Abramson, Brown & Dugan Attorneys

GlaxoSmithKline, the manufacturer of Paxil, has reportedly agreed to settle some 800 Paxil birth defect lawsuits for the sum of $1 billion.  The Paxil settlements will pay individual families approximately $1.2 million. 

The remaining 100 Paxil lawsuits include three that are set for trial later this year in Philadelphia. 

Paxil is a controversial anti-depressant drug that has been linked to birth defects in pregnant mothers who were taking the drug.  Such birth defects include cardiac problems and pulmonary hypertension.

Bristol-Myers Squibb is recalling 8 lots of its highly popular anti-clotting drug Coumadin because the quantity of the active ingredient may vary.  The recall affects more than 140,000 lots of 1 mg tablets of the anti-clotting drug.  While there have been no reports of problems associated with the recall, variations in Coumadin may have serious consequences for patients taking Coumadin after surgical procedures.  Those whose tablets contain too little of the active ingredient may be subject to an increased risk of blood clots while those whose tablets contain too much may bleed excessively. 

The tablets subject to the recall have expiration dates between June 2011 and November 2012.

The FDA has issued a public health advisory concerning the diet drug Que She.  The drug is marketed as an herbal supplement but contains active ingredients not listed on the bottle's label.  The active ingredients include:

Fenfluramine-best known as part of the fen-phen mixture that was removed from the marketin 1997 after causing serious cardiac valve damage

Propanolol-a prescription ingredient that may pose serious health risks to those with asthma or heart conditions

Ephedrine-an over-the-counter ingredient used to treat asthma but can cause an increased risk of cardiac problems.

While it's clear all three of these unlisted ingredients in Que She may be harmful of themselves, their risk may be greater in combination with each other and in combination with other prescription medication.

The FDA is urging consumers presently taking the diet supplement Que She to stop using it and report any adverse effects to a healthcare professional.

Methadone, a synthetic form of opium, entered the US market in 1947.  It was first used as a pain reliever.  During the Nixon administration, methadone clinics opened in Washington DC to treat those addicted to heroin.  Soon thereafter, methadone clinics sprang up around the clinic and were widely seen as a positive treatment for opium addiction.

However, methadone has become the fastest growing cause of narcotic deaths.  It's cheap and longer lasting than other pain relieving drugs such as Oxycontin.  It has been widely hailed by users as an alternative in fighting chronic pain.

Yet, methadone has been implicated in twice as many deaths as heroin.  The FDA has acknowledged that it's been slow to respond to the dangerous hazards of methadone as well as  physician ignorance concerning prescribing practices.

According to the NY Times, "The rise of methadone is in part because of a major change in medical attitudes in the 1990s, as doctors accepted that debilitating pain was often under treated. Insurance plans embraced methadone as a generic, cheaper alternative to other long-lasting painkillers like OxyContin, and many doctors switched to prescribing it because it seemed less controversial and perhaps less prone to abuse than OxyContin."

Methadone prescriptions have risen 700% from 1998 to 2006.  In spite of this dramatic prescription rise, experts believe doctors remain unaware of the dangers of methadone and the manner in which it is slowly metabolized in the body.  This ignorance can lead to prescribing too much methadone too quickly.  This can lead to a build-up of the drug and an intolerance to it, eventually contributing to methadone addiction, which is very difficult to break.

Dr. Bob Rappaport, a division director for the FDA noted, "Methadone is an extremely difficult drug to use, even for specialists. People were using it rather blithely for several years.”

In fact, for decades the FDA was part of the problem.  The FDA's package insert recommended initial doses of methadone up to 80 mg daily for pain.  Dr. Robert G. Newman, former president of Beth Israel Hospital in New York stated,

“This could unequivocally cause death in patients who have not recently been using narcotics.”

Finally, in 2006, the FDA changed course on methadone.  The federal agency issued a public health advisory entitled, "Methadone Use for Pain Control May Result in Death and Life-Threatening Changes in Breathing and Heartbeat".  In the advisory, the FDA noted that it had received reports of methadone-related deaths and acknowledged that methadone use can cause slow or shallow breathing and cardiac changes of which the methadone user is unaware.

Methadone treatment for chronic pain or drug addiction may be cheaper but it's a potentially dangerous alternative.  It remains difficult to prescribe and monitor properly and withdrawal from methadone has been shown to be more difficult that withdrawal from heroin. 

Portland Shellfish of Maine has issued a voluntary recall of its lobster meat because the lobster may be contaminated with Listeria monocytogenes, a bacteria that can be fatal in small children or those with weakened immune systems.  The bacteria can cause listeriosis which may manifest itself in the form of nausea, high fever, severe headaches, abdominal pain, and diarrhea. 

The following products are subject to the recall:

LOBSTER CLAW & KNUCKLE MEAT, CS 6 x 2 LB, packed under the Claw Island, Craig’s All Natural or Inland Ocean brand, production lot numbers 13210, 13310, and 13410, shipped between 05/14/2010 and 05/26/2010.

LOBSTER KNUCKLE MEAT, CS 6 x 2 LB, packed under the Inland Ocean brand, production lot numbers 13210, shipped on 05/13/2010.

