Unsafe Drug Alert: Benicar High Blood Pressure Medication

Nearly 67 million Americans are prescribed Benicar to treat their high blood pressure.

After research surfaced linking it to severe gastrointestinal side effects, the Food and Drug Administration ("FDA") required a warning label, a flood of "failure to warn" lawsuits ensued, and Benicar manufacturer Daiichi Sankyo entered into a $39 million settlement agreement with the United States Department of Justice. 

What is Benicar? 

High blood pressure medication "Benicar" is in a class of drugs known as "angiotensin II receptor blockers" ("ARB"), the active ingredient in which lowers the body’s blood pressure by keeping blood vessels dilated. 

Also marketed as "Benicar HCT", "Azor "and "Tribenzor", Benicar is manufactured by Daiichi Sankyo and received FDA approval on April 25, 2002. 

In 2012 alone, over 1.9 million patients were prescribed Benicar from which Daiichi Sankyo received billions in sales revenue. 

Bennicar Side Effects 

After years on the market, research surfaced linking Benicar patients to serious and  deadly gastrointestinal complications including: 

• Sprue like enteropathy (a disease with Celiac-like symptoms)
• Vinous atrophy (damages small intestines ability to absorb nutrients)
• Kidney problems and failure
• Liver impairment
• Dehydration
• Chronic diarrhea
• Nausea and vomiting
• Malnutition
• Significant weight loss
• Abdominal pain
• Angioedema (rapid swelling of the skin)
• Chest pain
• Hair loss and rashes
• Irregular heart beat
• Arthritis

Benicare Lawsuits

After research surfaced linking Benicar to severe side effects, in April 2014, the FDA ruled that Benicar required a label warning associating it with specific and significant gastrointestinal ailments.

Shortly thereafter, a flood of "failure to warn" lawsuits ensued and, in early 2015, Daiichi Sankyo entered into a settlement agreement with the United States Department of Justice.

Specifically, to resolve allegations that it paid kickbacks to induce physicians to prescribe Benicar over other ARBs in violation of the False Claims Act, Daiichi Sankyo agreed to pay $39 million.

Four Things Never to Say to an Insurance Adjuster After an Accident

For most people, "insurance company" means the agent who sold them their home, life, auto, or health insurance policy; a salt-of-the-earth family man with a ready smile, genuinely interested in your life and family, and whom, after you signed the policy application, let you keep the pen! 

After an auto accident, you'll meet another insurance company representative: the adjuster.  While pleasant and charismatic, she acts on behalf of the other driver’s insurance company when he negligently injured you.  She’s matter-of-fact and businesslike, and, because insurance companies are in the business of making money, her primary goal is to minimize your claim.  

To receive the compensation you deserve for your injuries and property damage, there are four types of statements you should never make to an insurance adjuster. 

1. “In My Opinion” or “I Think”

An adjuster may ask you several things in several ways, and all your answers will be used to prevent you from getting your claim's maximum value.  If you do not know the answer to a question, say nothing and only state the facts.  Don’t guess or estimate anything.

 2. “I’m Sorry” or “It Was My Fault”

Apologize for nothing.  Apologies can be interpreted as admitting fault, you did not witness the accident and everything you say will be used against you.  Even if you feel you are at fault, the other driver may have caused the accident or have just as much responsibility for it as you do.  These statements should never be made to any insurance adjuster, police officer, or other driver.

3.“I’m Not Hurt”

Volunteer nothing.  Just because you may not have any visible injuries, it does not mean you are fine.  Some injuries may not show up right away and the initial shock's adrenalin may prevent you from feeling the pain you may experience in the ensuing days.  Have a doctor document any pain you may be feeling and avoid signing a medical release without speaking to an experienced accident attorney.

4. Recorded Statements

You have no obligation to give a recorded statement.  Because what you say to an insurance adjuster can be taken out of context, never agree to provide a recorded statement.

 Many accident victims are not aware of their claim's value and may be tempted to accept the insurance company's first offer.  Do not rush into a settlement without consulting an attorney able to calculate your claim's value, taking into consideration immediate and future injuries and expenses such as medical bills, out-of-pocket expenses, lost wages, pain and suffering, and the impact an injury may have on your life.

Takata Airbag Injuries Causes Nationwide Recall

On October 21, 2014, the National Highway Traffic Safety Administration ("NHTSA") reported that recall of Takata Corp. supplied airbags would affect 4.7 million vehicles.

