Parker McDonald Law

Johnson & Johnson Continued to Market ASR Hip Device After Rejected by FDA

ParkerMcDonald — Thu, 23 Feb 2012 21:01:04 +0000

Fort Worth, Texas, Feb. 21, 2012 – Parker McDonald, P.C. reports on a recent investigation by The New York Times which found that healthcare giant Johnson & Johnson continued to market its DePuy ASR Hip Resurfacing System overseas after it was rejected by the Food and Drug Administration in the United States.

According to The New York Times, in a confidential letter sent to Johnson & Johnson, the F.D.A. told the company that studies and clinical data submitted to gain approval in the United States were inadequate to determine its effectiveness and safety. Johnson & Johnson continued to market the device overseas without notifying regulatory agencies, nor did the company address the nonapproval letter in financial reports or in presentations to analysts. Even so, it is not suggested that Johnson & Johnson violated the law.

Another model in the ASR hip device family, the DePuy ASR XL Acetabular Hip System, was cleared for use in the U.S. in 2005 through the highly controversial 510(k) process. The company used the 510(k) clearance process to fast track its XL Acetabular Hip System without conducting clinical trials, because DePuy claimed it was “substantially equivalent” to a device previously marketed in the U.S.

In August of 2010, DePuy voluntarily recalled both of its ASR hip replacement systems – the ASR XL Acetabular Hip Replacement System and the ASR Hip Resurfacing System. This recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients. Symptoms include severe pain, implant loosening, implant dislocation, and toxic heavy metal poisoning. The recall in the United States came nearly a year after the company withdrew the device from the Australian market.

Parker McDonald currently represents hundreds of clients across the country who have received the DePuy ASR XL Acetabular Hip System. The firm has established a website, www.hipimplantrecovery.com, to provide the latest information for concerned defective hip implant patients and their families.

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.

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The Traumatizing Tears of One Man’s Brain Injury

ParkerMcDonald — Thu, 23 Feb 2012 20:55:40 +0000

From high profile athletes to our servicemen and women, brain injuries have diminished many lives and even led some to take their own lives. Doctors can usually determine which event caused a brain injury, but the side effects don’t stop with the initial injury, they can increase over time.

Neurologist can amaze you with tales of how the human brain is deeply complicated. For example, when Richard Anderson was struck by a drunk driver on Aug. 4, 2004, launching him 26 feet to land on his head, it’s a miracle that he survived. After an immediate brain surgery, he spent three weeks in a coma and two months in in the hospital recovering. Anderson suffered a devastating traumatic brain injury that slowed his cognitive and speech abilities. His taste and sense of smell were lost. But for Anderson’s family, those issues wouldn’t be the most tragic impact of the accident.

For them, it was the tears. Anderson, once a reserved man, began to cry uncontrollably. It didn’t matter what topic he was discussing or with whom he was talking – the tears continued. Doctors believed he was depressed and prescribed him a cocktail of anti-depressant and anti-seizure drugs. Unable to escape his condition, Anderson removed himself from social interactions and working was out of the question. His wife and daughters were devastated, as you can imagine.

It wasn’t until 2009 that it occurred to his neurologist, Dr. Jonathan Fellus, that something else might be triggering the crying episodes. Fellus had overseen Anderson’s case since a month after the accident. He thought the anti-depressants were the best course of action for his lack of emotional control but, “… there came a point when he should have been better – and he wasn’t.”

Fellus did some research and found that the crying wasn’t a psychological issue but a physical one referred to as pseudobulbar affect (PBA). About 1 million Americans show signs of the condition, and like Anderson’s situation, it’s often overlooked. But, why is it overlooked? Physicians have already associated PBA with severe brain injuries, stroke, multiple sclerosis, Lou Gehrig’s disease and Alzheimer’s – all of which can manipulate brain function.

Andersons’ depression from his traumatic brain injury may have kept it hidden from his doctors. The Food and Drug Administration approved a drug called Nuedexta to treat PBA in 2010. It acts as a suppressant by binding brain receptors that control emotion. Treatment results in fewer fits and more emotional stability for patients. Anderson was one of the first of Fellus’ patients to take the drug, and the results have been dramatic.

The Anderson family and Fellus have praised the drug’s effectiveness. People who experience emotional episodes because of a traumatic brain injury should still be wary of the drug. A previously rejected version was suspected of causing heart issues. As representatives for clients who have encountered defective drugs and products, we want to ensure the best options are on the market to prolong the lives of those who need them. Ask your doctor if this drug will work for you.

