News and Reports
The following news articles are gathered and posted by The Nations Law Firm as a public service. We post articles related to our major practice areas, such as pharmaceutical litigation,business litigation and other civil trial matters, such as catastrophic injuries and wrongful death. We include the latest developments in the pharmaceutical and medical device cases, such as settlements, verdicts and court rulings.
We also post articles that we feel are of interest to our clients, such as health news and important safety alerts.
Some of the news articles are preceded by an introductory note, which I have written in an effort to provide some background and additional information or thoughts about the subject.
If you have any comments or suggestions about the news articles, please contact me.
Cindy L. Nations, J.D.
Articles
THE HIGH COST OF FAILING ARTIFICIAL HIPS
The most widespread medical implant failure in decades - involving thousands of all-metal artificial hips that need to be replaced prematurely - has entered the money phase. Medical and legal experts estimate the hip failures may cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. [Read the full New York Times article here...]
Posted December 28, 2011
Source: New York Times
IN LITIGATION, PRIVATE FACEBOOK POSTS ARE SUDDENLY LESS PRIVATE
It's the latest litigation tactic in the online age: Lawyers are trying to mine the private zones of Facebook and other social-media sites for photos, comments, status updates and other tidbits that might contradict what their opponents are saying in court. [Read more on lawyers and social networks here...]
January 27, 2011
Source: (original: Reuters Legal) Westlaw News & Insight
CAN JOHNSON & JOHNSON GET ITS ACT TOGETHER?
By NATASHA SINGER and REED ABELSON
LITTLE red flags jut out from the shelves at a CVS drugstore in suburban Boston, alerting shoppers to shortages of nearly a dozen Johnson & Johnson products.[Read more about Johnson & Johnson's shortage of products...]
URL: http://www.nytimes.com/2011/01/16/business/16johnson-and-johnson.html?_r=1&emc=eta1
Source: New York Times
January 15, 2011
ANOTHER JOHNSON & JOHNSON RECALL
More Johnson & Johnson products are being pulled from the shelves following a recall by their subsidiary company McNeil Consumer Healthcare. [Read more about the recent Johnson & Johnson recall …]
Source: McNeil Consumer Healthcare
January 14, 2011
A PINPOINT BEAM STRAYS INVISIBLY, HARMING INSTEAD OF HEALING
By WALT BOGDANICH and KRISTINA REBELO
Published: December 28, 2010
A fast-growing form of radiation therapy injures patients when its pinpoint beam is allowed to spread too far. [Read more....]
URL: http://www.nytimes.com/2010/12/29/health/29radiation.html?_r=1
Source: New York Times
December 28, 2010
DEPUY RECALLS 93,000 HIP IMPLANTS
DePuy Orthopedics, a subsidiary of Johnson & Johnson, announced a global recall of the following hip implants on August 24, 2010:
ASR™ XL Acetabular System
ASR™ Hip Resurfacing System
The devices were recalled because of a design defect that causes metallic ions to be released into the bloodstream and causes damage to surrounding tissue. The result is severe pain and potentially toxic levels of chromium and cobalt in the blood, the effects of which remains to be seen. The failed implants have to be replaced through revision surgery, which is more complicated than the original hip implant procedure. Although the recall was issued in July 2010, DePuy didn’t send the Dear Doctor Letter until the end of August.
Posted October 18, 2010
By Cindy L. Nations
THE NATIONS LAW FIRM ANNOUNCES NEW MANAGING PARTNER
HOUSTON – JULY 28, 2010 – The Nations Law Firm is pleased to announce that Cindy L. Nations has become the firm’s new managing partner effective July 28th, 2010.
Cindy Nations received her Bachelor of Arts in Psychology from The University of Texas at Austin, graduating with honors and with special honors in psychology.
Ms. Nations has fourteen years of experience in community mental health. She also worked in law firms for nine years before becoming an attorney. Ms. Nations spent several years living and working in Mexico where she mastered the Spanish language, and gained an understanding of Mexican culture.
Entering the University of Texas Law School, her studies focused on various types of litigation. While in school, she participated in a five-month clinic where she represented state hospital patients in mental health commitment hearings. Cindy Nations received her Doctor of Jurisprudence from The University of Texas Law School and is licensed to practice law in the State of Texas.
Ms. Nations has worked on cases in the areas of product liability, wrongful death, medical malpractice, breach of contract, qui tam, securities fraud and various types of personal injury. Her current practice focuses primarily on catastrophic injury, wrongful death, and pharmaceutical litigation. Ms. Nations has also written numerous legal articles covering a wide range of topics for use in CLE programs across the country and for TRIAL Magazine.
FDA ORDERS WARNINGS ABOUT DEADLY LEG CRAMP DRUG
By Cindy L. Nations
A malaria drug commonly used off-label to treat nighttime leg cramps can cause serious hematological reactions that could result in permanent kidney damage, hospitalization, or death. Today the FDA ordered the manufacturer to issue a Dear Healthcare Provider letter to prescribing doctors and a Medication Guide for patients. Qualaquin (quinine sulfate) is only FDA-approved to treat malaria. The label already warns that the risks outweigh the benefits if used for leg cramps. The FDA has reports of 38 serious adverse events, including 2 deaths from April 2005 to October 2008.
FDA Drug Safety Communication (PDF format)
Posted: July 8, 2010
Source: Law Offices of Howard L. Nations
www.howardnations.com
TAINTED DRUGS INVESTIGATED BY HOUSE COMMITTEE
By Cindy L. Nations
Last month, McNeil Consumer Healthcare, a unit of Johnson & Johnson, recalled six million bottles of Children’s Tylenol, Infants’ Tylenol, Children’s Motrin, Infants’ Motrin, Children’s Zyrtec, and Children’s Benadryl. The recall was initiated after discovering that some medicines had too much of the active ingredient or inactive ingredients that didn’t meet testing requirements or they contained tiny particles.
