Another Possible Down Side to Your Medical Device: Hackers

The Houston medical implant injury lawyers at Denena Points, PC have been discussing some of the dangerous down sides to medical devices. Sometimes they are poorly tested or not tested at all before being used as implants and surgical tools. Sometimes they have hidden defects or design flaws. And sometimes they’re used for unapproved purposes for which they’re not really suited.

But there’s another potential threat to your health from your medical device: hackers, malware, and the other dangers that routinely corrupt the other technological devices you might use. Just as your computer might crash from a stealthy piece of malware, so might your pacemaker. Or, imagine that the computer controlling a da Vinci robot was hacked just as a surgeon was using it to perform a heart valve replacement operation.

Our Houston medical implant injury lawyers have recently written about the large number of injuries and some deaths attributed to the robot and how those “adverse events,” as the FDA calls them, have been underreported. None of them that we know of have been linked to hackers or malware, but with the upsurge in cybercrime worldwide, it’s an increasingly likely scenario.

The growing reliance of the healthcare industry on technology coupled with the vulnerabilities of that technology, prompted the U.S. GAO in October 2012 to order the FDA to do something about strengthening security on medical devices. So the FDA has issued guidelines regarding stepped up security needs (which our Houston medical implant injury lawyers emphasize are not enforceable and have no teeth) to medical device manufacturers and the medical facilities that use the technologies.

And it’s not just medical devices, but other medical technologies that could be vulnerable. The dispensaries that prepare your medications and the software that contains your medical records (including allergy information and prescriptions you use) could also be corrupted. (Source: Willie Jones, IEEE Spectrum, 6/16/13) For instance, not too long ago, United Health group recalled its medical record software because it didn’t display crucial prescription data that doctors and hospitals need before they treat their patients. That particular problem appears to have been due to a flaw in the software itself, rather than a security breach. (Source: Wall Street Journal, Clint Boulton , 9/13) But as long as healthcare relies so strongly on technology, either is a possibility.

Click the link to learn about the FDA’s proposed security fixes to the problem of vulnerable medical devices.

U.S. Fatal and Serious Injuries from the da Vinci Robot Grew 34% Last Year

Continued from Part 1. The da Vinci robot is touted as the only multi-purpose robot of its type. The Houston surgical injury attorneys at Denena Points, PC understand that it has been used for prostate removal, heart bypass, heart valve repair, and hysterectomy surgeries. The robot’s computerized technology allows a surgeon to manipulate the laparoscopic surgical instruments attached to the robot’s arms while viewing the procedure in 3 dimensions.

The FDA noticed a 34% rise in the number of adverse event reports in its MAUDE (Manufacturer And User facility Device Experience) database related to use of the robot from 2011 to 2012. During the same time period, the actual number of procedures using the robot grew by only 26%.

A study by researchers from Johns Hopkins University examining the problem of the underreporting of injuries caused by the da Vinci robot was published on August 27, 2012 by the Journal for Healthcare Equality. The study covered 12 years of complications related to use of the robot. Researchers cross-referenced the reports in the FDA’s MAUDE database with reports they found in LexisNexus and public court records. Our Houston surgical injury attorneys point out that the researchers found that 245 incidents were reported that included 71 deaths and 174 nonfatal injuries. They found an additional five cases that had never been reported at all and three that were only reported months after the adverse event occurred.

The Houston surgical injury attorneys at Denena Points, PC note that the technique of cross-referencing reports in government databases with reports found in court records, news media stories, and LexisNexis is also used by those who want to study the incidence of amusement ride injuries and fatalities, another area where reporting is largely voluntary and haphazard at best.

Technically, medical device manufacturers are required to report serious injuries and deaths from their products to the FDA within 30 days. But where the manufacturer does not receive any report from a hospital or medical facility, which might want to minimize adverse events and sweep them under the rug if they can, the medical device maker has nothing to report. Hospitals are required to report medical device malfunctions to the manufacturers, but this doesn’t always happen.

When the FDA does receive an adverse event report, it puts the data in the MAUDE database. The FDA can issue warning letters to manufacturers who fail to report adverse events as required. And the agency can also exercise enforcement and compliance options, including issuing injunctions and seizing products. (But our Houston surgical injury attorneys remark that it’s rather difficult to know that the device maker failed in its obligations if the FDA never hears about adverse events.)

