Category

Defective Medical Devices

Zimmer Kinectiv Hip Implant Trial Ends in $2 Mil. Verdict for Injured Plaintiff

By | Defective Medical Devices, Metal on Metal Hip Replacement | No Comments

Plaintiff awarded more than $2 million in Zimmer Kinectiv hip replacement case decided at trial. He is represented by Boca hip replacement lawyer Joe Osborne.

 

In what is believed to be the first case involving a Zimmer Kinectiv hip implant system that went to trial, the judge found the defendant responsible for the plaintiff’s injuries, awarding him more than $2 million. After a two-week trial in Albuquerque, New Mexico, the judge found that the hip implant was a defective product and it caused a number of injuries to the plaintiff, Michael Brian McDonald, PhD.

Joseph Osborne, Jr., of Osborne & Francis in Boca Raton, Fla., represents Dr. McDonald, along with other plaintiffs around the country suing hip implant manufacturers due to injuries caused by the devices. “We are very happy for Dr. McDonald and satisfied that our efforts lead to compensation for all the serious medical problems, pain and suffering he needlessly had to endure and will continue to endure,” Osborne says.

Osborne tried the case with Randi McGinn and Allegra Carpenter of McGinn, Carpenter, Montoya & Love, P.A., of Albuquerque, N.M. There are a number of cases filed against Zimmer because alleged defective implants have caused injuries to patients.

In a 27-page decision filed on March 31, New Mexico Judge Nan G. Nash found that,

  • McDonald was implanted with Zimmer’s M/L Taper Hip Prosthesis with Kinectiv Technology in June 2010. Due to problems with the hip implant another surgery took place in October 2011 to replace it, then a third surgery was needed a month later for another replacement.
  • McDonald was poisoned by metallic particles (metallosis) from the replacement hip. Tissue in the hip area was so injured it couldn’t be surgically removed and it poses an ongoing threat of infection for McDonald, who his expected to continue to take antibiotics for the rest of his life.
  • The Zimmer hip replacement system limited McDonald’s functions, caused him pain, infections, multiple surgeries and although he’s currently is doing well, another hip replacement surgery may be needed at some point in the future.
  • A hip implant should not cause metallosis. A small amount of non-toxic corrosion or metal debris may occur with a hip implant, but one that causes enough corrosion or metal debris to cause toxic metal poisoning, as in Dr. McDonald’s case, creates an unreasonable risk of injury.
  • Zimmer didn’t fully or adequately test the hip implant components implanted in Dr. McDonald and because of the unreasonable risk of metallosis the hip replacement was found to be defective product and it created an unreasonable risk of harm to McDonald because it allowed the liberation of enough metal debris to injure his hip joint.

The total damages award, which doesn’t include punitive damages, totals $2,027,424.91. It includes,

  • $1 million for past and future pain and suffering,
  • $480,000 for lost enjoyment of life, and
  • $462,034 for past and expected future medical expenses.

“Dr. McDonald is just one of thousands of people who have suffered through defective hip implants made by various manufacturers. We have a lot of work to do for all our other clients and look forward to telling their stories and fighting for just compensation for what they’ve had to go through,” Osborne says.

If you or a family member have any questions about defective hip implants or have suffered injuries because of the Zimmer, or other, hip implant, contact Boca Raton hip replacement lawyer Joe Osborne at (561) 800-4011 or fill out this online contact form. You can discuss your case, how the law may apply and your best legal options to protect your rights and obtain compensation for your injuries.

Press Contacts:

Joe Osborne
josborne@realtoughlawyers.com
561-800-4011

Dennis Faulkner
dfaulkner@realtoughlawyers.com
561-800-4011

Defective Hip Replacement Attorney in Boca Raton Discusses the Implant Disaster

By | Defective Medical Devices | No Comments

Patients should be aware of possible risks and lifelong disabilities from failed hip implants says Joe Osborne defective hip replacement attorney in Boca Raton.

People have artificial hips implanted because the ones they were born with have deteriorated to the point the pain and lack of mobility is just too much. Joe Osborne, a defective hip replacement attorney in Boca Raton states “Unfortunately for many people who tried to solve the problem with a metal on metal artificial hip, one set of problems have been replaced by a new set of problems. These failed, defective hip replacements are arguably the worst disaster in orthopedic history. A conservative estimate is that 10% of all replacement hip implants will fail at some point,” adds South Florida attorney Joe Osborne.

