Los Angeles Personal Injury Lawyer - Pharmaceutical

Japanese Gangsters, Illegitimate Liver Transplants, Unauthorized Bank Accounts and UCLA

Paul Kiesel — Tue, 23 Jun 2009 20:02:46 GMT

First, the unauthorized bank account referred to in the title of this blog stems from the UCLA Willed Body fiasco that took place from 1999-2003. Henry Reid, the former Willed Body Program director at UCLA, who sold cadavers and cadaver parts to Ernest Nelson (body parts broker), used an unauthorized bank account that aesthetically (checks, invoices, etc.) appeared to be an authorized UCLA bank account (it was surreptitiously established by three UCLA employees), to embezzle tens of thousands of dollars over a four-to-six-year period.

Not surprisingly, during the same period that UCLA carelessly allowed its Willed Body Program to be run into the ground by Henry Reid, who, oddly, didn't testify in the trial against Ernest Nelson (even though it was pretty obvious by the copious exhibits presented to the jury that the trial against Ernest Nelson was in fact the trial against both of the hapless body brokers), UCLA allowed Japanese gangsters, who should have never been permitted into the U.S. (thanks, FBI), to receive liver transplants ahead of over 100 patients in terrible need of the same procedure.

From the Los Angeles Times:

UCLA Medical Center and its most accomplished liver surgeon provided a life-saving transplant to one of Japan's most powerful gang bosses, law enforcement sources told The Times.

In addition, the surgeon performed liver transplants at UCLA on three other men who are now barred from entering the United States because of their criminal records or suspected affiliation with Japanese organized crime groups, said a knowledgeable law enforcement official who spoke on condition of anonymity.

The four surgeries were done between 2000 and 2004 at a time of pronounced organ scarcity. In each of those years, more than 100 patients died awaiting liver transplants in the greater Los Angeles region.

The surgeon in each case was Dr. Ronald W. Busuttil, executive chairman of UCLA's surgery department, according to another person familiar with the matter who also spoke on condition of anonymity. Busuttil is a world-renowned liver surgeon who co-edited a leading text on liver transplantation and is one of the highest-paid employees in the University of California system.

Click here for the rest of the article.

Originally posted at InjuryBoard by Paul Kiesel

Ignorance meets Incompetence: The Criminal Trial of Ernest Nelson, UCLA Body Broker

Paul Kiesel — Fri, 29 May 2009 20:03:12 GMT

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Click here for other blog posts by this author.

Originally posted at InjuryBoard by Paul Kiesel

Ernest Nelson Found Guilty in UCLA Body-Parts Program Scandal

Paul Kiesel — Thu, 14 May 2009 15:53:39 GMT

SEE BOLD CAPS FOR EDITORIAL COMMENTS

From the Los Angeles Times:

A businessman accused of selling body parts from corpses donated to UCLA medical school in a scandal that tarnished the reputation of the university's willed body program THE PROGRAM, DURING 1999-2003, WHEN ERNEST NELSON AND HENRY REID, THE PROGRAM'S FORMER DIRECTOR, WERE PURCHASING AND SELLING PARTS FROM ONE ANOTHER, WAS NOT CONSIDERED AS VENERABLE AS UCLA HAS TRIED TO PORTRAY IT; IN FACT, UCLA'S WILLED BODY PROGRAM WAS STILL RECOVERING FROM A 1993 INCIDENT (CADAVERS, FROM THE WILLED BODY PROGRAM WERE HANDLED "WITHOUT DIGNITY" AND DUMPED INTO THE PACIFIC OCEAN ALONG WITH OTHER MEDICAL WASTE FROM THE SCHOOL OF MEDICINE) was found guilty today in Los Angeles Superior Court of conspiring to commit grand theft, embezzlement and tax evasion .

