The U.S. Food and Drug Administration (FDA) has proposed tightening regulations over heart defibrillators after dozens of recalls, failures and deaths attributed to the malfunctioning medical device. There are about 2.4 million automated external defibrillators (AED) in public places in the U.S. They are found in newsrooms, airports, casinos, even churches.  Using paddles that deliver an electrical jolt to the chest, an AED can re-establish a normal heart beat during a potentially fatal cardiac arrhythmia which, according to the American Heart Association, kills about 400,000 a year.

No one knows how many patients have died due to the malfunctioning devices, but the New York Times reports in one case a nurse was trying to help a patient in cardiac arrest when the defibrillator read “memory full” and it shut down. The patient died. In another instance the software showed an “equipment disabled” message. That patient also died.

The FDA reports that there have been 45,000 failures of defibrillator hardware and software since 2005, and manufacturers have had to recall AEDs 88 times. In order to improve that dismal record, the proposed order will require manufacturers to make available designs of the AEDs. The agency would also be given tighter controls on buying defibrillator components overseas.  Dr. William Maisel with the Center for Devices and Radiological Health (CDRH) announced plants could also be inspected, although historically the FDA has not had the personnel to inspect plants overseas.
The FDA could have downgraded AEDs to a lower or moderate risk device (Class I or II), but an expert panel convened in October 2011 recommended AEDs remain Class III (highest-risk medical device) and required pre-market approval (PMA),  higher degree of scrutiny than the current notification process.

One application for PMA approval would cost about $248,000 according to Dr. Maisel, but that would cover all models of AEDs made by the company. Dr. Maisel says the safety data has already been conducted by the companies so most will not have to do any additional clinical studies.   The revamp of FDA safety oversight should be completed by 2014.

AEDs are known as “pre-amendment devices” which means that they were already in the marketplace before 1976 when the FDA began regulating medical devices.  At that time there were 170 devices called Class III that were approved through the 510(k) notification process that were never required to submit PMAs.  The FDA’s website says 19 medical devices are still waiting to be reclassified, including the high-risk metal hip joints with uncemented acetabular components as well as cemented acetabular components.

How do we know they are safe and effective?

The simple answer, which would surprise most patients and physicians, is that we do not know if the medical devices are safe and effective. A study published in the Archives of Internal Medicine in 2011 found nearly three-quarters of medical devices that caused injury or death from 2005 to 2009 had entered the market through the 510(k) process.   Any changes in the 510(k) process, however, would also need to address the false notion that the PMA process leads to safer medical devices.  That is not necessarily the case, with the Birmingham metal-on-metal hip implant marketed by Smith & Nephew being a prime example of a PMA-approved medical devices that has injured untold thousands of patients who have had to undergo revision surgeries and suffered other bone and tissue damage and disability as a result of cobalt and chromium poisoning and premature failure of the devices.

For a diabetic, accurately monitoring his blood sugar level can mean a matter of life or a diabetic coma.

So this latest warning from healthcare giant Johnson & Johnson is especially troublesome.

Its popular OneTouch Verio IQ blood glucose meters have been found to be faulty when the blood sugar is especially high. Instead of providing a warning, they turn off.

J&J is recalling almost 1.9 million units following the death of a patient in Europe.

About 900,000 units were sold to U.S. consumers. The problem was detected when a high blood sugar of 1,024 milligrams per deciliter caused the device to trip off.

The company says the likelihood of reaching that level of blood glucose is remote but the failure to deliver an accurate reading could delay treatment that can result in serious complications including death or a diabetic coma.

Just for comparison, a diabetic wants to keep his blood sugars in the range of 160 milligrams per deciliter or below. Any higher and the sugar travelling through the body can damage the heart, eyes, blood vessels and other organs. Amputations, blindness, kidney failure and heart attack can result when blood sugar goes unchecked.

These meters were sold in the U.S. and in other countries. J&J’s LifeScan unit says it will replace them for free. Those recalled include the OneTouch VerioIQ, OneTouch VerioPro, and the OneTouch VerioPro+.

The VerioIQ meter can be used until replacement meters come in.

The problem was detected by internal company testing soon after the patient died following an inaccurate reading which may or may not have been linked to the medical device.