Dr. Martin A. Makary, an associate professor of surgery at Johns Hopkins and lead author of the report in the Journal for Healthcare Equality about deficiencies in da Vinci robot adverse event reporting, noted that the FDA’s reporting mandate lacks teeth. “In health care, one fifth of the economy,” there’s a “haphazard smattering” of reports that rely on “voluntary self-reporting with no oversight, no enforcement, and no consequences.” Dr. Makary also mentioned that a 2010 study had found that 56.8% (well over half) of surgeons surveyed anonymously admitted experiencing irrecoverable operative malfunctions while using the robot. (Source: New York Times Blogs, 9/9/13)

The Houston surgical injury attorneys at Denena Points, PC caution that complete and accurate adverse event reporting is necessary if patients and surgeons are to make informed choices about appropriate healthcare options in individual cases. Timely and accurate reports are also necessary to ensure that the FDA is alerted to defective medical devices and pulls them from the market as soon as possible, before they cause further injuries or deaths. Click the link to learn more about the widespread problem of medical device injury and fatality underreporting in the U.S. healthcare industry.

Underreported Injuries and Fatalities from the da Vinci Surgical Robot

Laparoscopic surgery has been a popular choice by many patients and surgeons when it’s possible. Laparoscopic surgeries tout smaller incisions and shorter recovery times. But it’s not always clear whether those claims represent the truth or aggressive marketing. (We suspect the latter.)

The da Vinci robot has been widely and aggressively marketed as a laparoscopic wonder-toy primarily for gynecological and urologic surgeries which make up about 80% of the robot’s workload. Claims about the advantages of the robot would have you believe that the robot is able to perform an operation with greater accuracy than a skilled surgeon’s human hand. (Ultimately, our Houston surgical injury lawyers note that it is still the surgeon who manipulates the robot through a computer.) But the welling number of reported injuries and deaths, even as researchers point out that these da Vinci robot injuries and deaths are vastly UNDERreported, indicates that the robot’s accuracy and advantages might be greatly overstated.

Intuitive Surgical Inc. of Sunnyvale, California makes the Da Vinci surgical robot. The FDA first approved the robot for surgical use in 2000. Since then, more than 1 million procedures have been performed using the robot. The robot was used for more than 360,000 surgeries in the United States just last year, up from slightly more than 290,000 in 2011.

Between the years 2007 and 2011, use of robotic devices for surgery grew by more than 400% in the United States. Around 1,400 of the robots, which cost between $1.5 and $2.5 million, have been purchased by U.S. hospitals. And since January 2000, our Houston surgical injury lawyers warn that literally thousands of mishaps involving the robot have been reported to the FDA.

The types of injuries reported from use of the da Vinci robot include:

• Punctured blood vessels and urinary tracts,
• Burns and tears to intestines, organs, or blood vessels,
• Severe injuries to the bowels,
• Excessive bleeding, and
• Fatal injury.

33% of deaths attributed to the da Vinci robot involved gynecological procedures, and 43% of all injuries related to hysterectomies. Not a good track record, in the opinion of our Houston surgical injury lawyers at Denena Points, PC. Continue to Part 2 to learn more about flawed medical device reporting requirements and lack of oversight and enforcement in the reporting system.

Lack of Safety Planning Blamed by NTSB in Deadly Midland Parade Wreck

Our Houston accident injury lawyers at Denena Points, PC are always writing about how almost all accidents are preventable with the proper safety precautions. But between equipment defects, complacency, distractions, lack of safety planning, the natural human tendency to rush things, and just plain human error, serious injury accidents continue to happen all the time. You might remember the tragic accident that happened last November in Midland when a freight train slammed into a parade float full of veterans at 62 mph. 4 vets died in the horrific crash and 11 more veterans and their spouses were injured.

The NTSB has just released the results of its yearlong investigation of that tragic accident. The safety agency says that a lack of safety planning by the City and by parade organizers led to the deadly crash. Details seem to indicate an almost complete disregard for safety planning. The parade had been a tradition for 9 years when safety planning went off the rails.