LOBSTER CLAW & KNUCKLE MEAT, CS 18 x 15 oz, packed under the Claw Island brand, production lot numbers 13210 and 13410, shipped between 05/25/2010 and 06/08/2010.

LOBSTER CLAW & KNUCKLE MEAT, CS 20 x 8 oz, packed under the Craig’s All Natural brand, production lot numbers 13210, shipped on 05/14/2010.

LOBSTER KNUCKLE MEAT, 1 LB bag, fresh, packed under Portland shellfish brand, production lot number 13310, shipped on 05/12/2010.

LOBSTER CLAW & KNUCKLE MEAT, 4 oz bag, fresh, packed under Portland shellfish brand, production lot number 13310, shipped on 05/13/2010.

LOBSTER CLAW & KNUCKLE MEAT, 1 LB bag, fresh, packed under Portland shellfish brand, production lot number 13210 and 13310, shipped on 05/12/2010 and 05/13/2010.

LOBSTER CLAW & KNUCKLE MEAT, 2 LB bag, fresh, packed under Portland shellfish brand, production lot number 13210 and 13310, shipped on 05/12/2010 05/13/2010, 05/14/2010.

LOBSTER CLAW & KNUCKLE MEAT, 5 LB bag, fresh, packed under Portland shellfish brand, production lot number 13210, shipped on 05/12/2010.

Wentworth-Douglass Hospital has sued its former pathology group as well as the two doctors in charge of that group Drs. Cheryl Moore and Glenn Littell.  The doctors own Young & Novis Professional Association, which does business as Piscataqua Pathology Associates and is a named defendant in the suit.

The lawsuit arose out of allegations that the doctors had scrubbed computer files owned by the hospital as they were departing the hospital.  The suit claims the doctors' actions are in clear violation of the Computer Fraud and Abuse Act which makes it illegal to access computer information without authorization or to access a computer with authorization but to alter the information within the computer system. 

According to the lawsuit, "Analysis by WDH revealed substantial amounts of information was deleted from the computer network including, but not limited to, specimen/slide photos; autopsy images; charts with patient specific information; College of American Pathologist Reviews; Quality Assurance information; documents, templates, forms and folders utilized by employees of the pathology department to process specimens; individual employee subfolders; and records related to complaints against Dr. Moore and Dr. Littell."

This is not the first imbroglio involving WDH and Doctors Moore and Littell.  In 2006, the doctors were involved in a dispute concerning patient privacy issues.

Inez Tenenbaum, chair of the Consumer Products Safety Commission has pledged to ban the manufacture and sale of drop-side cribs by the end of the year.  Now, she has an ally in the US Senate.  Senator Kirsten Gillibrand, the freshman senator from New York, has announced her intention to introduce legislation banning the dangerous cribs. 

"There still are thousands and thousands of children who are sleeping every night in drop-side cribs and we need to protect them," said Gillibrand.

While the CPSC has issued warnings about the dangers of the cribs, the cribs are still available for purchase and remain in use in homes across the country.  7 million such cribs have been recalled in the past five years.  The cribs have been implicated in the deaths of 32 infants since 2000. 

Large retailers such as Babies R Us and Wal-Mart have removed the drop-side cribs from their stores but the cribs are still available on the Internet.

The Consumer Product Safety Commission has issued another warning concerning the dangers of drop side baby cribs.  Citing the deaths of 32 infants and toddlers due to suffocation and/or strangulation since 2000, the federal agency noted the drop side crib dangers are not limited to any particular manufacturer.  In the last five years alone, the CPSC has issued 11 recalls involving 7 million drop side cribs due to hazards created by the drop side. 

In their investigation of drop side cribs, the CPSC has found drop side cribs to be more dangerous than fixed side cribs.  Factors that exacerbate hazards in older drop side cribs include:

• The longer a crib is used, the more wear and tear on hardware and joints, allowing screws to loosen and fall out and plastic parts to flex and break.

• Repeated assembly and disassembly increases likelihood that crib parts can be damaged or lost

• Wood warps and shrinks over time and glue can become brittle. This can lead to joint and slat failure

Teva Pharmaceutical, the maker of propofol, has received an FDA warning for manufacturing violations at its Irvine California facility.  The violations included a failure to test each lot of raw materials used to make propofol, an injectable drug that is one of the most widely used medicines for general anesthesia.  Propofol drew attention last June when it was implicated in the Michael Jackson death. 

The FDA inspection that resulted in the FDA warning letter also led to the recall of 57,000 vials of propofol for elevated toxins.  The FDA found 40 patients who had been affected by the toxic propofol.

Dr Sulieman Al Hourani, a locum surgeon at Fairfield General Hospital in Bury, Greater Manchester, England, was supposed to remove a cyst but instead removed an entire testicle.    A month after the botched surgery, the doctor was accused of stealing two boxes of dihydrocodeine from the hospital.  The General Medical Council has also learned that in 2006, the same surgeon was supposed to inject a patient with 10 mg of midazolam, a powerful sedative.  Rather than giving it to the patient, he injected the patient with 2 mg of the drug and injected himself with the remainder of the sedative.  While Dr. Hourani is no longer practicing in England, he has relocated and practicing medicine in Jordan. 