Over the last couple of years, J&J has issued about a dozen recalls for faulty medications, contact lenses and hip implants. You’ll recall the children’s Tylenol and Motrin recalls, the DePuy ASR metal-on-metal hip recall, a bone putty to stop bleeding and the complete overhaul of a nonprescription medicine factory that was taken over by the FDA after an inspection found contaminated products and dirty conditions.

Bloomberg reports 2012 sales of LifeScan diabetes care products at $2.6 billion.

Visit the company’s website www.onetouch.com or contact customer service at (800) 717-0276 to return the meter.

Consumers are being warned to stop using the Imaginarium Activity Walkers for children after the government received five reports of the wheels detaching. No children were injured.

The product is sold by Toys R Us which has issued a recall for 9,000 units of the walkers, used to help babies take their first steps. The walker has a wooden push handle at the top of the walker and the base has four wheels.  A small bolt and spacer attached to the front wheel can potentially detach and cause the child to fall and/or choke on the parts.

Consumers are encouraged to take the walkers back to the store for a full refund.

The Imaginarium Activity Walker was sold exclusively at Toys R Us stores from August 2011 through January of this year at a cost of about $30. The walker was made in China and imported by Toys R. Us Inc of Wayne, New Jersey.

Health Canada has issued a similar Consumer Product Recall.

The U.S. Consumer Product Safety Commission (CPSC) and its CPSC Safer Products site will continue to take consumer calls and complaints regarding this recalled product.

Federal law prohibits anyone from selling or re-selling a defective product on the retail or second-hand market where many children’s products end up.

The CPSC protects the public from thousands of consumer products that pose an unreasonable risk of injury or death. The cost to the nation for defective consumer products? More than $900 billion annually.

That may include baby products and children’s bedding with carcinogenic flame retardant chemicals, which were removed from the market in California beginning in January; defective baby furniture and cribs which can trap and suffocate infants; and defective child products containing lead, among many other products that have been recalled over the years.

The agency has been criticized for working too closely with manufacturers. In August 1995, the CPSC initiated a fast-track recall program to get defective products off of store shelves.

In a concession to manufacturers, the CPSC eliminated the preliminary determination to establish whether or not a product is defective in its design, its manufacturing or in its instructions for use. In return, manufacturers agreed to comply with a recall and to notify distributors, wholesaler and retailers within 20 days. This saves years of litigation and gets defective products off the store shelves quicker.

Under law, manufacturers must report any risks of serious injury or death to the CPSC and the agency receives about 300 a year. A failure to report a defective product can result in a civil penalty of up to $1.5 million.

In this case, the loss of the product itself will cost Toys R Us around $270,000; plus the overhead and costs involved in announcing and running the recall process. Why can’t we reach a program in which manufacturers actually test their products before placing them on the market; to, for example, determine whether the wheels will fall off before they go on the shelves for sale to unwary consumers.

The company can be reached at (800) 869-7787 from 9 a.m. to 11 p.m. ET Monday through Saturday and 11 a.m. to 7 p.m. Sunday.

I, and the other attorneys in my firm, represent people who experience tragedies in their lives. Sometimes clients do receive justice.

Sometimes the defendants make honest mistakes, other times their neglect is particularly egregious.

The case I recently tried, with Greg Barnhart and Matt Schwencke in my firm, was flagrant because the nature of the negligence was so preventable. The case was particularly tragic because of the emotional devastation suffered by the parents of a child struck down before his life even began.

How many times have you tried to pull out of a parking lot into traffic, only to have your vision of the roadway partially or totally blocked by a bush, a sign or some other obstruction? How many times as you pull across the sidewalk do you think to yourself, “Why the property owner couldn’t cut their bushes?”

My last case involved a death trap designed by the people who were supposed to make sure the trap did not exist: the land owner and their property management company.

The trap resulted in the death of 9 year old Andrew Curtis, struck and killed by a motorist who could not see him on his bike while exiting at Jupiter’s Villas on the Green Condominium complex. The trap resulted in the emotional destruction of the lives of Andrew’s parents, Tracy Curtis and Andre Kovacs.

This tragic crash occurred one afternoon while Andrew and his father Andre were riding their bikes and approaching the drive way to the condominium complex. Andre and Andrew could not see the car coming out of the exit way and the driver could not see them as a result of the unmaintained bushes and poor placement of a stop sign. The driver pulled through the exit and ran right over the top of Andrew’s head.

I am not a mother and when I handle cases involving the death of children, I always try to gain a firm appreciation for parents suffering the sudden and unexpected death of their children.  The emotional loss for parents who is devastating especially when the death is sudden, unexpected and preventable.

