Chrysler Decides to Recall 2.7 Million Jeeps After All

After initially rebuking and refusing to comply with a NHTSA recall that would recall over 2.7 million Jeep vehicles, Chrysler has announced today that it will recall the vehicles that the government previously requested to do so.  The 2.7 million vehicles include 1993-2004 Jeep Grand Cherokee and 2002-2007 Jeep Liberty SUVs.  Chrysler has stated that the dealership will complete “visual inspection of the vehicle” and “will, if necessary, provide an upgrade to the rear structure of the vehicle to better manage crash forces in low-speed impacts.”  NHTSA has responded that they are “pleased that Chrysler has agreed to take action to protect its customers and the driving public.”

Click here to read the full USA today article: Chrysler caves, recalls 2.7 million Jeeps

It was just two weeks ago, when the National Highway Traffic Safety Administration requested that Chrysler voluntarily recall and repair 1993-2004 model Jeep Grand Cherokees and 2002-2007 Jeep Liberty sport utility vehicles.  Chrysler initially refused.  Chrysler claimed that the vehicle was safe and there was no reason for the recall.

Why Did NHTSA ask Chrysler to recall 2.7 million Jeeps?

37 rear-end accidents that resulted in fires and 51 fatalities led NHTSA investigators to believe the vehicles have design flaws with defective fuel tank design and placement on vehicles.  According to NHTSA, “In our tentative view, there is a performance defect and a design defect.  The performance defect is that the fuel tanks installed on these vehicles are subject to failure when the vehicles are struck from the rear.  Such failure can result in fuel leakage, which in the presence of external ignition sources can result in fire.  The design defect is the placement of the fuel tanks in the position behind the axle and how they were positioned, including their height above the roadway. The defects present an unreasonable risk to motor vehicle because people in the MY 1993 – 2004 Jeep Grand Cherokee (ZJ and WJ), the MY 2002 – 2007 Jeep Liberty and in striking vehicles have burned to death in rear impact crashes, there have been fires (without fatalities) in these vehicles from rear impact crashes that have, or could have, led to deaths and injuries, and there have been leaks from Grand Cherokee and Liberty gas tanks from rear impact crashes that could have led to fire and death or injury.”

Ultimately, Chrysler decided to heed the warnings by NHTSA and recall the vehicles.  Although Chrysler still maintains that the Jeep is still one of the safest vehicles of their type at the time they were sold, the automobile company has decided to comply with NHTSA and recall these Jeeps.

Click here to read the NHTSA letter to Chrysler: June 3, 2013 Letter

Americans rely on their car manufactures to provide a safe well-designed vehicle.  Sadly, that is not often the case.  The Auto Defect Attorneys at the Brandi Law Firm have successfully represented many people injured from defective Toyotas, Fords, Chrysler, GM products and numerous other manufacturers and suppliers.  Often times, people involved in accidents do not examine the issues of defective vehicle design nor whether the car was truly crashworthy – does it contain the appropriate crash protection.  If you or a loved one has been injured in an auto crash, our attorneys at the Brandi Law Firm are available to consult with you.  Please contact our office at 800-481-1615 or email us.

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Chrysler vs. NHTSA Tug of War; Who Loses

On June 3, 2013, NHTSA requested that Chrysler voluntarily recall and repair 1993-2004 model Jeep Grand Cherokees and 2002-2007 Jeep Liberty sport utility vehicles totaling 2.7 million vehicles.  Chrysler refused placing its Jeep owners squarely in the middle of this powerful tug of war and has to June 18, 2013 to formally respond to NHTSA’s request.

Why Did NHTSA ask Chrysler to recall 2.7 million Jeeps?

