Topic: Defective Medical Devices

Your North Carolina Injury is Not the End of the World (Probably)–or At Least You Won’t Feel This Unhappy Forever

May 26, 2013, by Michael A. DeMayo

You’re deeply depressed by your recent North Carolina injury. Whether some idiot in a truck bashed your car by blowing through a stop sign, or a doctor misread your chart and gave you a medication that made you literally sick to your stomach, you are in pain. You are angry; you are confused; and you are deeply dismayed by your situation and the prospects for your future.

Obviously, what’s done is done. You can’t go back in time and undo the North Carolina truck accident or reverse the doctor’s negligent decisions. And you may indeed have a long road to hoe. You might never regain function of your leg. You might need to be in a wheelchair for the rest of your life. You might never be able to work as you once did. The brain damage caused by the accident may permanently limit your ability to be productive to two to three hours a day.

When you sit there and contemplate these scenarios–particularly the worst case scenarios–you can easily spiral into depression and apathy. This is really unfortunate. When you are depressed and/or apathetic, you may fail to take important kinds of action–such as contacting a reputable North Carolina mass tort law firm ASAP–because you feel too hopeless to persevere.

This is a shame, because science shows that our emotional immune systems are remarkably resilient.

Even IF a worst case scenarios plays out for you–e.g. you’re permanently hobbled by the accident or no longer able to work in a career that you love–these setbacks will not doom you to a lifetime of depression and unhappiness. Or at least they don’t necessarily mark you with that destiny.

That may sound very counterintuitive. But if you look at the research, those statements bare out.

Lottery winners notoriously experience euphoria for the first weeks or months after they win. But they ultimately wind up just as happy–and just as sad!–as they were before the pay day.

Likewise, people injured so severely that they are left as quadriplegics suffer extreme depression in the first few weeks and months. But they ultimately rebound to feel just as happy as they did before the devastating event.

This isn’t to say that you don’t have problems — that you shouldn’t feel depressed or anything. Rather, you should appreciate that your current emotional state is probably temporary.

Even more importantly, you need to avoid getting trapped by your emotions into “doing nothing” and/or into making impulsive and not-strategic actions that can have negative long-term implications for your finances and healthcare options.

To that end, consider connecting with the DeMayo Law team now at (877) 529-1222 for a free consultation, so that we can put you on a more strategic path with respect to your case.

North Carolina Class Action News: Legal Fight Over High Sugar, High Caffeine Energy Drinks — A Portent of A Larger Battle To Come?

May 23, 2013, by Michael A. DeMayo

Are we witnessing the beginnings of a major mass tort battle in North Carolina (and well beyond?)

Perhaps so. And big beverage companies may be on the receiving end.

Last year, for instance, a woman in Australia allegedly died from over consuming Coca-Cola. According to the Chicago Sun Times, a Maryland teenager died after drinking two large Monster Energy drinks in a single 24-hour period. These drinks contain a lot of caffeine and also a lot of sugar. While testifying before Chicago City Council, Edward Burke discussed a federal report “that showed the number of annual hospital visits tied to highly caffeinated energy drinks doubled between 2007 and 2011 — to 21,000.”

According to the President of Chicago Medical Society, Dr. Howard Axe, “super caffeinated energy drinks,” such as Red Bull, Monster Energy, and Rockstar, pose serious health risks, “including possible fatalities to adults and children, particularly those with preexisting conditions.”

The legal brouhaha in Chicago is focused on the adverse health effects of over consuming caffeine. Another, potentially more fraught and momentous debate has to do with the adverse effects of the overconsumption of liquid sucrose. As most famously articulated by pediatric obesity specialist, Dr. Robert Lustig, calories from liquid sucrose may have especially adverse effect on the liver because of the way the fructose component of sucrose gets metabolized by that organ. Lustig builds the case — at least in the doses that modern North Carolinians consume sugar — that “calorie is not a calorie.” The consumption of sugary liquid beverages, like Coca-Cola, Pepsi, and even many fruit juices, may be doing tremendous harm to our population and precipitating problems like metabolic disease, obesity, diabetes, and even heart disease.

So far, obviously, we have yet to see a major class action or mass tort lawsuit against beverage companies. But some health advocates are suggesting that we may be witnessing at least the beginnings of such machinations — they compare our current era to the era a few years before Big Tobacco was held to legal account for advertising and selling dangerous products.

If you have recently been harmed by a product or service, you are probably far less interested in the legal battle over energy drinks than you are with your own wellbeing, financially, medically, and otherwise.

 The team here at the law offices of Michael A. DeMayo proudly represents victims and their families in serious North Carolina personal injury matters. Please get in touch with us today by calling (877) 529-1222, so we can provide you a free consultation and help you get educated and informed about your options.

Our Illogical Reactions to Superstitions: Really Important to Understand, If You Want to Fight Your North Carolina Class Action Optimally…

May 19, 2013, by Michael A. DeMayo

Whether your son broke his ribs in an SUV rollover, your husband tore his ACL on an amusement park ride, or you suffered a devastating home fire when your space heater malfunctioned, you understand you have the potential to take some kind of legal action and perhaps to participate in a North Carolina class action or mass tort lawsuit.

But you are confused about what to do next. Should you connect with a legal team like DeMayo Law or “deal with the situation yourself” — i.e. work directly with an insurance company?

Everyone has different needs and sensitivities and comforts. But it’s important to be rational rather than impulsive when you make a big decision like this.

We often play to our superstitions rather than to logical common sense.

Consider the diverse nature of our strange beliefs. Whether you are afraid of the number 13; you bet your wedding date when you play the lottery; or you worry about a black cat crossing your path or something along those lines, part of you recognizes that you’re being ridiculous with the superstitions.