There are a number of injuries that can occur due to defects in artificial hips. They’re associated with the consequences of the corrosion of the implants and metallosis (metal poisoning, caused by metal leaching out of the metal joints which rub together) of the hip joint.

The corrosion and metal products are toxic to the hip joint. They cause destruction of tissue, muscle and bone, which requires additional surgery that would never have been needed but for the harm caused by the hip implant.

Even after the defective hip implant is removed and replaced the damage done can limit one’s physical abilities and cause pain indefinitely.

The dead tissue surrounding the hip; dead bone and dead muscle leave the joint either unstable or damaged forever as a result of the defective hip implant.

Over time complications from the removal surgery can appear, including the need for additional surgeries and potential infections, all resulting from the damage caused by the failed hip implant.

One example of the dangerous domino effect caused by defective replacement hip implants is illustrated by one client who we represent.

He worked in the construction industry and owned a very successful construction business. The client worked on roofs, laid tile and helped build houses.

Because of the implant and the physical nature of his work the damage to his hip joint was severe.

Even after the failed hip implant was removed, the destruction was so advanced that he has needed multiple surgeries to try and deal with the amount of tissue and bone that was destroyed by the toxic particles and the metallosis.

The client’s hip will never be the same. He walks with a cane. He lost his construction business and his life has been permanently scarred simply because he received an implant that is one of the biggest catastrophes in the history of orthopedic implants.

People more susceptible to these types of problems, according to the U.S. Food and Drug Administration, include females and those with,

Hip replacements on right and left hips,

Resurfacing systems with small femoral heads (less than or equal to 44 mm),

High doses of corticosteroids,

Kidney problems,

Suppressed immune systems,

Hip components not in ideal positions,

Suspected metal sensitivity (including cobalt, chromium and nickel)

Problems with obesity, and

High levels of physical activity.

If you suspect that you are having problems with your replacement hip implant then a defective hip replacement attorney in Boca Raton at Osborne & Associates can review your model and manufacturer, and can discuss your legal rights to compensation for the pain, suffering, physical limitations, additional medical treatments and impact on your life, relationships and ability to work. We can discuss how the law may apply and the best ways to protect your legal rights and interests. Call (561) 800-4020.

Boca Raton Medical Injury Attorney Osborne Reports IVC Filters Have Hidden Risks

By | Defective Medical Devices | No Comments

According to Boca Raton medical injury attorney Joseph Osborne, Inferior vena cava (IVC) filters are designed to prevent serious injuries but can cause them if they are defective or in the patient’s body too long.

Boca Raton medical injury attorney Joseph Osborne says, probably all medical devices started with a good idea and good intent. There was a medical problem that a person, or team of people, thought they could solve. Over time and with effort their idea became a product and it was put into the market. Too frequently this good intent and hard work actually ends up harming some patients, notes defective medical device  attorney Joseph Osborne. That’s what happened with the inferior vena cava (IVC) filter. If you have had one surgically implanted but not removed you may be in danger.

The inferior vena cava is the largest vein in the human body. It’s formed by the joining of the two common iliac veins at the level of the fifth lumbar vertebra in the spine and returns blood to the right atrium of the heart from bodily parts below the diaphragm, explains Boca Raton medical injury attorney Osborne.

The filter, which is a cone shaped set of wires, is surgically placed in the vena cava of those who are at risk of pulmonary embolism. That is the sudden blockage of a major blood vessel in the lung, usually by a blood clot. In most cases these clots are small and not life threatening, but they can damage the lung. If the clot is big enough it can stop the blood flow to the lung which can be fatal.

Retrievable IVC filters were designed to protect people temporarily from suffering a pulmonary embolism by preventing the movement of blood clots into the lungs. Permanent filters have long term side effects these filters were designed to avoid, however, many of these removable IVC filters are mistakenly being left in place too long or indefinitely.

The federal Food and Drug Administration (FDA) issued a safety warning in 2010 (which was updated in 2014) recommending that physicians caring for those with IVC filters consider removing them when the danger of a pulmonary embolism or a blood clot has passed. The FDA took this action because of possible long-term complications from IVC filters, including death due to a filter breaking up, moving within the body or poking through the vena cava.

