Drug & Device News

Dangerous Beds Recalled

Vail Products Inc. is recalling 5000 of its “enclosed” bed systems because they have been found to cause patient entrapments, resulting in severe neurological damage or death due to asphyxiation. Thirty people have been reported trapped by the devices, with death resulting for eight of these cases. The FDA has advised all users of Vail's beds to stop using them immediately.

Pharmacy's Drug Information Creates Warranty

A jury verdict holding Rite Aid pharmacies liable for breach of express warranty has been upheld by the Court of Special Appeals of Maryland because although the learned intermediary doctrine might normally have shielded the pharmacy from liability, when Rite Aid made the choice to provide its own literature describing a drug and its indications, it created an express warranty that the product would perform as described. Rite Aid Corp. v. Levy-Gray, 2005 Md. App. LEXIS 64 (Md. App. 6/3/05).

Plaintiff Ellen R. Levy-Gray contracted Lyme disease and was prescribed a 100-mg dose twice a day of doxycycline. The plaintiff's doctor did not give her any other specific information on how to take the drug, relying instead on the pharmacist to do so. Levy-Gray had her prescription filled at a Rite-Aid pharmacy. Along with her prescription, she received from Rite Aid a “patient package insert” (PPI) prepared and customized for Rite Aid by a non-party to the litigation. The cover page of the pamphlet informed readers: “Inside is everything you need to know about your prescription. It covers everything in writing from dosage to side effects. If you have any questions, just ask your pharmacist.” The inside of the pamphlet stated, in part: “Important Note: The Following Information Is Intended To Supplement, Not Substitute For, The Expertise And Judgment Of Your Physician, Pharmacist Or Other Healthcare Professional.” The PPI said to take doxycycline with food or milk if stomach upset occurs, “unless your doctor directs you otherwise.”

Levy-Gray did experience stomach upset when taking the medication and, because she was nursing an infant, she often drank milk or ate other dairy products close in time to when she took the medication. Neither her doctor nor the pharmacist had directed her otherwise. Dairy products in fact diminish the effectiveness of doxycycline.

Levy-Grey failed to recover properly from the Lyme disease and went on to develop post-Lyme syndrome, an autoimmune disease. She brought suit against Rite Aid for breach of express warranty under Md. Code Ann., Com. Law ' 2-313 (1975, 2002 Repl. Vol.) and won. Rite Aid appealed, arguing inter alia that Maryland law does not authorize a cause of action against pharmacists for breach of express warranty because the doctor, as the “learned intermediary,” is responsible for advising patients. The appellate court found that the jury could reasonably have concluded that Rite Aid's PPI created a warranty. “Indeed, the PPI furnished to Ms. Levy-Gray invited her reliance and evidences Rite Aid's intent that she rely on the affirmations of fact about doxycycline contained in the PPI. Its cover informed her that 'inside is everything you need to know about your prescription.'” Because of these assertions by Rite Aid's PPI, the appellate court upheld the jury's assignment of liability for breach of express warranty against the pharmacy.

FDA Holds First Meeting of Drug Safety Oversight Board

The FDA's Drug Safety Oversight Board (DSOB) held its inaugural meeting on June 17, 2005. The board did not discuss any product-specific issues, but dealt with preliminary policy and procedure issues. The FDA will post summaries of future board meetings at www.fda.gov approximately 1 week after each meeting.

Iressa' Use Restricted

The FDA is restricting sales and use of the lung cancer medication Iressa to patients who previously used or are currently using the drug. The agency's move came after AstraZeneca, the drug's manufacturer, failed to show in clinical trials that Iressa prolongs lives. Iressa was approved for treatment of non-small- cell lung cancer in May 2003.

Medtronic Device Prompts Warning Letter

The FDA issued a warning letter to Medtronic, maker of the Lifepak' 12 defibrilator, on June 9, advising the company that its device is considered adulterated within the meaning of section 501(h) of the Federal Food, Drug and Cosmetic Act. The FDA's past inspections have found failures of the therapy connectors due to impact damage; bent, broken, and worn pins in the cable connectors; and broken wiring in the cables. The agency previously recommended that Medtronic install a new therapy connector, replace all therapy cables with new versions, visually inspect therapy cables for damage and perform a product inspection procedure. Although these actions were implemented last year, there have been continued complaints of broken pins in the therapy cables used with the new connector. One death has been blamed on the malfunctioning device since the changes were implemented. The company was given 15 days to inform the FDA of steps it would take to correct the problem.

Merck Wants to Delay First Vioxx' Trial

Merck & Co. asked a Texas judge to postpone the first of several Vioxx trials now in the pipeline because the company claims recent negative publicity about the drug will taint the jury. The case, brought by Carol Ernst, blames Vioxx for her husband's death in 2001. Merck has asked for a 2-month delay in the litigation that was scheduled to begin July 11.

FDA Issues Nationwide Notification of Recall of Certain Guidant Products

The Food and Drug Administration (FDA) notified health care providers and patients on June 17 that the Guidant Corporation was recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators because the devices could develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.

