Virginia Personal Injury Blog - Medical Devices & Implants

“Wiihab” Proving to be a Powerful Rehabilitation Tool

Rick Shapiro — Tue, 27 Oct 2009 20:19:35 GMT

Hospitals routinely struggle to keep their patients motivated and active in the traditional rehabilitation routine. Why? Because most routines are repetitive, cause pain, and are not very exciting.

Enter the Nintendo Wii.

This popular video game system is no longer the exclusive domain of teenagers. People who were seriously injured in car, motorcycle, and truck accidents, people who suffered a stroke, and even our brave military men and women with combat wounds have discovered “Wiihab.”

Using the game console's motion-sensitive controller, Nintendo Wii games require actual body movements which mimic therapy exercises. However, since the games are entertaining and mentally engrossing, patients usually ignore or don’t even notice the rigor making Wiihab an effective form of steady rehabilitation, according to CBS News.

Our injury law firm is a big proponent of Wiihab, which is why we donated a Wii gaming system to the Lake Taylor Transitional Care Hospital in Virginia (VA). We witnessed the positive results of Wiihab. Within minutes of our donation, patients were playing, or watching and waiting to play, the Wii.

Studies are currently under way to quantify the effectiveness of Wiihab, but from what we’ve seen up to this point, it has great potential to help a lot of injured people.

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury and accident law and our attorneys have handled thousands of car and truck accident cases. Check out our case results to see for yourself. In addition, check out our FREE special reports on distracted driving and The Best Guide to Car Accident injuries in Virginia. Our primary office in based in Virginia Beach, Virginia (VA) although our lawyers hold licenses in NC, SC, WV, KY and DC. We are ready to talk to you by phone right now—we provide free initial confidential injury case consultations, so call us toll free at 1-800-752-0042. Our injury attorneys also host an extensive injury law video library on Youtube . Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

Originally posted at InjuryBoard by Rick Shapiro

X-Ray Risks: Steps You Need To Take to Reduce Radiation Exposure

Rick Shapiro — Thu, 22 Oct 2009 08:59:00 GMT

X-rays, by in large, are a great medical tool which assist doctors in making diagnoses and provide an internal view of the human body without making surgical incisions. However, this technology is not 100 percent safe. There are inherent risks due to the fact that X-rays rely on radiation (as the name implies). As an injury lawyer who represents people adversely effected by radiation exposure, this issue is important to me.

The most disturbing risk is the development of cancer. High frequency and exposure to radiation has been shown to cause genetic damage which leads to cancer, according to the American Cancer Society. Studies show that young people are at a higher risk due to the fact that they accumulate more radiation exposure over the years. Surprisingly, women are more susceptible to cancer development from X-ray exposure than men, even with the same level of exposure.

Here’s a video discussing the risks associated with X-rays:

http://www.youtube.com/watch?v=NWqfAjpr1iQ

There’s also a chance of developing cataracts and skin burns from X-rays. Once again, this usually occurs when you’re exposed to high levels of radiation and with fluoroscopy (i.e. continuous x-ray imaging) procedures, according to the FDA.

These risks do not mean you should avoid X-rays. Here are some simple steps you should follow when it comes to handling X-ray exposure:

Ask if you can use a lead apron or shield can be used
Don’t always ask for an X-ray
Ask your dentist if they use E or F speed film for X-rays since these films are much more efficient and reduce exposure
Remain aware of your X-ray history

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury and accident law and our attorneys have experience handling medical malpractice cases. Check out our case results to see for yourself. In addition, check out our FREE special reports on the Top 10 Tips from a Medical Malpractice Insider and the top 5 surgical errors you must know about. Our primary office in based in Virginia Beach, Virginia (VA) and we also have a North Carolina (NC) law office. Our lawyers hold licenses in NC, SC, WV, KY and DC. We are ready to talk to you by phone right now—we provide free initial confidential injury case consultations, so call us toll free at 1-800-752-0042. Our injury attorneys also host an extensive injury law video library on Youtube . Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

Originally posted at InjuryBoard by Rick Shapiro

Controversial Medical Device - Menaflex - Approved By FDA

Greg Webb — Wed, 07 Oct 2009 17:11:15 GMT

In a bid to get a controversial knee-surgery device known as Menaflex approved by the Food and Drug Administration (FDA), ReGen Biologics relied too heavily on two consultants with strong ties to Congress and the FDA. One consultant previously worked as the FDA’s associate chief counsel for medical devices and had regular contact with the agency about the device; the device was approved last December despite staff objections. Another top ReGen consultant is the former chief of staff to Senator Robert Menendez, who was among four lawmakers that signed a letter urging the FDA to review the case. Campaign finance records also show that one of these consultants contributed about $40,000 to Menendez and the other three New Jersey politicians that signed the letter.