The FDA recommended using generic drugs meanwhile. Now a generic drug manufacturer has issued a drug recall after discovering metal shavings in its ibuprofen. Although the recalled drugs are not children’s medications, the same company does manufacture children’s drugs. In fact, the company, Perrigo is the largest manufacturer of store-brand over-the-counter drugs in the country.
Both companies have been cited by the FDA for manufacturing violations. The House Committee on Oversight and Government Reform is investigating the Johnson & Johnson recalls in an attempt to determine why these tainted medications were not detected before reaching consumers. Officials from the FDA and Johnson & Johnson will be testifying at a congressional hearing today.
Fortunately, no injuries have been reported in connection with the recalled drugs. But it does raise the question, “With the myriad of regulations in place governing the manufacturing of medications, how does this keep happening time and time again?” Without significant change at the systems level, it’s just a matter of time before the next contaminated batch of medicine ends up in pharmacies and grocery stores across the country.
Source: Law Offices of Howard L. Nations
Posted: May 27, 2010
FDA IGNORED WARNINGS ABOUT CT SCAN RISKS
By Cindy L. Nations
According to an article published in the New York Times today, the FDA repeatedly ignored warnings from its own experts regarding the dangerous risks of CT scans. The issue arose in response to an application submitted by GE Healthcare for the FDA to approve the use of CT scans to screen for colon cancer in healthy patients. GE, who makes most of the CT scan devices, stands to gain huge profits if the application is approved. The FDA scientists oppose the application because the risks outweigh the benefits. Researchers estimate that as many as 14,000 people may die every year as a result of radiation-induced cancers. The FDA is holding a two-day meeting this week to discuss how to protect patients from radiation exposures. The GE application is still pending review.
Source: Law Offices of Howard L. Nations
Posted: March 29, 2010
WOMAN CONTRACTS DEADLY DISEASE FROM ARTHRITIS MEDICATION
By Cindy L. Nations
Another case of progressive multifocal leukoencephalopathy (PML) has been linked to the arthritis drug Rituxin. PML is an incurable viral disease that causes irreversible brain damage and death. Today the FDA issued a Safety Alert and the drug company Genentech issued a “Dear Healthcare Provider” letter to warn the medical community.
Rituxin (rituximab) is FDA-approved to treat rheumatoid arthritis and Non-Hodgkin’s lymphoma. So far 3 people have been infected with PML as a result of taking Rituxin. The latest casualty was a 73-year-old woman being treated for rheumatoid arthritis. She received one round of Rituxin injections in February 2009. Within 4-6 months later, she became ill. The first two victims, a 51-year-old woman and a 73-year-old woman, were taking Rituxin for systemic lupus, an “off-label” use, not approved by the FDA. Both women died from PML in late 2006.
Source: Law Offices of Howard L. Nations
URL: http://www.howardnations.com
Posted October 23, 2009
TYSABRI CAUSING DEADLY BRAIN DISEASE IN MS PATIENTS
By Cindy L. Nations
On September 16, 2009, the FDA issued a Safety Alert (pdf file) to notify healthcare professionals that they continue to receive reports of patients contracting PML while taking Tysabri (natalizumab). Tysabri is a medication used to treat relapsing multiple sclerosis or Crohn’s disease. Due to its high risks of adverse side effects, a patient must be enrolled in the TOUCH Prescribing Program in order to take this medication. Patients in TOUCH are closely monitored for any signs of PML or other serious reactions.
PML (progressive multifocal encephalopathy) is a viral disease that causes brain damage and death. At first, researchers believed that patients taking Tysabri with other medications were at higher risk of PML. However, on August 25, 2008, the FDA issued a Safety Alert (pdf file) to report 2 new cases of PML in Europe; both were being treated only with Tysabri (monotherapy). The Tysabri labels were changed to reflect that monotherapy patients were also getting PML.
According to the latest Safety Alert, there have been13 reported cases of PML in Tysabri monotherapy patients from July 2006 to September 2009. No changes are being made to the label at this time.
PML is not the only problem associated with Tysabri. In February 2008, a Safety Alert (pdf file) was issued to inform healthcare providers that Tysabri may cause severe liver injury, even as early as six days after the first dose. Physicians were warned to monitor patients closely for signs of liver dysfunction.
Source: Law Offices of Howard L. Nations
URL: http://www.howardnations.com
Published September 22, 2009
WEIGHT LOSS DRUGS LINKED TO SERIOUS LIVER INJURIES
By Cindy L. Nations
Today the FDA issued a safety alert to warn healthcare providers and consumers about reports of liver injuries occurring in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter version Alli.
Between 1998 and 2008, the FDA received 32 reports of serious liver injury in people taking orlistat; 27 required hospitalization and 6 resulted in liver failure. It is common knowledge that adverse events are underreported, so it is safe to assume that the actual numbers are much higher.
The FDA is analyzing the data and conducting a safety review of orlistat. At this point in time they are not recommending any label changes and suggest that consumers continue taking the drugs as prescribed or instructed. According to the FDA, “no definite association between liver injury and orlistat has been established at this time.”
However, consumers should seriously weigh the risks and benefits of taking orlistat, especially since its use is more for cosmetic purposes than medical necessities. And there are many alternatives, including diet and exercise, that could safely serve the same purpose.
People who choose to continue taking Xenical or Alli should watch out for any symptoms possibly associated with liver injury, particularly weakness or fatigue, fever, brown urine, or jaundice.
For more information, see the .PDF files FDA Safety Alert (.pdf file) , the FDA News Release (.pdf file) , and the FDA Early Communication (.pdf file) .
