September 5, 2012

The Dangers of “Drugged” Driving in Pennsylvania

Though everyone knows about the danger and irresponsibility of getting behind the wheel after drinking, few people talk about the similar risks associated with drugged driving. It’s about time that changes given the increasing occurrence of medication-related wrecks on Pennsylvania roadways.

PennDOT, Pennsylvania State and local police have all announced that they are part of a national effort to target drivers who are operating vehicles under the influence of drugs. The campaign has been dubbed “Drive Sober or Get Pulled Over” and is intended to raise awareness of the dangers of impaired driving. PennDOT’s spokeswoman Erin Waters said that while the number of alcohol-related crashes has been down the last few years, instances of drugged driving continue to increase.

This includes not only illegal drugs, but also increasingly, prescription medications. One recent example includes Kerry Kennedy, who was charged with driving under the influence after Ambien was found in her system following a crash into a tractor-trailer.

According to the National Institutes of Health, the problem of impaired driving is not limited to alcohol. Driving under the influence of prescription drugs raises many of the same concerns given that powerful medication can act on the brain to impair a person’s motor skills, reaction time and judgment. Drugged driving is a public health concern because it puts not only the driver at risk, but also passengers and others who share the road.

According to the National Highway Traffic Safety Administration’s (NHTSA) 2007 National Roadside Survey, more than 16% of weekend, nighttime drivers tested positive for illegal, prescription, or over-the-counter medications while more than 11% tested positive for illicit drugs. Another NHTSA study found that in 2009, among fatally injured drivers, 18% tested positive for at least one, a number that marked a 13% increase from 2005. These results indicate that not enough has been done to educate the public about the true danger of driving under the influence of medication.

Despite the information available regarding the danger of drugged driving, the nation’s laws have yet to reflect the severity of the crime. Though alcohol detection is relatively easy, the presence of illicit drugs is more difficult to measure and there is no agreed upon impairment limit. Many states, including Pennsylvania, don’t list specific requirements for what measurements of substances amount to intoxicated driving the way that 0.08% blood alcohol concentration is specified for alcohol-related arrests. Instead, Pennsylvania Consolidated Statutes § 75-380275 vaguely says that a person is guilty of DUI if he or she drives under the influence of a drug or combination of drugs to a degree which impairs his or her ability to safely drive.

As Pennsylvania personal injury attorneys who routinely see the damage that can result from such irresponsible behavior, it’s tragic to see increasingly frequent instances of yet another category of impaired driving in the state. Sadly, we too often see the life changing results that occur when people make the deadly decision to drive while impaired. If you or someone you know have been injured and you would like to discuss your case with an attorney, please contact one of our experienced personal injury attorneys today for a free consultation at (267) 809-8250.

Source:Increased Effort To Nab Drivers Under Influence Of Drugs And Alcohol,” by, published at Philadelphia.CBSLocal.com.

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August 29, 2012

Medical Device Recalls Hit Two-Year High

According a recent article on Dotmed.com, this past year has seen a massive number of medical device recalls. According to ExpertRecall, a company tasked with tracking food, drug and device recalls, a whopping 123 million such devices were recalled in the most recent quarter of the year, representing a nearly two-year high.

ExpertRecall pointed out that the number of device recalls is actually down slightly from the first quarter. However, the number of individual units affected by the recalls passed the 100 million mark for the first time since the third quarter of 2010. An analysis of FDA enforcement reports found that the second quarter of 2012 saw some 242 medical device recalls, a drop of 13% from the 277 recalls seen in the first quarter of this year. Though there was a drop, the most recent numbers still represent an increase of 4% from the same time last year.

The 123 million units recalled last quarter represent an astounding 50% increase on the 82 million units recalled in the first quarter of the year. Though the gap may seem larger, stepping back in time reveals an even difference. In the second quarter of 2011, only 16 million devices were recalled, about 1/8 as many as last quarter.

