Philadelphia Medical Malpractice Blog» Medical Malpractice

Philadelphia Paxil Litigation Shifts to Settlement

admin — Thu, 24 Jun 2010 15:03:36 +0000

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

Healthcare-Associated Infections (I sense a theme here…)

admin — Thu, 27 May 2010 18:39:02 +0000

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

Hospital-Acquired Conditions (Preventable Negligence

admin — Thu, 27 May 2010 17:24:36 +0000

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:

Foreign Object Retained After Surgery (Seriously? Still number 1 after all these years?)
Air Embolism
Blood Incompatibility
Stage III and IV Pressure Ulcers (Also a big Nursing Home Issue)
Falls and Trauma
- Fractures
- Dislocations
- Intracranial Injuries
- Crushing Injuries
- Burns
- Electric Shock
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
Catheter-Associated Urinary Tract Infection (Common and preventable)
Vascular Catheter-Associated Infection
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
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

Hospital X-rays miss “many fractures.”

admin — Thu, 25 Mar 2010 14:04:46 +0000

Source: American Journal of Roentgenology; BBC Health

A Duke University study published in the American Journal of Roentgenology (that’s x-rays) found that plain x-rays miss a surprising amount of fractures compared with MRI. How many? Out of 92 patients undergoing x-ray and then checked with MRI, 35 fractures were missed. That’s more than 1/3 of fractures for the slow at math. Oh and 11 patients had a fracture suggested by x-ray that wasn’t on the MRI (a false positive).

The problem? Well outside of the obvious, is that a negative finding read on an x-ray will not result in any additional study. In a Hospital Emergency Room Setting, the goal is to rule out traumatic fractures and move on to other diagnoses. Which means that patients are getting sent home with fractures that could potentially result in greater injury (ie. risk of fall, accident, extension of fracture, etc).

The suggestion of the authors was to use MRI in addition to x-rays, where doctors have doubts -particularly in the frail or elderly patient population. (Like you, I was looking to see if the study was funded by the MRI Manufacturers Association, but I could neither confirm nor deny that.) Hip and pelvic fractures are common among this group. (Who else thinks putting the call back upon the doctor is an inherently good idea?) Maybe I’m missing something (no pun intended) but if ER doctors are using x-ray to rule out fracture, why would they go any further once they get a negative result. Further, won’t the hospital administration and the Insurance Companies question the diagnostic rationale of obtaining an additional study when the first study was negative?

Okay, here is the point where I go off on an associated tangent, but a tangent, nonetheless. The point of this study was to use MRI as a back up where there were questions about an x-ray finding. Maybe the better practice would be to simply use MRI as the first study and do away with conventional and, apparently out-dated, x-ray technology?

What do I mean by “outdated?” A quick history lesson. It was 11/08/1895 when Wilhelm Conrad Röntgen accidentally discovered an image cast from his cathode ray generator. A week after his discovery, Rontgen took an X-ray photograph of his wife’s hand which clearly revealed her wedding ring and her bones. The photograph electrified the general public and aroused great scientific interest in the new form of radiation. Röntgen named the new form of radiation X-radiation (X standing for “Unknown”). Wilhelm’s wife, who served as chief tester would later die of radiation over-exposure. In 1913, William Coolidge invented the X-ray tube which then revolutionized the generation of X-rays and is the model upon which all X-ray tubes for medical applications are based. I’d consider that outdated. Hey, what do I know, I’m a lawyer, not a doctor.

~Posted by D.M. Schwadron, Esquire

Preventing Catastrophic Brain Injury with blood pressure checks.

admin — Mon, 15 Mar 2010 16:48:42 +0000

Source: BBC Health; The Lancet

A stroke is the interruption of blood to the brain. It is most commonly caused by vascular interruption from a blood clot or cholesterol blockage or cholesterol embolus. Rarely, it may also be caused by fungal endocarditis and fungal emboli following mitral valve replacement surgery.

Strokes have been classified as “brain attacks.” Like heart attacks, strokes can damage and kill tissue and result in temporary or permanent brain, injury, nerve injury (palsy), paralysis, loss of coordination and balance,neurological impairment, loss of speech and death. Predicting them and treating them before they occur can be critically important.

Researchers are calling for new guidelines for GP’s (General Practitioners or Primary Care Providers here in the US) to ensure that blood pressure remains at a steady level. While lower is preferential, it appears to be the fluctuation (change up or down) of blood pressure that determines the risk of stroke. Current guidelines call for a re-check of a high blood pressure only. If that second pressure is normal there is rarely treatment in the form of medication. And medication alone might not be the answer. Studies published in The Lancet have suggested that beta blockers (a common class of heart medication) may increase variation in blood pressure.