Source: Law Offices of Howard L. Nations
URL: http://www.howardnations.com
Published August 24, 2009
BODY-BUILDING SUPPLEMENTS LINKED TO SERIOUS INJURIES
By Cindy L. Nations
July 28, 2009
Today the FDA issued a Public Health Advisory (.pdf file) about the use of certain body-building supplements that contain steroids or steroid-like ingredients. The FDA sent a letter to the manufacturer of several products that claim to contain "steroid-like" ingredients, but actually contain synthetic steroids.
There have been reports of serious liver injury, strokes, kidney failure, and blood clots (pulmonary embolism and deep-vein thrombosis) in people using these supplements. The FDA is recommending that consumers stop using all body-building products that claim to contain steroids or steroid-like substances.
For more information, see Supplements for Athletes Draw Alert From FDA (.pdf file), published in The New York Times, July 29, 2009.
Source: Law Offices of Howard L. Nations
URL: http://www.howardnations.com
Published July 28, 2009
EDITORIAL :: TOBACCO, PUBLIC HEALTH, AND THE FDA
by Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.
More than a decade ago, David Kessler, then Commissioner of the Food and Drug Administration (FDA), launched a bold initiative to regulate tobacco. He believed that since nicotine is an addictive substance, it fell under the statutory authority of the FDA to regulate it as a drug and cigarettes as the delivery vehicle. [read more about Tobacco, Public Health and the FDA here...(.pdf file)]
Source: New England Journal of Medicine
Published: July 23, 2009
BAN IS ADVISED ON 2 TOP PILLS FOR PAIN RELIEF
By GARDINER HARRIS
A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver. [more about the effects of pain relievers on the liver here...(.pdf file) ]
Source:
New York Times
Published: July 1, 2009
F.D.A.’S SECRET FILES
The Food and Drug Administration has created a task force to recommend ways to reveal more information about how the agency makes decisions about the safety and efficacy of drugs and medical devices. Any move in the direction of greater transparency is bound to help both patients and their doctors better understand the risks and benefits they face. [more on FDA's Secret Files here...]
Source: New York Times
Published: June 3, 2009
FDA WEIGHS THE RISKS OF RITUXAN
DRUG FOR TREATING LYMPHOMA IS LINKED TO CASES OF FATAL BRAIN DISEASE
By Alicia Mundy
The Food and Drug Administration is discussing whether patients on the widely used cancer drug Rituxan should use it for a shorter period or take breaks, in light of reports linking the drug to dozens of cases of a rare and usually fatal brain disease, FDA officials said. [more on Rituxan and fatal brain disease here...]
Source: Wall Street Journal Health
Published June 1, 2009
HEART DEVICE CASES THROWN OUT OF COURT
By Cindy L. Nations
Earlier this week, a federal judge dismissed all of the cases from the Medtronic Sprint Fidelis leads MDL on federal preemption grounds. ...The cases were dismissed with prejudice, which means that the claimants cannot re-file their lawsuits at a later time. Essentially, if you were injured by a defective Medtronic lead, you're just out of luck. (read more on heart device cases thrown out of court here...)
Click here to see the Court's Opinion and Order:
http://www.mnd.uscourts.gov/MDL-Fidelis/Orders/2009/090105-08md1905ord.pdf
Source: Law Offices of Howard L. Nations
URL: http://www.howardnations.com
A National Pharmaceutical Litigation firm
Published January 9, 2009
RECALL OF DANGEROUSLY DEFECTIVE MORPHINE TABLETS
By Cindy L. Nations
The FDA issued a press release today announcing a voluntary recall of morphine tablets. The nationwide recall was initiated following the discovery of oversized morphine tablets containing up to twice the dose of the active ingredient. The tablets being recalled are morphine sulfate 60 mg. extended release tablets (Lot No. 91762). No injuries have been reported yet, but taking too much morphine can be life-threatening. At this point in time, Ethex Corporation, the drug manufacturer, is limiting the recall to one lot of tablets. The recall could be expanded if they discover the manufacturing defect in other lots.
This is not the first time a manufacturing error has been in the news this year. In April, a nationwide recall of Digitek tablets was initiated by the Actavis drug company for the same reason. Hopefully we are not seeing the beginning of a trend in which sloppy, careless manufacturing leads to the distribution of defective medications. Consumers already have enough to worry about today with so many medications having latent defects in design and lack of warnings about dangerous side effects. We should at least be able to trust that a 60mg. morphine tablet actually has 60mg. of morphine in it.
Source: Law Offices of Howard L. Nations
URL: http://www.howardnations.com
A National Pharmaceutical Litigation firm
Published June 9, 2008
FDA LOOKS INTO ARTHRITIS DRUG, CANCER LINK
By Lisa LaMotta
Drugs often do more than treat a certain condition. Sometimes they treat several and sometimes they even cause problems. In America, it is up to the U.S. Food and Drug Administration to weed out the drugs that will do more harm than good. Often this is done prior to the approval process and these drugs don't ever make it to market, but occasionally it takes 10 years of data to realize there could be a problem.
The FDA said Wednesday that it is looking into a class of drugs called tumor necrosis factor blockers because of 30 reports over the last decade that the drugs could cause cancer in children and young adults. [pdf format 21.2Kb]
Source: Forbes.com
http://www.forbes.com
Published June 4, 2008
DRUG COMPANIES FAILED TO DISCLOSE ZETIA RISKS
By Cindy L. Nations
Unpublished research was recently discovered showing that the popular cholesterol drug Zetia may cause liver damage when used long-term with other cholesterol drugs called statins. The studies were conducted by Zetia manufacturers Merck and Shering-Plough, who claim that the results were not scientifically important enough to be published.
