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Medical Malpractice Lawsuit Filed Against Valley Health By Former Employee Virginia Law Prevents Pharmacists From Compounding Drug To Treat At-Risk PregnanciesThe FDA has recently become apprised of something that plaintiff’s lawyers have known for years: Surgeons sometimes leave medical devices or parts of those devices in their patients.
Noting that the Center for Devices and Radiological Health receives almost 1000 reports of adverse effects each year, the FDA issued a Public Health Notification. These adverse effects have included more than 200 different medical devices that cause reaction in local tissue, infection, perforation and obstruction of blood vessels, and death.
The FDA has made the following recommendations to surgeons, none of which sound particularly earth-shattering:
1. Use medical devices in accordance with their labeled indications and the manufacturer’s instructions for use, especially during insertion and removal.
2. Inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure.
3. Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.
4. If the device is damaged, retain it to assist with the manufacturer’s analysis of the event.
5. Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs. leaving the fragment in the patient.
6. Advise the patient of the nature and safety of unretrieved device fragments including the following information:
a. The material composition of the fragment (if known);
b. The size of the fragment (if known);
c. The location of the fragment;
d. The potential mechanisms for injury, e.g., migration, infection;
e. Procedures or treatments that should be avoided such as MRI exams in the case of metallic fragments. This may help to reduce the possibility of a serious injury from the fragment.
In a landmark decision this week, the Supreme Court of the United States granted tort immunity to manufacturers of medical devices that have recieved FDA pre-market approval.
In Riegal v. Medtronic, the plaintiff had filed a lawsuit after a Medtronic catheter ruptured in Mr. Riegal's coronary artery during a heart surgery. Even though the catheter's labeling specifically warns against use for patients with diffuse or calcified stenoses, the doctor choose to use it in Mr. Riegal's heavily calcified artery. As the heart surgeon was inflating the catheter, it ruptured, leaving Mr. Riegal on life support and requiring emergency coronary bypass surgery.
The catheter had recieved FDA pre-market approval. Any medical device must undergo extensive screening by the FDA before it can be sold (hence the name "pre-market approval"). This screening includes an average of 1,200 hours of FDA review per application to ensure that each device has a "reasonable assurance" of the device's "safety and effectiveness," as weighed against hte probable risk of injury or illness resulting from use.
The result of this decision is to make it virtually impossible to sue manufacturers of medical devices - like pacemakers or catheters - as long as they have been pre-approved by the FDA. While the FDA does a great job in screening out medical devices not ready for the mass market, their screening process does not warrant giving blanket immunity to the makers of medical devices.
Even scarier? The Supreme Court will hear a case next term regarding the exact same issue - but with prescription drugs. This could be the end of manufacturer liability in the medical industry.
The American Academy of Orthopaedic Surgeons expects that the number of knee replacements done in the United States will increase by 525% in the next 22 years. Hip replacements are expected to more than double also by 2030.
The drastic increase in the number of joint surgeries will be caused by the aging American population, the increased demands of younger patients, the increased ability of surgeons to perform the surgery, and an increased level of arthritis in the general population.
While many people are genetically prone to develop arthritis as they get older, the growing weight of the average American is increasing the stress put on our joints. Surgeons have seen the average age of a joint replacement patient gradually creep down from about 70 years of age to somewhere around 65. They are attributing this age decrease to a weight and stress increase.
A recent Time magazine article suggested three lifestyle changes that can keep your knees and hips healthier longer. The first is weight control. According to Dr. Joseph Buckwalter, an arthritis specialist at the University of Iowa, each pound of weight that you lose takes 3-5 lbs. of pressure off of a bad joint.
The second thing to prevent joint pain late in life is to adequately address the problems when they occur. According to Dr. Buckwalter, treating joint injuries - including ankle sprains - properly as they occur can greatly decreased the risk of arthritic pain later in life.
Finally, Buckwalter points out that exercising regularly helps to maintain muscle strength, a full range of motion, and flexibility, all of which protect your joints. Daily exercise can be the difference between a mobile life and a surgery.