The dangers of IVC filters reached the public’s attention in September of last year when NBC News ran a story of injuries caused by their use. They reported,

·           At least 27 deaths and 300 injuries have been connected to these IVC filters.

·           Some of the injuries reported in the story included a filter breaking up with parts reaching one patient’s heart or the entire filter reaching another patient’s heart causing his death.

NBC News reported that after injuries and deaths became known the manufacturer hired a public relations firm to lessen their impact on the company and its sales (34,000 were sold before an improved version was introduced) spending its resources to protect its image instead of protecting its patients.

The company also hired an outside physician study of the filter and resulting injuries and deaths. The results, intended to be confidential but obtained by NBC News, were that these IVC filters had higher rates of relative risk for death, filter fracture and movement than all its competitors. “Further investigation is urgently warranted,” the author wrote. NBC found that the manufacturer had known for years about high risks of serious injuries and deaths due to its IVC filters.

If you have had an IVC filter implanted in you and it has not been removed you should contact your physician to discuss the dangers you’re facing and whether the filter should be removed. If you have such a filter, been injured by one, a family member has one or has been injured or killed by an IVC filter time is of the essence. Contact our office  so you can talk to a medical device liability attorney about your situation, how the law may apply in your case and your best legal options for obtaining compensation.

.

FDA Regulations on Transvaginal Mesh Products Increased

By | Defective Medical Devices, Medical Malpractice, Medical Products Lawsuit, Transvaginal Mesh, Transvaginal Mesh Lawsuit, Transvaginal Mesh Products | No Comments

Regulations on Transvaginal Mesh Products Increased by the FDA

Transvaginal mesh products have been used since the early 1990s with very little regulatory oversight. In the more than twenty years that followed, thousands of patients suffered unanticipated complicated and injuries due to the implant. As of January 4th of 2016 the FDA has announced that there are increased regulations for transvaginal mesh devices.

This has been a slow process for the FDA to take action. Studies conducted throughout 2008-2010 showed that the devices were becoming progressively dangerous for their recipients. The FDA even found that other natural means may be more effective than these artificial implants. Despite this information, manufacturers have knowingly continued to sell these dangerous implants. According to Boca Raton defective medical device attorneys, this knowing endangerment of consumers creates a great deal of potential liability for people that have received these transvaginal mesh implants.

These new regulations do not mean that consumers are out of danger. Some components of the regulations do not really impact the device manufacturers until 2018. Our leading Boca Raton medical device liability attorneys are concerned there will be many more innocent victims who receive these dangerous implants and suffer injuries as a result before the FDA protects them. Your only recourse is taking legal action to hold the manufacturers financially accountable.

There are 34 transvaginal mesh manufacturers in the United States. There are tens of thousands of potential victims that are suffering injuries from these faulty implants. Anyone that has one of these devices, even without current complications, is encouraged to speak with both a medical doctor and a products liability attorney to learn about their rights and options for ensuring their well-being.

You should be proactive if you have had a transvaginal mesh product implanted. At Osborne & Francis Law Firm PLLC, our Boca Raton transvaginal mesh device attorneys have already successfully recovered millions of dollars in compensation for these victims. Call us at 561-293-2600 or contact us online to schedule a free initial consultation to discuss your legal options.

Defective Inferior Vena Cava Implants

By | Defective Medical Devices, Wrongful Death | No Comments

Defective Inferior Vena Cava Implants Leading to Products Liability Lawsuits

Three major medical device companies (Gunther, C.R. Bard, and Cook Medical) are facing significant lawsuits for the defective inferior vena cava (IVC) implants they manufactured. The devices were intended to mitigate blood clots, but have had dire consequences for their recipients. Expert Boca Raton product liability attorneys estimate monetary damage pools for the subsequent lawsuits to range in the hundreds of millions of dollars.

The injuries these IVC devices have caused range from deep tissue damage to pulmonary embolisms, and even death. Manufacturers are responsible under product liability laws for the safety of the products sold. They at least have a duty to warn consumers about product dangers. Our Boca Raton defective medical device attorneys say manufacturers fell short by not warning patients about the dangers of the IVC implants.