This seems to be a classic case where an international database of bad doctors should be maintained and shared by hospitals and healthcare facilities throughout the world.  Because such information is not maintained and shared by the medical community this doctor may be harming patients in Jordan.

When we've blogged previously about prescription drug errors or medication errors, we've usually concentrated on dosage mistakes or hospital mistakes in which patients received the wrong medication altogether.

Now, a new study shows that another prescription error is becoming more prevalent.  Health Day is reporting that computer translations of prescription instructions in Spanish are often inaccurate and dangerously so.  "The technologies that are currently available to produce instructions in the patient's language are inadequate." said Dr. Iman Sharif, chief of the division of general pediatrics at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Delware.

According to Health Day, half of the Spanish language prescription translations reviewed for the study contained serious errors, some of which could lead to life threatening events.  One particular translation pitfall involved "Spanglish" (the mixing of English and Spanish).  For instance, the English word "once" means one time while the same word (spelled exactly the same) in Spanish means eleven.  Misspellings can also wreak havoc.

Dr. Sharif recommends patients whose primary language is other than English bring a competent translator so that proper instructions can be translated properly.  At some point, translation software needs to more accurately reflect the proper translation.

After years of reports concerning the hazards of Bisphenol A, the Environmental Protection Agency has decided to add the chemical to its list of "chemicals of concern".  Bisphenol is widely used to harden plastics such as baby bottles, soda cans, and food containers.  The chemical is so widespread that a recent study determined that 90% of Americans have traces of it in their systems.  Bisphenol has been linked to heart disease, cancer, and abnormal development in animals.  This past January, the FDA expressed concerns over bisphenol's effect on the health of ordinary Americans.

In spite of the new EPA classification, bisphenol will not be regulated or removed from the market. 

The Consumer Product Safety Commission has upgraded last month's warning to a recall concerning baby slings after several infants' deaths were linked to the baby slings.  One million Infantino "Sling Rider" and "Wendy Bellissimo" baby slings are being recalled after 3 infant deaths were reported.  The CPSC is urging consumers to immediately stop using the baby slings for infants younger than four months due to the risk of suffocation and death. 

According to the release issued by the CPSC, "Infantino LLC sold the slings in the United States and Canada from January 2003 through March 2010 at Walmart, Burlington Coat Factory, Target, Babies "R" Us, BJ's Wholesale, and various baby and children's stores and other retailers nationwide, and on the Web at Amazon.com for between $25 and $30."

I

The pesticide chlorpyrifos has been banned in US households but is still widely used as an agricultural pesticide on fruits and vegetables.  A new study has shown a link between the pesticide and early childhood development delays.  According to www.healthday.com, "the researchers found that a high level of exposure to the pesticide (greater than 6.17 pg/g in umbilical cord blood at the time of birth) was associated with a 6.5-point decrease in the Psychomotor Development Index score and a 3.3-point decrease in the Mental Development Index score in 3-year-old children."

"This study helps to fill in the gaps about what is known about the effect of the pesticide chlorpyrifos on the development of young children by showing that there is a clear-cut association between this chemical and delayed mental and motor skill development in children even when there are other potentially harmful environmental factors present," lead author Gina Lovasi, of Columbia University's Mailman School of Public Health, said in a news release.

The agricultural use of chlorpyrifos is under review by the Environmental Protection Agency.

Inez Tenenbaum, head of the Consumer Product Safety Commission, is preparing to issue a safety warning concerning the popular baby slings.  The warning is due sometime this week and will warn consumers about the dangers of suffocation.  In announcing the pending warning, Tenenbaum stated, "We know of too many deaths in these slings and we now know the hazard scenarios for very small babies. So, the time has come to alert parents and caregivers."  Tenebaum's remarks were made at a meeting of the Juvenile Products Manufacturers Association, an industry group that certifies infant products, including the baby slings.

In 2008, Consumer Reports wrote about safety concerns with the baby slings.  The majority of the complaints involved babies falling out of the slings.  However, a subsequent blog post raised suffocation issues with the slings and the product has been implicated in at least 7 infant deaths.

Those who favor the baby slings have cited the bonding effect between parent and child. Safety advocates have noted the potential for suffocation for small infants whose head and neck muscles are not developed, which can lead to a baby smothering itself against the parent unable to breathe.

In her remarks, Tenenbaum did not single a particular brand of baby slings.

The California Department of Health began issuing fines to hospitals for preventable medical errors in 2007.  The fines are based on self-reporting by hospitals of medical errors so the numbers reported may be lower than the medical errors that are actually occurring.  In the last six months, 13 California hospitals were fined for such preventable medical errors as leaving surgical instruments in patients, wrong site surgeries, and medication errors.  The report was published by www.clinicaladvisor.com.  Among the notable preventable medical errors were the following:

• The Los Angeles Community Hospital in Norwalk, where a patient who was supposed to have been restrained pulled out a tracheotomy tube and subsequently died.
• California Hospital Medical Center, where an emergency room resident misdiagnosed a woman with an ectopic pregnancy (she was not pregnant) and administered methotrexate, which caused immunosuppression and major adverse effects.
• Marina Del Rey Hospital, where intensive care nurses failed to monitor a patient's oxygen levels, resulting in the patient passing out and having to be put on a ventilator.
• St. Jude Medical Center, where a patient died in the emergency room after nurses failed to notice that the heart monitor was disconnected.
• Kaiser Foundation Hospital, where a 90-year-old patient was given medication intended for another patient, resulting in his being intubated and on a ventilator.
• Sharp Memorial Hospital in San Diego, where a surgical team left a sponge in the pleural cavity of a patient during surgery, necessitating a second surgery.
• San Francisco General Hospital, where surgeons left a gauze sponge in a patient which went unnoticed for three months until the patient returned to the hospital.
• John F. Kennedy Memorial Hospital, which received four fines for incidents involving the use of untrained and non-certified nurses in the emergency room, resulting in the death of a two-year-old child.
• Hoag Memorial Hospital, where a patient was injured when a metal gurney that she was lying on was placed in a room with an MRI machine. When the MRI was turned on, the gurney was pulled by magnetic force into the machine, crushing the patient's leg.

These are just some of the medical errors reported in a six month period by a state that requires such reporting.  It would be beneficial if our own state of New Hampshire had such reporting requirements.

Toyota's problems turned worse today as federal officials announced that Toyota executives may face criminal charges regarding their lack of disclosure to the US public concerning the Toyota recalls.  While it's still not clear what criminal charges Toyota may face, it seems certain that the charges may be related to product safety issues and Toyota's disclosures concerning product defects. 

According to an MSNBC report, "Eric Dezenhall, a crisis management consultant in Washington, said the subpoena might cause Toyota to limit its testimony because apologies are admissible in court. He predicted the company would walk a line between carefully phrased testimony and enough disclosure to describe the cars' mechanical problems and steps Toyota had taken to make the vehicles safer.

House investigators said they believe Toyota intentionally resisted the possibility that electronic defects caused unintended acceleration in their vehicles and then misled the public into thinking its recalls would fix all the problems.

Rep. Bart Stupak, D-Mich., who will run Tuesday's hearing, said documents and interviews demonstrate that the company relied on a flawed engineering report to reassure the public that it found the answer to the problem.

In a letter to Toyota, Stupak said a review of consumer complaints shows company personnel identified sticking pedals or floor mats as the cause of only 16 percent of the unintended acceleration reports.

Some 70 percent of the acceleration incidents in Toyota's customer call database involved vehicles that are not subject to the 2009 and 2010 floor mat and "sticky pedal" recalls.

In a letter to NHTSA, Stupak's committee raised questions about whether the agency lacked the expertise to review defects in vehicle electronics and said NHTSA was slow to respond to 2,600 complaints of sudden unintended acceleration from 2000 to 2010."

A popular diet supplement has been linked to a 2008 Selenium poisoning that was found to contain 200 times the amount of selenium stated on the product label.  "Total Body Formula" and "Total Body Mega Formula" supplements were mentioned in a report published by the Archives of Internal Medicine.

The selenium poisoning highlights a problem that is becoming increasingly evident with dietary supplements.  Dietary supplements and so-called "natural" products are not regulated by the FDA.  The federal agency becomes involved only if there is a public health concern regarding the supplement.  In many instances, the product label doesn't accurately reflect the contents or the ingredients of the product.  Perhaps more importantly, the ingredients' proportions are not properly documented either.

Facing a recall of approximately 8,000,000 vehicles, Toyota is facing Congressional scrutiny over safety issues involving sticking accelerator pedals in a number of Toyota models and brake defects in its popular Prius hybrid.  The recall is sending shock waves in political circles as well.  This morning, Transportation Secretary Ray LaHood told Toyota owners to stop driving their vehicles and return them to dealerships for repair.  This afternoon, Lahood has backed off that statement, saying he didn't mean what he said.

In spite of the political turmoil and potential economic fallout for the best selling automaker in the US, consumers are left to question the safety of their vehicles.  At least one Congressman echoed consumer concerns.  Henry Waxman (D-CA) commented, "Like many consumers, I am concerned by the seriousness and scope of Toyota's recent recall announcements."
Toyota said it would take months to complete repairs on the recalled vehicles since it would send notices to affected customers in batches of ten thousand to avoid overrunning repair shops.  So, it looks like Toyota owners will be dealing with this for quite some time.

The fourth medical malpractice myth concerns the relationship between malpractice cases and the cost of insurance premiums for doctors.  This is a common belief among medical professionals that medical malpractice claims directly correlate to higher insurance premiums.  However, the National Bureau of Economic Research has researched the issue and found there is no direct correlation between the two.  They have concluded that "increases in malpractice payments made on behalf of physicians do not seem to be the driving force behind increases in premiums."

Perhaps more importantly the group Americans for Insurance Reform has found that "not only was there no ‘explosion’ in lawsuits, jury awards or any tort system costs to justify the astronomical premium increases that doctors have been charged in recent years. These rate increases were rather driven by the economic cycle of the insurance industry, driven by declining interest rates and investments."

While medical malpractice claims insurers have complained about "financial crises" caused by medical malpractice lawsuits, their profits remain higher than most Fortune 500 companies. Former Missouri Insurance Commissioner Jay Angoff studied the issue and released a report entitled "No Basis for High Insurance Rates".  In it, Angoff concluded that malpractice insurance companies artificially raised doctors' premiums and misled the public about the nature of medical negligence claims.

