Screen shot 2012-11-05 at 10.52.34 AMA North Carolina widow filed a lawsuit last month against Takeda, the manufacturer of Actos. Norma Faique, widow of the late John Faique, is suing the company for her husband’s death. Actos is a prescription drug created to treat Type II diabetes.

As a Type II diabetes patient, Faique was prescribed Actos for three years before he was diagnosed with bladder cancer in October 2010. He died a month after his diagnosis on November 10, 2010. His widow is charging 18 counts against Takeda Pharmaceuticals including wrongful death, strict liability and negligence. She claims that if the company had properly warned consumers of the drug’s risks, her husband never would have taken it.

It wasn’t until seven months after John Faique’s death that the FDA (U.S. Food and Drug Administration) issued a warning stating “the use of the diabetes medication Actos (Pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”

hipski.jpg For the past two years, claim after claim has been filed against Johnson & Johnson subsidiary DePuy for their questionable ASR metal-on-metal hip replacements. As the two year anniversary of the manufacturer’s voluntary product recall is upon us, the window of opportunity to file your claim may be closing. It’s time to take action.

In August 2010, DePuy issued a voluntary recall of its ASR hip replacement system “after receiving new, then-unpublished data from a joint replacement registry in the UK.” More hip replacement patients than previously expected or reported to DePuy had to undergo a revision surgery. This process is painful, unfair and frustrating.

At Borchardt Law Firm, we strongly encourage those who have been affected by faulty medical devices to speak up, learn your rights, and file your claim. The time is now! Nobody should have to walk wounded daily, especially when it’s not their fault. If you or a loved one received a DePuy hip implant between 2005 and 2010 and are experiencing pain or adverse effects, don’t fight this alone. Give us a call; it may not be too late for you to receive the justice and wellness you deserve.

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A 77-year-old Domino’s Pizza delivery person was stabbed multiple times during a delivery in southeast Oklahoma City on Saturday night, October 20, 2012. Edward Thomas Hackett was stabbed by three men as he tried to leave after no one answered the door to the apartment. The attack took place at Southeast 48th Street and Sooner Road in the parking lot of an apartment building. Following the attack Mr. Hackett drove back to the Domino’s Pizza in Del City, about four blocks away, where police officers found him in a back room with a large cut on his abdomen just under his rib cage. He was taken to the OU Medical Center for surgery, and is now in fair condition, meaning that his vital signs are stable and he is conscious.

The law firm of Borchardt Law Firm are handling similar claims. If you or a loved one have been a victim of similar tragedy, please contact our firm.

Toll Free: 866.832.9300

TVM
A recent survey shows that specialists have decreased their use of travsvaginal mesh (TVM) for the surgical treatment of pelvic organ prolapse (POP).

In July 2011, the U.S. Food and Drug Administration issued a warning that TVM products put patients at a higher risk of developing adverse effects from the procedure. The FDA continued to say that “…serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”

Earlier this month the American Urogynecologic Society held its 33rd Annual Scientific Meeting in Chicago. At the event, a team headed up by Catherine Matthews, MD, from the Univeristy of North Carolina Chapel Hill presented the results of a November 2011 survey for surgeons. This survey’s purpose was to determine whether practitioners were heeding the TVM warning issued by the FDA just months before.

The survey revealed that almost one-fourth of the 281 specialists surveyed were observing the FDA warning by decreasing the use of vaginal mesh to correct POP cases.

Because of the potentially dangerous effects of TVM procedures, at Borchardt Law Firm, LLP we see the results of this survey as extremely positive. Thousands of women are currently suffering pain because of complications with this all too often faulty procedure. It’s exciting to see tangible results of doctors moving away from mesh solutions.

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Three people have been killed and five others suffered serious injuries in a recent nursing home van accident. The van was returning from a trip to Choctaw Casino on the southbound Highway 69/75 when authorities say a semi truck that was entering from an on-ramp hit the van, causing the van to hit another truck on it’s opposite site. The van then rolled over off of the highway. The three victims whom died in the accident are Beacon Hill nursing home residents Ann Brychta, who was 103, Wanda Gardner, 80, and Bruno Sperber, 75. A fourth resident of Beacon Hill, Kenneth Drake, 56, was taken to Plano in critical condition. The driver, another staff member, and Brychta’s son and his wife were all taken to Texoma Medical Center with serious injuries.

Borchardt Law Firm. has been retained to investigate and pursue the claims on behalf of some of the victims. Our condolences and thoughts go out to them and if anyone has any information please contact us.

Toll Free: 866.832.9300

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Last month, the Texas Department of Transportation (TxDOT) released their 2012 report on the most congested road segments in Texas. Topping the list is I-35W in Fort Worth. The DFW metroplex snagged 45 of the top 100 spots, including 5 in the top 10.

Stretching from I-30 to SH 183, this segment of I-35 racks up an average of 586,664 hours of delay-per-mile. Annually, this stretch of highway causes 1,160,961 hours of delay. It tested as the second most stressful highway to drive on in Texas according to the TxDOT congestion report. With these statistics, it carries a cost of lost time and wasted fuel of nearly $3 billion.

Fort Worth natives know that getting to DFW airport from I-30 eastbound is nearly impossible. The Texas Department of Transportation releases this report annually as part of their ongoing commitment to address traffic congestion. A calculated 2 million additional hours of travel time have been accumulated on a segment of highway that is only 3.7 miles long.

Screen shot 2012-09-26 at 10.36.44 AM.png New data show that metal-on-metal hip implants are not linked to an increased risk of cancer within the seven years after the procedure.