Traumatic brain injuries impact families like the Andersons around the country. Contact the experienced legal team at Parker McDonald if you have suffered a brain injury for any reason. We aim to right the wrongs of negligent parties.

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Parker McDonald Concerned Over Recent British Study Connecting Metal-On-Metal Hip Implants to Increased Cancer Risks

ParkerMcDonald — Wed, 22 Feb 2012 19:57:47 +0000

A recent British study connects metal-on-metal hip implants to cancer risks.

Parker McDonald, P.C., a Texas law firm representing hundreds of patients who received DePuy metal-on-metal hip implants, is concerned of suggested early findings from a British study on the effects of metal-on-metal hip implants reported by The Telegraph on January 28th, 2012. According to the article, the British study is thought to suggest that metal particles from metal implant devices may increase the risk of cancer and genetic damage. The study included 72 patients, 17 of which experienced genetic damage to the bladder, and three patients developed “full blown” cancer.

Metal-on-metal devices can create metal toxicity or metal ion debris due to wear from the metal cup and metal ball rubbing against each other. These ions may destroy surrounding tissue, bone, and muscle. The report released last week on the British study implies that these metal ions can cause major organ damage and increase the risk of cancer. According to the proposed study, in the article, it detected changes to cells in the bladders of more than one in five patients who were monitored after receiving metal-on-metal hip implants.

The DePuy metal-on-metal hip implant U.S. recall in August of 2010 created heightened scrutiny over the materials used in replacement hips. Manufacturers have used metal, ceramic and plastic pieces to construct the ball-and-socket structure. The metal-on-metal combination was marketed to be more durable, but high failure rates and metal toxicity has compromised the health of thousands of patients.

In May of last year, the FDA issued 145 orders for post market surveillance studies to 21 manufacturers of metal-on-metal hip systems, including Zimmer Holdings, DePuy, Wright Medical, Biomet, and Smith & Nephew. According to the FDA, data from the studies conducted will enable the agency to better understand metal-on-metal devices and their safety profiles.

If you or a loved one has a DePuy ASR or Pinnacle metal-on-metal hip implant you may have a claim against the manufacturer, contact Parker McDonald today. Visit http://hipimplantrecovery.com/ for more information on the defective hip implants, symptoms, and how to process a legal claim.

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results.

Parker McDonald Analyzes Hip Implant Study That Found Long Term Pain For Patients With Recalled Metal-On-Metal Hip Implants

ParkerMcDonald — Tue, 21 Feb 2012 19:08:33 +0000

The hip implant lawyers at Parker McDonald, P.C.,analyzed a report recently released by The American Academy of Orthopaedic Surgeons (AAOS) that summarizes the findings of studies published in July of last year. These studies revealed metal-on-metal hip implant patients are having long-term problems associated with their implants.

According to the recent metal-on-metal hip implant study, patients with these implants, such as the DePuy ASR XL Acetabular Hip Replacement System that was recalled in 2010, may still encounter pain even after corrective surgeries and physical therapy. A subsidiary of Johnson & Johnson, DePuy Orthopaedics is the defendant in hundreds of defective hip implant lawsuits alleging the recalled hip implants caused considerable pain and debilitation.

Patients have experienced adverse reactions that include metallosis, impaired movement, tissue damage, bone loss, muscle inflammation, and tumors. Metallosis occurs from the metal components of a hip implant when they rub against each other, causing metal particles to break off and enter the blood stream and surrounding tissue. Movement becomes limited and the toxins threaten the heart and nervous system.

Among other findings, the AAOS summary provides information on:

Studies comparing metal-on-metal Total Hip Arthroplasty (THA) to metal-on-polyethylene showed statistically significant increases in cobalt in the metal-on-metal groups. Cobalt levels ranged from 2.2-6.47 times greater in metal-on-metal groups versus metal-on-polyethylene groups.
Studies comparing metal-on-metal THA/hip resurfacing to a hip system without a metal component (i.e., ceramic-on-polyethylene, ceramic-on-ceramic) showed statistically significant differences in cobalt concentrations in each instance.Metal-on-metal groups had cobalt levels 1.66-5 times greater than non-metal hip systems.
Metal-on-metal hip resurfacing compared to ceramic-on-ceramic THA showed statistically significant increases in chromium. Levels in hip resurfacing patients were 1.88-3.13 times greater than ceramic-on-ceramic.
In the metal-on-metal group, patients with pseudotumors had cobalt levels 4.84 times higher and chromium levels 5.71 times higher than metal-on-metal patients without pseudotumors.
Hip joint aspirate was collected from patients with metal-on-metal THA. Significant differences were seen between the two groups with cobalt and chromium levels 13.7 and 7.69 times higher, respectively, in the group with pseudotumors.