A surgical tech nurse has been convicted and sentenced for infection 3 dozen patients and placing countless more in danger for hepatitis C because of her shoddy medical practices.  Kristen Diane Parker, infected with hepatitis C, exposed numerous unsuspecting patients to the blood borne disease.  Hepatitis C is a potentially deadly disease that attacks the liver which can lead to cirrhosis or cancer of the liver.  Hepatitis C is spread by contact with infected body fluids, especially blood.

Parker was originally charged with 21 counts of product tampering and 21 counts of obtaining a controlled substance through deceit.  The charges stem from Parker stealing the drug Fentanyl.  Parker stole the drug for her own use and would replace the used syringes with saline solution after injecting herself, potentially exposing other patients.

The surgical tech admitted to prosecutors that she had indeed stolen the Fentanyl in order to feed her drug addiction.  Fentanyl is a strong narcotic pain medication used to treat surgical patients.  During her interview with prosecutors, Parker said that she intended to replace the used syringes with clean syringes but became confused and placed the used syringes back in circulation for patient use.  The used syringes were filled with saline rather than the prescribed medication.

Johnson & Johnson had a particularly rough day yesterday.  First, they were hit with a federal complaint concerning kickbacks to Omnicare, a large pharmaceutical company that serves nursing homes.  The complaint alleges Johnson & Johnson paid Omnciare tens of millions of dollars in order for them to recommend and use J&J products. 

If that wasn't bad enough, J&J expanded their recall of the popular Tylenol product because of a foul odor.  The foul smell has been a headache for the maker of Tylenol and Motrin since 2008.  It's estimated that some 60 million bottles of the over-the-counter medicine are involved in the recall. 

Deborah Autor, head of the FDA's compliance office, was critical of how J&J has handled the problem.  "The company should have acted faster," Autor said. "All companies have a responsibility to ensure high quality, safety and effective of their products and protect consumers."

The FDA has issued a warning to consumers that a popular Morning Sickness remedy called Nzu has been found to contain high levels of lead and arsenic in a laboratory test.  High levels of lead have been shown to have harmful side effects on a developing fetus' brain and nervous system.  Arsenic is a known carcinogen and long-term exposure has been linked to bladder, skin, and lung cancers. 

Nzu is also called Calabash clay, Calabar stone, Mabele, Argile and La Craie. It generally resembles balls of clay or mud and is usually sold in small plastic bags with a handwritten label identifying it as “Nzu” or “Salted Nzu.”

Proctor & Gamble, in conjunction with the Consumer Product Safety Commission has issued a recall of Vicks Dayquil Cold and Flu Liquicaps because they do not meet the child-resistant.  The cold and flu medicine contains acetaminophen and is required to have a child-resistant cap.

The recall involves approximately 700,000 packages of the cold and flu product. The recall involves Vicks Dayquil Cold & Flu 24-Count Bonus Pack Liquicaps.  The medicine comes in orange packaging with the green Vicks symbol and has the following UPC# 3 23900 01087 1.

The product is sold in grocery stores, pharmacies and has been sold from September 2008 until the December 2009 recall.

No injuries have been reported.  However, the medicine can be harmful or fatal to children if several capsules are swallowed.

A class action lawsuit has been filed against GE Healthcare, the maker of CT scans which allegedly produce radiation overdoses.  The lawsuit was filed in US District Court in Alabama by a woman who received a botched CT brain scan.  The class action lawsuit alleges that the GE Healthcare CT scan fails to warn patients and healthcare workers when excessive radiation is produced by the scan. 

The FDA has been investigating CT scan radiation overdoses since October when Cedars-Sinai Hospital in California reported patients had been exposed to excessive radiation from CT scans. Thus far, the FDA investigation has not determined whether the excessive radiation stems from human error or CT scan equipment failure or defect.

Last week, former NH registered nurse Trinidad Smith pleaded guilty in U.S. District Court to an indictment charging her with consumer product tampering and obtaining a controlled substance by fraud and deceit.  During her plea hearing, Smith admitted to tampering with Demerol and Dilaudid syringes and vials that were maintained in a Pyxis machine for patients at Southern New Hampshire Medical Center. 

According to the NH Attorney General's press release, Smith gained access to the drugs by using her access code assigned to her by the hospital. 

"Smith admitted that after removing the drugs for her personal use, she replaced the medication in the syringes with saline and returned the tampered syringes to the machine for future use by patients.  As described at yesterday’s plea hearing, the investigation uncovered a total of 24 syringes and three vials that appeared to have been tampered with. Examination of the syringes revealed that their tamper resistant seals were cut or visibly broken with tape placed over the seals. The Forensic Chemistry Center of the Food and Drug Administration (FDA) found that the Dilaudid syringes were diluted by approximately 48% and 92%. Two of the syringes were also found to contain the active ingredient in Benadryl which certain patients are allergic. Further testing of the Demerol syringes determined that Demerol’s active ingredient was diluted by approximately 46% to 85%."

Besides the criminal issues, this raises huge safety concerns for patients at this hospital.  These are powerful drugs which must be carefully stored and monitored.