37 rear-end accidents that resulted in fires and 51 fatalities led NHTSA investigators to believe the vehicles have design flaws with defective fuel tank design and placement on vehicles.  According to NHTSA, “In our tentative view, there is a performance defect and a design defect.  The performance defect is that the fuel tanks installed on these vehicles are subject to failure when the vehicles are struck from the rear.  Such failure can result in fuel leakage, which in the presence of external ignition sources can result in fire.  The design defect is the placement of the fuel tanks in the position behind the axle and how they were positioned, including their height above the roadway. The defects present an unreasonable risk to motor vehicle because people in the MY 1993 – 2004 Jeep Grand Cherokee (ZJ and WJ), the MY 2002 – 2007 Jeep Liberty and in striking vehicles have burned to death in rear impact crashes, there have been fires (without fatalities) in these vehicles from rear impact crashes that have, or could have, led to deaths and injuries, and there have been leaks from Grand Cherokee and Liberty gas tanks from rear impact crashes that could have led to fire and death or injury.”

Chrysler responded the vehicle was safe and there was no reason for the recall. If you are an owner of one of these vehicles, how are you feeling?

NHTSA says they are unsafe and Chrysler says the Jeeps “do not pose an unreasonable risk”.

What is an unreasonable risk? What is a reasonable risk?

How comfortable are you driving one today?

How would you feel about buying one, even with a great price?

Jeep owners of these models are the rope in this tug of war and they eagerly await the June 18, 2013 deadline for Chrysler’s response.  Will Chrysler comply, or will it go to Court to fight it out with its armada of attorneys?

Many feel Chrysler was kept alive by taxpayer dollars, and now fueled by huge profits, have turned its back on the American people who kept alive this company.  No one knows if Chrysler will win in the courts, but many feel it has already lost in the Court of Public Opinion.

Click here to read the NHTSA letter to Chrysler: June 3, 2013 Letter

Americans rely on their car manufactures to provide a safe well-designed vehicle.  Sadly, that is not often the case.  The Auto Defect Attorneys at the Brandi Law Firm have successfully represented many people injured from defective Toyotas, Fords, Chrysler, GM products and numerous other manufacturers and suppliers.  Often times, people involved in accidents do not examine the issues of defective vehicle design nor whether the car was truly crashworthy – does it contain the appropriate crash protection.  If you or a loved one has been injured in an auto crash, our attorneys at the Brandi Law Firm are available to consult with you.  Please contact our office at 800-481-1615 or email us.

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Appellate Court Victory for Generic Fosamax Users

In a major victory for consumers who used the generic form of Fosamax, (Alendronate sodium) on June 13, 2013 the California Court of Appeal, Fourth Appellate District, Division Three ruled that people who used the generic Fosamax were not preempted by Federal law and the decision in PLIVA, Inc. v. Mensing (2011131 S.Ct. 2567 but could proceed against manufacturers of generic version for failure to adequately warn of safety issues regarding the products (Teva Pharmaceuticals USA, Inc, et al vs. Superior Court of Orange County, OLGA PIKERIE, Real Party In Interest, G047134).

In Mensing, the US Supreme Court ruled that any claim a generic drug company should have used stronger warnings than those approved for use on the equivalent brand‑name drug are preempted by federal law.  The court also held that a state could not require a generic drug manufacturer to provide information on its label in addition to information required on the brand‑name drug’s label, as that would make it impossible for the generic drug manufacturer to comply with both its duty under federal law to match the brand-name label and any claimed duty under state law to do more.  As a result of this impossibility, such a state requirement would be preempted by federal law.

However in the case of Olga Pikerie, the Court stated: “In this case, in contrast, plaintiff alleged that the brand‑name drug label was updated, but the generic drug manufacturers failed to update their products’ labels accordingly.  In other words, the generic drug labels did not match the brand‑name drug label.  Consequently, we conclude, plaintiff’s claims in this regard are not preempted by federal law.”

Fosamax was under patent protection to MERCK until 2008.  Fosamax was heavily marketed following its introduction to the consumer market in 1999.  Millions of patients were prescribed Fosamax to treat or prevent Osteoporosis, especially in women going through menopause.  However, there are potential dangerous side effects of Fosamax that Merck & Company (manufacturer of Fosamax) failed to alert the public about, especially atypical femur fractures.  For many, what was designed to make you stronger actually made you weaker.