The two consultants were part of an aggressive campaign by ReGen to obtain approval for Menaflex, which is a surgical mesh used to aid in repairing torn knee tissue. FDA staff scientists rejected Menaflex three times, citing concerns that patients may experience adverse effects and that the manufacturer had not provided enough evidence that the device was more effective than routine surgery. However, in late 2008, ReGen appealed to Andrew von Eschenbach, the FDA Commissioner, who ordered an expedited review by a panel of independent advisers, allowed ReGen input regarding the composition of the panel and refused to permit FDA staff scientists who had been reviewing the Menaflex applications to address the panel. An internal probe found ReGen had remarkable access to von Eschenbach and approval came after he met with the New Jersey legislators who asked von Eschenbach to handle the matter personally. According to the Center for Responsive Politics, ReGen has spent $500,000 lobbying in Washington since 2007. Three of the company’s executives also gave substantial sums of money to the campaigns of the lawmakers that signed the letter to the FDA, though the congressmen’s aides claim the contributions played no role in their decision to approach the FDA.

The exposure from this ReGen case and how the FDA is now considering approving the Menaflex has alarmed not only public interest groups seeking FDA reforms, but also the $200 billion medical device industry, which is also seeking changes to health-care reform legislation making its way through Congress.

Originally posted at InjuryBoard by Greg Webb

Hospitals In VA, MD, DC Must Report Avoidable Mistakes

Greg Webb — Thu, 06 Aug 2009 14:11:50 GMT

Over the past year, there have been hundreds of incidents of death or serious medical harm that were disclosed by hospitals in the Washington DC area, preventable errors that until recently have not required public reporting. Under laws that took effect last year in Virginia and a few years earlier in DC and Maryland, hospitals must report to health officials the many serious injuries that patients may suffer in the course of treatment. For example, in one case in DC, a patient was readmitted to the hospital complaining of serious leg pain after the surgeon operated on the wrong part of his spine.

While the public record in Virginia discloses the names of the hospitals involved, DC’s and Maryland’s do not. All three regions, however, give the American public a glimpse into the mistakes health experts call “never events”, because they should never happen: operations on the wrong body part, sponges being left in patients after surgery, and medication errors. At least twenty states require hospitals to report any incidence of hospital-acquired infection as well.

Patients, insurers and regulators are beginning to use this information to nudge health-care providers to ensure that such events never happen. In the past, insurance companies were billed when a doctor, nurse, or technician was responsible for injuring a patient; Maryland health regulators estimate that insurance companies paid $522 million last year to cover preventable complications in hospitals, which occurred in 55,000 of the state’s 800,000 inpatient cases. Now, however, many private and public insurers are following Medicare’s lead by refusing payment as a punishment to hospitals. They hope this act will encourage hospitals to make improvements in their system of care. For example, they will not pay for treating a urinary tract infection caused by a catheter.

In Maryland, the hospital association has agreed not to bill insurance companies for eight mistakes, such as transfusions using the wrong blood type and surgery on the wrong side. As part of a new initiative program, the state commission will begin ranking its hospitals on how often they commit fifty-two preventable mistakes; hospitals that commit the most mistakes will be required to bill insurers at a lower rate than hospitals who commit fewer mistakes. Fines will also be implemented as punishment for mistakes.

Additionally, the hospital association in Virginia has agreed not to bill insurance companies for several errors caused by hospital staff. Anthem Blue Cross and Blue Shield, Virginia’s largest private insurer, has stopped paying hospitals for four surgical mistakes: when the wrong body part is operated on; when the wrong procedure is done; when a foreign object is left in the patient requiring additional surgery, and when the wrong patient is operated on.