The Consumer Product Safety Commission has issued a recall of 2.1 million baby cribs for safety deficiencies that could lead to infant suffocation.  CPSC has recalled Stork Craft drop-side baby cribs for hardware safety problems.  The cribs are manufactured by Stork Craft Manufacturing, Inc. of British Columbia.  It's estimated that 1.2 million of the cribs have been sold in the United States.  According to the federal agency, at least 147,000 of the cribs may have a Fisher-Price label on them.  The cribs have been sold since 1993 at major retailers including Sears and Wal-Mart.

The problem with the cribs involves the drop-side which is attached with plastic hardware that may detach creating a space between the crib wall and the mattress.  Infants and toddlers can become trapped in the space or fall to the floor.  Thus far, there have been 110 documented cases of drop-side crib detachment, 67 of which were reported in the US. 

In the wake of yesterday's latest crib recall, some consumer advocates and child safety experts have called for an outright ban of drop-side cribs. 

"This has certainly been a hazard that we've been aware of for some time," said Nancy Cowles, director of Kids In Danger, a Chicago-based advocacy group. Drop-side cribs have been associated with "dozens of deaths" over the years, she added.

While it's understandable that the pending healthcare bills focus on addressing the lack of health insurance for many Americans, an important issue in healthcare has been largely ignored, namely, medical errors.  None of the proposals currently before Congress adequately address the problem of medical errors.  It's estimated that medical errors account for 200,000 deaths in the United States each year.  Yet, there's little interest in addressing mandatory reporting of medical errors that's been shown to improve the quality of medical care and reduce unnecessary deaths. 

Senators Chris Dodd and Joseph Lieberman have both strongly endorsed the mandatory reporting of medical errors but their voices have been largely ignored. 

"A national reporting system is an excellent idea,” Lieberman said. “It could easily and constructively be included in a health-care reform package. Disclosure ... is a deterrent to further medical errors, and we learn from disclosure.”

Medical malpractice relating to heart attacks may occur when doctors fail to correctly diagnose the symptoms of a heart attack or delay treatment of the heart attack.  Failure to properly and effectively diagnose a heart attack can lead to severe consequences for the patient including death.  Many of these failures to diagnose and/or treat heart attack victims occur in emergency rooms.  Such situations often occur when a doctor fails to recognize symptoms such as chest pain, shortness of breath, dizziness, nausea, or radiating arm pain.  Patients may often claim indigestion or other abdominal issues as the cause of their discomfort.  Emergency room doctors and nurses must consider the patient's risk factors as well as their symptoms and order the proper diagnostic tests which include an EKG, blood tests, cardiac catheterization, an angiogram, CT scan, and later,  a Thallium stress test.

Symptoms of a heart attack may be subtle so it's crucial for doctors to act effectively and promptly to avoid further heart damage.  Failure to do so may have serious health consequences for the patient and constitute medical malpractice on the part of the doctor.

Approximately 364,000 Dublin Energy Solution Roman Shades have been recalled due to strangulation hazards.  Reports of two near strangulations of infants prompted the product recall.  According to the Consumer Product Safety Commission, "Strangulations can occur when a child places his/her neck between the exposed inner cord and the fabric on the backside of the blind or when a child pulls the cord out and wraps it around his/her neck."

The Roman shades sold by Bed Bath & Beyond include all sizes and colors of the Roman Shades with exposed inner cords on the back.  The shades have been on the market and available for purchase since August 2007.  The shades were manufactured in China. 

A baby food recall has been announced that involves baby food Babies R Us and Toys R Us locations.  The foods in question include apple and carrot pouch foods made by Plum Organics.  The recall was issued because of a concern that the baby food may be tainted with botulism.  Botulism normally originates from improperly canned foods.  Botulism is a potentially fatal illness whose symptoms include nausea, vomiting, blurry vision, weakness, and general fatigue. These symptoms may be manifest within 6 hours to 10 days of ingestion.  Botulism poisoning can also cause paralysis of the breathing muscles.

The recalled product has been sold in 4.22 oz. packages and UPC 890180001221.

Complaints about iPods overheating have now caught the attention of the Consumer Products Safety Commission.  After a few years of complaints about iPods that grow so hot they can burn individuals as well as catch on fire, the federal agency will begin investigating the problem.  Some believe that the iPod problem concerns the device's lithium batteries which have had a history of overheating and catching on fire in other electronic equipment such as computers.

The CPSC will be reviewing 18 incidents, including the following:

• In 2002, an iPod in a 14-year-old Michigan boy's bedroom set off a smoke alarm in the middle of the night.
• In 2006, an iPod started smoking and sparking in the middle of the night at one Illinois residence. It was so hot that it burned the stereo it was sitting on.
• In 2007, a 4-inch flame shot out of an iPod while it was charging in Washington, D.C.
• Also in 2007, a man's shirt caught fire in Atlanta when the iPod in his pocket overheated.

Other cases were reported in New York, Washington state and Portland, Ore.

Target has agreed to pay a $600,000 for allegedly violating the lead paint in toys ban that has been in effect since 1978.  The Consumer Products Safety Commission has targeted the retailer since 2006 for the violation of the lead paint in toys ban.  The toys in question include Kool Toyz Products, Anima-Bamboo Collection Games, Happy Giddy Gardening Tools and Sunny Patch Chairs.  The toys have since been recalled by Target in conjunction with the CPSC.