Though good news was hard to find in the report, one indication showed some promise. Less than 7% of the recalls announced last quarter were Class I, meaning that the device carried a risk of serious injury or death. Moreover, these serious recalls accounted for less than 1% of the total units recalled in the quarter, thus affecting only a small number of patients.

It wasn’t just medical devices that saw millions of recalls last quarter, the group revealed that there were 69 pharmaceutical recalls in the second quarter of 2012. These 69 recalls amounted to a total of 12 million units of prescription drugs.

Companies affected by the recent recalls include Coviden PLC, which recently announced a voluntary recall of some DGPHP RFA high-power single use grounding pads. It also announced a voluntary global recall of some adult tracheostomy tubes.

CareFusion Corporation launched a recall earlier this summer of its EnVe ventilator due to potential risks that the device could compromise patient ventilation. The company also announced a voluntary recall of its AirLife Infant Breathing Circuit.

Abbott Laboratories recalled some Architect Toco IGG Reagent kits while General Electric’s medical systems unit recalled X-ray machines due to faulty wheels. Perhaps most uncomfortable of all, Johnson & Johnson announced just this week that they would be recalling certain hemorrhoidal circular staplers due to the potential risks of a misfire.

If you would like to speak with a Pennsylvania medical malpractice attorney about a potential claim, contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:Medical device recalls hit nearly two-year high,” by Brendon Nafziger, published at Dotmed.com.

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August 22, 2012

FDA Approval Process Allows Defective Devices to Get By

A recent study has found a major flaw in the Food and Drug Administration’s process that approves medical devices. At least four dangerously defective medical devices were expedited through FDA’s approval process with minimal testing. The four devices were the DePuy ASR hip implant, transvaginal mesh, heart rings, and defibrillator lead wires. Each of these devises has caused severe injuries and sometimes death. All of these devices were used in patients without any significant testing of their safety. The hip implant released metal fragments into the body and caused the surrounding tissue to decay. The transvaginal mesh broke through the vaginal wall. The heart ring was used in patients without being approved by the FDA at all, and the defibrillator wires short-circuited because they were not properly insulated.

The FDA’s approval process is known as the 510(k) clearance process. The purpose is to allow manufacturers to market medical devices to US consumers. It allows a device that is “substantially equivalent” to another device that is already being marketed to consumers. The FDA defines substantial equivalence as “the new device is at least as safe and effective as the predicate.” It also provides a list of factors that can determine whether the standard of “substantial equivalence” has been met.

“A device is substantially equivalent if, in comparison to the predicate it: has the same intended use as the predicate and has the same technological characteristics as the predicate or has the same intended use as the predicate and has different technological characteristics and the information submitted to the FDA does not raise any new questions of safety or effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed device.”

The Government Accountability Office (GAO) and the Institute of Medicine examined several of the medical devices that were marketed to consumers after being cleared through the 510(k) process. The study found that 75% of the recalled devices were approved through the 510(k) process. The Institute of Medicine has called for a complete revamping of the FDA medical device approval process. The Institute suggested that the process be "replaced with an integrated premarket and post market regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

What does this mean for legal practitioners with clients who have been injured by these dangerous medical devices? It is possible that the federal government’s lax approval process contributed to these dangerous devices being implanted in unsuspecting patients. It is however, very difficult to hold a government entity civilly liable. Only an experienced medical malpractice attorney will be able determine whether the government should be held accountable for its failure to properly test medical devices prior to being implanted into patients. If you would like to speak with a Pennsylvania medical malpractice attorney about a potential claim, contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:FDA Clearance Process Misses Defective Medical Devices Report Finds,” published at USPolitics.EINNews.com.

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August 15, 2012

FDA meets to discuss danger of metal-on-metal hip devices

The Food and Drug Administration recently announced it would be meeting with a panel of orthopedic experts to more fully explore the growing body of evidence showing that metal-on-metal hip devices have a higher failure rate than other similar devices, typically made of plastic or ceramic.