You understand that that you are using “magical thinking” and not logic. But even when you “call out” your superstitions — call your own bluff — you may not be able to overpower your subconscious resistance. You may not, for instance, ever feel comfortable sleeping on the 13th floor of a hotel. If you’re Russian, you may refuse to shake someone’s hand when they reach through a doorway to you.

Depending on how deeply you hold strange beliefs, they can really hamper your life.

The point is that wrestling with such strange beliefs–even when you make those beliefs conscious and you appreciate that they’re clearly irrational–is more challenging than meets the eye.

As much as we should “trust our guts” in certain situations, we also need to learn how and when to challenge our intuitions in order to achieve best results.

To that end, if you have reservations about connecting with an attorney–or if you have some strange belief about why you are not someone who “does” lawsuits, reflect on that received wisdom. Are those concepts actually serving you right now?

Consider, for instance, the worst thing that could happen, if you got a consultation with attorney, versus the best thing that could happen if you did. That the more that you can shine rational light on your fears, the more you can move beyond them and make more compelling and useful decisions.

Class Action Lawsuits “Brewing” For Budweiser

May 13, 2013, by Michael A. DeMayo

Anheuser-Busch, the maker of Budweiser Beer, is facing a pretty serious class action lawsuit that alleges that the brewer watered down its products prior to bottling.

Thus far, plaintiffs in Texas, Pennsylvania, Missouri, New Jersey, Colorado, Ohio, and California have all filed suit against the beer manufacturer based on whistleblowing testimony from former high placed employees in the business–at 13 separate breweries.

Will a North Carolina class action against Budweiser be next?

Anheuser-Busch has fought back vigorously against the bad press–the company recently took out full page ads in The New York Times, The L.A. Times, and eight other major newspapers touting the fact that the company provided 71 million cans of drinking water to the American Red Cross and other disaster organizations. The cheeky headline read “they must have tested one of these.”

But a lead attorney in the case, Josh Boxer, shrugged off the newspaper ad blitz as a “classic non-denial…(the) alcohol readings, taken six times a second as the finished product is bottled, will confirm the allegations made by the growing number of former employees who keep coming forward to tell us the truth.”

In court, Anheuser-Busch will need to produce data on its internal and alcohol testing procedures. Ten different products are tangled up in the legal matter, including well-known brands like Budweiser, Michelob, and Bud Ice as well as more “exotic” brands, like Hurricane High Gravity Lager and Bud Light Lime.

Do you have a potential Charlotte class action lawsuit?

The team here at the Law Offices of Michael A. DeMayo can help you understand and defend your rights to get compensation. Depending on your circumstances, you may want to file a personal injury suit or a mass tort action. Our team can help you strategize and determine the most effective, accurate course forward. Call us now for a free consultation, and get clarity on what you need to do.

The End of the Beginning of Your Quest for Justice After a North Carolina Injury

May 10, 2013, by Michael A. DeMayo

In the hours and days since your North Carolina injury–or your family member’s injury- you have been in a mad scramble to get medical care and make sense of your options.

What steps should you be taking (or not taking) to manage the medical crisis, collect evidence, and deal with the urgent logistics in your life? Who is going to take care of the kids while you’re hurt? Who’s going to handle the big work project that you had to drop to deal with the catastrophe? How will you pay the mortgage now that you’ve spent thousands of dollars out of pocket on ambulance and hospital services?

After you wrangle these urgent details, you then need to scramble to recalibrate everything in your life. You will also need to find a way to deal with the tremendous challenges of finding appropriate representation:

  • Do you have a case or not?
  • If so, what should you do first?
  • Whom can you trust?
  • How can you evaluate different law firms against one another?
  • How can you work effectively with a law firm to make sure that you get clear answers and good communication throughout the process?

All of these urgent questions might be on your mind. And they all need to be addressed.

The several lining–if there is one–is that, once you do get all of these things taken care of, assuming you have done everything effectively, you should enjoy renewed peace of mind.

The great gift that a solid North Carolina mass tort law firm can provide is the gift of clarity.

Even though your life may feel like it’s in a million pieces right now–if you know exactly what’s going to happen next and what to expect; and if you have trusted people working on your behalf–much of the stress and agitation will lift.

Obviously, even a superb law firm is not going to magically make your injury go away or eliminate the anger and frustration you feel about what happened. But you should feel a sense of relief and security that you are moving in the right direction.

And when people feel like their lives are moving in a positive direction, they often see passed their immediate limitations and handle the process with more grace and patience.

Connect with the DeMayo Law team right now for strategic, insightful assistance with your Charlotte personal injury matter.

Another DePuy Hip Lawsuit Filed by Patient Who Says He Needs Second Surgery

May 25, 2012, by Michael A. DeMayo

In the last couple of years, DePuy Orthopedics has been in the headlines over its hip implant devices. It was during the latter half of 2010 that the Johnson & Johnson company announced that it was recalling its ASR Al Acetabular Hip Replacement and its ASR Hip Resurfacing Systems, which were implanted in about 93,000 patients, because the devices appeared to be at risk of failing. Since then, Charlotte, North Carolina DePuy ASR lawyer Michael A. DeMayo has been providing free case evaluations to individuals seeking to explore their legal options over complications that may have been caused by their DePuy device.

Hip replacement surgery can take a toll on a person’s health and well-being even when it goes well. For a patient to fare even worse because a hip implant failed or was defective to begin with is unacceptable. For example, in one recent case that was filed just this month, the plaintiff, Larry Vanyi, is seeking damages for alleged complications that have resulted in him having to undergo a revision procedure. Vanyi, who was implanted with DePuy’s Pinnacle hip replacement product, is suing not just DePuy Orthopedics, but also, he is pursuing damages from the implant device’s designer, Dr. Thomas Schmalzreid. (Although this Pinnacle implant hasn’t been recalled, it is similar to the DePuy hip implants that were recalled and there have been calls from some medical experts to also take it off the market).