Lead paint has been associated with various disorders in children including neurological damage, stunted growth, deterioration of cognitive ability, and respiratory problems.

A flash fire during surgery has resulted in the death of an Illinois woman.  The fire occurred at the Heartland Regional Medical Center in Illinois.  The woman was severely burned and was transferred to Vanderbilt University Medical Center where she died six days later.  The state medical examiner determined the cause of death as thermal burn complications.

ECRI Institute, a research institute that tracks surgical fires, estimates that there are 550-650 fires reported annually.  Approximately 20-30 of those fires are deemed serious.

Mark Bruley, an ECRI accident and forensic investigator, estimates that 75% of surgical fires are caused by high oxygen levels under the surgical sheets.  The high oxygen levels can ignite the sheets, which are not necessarily flame-retardant.  Surgical fires may also occur when surgical equipment such as scalpels is sterilized with alcohol-based cleaning agents.  If the surgical equipment is not fully dry, the alcohol can lead to vapor ignition.  According to Burley, the surgical fires are 100% preventable.

Concerns about surgical fires have increased in the past few years as surgeons are using electrosurgical tools coupled with less flame retardant disposable synthetic fabrics instead of the traditional cloth drapes.

“What we’ve been advocating for years is that the open delivery of oxygen under the drapes essentially has to stop,” said Bruley.

Many of these surgical fires result in preventable injuries to the patient and legal action.

Some prominent department stores and children's clothing manufacturers have been cited and fined by the Consumer Product Safety Commission for manufacturing or selling children's sweatshirts with drawstrings around the neck.  The drawstrings pose a strangulation hazard to young children.

Among those cited and fined by the CPSC:  1) Kohl's Department Store has been fined by the CPSC $425,000 for its failure to report the drawstrings in children's sweatshirts; 2) Hill Sportswear was fined $100,000 for a similar failure to report; 3) Maran Inc. and K.S. Trading Corporation were fined $85,000 for for another failure to report concerning the sweatshirt drawstrings.

O'Neill's children's hooded sweatshirts have been recalled by their distributor La Jolla Sport USA  Inc. because of a strangulation threat concerning the sweatshirts' drawstrings.  According to the CPSC, approximately 2,300 sweatshirts are being recalled because of the health hazard.

The sweatshirts were manufactured in China and sold at Ron Jons' Surf Shop, Dillards and McCaulous stores nationwide from June 2009 through August 2009 for about $65.

IKEA, in cooperation with the Consumer Product Safety Commission, is recalling approximately 500 mattresses because they do not meet federal standards for open flames and pose a consumer hazard. 

The IKEA product is the IKEA KARLSTAD sofa-bed which has article number 801-215-12, supplier number 20789 with date stamps (YYWW) 0845 through 0927 located on a label attached to the underside of the sofa-bed frame. The mattress topper is not affected by this recall.

The sofa bed, which retails for approximately $850 has been available in IKEA stores nationwide since November 2008.

Several drug companies marketing over the counter topical Ibuprofen pain gels have been sent warning letters from the FDA.  According to the federal regulatory agency, such OTC pain gels require pre-marketing approval from the FDA.  The letter informed the drug companies that they must stop marketing their products until they receive approval from the FDA.

Companies that received the FDA warning letter include:

Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)

These products contain ibuprofen in combination with other active ingredients and are marketed for pain relief.  Thus far, the FDA has not approved any topical ibuprofen drugs.

The US Product Safety Commission has issued a recall of 51,750 generators due to a fire hazard associated with faulty fuel gauge.  This recall involves Homelite and Husky brand generators sold exclusively at Home Depot stores and Black Max brand generators sold exclusively at Sam's Club stores. Affected generators include Homelite models HG3500, HG3510, HG5700 and HG5700R, Husky models HU3650, HUCA5700 and HUCA7000 and Black Max models BM10700A, BM10700B, BM10711A, BM10700DG, BM10700R, BM10700BR & BM10722G. Generators included in this recall have manufacturing date codes between BML306-BMM151, CHL122-CHM151 and CRL153-CRM059. The model number and manufacturing date code are included on the data label located on the top or side of the generator engine. Products with a green "dot" on the outside of the package or a "silver dot" on the fuel gauge face are not included in the recall.  These generators have been sold exclusively at Sam's Club and Home Depot from July 2008 through May 2009. 

The Consumer Product Safety Commission in cooperation with Graco Children’s Products, Inc. has issued a recall of 2,400 Jump ‘n Jive™ Doorway Jumpers due to a choking hazard. According to the federal agency, the doorway jumpers include detachable toys that are attached to the jumper straps with strips of hook and loop fabric. The strips of fabric are not permanently attached to the toys and can become detached during use, posing a choking hazard. The doorway jumpers are sold in retail stores such as Babies R Us and other children’s stores as well as online from Amazon.com for approximately $55. CPSC is instructing consumers to stop using the toys and discard the detachable toys and fabric strips.