In its early years, our Houston accident injury lawyers notice that the parade organizers had routed the parade in a way that it did not cross the train tracks. Then in later years, they began to route the parade to cross the tracks, but alerted the railroad to their parade plans and posted police officers at the crossing to assure safety.

But last year, when the accident occurred, parade organizers didn’t even bother to obtain the required parade permit. And even if they had, the City of Midland did not require them to submit a safety plan in order to obtain the permit. The NTSB, concerned over this deadly Midland parade wreck and other fatal parade/event accidents in Edmond, Oklahoma, Bangor, Maine, and Damascus, Virginia, has made a series of safety recommendations for cities and counties on the need for parade and special events permits and safety plans. (Joan Lowy, Associated Press, by way of CBS local, 11/5/13)

I happened to look up parade safety regulations for another Texas city (Dallas) in order to get an example of what some cities in our state might require of parade organizers. Our Houston accident injury lawyers emphasize that the Dallas safety requirements are lengthy and specific. Like many major cities, Dallas prohibits candy or other items from being thrown from floats, and it requires a parade command center and plenty of easily identified volunteers all along the parade route for safety. Click the link to learn about Dallas’ parade safety requirements, which seem to closely mirror the requirements of most other large U.S. cities.

8 Halloween Safety Tips to Help Houston Kids Avoid Being Hit by Cars

You might be more concerned about poisoned candy and hidden razor blazes on Halloween than by car wrecks. But statistics show that October 31st is actually the most deadly day of the year for pedestrians. The Pearland pedestrian accident lawyers at Denena Points, PC note that the largest numbers of accidents occur between 6 and 7 p.m. and affect children aged 10 to 4 years.

The dark and scary costumes favored for Halloween, as well as children’s exuberance that might lead them to dash suddenly across the street from between parked cars, and drivers’ natural tendency to not perceive pedestrians especially at night makes for a potentially deadly mix on Halloween night. Therefore, our Pearland pedestrian accident lawyers offer these Halloween safety tips to help Houston kids avoid being hit by cars while out trick-or-treating.

1. Stay in well-lit areas. Children should carry flashlights to be able to see and be seen. Modern LED flashlights are generally efficient and bright.

2. Children should stay in groups for safety. Groups crossing streets are easier for drivers to spot. Halloween is one of the top three drinking nights for adults, so it’s essential for children to be safe, conspicuous, and not take chances against possibly drunk drivers.

Parents should accompany and supervise trick-or-treating children.

Remind children not to cross the street in unlit areas, from between parked cars or other visual obstructions, or mid-block.

Mark costumes and trick-or-treat bags with reflective tape or fluorescent markers to improve visibility.

Avoid masks that obstruct a child’s vision. The Pearland pedestrian accident lawyers at Denena Points, PC mention that you could choose face paints, hats, or well-fitting masks that don’t block vision instead.

Make sure costumes aren’t so long that children will trip over them.

If you’re driving your children to trick-or-treat, make sure that younger children have properly fitting car seats and that older children use seatbelts. And make sure that all children exit and re-enter the car on the passenger side away from oncoming traffic.

Drivers on Halloween should try to avoid residential neighborhoods that could be filled with trick-or-treating children; avoid distractions; avoid alcohol or find a designated driver or alterative transportation; make an extra effort to watch for small pedestrians in dark clothing; and drive more slowly for safety. The Pearland pedestrian accident lawyers at Denena Points, PC emphasize that pedestrians are more than twice as likely to be killed when hit by a car traveling 35 mph than they are when hit by a car traveling 25 mph. 10 mph in your speed could mean the difference between life and death for a child. Click the link to read about some of the primary injury risks for children and adults on Halloween night.

Lufkin Accident Traps and Kills Hudson Man Between Forklift and Sheetrock

Drake Thomas Floyd, 19, was in the process of unloading some sheetrock at McCoy’s Building Supply store in Lufkin, Texas when he became trapped between a truck and the sheetrock on a forklift. Our Houston forklift accident attorneys note that significantly, the emergency brake on the forklift had reportedly been set, but the vehicle rolled forward anyway and trapped and crushed Drake Floyd against the truck.