Vanyi is not the only hip implant patient to go after DePuy.  Thousands of plaintiffs have been making their claims to seek recovery for injuries and complications from their metal-on-metal hip replacement device. In North Carolina, please contact the Law Offices of Michael A. DeMayo LLP and find out if Charlotte injury lawyer DeMayo can help you.

Aside from a patient having to undergo replacement/revision surgery (within five years) again so soon after the initial implant procedure, there also have been reports of the device’s metal particles scattering in the body, potentially upping the risk of soft tissue damage or necrosis. Elevated chromium and cobalt levels may even result, as was allegedly experienced by another plaintiff, who has said that she has needed revision surgery because of her Bi-Lateral DePuy ASR hip implant.

In the Carolinas, getting financial recovery from a negligent manufacturer is part of North Carolina products liability attorney DeMayo’s job and one that he takes very seriously. Mr. DeMayo is not afraid to go after big corporations and litigate against them in court if necessary.

Signs you may be potentially suffering from hip implant failure or related complications:

  • Extreme pain when walking or having to bear weight
  • Swelling
  • Loss of mobility or flexibility
  • Severe pain in the implant area, potentially even extending to the back or groin

Charlotte, North Carolina Injury Lawyer Michael A. DeMayo is rated AV Preeminent by Martindale-Hubbell and in the last two years, the American Association of Trial Lawyers has chosen him as one of the 100 leading trial lawyers.  Mr. DeMayo and his law firm have either tried or settled more than 35,000 cases in the past two decades.

Contact our Charlotte, NC hip implant law firm today.

More Blog Posts:

Approximately 1,000 DePuy Lawsuits Already Filed Against Johnson & Johnson, North Carolina Injury Lawyers Blog, July 7, 2011

FDA Study Finds that Metal-on-Metal Hip Implants Don’t Offer More Advantages than More Traditional Devices, North Carolina Injury Lawyers Blog, December 29, 2011

10th Annual “Arrive Alive: Don’t Drink and Drive” Program a Success with High School Students, Parents, and Teachers, North Carolina Injury Lawyers Blog, May 8, 2012

North Carolina Car Accident Attorney DeMayo is also known for his community service activities and commitment to preventing underage drinking and driving.


Johnson & Johnson and 32 Other Transvaginal Mesh Manufacturers Ordered by FDA to Study Complication Rates

January 12, 2012, by Michael A. DeMayo

The Food and Drug Administration wants 33 manufacturers of transvaginal mesh products to study the rates of health complications, including organ damage, linked to these medical devices. The mandate comes six months after the federal agency reported a fivefold increase in injuries, deaths, and malfunctions related to vaginal mesh implants. The FDA has said that it so far has been unable to verify whether transvaginal mesh provides greater benefits than more traditional devices used to treat stress urinary incontinence and pelvic organ prolapse.  In fact, the federal agency has warned that mesh implants have been linked to pain during sex, bleeding, infection, severe pain, pelvic perforation, urinary tract erosion, perineal cellulitis, and organ perforation. If you or someone you love suffered health complications from transvaginal mesh, do not hesitate to contact our Charlotte, North Carolina defective medical device lawyers today.

CR Bard Inc., Endo Pharmaceuticals Holding Inc., and Johnson & Johnson, Boston Scientific are just a handful of the companies that the FDA has contacted. The federal regulator wants each manufacturer to gather data about potential complications and the outcomes of various transvaginal procedures and conduct trials on effectiveness and safety for three years. The FDA’s letters, which were sent out earlier this week, are calling for the studies to look into devices that are already available for use. Consumers, however, want mesh products that haven’t entered the market to be studied before they are released.

Currently, under the FDA’s 510(k) system, new mesh products that are similar to devices the federal agency has already approved don’t have to undergo human testing to receive their approval. Many of the transvaginal mesh implants that are currently in use can trace their approvals back to the Boston Scientific Corp. mesh (that was recalled in 1999.)

Transvaginal mesh devices have been blamed in over 650 products liability lawsuits against manufacturers. In 2010 alone, nearly 300,000 synthetic mesh products were implanted in women in the US.

Between 2008 and 2010 alone, the FDA was notified of 1,503 adverse occurrences related to mesh used in POP procedures—that’s 5 times more than the number of reports it received during the previous two years. It doesn’t help that for many of the women who experience transvaginal mesh complications they continued to experience ongoing pain afterwards. Additional surgeries to remove the medical device may have been required. (In some cases, the mesh can get so tangled up in scar tissue that it has to stay in the body.)

Our Charlotte, North Carolina transvaginal mesh lawyers know how devastating it can be to sustain injuries or health issues because a medical device failed and/or because of complications that you should’ve been warned about before you underwent the procedure.

J & J, CR Bard Must Study Safety of Vaginal Mesh, FDA says, Bloomberg, January 5, 2011

FDA warns against surgical mesh to repair pelvic problems,, July 13, 2011

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, FDA, July 13, 2011

More Blog Posts:

North Carolina Defective Medical Device?: FDA Warns of Serious Complications from Using Transvaginal Mesh to Repair Pelvic Problems, North Carolina Injury Lawyer Blog, July 27, 2011

FDA Study Finds that Metal-on-Metal Hip Implants Don’t Offer A Lot More Advantages Than More Traditional Devices, North Carolina Injury Lawyer Blog, December 29, 2011

Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?, North Carolina Injury Lawyer Blog, February 18, 2011

FDA Study Finds that Metal-on-Metal Hip Implants Don’t Offer A Lot More Advantages Than More Traditional Devices

December 29, 2011, by Michael A. DeMayo

According to a study commissioned by the U.S. Food and Drug Administration (FDA), metal-on-metal hip implants and ceramic-on-ceramic hip implants don’t appear to offer a lot more advantages than the older ceramic-on-polyethylene and metal-on-polyethylene versions. People who were implanted with all-metal hip devices also appear twice as likely to have to undergo revision surgery.  (Researchers in charge of the study compared newer and more traditional hip implants by looking at 18 studies involving over 3,000 patients. The results from 830,000 hip replacement surgeries were also examined.)