Prosecutors alleged that Ernest V. Nelson, 51, cut up heads, torsos and other parts from donated bodies and sold them without UCLA's permission to medical and pharmaceutical research companies, collecting $1.5 million between 1999 and 2003. THE PEOPLE, THROUGHOUT THE TRIAL AGAINST MR. NELSON, TRIED ARGUING THAT UCLA HAD LOST $1.5 MILLION VIA NELSON AND REID'S CHICANERY. HOWEVER, IF NELSON HAD STOLEN $1.5 FROM UCLA, THEN LOGICALLY SPEAKING, UCLA WOULD HAVE NEEDED TO HAVE SOLD THE PARTS ON ITS OWN AND COLLECTED THAT MUCH MONEY, RIGHT? AND IF THAT'S THE CASE, THEN UCLA WOULD HAVE BEEN PARTICIPATING IN ILLEGAL BODY PARTS TRAFFICKING; MEANING THEY NEVER WOULD HAVE (NOR SHOULD HAVE) BEEN ABLE TO MAKE THAT MUCH MONEY BY USING, NOT SELLING, THE DONATED BODIES FOR MEDICAL RESEARCH. THEREFORE, THE IDEA THAT NELSON STOLE OVER A MILLION DOLLARS FROM UCLA IS NOT ONLY A REACH, BUT IT'S AN OUTLANDISH ARGUMENT.

The bodies were donated to UCLA for medical and scientific research (AH, SEE, FOR RESEARCH, NOT FOR UCLA TO SELL AT $1.5 MILLION) at the university. The scandal over the sale of the body parts became public in 2004 and prompted UCLA to shut down the program for more than 18 months. UCLA ALSO HAD TO ATTEND TO OTHER PROBLEMS THAT WERE DISCOVERED THROUGHOUT THE PROGRAM, TOO: SANITARY ISSUES; "CADAVER ROOMS" THAT WERE OVERCROWDED; MAJOR ACCOUNTING, BOOKKEEPING AND INVENTORY ISSUES, ETC.

Prosecutors said Nelson hatched the scheme with the director of the willed body program, Henry Reid (WHO, BY THE WAY, WAS NEVER CALLED TO THE STAND TO TESTIFY AGAINST NELSON, EVEN THOUGH THE PEOPLE'S CASE WAS LARGELY BUILT AROUND REID'S ACTIONS, INTENT AND MALEVOLENCE AND THEN HOW NELSON WORKED WITH HIM TO SELL THE BODY PARTS (AND PREPARE THEM) TO PHARMACEUTICAL AND MEDICAL RESEARCH COMPANIES. WHY WASN'T REID CALLED TO THE STAND? BECAUSE, INCREDULOUSLY, THE PROSECUTION FORGOT TO FILE THE CORRECT PAPERWORK AND FOLLOW ADMINISTRATIVE PROCEDURES IN ORDER TO TRANSFER REID TO LOS ANGELES FROM THE FEDERAL PRISON HE'S CURRENTLY RESIDING IN WITHIN A TIMELY MANNER.), who pleaded guilty last year to conspiring to commit theft. Reid received checks from Nelson totaling $43,000 in return for giving him access to the bodies, prosecutors said.

Nelson's attorney argued that the payments to Reid were legitimate. He accused the program director of pocketing the money instead of forwarding it to the university. (WHICH WAS AN INTERESTING ARGUMENT: UCLA HAD THREE OF ITS EMPLOYEES, INCLUDING DR. ROBERT B. TRELEASE, A PATHOLOGY PROFESSOR WHO FREQUENTLY USED BODIES FROM THE WILLED BODY PROGRAM TO INSTRUCT MEDICAL STUDENTS AND WHO, IN THE PAST, HAD A MORE ACTIVE ROLE WITHIN THE PROGRAM, SET UP A BANK ACCOUNT, COUNTER TO TYPICAL UCLA ACCOUNTING PRACTICES, AT A WESTWOOD BANK OF AMERICA BRANCH, WHICH WOULD BE THE SAME ACCOUNT USED BY HENRY REID TO FUNNEL THE MONEY MADE FROM SELLING PARTS TO NELSON, INTO HIS OWN PERSONAL BANK ACCOUNT. UCLA, BASED ON THIS INFORMATION, SHOULD HAVE KNOWN THEN WHAT WAS GOING ON WITH THAT BANK ACCOUNT, CONSIDERING THREE RESPECTED EMPLOYEES SET UP THE ACCOUNT BACK IN 1995, TWO YEARS BEFORE REID BECAME THE PROGRAM'S DIRECTOR... HMM...?)

CLICK HERE FOR THE ENTIRE LOS ANGELES TIMES ARTICLE WITHOUT MY COMMENTARY.

Originally posted at InjuryBoard by Paul Kiesel

Ethex Expands Recent Recall Even Further

Paul Kiesel — Thu, 05 Feb 2009 20:37:09 GMT

From Forbes:

Associated Press - KV Pharmaceutical Co. is issuing its fourth product recall in about three months because some of its prescription prenatal and iron supplements were made under unsatisfactory conditions.

