Drug maker GlaxoSmith Kline has agreed to begin settling cases where plaintiffs allege the use of antidepressant Paxil caused birth defects.

 Only one case in Philadelphia’s mass tort Paxil program has gone to trial. Children born with birth defects where a mother is taking the Paxil drug during pregnancy is such [...]]]> Source: The Legal Intelligencer, June 2010

Drug maker GlaxoSmith Kline has agreed to begin settling cases where plaintiffs allege the use of antidepressant Paxil caused birth defects.

 Only one case in Philadelphia’s mass tort Paxil program has gone to trial. Children born with birth defects where a mother is taking the Paxil drug during pregnancy is such a devastating circumstance. We at the Lewis Law Firm want to hear from any family who has not yet exercised their rights to seek compensation. Contact us.

 Posted: Gayle Lewis, Esquire

The CDC’s National Healthcare Safety Network (NHSN) (If you think we have too many governmental organizations now, just wait) has compiled its first (Yes, first) State-Specific Summary and Report on Healthcare-Associated Infections.

The results of the NHSN’s 18 page (including references) report are not entirely clear.  However there are [...]]]> Source:  US Centers for Disease Control & Prevention

The CDC’s National Healthcare Safety Network (NHSN) (If you think we have too many governmental organizations now, just wait) has compiled its first (Yes, first) State-Specific Summary and Report on Healthcare-Associated Infections.

The results of the NHSN’s 18 page (including references) report are not entirely clear.  However there are some interesting things which can be discerned from the Government-speak and statistical analysis.  Between January of 2009 and June of 2009 (That’s 6 months)  The State of New Jersey reported 72 central line-associated bloodstream infections from 100 different healthcare facilities in the state. The facilities are not specifically identified in the report.  Neither do we know, for example, if 1 or 2 of those facilities accounted for the majority of the 72 blood stream infections from central-lines.

During the same time frame, the Commonwealth of Pennsylvania reported 204 central line-associated bloodstream infections from 253 different healthcare facilities. You may be wondering how this compares with infections in the State of Rhode Island.  Well Rhode Island reported only 1-4 central line-associated bloodstream infections from 16 healthcare facilities between January 2009 and June 2009.  New York reported 182 central line-associated bloodstream infections from 182 facilities.

Here’s where it gets interesting.  Well to us anyway.  Between January 2009 and June 2009, 818 hospital-associated infections were observed in the Commonwealth of Pennsylvania. Oddly, the NHSN predicted that number would be 1,176.83 which at first glance might suggest that Pennsylvania hospitals are doing something right.  That is until you recognize that there were 818 hospital-associated infections observed and who knows how many others might have been unobserved or unreported as hospital-associated infections.

During the same time frame, the State of New Jersey reported 183 observed hospital-associated infections which was close to the predicted 222.97.

So what does this all mean?  First of all, the report is the result of a limited mandate to report specifically on central line-associated blood stream infections.  Although it is clear from the total number of observed infections in the report that more types of infections were reported.

The back story: From June 2008 to December 2008, Pennsylvania’s own Department of Health reported 13,771 hospital-acquired infections, the most common were Urinary Tract Infections from catheters (UTI’s) (24.83%), surgical site infections (22.23%) and intestinal infections (18.15%).  So why is the CDC concerned only with central line-associated blood stream infections?  Good question.  30% of Pennsylvania hospitals using central lines had more infections than expected as compared with the rest of the US. Therefore Pennsylvania was flagged for reporting.

The State of New Jersey, late to the infection reporting party, only implemented legislation requiring reporting in 2007.  Accordingly, the NJ Department of Health and Senior Services first report on State hospital-associated infections will not be released until the end of 2010.  We await that report.

~Posted by D.M. Schwadron, Esquire

The US Department of Health and Human Services is a broad agency.  One of it’s charges is the administration of Medicare and Medicaid.  In this time of financial unrest, one of the measures taken by the Department is to reduce the amount of reimbursement to [...]]]> Source:  The US Centers for Medicare & Medicaid Services (CMS)

The US Department of Health and Human Services is a broad agency.  One of it’s charges is the administration of Medicare and Medicaid.  In this time of financial unrest, one of the measures taken by the Department is to reduce the amount of reimbursement to hospitals.  How does one do that?  by identifying things which occur in hospitals that are “reasonably preventable” of course.  Let’s review the Government’s own top 10 list of HAC’s or Hospital Acquired Conditions.