A Tokyo-based supplier of seat belts, steering wheels and other auto parts, Takata's airbags contain faulty inflator mechanisms causing rupture and release metal shrapnel when deployed in a collision.  Presently, 4 deaths and 139 injuries (particularly affecting the face and neck) have been attributed to the defective Takata airbags.  

Since 2008, over 14 million vehicles have been recalled for Takata defects from automakers including Toyota, Honda, Mazda, BMW, Nissan, General Motors, Ford, Mitsubishi and Subaru.

Because the defect has been specifically seen in vehicles located in high humidity regions, the NHTSA advised that Florida, California, Hawaii, Texas, Louisiana, Mississippi, Alabama, Georgia, and South Carolina vehicles owners take immediate action. 

The Center for Auto Safety has warned that the potential for defective airbags goes beyond the recall's identified areas which does not include the 2 states - - Virginia and Oklahoma - - in which people have been killed due by defective airbags metal shrapnel.  

The vehicles contained in the "Takata Airbag Recall" list currently include:

◦2002–2004 Lexus SC

◦2003–2004 Toyota Corolla and Tundra

◦2002–2004 Toyota Sequoia

◦2003– 004 Pontiac Vibe

◦2001–2007 Honda Accord (4 cyl)

◦2001–2002 Honda Accord (6 cyl)

◦2001–2005 Honda Civic

◦2002–2006 Honda CR-V

◦2003–2011 Honda Element

◦2002–2004 Honda Odyssey

◦2003–2007 Honda Pilot

◦2006–Honda Ridgeline

◦2003–2006 Acura MDX

◦2002–2003 Acura TL/CL

◦2001–2003 Nissan Maxima and Pathfinder

◦2002–2003 Nissan Sentra

◦2001–2003 Infiniti I30/I35

◦2002–2003 Infiniti QX4

◦2003 Infiniti FX

◦2003–2004 Mazda 6

◦2004–Mazda RX-8

◦2000–2005 BMW 3 Series Sedan and Sports Wagon

◦2000–2006 BMW 3 Series Coupe

◦2000–2006 BMW 3 Series Convertible

◦2001–2006 BMW M3 Coupe and  Convertible

◦2002–2003 Buick LeSabre and Rendezvous

◦2002–2003 Cadillac DeVille

◦2002–2003 Chevrolet Trailblazer, Impala, Monte Carlo and Venture

◦2002–2003 GMC Envoy and Envoy XL

◦2002–2003 Oldsmobile Aurora, Bravada and Silhouette

◦2002-2003 Pontiac Bonneville and Montana

◦2005-2007 Mustang

◦2005-2006 GT

◦2004 Ranger

5 Tips For Picking Automobile Insurance

Which automobile insurance company is right for you?   

Whether bringing a car accident claim or just trying to understand costs, coverage and exclusions, avoiding the stinkers will make an enormous difference in both what you are able to recover and how you are treated. 

However, because Pennsylvania Insurance Department's website http://www.insurance.pa.gov/portal/server.pt/community/insurance_pa_gov/ lists hundreds of insurers, choosing the best carrier can be challenging.  

In selecting an insurance company the main points to consider are stability, service, comfort, licensing and cost.  

1. Stability 

Insurance is purchased for financial protection and to provide peace of mind.   

Research insurance companies to determine if the insurer is stable, financially sound, and likely to be around for the duration.   

Remember, because they are paid commissions by the insurance companies, insurance agents and brokers are often conflicted and unable to provide you fair and unbiased information.  

2. Service 

Your insurance company and its representatives should be able to answer your questions and handle your claims swiftly, efficiently and fairly.   

Talking to other customers who have used a particular company or agent is an excellent way of determining what level of service is being provided.  Further, in addition to state insurance departments, many national claims databases exist listing and indexing complaint information for particular a insurance company and service relative to the number of policies it sold.   

3. Comfort 

Whether purchasing insurance from a local agent or directly from the company over the phone or the Internet, you must be comfortable both with the insurance you purchased and ease and responsiveness of communication with the insurer.   

Make sure that the agent or company will be easy to reach if you have a question or need to file a claim.   Consider whether you prefer a company that has agents you can visit locally or how quickly and satisfactorily it responds to information requests. 

