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In June of 2011, just two days after Actos was pulled off the shelves in France and Germany, the FDA warned doctors and patients in the U.S. about the increased risk of bladder cancer while taking the medicine for over a year. Takeda, the largest pharmaceutical company based in Japan, is now facing hundreds of defective prescription drug lawsuits and a severe loss in sales as patients are warned about the drug. The once-a-day pill was created to help control blood sugar levels for patients with type 2 diabetes.

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According to the American Diabetes Association, type 2 diabetes is the most common form of diabetes; it affects millions of Americans every day. With type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary for the body to be able to use glucose for energy. When you eat food, the body breaks down all of the sugars and starches into glucose, which is the basic fuel for the cells in the body. Insulin takes the sugar from the blood into the cells.

Untreated patients with type 2 diabetes may experience constant fatigue, weight loss, blurred vision, increased thirst and several other serious side effects. “Actos focuses on two of the common problems that lead to high blood sugar in type 2 diabetes. The medication helps your body better use the insulin it makes, and also stops your liver from making more sugar when it doesn’t need to. By treating these problems, the sugar in your blood can get to where it needs to go so it doesn’t continue to build up in the bloodstream” (Actos Website) Actos appeals to patients due to the ease of taking it and the short term results but now the drug proves to have much more serious long term side effects that Takeda failed to mention to their patients. “The FDA analyzed data from the first five years of a 10-year Actos safe study Takeda begun in 2001 and concluded this June that the risk of bladder cancer was 40 percent higher for patients taking Actos for at least a year, although still small: an extra 28 cases a year for every 100,000 people taking it.” (CBS News)

(Visit the Mayo Clinic site to read more about bladder cancer symptoms)

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In 2006, large commercial trucks were involved in nearly 17,000 accidents in Texas. Due to the tremendous weight and force of big rig trucks, the fatality rate in those accidents far exceeded the fatality rate in accidents involving only passenger vehicles. Trucking companies across Texas are abiding to new regulations in hopes to prevent more accidents.

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“These regulations only apply to property carriers and commercial motor vehicle drivers. Passenger carriers and their drivers will continue operating under the pre-2003 rules while fatigue issues specific to the passenger carrier industry are assessed.”(Federal Motor Carrier Safety Administration (FMCSA))

To see all regulations and read more about Hours-of-Service policies please go to The U.S. Department of Transportation – Federal Motor Carrier Safety Admininstration

SIMPLY stated the new rule means:

• Drivers may drive up to 11 hours in the 14-hour on-duty window after they come on duty following 10 or more consecutive hours off duty.

• The 14-hour on-duty window may not be extended with off-duty time for meal and fuel stops, etc.

• The prohibition on driving after being on duty 60 hours in 7 consecutive days, or 70 hours in 8 consecutive days, remains the same, but drivers can “restart” the 7/8 day period anytime a driver has 34 consecutive hours off duty.

• CMV drivers using the sleeper berth provision must take at least 8 consecutive hours in the sleeper berth, plus 2 consecutive hours either in the sleeper berth, off duty, or any combination of the two.

Short-Haul Provision

Drivers of property-carrying CMVs which do not require a Commercial Driver’s License for operation and who operate within a 150 air-mile radius of their normal work reporting location:
• May drive a maximum of 11 hours after coming on duty following 10 or more consecutive hours off duty.

• Are not required to keep records-of-duty status (RODS).

• May not drive after the 14th hour after coming on duty 5 days a week or after the 16th hour after coming on duty 2 days a week.
• Employer must:

• Maintain and retain accurate time records for a period of 6 months showing the time the duty period began, ended, and total hours on duty each day in place of RODS.
Drivers who use the above-described Short-haul provision are not eligible to use 100 Air-mile provision 395.1(e) or the current 16-hour exception in 395.1 (o).

“In developing these hours-of-service regulations, the Federal Motor Carrier Safety Administration (FMCSA) systematically and extensively researched both United States and international health and fatigue studies and consulted with Federal safety and health experts. Our roads are better designed, constructed, and maintained in a nationwide network to provide greater mobility, accessibility, and safety for all highway users. Vehicles have been dramatically improved in terms of design, construction, safety, comfort, efficiency, emissions, technology, and ergonomics. These factors, combined with years of driver fatigue and sleep disorder research, led to a revision of the hours-of-service regulations for drivers.” (FMCSA)

Large truck cases present complex issues, and often require an expert to review the circumstances of the accident. To litigate successfully against a truck driver or trucking company, the plaintiff must prove that the driver or company acted negligently. That is, you must show that the driver or company failed to exercise reasonable care:

• the truck driver was impaired by fatigue, drugs, or alcohol;
• the truck driver or the trucking company failed to maintain the truck in a safe operating condition;
• the truck driver or trucking company violated federal trucking safety rules or regulations
• the truck driver or the trucking company overloaded or improperly loaded the truck
• the truck driver operated the truck in an unsafe manner.

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Is DePuy Orthopaedics facing yet another possible recall due to a defective medical device? August of 2010, the DePuy ASR XL Acetabular was recalled due to unusually high rates of hip implant failure within only a few years of surgery. DePuy estimated the failure rate to be about 12-13 percent and was designed to last up to 15 years. However, results showed otherwise. Several patients ended up in constant pain resulting to a revision surgery.