When the patent expired, several other companies made the generic version (Alendronate sodium) including Teva Pharmaceuticals USA, Inc. (Teva), Barr Pharmaceuticals LLC (Barr), Barr Laboratories, Inc. (Barr Labs), Mylan Pharmaceuticals, Inc. (Mylan), Caraco Pharmaceutical Laboratories, Ltd. (Caraco), Sun Pharmaceutical Industries, Inc. (Sun), and NorthStar Rx LLC (NorthStar).  Fosamax and alendronate sodium belong to the class of drugs known as bisphosphonates and they are indicated for the treatment and prevention of osteoporosis.

FDA Letter

On October 13, 2010, the U.S. Food and Drug Administration warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis, stating:

“FDA has reviewed all available data, including data summarized in the American Society for Bone and Mineral Research (ASBMR) Task Force report regarding bisphosphonates and atypical subtrochanteric and diaphyseal femur fractures, released on September 14, 2010.  These atypical femur fractures can occur anywhere in the femoral shaft, from just below the lesser trochanter to above the supracondylar flare, and are transverse or short oblique in orientation without evidence of comminution.  The fractures can be complete (involving both cortices) or incomplete (involving the lateral cortex only), and may be bilateral.  Many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. The exact incidence of atypical femoral fractures is unknown but appears to account for less than one percent of hip and femoral fractures overall. Therefore, atypical fractures are very uncommon.  Although atypical femoral fractures have been predominantly reported in patients taking bisphosphonates, they have also been reported in patients who have not taken bisphosphonates.

The optimal duration of bisphosphonate treatment for osteoporosis is unknown.  Bisphosphonate medications approved for the prevention and/or treatment of osteoporosis have clinical trial data supporting fracture reduction efficacy through at least 3 years of treatment and, in some cases, through 5 years.  The FDA is continuing its evaluation of data supporting the safety and effectiveness of long-term use (greater than 3 to 5 years) of bisphosphonates for the treatment and prevention of osteoporosis and will provide additional guidance at the completion of our review.

In summary, FDA is continuing its ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures.  As of this notice, the FDA is notifying patients and healthcare professionals of new Warnings and Precautions information that is being added regarding this risk to the labels of all bisphosphonate products approved for the prevention or treatment of osteoporosis.  A new Limitations of Use statement will describe the uncertainty of the optimal duration of use of bisphosphonates for the treatment and/or prevention of osteoporosis.  In addition, the FDA will require that a Medication Guide be included with all bisphosphonate medications approved for osteoporosis indications to better inform patients of the risk for atypical femur fracture.”

http://www.fda.gov/Drugs/DrugSafety/

Olga Pikerie was prescribed and took Fosamax and/or alendronate sodium from 2006 to 2011 when she suffered a left femur fracture.  Pikerie’s complaint alleged prolonged use of Fosamax and/or alendronate sodium might cause fractures of the femur due to suppression of bone turnover.  Her suit claimed that “ the Teva Defendants’ alleged failures to (1) update the alendronate sodium labels to match the updated Fosamax label; (2) communicate the updated safety information to physicians and other health care professionals; (3) stop marketing alendronate sodium after learning about safety issues regarding the drug; and (4) request the FDA to order a change to the Fosamax label, which would have enabled the Teva Defendants to then update the alendronate sodium labels to match the Fosamax label.”

The Court concluded her case was not pre-empted under federal law and will allow her cases and those of other users of generic Fosamax to proceed.  This case arose when the Teva Defendants filed a Demurer to the original complaint, lost, and asked the Appellate Court to overturn the Trial Court by way of Special Writ of Mandate/Prohibition claiming cases against generic manufacturers were barred by the legal doctrine of federal pre emption.

Additional Studies

A study published May 21, 2012 on-line by the Archives of Internal Medicine said it found a link between bisphosphonate use (one of which is Fosamax) and atypical thigh fractures.

