify the FDA of its results, as well as, if additional lots are to be recalled.

The recalled lot totaling just over 10,000 consumer-size bottles were distributed nationwide from August 2008 to October 30, 2008 through retail outlets and online sales.

Consumers who purchased STARCAPS Lot 12/2011 – 84810 should immediately discontinue their use and return it to Balanced Health Products, Inc at the address on the product label.

Consumers with questions may contact the company at (212) 794-9793 from 10:30am to 4pm EST Monday through Friday.

Consumers who experience adverse events with any lots of this product should seek immediate help from their physician or healthcare provider.

Retail stores are being notified by fax or registered mail to immediately stop all sales and return product to the company.

This recall is being made in cooperation with the US Food and Drug Administration.

Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

Wednesday, November 19, 2008

Vaginal Sling News-Mentor Ob Tape

Urinary stress incontinence is a common problem for women - some 13 million of them in this country alone - particularly after childbirth and as they age. There are diaper-like products on the market for such women, but many choose to medically correct the problem so they no longer have this inconvenient embarrassment in their life. Imagine their horror when the very procedure meant to help them ends up harming them far worse than the original incontinence. This is what has happened to many women who had the Mentor ObTape Vaginal Sling surgically inserted.

Mentor is a California company that manufactured an ObTape Vaginal Sling, an implanted device that is designed to replace eroded or weakened muscles in the urethra and support the bladder. The problems occur because the material the sling is made of doesn’t allow the tissue where the sling is attached to heal; the material itself prevents the needed nutrients and oxygen from reaching the tissue. Women have suffered infection, scarring, painful intercourse, vaginal discharge, pain, mesh extrusions, abscess, and return of the very condition meant to be rectified by this device – urinary stress incontinence. The complications from the Mentor ObTape Vaginal Sling often required patients to undergo surgery and, unfortunately, often serious and permanent injuries. Mentor’s ObTape Vagina Sling came on the market in 2003, and in less than 3 years was taken off the market. Mentor never stepped up and issued a recall; Mentor simply stopped marketing the Ob Tape in March, 2006, but it never actually recalled the product – Mentor just let it die a slow death.

In October, 2006, the Journal of Urology reported on a study which looked at 67 women who had been implanted with the Mentor ObTape Vaginal Sling. More than 13% developed vaginal extrusions. Others had chronic vaginal discharge, and one patient developed an abscess that led to complications. The most telling part of the study was that none of the control group of 56 women who used another type of vaginal sling experienced the complications seen with the Mentor ObTape Vaginal Sling.

This Mentor ObTape Vaginal Sling tried a new innovative design, which is commendable, but you cannot put a product on the market without adequate testing. Apparently, the ObTape Vaginal Sling pushed into and through the vaginal wall causing tearing, cutting, and sometimes permanent erosion of the vaginal tissues.

ObTape lawyers intend to argue that although Mentor won approval of ObTape from the FDA because it was "substantially equivalent" to slings already on the market, the ObTabe Sling is actually a very different product grounds ObTape was a new and unique product. But the Mentor ObTape Vaginal Sling was different because vaginal slings had historically been made with a mesh design, allowing the sling to breathe and get nutrients to the body’s tissue.

Mentor ObTape Vaginal Sling lawyers will argue to consolidate for discovery purposes the 22 filed Mentor ObTape Vaginal Sling lawsuits in an MDL (basically a class action for discovery purposes). Oral arguments will be held in late November in Charleston, South Carolina.

There are approximately 35,000 women used the Mentor ObTape Vaginal Sling between 2003 and 2006. This means that 7,000 women have potential OBTape Vaginal Sling lawsuits. Why only 22 ObTape lawsuits? Of course, many women have a hard time coming forward because this is such a private issue. There are 13 million women with this problem, yet many – between 50-70% in some studies – do not receive any treatment for urinary incontinence, most likely because of the privacy issues involved (and because they don’t realize how many others – including their friends and family - suffer from the same condition). But I also think many women do not realize that there are ObTape lawsuits pending around the country and there is a great possibility these women will receive the financial compensation they deserve for the Mentor ObTape Sling injuries.

Tech: ReQall - A "Memory" Tool

Playing around with ReQall now.

From their site:

"ReQall is the best memory tool you may ever have, connecting all the ways you communicate in one easy, seamless system. Best of all, reQall works with the technology you already use—nothing to buy, nothing to install."

Worth a look if you have time.

Thanks to Nicole Black, whose blog talked about ReQall here.

Tuesday, November 18, 2008

Duragesic: Justice in Chicago

My good friends at Heygood, Orr, Reyes, Pearson & Bartolomei received long due justice in a case involving a Duragesic pain patch for a client after a long trial in Chicago.

The story: Janice DiCosolo, 38, of Cicero died on Feb. 15, 2004, while using a Duragesic patch that her doctor prescribed to reduce pain caused by a neurological condition called reflex sympathetic dystrophy.

The mother of three died because the patch delivered a fatal dose of its main ingredient, the powerful narcotic pain reliever fentanyl, according to her family's lawyers.