Liability for victims in these cases depends on the extent of the harm that they have suffered. Individual plaintiffs that are younger professionals that die as the result of the IVC device are legally entitled to more damages than plaintiffs that are older and only suffer tissue damage from their devices. Even minor damage can lead to significant settlement for plaintiffs. Potential plaintiffs should speak with an experienced Boca Raton products liability attorney to learn about their rights and legal options regarding their IVC device.

There are nearly a quarter million of these implants that are put into peoples’ bodies each year. Gunther, C.R. Bard and Cook Medical have hundreds of thousands of potential plaintiffs that could recover settlements from these manufacturers. The potential liability for these companies could reach into the hundreds of millions of dollars in damages to the victims that have been harmed by these defective devices.

The medical product liability attorneys at Osborne & Associates Law Firm, P.A. proudly serve clients throughout Palm Beach, Dade & Broward counties. Call us at 561-293-2600 or contact us online to schedule a free initial consultation to discuss your case.

Bard sells bad blood filters

By | Defective Medical Devices, Hospital Negligence | No Comments

Medical Device Manufacturer Knowingly Sells Dangerous Blood Filters to Innocent Patients

People entrust implanted medical devices to make their lives better and keep them healthy. Although it is understandable that medical devices may sometimes fail, it is unconscionable to think a medical device manufacturer would knowingly enable inherently dangerous medical devices to be implanted into patients. C.R. Bard has put hundreds of thousands of patients at risk with their G2 and G2 Express blood clot filters.

The G2 Express devices were put on the market after the G2 devices were known to cause deaths to several patients in Florida. However, the G2 Express was nearly identical to its predecessor and confidential documents from the company show that Bard knew that the G2 Expresses were as dangerous as the G2 units. Defective medical device attorneys say that people in the Boca Raton area are particularly at risk for having one of these faulty implants due to the local demographics.

The executives at Bard made a profit-driven decision to endanger people’s lives in order to maintain their bottom lines. They deserve to be held financially responsible for all of the victims they have put at severe risk and harmed. According to Boca Raton defective medical device attorneys, punitive damages are more likely to be applicable in cases like this where a business knowingly risks peoples’ lives. Bard has some accountability owed towards every one of the more than 160,000 people that received one of the G2 Express devices.

There is only one way to get corporations like Bard to stop putting profits before the lives of consumers. Defective medical device victims need to hire our experienced Boca Raton personal injury attorneys to recover financial compensation and nullify the profits recovered from their nefarious actions.

Call today to discuss your legal options if you were the recipient of a Bard medical implant. At Osborne & Associates Law Firm, P.A., our Boca Raton defective medical devices attorneys offer free initial consultations to inform you of your rights. Call us at 561-293-2600 or contact us online to make an appointment.

Update On Stryker Hip Lawsuits

By | Defective Medical Devices, Hip Replacements, Medical Products Lawsuit, Medical Products Liability, Metal on Metal Hip Replacement, Stryker Hip Replacement | No Comments

Update on Stryker Hip Lawsuits

With compensation payments under the Stryker hip replacement settlement agreement almost complete, what’s next for other victims of the ABG ii modular-neck hip stem and rejuvenate modular-neck hip stem devices?

A settlement arrangement for damage caused by these products was reached late last year that covered eligible claimants who underwent revision surgery prior to November 2, 2014. Originally, these patients were only given a few weeks to enroll, though the deadline was extended many times, finally closing on April 16, 2015. Stryker informed the courts on June 12, 2015 that 95% of patients who were eligible to file under the settlement had enrolled in the program. Stryker estimated that payment distributions, which will likely exceed $1.4 billion, would be completed this fall.

By no means has the chapter closed on this issue, however. Patients continue to experience problems, and there are certainly many other potential victims out there that were not eligible for the recently closed settlement program.

Patients continue to experience problems due to Stryker’s hip implant products

The U.S. Judicial Panel established multidistrict litigation in June 2013 for ABG II and Rejuvenate lawsuits in U.S. District Court for the District of Minnesota. MDL 13-2441 occurs on a federal level. Patients throughout the United States who wish to bring federal claims against Stryker for damages they have suffered due to the company’s hip implants are typically transferred to this centralized multidistrict litigation.