This is not the first time that Zetia has been under public scrutiny. The drug companies were recently criticized for failing to promptly release data from the Enhance trial, which was completed in 2006. The Enhance data may possibly show a link between Zetia and elevated liver enzymes. Merck and Shering-Plough say the full Enhance study results should be released in March of 2008.
The current label for Zetia contains only mild warnings about the drug’s potential to cause liver problems. Based on the newly-released research data, the FDA will determine whether or not stronger warnings may be necessary.
Source: Law Offices of Howard L. Nations
URL: http://www.howardnations.com
Published January 2, 2008
PHARMACEUTICAL INFLUENCE IS PERVASIVE BUT HARD TO QUANTITATE
by Abigail Zuger, M.D.
The methods used by pharmaceutical companies to market their wares have undergone increasing scrutiny in recent years. This year, several research groups attempted to provide quantitative data on these controversial tactics. [pdf format 22.8Kb]
Source: Journal Watch General Medicine
http://general-medicine.jwatch.org
Published December 28, 2007
LILLY MAY FACE MORE ZYPREXA LAWSUITS AFTER FDA LETTER
Eli Lilly & Co. may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from U.S. regulators. ... Howard Nations, an attorney representing about 185 Zyprexa users with pending cases, said he didn't expect a new round of lawsuits because Judge Weinstein ``wants the cases disposed of.'' He said he does think the FDA letter will bolster claims in remaining suits by showing that Lilly didn't properly warn people of the risks of using Zyprexa. [pdf format 47.1Kb]
Source: Bloomberg
June 29, 2007
IN THE STENT ERA, HEART BYPASSES GET A NEW LOOK
By BARNABY J. FEDER
In light of new concerns over stents' risks, surgery may be poised for a comeback for treating plaque-clogged arteries. [pdf format 157.8Kb]
Source: New York Times
www.nytimes.com
Published: February 25, 2007
LATEST FINDINGS ON STENTS
Recent reports comparing drug-eluting stents with bare metal stents have suggested potentially greater risks for stent thrombosis and for death and myocardial infarction with drug-eluting stents. [pdf format 114.8Kb]
Source: Journal Watch
http://general-medicine.jwatch.org
February 15, 2007
F.D.A. WIDENS SAFETY REVIEWS ON NEW DRUGS
By GARDINER HARRIS
The Food and Drug Administration announced changes intended to ensure that marketed drugs are as safe as advertised. [pdf format 144.6Kb]
Published by New York Times
January 31, 2007
Washington
U.S. DEPT. OF HEALTH & HUMAN SERVICES
Agency for Healthcare Research & Quality - FINAL REPORT
January 17, 2007
Efficacy and ComparativeOff-Label Use of Atypical Antipsychotics
PSYCHIATRY TRAINEES PERCEIVE STIGMA IN MEDICATION TREATMENT
Peter Roy-Byrne, MD
If psychiatrists are sensitive to negative views about psychiatric medication, what do their patients think? [Read full article on psychiatry trainees here.]
Published in Journal Watch Psychiatry
December 18, 2006
DOCTORS TREATING WOUNDED AMERICAN SOLDIERS WITH DANGEROUS DRUG
by Robert Little, Sun Reporter
Despite the fact that Recombinant Activated Factor VII has been linked to deadly blood clots in the lungs, hearts and brains of patients, American military doctors in Iraq are routinely using the blood coagulating drug on hundreds of wounded soldiers. At least 43 deaths have been attributed to Factor VII so far. Factor VII is approved for treating rare forms of hemophilia. [BALTIMORE SUN]
http://www.baltimoresun.com/news/nation-world/bal-factor7part1,0,1091401.story
Originally published in The Baltimore Sun
November 19, 2006
DANGEROUS DECEPTION - HIDING THE EVIDENCE OF ADVERSE DRUG EFFECTS
by Jerry Avorn, M.D.
http://content.nejm.org/cgi/content/full/355/21/2169?query=TOC
Published in the New England Journal of Medicine
November 23, 2006
COLA 'IS BAD' FOR WOMEN'S BONES
Women who regularly drink cola could be increasing their risk of osteoporosis, US researchers believe. [more from BBC linking Cola and brittle bones...]
Source: BBC News UK
06 October 2006
Note: The business of pharmaceuticals in the United States is highly competetive and is worth billions of dollars. For years, pharmaceutical companies have showered physicians with gifts -- from ballpoint pens to all-expense paid vacations -- all under the guise of educating physicians on their products. In the industry, this is called "detailing".
Several years ago, the Stanford Center for Research in Disease Prevention conducted a study about the cost of pharmaceutical marketing. The study found that in 1998 free samples given to physicians totaled $6.6 billion of retail value, representing 51.9 percent of the drug promotion expenditures. Pitches by drug-industry reps to in-office physicians - a practice known as detailing - totaled $3.5 billion, accounting for 27.8 percent of the total. Ads in medical journals totaled $540 million, representing a modest 4.3 percent of total drug-promotion expenditures.
Current figures show that physician promotion (free samples, conferences, journal ads, detailing) accounts for nearly 85% of the total spending on prescription drug promotion. Pharmaceutical companies spend over $14 billion dollars per year on detailing.
New York Times
May 20, 2006
UNEASE ON INDUSTRY'S ROLE IN HYPERTENSION DEBATE
By STEPHANIE SAUL
Three pharmaceutical companies donated $700,000 to a medical society that used most of the money on a series of dinner lectures last year to brief doctors on the latest news about high blood pressure.
The same three companies - Merck, Novartis and Sankyo - also gave the money that the medical society used to formulate the main talking point of those briefings, an expanded concept of high blood pressure that many doctors say would increase the number of people taking drugs. [more on hypertension debate...]