4. Licensing 

For your state insurance department to regulate your carrier and resolve any problem you may have, a prospective insurance company must be licensed to operate in your state.   

Contact the state insurance department (http://www.iii.org/state-organizations) to determine which companies are licensed in your state. 

5. Cost

 Because insurance policies' coverage and prices vary greatly, shopping around is critical.  

Get at least three (3) price quotes from companies, agents and from the Internet.  

Further, your state insurance department http://www.iii.org/state-organizations may publish a guide listing what insurers charge for different policies in various parts of your state.

Prescription Medication Error Medical Malpractice

According to a recent Yale-New Haven Hospital study, 3 out of 4 patients leave the hospital with either the wrong prescriptions or a lack of understanding about their medications.  

The chief researcher, Dr. Leora Horwitz, who also practices at the hospital, said healthcare providers “do a relatively poor job of educating patients about their medications.”  

Medical malpractice mistakes involving medication errors injuring more than 1.3 million persons a year.  

The study looked at 377 Yale-New Haven Hospital patients, ages 64 and older, who had been admitted with heart failure, acute coronary syndrome or pneumonia, then discharged to home.  

Of that group, 307 patients - - 81% - - either experienced a provider error in their discharge medications or had no understanding of at least one intended medication change.  

“We’re talking about the vast majority of our patients going home at potential risk” of medication problems, Horwitz said. “That’s huge. Collectively, something is not right.”  

The Yale study relied on interviews with patients after discharge, who were asked about their medication regimen. The researchers also reviewed patients’ admission and discharge medication records to see if all changes were intentional, or if any appeared to be errors.

Other study findings include:

•24% of medication changes were due to provider error.

•The average patient had no understanding of 60% of all stopped, re-dosed and new medications.

•Errors and misunderstanding were more common for medications not related to patient’s primary diagnosis than for those related to main ailment being treated.

•The electronic medical records system used at Yale and other hospitals makes it hard to track and reconcile medication changes.

•Patient discharge lists don’t flag which prescriptions are new and which have been stopped.

•Patients at many hospitals get a quick drug rundown from a nurse before discharge, but not a thorough review that ensures they understand the medications. 

Dr. Horowitz recounted a horror story in which one of her patients switched to a new beta blocker for high blood pressure during an inpatient hospital stay.  She landed back in the hospital after discharge when she took both the new medication and her old beta blocker – a combination that lowered her heart rate and blood pressure to dangerous levels.  

Medical malpractice errors – including prescription mistakes – are responsible for up to 98,000 wrongful deaths in American hospitals each year.  

The full Yale-New Haven Hospital is at: http://www.nhregister.com/articles/2012/12/03/news/doc50bd213d5f662015750301.txt

Higher Gas Prices Result in Motorcycle Fatalities

While traffic fatalities have dropped to record lows, motorcycle deaths have risen reflecting both an increase in the number of riders and cycles' inherent vulnerability. 

A strong relationship exists between gasoline prices and motorcycle fatalities - - as gas prices rise, so do the number of fatalities - - and wearing helmets is still the best method of reducing motorcycle deaths.  

Dangers of Motorcycle Travel 

According to the National Safety Council ("NSC"), motorcycles are the highest-risk form of travel and do not follow normal highway fatalities trends because circumstances leading to motorcycle deaths differ from automobile crashes. 

In 1975, 44,525 people died in US highway accidents of which 3,189 were motorcyclists.

By 2012, total highway fatalities had dropped to 33,561, while motorcycle deaths rose to 4,957.

In Pennsylvania, between 2001 and 2013 motorcycle fatalities rose 43% while fatalities in other vehicles dropped 27%.

Although millions more cars and motorcycles are on the road now than in 1975, the fatality rate has dropped for both vehicles with a threefold nationwide drop in car fatalities compared with a 14% drop for motorcycles.

Unlike motorcycles, cars have become safer by seat belts, air bags, antilock brakes and electronic stability control.  Conversely, according to the Governors Highway Safety Association ("GHSA"), little can be done to improve motorcycle safety other than helmet wearing which, unfortunately, has diminished over the past 30 years. 

In 1975, 47 states required all motorcyclists to wear helmets but that number has dropped to 19.

New Jersey requires helmets, but in 2003 Pennsylvania repealed its mandatory helmet law requiring helmets only for those under 21 or licensed for less than 2years (unless they have completed an approved safety course).