Authorities did not know how long Mr. Floyd had been trapped against the truck. Customers on the loading dock found him in that state. Mr. Floyd reportedly was in a state of cardiac arrest, and had likely been deprived of oxygen for some time before rescuers revived him with a defibrillator. Drake Floyd suffered serious internal crush injuries from the Lufkin forklift accident and was airlifted from Lufkin to a Houston hospital for his critical injuries, where he died peacefully.

Drake Floyd was the son of the public works director for the City of Lufkin, and a well-respected employee of McCoy’s and alumnus of his Lufkin high school. (Sources: Francesca Washington, ktre.com; and Rhonda Oaks, The Lufkin News, 8/29/13)

The Houston forklift accident attorneys at Denena Points, PC express their deepest sympathies to Mr. And Mrs. Steve Floyd, and to other family, friends, and colleagues of Mr. Drake Floyd.

The Serious Hazard Posed by Forklifts in the Workplace

Our Houston forklift accident attorneys report the following key numbers about forklift injuries in the American workplace:

• According to U.S. Bureau of Labor Statistics data, around 100 U.S. workers die each year in fatal forklift accidents.
• Almost 35,000 U.S. workers each year receive serious forklift accident injuries on the job.
• Over 61,000 U.S. workers receive non-serious injuries each year in forklift accidents.
• Deaths and serious injuries from crushing are the most common type of forklift accident.
• In 29% of all forklift injury cases, it’s the forklift driver who is injured.
• 11% of forklift fatalities occur when the victim gets crushed between two vehicles, as happened in the tragic Lufkin accident at McCoy’s Building Supply.
• 25% of victims are crushed between a forklift and another surface such as a loading dock.
• Some of the forklift accidents are linked to equipment defects or to negligent maintenance of the forklift’s brakes, steering, or hydraulic systems. The Houston forklift accident attorneys at Denena Points, PC mention that an equipment defect or maintenance issue might be at fault in the tragic Lufkin accident, since reports indicated that the machine’s emergency brake had been set prior to the vehicle rolling forward to crush the young employee of McCoy’s Building Supply.

Click the link to read some important tips regarding forklift safety.

Sebastian Sanchez Killed on TCU Job as Texas Work Fatalities up 20%

Construction worker Sebastian Sanchez, 30, of Fort Worth was working on a demolition job on the TCU (Texas Christian University) campus on Monday when a chimney fell on him, causing him fatal injuries. Mr. Sanchez was engaged in demolition of a property on the TCU campus for Zamora Construction when the chimney collapse occurred.

The hearts and prayers of our Texas construction accident attorneys at Denena Points, PC are with the family, friends, and colleagues of Mr. Sanchez on this tragic occasion.

Mr. Sanchez’s death adds to the alarming number of fatal on-the-job injuries that have plagued Texas over the past years. Our Texas construction accident attorneys have recently written about the new data from the Texas Department of Insurance and the U.S. Bureau of Labor Statistics showing that fatal on-the-job injuries went up 20% in Texas in 2012 from 2011.

The agencies’ data points out that the most dangerous occupation in Texas is driving an 18-wheeler. The second most dangerous occupation is being a construction worker. The construction industry suffers from a Fatal Four: the four causes of construction worker death that most frequently bring tragedy to these workers and their families.

One of these primary causes of fatal on-the-job injuries in the construction and demolition industry is being struck by an object. Sometimes the object is one that has been hoisted aloft by a crane. In other instances, like the tragic chimney collapse at TCU, it’s rubble from a structural collapse.

Most construction accidents are preventable with proper care. Click the link to learn more about the Fatal Four causes of most construction worker deaths as identified by U.S. OSHA.

Contact the Texas Construction Accident Attorneys at Denena Points, PC if You Need Help after a Fatal On-the-Job Injury has Changed Your Family’s Life

Tony Denena and Chad Points have spent the last 14 years helping victims and their families make successful financial recoveries after suffering needless harm in serious accidents. Our Texas Board Certified attorneys provide a FREE initial legal consultation, without obligation, to discuss the specifics of your personal injury or wrongful death case and to evaluate your legal options and eligibility for just financial recovery. Reach us anytime through our online contact form or call us direct at 713-807-9500. Let our Texas construction accident attorneys help you hold those responsible for your tragic accident accountable for their negligence.