The FDA’s chief scientist for medical devices, William Maisel, has said, “The FDA has been aware of some of these problems for three years and has made recommendations in the past, but I think what you'll see coming out of these meetings are more specific recommendations for follow-up care.” Dr. Maisel was quick to say that the agency would not announcing any new recommendations right away, but would instead need time to fully investigate its options.

The problem is a significant one for Americans given that some 285,000 hip replacement surgeries are performed each year. Nearly half a million people in the United States have all metal hip implant devices. The reason the devices were used in the first place is because it was thought that metal-on-metal hip implants lasted longer than those made from other materials. The all-metal devices were given primarily to younger, more active patients. The most recent date from 2006 suggests that a whopping 32% of all hip replacement surgeries involved metal-on-metal devices.

This view of the all-metal devices has shifted in recent years as doctors have reported increasing problems with the devices. Metal debris can break off when the pieces rub against each other. The debris can then spread and cause severe pain and even tissue damage. The most extreme reactions involve pieces that get in the bloodstream and cause problems in the heart, kidneys, nerves and even thyroids. Such splintering also frequently necessitates further revision surgeries, a painful and expensive process. Though there are certainly some people that experience no problems with the devices, there is data that shows that all-metal devices require revision surgeries three to four times more often than devices made of other material.

Some say that the devices have lost their value. Initially they were used because the plastic and ceramic versions were breaking down too quickly. Scientists point out that medical plastic has improved substantially in recent years and is plenty strong enough to last without degradation.

Dr. Maisel says that there are currently no plans to stop doctors from implanting the devices in the first place. “Doctors can still use them,” but down the road there could be changes. For now, the FDA is focused on improving care for patients who have already had the devices implanted.

The FDA is considering a variety of recommendations for patients including blood tests to test for metal levels and imaging scans of the joint and surround tissues. One problem with all these recommendations is that they happen after the fact. Even excellent post-op care often does not show symptoms until after the damage has been done.

If you would like to speak with a Pennsylvania medical malpractice attorney about a potential claim, contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:FDA to study growing failure of metal hip devices,” by Janice Lloyd, published at USAToday.com.

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August 8, 2012

FDA Moves To Track Medical Devices

The FDA made a major announcement recently which will make medical devices a lot like mass-produced consumer devices such as cars and microwaves. The new proposed rule will require that each medical device manufactured be given a unique code which will help with tracking and hopefully assist the agency in catching safety problems earlier.

While similar codes are already found in almost all consumer products, the barcodes have been noticeably absent from such critical devices. The rule says that device makers will begin by placing barcodes on their riskiest devices, like implants or pacemakers. Over-the-counter or incredibly low-risk devices, think bedpans, will not be given a tracking code.

The FDA will then place all the codes in a public database which they hope will allow doctors and regulators to detect problems more quickly and notify affects patients in much less time about any dangers. Companies and hospitals will be able to access the database and quickly pull products that are affected by recalls or other problems. The codes will also benefit the device makers by helping to prevent counterfeit or stolen products from entering the supply chain.

The plan is for the code to be printed on labels for the device and also to be found in the devices themselves. The FDA is projecting the program will cost U.S. companies approximately $500 million to implement the proposal over the next ten years.

The rollout has been much slower than anticipated, with this announcement coming some five years after Congress first instructed the FDA to introduce such codes. The agency said it took its time rolling out the rules by testing a pilot program and by coming up with standard international codes that would work with regulators abroad, including those in Canada, the European Union and Japan.

Currently the public will have 120 days to comment on the proposed rule and the FDA will consider the feedback before making a final ruling which will likely happen in the next six months.

If you would like to speak with a Pennsylvania medical malpractice attorney about a potential claim, contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:FDA Plans IDs to Track Medical Device Safety,” by Anna Yukhananov, published at InsuranceJournal.com.

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August 1, 2012

Software Failures To Blame For Many Medical Device Recalls

The Food and Drug Administration just released some surprising news that it found poor software quality is to blame for many of the recalls that have been seen in the medical device industry. The FDA’s research revealed that such glitches were responsible for 24% of all such recalls.