Source:
The New York Times
http://www.nytimes.com
Posted May 20, 2006Source: F.D.A. website
http://www.fda.gov
SCIENTISTS WILL GATHER TO DISCUSS SAFETY OF ABORTION PILL
By GARDINER HARRIS
May 11, 2006
Worried about a bacterial infection that led to the deaths of at least five women who took the abortion pill RU-486, scientists from the nation's leading public health agencies will gather in Atlanta today for the first meeting in 10 years on the drug's safety.
Scientists from the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health will consider whether the means of administering abortion drugs make pregnant women more susceptible to the bacterium Clostridium sordellii.
They will also discuss whether the deaths may signal the emergence of a new and more virulent strain of the bacterium that poses a threat to pregnant women generally, not just those who use RU-486. [more on the safety of the abortion pill...]
Source:
The New York Times
http://www.nytimes.com
Note:
Another defective medical device is being recalled. Although no injuries or deaths have been reported as of yet, it is a well-known fact that serious adverse events from medical devices and pharmaceuticals are severely underreported. The FDA estimates that it only receives reports of 1 in 10 to 1 in 100 serious adverse events that actually occur.
On May 5, 2006, the FDA issued a notice of the Class I recall. See the Respironics press release below.
This isn't the first time Respironics has had to recall a defective prpoduct from the market. On September 21, 1993, Respironics issued a voluntary recall of their battery adapter cables. There was a risk that the cables would overheat melting the insulation and potentially causing a fire.
The Nations Law Firm will be monitoring the newly issued ventilator recall. Hopefully, there will be no injuries or deaths as a result of this defect. However, if you or someone you know has suffered serious injury from using a Respironics ventilator, please contact our offices for a free consultation with one of our attorneys.
RESPIRONICS ISSUES WORLDWIDE RECALL OF PLV(R) CONTINUUM(TM) VENTILATOR
May 5, 2006
MURRYSVILLE, Pa., PRNewswire-FirstCall/ -- RESPIRONICS, INC.
(Nasdaq/NMS Symbol: RESP) announced today that it has voluntarily recalled 269 ventilators representing all models and serial numbers of the PLV(R) Continuum(TM) Ventilator. This recall is being conducted because the ventilator may suddenly stop providing mechanical ventilation. This could result in serious injury or death. The recalled ventilators should not be used until the problem is corrected.
Source:
http://www.respironics.com
Respironics Press Release
Issued May 5, ,2006
INJURY TO RESEARCH VOLUNTEERS - THE CLINICAL-RESEARCH NIGHTMARE
Alastair J.J. Wood, M.D., and Janet Darbyshire, M.B., Ch.B.
May 4, 2006
At 8 a.m. on Monday, March 13, 2006, eight healthy young men entered a trial of a drug under development by the small German immunotherapeutics company TeGenero. Six of the volunteers were assigned to receive active drug, and two were to receive placebo...
However, after receiving injections of TGN1412, the six volunteers became desperately ill, had multiple-organ failure, and were transferred to an intensive care unit...As of April 5, five of the volunteers had been discharged from the hospital, and the other man appeared to be recovering. This unexpected and devastating outcome is currently under investigation by the relevant authorities under the supervision of the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), which originally approved the trial and its protocol. A preliminary report has now been completed and released. [more on injury to research volunteers...]
Source:
New England Journal of Medicine
http://content.nejm.org
Volume 354:1869-1871
May 4, 2006 Number 18
Note:
The Heart Rhythm Society is an international professional group representing more than 4,200 cardiac implant specialists in 78 countries. They focus on education and advocacy for cardiac arrythmia professionals and patients. In 2005, hundreds of thousands of defective pacemakers and defibrillators were recalled and numerous deaths occurred as a result of device failures. Manufacturers of the defective devices, such as Guidant Corporation, have been accused of deceiving and misleading doctors and patients. In an effort to avoid disasters such as this in the future and to better protect the patients, the Heart Rhythm Society has issued a proposal for how to better monitor the safety of medical devices once they're on the market and how to effectively deal with the discovery of dangerous defects. The HRS is accepting public comment until May 30, 2006.
To read the draft, click here for the .PDF file .
INT'L GROUP WANTS BETTER HEART DEVICE SAFETY TRACKING
Apr 26, 2006
By Lisa Richwine
WASHINGTON (Reuters) - Makers of implanted heart devices should track their performance better and ask independent experts to evaluate their safety, an international doctors' group proposed on Wednesday.
Regulators also should improve surveillance of potential problems with implanted cardioverter defibrillators (ICDs) and pacemakers on the market and use simple language to explain concerns, the Heart Rhythm Society said in draft guidelines.
Source: Reuters UK
http://uk.reuters.com/
FDA IS CRITICIZED OVER DRUGS' SAFETY PROBLEMS
RESPONSE TO APPROVED MEDICATIONS CITED
Monday, April 24, 2006
By Marc Kaufman
Washington Post Staff Writer
The Food and Drug Administration is sometimes too slow in picking up safety problems once drugs are on the market and in responding to emerging danger signals, a federal study concluded in a report to be released today.
The review by the Government Accountability Office found that the FDA does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings.
The report also calls on Congress to consider expanding the FDA's authority to require that drug companies conduct studies of already-approved products. The agency's ability to order post-market studies is now limited, and many drug companies have been slow to conduct studies that they had agreed to undertake as a condition of gaining FDA approval.
The GAO inquiry was requested by Congress in 2004 after the sudden withdrawal of the blockbuster painkiller Vioxx, which was found to increase the risk of heart attacks and strokes in long-term users. Several bills that would toughen the FDA's safety oversight were introduced after the Vioxx withdrawal, and the report offers their sponsors new ammunition.
[more on the FDA drug safety problems...]
To view the GAO Report, please click here for the .PDF file...