The jury was told that fentanyl is a painkiller 100 times more powerful than morphine. The patches, prescribed for people combating chronic pain, are to be worn for 72 hours and then discarded. Janice DiCosolo was found wearing one when she died.

At least one lot of Duragesic patches in February 2004 was recalled, a day after DiCosolo died, because of improper sealing of the adhesive backing of the devices, defense lawyer David Sudzus wrote in a court filing. The patch worn by DiCosolo was from that lot, he said.

The jury forewoman, Peggy Rounsfull, 51, of Glenview, said, it was the fentanyl that appeared to have killed DiCosolo.

``There was no way of getting around the fact that she had too much fentanyl,'' Rounsfull said. (Link here)

The Johnson & Johnson units that make and sell the Duragesic pain-killing patch must now pay $16.6 million to the family of a Chicago-area woman.

Wednesday, November 12, 2008

Vehicle Tires: Time to Replace Them?

From my friend and fellow lawyer Rob Bunch, this article:

With all of the information contained on a tire’s sidewall, it’s no wonder the average consumer has difficulty deciphering it all. While most know how to tell a tire’s size and width, the manufacturer, and the maximum inflation pressure, the tire’s DOT serial numbering system may not be so easy to understand. A tire’s DOT number contains valuable information, especially when a tire was manufactured, but it was never meant to be very consumer friendly and was never meant to be decoded by the consumer. Having the means to tell when a tire was manufactured can mean the difference between safety and catastrophic results.

Some experts believe that tires have a shelf life and ignoring that could be fatal. Tires can sit on store shelves for years before they are sold; sometimes as long as five years; each can still be sold as new tires. There is no expiration date on tires, but research and tests show as tires get older, even if they haven’t even been driven a mile, the tires may begin to dry out, and the degradation process starts to take place.

After six years of age, tires can become unreliable or even dangerous. Tires may look great on the outside, but not much is known about what is going on inside the tire. After a time, tires begin to dry out and become less elastic even if they are not in use, making tread separation more likely even if they have plenty of tread depth and appear new. When a tire detreads at highway speeds, it becomes difficult if not impossible to retain control of a vehicle.

For decades, the tire industry has taught drivers to use the so-called “penny test” as a way to tell when a tire needed to be replaced. As late as last summer, they have recommended that the “penny test” is outdated, compromises safety, and should give way to the “quarter test.” Why not arm consumers with the knowledge of determining when their tires were manufactured by decoding the DOT serial number and then recommend that they replace them at a certain age, no matter what the tread depth? Or better yet, why not imprint an expiration date on the tires?

The U.S. tire industry has fought efforts to require an expiration date on tires. The industry says, given the improvements in tire production, age is not a key factor in a tire’s performance. However, the British Rubber Manufacturer’s Association issued a forceful warning to its British consumers stating “BRMA members strongly recommend that unused tires should not be put into service if they are over 6 years old . . .”. This is something that would come as news to most U.S. car owners, but seems to be known by everyone but the American consumer. In fact, the head of the U.S. Rubber Manufacturers Association has gone on record saying that there is no need for U.S. drivers to be given the same warning that British car owners have received.

U. S. car manufacturers have been warning their customers for years about the problems with aging tires. In fact, Ford Motor Company has asked the federal government to impose a 6 year age limit or expiration on tires.

So just how do you tell when your tires were manufactured? Begin by locating the DOT number on the sidewall of your tire. Up until last year, the DOT number was molded on the inside of tires, making it extremely difficult to locate. To read it, the consumer either had to put their vehicle on a lift or crawl under it with a flashlight to find it. Once you have located your DOT number, identify the 3 or 4 numbers at the very end of the serial number. If a tire has three numbers, it means that the tire was made prior to January 2000. If a tire has four numbers, it indicates that the tire was manufactured after January 1, 2000. The first two numbers in the date of manufacture indicate the week in which the tire was made.

I your tire has 036 as the last three digits of your DOT number, it indicates that the tire was manufactured in the third week of 1996. If your tire has 4604 as the last four digits of your DOT number, it indicates the tire was manufactured in the 46th week of 2004. Experts urge motorists to check their tires’ manufacturing date and replace them after six years of age.

Tuesday, November 11, 2008

Voluntary Recall of Potentially Oversized Tablets Expanded

From the medical news site

ETHEX Corporation announced the voluntary recall of lots of five generic medications because they may contain more than the labeled amount of active ingredient, the FDA said.

The recall applies to 150-, 225-, and 300-mg propafenone HCl tablets, 30- and 60-mg isosorbide mononitrate extended-release tablets, 15-mg morphine sulfate extended-release tablets, 15- and 30-mg morphine sulfate immediate-release tablets, and 10-mg dextroamphetamine sulfate tablets.

Overdoses of all four of the drugs can have serious and life-threatening complications, according to an FDA press release announcing the recall.

These include arrhythmias and low blood pressure with propafenone HCl, fainting and low blood pressure with isosorbide mononitrate, respiratory depression and low blood pressure with morphine sulfate, and rapid heart rate and high blood pressure with dextroamphetamine sulfate, the agency said.