To correct these issues, thousands of patients have required painful revision surgery to replace the faulty implant with a new model. Even after surgery, weeks of physical therapy are needed.

As hip implant recall attorneys,Parker McDonald continues to track and analyze news about these potentially harmful products. It is imperative that patients who received a metal-on-metal implant seek the advice of their physician to determine if they are at risk. With ongoing litigation against DePuy Orthopaedics, those who have experienced difficulties may be entitled to compensation. For more information on the DePuy hip implant recall visit http://hipimplantrecovery.com/ or call 800-990-4884.

About Parker McDonald

Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.

No Refusal Policy for Upcoming Holidays

ParkerMcDonald — Fri, 17 Feb 2012 20:37:42 +0000

Texans have another line of defense against drunk drivers, now. The past holiday season prompted many Texas counties to adopt a wider scope with a “no-refusal policy” to catch intoxicated drivers. Many drivers know that they don’t have to submit to a breathalyzer test. However, a simple ‘no’ will not be enough for drivers that police officers reasonably suspect of drinking and driving.

The no-refusal order is not something new to Texas. In 2011, Texas and other states across the country began an aggressive anti-DWI campaign. They initiated no-refusal weekends, which incorporate major holidays or events that typically accumulate a large number of drunk drivers. If a driver refuses the traditional breathalyzer test, police officers can have a blood sample drawn.

Don’t You Need a Warrant for That?

The answer is yes – however, law enforcement has that covered. During these weekends, a judge is designated to issue warrants. An on-site nurse then draws blood from the suspect.. Before the no-refusal policy, drunken driving prosecutors had little evidence to support their cases. Now that more counties are adopting stricter policies, convictions are coming at a higher rate.

The cities of San Antonio and Houston are two of the largest supporters of the anti-DWI strategy. Bexar and Harris counties have outstanding numbers of deaths associated with DWI incidents. In 2010, Bexar had a population of 1,714,773 people and 6,000 DWI arrests.

Both counties expanded the program from major holiday weekends to every weekend. Harris County was awarded a three-year, $700,000 grant from the Texas Department of Transportation to continue the program until 2014.

The policy has gained tremendous support from organizations like Mothers Against Drunk Driving (MADD). It has been hailed as a major step in the right direction to deter drivers from getting behind the wheel while intoxicated.

DFW No Refusal Weekends

No-refusal weekends are already in place in Dallas and Tarrant Counties, although not to the extent of Houston and San Antonio. As we near the beginning of Mardi Gras and St. Patrick’s Day celebrations, we can expect that law enforcement will use more no-refusal dates.

While this strategy has been successful, drunk driving is still a problem that claims too many victims each year. We encourage drivers to be proactive and stay off the roads as much as possible during these holidays. As personal injury attorneys, Parker McDonald fights for those who lose the most in an accident. Were you injured in a car accident with a drunk driver? Contact us for a no obligation consultation to determine how we can get you back on the right track.

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Can Reality TV Stars Claim Defamation of Character Against the Media?

ParkerMcDonald — Thu, 09 Feb 2012 21:53:06 +0000

On any given night and channel, the latest reality TV shows are in rotation – everything from watching a couple remodel their home to young adults over-indulging themselves. Millions of viewers watch, and many of them, along with bloggers and journalists, express their opinions about the reality stars all over the Internet.

So, what keeps reality TV so real? A waiver. It guards against lawsuits from physical alterations, daring stunts and negative (truthful) portrayals of a show’s characters. But, like everything in the media, once information or an image is released trying to control it is impossible. Media outlets can control the tone and tenor of the coverage, though, and that is why the mother of one reality TV star is taking action.

If you haven’t heard of TLC’s Toddlers & Tiaras, it’s a behind-the-scenes view into the world of mini-pageant queens. The drama is nearly comparable to that of MTV’s Jersey Shore – on a PG level, of course. Since the show aired, it has drawn controversy. And, while some tactics are certainly questionable, the show has a large following. What could be more adorable than a 5-year-old dressing up like a doll? Possibly nothing … until several media outlets hosted some video footage and leveled criticism at girl and her mother.