The initial settlement program, that is now closed, paid compensation to about 4,000 claimants. But approximately 20,000 patients received ABG II or Rejuvenate hip implants. In January, more than 2,000 cases were pending as part of MDL 13-2441, and the numbers make it evident that new claimants will continue to file for yet some time. It’s not yet known whether the company will enter into a new settlement agreement to establish a program to address the yet uncompensated victims of their products. But the Stryker 2015 third quarter market report demonstrates that the company appears to be operating strongly with increasing net sales.

At Osborne & Associates, P.A. our team of medical products and device liability attorneys are skilled in handling complex medical device injury claims, such as Stryker hip replacement injuries. We understand these multi-jurisdictional cases and our combined experience spans more than five decades. If you or someone you care about has experienced problems due to a Stryker hip implant device, please call us at 561-293-2600 or contact us online to discuss your case in-depth.

Stryker Hip Replacement Cases Find Way to Court

By | Defective Medical Devices, Hip Replacements, Medical Products Lawsuit, Medical Products Liability, Metal on Metal Hip Replacement, Stryker Hip Replacement | No Comments

Problematic Hip Replacement Cases Find Way to Court

Osborne & Associates Law Firm, P.A. takes its first Stryker hip replacement failure case to trial

Boca Raton, FL.—A surge of newly filed lawsuits across the country are drawing attention to legal issues involved specifically around Stryker hip replacements. Osborne & Associates Law Firm, P.A., a leading mass tort law firm in Boca Raton, Florida sends its first Stryker hip case to trial this December.

Stryker voluntarily recalled its Rejuvenate, ABG II and Accolade modular-neck hip stems in 2012 after the implants showed signs of corroding and fretting, according to DrugWatch. Severe, crippling pain has led patients to mandatory revision surgeries. In addition to the discomfort, the Stryker hip replacement failures have been found to cause metal poisoning and can lead to medical concerns for the heart, nervous system and thyroid.

So far, thousands of lawsuits have been filed against the manufacturer. Some of the cases filed against Stryker include:

  • Failure to properly test the device
  • Failure to market the product correctly to doctors and the public
  • Failure to warn about dangers and risks
  • Product corrosion, leaving metal toxicity in patients

Stryker has a responsibility to supply properly designed products with warnings about risks to the public. According to Stryker, the combined recall and lawsuits could cost the company as much as $1.3 billion. Injured victims may be compensated for:

  • Medical expenses involving hip replacement
  • Healthcare and caregiver costs
  • Physical or mental pain and suffering
  • Loss of consortium or any other punitive damages

The Boca Raton attorneys at Osborne & Associates Law Firm, P.A have extensive experience successfully litigating even the most challenging cases, helping clients determine if and when to file a Stryker hip replacement lawsuit. Previously, they have helped numerous clients recover lost wages, pain and suffering and medical bills after faulty devices produced by Wright Medical caused similar medical concerns. Other successful recovery stories Osborne & Associates boasts include cases fought against the Fresenius Medical Care manufacturer for GranuFlo, a dialysis treatment product and Bair Hugger Therapy products used to treat hypothermia during surgery.

If you have a Stryker hip replacement and need help, call Osborne & Associates Law Firm, P.A. at (561) 293-2600 or visit their website at oa-lawfirm.com to schedule a free consultation. Each case is strategically crafted to help victims recover substantial compensation for their injuries. In addition to medical device litigation, the firm covers cases involving products liability, personal injury and medical malpractice.

Did a Deadly Blood Clot Filter Get FDA Approval For Use With a Fraudulent Signature?

By | Defective Medical Devices, Medical Products Liability | No Comments

C.R. Bard’s Recovery filter is linked to hundreds of injuries and several deaths, calling approval process into question

NBC News recently opened an investigation into the Recovery filter by C.R. Bard, Inc., a medical device designed to help decrease a patient’s risk of blood clots hitting the lungs or heart. Reports from hundreds of patients about serious medical issues after implantation, as well as at least 27 deaths, show that the device may cause more harm than good.

When patients or doctors argue that a medical device is defective, one of the first questions asked is about how such a product made it to the general market. Many are calling the approval process into question as it relates to the Recovery filter, since further research has highlighted the serious risks associated with implantation.