Earlier this year, the drug maker voluntarily withdrew three lots of 5-mg dextroamphetamine sulfate tablets and 60-mg morphine sulfate extended-release tablets. (See: Dextroamphetamine Sulfate Tablets Recalled)

The following lots are involved in the current recall and were shipped before May 22:

* 150-mg propafenone HCl tablets (73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011)
* 225-mg propafenone HCl tablets (71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011)
* 300-mg propafenone HCl tablets (72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011)
* 30-mg isosorbide mononitrate extended-release tablets (62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009)
* 60-mg isosorbide mononitrate extended-release tablets (63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009)
* 15-mg morphine sulfate extended-release tablets (81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010)
* 15-mg morphine sulfate immediate-release tablets (77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011)
* 30-mg morphine sulfate immediate-release tablets (75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011)
* 10-mg dextroamphetamine sulfate tablets (73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011)

Source here.

Monday, November 10, 2008

The Internet, Clients and My Law Office

This recent report caught my eye:

A report, released in August, says 40% of people 50 to 64 years old and 27% of adults 65 and older are getting information online every day, compared to about 55% of those 18 to 49. The study surveyed 2,251 adults 18 and older from April 8 to May 11 of this year. Source here.

Does your law office make an extra effort to gather your clients' emails? We have done so, aggressively, this year. The result? I am now seeing a decrease in postage and copy costs. I filed a lawsuit for a client, and when we received a "Notice of Removal" on the matter, simply emailed it to her. No need to copy and send 125 pages. We explained it in detail in an email PDF letter, asked her to call, and spoke at length. In that one case, we probably saved the client $20 just on one mailing. Now, multiply that over a typical caseload, and you have substantial (to me) savings to the client.

I've sent settlement papers, updates and other papers to client over the age of 65. All appreciate the ease of email. Informally, nearly 2/3rds of our clients over the age of 50 in our office now have and use email.

Are you doing all you can to gather your client's emails?

Relion Syringe Recall

From the FDA:

FDA is urging patients and health care professionals to check packaging carefully for syringes labeled as 100 units for use with U-100 insulin from lot number 813900.

The recall applies to the following product information:
-- ReliOn 1cc, 31-gauge, 100 units

The syringes were distributed by Can-Am Care and sold only at Wal-Mart stores and Sam's Clubs.

Recalled syringes should be returned to a local Wal-Mart or Sam's Club pharmacy for a replacement.

Consumers and health care professionals who suspect they have the recalled product are asked to call toll-free at (866) 780-5436 or go to

The Tyco Healthcare Group LP (Covidien) is recalling ReliOn brand syringes because they may lead to patients receiving an overdose of as much as 2.5 times the intended dose. An overdose of insulin can lead to hypoglycemia, serious health consequences, and even death.

Saturday, November 08, 2008

My Law Partner's Verdict For The Little Guy: $2.298Million

One of my law partners just completed a retaliatory discharge case in Alabama involving Dollar General.

A retaliatory discharge claim against an employer is generally allowed where an employee has been fired for exercising a right under state law, or the discharge of the employee violate public policy.

The former employee was allegedly fired from Dollar General after she reported an injury. Joey James said: "My client proved that Dollar General has a company policy that fines its’ managers $7500 for every employee injury reported from their store. The money comes straight out of the manager’s yearly bonus check.”

The former Dollar General employee hurt her hand on the cash drawer. It then became infected and her arm had to be amputated. Dollar General denied her worker's compensation claim three days after her arm was amuptated.

The jury deliberated less than three hours before reaching the $2,298,000 verdict.

This to me is a clear victory for all working men and women.

Tuesday, November 04, 2008

Preemption Before U.S. Supreme Court

A good piece on the WSJ Law Blog regarding the Levine v. Wyeth case, which is front and center on the preemption issue.

Preemption simply stated is the position that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

In part from the WSJ Blog:

"At the center of the case is the delivery technique for an antihistamine called Phenergan. Diana Levine, the plaintiff, sought treatment for nausea. Clinicians administered Phenergan using a delivery technique called “IV push,” as opposed to “IV drip.” As a result, Levine, a guitar player, developed gangrene in her arm, which eventually required its amputation. Both Wyeth and the FDA were aware that the “IV push” risked inadvertent arterial injection and gangrene, but the FDA nevertheless approved labeling for Phenergan that warned against – but did not prohibit – IV push administration. (For more background, go to Scotus blog.) Superior court in Vermont had instructed a jury that the label’s compliance with FDA regulations did not establish its adequacy when considering Wyeth’s negligance. The jury awarded Levine more than $6 million in damages. "

Go here for more.

From various sources, it looks like the justices took issue with Wyeth’s argument that it couldn’t update its label to add stronger warnings without first getting FDA approval. “Wyeth could have gone back to the FDA anytime” to update the label, Justice David Souter said. “And it simply didn’t do it.” Source.

You can also read the transcript of the argument here.