Late Tuesday, KV said it is voluntarily pulling dozens of prescription iron supplements and prenatal vitamin capsules and tablets because the products were made under conditions that didn't comply with industry standards. The recall includes products made by its Ther-Rx and Ethex divisions.

The company also extended a recall of five drugs made by Ethex, KV's generic business. Those drugs, along with dozens of others, were recalled last week at the wholesale level because of manufacturing problems. The new recall extends to the retail level.

In afternoon trading, KV shares lost 10 cents, or 13.9 percent, to 62 cents.

KV has issued four spates of product recalls since Nov. 7, citing manufacturing problems and accidentally oversized pills. On Jan. 26, the company recalled most of its products, and stopped its manufacturing and shipping operations. It warned that the Food and Drug Administration might choose to investigate or file charges.

Originally posted at InjuryBoard by Paul Kiesel

Another Ethex and KV Pharma Drug Recall

Paul Kiesel — Mon, 02 Feb 2009 16:45:35 GMT

For the fifth time in just over 12 months, Ethex Corporation, a subsidiary of KV Pharmaceutical (drug manufacturer), issued another voluntary recall on several of their drug products, including various sized morphine sulfate tablets.

As noted previously in this blog, Ethex has had a serious problem with the consistency of its drug products' tablet size, as many of its prescription drugs, particularly morphine sulfate, have been manufactured twice the size than the product label suggests. This reoccurring problem can lead to drug dependency, myriad health problems, and even death.

Below is the drug recall information listed on Ethex Corp.'s website. Anyone in possession of these listed drugs and lot numbers should immediately consult a physician.

ETHEX Corporation Issues Nationwide Voluntary Recall of Products

St. Louis, Jan. 28, 2009 – ETHEX Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a nationwide voluntary recall of the products identified below (all lots within their expiration dates) at a wholesale or a retail level as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace.

Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to WHOLESALE Level:

Amlodipine Besylate Tablets, 10mg (58177-538-26 & 538-11)
Amlodipine Besylate Tablets, 2.5mg (58177-536-26)
Amlodipine Besylate Tablets, 5mg (58177-537-26, 537-07 & 537-11)
Benazepril HCl Tablets, 10mg (58177-342-04 & 342-08)
Benazepril HCl Tablets, 20mg (58177-343-04 & 343-08)
Benazepril HCl Tablets, 40mg, (58177-344-04 & 344-08)
Benazepril HCl Tablets, 5mg (58177-341-04)
Benzonatate Capsules, 100mg (58177-091-04 & 091-08)
Benzonatate Capsules, 200mg (58177-092-04 & 092-08)
Bromfenex ER Capsules (58177-019-04)
Bromfenex PD ER Capsules (58177-020-04)
Buspirone HCl Tablets, 10mg (58177-265-04 & 265-08)
Buspirone HCl Tablets, 15mg (58177-309-04 & 309-08)
Buspirone HCl Tablets, 5mg (58177-264-04 & 264-08)
Codeine Phosphate/Guaifenesin Tablets, 10mg (58177-223-04)
Dextroamphetamine Sulfate Tablets, 10mg (58177-312-04)
Dextroamphetamine Sulfate Tablets, 5mg (58177-311-04)
Dextroamphetamine Tablets, 10mg (58177-312-04)
Diltiazem HC1 Capsules, 120mg (58177-061-11)
Diltiazem HC1 Capsules, 120mg (58177-061-19 & 061-26)
Diltiazem HC1 Capsules, 180mg (58177-062-09 & 062-11)
Diltiazem HC1 Capsules, 180mg (58177-062-19 & 062-26)
Diltiazem HC1 Capsules, 240mg (58177-063-09 & 063-11)
Diltiazem HC1 Capsules, 240mg (58177-063-19 & 063-26)
Diltiazem HC1 Capsules, 300mg (58177-064-19 & 064-26)
Diltiazem HC1 Capsules, 360mg (58177-065-09 & 065-11)
Diltiazem HC1 Capsules, 360mg (58177-065-19 & 065-26)
Diltiazem HC1 Capsules, 420mg (58177-066-09 & 066-11)
Diltiazem HC1 Capsules, 420mg (58177-066-19 & 066-26)
Disopyramide Phosphate ER Capsules, 150mg (58177-002-04)
Doxazosin Mesylate Tablets, 1mg (58177-266-04 & 266-08)
Doxazosin Mesylate Tablets, 2mg (58177-267-04 & 267-08)
Doxazosin Mesylate Tablets, 4mg (58177-268-04 & 268-08)
Doxazosin Mesylate Tablets, 8mg (58177-269-04 & 269-08)
Ethedent Chewable Tablets, .25mg (58177-432-40)
Ethedent Chewable Tablets, .5mg (58177-433-40 & 433-09)
Ethedent Chewable Tablets, 1mg (58177-434-40 & 434-09)
EthexDerm BPW-10, 10% (58177-929-65)
EthexDerm BPW-5, 5% (58177-928-65)
Ethezyme 650 (58177-868-02)
Ethezyme 830 Papain-Urea (58177-816-02)
Ethezyme Papain-Urea (58177-804-02)
ETH-Oxydose Concentrated Solution (58177-914-04 & 914-56)
Guaifenex DM ER Tablets (58177-213-04)
Guaifenex GP ER Tablets (58177-373-04)
Guaifenex PSE 120 ER Tablets (58177-208-04)
Guaifenex PSE 60 ER Tablets (58177-214-04)
Guaifenex PSE 80 Tablets (58177-413-04)
Guaifenex PSE 85 Tablets (58177-478-04)
Hista-Vent DA Tablets (58177-227-04)
Hista-Vent PSE tablets (58177-426-04)
Histinex HC Liquid (58177-877-07 & 877-12)
Histinex PV Liquid (58177-883-07)
Hydrocodone Bitartrate & Acetaminophen Liquid (58177-909-07)
Hydrocodone Bitartrate/Guaifenesin Liquid (58177-881-07)
Hydrocortisone and Iodoquinol Cream, 1% (58177-803-02)
Hydroquinone 4% Cream w/SS, 1oz. (58177-802-02)
Hydroquinone 4% Cream, 1oz. (58177-801-02)
Hydro-Tussin CBX Liquid (58177-924-07)
Hydro-Tussin DHC Syrup (58177-926-07)
Hydro-Tussin DM Liquid (58177-906-07)
Hydro-Tussin EXP Liquid (58177-927-07)
HydroTussin HC Syrup (58177-915-07)
Hydro-Tussin Liquid (58177-890-07)
Hydro-Tussin XP Liquid (58177-916-07)
Hyoscyamine Orally Disintegrating Tablets, .125mg (58177-423-04)
Hyoscyamine Sublingual Tablets, .125mg (58177-255-04)
Hyoscyamine Sulfate ER Tablets, .375mg (58177-237-04)
Hyoscyamine Sulfate ER Capsules, .375mg (58177-017-04)
Hyoscyamine Sulfate Oral Tablets, .125mg (58177-274-04)
Isosorbide Mononitrate ER Tablets, 120mg (58177-201-04)
Isosorbide Mononitrate ER Tablets, 30mg (58177-222-04, 222-08 & 222-11)
Isosorbide Mononitrate ER Tablets, 60mg (58177-238-04, 238-08 & 238-11)
Meperidine/Promethazidne Capsules (58177-027-04)
Morphine InveAmp, 20mg x 1mL (58177-886-56)
Morphine InveAmp, 5mg/.25mL (58177-888-80)
Morphine Sulfate Concentrated Oral Solution 20mg/1ml (58177-886-01, 886-03 &886-05)
Morphine Sulfate Concentrated Oral Solution, 20mg/1ml (58177-886-57)
Morphine Sulfate ER Tablets, 100mg (58177-340-04)
Morphine Sulfate ER Tablets, 15mg (58177-310-04)
Morphine Sulfate ER Tablets, 200mg (58177-380-04)
Morphine Sulfate ER Tablets, 30mg (58177-320-04)
Morphine Sulfate ER Tablets, 60mg (58177-330-04)
Morphine Sulfate IR Tablets, 15mg (58177-313-04)
Morphine Sulfate IR Tablets, 30mg (58177-314-04)
NitroQuick Sublingual Tablets, .3mg (58177-323-04)
NitroQuick Sublingual Tablets, .4mg (58177-324-18 & 324-04)
NitroQuick Sublingual Tablets, .6mg (58177-325-04)
Nystatin Topical Powder, USP 15 grams (58177-839-45)
Nystatin Topical Powder, USP 30 grams (58177-839-46)
Nystatin Topical Powder, USP 60 grams (58177-839-61)
Ondansetron Orally Disintegrating Tablets, 4mg (58177-363-22)
Ondansetron Orally Disintegrating Tablets, 8mg (58177-364-22 & 364-56)
Oxycodone HCl Capsules, 5mg (58177-041-04 & 041-11)
Oxycodone HCl IR Tablets, 10mg (58177-461-04)
Oxycodone HCl IR Tablets, 15mg, (58177-445-04)
Oxycodone HCl IR Tablets, 20mg (58177-462-04)
Oxycodone HCl IR Tablets, 30mg (58177-446-04)
Oxycodone HCl IR Tablets, 5mg (58177-625-04 & 625-11)
Pangestyme CN 20 (58177-030-04)
Pangestyme CN10 (58177-029-04)
Pangestyme EC 100 (58177-031-04)
Pangestyme EC 250 (58177-031-06)
Pangestyme MT16 (58177-028-04)
Pangestyme UL12 (58177-048-04)
Pangestyme UL18 (58177-049-04)
Pangestyme UL20 (58177-050-04)
PhenaVent Capsules (58177-078-19)
PhenaVent D Tablets (58177-444-04)
PhenaVent LA Capsules (58177-095-19)
PhenaVent PED Capsules (58177-079-04)
Plaretase 800 (58177-416-04 & 416-08)
Potassium Chloride ER Capsules, 10mEq (58177-001-04, 001-08, 001-09, & 001-11)
Potassium Chloride ER Capsules, 8mEq (58177-677-04 & 677-08)
Potassium Chloride ER Tablets, 20mEq (58177-202-04, 202-08, 202-09 & 202-11)
Prednisolone Sodium Oral Solution (58177-932-05)
Prednisolone Syrup 15mg/5mL (58177-910-05 & 910-07)
Prednisolone Syrup 5mg/5mL (58177-912-03)
Propafenone HCl Tablets, 150mg (58177-331-04 & 331-11)
Propafenone HCl Tablets, 225mg (58177-332-04)
Propafenone HCl Tablets, 300mg (58177-333-04)
Pseudovent 400 Capsules (58177-096-04)
Pseudovent Capsules (58177-045-04)
Pseudovent PED Capsules (58177-046-04)
Tri-Vent DM Syrup (58177-925-07)
Tri-Vent DPC Liquid (58177-923-07)
Tri-Vent HC Liquid (58177-920-07)