The National Highway Traffic Safety Administration ("NHTSA") estimated that in 2011 helmets saved 1,617 motorcyclists' lives and would have saved 703 additional lives if all motorcyclists wore helmets.

Further, according to Pennsylvania's Motorcycle Dealers Association, motorcyclists are much less visible to motorists distracted driving by talking on cellphones or texting which likely has contributed to accidents.

Gasoline Price and Motorcycle Fatality Correlation

An NSC analysis charting the trend since 1976 shows a strong correlation between gasoline prices and motorcycle fatalities. 

Specifically, because higher gas prices encourage using fuel-efficient motorcycles instead of cars leading to more - - and more inexperienced - - motorcyclists, as gas prices rise, so do the number of motorcycle deaths.

To reduce motorcycle fatalities, the GHSA recommends:

°Increasing helmet use.  In 2012, the U.S. Government Accountability Office concluded  that laws requiring all motorcyclists to wear helmets are the only strategy proven to be effective in reducing fatalities.

°Reducing drunken riding.  In 2010, 29% of fatally injured riders had a blood alcohol concentration at or above 0.08 % legal limit, the highest among all motorists.

°Reducing speed. 35% of motorcycle riders involved in fatal crashes were speeding and almost half of these crashes did not involve any other vehicle.

°Improving training.  While all states offer training, some courses may not be provided at convenient times and locations.

°Encouraging drivers to share the road.  According to NHTSA, when motorcycles crash with other vehicles, the other vehicle usually violated motorcyclist's right of way.

Injury Claims Against The Government

Ever get clobbered by the Government, literally?

Victims of accidents due to federal and state government employees' negligence - - and aviation, maritime, and negligent healthcare claimants at government owned facilities and military hospitals - - bring personal injury actions against the state or federal government to pay damages for losses and suffering.

What Are Governmental Claims

Like any other institution, the federal government and its employees can harm people through negligence.  A Veterans Administration doctor may cause a wrongful death through negligence and medical malpractice.  A law enforcement officer may commit a heinous act of brutality resulting in serious injuries.  A contractor working on a government project may cause a construction accident.

But suing the government to pay for losses and suffering caused by its employees' negligence and wrongdoing is different from any other personal injury action and requires getting around sovereign immunity, a legal doctrine immunizing the state from prosecution for a legal wrongdoing.

Federal Tort Claims Act

The Federal Tort Claims Act ("FTCA") is a statute enacted by the United States Congress in 1946 permitting private parties to sue the United States in a federal court for torts committed by persons acting on the United States' behalf.

The FTCA provides a limited waiver of the federal government's sovereign immunity when its employees are negligent within the scope of their employment.   Under the FTCA, the government can only be sued "under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred."  Thus, the FTCA does not apply to conduct that is "uniquely governmental" and incapable of performance by a private individual.

The FTCA further provides that the government is not liable when any of its agents commits the torts of assault, battery, false imprisonment, false arrest, malicious prosecution, abuse of process, libel, slander, misrepresentation, deceit, or interference with contract rights.  However, the FTCA provides an exception that the government is liable if a law enforcement officer commits assault, battery, false imprisonment, false arrest, abuse of process, or malicious prosecution.

FTCA Exposure Exceptions

The FTCA is limited by a number of exceptions pursuant to which the government is not subject to suit, even if a private employer could be liable under the same circumstances.

These exceptions include the "discretionary function exception" barring a claim "based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused."  28 U.S.C. §2680(a).

In order to determine whether conduct falls within the discretionary function exception, the courts must apply a two‑part test.  First, determine whether the conduct involved "an element of judgment or choice" which is not satisfied if a "federal statute, regulation, or policy specifically prescribes a course of action for an employee to follow."

If an element of judgment is established, the second inquiry is "whether that judgment is of the kind that the discretionary function exception was designed to shield" in that it involves considerations of "social, economic, and political policy."

Mechanics of Bringing a Government Claim

The FTCA specifies that government's liability is to be determined "in accordance with the law of the place where the [allegedly tortious] act or omission occurred."

Thus, in an action under the FTCA, a court must apply the law the state courts would apply in the analogous tort action, including federal law.  

A plaintiff cannot bring an FTCA claim against the United States based solely on conduct that violates the Constitution because such conduct may violate only federal, and not state, law