Drug & Device News

FDA Takes X-Ray Manufacturer to Task

GE OEC Medical Systems Inc. in January signed a consent decree of permanent injunction prohibiting it from manufacturing or distributing X-ray machines from its Salt Lake City and Lawrence, MA, facilities. The X-ray systems previously manufactured at these locations were used during diagnostic, surgical, and interventional procedures, such as orthopedic, cardiac, critical-care and emergency room procedures.

The FDA issued its initial Warning Letter to the company in March 2005 following an inspection that revealed violations of the FDA's current good manufacturing practice (CGMP) requirements as set forth in the Quality System (QS) regulation for devices. When a second inspection in 2006 showed the previously-reported problems continued ' including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions ' the FDA imposed this more stringent enforcement action. The decree will require GE OEC Medical Systems to hire an independent expert to conduct inspections of the affected facilities and to certify to the FDA that corrections have been made before manufacturing and distribution may resume.

 

Leaked Court Documents Show Zyprexa Dangers Suspected Early On

The London Times online reports that as early as 1998, Eli Lilly was concerned about a possible link between use of its schizophrenia and bipolar disorder drug Zyprexa' and the onset of diabetes. Pagnamenta, The Times Online, 1/24/07, accessed at http://business.timesonline.co.uk/ article/0,,13129-2560841,00.html.

Meanwhile, on Jan. 4, Eli Lilly announced it had reached a settlement with 14 plaintiff firms suing on behalf of those claiming injury from Zyprexa use. These settlements follow earlier agreements reached in June 2005 covering approximately 8000 claims. In announcing the latest settlement, Sidney Taurel, chairman of the board and chief executive officer of Eli Lilly stated, 'While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians.' See http://www.prnewswire.com/cgi-bin/micro_stories.pl?ACCT=916306&TICK=LLY&STORY=/www/story/01-04-2007/0004499532&EDATE=Jan+4,+2007.

 

Retrial for No-Caused Vioxx User Begins

The retrial of postman Frederick Humeston's case against Merck & Co. Inc. for injuries allegedly cause by his use of Vioxx' began Jan. 22, with both sides continuing to conflict over the question of whether Merck warned consumers and their doctors of the painkiller's cardiovascular risks. Humeston's case ended the first time around in a no-cause verdict in late 2005. Superior Court judge Carol Higbee last August vacated that verdict because of new evidence showing Merck withheld important cardiovascular safety data gleaned from an earlier clinical study from consumers and the medical community.

FDA Statement on Effectiveness of Newer Birth Control Pills

The FDA issued a statement Jan. 23 in response to widespread national news coverage of supposed FDA concerns about the efficacy of lower-dose hormonal birth control drugs. Said the FDA statement, 'The stories inaccurately report that the products are significantly less effective at preventing pregnancy than those approved decades ago. In fact, the newer generation products are highly effective in preventing pregnancy. The stories also mistakenly state that FDA called the meeting to discuss the need for higher standards of efficacy for the newer products.' The statement is available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01550.html.

 

Class Status Denied for Paxil Suit Plaintiffs

U.S. District Judge Timothy Savage, who is overseeing the case of Blain v. SmithKline Beecham Corp., declined to certify a class action on behalf of minors who took the antidepressant drug Paxil' and later attempted or committed suicide. The plaintiffs claim the drug's manufacturer failed to warn consumers and physicians of evidence that use of Paxil induced suicidal ideation in pediatric patients. The judge found that there were only a minimal number of common legal issues presented in the cases and that these would be 'overwhelmed' by the unique factual and legal issues in the individual cases. The 32-page opinion explained that the proposed class failed to fulfill almost all the requirements of Rule 23 of the Federal Rules of Civil Procedure ' adequacy of representation, commonality, predominance, superiority and typicality.

 

Drug Poisoning Deaths Rapidly Rising

The Centers for Disease Control reports that deaths from accidental overdose of both prescription and non-prescription drugs rose significantly between 1999 and 2004. Morbidity and Mortality Weekly Report, 2/8/07, available at: http://www.cdc.gov/od/oc/media/mmwrnews/2007/n070208.htm#1 . Deaths from all unintentional poisonings were up a whopping 62.5% over that period, largely due to prescription drugs ' in particular prescription painkillers. Caucasians suffered an overall poisoning death increase of 75.8%, while deaths among women were up 103%, although men still die from poisonings more often than women.

Improper Use of Topical Skin-Numbing Product Can Be Life Threatening

The FDA issued a Public Health Advisory on February 6 concerning the dangers associated with the use of topical anesthetics to numb the skin in preparation for cosmetic procedures, some medically supervised and others not. These topical anesthetics contain drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel, excessive amounts of which can enter the bloodstream if applied too liberally. This practice can result in irregular heartbeat, seizures and death in some users. The Advisory is available at: http://www.fda.gov/ cder/drug/advisory/topical_anesthetics.htm.

 

Prescription Medication in Diet Supplement Potentially Hazardous

Livrio3', a diet supplement sold by Ebek Inc., was voluntarily pulled from the market in January after the FDA's laboratory analysis of the product disclosed it contained tadalafil, an FDA-approved drug used to treat erectile dysfunction. Tadalafil was not listed as an ingredient on the supplement's label. The drug can interact with other prescription drugs and has been shown to lower blood pressure levels, sometimes to a dangerous degree. The recall message can be viewed at: http://www.fda.gov/oc/po/firmrecalls/ebek01_07.html..