Products Recalled to RETAIL PHARMACY Level:

Hydromorphone HCl Tablets, 2mg (58177-620-04 & 620-11)
Hydromorphone HCl Tablets, 4mg (58177-621-04 & 621-11)
Hydromorphone HCl Tablets, 8mg (58177-449-04)
Metoprolol Succinate ER Tablets, 50mg (58177-369-04, 369-09 & 369-11)
Metoprolol Succinate ER Tablets, 100mg (58177-368-04, 368-09 & 368-11)
Metoprolol Succinate ER Tablets, 25mg (58177-293-04, 293-09 & 293-11)
Metoprolol Succinate ER Tablets, 200mg (58177-358-04, 358-09 & 358-11)

Any wholesale or retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers (and to retailers for Hydromorphone HCl and Metoprolol Succinate only) nationwide who received any inventory of the recalled products with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their healthcare providers.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the company is unable to determine when distribution of these products will resume.

Any adverse reactions experienced with the use of these products 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, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The recall announcement is posted on www.kvpharma.com.

Originally posted at InjuryBoard by Paul Kiesel

Former UCLA Willed Body Director Owes Medical School $500,000

Paul Kiesel — Fri, 30 Jan 2009 19:23:38 GMT

"He needs to get this behind him."

That's what Superior Court Judge Curtis Rappe told the attorney representing former UCLA Willed Body Director Henry Reid, as he pled to keep his client out of state prison for a little while longer.

Defense counsel's motion and lugubrious plea (due to his client's medical issues, which should have been dealt with sometime between October 17, 2008 -- when Mr. Reid pled guilty -- and today) were denied and Mr. Reid turned himself over to the court this morning to begin the first day of almost 1550 days (four years and four months, minus time served) behind bars. Additionally, Mr. Reid owes UCLA (Geffen School of Medicine) $500,000 in restitution.