Source: The Washington Post
http://www.washingtonpost.com
BAUSCH & LOMB "WITHDRAWS" RENU CONTACT LENS SOLUTION
April 14, 2006
In what it is calling a "voluntary market withdrawal," Bausch & Lomb is asking retailers to stop selling ReNu with MoistureLoc, a contact-lens solution that's suspected of causing a serious eye infection. Many major retailers have already pulled the product and the company has suspended shipments. ...
Earlier this week, CDC and the Food and Drug Administration said they had information on 109 suspected cases of Fusarium keratitis, an infection that can lead to blindness. Of the 109 cases, 30 had been reviewed and 26 of those involved patients who had used ReNu. [more on Bausch & Lomb's withdrawal of Renu contact lens solution...]
Source: http://www.consumeraffairs.com
BRITISH RETHINKING RULES AFTER ILL-FATED DRUG TRIAL
April 8, 2006
By Elisabeth Rosenthal
International Herald Tribune
In February, when Rob O. saw the text message from Parexel International pop up on his cellphone in London — "healthy males needed for a drug trial" for £2,000, about $3,500 — it seemed like a harmless opportunity to make some much-needed cash. Parexel, based in Waltham, Mass., contracts with drug makers to test new medicines.
Just weeks later, the previously healthy 31-year-old was in intensive care at London's Northwick Park Hospital — wires running directly into his heart and arteries, on dialysis, his immune system, liver, kidneys and lungs all failing — the victim of a drug trial gone disastrously bad. [more on the ill-fated drug trial...]
Source: The New York Times
http://www.nytimes.com
April 8, 2006
F.D.A. PLANS TO INTENSIFY OVERSIGHT OF HEART DEVICES
By Barry Meier
April 7, 2006
The Food and Drug Administration plans to strengthen how it monitors critical heart devices like defibrillators by appointing outside medical experts to help it review the safety of units already on the market, a top agency official says.
The move would be the first time the F.D.A. would have outside experts regularly advising it about the safety of medical devices being sold ...
Both the agency's action and the medical group's report, which will be released in a few weeks, follow a controversy last year over decisions by the Guidant Corporation not to publicize life-threatening defects in some of its defibrillators. The episode also highlighted gaps in the F.D.A.'s oversight of such products, as well as a lack of uniform standards in the industry governing how and when device flaws are disclosed. [more on FDA plans to intensify oversight of heart devices...]
Source: The New York Times
http://www.nytimes.com
April 7, 2006
FDA APPROVES FIRST ATTENTION DEFICIT PATCH
April 06, 2006
WASHINGTON - The FDA on Thursday approved the first skin patch to treat attention deficit hyperactivity disorder in children.
The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami. ...
The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.
Source: APA Online
http://www.psycport.com
FDA APPROVES ADHD PATCH
April 6, 2006
The U.S. Food and Drug Administration (FDA) has approved Daytrana (methylphenidate transdermal system), the first and only non-oral medication for the treatment of attention deficit hyperactivity disorder (ADHD).
Daytrana, a once daily transdermal patch formulation of methylphenidate, will be available in 10 mg, 15 mg, 20 mg and 30 mg dosage strengths. Daytrana is licensed globally to Shire by Noven and will be available in pharmacies in the U.S. in mid 2006. [more on ADHD patch...]
Source: http://www.drugs.com
Published April 2006
MERCK SHARES FALL AFTER LOSING VIOXX TRIAL SHARES OF MERCK FALL 4 PERCENT AFTER LOSING NEW JERSEY VIOXX TRIAL
By JOHN CURRAN
The Associated Press
ATLANTIC CITY, N.J. Shares of Merck & Co. fell Thursday after a New Jersey jury found that the drugmaker concealed the dangers of its painkiller Vioxx in a split verdict that gave one of two plaintiffs in the trial $4.5 million in compensatory damages.
Shares of Merck, which is facing many similar lawsuits, fell $1.47, or 4 percent, to $34.52 in early trading on the New York Stock Exchange.
The trial was the first to address long-term use of the drug and some analysts said the Superior Court jury's decision Wednesday could prompt Merck to rethink its policy of battling each lawsuit individually.
Source: ABC News
http://abcnews.go.com/business
April 6, 2006
MERCK FACES PUNITIVE PHASE OF VIOXX TRIAL
April 6, 2006 9:39:40 AM
NEW YORK (Reuters) - The punitive phase of a trial involving the Merck & Co. (MRK.N) painkiller Vioxx was set to start on Thursday after a jury found the drugmaker failed to warn Vioxx users of heart risks and ordered it to pay a 77-year-old plaintiff at least $4.5 million in damages.
Merck shares fell nearly 4 percent to $34.57 in early trade on Thursday, a day after the jury in Atlantic City, New Jersey, found that Vioxx had been a substantial contributing cause of a heart attack suffered by John McDarby. The jury determined the drug was not a significant cause of a heart attack suffered by a second plaintiff, Thomas Cona.
Merck pulled the $2.5 billion-a-year drug off the market in September 2004 after a study showed it doubled the risk of heart attack and stroke among people who used it for at least 18 months.
The drugmaker has been hit with nearly 10,000 Vioxx-related lawsuits.
Source: WallSt.Net
http://www.wallst.net/
April 6, 2006
ADHD DRUGS AND CARDIOVASCULAR RISK
By Steven E. Nissen, M.D.
April 6, 2006
On February 9, 2006, the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) voted by a narrow margin - eight to seven - to recommend a "black box" warning describing the cardiovascular risks of stimulant drugs used to treat attention deficit-hyperactivity disorder (ADHD). This action was unexpected, largely because the FDA had not requested a review of current labeling [more on ADHD drugs and cardiovascular risk...]