Meantime, according to WebMD, data from the registries in England and Wales, New Zealand, and Australia showed that metal-on-metal hip implant devices have exhibited higher rates of early implant failure than the metal-on-polyethylene versions. Also, there is no evidence that the newer types of hip implants do improve quality of life or functioning or decrease the need for repeat surgeries. In fact, a recent study that was conducted in England found that all-metal hip devices had a three times greater rate of early failure than their metal and plastic counterparts, which can last for up to 15 years or longer.

Throughout the state, our Charlotte, North Carolina defective medical device lawyers represent clients who suffered injury from DePuy hip replacement devices and other hip implants. Contact the Law Offices of Michael A. DeMayo, LLP today and ask for your free case evaluation.

The New York Times reports that legal and medical experts believe that hip failures could cost billions of dollars in the years to come—especially as not just one device or one company but an entire class of products are involved. Already, more than 5,000 defective all-metal replacement hip lawsuits and complaints have been filed. Many of these defective medical device lawsuits (by over 3,500 patients) were filed against Johnson & Johnson over its recalled DePuy hip implants. DePuy is also the defendant in more than 560 defective hip device lawsuits involving its Pinnacle model. In the next 10 years, tens of thousands of US patients may have to undergo replacement procedures.

Many of the devices are failing because the worn metal parts are damaging tissue, crippling patients, or shedding debris. It was just earlier this year that the FDA told 21 manufacturers of all-metal hip implant devices to commission post-market studies to determine whether their medical devices was shedding toxic amounts of metal debris inside patients.  Hip implant makers who received the notice included DePuy, Zimmer, Biomet, Stryker, and Wright Medical. One reason this debris is proving dangerous is because after the body emits scavenger cells to neutralize these foreign particles, they can turn into biologically active metal ions that can damage the muscle and tissue. Even now, there may be many implant users whose tissues are being destroyed even though they are not experiencing any obvious symptoms.

The High Cost of Failing Artificial Hips, The New York Times, December 27, 2011

Metal-on-Metal Hip Implants Offer No Advantages over Older Versions, FDA Study Finds, News Inferno, November 30, 2011

Metal-on-metal hip implants, Food and Drug Administration

More Blog Posts:

North Carolina Defective Medical Device?: FDA Warns of Serious Complications from Using Transvaginal Mesh to Repair Pelvic Problems, North Carolina Injury Lawyer Blog, July 27, 2011

Approximately 1,000 DePuy Hip Lawsuits Already Filed Against Johnson & Johnson, North Carolina Injury Lawyer Blog,  July 7, 2011

Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?, North Carolina Injury Lawyer Blog,  February 18, 2011


North Carolina Defective Medical Device?: FDA Warns of Serious Complications from Using Transvaginal Mesh to Repair Pelvic Problems

July 27, 2011, by Michael A. DeMayo

The FDA says that serious complications have been linked to surgical mesh that is implanted in the body to repair pelvic organ prolapse and stress urinary incontinence. While the federal agency had issued an early warning in October 2008 about health risks linked with using this medical device to treat SUI and POP, now the government wants surgeons and patients to know that serious complications are not rare. Also, the FDA says that it is unclear whether transvaginal POP repair using mesh is in fact more effective than opting for non-mesh repair to treat the same pelvic problems.

If you or someone you love suffered the following complications after undergoing transvaginal POP repair using surgical mesh, do not hesitate to contact our Charlotte, North Carolina defective medical device law firm today:

• Mesh erosion through the vagina
• Infection
• Pain
• Dyspareunia
• Urinary problems
• Organ perforation
• Bleeding
• Neuro-muscular problems
• Vaginal scarring
• Vaginal shrinkage
• Emotional issues

The FDA says that it has received more than 2,000 reports of complications from use of surgical mesh. Many of these reports came from the manufacturers of these devices. Some patients had to undergo additional surgeries and hospitalization and experienced impaired quality of life.

Our North Carolina transvaginal mesh lawsuit law firm cannot stress how important it is for manufacturers to make products that will not cause injury or other health complications for a patient. With so many women suffering from some type of pelvic prolapse—the Los Angeles Times reports that up to 50% of all women end up suffering from this condition, which involves organs (bladder, uterus, bowel, rectum, or intestines) slipping out of place following a hysterectomy, menopause, childbirth, or with age—this condition requires treatment more often than one would think. Some 75,000 such procedures are conducted annually.

Mesh used in pelvic surgeries under scrutiny, Los Angeles Times, July 25, 2011

FDA warns against surgical mesh to repair pelvic problems,, July 13, 2011

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, FDA, July 13, 2011

Related Web Resources:
Pelvic Organ Prolapse, American Urogynecologic Society

Stress incontinence, MedlinePlus

More Blog Posts:

Approximately 1,000 DePuy Hip Lawsuits Already Filed Against Johnson & Johnson, North Carolina Injury Lawyer Blog, July 7, 2011

Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?, North Carolina Injury Lawyer Blog, February 18, 2011

Approximately 1,000 DePuy Hip Lawsuits Already Filed Against Johnson & Johnson

July 7, 2011, by Michael A. DeMayo

According to The Wall Street Journal, about 1,000 defective medical device lawsuits have been filed in federal and state courts accusing Johnson & Johnson of continuing to make its metal-on-metal hip joints even while knowing that there were problems with some of them. J & J’s DePuy Orthopaedics Inc. finally recalled the hip replacement devices last year, while promising to cover all medical expenses incurred as a result of problems with the device. If you believe that the pain that you or a love one is experiencing is because of a DePuy hip implant, contact our Charlotte, North Carolina DePuy defective medical device lawyers today.