They will never see Andrew his first homerun, surf his first tough wave or see the joy of his first soccer goal. They will not see their child go to the prom, attend college, fall in love for the first time, get married or have grandchildren run through their home.

No amount of money will ever make it better. In our society, though, the rendering of a full verdict is the only way a parent who has suffered losing their beloved son can legally obtain some amount of justice, some amount of closure.

We were in trial on the case for several weeks. We made multiple efforts to reasonably resolve the case with the defendants in an effort to keep our clients from having to relive losing their son over again, the defendants were not interested.

After requiring my clients to relive losing their son and the circumstances of that loss, the jury found that the condominium’s property management company 60% at fault and the condominium association 30% at fault and awarded a $12 million verdict. Sadly, the defendants even tried to place blame on Andrew’s father Andre, claiming that he should have been able to keep Andrew from being struck by the car.

Clearly our trial team had illustrated my clients’ devastation to the jury in a way they would ask to give my clients what they really needed: someone who said they understood and were sorry for their loss.

After the verdict was read, the foreperson said, “Judge, we just have one request, can we hug the parents?” It was the most moving moment in my 18 year professional career.

Attorney Cal Warriner was interviewed by the Palm Beach Post as set forth in an article published in Sunday’s paper. Mr. Warriner raised as number of valid points, but two dealt with short cuts to FDA approval and a national joint registry:

Would any patients have been harmed by the Stryker Rejuvenate and the ABG II hip implants if short cuts to approval through the Food & drug Administration were prohibited?

Would less patients have been harmed by the Stryker Rejuvenate and the ABG II hip implants if the United States had an effective joint replacement registry in place similar to the one in Australia?

The FDA permits orthopedic device manufacturers to short cut the approval process if a manufacturer can demonstrate that a product for which they seek approval is “equivalent to a device” already approved by the FDA. If the manufacturer can demonstrate the substantial equivalence of their device, they may bypass the lengthy and expensive clinical trial and scientific scrutiny that new devices are put through.

But, what if the “new device” differs from the already approved device in ways that might create problems? The FDA is largely funded by the same device and drug manufacturers they regulate and they have little funding or staff to conduct independent device evaluation. If the manufacturer represents “substantial equivalence”, the device is likely to get approved if it appears to be a similar device.

The “short cut” process is great for device manufacturers, but reasonable suspicion exists as to its benefit for consumers.

The Australian Orthopaedic Association National Joint Registry has proved successful in repeated instances. Long before the FDA has recalled problem medical devices in the United States, Australia and the European Union (who also maintains a device database) have alerted to problems in devices such as Stryker’s Rejuvenate, Depuy and other joint replacement devices.

Does the United States maintain a device database? Yes. It has only a year ago begun to accumulate data; so, in fairness, it will be several years before we really can gauge its success. There does seem to be some differences between the AJRR (American Joint Replacement Registry) and the Australian registry.

The United States Registry includes, as contributors, manufacturers including:

• Aesculap Implant Systems, Inc.
• DePuy Orthopedics, Inc.
• Exactech, Inc.
• Stryker
• Zimmer, Inc.
• Biomet, Inc.
• Consensus Orthopedics
• DJO Surgical
• Smith & Nephew plc
• Wright Medical Technology, Inc.

So, of the 17 listed financial contributors to the American registry, 10 of them are some of the largest manufacturers of medical devices in the world. In contrast, the Australian registry is funded by the departments in the Australian government charged with regulating the medical device industry.

In all fairness, the FDA’s “short cut” to medical device approval seems like a process to benefit manufacturers more than consumers. But, an oversight organization, such as the American registry funded largely by the medical device manufacturers seems like a classic case of the fox guarding the hen house!

Stryker is finally acknowledging that their Rejuvenate and ABG II modular hip product line can cause serious problems in patients – even if they aren’t yet feeling symptoms of metal poisoning or tissue destruction.

Since the Rejuvenate product recall on July 4th, Stryker has been telling patients that if you aren’t feeling any symptoms, you should not return to your orthopedic specialist unless it’s part of your individual treatment plan.

Since June, we have been warning patients of heavy metal toxicity, tissue necrosis, and irreversible skeletal damage.