Section 5001(c) of Deficit Reduction Act of 2005 requires the Secretary to identify conditions that are:  (a) high cost or high volume or both, (b) result in the assignment of a case to a DRG that has a higher payment when present as a secondary diagnosis, and (c) could reasonably have been prevented through the application of evidence‑based guidelines.

The Inpatient Prospective Payment System (IPPS) Fiscal Year (FY) 2009 Final Rule, CMS included 10 categories of conditions that were selected for the HAC payment provision.  The IPPS FY 2009 Final Rule is available in the Statute/Regulations/Program Instructions section, accessible through the navigation menu at left.

The 10 categories of HACs include:

1. Foreign Object Retained After Surgery (Seriously? Still number 1 after all these years?)
2. Air Embolism
3. Blood Incompatibility
4. Stage III and IV Pressure Ulcers (Also a big Nursing Home Issue)
5. Falls and Trauma
   • Fractures
   • Dislocations
   • Intracranial Injuries
   • Crushing Injuries
   • Burns
   • Electric Shock
6. Manifestations of Poor Glycemic Control  (If you’re in the hospital they should be controlling this)
   • Diabetic Ketoacidosis
   • Nonketotic Hyperosmolar Coma
   • Hypoglycemic Coma
   • Secondary Diabetes with Ketoacidosis
   • Secondary Diabetes with Hyperosmolarity
7. Catheter-Associated Urinary Tract Infection (Common and preventable)
8. Vascular Catheter-Associated Infection
9. Surgical Site Infection Following:
   • Coronary Artery Bypass Graft (CABG) – Mediastinitis
   • Bariatric Surgery
     • Laparoscopic Gastric Bypass
     • Gastroenterostomy
     • Laparoscopic Gastric Restrictive Surgery
   • Orthopedic Procedures
     • Spine
     • Neck
     • Shoulder
     • Elbow
10. Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)

We aren’t suggesting that everything hospitals do is incorrect.  However, if the US Government is limiting reimbursement or withholding reimbursement to hospitals when these incidents occur then it may be a good indicator that a hospital has committed an act of malpractice.

~Posted by D.M. Schwadron, Esquire

Men should discuss the benefits and risks of prostate cancer screening with their doctors, according to revised prostate cancer screening guidelines from the American Cancer Society (ACS).  Yes. That’s what they said.  Not much of a guideline is it?

Okay they say a little more.  But really, only a little.  The American Cancer [...]]]> Source: American Cancer Society

Men should discuss the benefits and risks of prostate cancer screening with their doctors, according to revised prostate cancer screening guidelines from the American Cancer Society (ACS).  Yes. That’s what they said.  Not much of a guideline is it?

Okay they say a little more.  But really, only a little.  The American Cancer Society recommends that doctors more heavily involve patients in the decision of whether to get screened for prostate cancer.

ACS recommends that men with no symptoms of prostate cancer who are in relatively good health and can expect to live at least 10 more years have the opportunity to make an informed decision with their doctor about screening after learning about the uncertainties, risks, and potential benefits associated with prostate cancer screening. These talks should start at age 50. Men with no symptoms who are not expected to live more than 10 years (because of age or poor health) should not be offered prostate cancer screening. For them, the risks likely outweigh the benefits, researchers have concluded.

ACS recommends men at high risk – African-American men and men who have a father, brother, or son diagnosed with prostate cancer before age 65 – begin those conversations earlier, at age 45. Men at higher risk – those with multiple family members affected by the disease before age 65 – should start even earlier, at age 40.

For men who choose to be screened after discussing the pros and cons with their doctor, the new guidelines make the digital rectal exam (DRE) optional and offer the option of extending the time between screening for men with low PSA levels.

There it is. No specific PSA recommendations, or even whether PSA testing should be considered mandatory.  So start “talking to your doctor” about screening.  Does this sound an awful lot like the burden of screening for Prostate Cancer is being placed back upon the patient? Yeah. It sounds that way to me too.

~Posted by D.M. Schwadron, Esquire

Apparently stopping death or irreparable damage from a heart attack could be as simple as inflating a blood pressure cuff.  This according to a recent Danish (The Country) study.

How does it work and why does no one seem to know about this?  Well, it is thought that a brief stoppage [...]]]> Source: U.S. National Institutes of Health

Apparently stopping death or irreparable damage from a heart attack could be as simple as inflating a blood pressure cuff.  This according to a recent Danish (The Country) study.

