C.R. Pharmacy Services d/b/a Fifth Avenue Pharmacy and Fifth Avenue Compounding Litigation in Iowa; Doctor Sued

Iowa court denies new trial in pharmacy lawsuit

DAVID PITT, Associated PressCopyright 2012 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

DAVID PITT, Associated Press

Updated 07:13 p.m., Friday, June 29, 2012inShare

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DES MOINES, Iowa (AP) — A woman left with eye problems when she didn't get the right medication after surgery won't get a new trial in her lawsuit against a pharmacy, even though new evidence that surfaced as the trial was beginning surprised her attorney, the Iowa Supreme Court ruled Friday.

The case centered on medication prepared by C.R. Pharmacy Service, which does business as Fifth Avenue Pharmacy. The medication was to be applied by Misty Whitley's doctor immediately after surgery. However, after Whitley developed problems, it was discovered she did not get the right medication.

Whitley, of Marengo, sued Dr. Lee Birchansky and the Cedar Rapids pharmacy in 2007 but dropped Birchansky from the lawsuit and pursued a malpractice and negligence claim against the pharmacy claiming it supplied the wrong product for her surgery. A jury found a verdict in favor of the pharmacy.

Whitley has since filed a new lawsuit against Birchansky after the pharmacy manager discovered documents that indicated the medication ordered by Birchansky had not been picked up by his office from the pharmacy until after the surgery had been completed.

Those documents were at the heart of the appeal that led to the Supreme Court's decision Friday. The manager who discovered the documents a few weeks before the trial told his attorney. However, that information was not passed on to Whitley's attorney.

The Supreme Court found the pharmacy's attorney violated a duty to disclose the new information, but it said the judge did nothing wrong in allowing the evidence. The judge delayed the trial so Whitley's attorney could explore the new evidence and interview additional witnesses.

The saga began when Whitley went to the Fox Eye Clinic in Cedar Rapids in 2005 hoping to improve nearsightedness with a procedure that involves using a laser to sculpt the shape of the cornea. Then, in March 2006, she had a corneal scraping procedure to repair scarring of the cornea in both eyes, a common risk with laser eye surgery.

After that surgery, her eyes developed signs of cataracts and glaucoma. An investigation and testing revealed the substance applied to her eyes after surgery was not the medicine ordered by her ophthalmologist Birchansky.

She had to undergo corneal transplant surgery. After a subsequent accident, she lost her left eye.

Whitley asserted the pharmacy delivered the wrong prescription, which the doctor applied to her eyes. The pharmacy maintained it delivered the correct prescription and the doctor mistakenly applied the wrong substance.

Then, at the beginning of the trial, the pharmacy's attorney said it could not be at fault because it didn't deliver the medication before the surgery took place. The attorney disclosed the documents on the second day of the trial during questioning of the doctor.

Whitley's attorney wanted the evidence excluded from the trial, but the district court judge denied that request.

The Iowa Court of Appeals ordered a new trial, finding that the surprise Whitley's attorney encountered by the new evidence was too prejudicial for the district court to refuse to exclude the evidence.

The Supreme Court reversed that decision and agreed with the district court judge that the evidence should have been allowed.

"The district court did not abuse its discretion when it made its decision to grant a continuance and deny the request to exclude the evidence," the justices wrote. "Based on the circumstances existing at the time the decision was made, the trial court pursued a reasonable course of action."

Robert Breckenridge, of Ottumwa, who represented Whitley, said he continues to believe the conduct of the pharmacy's attorneys should not have been rewarded by the court.

Court records show a scheduling conference in the lawsuit against Birchnasky is set for July 24.

Birchansky's attorney, Hayward Draper, of Des Moines, said the case was dropped against the doctor the first time because Whitley's attorneys concluded the doctor provided good care and did nothing wrong in his treatment of her.

"The new lawsuit is completely without merit because Dr. Birchansky did provide good care and did do nothing wrong," Draper said.

An attorney for the pharmacy, Chris Bruns, of Cedar Rapids, said the pharmacy had not authorized him to comment further about the case.

Read more: http://www.mysanantonio.com/news/article/Iowa-court-denies-new-trial-in-pharmacy-lawsuit-3674230.php#ixzz1zHhIPTy1

To review the Iowa Supreme Court decision click here.

Code of Federal Regulation for Incurin (Estriol) tablet

Oral Dosage Form New Animal Drugs; Estriol

A Rule by the Food and Drug Administration on 12/16/2011

Publication Date:

Friday, December 16, 2011

Agencies:

Department of Health and Human Services

Food and Drug Administration

Dates:

This rule is effective December 16, 2011.