Now, (6) months after our warnings and (5) months after the Stryker recall, Stryker has a different message: “It is important that you follow-up with your surgeon, even if you are not experiencing symptoms such as pain and/or swelling at or around your hip” and even recommending that if you are unsure if you have the Rejuvenate or ABG II, to find out immediately.

Stryker’s about-face in this situation is predictable given the obvious problems with Rejuvenate and ABGII hip systems. It is inexcusable, however, for Stryker to tell patients that failure rates are so low that they need not be concerned, when “heavy metal toxicity, tissue necrosis, and irreversible skeletal damage” was medically predictable at the time of the recall.

Why did Stryker delay these recommendations for so long; when we at Searcy Denney have been asking Stryker since their voluntary recall this summer to acknowledge that their device is causing serious harm to patients? For now, we are left to guess, until we discover in the process of litigating lawsuits on behalf of victims.

According to Reuters, Stryker has now employed a company called Broadspire to administrate the claims process for future incurred medical expenses. Although it is not clear what expenses Stryker may cover, we hope they intend to compensate for at least replacement of faulty hips to prevent continued injury to patients.

But, as we have warned before, you should always speak with a lawyer before negotiating or dealing with a third-party claims administrator like Broadspire. Whether you hire a lawyer or not is a different issue, but at least speak with one.

Do not be misled. These companies often portray themselves as wanting to help patients and they really may want to help patients; but at the end of the day, they work for, their loyalty is to Stryker and not the patient. If they can secure a full release for their employer by paying pennies on the dollar of a victim’s actual losses, they will because that is their job.

A lawsuit is filed…and that is often when the real work begins for all the parties involved.

In some cases, neither the plaintiff nor the defendant has all the proof; documents, data and other types of evidence; they need to fully prove their respective cases. So, each party is allowed to ask questions and request documents (data) from each other.

This is a journey called “discovery”. Once it involved going to filing cabinets and boxing up sometimes hundreds of boxes of paper. In our digital world, the discovery process can be a frightening experience for those unprepared and an experience fraught with error for those not sufficiently informed.

Let’s take a look at what is faced in the digital discovery world today.

Many in the United States are convinced that we manage more email than anywhere else and that is simply untrue. We only represent around 14% of the world’s total email volume; with Asia and Europe beating us by two and three times our volume.

Last year the average number of business emails received and sent daily by a single worker averaged 105. If you are involved in a lawsuit with a company in which a single department has   25 workers, you may be dealing with as many as 958,125 email documents generated in a single year. If (3) of the company’s departments have relevant documents and data, you are now   trying to sift through nearly two million emails or an average of 3 million pages (not including attachments).

(more…)

When I first received the news blurb I thought it was a joke; but this is no laughing matter!

Apparently, in addition to trying to avoid sunburn, at least one brand of spray-on sunscreen can cause you second and third degree burns.

The maker of Banana Boat UltraMist Sunscreen has ordered a removal of the product from store shelves after reports of at least five people who have been burned as a result of the sunscreen. Included in the recall are products like:

• UltraMist Sport
• UltraMist Ultra Defense
• UltraMist Kids

One man, Brett Sigworth of Stow, Mass., related to CBS News, “I sprayed on the spray-on sunscreen, and then rubbed it on for a few seconds. I walked over to my grill, took one of the holders to move some of the charcoal briquettes around and all of a sudden it just went up my arm”.

I confess that I have never read the ingredients in sunscreens before and dermatologists report that is pretty common for most users. Apparently, the spray applicator is allowing too much of the liquid to be applied and the alcohol and petroleum ingredients in the sunscreen are not drying fast enough. Too much of these flammable ingredients, too close to a flame and there is a significant risk of flammability.

Interestingly, the product label includes the recommendation to “apply liberally” and to “reapply as needed”. The label ingredients set forth glycerin as one of the ingredients; a compound that has been promoted as a substitute to diesel fuels.

Consumers are urged to discontinue use of any of these products and to contact the manufacturer, Energizer, at 800-723-3786 or by email at, SUNCARE@customerfollowup.info.

On Wednesday, October 10, 2012, Toyota recalled over 7 million vehicles worldwide to fix faulty window switches that can cause fires.  This is not the first major recall involving Toyota.

It seems the more Toyota tries to improve its image after several safety issues involving their product, the more problems they have.  Toyota used to have a reputation for manufacturing safe, as well as economical vehicles, and over the past few years that reputation has dramatically changed.