The 2010 recall included about 93,000 artificial hips—the ASR XL Acetabular Hip Replacement product and the ASR Hip Resurfacing Systems—over concerns that their failure rate was too high. The National Joint Registry of England and Wales had found that within five years of hip replacement surgery with a DePuy product, 1 in 8 patients had to undergo a revision surgery because the medical device had failed. According to J & J, about 37,000 patients in the US and approximately 93,000 patients globally had received a recalled DePuy hip device. Those who have contacted DePuy since the recall was announced have complained of inflammation, infection, pain, and cobalt and chromium, which are both potentially toxic metals appearing in the blood stream.

Going through hip replacement surgery once is uncomfortable and disruptive enough without having to do it again because the implant used was defective or failed. Not only are there risks involved anytime one undergoes surgery, but the recovery time is often long and other health complications can result.

Hip Joints Set Off New Rush to Court, The Wall Street Journal, July 8, 2011

DePuy Hip Recall Guide

New DePuy hip implant gets FDA approval amid lawsuit over old one, MEDCity, June 17, 2011

National Joint Registry of England and Wales

More Blog Posts:

Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?, North Carolina Injury Lawyer Blog, February 18, 2011

DePuy ASR Hip Replacement Products Recalled, North Carolina Injury Lawyer Blog, September 16, 2010

Johnson & Johnson Recalls Defective Duragesic Pain Patches, North Carolina Injury Lawyer Blog, January 5, 2009

Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?

February 18, 2011, by Michael A. DeMayo

According to a report in the Archives of Internal Medicine, there are questions as to whether the Food and Drug Administration is doing a good enough job of protecting Americans from defective medical devices. This is obviously an issue of concern for patients, as well as for our Charlotte, North Carolina defective medical devices attorneys who are familiar with how dangerous faulty/malfunctioning devices can be for patients.

Researchers looked at 113 devices that the FDA recalled between 2005 and 2009. The recalls were issued because of the health risks the devices posed. It now appears that 71% of these devices were approved without ever being tested on people—primarily because they were considered similar enough to at least one other product already in the marketplace. Just 19% of the products had to go through tougher review.

The FDA’s less strict approval process, which attempts to get medical devices out there sooner rather than later, is hurting patients. Yet, according to the Washington Post, seeing as over 19,000 medical devices were approved during those four years, there really weren’t that many recalls issued. FDA spokeswoman Karen Riley noted that many people have benefited from the approval of many of these medical devices. She did also say, however, that the researchers’ findings show a need for better safeguards. The agency is making 25 changes to ensure this.

While it is true that medical devices can save lives, defective ones have also been a source of serious injury and death. It is important that manufacturers make sure their products are safe before releasing them into the market and that the government does its job by checking to make sure a medical device is safe before placing its stamp of approval on it.

Examples of defective medical devices:

• DePuy Hip Replacement Systems
• Guidant Cardiac Defibrillator
• Medtronic Defibrillators
• Duragesic Pan Patch
• Nuvaring
• Knee Implants
• Guidant Pacemakers

Study of recalled medical devices faults lax FDA testing methods, The Washington Post, February 15, 2011

Medical Device Recalls and the FDA Approval Process, Archive of Internal Medicine, February 14, 2011

Related Web Resource:
US Food and Drug Administration

Related Blog Posts:
Banning Defective Medical Devices: Report Raises Questions About Whether FDA is Doing Enough to Protect People, North Carolina Injury Lawyer Blog, November 24, 2010

Medical Device-Related Complications Send Over 70,000 Children to the ER Every Year, North Carolina Injury Lawyer Blog, November 24, 2010

Supreme Court Places New Limits on Products Liability Lawsuits Filed Against Medical Device Manufacturers, North Carolina Injury Lawyer Blog, February 20, 2008

Banning Defective Medical Devices: Report Raises Questions About Whether FDA is Doing Enough to Protect People

November 24, 2010, by Michael A. DeMayo

A new report published in BMJ, a British medical journal, is questioning the US Food and Drug Administration’s ability to keep defective and dangerous medical devices out of the market. The paper contends that inadequate manpower, an insufficient budget, lack of authority, and the agency’s co-opting by special interests, medical devices makers, and political forces are rendering the FDA unable to do its job to protect the public.

The authors of the study, Dartmouth Institute for Health Policy and Clinical Practice instructor Shannon Brownlee and medical investigative journalist Jeanne Lenzer, talk about the deficiencies in the FDA’s post-approval surveillance process. For example, since the agency approved the vagus nerve stimulator (VNS) by Cyberonics 13 years ago, there have been reports of approximately 900 deaths involving people that used the medical device. The FDA still does not know what caused these fatalities or if a VNS even was a cause of death. Some 60,000 people are currently using a VNS, which is designed for treating epilepsy and is also approved treating depression. Cyberonics is seeking to widen the approval for VNS so that it can be used for treating traumatic brain injury, stroke, and obesity.

Recently, the FDA took back its approval of the Menaflex Collagen scaffold knee replacement device. The agency admitted that it approved the medical device without properly researching it because of political pressure and the flexible requirements that exist to fast-track certain devices. Under the 510(k) program, new medical devices can be approved quickly if their makers can show that the product works in the same that other medical devices currently in the market do.