Although these typically harmful medical devices have caused a multitude of other health defects, the U.K. National Joint Registry (NJR) stated earlier this month in their annual report that it cannot link the hip replacement surgery with cancer in the short term.

While this is good news for hip replacement patients and the medical community, the NJR also said, “We must, however, point out that many cancers have prolonged latency after initial exposure to carcinogens and thus long-term follow up is needed to provide a definitive answer.”

Big-name manufacturers that have faced lawsuits include DePuy Orthopaedics and Stryker Corporation. Manufacturers such as these must be held responsible for the adverse effects of their products that suffering patients must endure. Metal-on-metal hip implants have extremely high failure rates. Although they are expected to last an average of 15 years, an estimated 80% of DePuy implants fail just 8 years after surgery.

Problems after surgery range from pain, swelling, limited mobility, trouble walking, and dislocation, to a very serious disease called metallosis. The grinding that occurs between parts of the hip replacement can release metal debris into the body and bloodstream, causing the blood levels of chromium and cobalt to become dangerously high. This metal poisoning in the blood can cause cardiovascular, neurological, thyroid and renal issues in the body as well as destroying muscle, tissue, and bone.

Many variations of these metal-on-metal replacements were FDA cleared by the 510(k) program, which acts as a fast track for getting innovations in medicine on the market. Although this process makes cutting-edge products readily available to patients in need, it has also proven to be dangerous. Because manufacturers don’t necessarily have to guarantee their safety or effectiveness as they would in a typical FDA clearance, corners are cut and consumers are put in potential harm.

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laydown PM.pngThe legal controversy surrounding transvaginal mesh procedures is nothing new. The complications with surgeries, warnings from the U.S. Food and Drug Administration, abounding lawsuits, and unhappy patients seem to be ever-present in the media. However, something that may have been flying under consumers’ radars is that some drug manufacturers are under scrutiny for deliberately withholding vital information from consumers.

On Aug. 8, 2012, New Jersey judge, the Honorable Carol E. Higbee, issued an Order for drug manufacturer Ethicon to release all of their communications with the U.S. Food and Drug Administration (FDA). Ethicon is a subsidiary of healthcare superpower Johnson & Johnson. Higbee has presided over all transvaginal mesh (TVM) lawsuits filed in New Jersey state court. Although FDA warnings for TVM cases have been in effect since 2008, after thousands of cases Judge Higbee continues to crack down on these companies to hold a high standard of transparency.

The mesh treatment was originally known as the magic cure for urinary issues and bladder, bowl and uterine prolapse. Over time, procedure complications can cause mesh erosion, contraction, migration and exposure, as well as the formation of scar tissue.

Bayer could have to pay up to or more than $1.2 billion in order to settle personal injury lawsuits over the company’s Yaz and Yasmin oral contraceptives. For Bayer’s second quarter stockholder update, Bayer told its investors that it is currently facing nearly 13,000 Yaz and Yasmin lawsuits. In July 2012, Bayer accepted a settlement totaling just over $400 million. The German company paid this amount in order to settle approximately a third of the total number of Yaz and Yasmin lawsuits filed against them at that time. Bloomberg reported on July 31st that Bayer has settled 1,877 Yaz lawsuits for $402.6 million, at an average of around $212,000 per case. In addition, Bayer has more than doubled its reserves for settling these cases to over $610 million, which could prove to be positive news for those negatively affected by the drug that have yet to file a claim.

These lawsuits were filed by users of Yaz or Yasmin oral contraceptives, who suffered from venous thrombo-embolic blood clot injuries, such as a pulmonary embolism and/or deep vein thrombosis. Attorneys defending the women who have been hurt by these drugs have cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. Bayer failed to warn that users of Yaz and Yasmin were much more likely to suffer these types of injuries than users of older, less expensive birth control pills.

Drug-industry analysts, such as JPMorgan Chase & Co.’s Richard Vosser, have said that Bayer may have to pay more than 2 billion Euros (approximately 2.6 billion US dollars) in order to resolve all of these cases. Bayer recently made a statement telling its investors it is currently settling only those cases alleging blood clot injuries, which is said to number around 6,000 of the total cases.

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The U.S. Food and Drug Administration approved the first generic form of the diabetes drug, Actos, on August 17, 2012. Actos (pioglitazone) is used for patients with type 2 diabetes; it is designed to help bodies effectively use the insulin it makes and stops the liver from making unnecessary sugar. Although regulating these processes is important, prospective and current consumers should be wary of the ties Actos has with increased risk of bladder cancer and heart failure.

Typically, the approval of a generic drug is to be celebrated because it allows greater, more affordable access to quality drugs for Americans. However, Actos has been accumulating lawsuits in recent years because of its ties with bladder cancer. The brand-name drug already has a Black Box Warning due to its ties with causing or worsening heart failure. In the words of patient advocate Trisha Torey, a “Black Box” or “Boxed” Warning is the strongest form of warning issued by the FDA about a drug, the step taken just short of removing the drug from the market.

So, if Actos has been proven to be harmful and lawsuits are continuing to be filed, why did the FDA follow through with this approval? In 2011 the FDA announced that prolonged use of Actos at a high dosage may increase risk of bladder cancer and the warning was added to the label. By definition, generic drugs are similar to brand-names “…in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.” (FDA Website) The generic, Pioglitazone, has met all of the standards as the innovator drug and is assured by the FDA in having the same quality, strength, purity and stability as Actos.

Although generic prescriptions are less expensive, there is a hidden cost to consumers. Even though the two products are nearly identical, brand name drug manufacturers are able to be sued while generics are not in most cases. Because of the prevalence of this potentially dangerous drug, it is extremely important for consumers to be aware and informed.

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