Due to the design of the ASR, the metal material was a leading factor in the failure. Adverse Event Reports disclosed to the Food and Drug Administration (FDA) that the DePuy ASR hip system is associated with “loosening, pseudotumour and metallosis” / (sic) metalosis.” Metallosis occurs when the DePuy ASR metal ball rubs against the metal cup which releases metal shavings of cobalt and chromium into the tissue and circulatory system. This causes tissue necrosis and osteolysis, killing or severely damaging body cells and tissue.

Four months after the recall an article written in the New York Times discussing the issues with DePuy hip replacements stated, “failures in new implants are much more likely rather than failures with new drugs because unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients. That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing. With the ASR, that process unfolded with devastating results. ‘You are basically testing these devices in an uncontrolled way on a large number of people,” said Dr. Sidney M. Wolfe, the director of the Public Citizen’s Health Research Group and a longtime F.D.A. critic.'” That August DePuy issued a recall for more than 90,000 of the DePuy ASR metal hip implants. Read more about the recall in The New York Times.

Now, concerns have developed about all metal-on-metal hip implant procedures causing surgeons and doctors to rethink implants. DePuy Orthopaedics still offers one other type of metal-on-metal hip implant, the Pinnacle. The Pinnacle has a slightly different design, using a cup and a liner, whereas the ASR only uses the metal cup. Patients and surgeons are able to choose a metal-on-metal, metal-on-ceramic, or a metal-on-polyurethane line to be inserted inside the metal outer cup for the Pinnacle. However, studies have shown the metal-on-metal option for the Pinnacle has proven to cause very similar problems as the ASR model, mainly concerning the release of metal shavings of cobalt and chromium into the tissue and circulatory system.

In May 2011, nearly 60 DePuy hip lawsuits were incorporated in multidistrict litigation (MDL), all citing problems with the Pinnacle procedure. As of today, DePuy claims their Pinnacle device is safe, and any problems that have been accounted for are from surgeon error, though the Pinnacle is the subject of these recent lawsuits and were recently concentrated in the Northern District of Texas.

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Picking a nursing home for your loved ones can be a very challenging process. Sometimes you may think, “I need a nursing home lawyer.” Our firm, Borchardt Law Firm, offers these suggestions in the hopes of avoiding nursing home abuse or neglect. Sadly, we have seen and dealt with many cases involving nursing home neglect and abuse. We want to help out in any way we can to avoid these outlaws. Of course, these steps will not guarantee a good outcome. Our first recommendation is to visit the state website to compare facilities that you are considering. The Texas Department of Aging and Disability (DADS) is responsible for licensing and overseeing long term care nursing facilities. The department inspects the facilities and issue reports commonly known as “state reports” or “inspection reports.” DADS maintains a comparison of all facilities licensed in Texas. The DADS website is a great place to start your search for an acceptable nursing home.

After visiting the DADS website and completing your research we recommend you always visit the facility before making a decision. Finding the right nursing home may take time, be certain that both you and your loved one feel comfortable about the decision. Here are a few recommendations we suggest while visiting the facility.

1. Take your time to see if the facility is clean and acceptable.
2. Ask the facility to review their last inspection report or state report.
3. Take a look at their food menu and taste the food.
4. Look around to determine whether there are enough people, nurses and nurse aides to care for the residents.
5. If you can, visit with some residents
After visiting the facility, get to know the staff and which physician will be responsible for your loved one. Many times, your family physician(s) will not be responsible for the care of your loved one at a nursing home, so be sure to meet and get to know your new physician and nurses. You can then do a preliminary background check on that physician by going to the Texas Board of Medical Examiners website.

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On July 1, 2011,the Supreme Court of Texas modified long existing common law known as the collateral source rule in such a manner as to inhibit the victims of car wrecks, truck wrecks, defective products and bad drugs from getting a fair recovery from a jury in Texas. In the case of Haygood v. Escobedo, Tex. Sup. Ct. No. 09-0377, July 1, 2011, the Court concluded that health care providers make it a practice to set their full charges as high as possible in order to attempt to influence private insurers and medicare to increase reimbursement rates. As a result, the Court concluded that juries should ignore these charges by health care providers in determining the award of reasonable and necessary medical expenses and only consider what the health insurance carrier or Medicare actually paid under its reimbursement agreement. While innocuous on its face, the Court well knows that the amount of medical expenses presented to the jury during trial impacts the award of other elements of damages such as pain and suffering. By refusing to allow the jury to consider the full charge of the health insurance carrier in determining damages and only allowing the amount paid under a reimbursement agreement with the private health insurance carrier or Medicare, it can be concluded that jury verdicts in cases where the victim of personal injury has private insurance will be smaller.

The collateral source rule was intended to prevent the wrongdoer to benefit from a person having insurance independently purchased from a third party. In my opinion, what is wrong with this opinion is that a person who did not purchase private health insurance will continue to be able to submit the full amount of the bill charged by the health insurance provider and as a result will in all probability have disparately higher jury awards when compared to the victim with the good judgment to purchase such coverage. As a result, in my opinion, the Haygood opinion accomplishes exactly what the collateral source rule was designed to prevent. It has the effect, whether unintended or not, to influence jury verdicts against wrongdoers lower in cases where the personal injury plaintiff did the prudent thing by purchasing health insurance.

Mike McGartland