Also in court today was Mr. Reid's co-defendant Ernest Nelson (whose attorney filed for a continuance of trial), the body broker. Mr. Nelson owned and operated a company that supplied private medical, pharmaceutical and hospital research companies with human cadavers or individual body parts. Mr. Nelson's trial date is set for April 20, 2009. He continues to declare his innocence in the Willed Body matter, however, he is also facing several severe tax charges that document his financial indiscretions unfavorably (he chose not to pay his taxes after making all the money he did selling body parts -- at high costs -- to the myriad of companies purchasing his cache of parts).

As part of Mr. Reid's plea agreement, he has stated he will cooperate in Mr. Nelson's case.

The indictment, handed up last year, alleged that Mr. Reid and Mr. Nelson deprived the UCLA Willed Body Program of "its donor bodies for personal financial gain."

According to the court papers, Mr. Reid's role "was to provide Ernest Nelson with a steady supply of donated human body parts, while Ernest Nelson would receive compensation for supplying the parts to companies and in turn would give Henry Reid money for his personal use instead of paying the UCLA WBP."

The Willed Body Program receives donations from people who have willed their bodies to the school for medical education and research purposes -- primarily for use in training medical students and assisting with medical and scientific research.

Kiesel Boucher Larson represents several of the plaintiffs whose family members were treated inappropriately (not according to contracts their decedents signed) and without any respect by Mr. Nelson, Mr. Reid, and the UCLA Willed Body Program.

Originally posted at InjuryBoard by Paul Kiesel

Walgreens Sends Urgent Drug Recall Information Letter Out to Ethex Morphine Sulfate Prescription Customers

Paul Kiesel — Fri, 09 Jan 2009 21:34:04 GMT

Ethex Corporation has been recalling (four times in the past year to be exact) several of its prescription drug products, due to some of the tablets being oversized (upwards of twice the appropriate level of the active ingredient).

Below is the content of Walgreens' recall letter per Ethex's Morphine Sulfate oversized tablets:

The manufacturer of Morphine Sulfate IR tables, Ethex Corp., is recalling several lots of this medication because there is the possibility that some tablets may be oversized and may contain more than the appropriate level of active ingredient. Your prescription may have included product from one of these affected lots.

We do not recommend that you discontinue taking Morphine Sulfate IR tablets without speaking to your physician. We ask that you attempt to contact your physician or other health care provider and share this information with them. You may return any remaining Morphine Sulfate tablets to your local Walgreens pharmacy for a refund. If you have any questions about this recall, you may contact the manufacturer at 1-800-748-1772 from Monday through Friday 8 a.m. to 5 p.m. C.S.T or via e-mail at customer-service@ethex.com.

*Also, anyone who wants to learn more about Ethex's recalls over the past 90 days can click here and browse several blogs that have further information.

Originally posted at InjuryBoard by Paul Kiesel

KV Pharmaceutical and Ethex Corporation: We've Got an Oversized Pill Problem

Paul Kiesel — Wed, 07 Jan 2009 21:53:01 GMT

Two days before Christmas, KV Pharmaceutical Co. lost half its value in New York trading after the drugmaker, announcing a fourth recall of medicines that may contain excess doses, stopped shipping prescription tablets, according to Bloomberg News.

When asked how many pills were affected or how many lots had improperly sized tablets of medicine, David Van Vliet, KV's interim CEO, said, "We’re not sure that there are any problems with these products."

Hmm...?

If there isn't anything wrong with what KV and its subsidiary company Ethex were shipping out to the public, then why would the company risk further economic damage, and take a large material hit to its operating procedures, as it did on November 13 when the company was unable to file its Q3 earnings because of an October and November drug recall (oversized morphine sulfate tablets)? Because the two companies are cogent that some, maybe not all, of the drugs that were being shipped out were, once again, oversized. And because the last thing a company like KV needs is someone to ingest a double dosage of morphine sulfate (which can result in death or at the least drug dependency) or one of its other 17 drugs that have been affected by recalls this past year.

For the acting CEO of KV to hastily halt shipments, based on a hunch, seems ridiculous. Mr. Van Vliet has to be aware that there are fundamental problems at KV and Ethex (especially when it comes to quality control), because this was the fourth time in 2008 the company had to suspend large shipments of its drugs, due to carelessness of the tablets being oversized.

Originally posted at InjuryBoard by Paul Kiesel

Morphine Overdose Killed Army Soldier

Paul Kiesel — Thu, 04 Dec 2008 20:30:06 GMT

Earlier this year, a Fort Huachuca soldier died of a morphine overdose at the Army base's medical barracks, an investigation concluded this week, and authoritites are trying to determine who provided the drug, according to the Associated Press.