The New England Journal of Medicine
PerspectiveSource:
U.S.Food & Drug Administration
www.fda.gov
GATIFLOXACIN LINKED TO DANGEROUSLY HIGH AND LOW BLOOD GLUCOSE
Elizabeth Thompson Beckley
April 1, 2006
The risk of developing serious hyperglycemia was almost 17 times greater for elderly patients who took the antibiotic gatifloxacin (Tequin, Bristol-Myers Squibb) than for those who took another antibiotic, according to two Canadian studies published a month ahead of schedule by the New England Journal of Medicine.1
In the same population, those who took gatifloxacin were four times more likely to be hospitalized for hypoglycemia. [more on Gatifloxacin...]
DOC News April 1, 2006
Volume 3 Number 4 p. 8
© 2006 American Diabetes Association
SERIOUS ADVERSE DRUG EFFECTS - SEEING THE TREES THROUGH THE FOREST
By Jerry H. Gurwitz, M.D.
March 30, 2006 edition
The medical community and the public have been buffeted by a steady stream of news linking the use of widely prescribed medications with serious health risks. The latest in this barrage of unsettling reports is an article by Park-Wyllie et al. that appears elsewhere in this issue of the Journal1 regarding the association of the fluoroquinolone gatifloxacin with dysglycemia....
Changes in drug labeling are often direct-mailed or faxed to doctors or other health care providers.5 Unfortunately, several studies have suggested that such mailings do not result in changes in prescribing practice.6 Furthermore, a recent study found that physicians and other health care providers frequently prescribed drugs in violation of warnings of important risks, including those contained in black boxes.7 Although technologic innovations, such as electronic-health-record–based alerts, hold promise for reducing the risk of unsafe prescribing (especially related to drug–drug, drug–laboratory, and drug–disease interactions), such systems are not yet widely available, particularly in the outpatient setting....
Gatifloxacin now takes its place among an ever-growing list of medications that have been associated with very serious adverse effects. The most immediate question is what should be done with gatifloxacin. It seems clear that the drug's place among broad-spectrum antibiotics available for outpatient use is tenuous at best. For every approved indication for gatifloxacin, there are safer, equally effective, and less costly alternatives. In comparison with other recent experiences regarding adverse drug effects, this choice should not be a difficult one for physicians, patients, regulators, and manufacturers.
Source: The New England Journal of MedicineSource:
U.S. Food & Drug Administration
http://www.fdaadvisorycommittee.com
PANEL ADVISES DISCLOSURE OF DRUGS' PSYCHOTIC EFFECTS
By GARDINER HARRIS
March 23, 2006
GAITHERSBURG, Md., March 22 — Stimulants like Ritalin lead a small number of children to suffer hallucinations that usually feature insects, snakes or worms, according to federal drug officials, and a panel of experts said on Wednesday that physicians and parents needed to be warned of the risk.
The panel members said they hoped the warning would prevent physicians from prescribing a second drug to treat the hallucinations caused by the stimulants, which one expert estimated affect 2 to 5 of every 100 children taking them. Instead, they said, the right thing to do in such cases was to stop prescribing the stimulants. [more on disclosure of drugs' psychotic effects...]
Posted on The New York Times website
View article here.
HIGH COURT BLOCKS SUIT CLAIMING INVESTMENT FRAUD
March 21, 2006
WASHINGTON (AP) -- The Supreme Court made it harder Tuesday for investors to join forces to file high-stakes fraud lawsuits against companies.
The 8-0 decision blocks state class-action lawsuits by stockholders who contend they were tricked into holding onto declining shares.
Justice John Paul Stevens, writing for the court, said that to rule otherwise would allow ''wasteful, duplicative litigation.''
The decision does not shut the door to lawsuits filed by individual stockholders, but rather to suits brought on behalf of large groups.
''There had been some upswing in these after the Enron and WorldCom scandals,'' said Columbia Law School professor John Coffee, who believes it will be too expensive for individual stock owners to pursue such suits.
It was a major victory for Merrill Lynch & Co., which faced a spate of lawsuits prompted in part by New York Attorney General Eliot Spitzer's 2002 probe into the investment banking firm's practices.
Source: The Associated Press
Posted on The New York Times website
REVISITING SCHIZOPHRENIA: ARE DRUGS ALWAYS NEEDED?
March 21, 2006
By BENEDICT CAREY
The only responsible way to manage schizophrenia, most psychiatrists have long insisted, is to treat its symptoms when they first surface with antipsychotic drugs, which help dissolve hallucinations and quiet imaginary voices.
Delaying treatment, some researchers say, may damage the brain.
But a report appearing next month in one of the field's premier journals suggests that when some people first develop psychosis they can function without medication — or with far less than is typically prescribed — as well as they can with the drugs. And the long-term advantage of treating first psychotic episodes with antipsychotics, the report found, was not clear. [more on schizophrenia...]
The New York Times
JAGGED LITTLE PILLS
March 19, 2006
By LAUREN SLATER
Op-Ed Contributor
Somerville, Mass.
Our psychotropics seem to go through fairly predictable 20-year cycles, so eerily consistent that at this point we should be able to pinpoint in precisely what year our newest superstar will fumble. What's odd is that we don't. Rather, each time the negative side effects come into view, we act slapped, surprised, as though this were the strangest thing in the world. [more on jagged little pills...]
AFTER 2 MORE DEATHS, PLANNED PARENTHOOD ALTERS METHOD FOR ABORTION PILL
March 17, 2006
By Gardiner Harris
WASHINGTON, March 17 — After receiving reports that two more women died after taking abortion pills, Planned Parenthood, the nation's largest provider of abortion and contraceptive services, announced that it would immediately change the way it gives the medicines.