Of 477 patients fifty years and older hospitalized at one center for a subtrochanteric or femoral shaft fracture, 39 had atypical fractures and 438 had common fractures.  The study examined patients between 1990 and 2010.  Among those with atypical fractures, 82.1% had been taking bisphosphonates compared with just 6.4% of those with common fractures, Raphael P.H. Meier, MD, from University Hospitals of Geneva, and colleagues reported online in the Archives of Internal Medicine.

They also noted that the atypical-fracture group had a longer treatment period on bisphosphonates – including alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), and ibandronate (Boniva) – than the classic-fracture group, at a mean of 5.1 years versus 3.3 years (P=0.02).  The study concluded that: “Atypical femoral fractures were associated with bisphosphonate use; longer duration of treatment resulted in augmented risk.  The incidence of atypical fractures increased over a 12-year period, but the absolute number of such fractures is very small.”

According to Douglas Bauer, MD, of the University of California San Francisco, in an accompanying commentary to the article the study “adds further data suggesting that the association between bisphosphonate use and atypical fractures is causal”.

This decision will allow countless people who suffered atypical femur fractures on Fosamax or its generic equivalent to hold the manufacturers accountable.  The Brandi Law Firm continues to represent a number of people who used Fosamax or its generic equivalent and suffered atypical femur fractures.  We believe that ultimately Merck and the generic manufacturers will be held accountable in these cases.  If you would like more information, check the video below or go to our website, or contact us.

Fosamax, Used to Treat Osteoporosis, Is Linked To Unusual Bone Fractures in The Femur

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Safety or PR? Chrysler Recalls 630,000 Vehicles While Refusing to Recall 2.7 Million Jeeps

In what some say is a public relations move designed to shore up its safety image in light of its refusal to recall Grand Cherokee and Liberty models, Chrysler announced on June 6, 2013 it was recalling about 630,000 newer SUVs for transmission and airbag defects while standing by its position that 2.7 million Grand Cherokees and Liberty models made over 15 model years meet or exceed all U.S. safety standards.

According to Chrysler and filings with the National Highway Traffic Safety Administration, Chrysler will recall 630,000 Jeeps to fix airbag deployment problems and transmission oil leaks as the 2010-2012 Jeep Compass and Patriot may deploy the side airbags too late in a crash, or not at all, due to a software error.  Chrysler said that during a rollover, the vehicle’s lateral acceleration sensors could send a faulty signal to the airbag module, which could also delay the seatbelt pre-tensioners or cause them to deactivate.  In total, 254,396 vehicles are affected in the U.S.

The recall also affects 181,131 Wranglers equipped with automatic transmissions.  A tube carrying fluid for the power-steering system can be in “hard contact” with the transmission oil cooler tube, which was switched from steel to a softer aluminum starting in the 2012 model year, Chrysler said.  In August 2012, Chrysler fitted rubber parts to cushion the tubes and later redesigned the power-steering tube to be farther away from the transmission tube, which was fitted with a sleeve, starting in February 2013.  The problem has occurred in at least 81 customer vehicles.  Starting in July, dealers will replace the power-steering tube system with the latest design and fit sleeves on the transmission oil cooler tube.

But Chrysler is no stranger to the controversy over refusal of a safety recall.  In the 1990′s Chrysler successfully fought off a recall when its legal team consisting of current Chief Justice John Roberts and an armada of attorneys fought the NHTSA in the courts and defeated NHTSA’s attempt to recall about 91,000 Cirrus and Dodge Stratus cars from model year 1995 because of concerns about the strength of seat-belt anchors.  With Roberts as its lawyer, Chrysler won a 1998 appeal, getting the recall thrown out on a finding NHTSA had not given complete notice of the defects.