The devices affected are the PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002; the CONTAK RENEWAL, manufactured on or before Aug. 26, 2004; and the CONTAK RENEWAL 2, Model H155, manufactured on or before Aug. 26, 2004. Problems were later disclosed concerning CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF. The FDA has declined to make a recommendation as to whether individual patients who have one of the Guidant devices should have it surgically removed and replaced because while the devices pose some risk to users, removal surgery also poses risks. The FDA has, however, warned patients that they should seek immediate medical assistance if they receive a shock from their devices or hear those devices beeping. Guidant has agreed to pay the cost of defibrillator replacement in certain cases.

Dangerous Beds Recalled

Vail Products Inc. is recalling 5000 of its “enclosed” bed systems because they have been found to cause patient entrapments, resulting in severe neurological damage or death due to asphyxiation. Thirty people have been reported trapped by the devices, with death resulting for eight of these cases. The FDA has advised all users of Vail's beds to stop using them immediately.

Pharmacy's Drug Information Creates Warranty

A jury verdict holding Rite Aid pharmacies liable for breach of express warranty has been upheld by the Court of Special Appeals of Maryland because although the learned intermediary doctrine might normally have shielded the pharmacy from liability, when Rite Aid made the choice to provide its own literature describing a drug and its indications, it created an express warranty that the product would perform as described. Rite Aid Corp. v. Levy-Gray, 2005 Md. App. LEXIS 64 (Md. App. 6/3/05).

Plaintiff Ellen R. Levy-Gray contracted Lyme disease and was prescribed a 100-mg dose twice a day of doxycycline. The plaintiff's doctor did not give her any other specific information on how to take the drug, relying instead on the pharmacist to do so. Levy-Gray had her prescription filled at a Rite-Aid pharmacy. Along with her prescription, she received from Rite Aid a “patient package insert” (PPI) prepared and customized for Rite Aid by a non-party to the litigation. The cover page of the pamphlet informed readers: “Inside is everything you need to know about your prescription. It covers everything in writing from dosage to side effects. If you have any questions, just ask your pharmacist.” The inside of the pamphlet stated, in part: “Important Note: The Following Information Is Intended To Supplement, Not Substitute For, The Expertise And Judgment Of Your Physician, Pharmacist Or Other Healthcare Professional.” The PPI said to take doxycycline with food or milk if stomach upset occurs, “unless your doctor directs you otherwise.”

Levy-Gray did experience stomach upset when taking the medication and, because she was nursing an infant, she often drank milk or ate other dairy products close in time to when she took the medication. Neither her doctor nor the pharmacist had directed her otherwise. Dairy products in fact diminish the effectiveness of doxycycline.

Levy-Grey failed to recover properly from the Lyme disease and went on to develop post-Lyme syndrome, an autoimmune disease. She brought suit against Rite Aid for breach of express warranty under Md. Code Ann., Com. Law ' 2-313 (1975, 2002 Repl. Vol.) and won. Rite Aid appealed, arguing inter alia that Maryland law does not authorize a cause of action against pharmacists for breach of express warranty because the doctor, as the “learned intermediary,” is responsible for advising patients. The appellate court found that the jury could reasonably have concluded that Rite Aid's PPI created a warranty. “Indeed, the PPI furnished to Ms. Levy-Gray invited her reliance and evidences Rite Aid's intent that she rely on the affirmations of fact about doxycycline contained in the PPI. Its cover informed her that 'inside is everything you need to know about your prescription.'” Because of these assertions by Rite Aid's PPI, the appellate court upheld the jury's assignment of liability for breach of express warranty against the pharmacy.

FDA Holds First Meeting of Drug Safety Oversight Board

The FDA's Drug Safety Oversight Board (DSOB) held its inaugural meeting on June 17, 2005. The board did not discuss any product-specific issues, but dealt with preliminary policy and procedure issues. The FDA will post summaries of future board meetings at www.fda.gov approximately 1 week after each meeting.

Iressa' Use Restricted

The FDA is restricting sales and use of the lung cancer medication Iressa to patients who previously used or are currently using the drug. The agency's move came after AstraZeneca, the drug's manufacturer, failed to show in clinical trials that Iressa prolongs lives. Iressa was approved for treatment of non-small- cell lung cancer in May 2003.

Medtronic Device Prompts Warning Letter

The FDA issued a warning letter to Medtronic, maker of the Lifepak' 12 defibrilator, on June 9, advising the company that its device is considered adulterated within the meaning of section 501(h) of the Federal Food, Drug and Cosmetic Act. The FDA's past inspections have found failures of the therapy connectors due to impact damage; bent, broken, and worn pins in the cable connectors; and broken wiring in the cables. The agency previously recommended that Medtronic install a new therapy connector, replace all therapy cables with new versions, visually inspect therapy cables for damage and perform a product inspection procedure. Although these actions were implemented last year, there have been continued complaints of broken pins in the therapy cables used with the new connector. One death has been blamed on the malfunctioning device since the changes were implemented. The company was given 15 days to inform the FDA of steps it would take to correct the problem.

Merck Wants to Delay First Vioxx' Trial

Merck & Co. asked a Texas judge to postpone the first of several Vioxx trials now in the pipeline because the company claims recent negative publicity about the drug will taint the jury. The case, brought by Carol Ernst, blames Vioxx for her husband's death in 2001. Merck has asked for a 2-month delay in the litigation that was scheduled to begin July 11.