Given this revelation, the FDA’s Office of Science and Engineering Laboratories will now begin dedicating significantly more time testing software quality and security. The goal will be to help reduce the failure rate cited in the most recent annual report released just this week. The agency will increase its efforts to avoid injury or death thanks to poorly designed or written software.

In a statement, the FDA said that it is developing “techniques and laboratory expertise to assist our review staff in identifying potential vulnerabilities and evaluating risk mitigation measures.” The procedures the agency will put into place are in line with those in other regulated industries and are intended to be rigorous. The statement continued saying, “Manufacturers are responsible for identifying risks and hazards associated with medical device software/firmware, including risks related to security, and are responsible for putting appropriate mitigations in place to address patient safety.”

There are multiple potential problems associated with software issues in medical devices. The first is obviously the risk such a failure can pose to a patient’s health and safety. The less obvious, but nonetheless important risk is to a patient’s privacy. Such devices can store vast troves of sensitive personal medical data that if compromised could reveal far more than a patient would feel comfortable with. There are even some devices that are connected to networks and which could conceivably be vulnerable to hacking attacks.

It was just this past month that Google reported disabling a hacked website that existed to distribute software updates for an array of medical devices. Among the devices receiving updates from the website include AVEA ventilators.

In 2011 researches with UC Berkeley and Carnegie Mellon, among others, found vulnerabilities in the software used to regular patient’s heartbeats in external defibrillators. The group said that, “Our assessment demonstrates real vulnerabilities in medical devices and their software and gives a first glimpse into the viability of malware that can be expected in software-based medical devices.”

In 2008, the FDA started building a national electronic safety system designed to monitor the performance of medical devices. The system is called the Sentinel Initiative and a pilot version of it is currently in use. Hopefully the agency gets its system up and running as the dangers of bad software in medical devices appears to be on the rise.

If you would like to speak with a Pennsylvania medical malpractice attorney about a potential claim, contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:FDA: Software Failures Responsible for 24% Of All Medical Device Recalls,” by Paul Roberts, published at ThreatPost.com.

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July 25, 2012

Lawsuit filed against the maker of Pradaxa due to deadly internal bleeding

A man from Tennessee has filed a lawsuit against Boehringer Ingelheim Pharmaceuticals, Inc., the maker of Pradaxa. The drug company is being sued by the man who claims his father died as a result of side effects he experienced while taking the blood-thinning drug. Melvin Giles, Jr. sued Boehringer Ingelheim in the U.S. District Court for the Middle District of Tennessee.

According to the suit, Giles’ father was prescribed the drug as a blood thinner. The medication is usually used to reduce the chance of blood clots developing and leading to a stroke in patients who present special risks for such problems. Giles’ father was given the medication in February of 2011 and in June of that same year suffered severe internal bleeding and died as a result. His son claims that the bleeding he suffered was the result of Pradaxa.

Giles claims that the drug maker either knew or should have known about the potential for the dug to cause such serious complications. The suit cites as proof the 932 incidents reported to the FDA between October 2010 and March 2011 related to side effects of the medication. Some 120 of these reports involved death from Pradaxa bleeding, and 500 were severe and life-threatening bleeding events related to the medication. These numbers have gone on to spike and according to a new report from the Institute for Safe Medicine Practices (ISMP), the U.S. Food & Drug Administration received 3,781 adverse event reports associated with Pradaxa in 2011, more than were associated with any other drug the agency monitors.

Pradaxa also led in reports of deaths (541), hemorrhage (2,367), kidney failure (291) and stroke (644), according to ISMP’s most recent report. Pradaxa was also a suspected cause of 15 reports of liver injury made to the FDA.

The problems with Pradaxa began in 2011 when the drug became the subject of an investigation in New Zealand after as many as five elderly patients died as a result of internal bleeding. Another 36 patients reportedly suffered similar bouts of serious internal bleeding but managed to survive. These reports came on the heels of similar news in Japan that regulators asked Boehringer Ingelheim to notify doctors about potentially deadly bleeding associated with the drug.