Pfc. Eli Baker, 22, had just finished boot camp and was still in the process of training at the Central Arizona Army base when he was found dead on January 28 in Fort Huachuca's Warrior Transition Unit.

The unit provides medical and mental-health support for soldiers wounded in action or for troops recovering from other medical conditions.

Chris Gray, a spokesman for the U.S. Army Criminal Investigation Command, said," We have reason to believe that someone supplied him with that morphine, but he was not prescribed that morphine."

That statement issued by the Army must be disappointing to the family of Eli Baker, as 1. It'd be immediately obvious, particularly in the military, to find out whether Mr. Baker had been prescribed morphine (and it took them 11 months to figure this out?) and 2. Unless Mr. Baker had been prescribed the morphine, naturally, someone would have had to given it to him.

The most interesting aspect of the Army's investigation into what is ostensibly a case of negligent homicide, is what they've omitted. They have not suggested or disclosed that the morphine table came from the Warrior Transition Unit. And they have not connected the morphine overdose to the FDA's three recalls on Ethex Morphine Sulfate tablets, which occurred four months after Mr. Baker's death. (*Two of the recalls were voluntarily made by Ethex, after the FDA issued the first; the FDA then issued, simultaneously, two more recalls on 17 other Ethex generic products.)

The FDA doesn't typically mandate a recall on a product unless the agency is fearful of life-threatening consequences, and the FDA has yet to receive any of the recalled lots of Ethex Morphine Sulfate. Does this mean that Mr. Baker's death was the result of an oversized tablet? No, but unless the Army investigates the Warrior Transition Unit's stock of medication (and who may have been prescribed morphine at the Army base upon or before Mr. Baker's arrival), and examine whether or not the facility was stocked with any Ethex products, Eli Baker's family will lack the closure it deserves and this case will likely go unsolved.

Originally posted at InjuryBoard by Paul Kiesel

Rite Aid Warning Customers About Ethex Drug Recall

Paul Kiesel — Thu, 20 Nov 2008 15:35:00 GMT

Rite Aid customers should be receiving a letter this week, informing them that a major drug manufacturer, Ethex (a subsidiary of KV Pharmaceutical), has issued a recall of several of its generic products, including Morphine Sulfate.

Ethex sent out oversized tablets -- some double the expected dosage -- of over 10 of its prescription medicine. The recall includes a stimulant, morphine (Morphine Sulfate) and couple of Ethex heart medication products.

In Boise, Idaho, some customers have already received the letter from Rite Aid warning them to cease taking these prescriptions and to return the product to a Rite Aid pharmacy. Mark Phillips, an assistant pharmacy director at Boise's Saint Alphonsus, said that taking a double-dose of any of the recalled products can lead to serious effects, even death.

KBCI, a local Boise news station, reported that a Rite Aid spokeswoman said the company has pulled all the affected prescriptions from their shelves. They have also sent a letter to everyone who has filled a prescription for the drugs in the last 12 months, even if they may not be affected by the recall.

Below is the press release sent out by Ethex on November 7, 2008. Anyone who has taken Ethex's Morphine Sulfate or other drugs affected by the recall and would like to know what their options and rights are as a consumer should get in touch with Mr. Paul R. Kiesel or Ms. Helen Zukin at 310-854-4444:

ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic/non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.

Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.

The lots involved in the recall were all shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010

Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011

Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011

Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "331" with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "332" with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "333" with a bisect on the reverse.

The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed "E" bisecting "30" on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed "E" bisect "60" on one side and bisect on the other side.

The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with "15" on one side and an "E" on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a "15" on one side and an "ETH" on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with "30" on one side and an "ETHEX" on the reverse.

The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge, orange mottled tablet debossed "ETHEX" and "312" on one side and double-scored on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers who have received any inventory of the recalled product lots with instructions for returning the recalled products. The notification also includes instructions for the retailers/pharmacies to contact consumers who were dispensed these drugs for replacement of the product and/or refund. If the wholesalers and retailers have not already done so, they are urged to contact the number below regarding procedures for returning the recalled products. If consumers have any questions about the recall, they should call the number listed below for customer inquiries, their physician, their pharmacist or other health care provider.

Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8:00 am to 5:00 pm Central Standard Time (CST).

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may 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, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Originally posted at InjuryBoard by Paul Kiesel