How does it work and why does no one seem to know about this?  Well, it is thought that a brief stoppage of blood flow improves the ability of organs to withstand stress and prevents tissue damage.  The admittedly small study of 142 patients rushed to hospital emergency rooms for heart attacks who received this treatment managed to retain 30% more of their heart tissue than those who did not.  The cuff was inflated for 4 minutes, relaxed and then inflated again.  Repeating this procedure 4 times appears to have done the trick according to the study’s author, Dr. Hans Erik Botker, a professor of cardiology.

Unfortunately it may take some time before the rest of the world adopts the European model of treatment. One group at Emory University in Atlanta is currently attempting similar treatment here in the United States.  Dr. Jacob Vinten-Johansen has added the inflation variation with a balloon catheter, slightly more invasive.  According to Dr. Vinten-Johansen, “The United States cardiology community is a bit slower to embrace these things and the regulatory situation is better in Europe.”

Regulations here in the States require a consent for what is deemed an “experimental procedure.”  Not always something easy to obtain (No, not because of trial lawyers) as patients having heart attacks aren’t necessarily able to provide a consent.  Similar techniques are being used to attempt to treat stroke as well.

~Posted by D.M. Schwadron, Esquire

Turkey Hill Dairy of Conestoga, Pa., is recalling its 1.5 qt. (48 oz./1.42L) packages of Chocolate Marshmallow Premium Ice Cream because the product may contain almonds that were inadvertently added during production. (Inadvertently added almonds?)

No illnesses have been reported to date in connection with this issue, [...]]]> Source: U.S. Food & Drug Administration

Turkey Hill Dairy of Conestoga, Pa., is recalling its 1.5 qt. (48 oz./1.42L) packages of Chocolate Marshmallow Premium Ice Cream because the product may contain almonds that were inadvertently added during production. (Inadvertently added almonds?)

No illnesses have been reported to date in connection with this issue, although people who have allergies to almonds run the risk of serious or life-threatening allergic reactions if they consume these products. The product is safe for consumption by consumers without nut allergies.

The recalled Chocolate Marshmallow Premium Ice Cream is limited only to select stores in central Pennsylvania. All affected stores are directly delivered to and serviced by Turkey Hill Dairy and have been instructed to remove the product from their shelves.

The recall was initiated after it was discovered that the recalled product was distributed in packaging that did not identify almonds as an ingredient. It is believed that less than 150 containers of ice cream were potentially exposed to almonds. All affected containers would have been purchased by consumers after January 28, 2010.

The product comes in a rounded, rectangular, cream-colored, paperboard, 48 oz. packages with farm scene and ice cream scoop graphics. The affected product is marked on the bottom of the package with the code “01/18/2011 56/L1”. Preceding the code is a four-digit number indicating the production time. The recalled product includes a time between 02:25 and 02:35.

Consumers who have purchased affected 48 oz. packages of Chocolate Marshmallow Premium Ice Cream with the previously mentioned code can return them to the place of purchase for a full refund. Consumers with questions may contact Turkey Hill Dairy at 1-800-MY-DAIRY (1-800-693-2479).

~Posted by D.M. Schwadron, Esquire

Trader Joe’s Company of Monrovia, California is voluntarily recalling Trader Joe’s Chocolate Chip Chewy Coated Granola Bars, UPC 82818, Use by Dates/Lot Codes 16JUL10H2 and 17JUL10H1, manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings, Inc. because it has the potential to be contaminated with Salmonella, [...]]]> Source:  U.S. Food & Drug Administration

Trader Joe’s Company of Monrovia, California is voluntarily recalling Trader Joe’s Chocolate Chip Chewy Coated Granola Bars, UPC 82818, Use by Dates/Lot Codes 16JUL10H2 and 17JUL10H1, manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings, Inc. because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The product involved in this recall was distributed at Trader Joe’s stores nationally and comes in a 7.4 oz box marked with Use by/Lot Codes 16JUL10H2 and 17JUL10H1 on the top of the box and stamped individually on the side of each granola bar. Production of the product has been suspended while FDA and Bloomfield Bakery continue their investigation.

No illnesses have been reported to date in connection with this product.

At Trader Joe’s we take the safety of our customers and the integrity of our products very seriously. Customers who have purchased Trader Joe’s Chocolate Chip Chewy Coated Granola Bars, Use by/Lot Codes 16JUL10H2 and 17JUL10H1 are urged to return them to any Trader Joe’s for a full refund. Customers with questions may contact Trader Joe’s Customer Relations Monday through Friday, 6am to 6pm PST at (626) 599-3817.