C.R. Bard’s march toward approval for this device started back in 2002, when the company hired a regulatory specialist by the name of Kay Fuller to help them obtain clearance from the Food and Drug Administration (FDA). The FDA had already rejected one of Bard’s applications. The device is a small metal trap, designed for implantation inside a patient’s inferior vena cava to stop blood clots from entering the heart or lungs.

Fuller has since shared her own concerns with the device as a result of a small clinical trial early on. She said she was not allowed to see the results of that vital performance test, raising red flags for her. When she shared those concerns with officials at Bard, she felt they did not want to hear what she had to say. According to Fuller, the company made it clear that she would not be a part of the process unless she let the issue go. Her response was to deny signing the document for the FDA application. The FDA application, however, bears her name on the signature line.

When Fuller had the chance to review the document, she was firm in her belief that it was not her signature and provided a sample of her signature to NBC News as proof. There was a notable difference in the two signatures. Fuller shared her concerns about the device with the FDA, but resigned from her position at Bard. Once C.R. Bard obtained regulatory clearance to market the Recovery filter, it was implanted in at least 34,000 patients.

If you or someone you love has suffered the consequences of the Bard IVC Recovery filter, contact premier Boca Raton defective device attorneys at Osborne & Associates Law Firm, P.A. for a consultation. We can be reached by phone at 561-293-2600 or contact us online. Our attorneys have more than 50 years of combined experience helping injured victims throughout South Florida recover the compensation they deserve.

.

See the NBC News story by clicking the links below.

Part 1 – Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?

http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536

Part 2 – Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?

http://www.nbcnews.com/health/heart-health/did-forged-signature-clear-way-dangerous-medical-device-n417246

Dangerous Blood Clot Filter May Put Patients at Risk

By | Defective Medical Devices, Medical Products Liability | No Comments

Why the Recovery filter is getting negative press for fatal and serious injuries

In a time when defective medical devices and medications are unfortunately all too common, now questions are being raised about the Recovery filter, which allegedly has put thousands of Americans at risk for deadly blood clots. Perhaps what’s most alarming about this story is not that the device has flaws- but that there is evidence indicating the manufacturer, C.R. Bard, Inc. may have known about it and sold the devices in spite of the potential risks.

The device works by inserting into a patients largest vein, the inferior vena cava, to prevent blood clots from reaching the lungs or heart — a pulmonary embolism. To date, at least 27 patients have died after having the Recovery filter implanted. According to an investigation by NBC News, there are hundreds of other patients who have suffered non-fatal issues, too.

One patient, Dodi Froehlich, had the filter implanted after a serious car accident that put her at a high risk for blood clots. Dodi considers herself lucky to have escaped death after being a victim of this supposedly-helpful filter. Just a few months after it was implanted, she passed out after getting a serious headache. What doctors discovered was that part of the filter broke off and penetrated her heart, initiating immediate and risky open-heart surgery. Even though Dodi’s life was saved by the surgeons who were able to remove the piece of the filter, other patients have suffered a deadly fate.

Shortly after patients began reporting issues with the filter, C.R. Bard hired a public relations firm. The PR firm created a crisis management plan to minimize the defective device’s impact on the manufacturer’s reputation and stock prices. Bard also hired a private physician to conduct an in-house study, the results of which showed that this particular filter came with a higher risk of fracture, movement, and death when compared to IVC filters manufactured by Bard’s competitors.

Rather than recalling the device at this point, the company continued to sell this version of the filter for three more years before replacing it with a modified device known as the G2. This development is concerning, given that nearly a quarter of a million blood clot filters are implanted in patients every year from 11 different companies, but Bard’s first version showed signs of problems early on.

If you or a loved one have been injured by a defective medical device like the Recovery filter, contact leading Boca Raton defective medical device attorneys at Osborne & Associates Law Firm, P.A. to learn about your legal options. Our office is conveniently located in Boca Raton and we serve clients in Boca Raton, West Palm Beach, Broward County and throughout South Florida. Call 561-293-2600 or contact us online.

 

Clink the links to see the full story by NBC News.

Part 1 – Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?

http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536

Part 2 – Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?

http://www.nbcnews.com/health/heart-health/did-forged-signature-clear-way-dangerous-medical-device-n417246