Target has issued a recall of 43, 000 Circo Booster Seats because the booster seat restraint buckle can open unexpectedly causing the child to fall and suffer injury. The recall was issued after Target received reports of children falling from the booster seats after the buckle opened. Three of the reports involved injury to the children. According to the Consumer Product Safety Commission, “this recall involves Circo booster seats with manufacture date codes XJ0811, XJ0812, XJ0901, and XJ0902. The plastic booster seat is blue with green trim and has white straps. The manufacture date code is printed on the backside of the seat next to the consumer warning information. “Circo” can be found on a label located in the front of the seat.” The seats are manufactured in China and have been sold at Target stores nationwide for $13. The Consumer Product Safety Commission urges consumers to stop using the booster seats.

Frigidaire has recalled 35,000 washing machines because of a potential fire hazard. The washing machines have a defective drain pump that can cause heat to build within the machine and start a fire. The affected products include Crosley®, Frigidaire®, Kelvinator®, Kenmore®, Wascomat®, and White-Westinghouse®. Model and Serial numbers are provided for the recalled products at the Consumer Product Safety Commission website: http://www.cpsc.gov/cpscpub/prerel/prhtml09/09292.html The Consumer Product Safety Commission is warning all owners of these products to stop using them immediately and call Frigidaire to schedule a free repair of the washing machine.

Abbott Vascular has issued a voluntary recall of four lots of its Powersail coronary dilation catheter after the company received reports of problems related to its distal shaft. The total number of catheters recalled is estimated to be 550. One complaint showed evidence that a patient suffered a post-procedure heart attack. The FDA classified the voluntary recall as Class I, indicating that the defective product could seriously injure or kill patients. While the product defect can be detected prior to use, there are serious consequences if the defect is not found prior to use, including myocardial infarction and embolism. The defective distal shaft may leak contrast fluid which in turn may cause catheter functional failures and serious injury, including death. An Abbott spokesperson has stated that all defective catheters have been accounted for and the ones that were used performed successfully.

A Brazilian priest working at a local Boston parish has been suspended for allegations of sexual abuse. The Reverend Pedro Jose Damazio had been living at St. Anthony of Padua Catholic Church in Cambridge and working with the Brazilian Catholic community throughout the Archdiocese at the time of his suspension. A spokesperson for the Archdiocese of Boston said the Archdiocese is cooperating fully with law enforcement officials and has notified Rev. Damazio's home diocese in Brazil. Further details were not forthcoming. The Archdiocese of Boston was rocked by the priest abuse scandal in 2002. The scandal in Boston and the Boston Globe's Spotlight Team investigation led to investigations, criminal charges, and hundreds of lawsuits across the country.

A Seattle based reporter has uncovered some disturbing news about Apple's iPod MP3 players. The iPods may smolder, smoke, and burst into flames. The exclusive KIRO7 news investigation by reporter Amy Clancy reveals that the cause of the overheating and fires may be linked to the lithium batteries in iPod models. These iPod defects have caused injury to their owners and are documented in 800 pages of investigative materials obtained from the Consumer Product Safety Commission. Initially, Apple lawyers attempted to block the release of the documents. However, Clancy prevailed in her Freedom of Information Act request. The CPSC documents reveal 15 burn and fire related incidents associated with the Ipod. Initial consumer complaints to Apple's customer service department were dismissed as isolated incidents. While a product recall has not been issued, the CPSC has warned Apple of its legal obligation to inform the federal agency of any product defects. According to Clancy's article on the subject, "Apple has been notified by the Consumer Product Safety Commission that it is the California company’s obligation to 'inform the Commission of defects associated with this product which could create a substantial product hazard under 15 U.S.C 2064(a).' The documents further reveal, if Apple 'receives any information regarding other potential defects or hazards, it must report this information to the Office of Compliance and Field Operations immediately.' And that the CPSC staff 'will assess any new information concerning this product to determine if action should be taken to protect the public.' One of the reasons the CPSC gives for not taking action now is because 'the current generation of iPods uses a battery which has not been shown to have similar problems.' When asked by Clancy, when this “current generation” of batteries started being used, and what type of battery it is, Apple would not comment. But earlier this year a lawsuit against Apple was filed in Cincinnati because, the lawyer claims, an iPod Touch, one of Apple’s newest edition of iPods, also powered by a lithium ion battery, exploded and caught fire while in a teenager’s pocket. The suit claims the boy suffered second-degree burns to his leg, and that the iPod was off at the time. This incident is not included in the CPSC’s file."

Haier America Trading LLC has agreed to pay a civil penalty of $587,500 for failure to disclose a product defect in their Oscillating Tower Fan, model FTM140GG. The fine stems from the company's failure to immediately inform the US Consumer Product Safety Commission of the known fire hazard. According to the defect allegations, repeated bending of the fan's wires during oscillation caused the wired to break, posing a significant risk of hazard to the consumer. From May to October 2004, the company received 14 reports of incidents, some of which included fires. There was one report that included injury. In spite of the reports, no report was filed with the Consumer Products Safety Commission, even though Haier America was required to do so under federal law. No report was forthcoming until December 2004 when the federal agency asked for a report. A full year later, the product was recalled from the market. “Prompt reporting in this case could have prevented fires and injuries,” said CPSC Chairman Inez Tenenbaum. “Companies have a responsibility to immediately let us know of potential hazards, and we will hold them to their duty.” The Consumer Product Safety Commission is still interested in any unreported incidents regarding the oscillating fan defect.