Pradaxa was heavily marketed when it was first introduced as a safer alternative to traditional blood thinners such as warfarin. The benefit was that Pradaxa does not react with certain foods in the same way that warfarin does which can increase the likelihood of bleeding. The problem is that warfarin bleeding can be controlled and even stopped by administering vitamin K. The danger of Pradaxa is that there is currently no known antidote for Pradaxa-caused bleeding, making injuries associated with the product far more deadly.

If you or someone you know have been injured and you would like to discuss your case with an attorney, please contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:Wrongful Death Suit Filed After Pradaxa Bleeding Death,” by Elise Kramer, published at InjuryLawyer-News.com.

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July 18, 2012

Magnets present terrible danger to unsuspecting children

A few months ago one unfortunate couple made a purchase they’ll likely regret for the rest of their lives: a bag of magnets. They were shopping near their hometown and came across some high-powered magnets that could be used to form various shapes. The couple bought them for a little amusement. When they got home they made sure to put the toys away on an upper shelf. Apparently the shelf was not high enough to keep their young son, 2-year-old Braylon, away. He found the bag of magnets and ended up swallowing eight of them.

Rather than just simply passing the round balls, they magnets fused together and, in the process, wreaked havoc on the digestive tract of the little boy. The high-powered magnets attached to each other and, in doing so, twisted and ultimately perforated the boy’s intestines.

Since the terrible accident the child has been in the hospital. Most of the time was spent in the ICU given the severity of his injuries. Braylon has had six surgeries, developed a blood infection and had to be fully sedated for three weeks. Though he’s scheduled to leave the hospital soon, he’ll have to return for additional surgeries. He’s currently scheduled to get an intestinal transplant due to the amount of tissue that had to be removed in his previous surgeries.

Shockingly, given the horrible damage inflicted on Braylon and others just like him, there has not yet been a thorough study of the impact of magnets ingested by children. The Consumer Products Safety Commission (CPSC) has said that since 2008 it has received some 200 reports of similar incidents involving children and high-powered magnets.

As a result, one of the doctors that worked with Braylon, Dr. Adam Noel, decided to conduct a survey of his own. Dr. Noel polled a group of pediatric gastroenterologists for their thoughts on the issue. The 33 physicians who responded to his survey said that they have seen a total of 82 young patients who have swallowed magnets. Sadly, the vast majority of these children suffered life-threatening bowel perforations.

Dr. Noel and a group of other concerned doctors will be meeting with officials from the CPSC to discuss ways to ensure that additional children don’t suffer from similar accidents. The companies that make the toys insist that their products are perfectly safe if used per the instructions. Doctors disagree, pointing out that children can then easily get ahold of the magnets and, possibly mistaking them for candy, swallow them; unaware of the danger they are placing themselves in.

For information on how to protect your legal rights if you or a loved one has been seriously injured in an accident, contact one of our experienced Pennsylvania injury attorneys today for a free consultation at (267) 809-8250.

Source:Powerful magnets in toys raise risks from swallowing,” by Elizabeth Cohen, published at CNN.com.

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July 11, 2012

Important Warning Signs of Bad Doctors

It’s not at all unusual for patients to put tremendous faith in the hands of their doctors. They often assume given their education and level of training that they are in safe hands. One study found that 70% of people totally trust what their doctor says and never even bother asking for a second opinion. Trust is a good thing, blind trust, however, can be dangerous. There are certain warning signs that all patients should be on the watch for to avoid having preventable mistakes happen to them.

The first sign is a sleepy doctor. According to the Journal of the American Medical Association, surgeons who slept for less than six hours the night prior to performing a surgery had twice as many surgical complications as those surgeons who got enough sleep. Many doctors understand the benefits of sleep but often cannot help being stuck at the hospital for terribly long shifts, sometimes even 24 hours. This lack of sleep combined with the stress of the job can result in poor decisions from the overworked docs. These wrong decisions lead to medication errors or misdiagnoses.