Compounding Pharmacy Recall Refusal Reveals Weakness of FDA Authority

The Texas drug recall lawyers at Denena Points, PC note that a Dallas-based compounding pharmacy, NuVision Pharmacy, has refused to conduct a recall of its sterile products that was requested by the U.S. FDA in mid-May. So the FDA re-issued its warning regarding the company’s products just a couple of days ago. The FDA letter requesting recall of the NuVision products cited FDA observations of poor sterile production practices discovered by their investigators in an April inspection of the Dallas compounding pharmacy.

Contaminated Sterile Drugs Could be Extremely Dangerous to Your Health

The FDA emphasizes that if a “sterile” medicine becomes contaminated with microbes, patients might be at risk for “serious, potentially life-threatening infections.” That is in fact what occurred last September when “sterile” injectable drugs from NECC compounding pharmacy in Massachusetts became contaminated. Nearly 70 people died and more than 700 became seriously ill with fungal meningitis and related infections.

NuVision Continues to Defy the FDA Based on its Status as a “Compounding Pharmacy” rather than a Drug “Manufacturer”

But NuVision continues to refuse to conduct a recall of its sterile products. The company maintains that it is in compliance with applicable laws. NuVision says that the new FDA inspections of compounding pharmacies since the fungal meningitis outbreak are being conducted under FDA standards 210 and 211, which are only applicable to manufacturers. And that compounding pharmacies are not “manufacturers” under the law. As such, NuVision claims that only the U.S. Pharmacopoeia rules 795 and 797 and state laws governing compounding pharmacies apply to its activities. (Source: Tom Wilemon, The Tennessean, 8/16/13)

Our Texas drug recall lawyers point out that Texas state laws do not require compounding pharmacies to follow manufacturing standards. Technically, NuVision’s claims are all pretty much correct. But the gaping hole in FDA regulatory authority that NuVision’s claims reveal is also the very reason why some lawmakers are pushing for new rules giving the FDA stronger authority over compounding pharmacies.

Many Compounding Pharmacies have in Fact Morphed into Drug Manufacturers and Should be Governed Accordingly

The Texas drug recall lawyers at Denena Points, PC mention that, technicalities of the law aside, many compounding pharmacies have broken away from their former role of mixing individual prescriptions for individual patients with special needs into a new role involving mass production and distribution of drugs much like any other drug manufacturer. And if a compounding pharmacy’s activities have passed into the realm of mass production manufacturing, the company should no longer enjoy the protection of laws designed for a far different and more limited type of activity.

Our Texas drug recall lawyers strongly believe that ALL drug manufacturers should be properly and closely regulated for the sake of everyone’s safety, no matter what functional title they use to describe their business. Click the link to read more about some of the limits on FDA regulatory authority and its implications for your health.

US Gets New Rail Safety Rules After Canadian Derailment that Killed 47

You might recall the deadly derailment in Québec, Canada that occurred on July 6. A train nearly a mile long had been parked overnight with just one person assigned to it. Our Bay City train accident injury attorneys point out that this train contained 72 tankers filled with crude oil when it rolled out of park, down an incline, and derailed and exploded in downtown Lac-Megantic.

The explosion of several tankers destroyed 40 buildings and 47 lives, injuring others and leaving many of the town’s 6,000 residents grief-stricken. Canada has since banned one-man crews for trains bearing dangerous or explosive cargos, and will no longer permit these trains to be left unattended on a main track.

The U.S. FRA (Federal Railroad Administration), recognizing that the same type of accident could happen here, has issued its own set of 6 orders intended to keep trains operating on main track lines or sidings from moving unintentionally. The Bay City train accident injury attorneys at Denena Points, PC clarify that the 6 new rail safety measures focus on trains that carry hazardous, potentially explosive, materials like ethanol and crude oil. The FRA said on August 2 that all railroads must comply with the new rail safety measures within 30 days.