In August, DePuy Orthopaedics recalled about 93,000 artificial hips over concerns that the medical devices had a 12 – 13% failure rate. Metal particles from the implants have also been known to cause cobalt toxicity.

Our Charlotte, North Carolina defective medical device lawyers know that it can be very upsetting to discover that you or your loved one developed health issues or now have to undergo yet another medical procedure because the manufacturer of your medical device was negligent.

Is the FDA doing its job?, Washington Post, November 3, 2010

Why the FDA can’t protect the public, BMJ, November 2010

FDA Determines Knee Device Should Not Have Been Cleared for Marketing, FDA, October 14, 2010

DePuy ASR Hip Replacement Products Recalled, North Carolina Injury Lawyer Blog, September 16, 2010

Related Web Resources:
US Food and Drug Administration

VNS Therapy, Cyberonics

DePuy ASR Hip Replacement Products Recalled

September 16, 2010, by Michael A. DeMayo

DePuy Orthopaedics, Inc., a Johnson and Johnson unit, is recalling its ASR Hip Resurfacing Systems and ASR XL Acetabular Hip Replacement products. ASR Hip Resurfacing Systems is a partial hip replacement product, and ASR XL Acetabular Hip Replacement is a total hip replacement system. Some 93,000 patients around the world have been implanted with one of these medical devices.

The recall comes in the wake of information from the National Joint Registry (NJR) of England and Wales noting that within five years of the original hip replacement procedure involving one of these products, 1 in 8 patients had to undergo a second procedure known as revision surgery. Considering that many hip replacement patients tend to be older and may be suffering from other health issues, undergoing even one surgery can be tough and can result in complications. To have to undergo a second surgery can take an even greater toll on a patient’s health, as well as cause additional pain and suffering.

Although DePuy Orthopaedics has said that it will cover medical expenses, testing, and monitoring related to the recall, it is not known at this time what the company won’t be covering and whether patients will receive medical payments in a timely manner.

Your orthopedic surgeon can help you determine how well your ASR hip implant is working and whether you need to undergo a second surgery.

Signs of a possible problem with your ASR hip implant:

• Difficulty walking
• Pain when walking
• High level of microscopic metal particles around your hip (a blood test can help determine this)
• Dislocation of the implant
• Swelling

It is important that you contact the Law Offices of Michael A. DeMayo to find out if you have grounds for a North Carolina defective medical devices case.

Related Web Resources:
ASR™ Hip System Recall Guide, DePuy

DePuy Orthopaedics

National Joint Registry (NJR)

Charlotte, North Carolina Injury Attorney Michael A. DeMayo Now a Member of the Multi-Million Dollar Advocates Forum

August 10, 2010, by Michael A. DeMayo

Michael A. DeMayo, a Charlotte, North Carolina personal injury lawyer, is now a member of the Multi-Million Dollar Advocates Forum, one of the most prestigious groups of trial lawyers in the country. Members must have won multi-million dollar verdicts, settlements, and awards for their clients. Attorney DeMayo, who is founder and president of the Law Offices of Michael A. DeMayo, is also a Life Member of the Million Dollar Advocates Forum. Less than 1% of US attorneys belong to this group, known for its excellence in advocacy and for having obtained for at least one client an award, settlement, or verdict of $1 million or greater.

Charlotte, Personal Injury Attorney DeMayo leads a team of dedicated professionals with over 100 years of combined legal experience. They are committed to obtaining the financial recovery that their clients and families are owed by negligent parties. Our North Carolina law firm represents victims and surviving family members with all types of injury cases, including those involving medical malpractice, automobile accidents, truck accidents, slip and fall, products liability, defective medical devices, dangerous drugs, nursing home neglect and abuse, motorcycle accidents, dog bites, pedestrian accidents, and workers’ compensation. The Law Offices of Michael DeMayo is located in Charlotte, Monroe, Hickory, and Lumberton, North Carolina. We also represent clients with South Carolina personal injury cases in the counties of Marlboro, Chesterfield, York and Lancaster.

Charlotte, North Carolina Car Accident Lawyer Michael A. DeMayo is also an active member of the community. Each year, his law firm awards college scholarships to a number of high school seniors for their innovative and creative ideas on ways to stop teens from driving drunk.

Multi-Million Dollar Advocates Forum & Million Dollar Advocates Forum

Michael A. DeMayo, Esq.

Verdicts & Settlements, Law Office of Michael A. DeMayo

Medical Device-Related Complications Send Over 70,000 Children to the ER Every Year

July 27, 2010, by Michael A. DeMayo

According to a new study, more than 70,000 teenagers and children end up in the emergency room every year because of medical device complications. Other findings by the US Food and Drug Administration researchers:

• Approximately ¼ of the issues involve contact lenses use, which can lead to eye abrasions and infections.
• Hypodermic needles that break off in the skin is another common cause of medical-device-related child injuries.
• Ear tubes can cause infections.
• Illegal drug use involving hypodermic needles that break can also lead to injuries.
• Pelvic devices used to conduct gynecological exams on teenagers can cause skin tears.
• The most serious medical device-related issues involved chest catheters for cancer patient, implanted devices, and insulin pumps.

Two of the most common reasons for medical device-related to injuries to minors are misuse and malfunction. Also many medical devices used on kids were made for adults.

Our Charlotte, North Carolina defective medical devices attorneys want to remind you that you may be able to hold the manufacturer of a malfunctioning or a defective medical device liable for North Carolina products liability. Inadequate warnings or incomplete instructions can also be grounds for a case.

We know how horrible it can be to discover that the medical device your child is using is harming rather than helping him/her. In some cases, the medical professional that determined that your son or daughter should use the medical device must be held liable for North Carolina medical malpractice.