Finally, in DC, hospitals, nursing homes and clinics have reported 529 mistakes form July 2007 to June 2008; fourteen of these led to the death of a patient. So far, the District has tried not to use financial incentives to affect the hospitals’ behavior.

Originally posted at InjuryBoard by Greg Webb

Continuous Infusion Pain Pumps Causing Cartilage Death

Michael Phelan — Tue, 21 Jul 2009 15:09:40 GMT

Studies show a strong association between the intra-articular (inside the joint space) use of high volume pain pumps following arthroscopic shoulder surgery and an otherwise unexplainable loss of hyaline cartilage in the shoulder joint. According to a study authored by Hansen, et al. and published in the American Journal of Sports Medicine, the complication, know as PAGCL, is permanent and can lead to extreme pain and lifelong suffering in 63% of the patients who receive continuous anesthetic via a post-operative pain pump.

What is PAGCL?

PAGCL is an acronym for:

Postarthroscopic (after arthroscopic surgery)

Glenohumeral (joint of glenoid fossa + humeral head)

Chondrolysis (breakdown of cartilage cells)

Symptoms of PAGCL

The symptoms of chondrolysis are experienced over a gradual period of time, with the intitial symptoms often occurring around three to four months after the pain pump's administration. Symptoms include:

-Loss of shoulder cartilage
- Shoulder joint clicking, grinding, or popping
- Shoulder pain
- Shoulder weakness or stiffness
- Decreased range of movement
- Pain of moving at joint

Did the FDA Approve Pain Pumps for Intra-articular Use?

Continuous infusion pain pumps were not approved by the Food and Drug Administration for intra-articular use. Moreover, the manufacturers of these pumps have not published any clinical studies regarding the use of intra-articular administration of continuous infusion pain medicine. While widely used and promoted by the pump manufacturers, this form of anesthetic delivery is an off-label use and poses a serious risk to 63% of the patients on whom the device is used. In January 2009, Health Canada published a "Canadian Adverse Reaction Newsletter" urging surgeons to discontinue use of pain pumps regardless of manufacturer.

To discuss your legal rights, contact us

TOLL FREE at 866-584-2904

Originally posted at InjuryBoard by Michael Phelan

Medtronic Reveals Massive Payments to Doctor Accused of Falsifying Medical Research

Michael Phelan — Thu, 18 Jun 2009 16:02:51 GMT

A former military surgeon accused by the Army of falsifying a medical journal study involving one of Medtronic's products received approximately $800,000.00 from Medtronic between 2001 and 2009, according to information released on Wednesday by the company. Medtronic said the payments to Dr. Timothy R. Kuklo were reimbursement for travel expenses, speaking engagements, training other doctors or other consulting services. The Justice Department is currently investigating whether Medtronic paid doctors like Dr. Kuklo to help market medical devices for unnaproved uses.

The surgeon, Dr. Timothy R. Kuklo, claimed in the study that the use of a Medtronic bone growth product called Infuse had proved highly beneficial in treating leg injuries suffered by American soldiers in Iraq. The British medical journal that published the article retracted it this year after an internal Army investigation found that Dr. Kuklo had forged the names of four other doctors on the study and had cited data that did not match military records. Other doctors at Walter Reed Army Medical Center, where Dr. Kuklo worked until August 2006, said that he had also overstated the benefits of the Medtronic product.

Medtronics is under investigation by the Justice Department and Senator Charles Grassley, Republican of Iowa, in connection with possibly illegally marketing of Infuse through outside physicians like Dr. Kuklo who work for it as consultants. The company has denied doing so. Last month, it suspended Dr. Kuklo’s consulting contract. In information released on Wednesday, Medtronic said that it made about $788,280 in direct payments to Dr. Kuklo between 2001 and 2009. It described those funds as either reimbursement for travel expenses, or payments for speaking or training other doctors on Medtronic’s behalf, or for consulting. The company said that those consulting services included working on the design of new or existing orthopedic products and surgical instruments.

It is legal for military doctors to receive payments from medical products companies, but they are supposed to seek permission from officials. Army officials have said they have not found records to indicate that Dr. Kuklo sought or received such clearance.