In 2009 and 2010 Toyota recalled many of their vehicles due to safety issues involving sudden acceleration that led to many crashes.

Toyota seemed to be on the road to recovery until this recent recall involving cars, trucks and SUV’s produced from 2005 through 2010.  If you, the consumer, receive a recall notice, do not hesitate to bring your vehicle in for service.  For other links to Toyota recalls:

2009 – 2011 Toyota Vehicle Recalls

Toyota.com Safety Recalls

On March 10, 2010, the Stryker Orthopaedics Division announced the release of a new hip replacement, the ADM X3 Mobile Bearing Acetabular System.  Calling it the “next-generation of technology” in hip replacements, the company announced that Hall of Famer, Johnny Bench, would become the first patient in the world to receive the device. What is missing from that press release and all associated “speaking tour” videos cut by Mr. Bench is what stem was implanted in Mr. Bench.

Stryker was aggressively trying to distance itself from the complications associated with metal-on-metal hip implants that have been generating news headlines, thousands of injured patients around the globe, and defective product lawsuits.

A deeper look into the company’s website shows this latest generation is made of precisely engineered polyethylene, “designed to help minimize the risk of wear and consequently help prolong the life of the implant.”  And the X3 mobile bearing hip system offering a large head, thought to be more stable than a smaller diameter head.

Good luck on the newest generation of hip replacements if the past is any indication. And, perhaps the silence is because Mr. Bench was the unfortunate recipient of either a now recalled Rejuvenate or ABG II modular stem.

Bench became a paid spokesman for Stryker after he received his first hip implant in 2004.  The former professional baseball catcher, who played in the Major Leagues for the Cincinnati Reds from 1967 to 1983, blamed the 400,000 squats he did during his 17-year career for his arthritic and deteriorating left hip.

Bench received a Stryker ceramic hip that year. But by 2005, complaints began to surface about the poorly-fitting and squeaking implant which wore unevenly causing pain, bone fractures, and difficulty walking in some patients.

The U.S. Food and Drug Administration (FDA) warned Stryker about the complaints in a six-page letter.  Bench had experienced some squeaking in his left hip but was quoted as saying, “I don’t care if it plays ‘Dixie’”.

The FDA inspected the Stryker manufacturing plants in Cork, Ireland and in Mahwah, New Jersey and found quality control problems at different stages of manufacturing including the discovery of staph bacteria in New Jersey.  The FDA then sent a warning letter to Stryker at its Kalamazoo, Michigan headquarters to president and CEO Steven MacMillan dated November 2007, saying it could seize products if the problems were not corrected.

Stryker recalled two products in the Trident line including the two hip replacement cups, the Trident Acetabular PSL Cup, and the Trident Hemispherical Cups made in Cork, Ireland.

On July 6, 2012, the company recalled the Stryker Rejuvenate and ABG II Modular-Neck Stems due to 60 reports of metal toxicity that led to an early revision or removal of the hip. The surgeon who implanted Mr. Bench with the new ADM bearing surface in 2010 is known to have been a user of the Rejuvenate and ABG II stems.

The Stryker Rejuvenate and ABG II had metal neck components of chromium and cobalt and a stem coated with titanium that led to complications including metallic debris in the bloodstream even without a metal-on-metal junction.  Since they do not involve a metal ball and socket, they were not considered metal-on-metal hip replacement devices. But a revision of a stem component, which is placed deep inside the patient’s femur, can be a complicated and difficult surgery.

The Rejuvenate was approved by the FDA in June 2008, with the ABG II was approved in November 2009.  Both systems received 510(k) notification approval as Stryker said they were similar enough to other devices already on the market.

That meant the company got a pass on providing clinical studies to prove safety and efficacy. That’s the problem.

The newer Stryker devices are modeled on systems that were already found to be defective and resulted in adverse events such as neck fractures, bone fractures and dead tissue response.

So far there has been no press release from Stryker telling us how Johnny Bench is doing with his right hip replaced with the latest and greatest version of a hip device that may or may not have been based on the design of the defective models preceding it. How embarrassing would it be for Stryker if Mr. Bench in fact had been implanted with defective and recalled Stryker products in both hips?

Word of caution – never volunteer to become the first person to receive a newly issued medical device that is permanently implanted – especially if there were no safety inspections required under the fast-track 510(k) FDA approval process.

Don’t hold your breath for an updated press release.