In refusing the request for a recall of the 2.7 million Cherokee and Liberty models, Chrysler chose to ignore the June 3, 2013 NHTSA statement that:

“In our tentative view, there is a performance defect and a design defect.  The performance defect is that the fuel tanks installed on these vehicles are subject to failure when the vehicles are struck from the rear.  Such failure can result in fuel leakage, which in the presence of external ignition sources can result in fire.  The design defect is the placement of the fuel tanks in the position behind the axle and how they were positioned, including their height above the roadway.  The defects present an unreasonable risk to motor vehicle because people in the MY 1993 – 2004 Jeep Grand Cherokee (ZJ and WJ), the MY 2002 – 2007 Jeep Liberty and in striking vehicles have burned to death in rear impact crashes, there have been fires (without fatalities) in these vehicles from rear impact crashes that have, or could have, led to deaths and injuries, and there have been leaks from Grand Cherokee and Liberty gas tanks from rear impact crashes that could have led to fire and death or injury.”

NHTSA requested that:”ODI requests that Chrysler initiate a safety recall on MY 1993-2004 Jeep Grand Cherokee and MY 2002-2007 Jeep Liberty vehicles and implement a remedy action that improves their performance in rear-impacts and crashes.  ODI requests that Chrysler notify all owners of the defect and that it provide a free remedy to the owners of each of the above vehicles in accordance with 49 U.S.C. § 30118-30120.”

Chrysler has maintained the vehicles meet federal standards and therefore there is no need to take any action.  But NHTSA disagreed, stating

“Chrysler maintains, and we do not dispute, that the Grand Cherokee and Liberty vehicles complied with the requirements of Federal motor vehicle safety standard (FMVSS) No. 301, Fuel System Integrity, that was applicable when the vehicles were manufacturedAs NHTSA has noted in the past, a federal motor vehicle safety standard is a “minimum standard for a motor vehicle . . . performance.” 49 U.S.C. 30102(a)(9). The existence of a minimum standard does not require NHTSA to ignore deadly problems.  Viewed another way, a FMVSS does not preclude a finding of a safety related defect in a vehicle when supported by the evidence.”

Where do we go from here?

According to NHTSA letter:

“If Chrysler decides not to conduct the requested recall, it must provide ODI with a full explanation of its decision, including any additional analysis of the problem beyond Chrysler’s past presentations.  If Chrysler fails to initiate a recall, NHTSA may proceed to an Initial Decision that these vehicles contain a safety-related defect.  See 49 U.S.C. § 30118.  An Initial Decision will be accompanied by the publication of a Federal Register notice describing the alleged defects, the safety consequences of these defects, the ODI investigation, the scheduling of a public meeting, and the issuance of a press release to inform the public of this matter.”

Now the ball shifts to Chrysler who can use its reservoirs of cash from it 2012 billion dollar profit to do what it did in the 1990s, fight it out in federal court, a fight that could ultimately land in lap of its former lawyer Supreme Court Justice Roberts.  In the meantime, there is no relief for the consumers whose taxes bailed out Chrysler and are now caught in a tug of war between Chrysler and NHTSA driving cars that NHTSA says are defective.

Americans rely on their car manufactures to provide a safe well-designed vehicle.  Sadly, that is not often the case.  The Auto Defect Attorneys at the Brandi Law Firm has successfully represented many people injured from defective Toyotas, Fords, Chrysler, GM products and numerous other manufacturers and suppliers.  Often times, people involved in accidents do not examine the issues of defective vehicle design nor whether the car was truly crashworthy – does it contain the appropriate crash protection.  If you or a loved one has been injured in an auto crash, our attorneys at the Brandi Law Firm are available to consult with you.  Please contact our office at 800-481-1615 or email us

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Dan Dell’Osso Finishes 67th out of 1500 in Legendary Dipsea Trail Race

On June 9, 2013, nearly 1,500 elite runners challenged the Dipsea trail in a thrilling race from Mill Valley, up stairs, over mountains, up and down gullies in a treacherous 7.4-mile trek to the sea.  First run in 1905, the Dipsea is the oldest trail race in America and draws competitors from around the globe.  It is run every year on the second Sunday in June.  The scenic 7.4-mile course from Mill Valley to Stinson Beach is considered one of the most beautiful courses in the world. The stairs and steep trails make it a grueling and treacherous race as runners climb 688 stairs leading up the side of Mount Tamalpais, and then pass through Muir Woods National Monument, Mount Tamalpais State Park, and the Golden Gate National Recreation Area.