The incident in question doesn’t actually involve the show, rather a charity event that Isabella Barrett, one of the mini pageant stars, attended. A video that surfaced features Isabella dancing in her seat while singing the lyrics to “I’m Sexy and I Know It” at a New York nightclub. All kinds of questions come to mind – and several online media outlets raised most of them

But, one they didn’t ask is: How far can the law go to protect these starlets? Susanna Barrett, the mother of Isabella, has taken that question to court, ostensibly to defend her daughter’s image.

Barrett has filed a lawsuit against Warner Bros. Entertainment, Associated Newspapers Limited, and AOL, Inc., (owners of the various media sites) citing damages to the tune of $30 million. The defendants have 20 days to respond to the complaint before they will be ordered to appear in court. The suit states that because of their headlines, Isabella is now perceived in a sexual manner and essentially a target for sex offenders.

Is this protected speech under the First Amendment? Has the media gone too far, or are they just pointing out the obvious? What liability do media outlets have when they report on the perception of a reality TV star? Regardless of the direction a piece may have, facts are facts. They do have video, and the lyrics of the song are clear.

Several publications stated that it was her mother who stood with her, encouraging as she sang. It was purportedly a hired deejay, instead, but the outlets labeled her as a parent that allowed her child to act in such a way. A behavior that isn’t very different to a pageant, but taken out of context, could be seen as something very damaging. Is it the court’s responsibility to separate someone from what they do and protect who they are?

We think so. To negatively characterize a child who dreams of winning crowns and bash a parent for supporting those dreams is harsh. Parents are no different on the sidelines of a sporting event. A waiver cannot protect people from life outside of a show – that has to be the law’s job.

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Parker McDonald Law Firm Examines Bill Aimed At Blocking Medical Devices Tied To Recalls

ParkerMcDonald — Thu, 09 Feb 2012 21:43:18 +0000

New developments are emerging out of Washington, D.C., on mounting complaints surrounding medical product recalls. Parker McDonald P.C. represents victims of defective medical devices, and new legislation may be on the way to keep these products from reaching the market.

Parker McDonald, citing a recent Bloomberg study, reported today that House Democrats are pushing to close a loophole in the medical device approval process. Representative Edward Markey of Massachusetts is leading the bill to prevent manufacturers from receiving medical device approval when a new product is similar to one already taken from the market.

Companies rely heavily on the FDA’s 510(k) process to ensure that their product will hit the market as soon as possible without the costs of conducting clinical trials. This fast-paced approach used by manufacturers has come under review in recent years.

Transvaginal mesh is the most recent product to draw scrutiny. The number of complaints received by the FDA has increased in the past few years. In July of last year, the FDA issued a safety alert to inform the public that serious complications associated with transvaginal surgical mesh to treat pelvic organ prolapse or stress urinary incontinence are not rare. Just last month, the FDA ordered manufactures to perform more conclusive studies on the safety levels of their surgical mesh implants.

According to a recent report by Bloomberg, the FDA continued to approve transvaginal mesh devices made by Johnson & Johnson and other health-care companies based on their similarity to a Boston Scientific device that had been pulled from the market due to safety complaints. Representative Markey’s bill seeks to eliminate this characteristic of the 510(k) process by ensuring “that devices do not mimic the mistakes made by other products.”

The potential impact of this bill may be felt by both manufacturers and patients if it gains the support of Congress and the White House. With ongoing litigation in several states concerning allegedly defective DePuy hip implants, which were approved through the 510(k) process, manufacturers could be facing a wave of reforms on top of financial payouts.

Parker McDonald will continue to monitor this situation as well as the recall status of vaginal mesh implants. If you are a victim of a defective medical device, visit parkermcdonaldlaw.com or contact us at 800-990-4884.

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Heavier Trucks May Increase Driving Safety Risks

ParkerMcDonald — Mon, 06 Feb 2012 10:30:39 +0000

On any given day there is no shortage of accidents involving commercial trucks. Although accident reports have decreased in the last few years, it’s been largely attributed to restrictions and new policies. Just last year, the National Transportation Safety Board proposed a nationwide ban that would prevent commercial truck drivers from using cell phones while driving.

The ban is a big stride in the improvement of highway safety and the strictest to date. It appears that Congress wants to follow it up, however, with a law that would impede the progress made by the NTSB.

Efficiency over safety

For drivers, adding more weight to top-heavy tractor trailers would seem to increase a likely hazard. However, Congress is considering doing just that with the Safe and Efficient Transportation Act. If passed, the law would raise the national weight limit for commercial trucks by 17,000 pounds. That means trucks could be capable of carrying up to 97,000 pounds, which isn’t favorable for accident statistics.