~Posted by D.M. Schwadron, Esquire

I know, I know…Let them sleep on their backs…No wait, only on their stomachs…No wait, on their backs but no pillows…or blankets…No smoking…No pets…Never in bed with you…

Perhaps it’s no wonder why the Amercian Academy of Pediatrics is constantly revising guidelines [...]]]> Source:  U.S. National Institutes of Health; Journal of the American Medical Association, February 3, 2010

I know, I know…Let them sleep on their backs…No wait, only on their stomachs…No wait, on their backs but no pillows…or blankets…No smoking…No pets…Never in bed with you…

Perhaps it’s no wonder why the Amercian Academy of Pediatrics is constantly revising guidelines for infant sleep.  There is a wealth of information seemingly linking SIDS (Sudden Infant Death Syndrome) with, well, everything.  The latest?  Serotonin. Huh?  Okay, back to biochemistry class we go.  Serotonin is a neurotransmitter, don’t worry about what kind, it’s presence or absence in sufficient quantities is  broadly responsible for the regulation of mood, appetite, sleep, muscle contraction, and some cognitive functions including memory and learning. Modulation of serotonin at synapses is thought to be a major action of several classes of pharmacological antidepressants.  As an interesting aside (well interesting to me anyway) certain foods, carbohydrates mostly -pasta, chips also seem to have a serotonin level response.

So why all the chemistry talk? Because researchers studying the brains of infants who have died from SIDS have found that they were producing low levels of serotonin. No, they weren’t depressed, well not emotionally anyway.  However, to the extent that serotonin may be responsible for breathing they may be onto something.  How much lower?  26% lower according to this study. Measures of an enzyme required to manufacture serotonin (tryptophan hydroxylase for those of you playing the home game) were also 22% lower in the brains of the SIDS death infants studied.

Yes, they are still currently recommending the whole back sleeping thing. For a complete list of sleeping guidelines see http://www.nicdh.nih.gov/sids/ or speak with your pediatrician or obstetrician.

~Posted by D.M. Schwadron, Esquire

Admittedly it was a small, focused study of 36 newborns, 17 of whose mothers smoked during pregnancy.  It is, however, alarming and instructive.  Babies that had been exposed to cigarette smoke in utero (While in Mommy’s belly) demonstrated abnormal heart rates and blood pressures.

But that’s not all. . .rather than [...]]]> Source:  BBC Health; Karolinska Institute (Sweeden)

Admittedly it was a small, focused study of 36 newborns, 17 of whose mothers smoked during pregnancy.  It is, however, alarming and instructive.  Babies that had been exposed to cigarette smoke in utero (While in Mommy’s belly) demonstrated abnormal heart rates and blood pressures.

But that’s not all. . .rather than dissipate with age, the abnormalities appear to have worsened from one week to age one. According to lead researcher, Dr. Gary Cohen, “Babies of smokers have evidence of persistent problems in blood pressure regulation that start at birth and get worse over time” and “[E]arly life exposure to tobacco can lead to long lasting reprogramming of the infant blood pressure control mechanism.”

And Dr. Cohen adds, this might be the mechanism which explains why infants of smokers are at increased risk for SIDS (Sudden Infant Death Syndrome) or “Cot death” as it is known in the UK.

~Posted by D.M. Schwadron, Esquire

Breast cancer is the second leading cause of death among women. An estimated 192,000 women will be diagnosed with breast cancer this year.

Not all breast cancers are the same, however.  Some breast cancers are hormone positive meaning that the presence of certain hormones (estrogen for example) contributes to cancer and [...]]]> Source: U.S. Food & Drug Administration

Breast cancer is the second leading cause of death among women. An estimated 192,000 women will be diagnosed with breast cancer this year.

Not all breast cancers are the same, however.  Some breast cancers are hormone positive meaning that the presence of certain hormones (estrogen for example) contributes to cancer and its rate of growth.  Breast cancer may also be protein based with HER2 being a common protein positive breast cancer.

Two chemotherapy drugs which have been effective in treating cancer, Tykerb (lapantinib) and Femara (letrozole) have now been approved for use in combination with one another. When a drug receives FDA approval it is typically for a “labeled use” only, meaning that it was developed to treat one specific disease or condition in a specific manner.  While medications are used “off label” at times at the discretion of physicians, the explicit approval of the FDA results in wider adoption and use.

Accordingly when the FDA permits the extension of approvals for the use of breast cancer drugs it is a big deal.  It is hoped that the combination of the two medications will be twice as effective in slowing the progression of  this killer of women.

~Posted by D.M. Schwadron, Esquire