The FRA orders include provisions that:

No train or vehicles carrying the specified hazardous materials can be left unattended on a main track or side track outside a train yard or terminal (unless specifically authorized); and that
To receive authorization to leave a train unattended, railroads must develop and submit to the agency a process for securing unattended trains hauling hazmat such as locking or disabling the locomotive and employee reporting measures to ensure that they apply the correct number of hand brakes.

What the U.S. FRA Orders Do NOT Do for Safety

The U.S. FRA, unlike Canada, does not ban one-man crews, but recommends that railroads take a good look at their staffing needs, especially regarding trains that transport HAZMAT. (Source: Associated Press by way of the Houston Chronicle, 8/2/13) The 6 new rail safety measures ordered by the FRA only address unintended movement of the train, and do not seem to provide anything like a comprehensive framework for ensuring the safety of these trains and the materials they carry. The FRA says that it is conducting additional meetings and waiting for the results of the Canadian derailment investigation to decide what further measures might be appropriate.

Our Bay City train accident injury attorneys don’t want to call the FRA’s new rail safety measures merely cosmetic. They’re a good first step towards ensuring additional safety in a nation filled with trains carrying crude oil, natural gas, propane, and toxic chemicals, among other hazardous and potentially explosive substances. Particularly as the Bay City train accident injury attorneys at Denena Points, PC reside along the Texas Gulf Coast, a national hub for the transport of all kinds of combustible materials, we would like to see a truly thorough and comprehensive series of rail safety measures, including an end to authorizations for leaving trains transporting dangerous substances to be left unattended. Ever. Click the link to read about a U.S. train derailment disaster.

FDA Recall Request Refused by Company after B-50 Supplements Sicken 30

Mira Health Products Ltd. of Long Island, NY manufactures the B-50 supplement tablets, marketed as Healthy Life Chemistry by Purity First B-50 and sold online and in retail stores. Our Lake Jackson vitamin supplement recall attorneys note that the B-50 tablets that are in dispute under the requested recall are laced with potentially dangerous anabolic steroids dimethazine and methasterone, a controlled substance.

At least 29 people from across the nation have been sickened by the B-50 supplements and at least one has been hospitalized. More illnesses and hospitalizations might be attributable to the product, but have not yet been linked to the B-50 vitamins as the source of the illness, which could appear to be the result of environmental contamination. The B-50 tablets have generated a nationwide health alert.

The FDA has asked Mira Health Products to voluntarily recall the B-50 vitamins, but the company has refused. The company’s refusal could result in seizures and sanctions against Mira Health Products.

As demonstrated by the many illnesses and hospitalization reported from using the B-50, our Lake Jackson vitamin supplement recall attorneys emphasize that vitamins laced with anabolic steroid ingredients not disclosed to the consumer pose real health hazards. Men who have taken the contaminated product have reported impotence. And women taking the product have reported missed menstrual periods and the growth of facial hair. (Source: Delthia Ricks, Newsday Arizona Daily Star, 8/2/13)

Contact the Lake Jackson Vitamin Supplement Recall Attorneys at Denena Points, PC to report Your Illness from the Steroid-Contaminated B-50 Tablets

We could help you get started taking proper action to ensure the FDA knows about your illness and to help you recover the just financial compensation you deserve after a needless injury from a contaminated product. Contact us at 281-369-4363 or through our online report form to receive a free, no obligation initial legal consultation to discuss your illness and evaluate your potential eligibility for financial recovery. We never charge you attorneys’ fees unless we win your case, so there’s no financial risk to you. Call us today and let us help you recover.

FDA Oversight of Vitamin and Dietary Supplement Industry Weak

The Lake Jackson vitamin supplement recall attorneys at Denena Points, PC note that the U.S. FDA doesn’t have the same authority to regulate the vitamin and health supplement industry as it does food products and pharmaceuticals. The agency’s authority is largely limited to requesting voluntary recalls where dangerous supplements have become apparent, and to issuing health warnings on those products.

We note that some supplement products can be deadly. For example, the FDA issued a warning regarding a DMAA supplement product several months ago after numerous injuries and deaths were reported from the dangerous product. Click here to read more about FDA regulation of vitamin and dietary supplements.