Like the fable the tortoise and the hare, it appears that slow and steady really does win the race when it comes to blood pressure and decreasing the risk of stroke or at the very least predicting those patients at risk for stroke.

~Posted by D.M. Schwadron, Esquire

Hospital Medicine Errors in the UK. Lessons for US.

admin — Mon, 15 Mar 2010 16:22:28 +0000

Source: BBC Health; National Patient Safety Agency (NPSA)

Roughly equivalent to our JCoHA (Joint Commission) here in the US, the NPSA has been taking notes on the administration of medications in English and Welsh Hospitals. Their findings? In every hospital in England and Wales, there were reports of patients not receiving their medications on time or at all.

From 9/06 to 6/09, the NPSA recorded reports of 68 cases of severe injury and 27 deaths with an additional 21,000 cases of drug administration delays or non-administration. Since reports to the NPSA are voluntary, the organization believes that these figures are underestimated.

Alarmingly, antibiotics (drugs to treat infection) and anticoagulants (blood thinners) and cardiac drugs are the most likely to harm patients if missed. Although even antidepressants and Parkinson’s Disease drugs can have dramatic effects upon patient wellness if they are not timely received.

And if this is happening in England and Wales, consider the implications for an area as populated as the US with all of its hospitals and nursing home facilities.

~Posted by D.M. Schwadron, Esquire

Revised Screening Guidelines for Prostate Cancer

admin — Fri, 05 Mar 2010 16:30:37 +0000

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

Heart attack? Cut off blood flow to the arm.

admin — Tue, 02 Mar 2010 16:00:03 +0000

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

Nursing Home Care and Pressure (bed) Sores

admin — Tue, 09 Feb 2010 21:01:47 +0000

Source: U.S. Centers for Disease Control and Prevention

In 2004 a National Survey was conducted of Nursing homes in the U.S. Unfortunately this is the most recent comprehensive study of its type. Among the Data from the National Nursing Home Survey, 2004 was the following:

In 2004, about 159,000 current U.S. nursing home residents (11%) had pressure ulcers. Stage 2 pressure ulcers were the most common.
Residents aged 64 years and under were more likely than older residents to have pressure ulcers.
Residents of nursing homes for a year or less were more likely to have pressure ulcers than those with longer stays.
One in five nursing home residents with a recent weight loss had pressure ulcers.
Thirty-five percent of nursing home residents with stage 2 or higher (more severe) pressure ulcers received special wound care services in 2004.

Pressure ulcers, also known as bed sores, pressure sores, or decubitus ulcers, are wounds caused by unrelieved pressure on the skin. They usually develop over bony prominences, such as the elbow, heel, hip, shoulder, back, and back of the head.

Pressure ulcers are serious medical conditions and one of the important measures of the quality of clinical care in nursing homes. From about 2% to 28% of nursing home residents have pressure ulcers. The most common system for staging pressure ulcers classifies them based on the depth of soft tissue damage, ranging from the least severe (stage 1) to the most severe (stage 4). There is persistent redness of skin in stage 1; a loss of partial thickness of skin appearing as an abrasion, blister, or shallow crater in stage 2; a loss of full thickness of skin, presented as a deep crater in stage 3; and a loss of full thickness of skin exposing muscle or bone in stage 4. Clinical practice guidelines for pressure ulcers have been developed and provide specific treatment recommendations for stage 2 or higher pressure ulcers, including proper wound care (5).

More than 1 in 10 nursing home residents had a pressure ulcer.

Of the 1.5 million current U.S. nursing home residents in 2004, about 159,000 (11%) had pressure ulcers of any stage. Stage 2 was the most common (5%), accounting for about 50% of all pressure ulcers. Stages 1, 3, and 4 made up about the other 50% of all ulcers.

Summary:

Overall, 11% of nursing home residents had pressure ulcers in 2004. Various demographic and clinical factors were related to having a pressure ulcer in a nursing home. Residents in a nursing home for a year or less since admission, who had a recent weight loss, or who had high immobility had the highest prevalence of pressure ulcers. Among residents with a pressure ulcer of stage 2 or higher, 35% received special wound care services.

This suggests that a minority of nursing home residents with stage 2 or higher pressure ulcers received wound care in accordance with the clinical practice guidelines. Pressure ulcers are serious and all too common medical conditions in U.S. nursing homes, and remain an important public health problem. Information from this Data Brief on pressure ulcer prevalence and service use among nursing home residents with pressure ulcers may provide a foundation for targeting public health efforts.

~Posted by D.M. Schwadron

As if you weren’t confused enough about SIDS. . .

admin — Thu, 04 Feb 2010 15:01:09 +0000

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