The ascent over the southern shoulder of Mount Tam reaches its apex around the top of Cardiac Hill, about 4.5 miles into the race. Among the challenges facing participants are the Dipsea Trail’s uneven footing, single-track footpaths, and almost invariably steep terrain, featuring about 2,200-foot (671 m) elevation gain and loss over the course.  The uniqueness of the Dipsea Race course owes largely to the opportunity for competitors to choose from any of several alternate routes on diverging and converging trails, adding a competitive premium for strategy, experience, and familiarity with the course.

The Brandi Law Firm is proud to announce that attorney Dan Dell’Osso, fresh from a case starting trial in Reno, Nevada, finished 67th in the incredible time of 56:21.  Special congratulations to Dan for his extraordinary effort.  He went after this racecourse with the same determination he brings to his cases, as witnessed by Best Lawyers naming him Trial Lawyer of the Year in 2012.  Congratulations, Dan.

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Chrysler Refuses NHTSA Request for Safety Recall for Grand Cherokee and Liberty

On June 5, 2013, Chrysler Group LLC, who many feel owes its existence to the $12.5 billion payout by American taxpayers in 2009, took the extremely rare step of rejecting a safety recall requested by the US auto safety regulatory, the National Highway Traffic Safety Administration [NHTSA] despite the fact the rate of collisions in Chrysler’s Grand Cherokee and Liberty was double that of other sport utility vehicles.

Here, NHTSA requested that Chrysler recall and repair 1993-2004 model Jeep Grand Cherokees and 2002-2007 Jeep Liberty sport utility vehicles.  NHTSA reports that these vehicles were involved in 37 rear-end accidents that resulted in fires and 51 fatalities and that these vehicles have defective fuel tank design and placement.  The total number of vehicles affected is 2.7 million.

NHTSA provided this photo of a Grand Cherokee it says was involved in a fire crash.

This is the first time since 1996 that an automaker has blatantly refused a recall demand for safety concerns.  In a statement attempting to justify leaving vehicles NHTSA believes unsafe on the road Chrysler argued the vehicles, “do not pose an unreasonable risk” and NHTSA’s conclusions are “an incomplete analysis of the underlying data”.

Other observers suggested Chrysler balked for cost reasons, not safety issues, raising the spectra of yet another company placing profits before safety.  According to the WSJ article “Dennis Virag, president of Automotive Consulting Group in Ann Arbor, Mich., estimated it could cost Chrysler about $200 a vehicle to comply with the recall, or about $540 million.  Other industry experts estimated that it could cost Chrysler between $350 and $400 a vehicle.”  For 2012 Chrysler netted $1.7 billion in profits as auto sales in the US, where Chrysler sells three out of four of its cars, rose to a five-year industry high of $14.5 million in 2012.  In 2012 Chrysler’s sales rose 21% vs. the industry average of 13%.  According to auto pricing site TrueCar.com consumers paid an average of $29,630 for a Chrysler in 2012, up about $1000 from 2011.

Click here to read the full Wall Street Journal article: Chrysler Balks at Jeep Recall

NHTSA Administrator David Strickland said, “NHTSA hopes that Chrysler will reconsider its position and take action to protect its customers and the driving public.”  In its letter, NHTSA indicated that the rate of fatal rear-end collisions involving fires in the affected Grand Cherokee and Liberty was double that of sport-utility vehicles that also placed the fuel tank behind the rear axle.

Click here to read the NHTSA letter to Chrysler: June 3, 2013 Letter

In litigation involving auto manufacturers over the years, internal documents have shown some companies balanced the cost of recalls vs. the expected costs in litigation from suits for death and injuries, and concluded not to do a safety recall.  Only time will tell why Chrysler refused to help its customers here in the face of a NHTSA safety request because of a doubling of the safety rate in similar rear end fatal collisions.