Those who still support the concept of preemption for medical device manufacturers need to explain to the rest of us how the FDA is supposed to protect patients from this ubiquitous greed. Studies and clinical trials used by the manufacturers to gain approval of devices and drugs are sometimes rigged and the medical literature is sometimes ghost-written by industry insiders. The FDA is under-staffed and underqualified to root out this corruption. The primary examples of this type of corruption being exposed are private lawsuits.

Originally posted at InjuryBoard by Michael Phelan

Vermont Law Makes Payments to Doctors Public

Greg Webb — Sat, 30 May 2009 22:06:08 GMT

In an attempt to crack down on the medical industry’s payment to physicians, Vermont legislators have passed a law that requires drug and device manufacturers to publicly release the amount of all money given to doctors and other healthcare providers, naming names and listing the actual dollar amounts. This law is scheduled to go into effect July 1, and would also ban almost all industry gifts, even meals, to nurses, doctors, medical staff, pharmacists, health care facilities and healthcare administrators. It is believed to be the strictest state effort to regulate the marketing of medical products to physicians, though Minnesota and Massachusetts have less stringent laws in place. Ideally, the measure would allow residents of Vermont to annually learn how much each doctor was paid by makers of the brand-name drugs for which they wrote patients’ prescriptions, or how much money surgeons received from the manufacturers of certain devices, like stents, that they implant.

National legislators and medical groups are monitoring the different state laws, like the one in Vermont, in their quest to discover a link between health care costs and industry marketing. In Congress, Republican Senator Grassley and Democratic Senator Kohl have sponsored a bill that would require disclosure of the pharmaceutical industry’s payment to doctors. Vermont’s law, however, goes even further by showing the issue is inappropriate gift giving. It requires all payments to any health care provider be disclosed, as well as requiring device manufacturers to disclose information as well; the law is also the first to ban all free meals, which was a favored gift used in marketing to doctors, and closed a loophole that allowed companies to not disclose information by calling them “trade secrets”. The required disclosures, however, do not include payments for clinical research on products that are still under examination by the Food and Drug Administration (FDA).

Vermont legislators passed the measure after information was released by the attorney general stating manufacturers of medical products spent about $2.9 million in fiscal year 2008 on marketing to healthcare personnel in their state. About half of Vermont’s physicians were also given compensation from pharmaceutical companies; the manufacturers focused mainly on those doctors they considered “elite”, with only four percent of these doctors receiving more than sixty percent of the payments. The reports also raised the point that if drug manufacturers were willing to spend that much money in the small state of Vermont, what would the results be in the big states of New York and California?

This law is, at least at first glance, a positive step in curbing the corporate greed of the medical device and pharmaceutical industries. It will be interesting to see how this law plays out over the coming years as far as its success in actually accomplishing its goal and, perhaps, curbing health care costs. Hopefully, there are no bad, unintended consequences.

Originally posted at InjuryBoard by Greg Webb

"All-Hands Meeting" Called At FDA To Discuss Lax Medical Device Oversight

Michael Phelan — Tue, 28 Apr 2009 11:20:27 GMT

Nine scientists signed letters to President Obama charging that Food and Drug Administration officials had acted illegally and that patients were routinely put at risk by unsafe medical devices approved by the FDA for sale despite significant and often unanimous objections from scientific reviewers at FDA. These scientists sent many e-mails to the FDA's prinicpal deputy commissioner, seeking his intervention, but the deputy commissioner, Joshua Sharfstein, M.D., replied that he was "already burning the candle at both ends to keep up with his job." The nine dissident scientists sent an extensive memorandum to Dr. Sharfstein charging that the "regulatory review process for medical devices has been severely distorted" and that those who raised concerns about unsafe devices had been retaliated against by agency managers.

Amond the devices alleged to have been approved inappropriately are imaging equipment for detecting breast cancer and an orthopedic knee device. The FDA also allowed hospitals to wash and reuse sterile surgical devices intended for just one use. Sounds like a great idea in this era of MRSA and other deadly bacteria and viruses. Undue influence from the device manufacturers is no-doubt a cause for some of these inappropriate approvals. The other reason is captured in Dr. Sharfstein's above-cited quote- the agency is too understaffed to do its job; hence it relies too much on safety and efficacy information provided by the drug and device manufacturers. The fox has been allowed to guard the chicken house. This is why preemption arguments are such a joke. When Newt Gingrich introduce the Contract With America, it contained a provision to turn the FDA over completely to the drug and device industry and let them regulate themselves. Thank God that did not happen.