Congress has concluded that, in order to increase the overall efficiency of our transportation system, trucks need to be able to carry more to cut costs. The proposal is backed by 200 companies that form the Coalition for Transportation Productivity. Brands like Hershey, MillerCoors and Home Depot have large stakes in pushing the law through Congress. Supporters believe that, with more weight on the trucks, reductions in costs and highway traffic will incur benefits for consumers.

Will the benefits really be worth it?

Aside from the possible increase in collisions, what other impacts can drivers expect? Opponents of the bill agree that heavier trucks will only damage the already crumbling infrastructure around the nation. You’ve probably noticed the various construction projects throughout your state, but the truth is, roads are breaking down faster than they can be repaired or replaced.

Heavier trucks carry the possibility of eroding existing roads and wearing down new ones more quickly. The result could be another incident like the Minneapolis bridge collapse in 2007. This tragic accident created only a mild legislative response to improve the conditions of roads and bridges across the country.

What does this mean for drivers?

It doesn’t take an expert driver to understand that the heavier you are, the more time and space you need to halt momentum and come to a complete stop. With this proposed weight increase, truck drivers would need 25 percent more stopping space. This could possibly cause more congestion as trucks slowdown in high traffic areas and construction zones.

However, supporters continue to argue that this is the best solution to meet safety and economic initiatives. Only six axle trucks will be affected – leveling their stopping capability to a five axle truck carrying 80,000 pounds.

A spokesman of the American Trucking Associations thinks that a six axle truck carrying up to 97,000 pounds will help road conditions because the trucks will be able to better balance their weight. This is important to all of us, since statistics show truck fatalities are rising – with 448 people killed in Texas alone. Although other factors do play a part in trucking accidents, every factor should be accounted for to ensure road safety stays a top priority.

Parker McDonald will continue to monitor the development of this story as news is released. If you or a loved one has been involved in a trucking accident, you know how painful and costly the damage is.

Johnson & Johnson Settles Texas Medicaid Fraud Lawsuit

ParkerMcDonald — Thu, 26 Jan 2012 22:17:37 +0000

Trust is the most valuable commodity on the market. So, why is it that consumers seem to put their trust in manufacturers that repeatedly take advantage of them?

The latest big lawsuit emerged with conglomerate Johnson & Johnson (J&J) as its target. Its subsidiary, Janssen Pharmaceuticals Inc., developed and marketed the antipsychotic drug Risperdal. Texas officials claimed the company continually made false or misleading statements about the safety and effectiveness of the drug and engaged in illegal marketing techniques. Johnson & Johnson recently agreed to pay $158 million to settle Texas’ claims.

Research studies showed many patients experienced unnatural weight gain, inducing vulnerability to diabetes. The results of the study were never released. In fact, one expert witness for Texas said the company actually hid these studies from the public. Additionally, the company marketed the drug for unapproved uses, including children with psychiatric disorders.

The lawsuit initially pursued a $579 million settlement against the company to repay the Texas Medicaid program and up to $500 million in penalties. Many analysts call the $158 million settlement a victory for Johnson & Johnson due to the billions that were profited from Risperdal.

This is not the first case citing Janssen for medical negligence. A court in South Carolina handed down a judgment for $327 million last year for similar reasons and in Louisiana they were ordered to pay $258 million. Drug manufacturers make billions off the medical system, and sometimes it’s by manipulating it to their advantage.

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Johnson & Johnson Takes $3 Billion Hit

ParkerMcDonald — Thu, 26 Jan 2012 20:46:45 +0000

Healthcare giant Johnson & Johnson has set aside more than $3 billion for costs related to the recall of its ASR hip implant that was designed and manufactured by its subsidiary DePuy Orthopaedics. It appears as though Johnson & Johnson is finally recognizing the significant damage its defective product has caused thousands of patients. Many individuals that received an ASR implant have experienced severe metal toxic poisoning, tissue and bone damage, pain, implant loosening, and implant dislocation.

The $3 billion charge will be set aside for medical costs, patients, and lawyers currently involved in the product liability litigation.

The company forecast 2012 earnings of $5.05 to $5.15 per share, fell below the Wall Street estimate of $5.21, largely due to the litigation revolving around artificial hips.

Parker McDonald, P.C. currently represents hundreds of clients across the countries who have received a defective hip implant. Contact us today if you, or a loved one, have received a defective hip implant.