Effective Date:

12/16/2011

Entry Type:

Rule

Document Citation:

76 FR 78149

Page:

78149 -78150 (2 pages)

CFR:

21 CFR 520

Agency/Docket Number:

Docket No. FDA-2011-N-0003

Document Number:

2011-32214

Shorter URL:

https://federalregister.gov/a/2011-32214

Action

Final Rule.

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of estriol tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.Show citation box

Table of Contents

• DATES:
• FOR FURTHER INFORMATION CONTACT:
• SUPPLEMENTARY INFORMATION:
• List of Subjects in 21 CFR Part 520

DATES: Back to Top

This rule is effective December 16, 2011.

FOR FURTHER INFORMATION CONTACT: Back to Top

Lisa M. Troutman, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, (240) 276-8322, email: lisa.troutman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Back to Top

Intervet, Inc., 556 Morris Ave., Summit, NJ 07901, filed NADA 141-325 that provides for the veterinary prescription use of INCURIN (estriol) Tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs. The NADA is approved as of July 24, 2011, and the regulations are amended in 21 CFR part 520 to reflect the approval.

A summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The Agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.Show citation box

Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning on the date of approval.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520 Back to Top

Animal drugs.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Back to Top

1. The authority citation for 21 CFR part 520 continues to read as follows:

Authority: Back to Top

21 U.S.C. 360b.Show citation box

2. Add § 520.852 to read as follows:

§ 520.852 Estriol.

(a) Specifications. Each tablet contains 1 milligram (mg) estriol.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer at an initial dose of 2 mg per dog per day. The dosage may be titrated to as low as 0.5 mg per dog every second day, depending on response.

(2) Indications for use. For the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: December 9, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

[FR Doc. 2011-32214 Filed 12-15-11; 8:45 am]

Canadian Operator of Internet Drug Outlet Indicted for Distribution of Fake Drugs to US Consumers

From the National Association of Boards of Pharmacy website:
June 27, 2012 01:15 PM

Andrew J. Strempler, a Canadian citizen, was arrested by United States officials in Florida and faces charges relating to his operation of a Web site selling drug products to US residents including distribution of counterfeit and non-Food and Drug Administration (FDA)-approved drugs. “According to the indictment, from around January 2005 through June 9, 2006, Strempler and his co-conspirators unlawfully enriched themselves by selling prescription drugs to individuals in the United States, falsely representing that RxNorth was selling safe prescription drugs in compliance with regulations in Canada, the United Kingdom and/or the United States. The indictment further alleges that Strempler obtained the prescription drugs from various other source countries without properly ensuring the safety or authenticity of the drugs. In fact, the indictment alleges that some of the drugs sold by Strempler included counterfeit drugs,” indicates a press release from the US Attorney’s Office, Southern District of Florida. Strempler faces one count of conspiracy to commit mail fraud and wire fraud, in violation of Title 18, US Code, Section 1349, and two counts of mail fraud, in violation of Title 18, US Code, Section 1341. The government is also seeking forfeiture of $95 million.

Wifredo A. Ferrer, US attorney for the Southern District of Florida stated, “FDA regulations are designed to promote and ensure the safety and integrity of prescription drugs sold and used in the United States. The US Attorney’s Office is committed to assisting the FDA enforce these regulations to protect American consumers from unsafe, adulterated and counterfeit drugs.” David W. Bourne, special agent in charge, FDA, Office of Criminal Investigation (OCI), Miami Field Office, stressed that the FDA OCI is committed to “aggressively pursuing individuals” who seek to sell counterfeit, adulterated, and misbranded drug products to US consumers via the Internet. Strempler appeared in federal court on June 14, 2012, before US Magistrate Judge John O’Sullivan. If convicted, Strempler faces a possible maximum statutory sentence of up to 20 years in prison on each count.

Additional details about the charges against Strempler are available in the US Attorney’s Office press release. The indictment (PDF) is available for download from the Department of Justice Web site. The press release notes that an indictment is only an accusation and a defendant is presumed innocent until proven guilty.

In California One of Common Errors is Incorrect NDC codes for Compounded Drugs

License Renewal

Processing Delayed

Atlantic Associates, Inc., the CURES data collection

vendor, has identified to the Board the four most often

occurring reporting errors. Pharmacies are entering:

1. Invalid NDC numbers;

2. Incorrect NDC codes for compounded

formulations: They should be entering the NDC

code for the main active ingredient and identifying

the prescription as a compounded drug; and

3. Invalid prescriber DEA numbers.

4. Pharmacies are also failing to enter the Method of

Payment: Cash, Medicaid/Medi-Cal, Medicare,

Commercial Insurance, Major Medical, or

Workman’s Compensation.

To ensure proper data collection, those who are

responsible for making CURES entries must make every

effort to enter valid and accurate information.

List found here.