There are signs that the FDA may take steps to kick the fox out of the chicken house. On April 10, Donna-Bea Tillman, director of the FDA's office of device evaluation, announced an "all-hands meeting" of all scientists within the office to discuss the strategic direction of the device center. This would be the first meeting of its kind in years. Under the previous administration, meeting time was awarded to industry lobbyists rather than the scientists charged with evaluating safety.

Originally posted at InjuryBoard by Michael Phelan

Pain Pump delivers medication directly injured spinal cord

Doug Landau — Thu, 02 Apr 2009 16:12:00 GMT

What is a pain pump?

A pain pump is designed to deliver medication directly to the surgical wound site or in close proximity to the nerves associated with the surgical area for post-operative pain management. According to the Mayfield Clinic, the pain pump infuses the medication at an hourly flow rate or combination of an hourly flow rate and controlled doses.

Intrathecal drug delivery, or “pain pump,” is a method of giving medication directly to your spinal cord. The system uses a small pump that is surgically placed under the skin of the stomach and delivers medication through a catheter to the area around the spinal cord – similar to an epidural that women may have during childbirth.

A pain pump may be a treatment option if all other traditional methods have failed to relieve an injured victims long-term symptoms. Because the medication is delivered directly to the spinal cord, a patient with a back injury's symptoms can be controlled with a much smaller dose than is needed with oral medication. The goal of a drug pump is to better control symptoms and to reduce oral medications; thus reducing their associated side effects.

We have seen clients, especially from automobile accidents or falls from a great height, with stomach problems from strong pain medications, including ulcers and uneven pain control. Sometimes, the direct delivery of a pain pump or spine stimulator can bypass the stomach and avoid these problems and side effects.

Originally posted at InjuryBoard by Doug Landau

Congressmen Push To Nullify Supreme Court’s Medical Device Decision

Greg Webb — Tue, 03 Mar 2009 08:00:00 GMT

Some members of Congress are attempting to remove a 2008 Supreme Court decision that stands as a barrier against suing medical device manufacturers. This ruling has barred patients, or their survivors, from suing manufactures of complex medical devices if the Food and Drug Administration (FDA) has approved the products sale. Since this ruling, judges from around the country have cited it in dismissing cases against a wide range of manufacturers. For example, situations in which a woman was burned internally by a device that was meant to reduce menstrual bleeding, and numerous patients who claim they were injured by faulty heart implants or joints.

Recently, however, some members of Congress have decided they want to give potential plaintiffs a chance at legal action. Two House Democrats plan to reintroduce legislation that will nullify the Supreme Court Decision. A similar bill introduced in the Senate last year is also expected to be reintroduced. The legislators, as well as patient advocates, say the Supreme Court’s decision has left patients legally powerless against “spotty oversight of products” by the FDA. With the Supreme Court ruling, patients are facing a dangerous situation in which the FDA is incapable of keeping dangerous products off the market and patients cannot sue companies for restitution.

The House Energy and Commerce Committee is expected to hold hearings this session to determine whether the FDA’s process for device approval is adequate after numerous claims that it does not have the necessary resources to asses all risks that a device poses once it gets on the market. Opposition to the legislation claims the FDA is the appropriate body to set national safety standards and allowing juries to undermine its decisions will hinder product innovation.

Many believe the Supreme Court’s decision does not reflect the unpredictability of the FDA review process. Recently, for example, when doctors extracted a faulty electronic cable from a patient’s heart, a vessel was punctured causing excessive bleeding. The patient died two days later and a lawsuit against Medtronic, the manufacturer of the faulty device, was thrown out. This cable, called a lead, was never tested in humans before it went on the market and before Medtronic could recall the product, it was implanted in more than 235,000 patients; five of these patients may have died due to the problem.

The Supreme Court is currently deciding whether it should give the same type of legal protections to drug manufacturers in the case of Wyeth v. Levine. Hopefully, the Court will not grant such broad-reaching immunity for drug manufacturers. Drug companies, like all persons and entities in our country, should be held responsible for wrongful conduct, especially when such conduct sacrifices safety in the name of profits.

Originally posted at InjuryBoard by Greg Webb