Another sign for worry is a doctor’s personal bias. According to a study conducted by The Journal of Law, Medicine & Ethics, some physicians admit to assuming that women exaggerate their symptoms. Due to this unfortunate and unfounded bias, women may not be given the treatment they deserve. Patients should be on the lookout for doctors who seem eager to impose their own views on a patient’s care.

A third sign of trouble is when a doctor is prescription happy. Going for the prescription pad is the fast fix to problems and lets doctors avoid the time of actually listening to patients describe their illness and formulate non-prescription alternatives. Rather than simply accepting the prescription and hurrying out the door, stop your doctor and ask if there are any non-drug alternatives. Ask why the doctor selected that specific medicine over others and make sure to get a list of pros and cons for taking the drug. If the doctor acts like you’re a bother, it may be time to get a second opinion.

Finally, patients should make sure the doctor is up-to-date, both with his equipment and his information. While age isn’t a determining factor, a doctor needs to be on the cutting edge and should not be using old or outdate diagnostic or screening methods. Given the increase in modern medical technologies, it is important doctors keep up to ensure patients receive the best possible care.

Patients need to remember to ask questions and ask them often. Always ask why you’re being given a medication and for how long. Keep track of your symptoms and any feedback you receive from your doctor. If your condition is not improving or you are receiving conflicting messages from the medical team that might be a sign that it’s time to look for a new doc.

If you would like to speak with a Pennsylvania medical malpractice attorney about a potential claim, contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:Doctors behaving badly: 7 types to watch out for,” by Kristen Dold, published at MSNBC.com.

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July 4, 2012

The danger of being on the cutting edge

Who doesn’t love a new gadget? Whether it’s the latest iPhone or a new videogame console, we all love our technology. Sometimes, though, this rush can be to our determent. A good example of the danger of rushing involves the da Vinci Surgical Robot.

According to the manufacturer, Intuitive Surgical, the device makes a surgeon’s job much easier, allowing smaller incisions and increased recovery time. The manufacturer says the da Vinci Robot can be used to treat obesity, endometriosis, throat cancer, prostate removal, kidney cancer, coronary artery disease, and gallbladder removal. The robot has four arms: three for surgical instruments and a fourth with an attached camera. It claims to give doctors an increased range of motion and to provide a less invasive way of achieving many traditional surgeries. Sounds great, right? Unfortunately there’s more to the story.

While the benefits touted by the manufacture may be true to an extent, there have also been reports of serious injuries related to the use of the robot. Part of the problem appears to be a rush to train surgeons who are being put in control of the powerful machines before they are ready. Patients who have been injured by the robots have begun filing lawsuits and recently requested that a panel of federal district court judges consolidate the litigation before a single federal court.

A few years ago the Wall Street Journal ran a big article on the Robot which mentioned the previously little known problems associated with the device. The article recounted how one patient was so badly injured by the da Vinci that she required four additional surgeries to repair the damage caused from the machine. In other cases, two patients suffered severely lacerated bladders.

Plaintiffs who have filed lawsuits against the manufacturer claim that complications from the procedures include tears and burns to the uterus, intestines, and blood vessels, as well as vaginal cuff dehiscence - a separation of the vaginal incision, after which abdominal or pelvic contents leak out through the opening. A 2009 study noted that vaginal cuff dehiscence with small bowel evisceration after hysterectomy may be occurring more frequently with the advent of similar robotic laparoscopic hysterectomies.

The Robot itself does not appear to be to blame; it’s actually the doctors and their lack of training that’s the problem. Intuitive Surgical only offers two days of free training for two surgeons at each purchasing hospital. Any more training and the hospitals have to go out of pocket to pay. Such a short time does not come close to meeting the training needed to properly operate such a complicated device. The Reviews in Urology journal said that a surgeon should perform up to 200 cases to be proficient with robotic surgery, far more than can be done in a only two days of training.