Medical Device Problems Hurt 70,000+ Kids Annually, NPR, July 26, 2010

Medical device problems hurt 70,000+ kids annually, BusinessWeek, July 26, 2010

Related Web Resources:
Injuries Among Children and Adolescents, CDC

Journal of Pediatrics

The Law Offices of Michael A DeMayo LLP, A North Carolina Personal Injury Law Firm, Supports the Fight Against Drunk Driving and Helps to Build Habitat for Humanity Homes

May 19, 2009, by Michael A. DeMayo

This month, The Law Offices of Michael A DeMayo participated in two community service events. The first event was Walk Like MADD, which is hosted by Mothers Against Drunk Driving. Charlotte Personal Injury Attorney Michael A DeMayo served as the honorary chair for the annual 5k walk, which took place on May 2. Proceeds from the walk will go toward helping drunk driving victims and fund programs to prevent underage drinking and drunk driving.

Over two dozen of the North Carolina injury law firm’s employees and their families took part in the event. Together, they helped raise over $2,500. Attorney DeMayo and his staff are familiar with the struggles that drunk driving accident victims and their families face. He and his law firm represent North Carolina and South Carolina clients that have been injured and those whose loved ones have died in drunk driving accidents in their pursuit to recover personal injury or wrongful death compensation from all negligent parties. Just last year, the National Highway Traffic Safety Administration reported that both states experienced the largest spike in DUI fatalities among all US states between 2006 and 2007.

This past Saturday, employees from the Charlotte branch of the Law Offices of Michael A DeMayo participated in another event, this one at a Habitat for Humanity house. They pulled up their sleeves and spent the morning hanging dry wall at the home, which is being built for a low-income family. The North Carolina personal injury law firm, which also has law offices in Monroe and Hickory, made a $15,000 donation to this worthwhile cause.

Attorney DeMayo praised Habitat for Humanity for helping so many people in the Charlotte community that are in need of affordable housing. He also touted the benefits that his employees reaped by volunteering for this “great, team building” experience.

The Law Offices of Michael A DeMayo, LLP also helps clients with injury or wrongful death cases involving medical malpractice, nursing home abuse or neglect, defective medical devices, products liability, dog bites, and workers’ compensation.

Related Web Resources:
Walk Like MADD, Charlotte, NC

Habitat for Humanity, Charlotte

NHTSA Ranks North Carolina and South Carolina as Two US States With Greatest Increase In DUI Deaths, North Carolina Injury Lawyer Blog, September 2, 2008

Johnson & Johnson Recalls Defective Duragesic Pain Patches

January 5, 2009, by Michael A. DeMayo

Johnson & Johnson is announcing the recall of two lots of Duragesic pain patches. The recall, by its PriCara Division, is being issued because tears in the patches could expose users to the product’s gel and may result in an overdose. The recalled patches were made by ALZA Corp.

Recalled lots include:

• Duragesic 50 mcg/hr patches, lot number 0817239
• Sandoz Inc 50 mcg/hr patches, lot number 0816851

J & J is conducting the recall with the Food and Drug Administration. This is not the first recall involving improperly sealed Duragesic pain patches. In February 2008, J & J recalled some 32 million Duragesic Pain Patches over similar concerns. In 2004, Janssen Pharmaceuticals Products recalled 75 patches over leakage concerns also.

In 2007, the Food and Drug Administration issued a warning that accidental overdoses have been associated with use of the pain patch. The FDA has received over 100 reports of deaths that may have been related to use of fentanyl pain patches.

Duragesic, also known as fentanyl, is an opioid pain reliever that is 100 times stronger than morphine. You are not supposed to use fentanyl if you have drug allergies or a history of mental illness, seizures, breathing problems, heart problems, drug or alcohol dependence, low blood pressure, depression, liver disease, kidney disease, a brain tumor, or a head injury. Direct skin exposure to the gel that is inside the patch can cause respiratory problems, nausea, drowsiness, sedation, serious health complications, or lead to fatal overdoses.

Direct Exposure to Duragesic’s Gel:
If you or anyone has come into direct contact with fentanyl gel, it is important that you wash the skin completely with water only. Do not use soap or rub the skin too much. Do not directly handle patches that are torn or have cut edges. Use gloves or tissue instead. You can also get rid of the patches by flushing them down the toilet.

Medical device makers and pharmaceutical drug manufacturers are supposed to make sure that their products are safe for consumer use and free from defects that can cause illness, injury, or death. If you or someone you love was injured by a defective or dangerous medical device, you may be able to file a products liability claim or lawsuit against the negligent manufacturer.

J&J Recalls Two Lots of Pain Patch, The Wall Street Journal, December 31, 2008

Duragesic Patch Recall Adds to Johnson & Johnson Patch Woes, News Inferno, February 13, 2008

Related Web Resources:


Johnson & Johnson

US Food and Drug Administration

Boston Scientific Sued for Wrongful Death Caused By Defective Cardiac Defibrillator

May 20, 2008, by Michael A. DeMayo

The family of a man who died after he was implanted with a cardiac defibrillator is suing Boston Scientific for his wrongful death. They allege that the defibrillator was defective and caused his death. Boston Scientific used to be called Guidant Corp. Also named as defendants in the products liability lawsuit are Guidant Puerto Rico Corp. and Guidant Sales Corp.

Joseph Robert was implanted with an Implantable Cardioverter Defibrillator (ICD), a Medtronic InSync Sentry defibrillator with Guidant leads, on October 26, 2000. This device is designed to monitor the person’s heart and when there is rapid, abnormal heart rhythm, the ICD is supposed to send energy to the heart muscle so that the heart can beat at a normal rate again.