At first glance, it might seem like taking the free drug samples from your doctor is a great way to save money on prescriptions. It also saves you a trip to the pharmacy. But an MSNBC article points out some of the pitfalls of drug company handouts.
First, according to a new study from the University of Chicago, patients who take those "free" samples end up spending much more money on the drug in the long run. Patients who took a free sample spent almost 40% more on the drug over the the first six months, and 20% more than those who didn't over the next six months.
Dr. William Shrank, of Harvard Medical School, said "This builds on a growing body of literature that shows that samples are not aimed to help the uninsured and the poor, but to increase the sale of branded drugs." This study, Dr. Shrank noted, is a close follow-up to a January study that found that free drugs were more likely to be distributed to the wealthy and insured than to the uninsured.
Other studies have found that when drug companies are giving free handouts to physicians, the doctors are more likely to write prescription for the brand-name drug than for the generic. Drug companies should not be injecting themselves into our personal relationship wtih our physician for profit. The government should step in and impose certain restrictions on the abilities of the drug companies to give handouts to physicians and patients.
CNN ran a great article by Elizabeth Cohen that offers tips which bear repeating here.
How do you select an Emergency Room for your children? If you're lucky and live in an area that has lots of health care choices, you should carefully consider which one you want your kids going to. The fact of the matter is that not all hospitals and emergency rooms are created equal. Some are better staffed with pediatricians than others. Some have better equipment for treating children (i.e. child-sized oxygen masks). Some even have cartoons and kids magazines in the waiting room to put your child's nerves at ease.
Where do you live?
Obviously, if the closest hospital to you is a children's hospital, that should be your first choice. But what if you were going to pass a general hospital to get to a children's hospital? Is it worth the extra time?
Dr. Emory Petrack of the Rainbow Babies and Children's Hospital in Cleveland says that when you have a "truly critical emergency" on your hands, you must get to the nearest hospital - regardless of whether it's a children's hospital or a general one. Also, if it's a relatively small problem (a minor burn or a small cut), then the extra distance to the children's hospital might not be worth it. However, those middle-ground cases (not life-threatening and not minor) could be worth the extra mileage.
If you live far away from a children's hospital, you might have your work cut out for you. Dr. Petrack says you have to find out which hospitals in your area are "child-friendly." The Joint Commission has a list of ERs here. After going to the link, choose "Pediatric Facility" from the "Type of Provider" list and input your ZIP code to find out which ERs offer services for children.
If you’ve been paying attention to the news over the last few months, you’ve undoubtedly heard about the blood thinning drug heparin. Several months ago it was revealed that heparin contamination had killed over 80 patients, and in the past newborn babies have been the victims of deadly heparin overdoses.
Unfortunately there have been more victims of a heparin related medical mistake. A Texas hospital recently reported that 17 newborns received an overdose of heparin, which may have resulted in the death of two of the babies.
What makes this case especially disturbing is that this is at least the third time that newborns have been overdosed on heparin by accident. That’s right – the third time! So this is hardly a new or unique issue. In fact, it should be something that medical professionals and hospitals are on the alert for. Apparently not.
Read more about the recent heparin overdose in our law library article “Why is Heparin Killing Babies?”
Just days after our blogon choosing the best children's hospital for your child, the Joint Commission has issued new guidelines aimed at curbing pediatric medication errors in hospitals. A recent study in the medical journal Pediatrics reveals that as many as 7.3% of all children treated at hospitals experienced an "adverse drug event."
The Joint Commission's new guidelines include tips like:
Children in hospitals are often more vulnerable than adults for several reasons. They are sometimes unable to articulate what hurts, they have weaker immune systems, and their bodies are ill-equipped to fight off certain illnesses. The new guidelines by the Joint Commission should help doctors and parents work together to prevent over-medication in hospitals and should ultimately reduce the number of medical malpractice incidents that occur in our hospitals.
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