Intuitive Surgical says that it is up to the hospitals to create guidelines for training their doctors. Given the increasing number of lawsuits associated with the product, patients can only hope the doctors and the maker of the robot work out a solution that ensures the safety of those preparing to go under the knife.

If you would like to speak with a Pennsylvania medical malpractice attorney about a potential claim, contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:Use of surgical robots booming despite hefty cost,” by Carol Ostrom, published at SeattleTimes.com.

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January 23, 2011

Philadelphia Abortion Clinic Shut Down Likely to Lead to Lawsuits

A West Philadelphia abortion clinic was closed after investigators accused Dr. Kermit B. Gosnell of killing babies born alive during late-term abortions and allowing untrained non-medical staff to medicate a patient who died after the procedure. The 69 year old doctor also worked for some years at a Delaware clinic and is alleged to have told women at that clinic who were too far along in their pregnancies to obtain an abortion under Delaware law (which has a 20 week or 5 month cut-off) to come to his Philadelphia office where he would charge them more money, but where abortions are legal up to 24 weeks (6 months) of pregnancy. Gosnell has been charged along with with 2 staff people of the Philadelphia clinic and all are currently incarcerated pending further criminal proceedings, which could include the risk of death penalty for Gosnell.

The charges include allegations that babies who Gosnell aborted lived for up to 20 minutes after the procedure, at which time Gosnell or a staff member would murder the babies. Further, it is alleged that Gosnell allowed the two charged staff members, who were not medically trained, to adminster anesthesthia and perform ultrasoundes. One staff person is reported to have created her own drug "cocktails" for patients and, in the case of the patient who died, altered medical records so that later treating physicians would not know how much of what drug she had been given. Finally, it is alled that one staff member who routinely treated patients had hepatitis, but did not take precautions, including wearing gloves, to protect patients from contracting the disease.

While Dr. Gosnell's criminal charges are certainly a huge problem for him, it is likely that civil medical malpractice lawsuits will soon be filed by patients who treated at Gosnell's Women's Medical Society clinic in West Philadelpia. As a licensed pediatrician who spent years practicing in a neonatal intensive care unit for infants and attending hundreds of deliveries, Dr. Aussprung is in a particularly unique position to evaluate the claims of women who received treatment at the hands of Dr. Gosnell or his employees. Dr. Aussprung has been trained to deal with newborn complications, premature birth and fetal demise, which are all issues that will likely arise in any cases filed against Dr. Gosnell.

October 21, 2010

Bridgewater, PA Physician Settles Breast Implant Case

Dr. Beverly Carl was sued by a patient after utilizing saline breast implants rather than silicone implants during the patient's breast enlargement surgery. Dr. Carl knew that Ms. Daly had signed a medical consent form for surgery that specifically required the sue of silicone implants. After Ms. Daly had been placed under anesthesia for the surgery, Dr. Carl realized that her office had provided her the wrong type of implants, but Dr. Carl went forward with the surgery after asking Ms. Daly's fiance for authority to use saline implants in lieu of silicone ones. The patient, Brittany Daly, found out that the wrong type of implants were used after she awoke from surgery and was told by her fiance that Dr. Carl had asked him to agree to saline implants. Ms. Daly sued Dr. Carl, alleging that Dr. Carl should have awoken her from anesthesia to tell her about the error. The complaint also alleged that Dr. Carl continued Ms. Daly under anesthesia two hours longer than necessary in an attempt to fix the problem. Finally, the complaint alleged that Dr. Carl violated Ms. Daly's rights by asking Ms. Daly's fiance for authorization to change the type of implant used in the surgery.

Although the complaint against Dr. Carl did not explain why Ms. Daly wanted silicone implants, it is the case that silicone implants are generally considered to have a more "natural" look and feel than saline implants because the gel in silicone implants is similar in texture to breast tissue. In addition, it is more difficult to rupture a silicone implant than a saline one and when a saline implant does rupture, it deflates such that the problem is immediately visible whereas a silicone implant appears the same for some period of time even after rupture.

Dr. Carl agreed to a confidential settlement this summer.