The change partly resolves a long-running dispute between Planned Parenthood and the Food and Drug Administration over the safest way to provide pill-based abortions.
The F.D.A. has now received reports that six women in the United States died after taking RU-486, or Mifeprex. A seventh died in Canada. The two most recent deaths and two of the previous four underwent their procedures at Planned Parenthood clinics, a spokeswoman said.
Federal officials do not yet know the cause of the latest two deaths. The previous four resulted from systemic infections with a virulent bacteria, Clostridium sordellii. Planned Parenthood announced in a statement that one of the two recent deaths occurred within days of the victim's undergoing a pill-based abortion, while the other woman died within five weeks. [more on abortion pill...]
TWO WOMEN DIE AFTER USING ABORTION PILL
Posted March 17, 2006
By Andrew Bridges
Associated Press. WASHINGTON - Two more women have died after using the abortion pill RU-486, regulators said Friday in a warning that brought renewed calls for pulling the controversial drug from the market.
The organization that provided the pill to the two women said it would immediately stop disregarding the approved instructions for the pill's use.
The Food and Drug Administration warned doctors to watch for a rare but deadly infection previously implicated in four deaths of women who had taken the drug. The drug, also called Mifeprex or mifepristone, has not been proved to be the cause in any of those cases.
Nor has the FDA confirmed the cause of the latest two deaths. However, in one of them, the woman's symptoms appeared to resemble those in the cluster of four cases in California where the women died from an infection of the bloodstream, or sepsis.
The Mercury News
http://www.mercurynews.com
SURGICAL DEVICE POSES A RARE BUT SERIOUS PERIL
Published: March 17, 2006
By BARNABY J. FEDER
Kristina A. Fox entered a Portland, Ore., hospital in the fall of 1998 hoping a routine, minimally invasive form of surgery called laparoscopy would relieve a painful gynecological condition.
She went home the same day destined to become part of a simmering debate over whether medical device makers and health care providers have been overlooking - some would say ignoring - an easily preventable, but potentially devastating, laparoscopy hazard. [more on perilous effects of surgical device...]
Source: The New York Times
Read article locally H-E-B PRESS RELEASE
6 FALL SERIOUSLY ILL DURING DRUG TEST IN LONDON
By THE ASSOCIATED PRESS
March 15, 2006
LONDON, March 15 (AP) - Six men taking part in trials of a new drug to treat autoimmune diseases and leukemia became seriously ill, a hospital official said Wednesday. British regulators immediately suspended the tests.
Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said two of the men were in critical condition and four were in serious condition but showing signs of improvement. All six fell ill on Tuesday night.
A research organization based in Waltham, Mass., the Parexel International Corporation, which supervised the trial, identified the drug as TGN1412, a monoclonal antibody developed by TeGenero AG., of Würzburg, Germany.
"The drug, which is untested and therefore unused by doctors, has caused an inflammatory response, which affects some organs of the body," Dr. Suntharalingam said.
The Medicines and Healthcare Products Regulatory Agency, which ordered the tests suspended, said the six were the only people given the drug in a small trial. Two other patients received placebos.
"Our immediate priority has been to ensure that no further patients are harmed," said Kent Woods, the agency's chief executive. "We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."
The names of the six men were not released. But one woman said her boyfriend, a 28 year old London bar manager, was among them.
"They just keep saying, 'He's very, very sick and we are doing all we can,' " Myfanwy Marshall told the BBC. "They are saying he could be lying there in six months. He needs a miracle - those were their words."
Ms. Marshall said her boyfriend had decided to take part in the trial for the cash, about $3,500, to pay bills.
Dr. Herman Scholtz, chief of Parexel International Clinical Pharmacology, said such adverse drug reactions were extremely rare.
TeGenero's chief executive, Dr. Benedikte Hatz, said, "These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies, which enabled us to progress investigations into human volunteers."
Dr. Thomas Hanke, Parexel's chief scientific officer, said the company had "adhered to standard clinical research guidelines." He said TGN1412 had not caused any problems in previous tests and called for a speedy investigation.
CONGRESS, CONTROLLED SUBSTANCES, AND PHYSICIAN-ASSISTED SUICIDE - ELEPHANTS IN MOUSEHOLES
March 9, 2006
by George J. Annas, J.D., M.P.H.
The U.S. Supreme Court's decision in Gonzales v. Oregon to reject the U.S. attorney general's authority to prohibit physicians in Oregon from prescribing Schedule II drugs for their terminally ill patients to commit suicide can seem paradoxical and confusing.1 How is it that California cannot permit the patients of physicians who recommend marijuana, a Schedule I drug, to possess legally and use marijuana that they may need to survive, but Oregon can legally permit physicians to prescribe Schedule II drugs and patients to possess and use such drugs to end their lives? [more on Congress, controlled substances and physicial-assisted suicide...]
The New England Journal of Medicine
PUBLIC CITIZEN PETITIONS FDA TO BAN DARVON PRODUCTS
PRESCRIPTION PAINKILLER CAUSES MANY FATALITIES; PETITION FILED TODAY WITH FDA
February 28, 2006
WASHINGTON, D.C. – Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately begin to phase out the widely prescribed pain reliever propoxyphene (Darvon, Darvocet and generic versions) from the market because the drug has been associated with more than 2,000 accidental deaths, is physically addictive and is no more effective than safer alternatives. [more on petition of FDA to ban Darvon products...]
Public CitizenThe U.S. Food and Drug Administration (FDA) today unveiled a major revision to the format of prescription drug information, commonly called the package insert, to give healthcare professionals clear and concise prescribing information. In an effort to manage the risks of medication use and reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. The new format will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources.
[more on Rx drug labeling...]
Posted on FDA Advisory Committee website
http://www.fdaadvisorycommittee.com