In 2005, Roberts was admitted to a hospital for an ICD upgrade to a Vitality 2 biventricular automatic implantable cardioverter-defibrillator. His original ICD was being replaced because it had been found defective and dangerous. Roberts died nearly three weeks after the second device was implanted.

Patsy Roberts, one of the plaintiffs in this products liability wrongful death case, says that in 2007, she found out that Boston Scientific recalled the Vitality 2 because it was considered dangerous and defective also.

The plaintiffs claim that the defendants were grossly negligent and engaged in fraud, misrepresentation, breach of express warranties, breach of continuing duty to warn, breach of implied warrant of fitness, and breach of warrant of merchantability. They also say that the defendants violated the Texas Deceptive Trade Practices-Consumer Protection Act.

They are asking for damages for Joseph’s pain, suffering, and mental trauma before he died, as well as for their own pain and suffering, loss of consortium, loss of affection, grief, and other associated costs.

In North Carolina and South Carolina, our defective medical device lawyers have represented victims and their families whose lives have been catastrophically affected by a defective Guidant cardiac defibrillator. We believe that manufacturers of defective medical devices and the other liable parties should be held financially liable for your pain, suffering, and associated costs.

Wrongful death suit filed against Boston Scientific over cardiac defibrillator, Southeast Texas Record, April 21, 2008

Sudden Cardiac Deaths, Get the Facts 2006,

Related Web Resources:

Boston Scientific

FDA: Some Guidant Defibrillators Recalled, WebMD, June 17, 2005

Supreme Court Places New Limits on Products Liability Lawsuits Filed Against Medical Device Manufacturers

February 20, 2008, by Michael A. DeMayo

Now, more than ever, it is important to speak with an experienced defective medical device attorney to discuss your case. In an 8-1 vote today, the U.S. Supreme Court voted to place new limits on defective medical device lawsuits filed against Medtronic Inc. and other medical device manufacturers: Patients cannot sue a medical manufacturer if the product that caused the injury was cleared by a strict federal review process.

In this latest case, the Supreme Court barred a lawsuit filed by the widow of a man who was permanently injured when his Medtronic heart catheter burst while he underwent angioplasty surgery. The Medtronic product had been gone through the U.S. Food and Drug Administration’s pre-market approval process. When the device burst, the patient developed a complete blockage and had to undergo emergency bypass surgery. He died three years ago.

The Bush administration and medical device manufacturers had both argued in favor of precluding state law claims with the more rigorous pre-market review process.

This new ruling could work in favor of medical devices makers that have been named as defendants in the thousands of defective products lawsuits that are still pending. It could also work in favor of drug manufacturers. Drug makers are also trying to get the U.S. Supreme Court to place limits on lawsuits filed by people injured from taking a dangerous or defective drug.

Lawsuits that will be most impacted by the ruling are cases involving medical devices that have undergone the FDA’s yearlong pre-market approval process. This is an arduous process, which is why only 43 new applications were filed in 2005. A fast-track review is available to new devices that are similar to products that are already being sold in the marketplace.

The Supreme Court’s ruling does leave room for defective medical device lawsuits filed under state rules that are considered parallel to federal requirements.

Our North Carolina and South Carolina defective products law firm has helped many injured patients and their families recover compensation from medical device makers and drug manufacturers. We have the experience and resources to help you explore your options and take the necessary and available steps to pursue your case.

Patient Medical-Device Suits Curbed by Top U.S. Court,, February 20, 2008

Justices Make It Tougher to Sue Medical Device Makers, The New York Times, February 20, 2008

Related Web Resources:

Read the Supreme Court Decision, Justia & Oyez

Medtronic, Inc.

Medtronic Injury Case Before the Supreme Court Will Impact Fate of Defective Medical Device Lawsuits

January 17, 2008, by Michael A. DeMayo

Medical device manufacturer Medtronic wants the U.S. Supreme Court to rule that medical device makers are exempt from products liability lawsuits, if a device that caused the injury is FDA approved.

The specific case, Riegel v. Medtronic, stems from a personal injury lawsuit filed by the family of Charles Riegel, a man whose Medtronic-manufactured balloon catheter burst while he was undergoing a medical procedure to clear his arteries.

In the lawsuit against Medtronics, Riegel cited negligent design and labeling and manufacturing issues. The catheter was FDA approved. The lawsuit was thrown out at both the U.S. District Court level and the US Court of Appeals level before arriving at the Supreme Court.

Medtronics claims that amendments to the Food, Drug, and Cosmetic Act say that FDA-approved medical devices are preempted from product liability lawsuits in state civil courts. The amendments, however, do not say that federal standards are preempted by state common law claims. This, however, is what Medtronics is claiming and the Bush Administration supports with the device maker’s assertion.

If the Supreme Court decides that Medtronics is right, anyone injured by a defective medical device won’t be able to file a personal injury claim or lawsuit.

Last December, Medtronics agreed to pay $114 million to settle 2,682 products liability lawsuits by people who had used the company’s Marquis implanted cardiac defibrillators. A battery problem had caused some of the defibrillators, implanted in patients at risk of heart attacks, to fail. ICD’s had to be surgically replaced in 11,000 patients.

Last year, Medtronic announced an international recall of heart-defibrillator wires, which were fracturing at a rapid rate. Some 235,000 people have these wires implanted in their chests.

If you have been injured or suffered health problems or have had to undergo a medical procedure because of a defective medical device, you should contact our North Carolina or South Carolina products liability law firm immediately.

Medtronic Supreme Court Case Could Have Dire Consequences for Consumers Injured by Defective Medical Devices, NewsInferno, January 3, 2008

Medtronic to Pay $114 Million In Settling Heart-Device Suits, The Wall Street Journal, December 21, 2007

Related Web Resources:

Riegel v. Medtronic, Supreme Court Docket



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