FDA Takes X-Ray Manufacturer to Task

GE OEC Medical Systems Inc. in January signed a consent decree of permanent injunction prohibiting it from manufacturing or distributing X-ray machines from its Salt Lake City and Lawrence, MA, facilities. The X-ray systems previously manufactured at these locations were used during diagnostic, surgical, and interventional procedures, such as orthopedic, cardiac, critical-care and emergency room procedures.

The FDA issued its initial Warning Letter to the company in March 2005 following an inspection that revealed violations of the FDA's current good manufacturing practice (CGMP) requirements as set forth in the Quality System (QS) regulation for devices. When a second inspection in 2006 showed the previously-reported problems continued ' including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions ' the FDA imposed this more stringent enforcement action. The decree will require GE OEC Medical Systems to hire an independent expert to conduct inspections of the affected facilities and to certify to the FDA that corrections have been made before manufacturing and distribution may resume.

 

Leaked Court Documents Show Zyprexa Dangers Suspected Early On

The London Times online reports that as early as 1998, Eli Lilly was concerned about a possible link between use of its schizophrenia and bipolar disorder drug Zyprexa' and the onset of diabetes. Pagnamenta, The Times Online, 1/24/07, accessed at http://business.timesonline.co.uk/ article/0,,13129-2560841,00.html.

Meanwhile, on Jan. 4, Eli Lilly announced it had reached a settlement with 14 plaintiff firms suing on behalf of those claiming injury from Zyprexa use. These settlements follow earlier agreements reached in June 2005 covering approximately 8000 claims. In announcing the latest settlement, Sidney Taurel, chairman of the board and chief executive officer of Eli Lilly stated, 'While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians.' See http://www.prnewswire.com/cgi-bin/micro_stories.pl?ACCT=916306&TICK=LLY&STORY=/www/story/01-04-2007/0004499532&EDATE=Jan+4,+2007.

 

Retrial for No-Caused Vioxx User Begins

The retrial of postman Frederick Humeston's case against Merck & Co. Inc. for injuries allegedly cause by his use of Vioxx' began Jan. 22, with both sides continuing to conflict over the question of whether Merck warned consumers and their doctors of the painkiller's cardiovascular risks. Humeston's case ended the first time around in a no-cause verdict in late 2005. Superior Court judge Carol Higbee last August vacated that verdict because of new evidence showing Merck withheld important cardiovascular safety data gleaned from an earlier clinical study from consumers and the medical community.

FDA Statement on Effectiveness of Newer Birth Control Pills

The FDA issued a statement Jan. 23 in response to widespread national news coverage of supposed FDA concerns about the efficacy of lower-dose hormonal birth control drugs. Said the FDA statement, 'The stories inaccurately report that the products are significantly less effective at preventing pregnancy than those approved decades ago. In fact, the newer generation products are highly effective in preventing pregnancy. The stories also mistakenly state that FDA called the meeting to discuss the need for higher standards of efficacy for the newer products.' The statement is available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01550.html.

 

Class Status Denied for Paxil Suit Plaintiffs

U.S. District Judge Timothy Savage, who is overseeing the case of Blain v. SmithKline Beecham Corp., declined to certify a class action on behalf of minors who took the antidepressant drug Paxil' and later attempted or committed suicide. The plaintiffs claim the drug's manufacturer failed to warn consumers and physicians of evidence that use of Paxil induced suicidal ideation in pediatric patients. The judge found that there were only a minimal number of common legal issues presented in the cases and that these would be 'overwhelmed' by the unique factual and legal issues in the individual cases. The 32-page opinion explained that the proposed class failed to fulfill almost all the requirements of Rule 23 of the Federal Rules of Civil Procedure ' adequacy of representation, commonality, predominance, superiority and typicality.

 

Drug Poisoning Deaths Rapidly Rising

The Centers for Disease Control reports that deaths from accidental overdose of both prescription and non-prescription drugs rose significantly between 1999 and 2004. Morbidity and Mortality Weekly Report, 2/8/07, available at: http://www.cdc.gov/od/oc/media/mmwrnews/2007/n070208.htm#1 . Deaths from all unintentional poisonings were up a whopping 62.5% over that period, largely due to prescription drugs ' in particular prescription painkillers. Caucasians suffered an overall poisoning death increase of 75.8%, while deaths among women were up 103%, although men still die from poisonings more often than women.

Improper Use of Topical Skin-Numbing Product Can Be Life Threatening

The FDA issued a Public Health Advisory on February 6 concerning the dangers associated with the use of topical anesthetics to numb the skin in preparation for cosmetic procedures, some medically supervised and others not. These topical anesthetics contain drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel, excessive amounts of which can enter the bloodstream if applied too liberally. This practice can result in irregular heartbeat, seizures and death in some users. The Advisory is available at: http://www.fda.gov/ cder/drug/advisory/topical_anesthetics.htm.

 

Prescription Medication in Diet Supplement Potentially Hazardous

Livrio3', a diet supplement sold by Ebek Inc., was voluntarily pulled from the market in January after the FDA's laboratory analysis of the product disclosed it contained tadalafil, an FDA-approved drug used to treat erectile dysfunction. Tadalafil was not listed as an ingredient on the supplement's label. The drug can interact with other prescription drugs and has been shown to lower blood pressure levels, sometimes to a dangerous degree. The recall message can be viewed at: http://www.fda.gov/oc/po/firmrecalls/ebek01_07.html..