Americans rely on their car manufactures to provide a safe well-designed vehicle.  Sadly, that is not often the case.  The Auto Defect Attorneys at the Brandi Law Firm has successfully represented many people injured from defective Toyotas, Fords, GM products and numerous other manufacturers and suppliers.  Often times, people involved in accidents do not examine the issues of defective vehicle design nor whether the car was truly crashworthy – does it contain the appropriate crash protection.  If you or a loved one has been injured in an auto crash, our attorneys at the Brandi Law Firm are available to consult with you.  Please contact our office at 800-481-1615 or email us

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Ford Recalls 450,000 Vehicles Due to Fuel Leak; 3rd Fuel Line Recall in Last Year

What is happening at Ford with fuel line leaks?

For the third time since July 2012, Ford once again is recalling vehicles due to fuel line leaks and the specters of auto fires bring the total number of Ford vehicles recalled to over 550,000.

In July 2012, Ford recalled over 11,000 2013 Ford Escape SUVs, because of defects in the fuel line.  Six months ago, 80, 000 2013 Ford Fusions were recalled to check for engine leaks.  Since the Ford Fusion was redesigned in fall of 2012, there have been multiple recalls.  This was the second time the Ford Fusion was recalled due to fuel leak problems, and now the third recall for the same problem.

On May 31, 2013, Ford announced that it will recall over 450,000 2013 vehicles due to a faulty fuel delivery module.  The problem is that the fuel delivery module could develop cracks and fail during driving causing fuel to leak in the presence of ignition which can potentially cause a fire.  The models included in this recall are 2013 Ford Explorer, Taurus, Flex, Fusion, Police Interceptor Sedan and Police Interceptor Utility vehicles.  Additionally, certain 2013 Lincoln MKS, MKT, and MKZ vehicles are also affected by this recall.

Ford has received over 600 complaints in the last 2 months, because of this issue.  Unfortunately, Ford currently does not have enough replacement parts for all owners resulting in some owners will not be notified about the replacement parts for their vehicle until September 2013.

What are you supposed to do if you are one of the unfortunate owners who relied on Ford and who will not be notified until September 2013 because Ford does not have enough replacement parts?

Many consumers feel that Ford, whose advertizing slogan is “Quality is Job One”, is clearly not living up to its claims.  History tells us this is clearly not the first time (Remember the Pinto???).

In a February 12, 1999 decision, (FORD MOTOR COMPANY v. AMMERMAN No. 49A05-9608-CV-322) the Indiana Court of Appeals referred to Ford’s behavior in launching the “dangerous and defective” Bronco II as “highly reprehensible” stating:

“The trial court observed and we agree that the record shows:[t]he Bronco II’s which rolled off the assembly line are dangerous and defective.  Ford’s knowledge of the defect cannot be reasonably questioned.  The continued push to production of this product after all of the internal protestation to the contrary, is the crassest form of corporate indifference to the safety of the ultimate user or consumer and constitutes gross negligence.”

The May 16, 2013 edition of Autoguide reports that Consumer Reports found six of the least reliable cars and trucks are Ford products including the Ford Flex Eco Boost, Lincoln MKX, Lincoln MKT, Ford Explorer V6, 2WD,  Ford Focus Hatchback, and Ford Explorer, V6 4WD.

In 2012, Ford launched 25 new vehicles and 31 different power trains but in light of the number of recalls at Ford in the last year consumers have to ask if Ford ever got the message from the 1999 Indiana appellate Court decision in Ford Motor Company vs. Ammerman.

Click here to read the full CNN article: Ford Recalling 465K Cars for Fuel Leak

Ford will notify owners and replace the damaged fuel module free of charge.  The recall is expected to begin on July 15, 2013.  Owners may contact Ford Motor Company Customer Relationship Center at 1-866-436-7332.  Ford’s recall campaign number is 13S04.

Click here to read the full recall: Ford Fuel System Recall

Americans rely on their car manufactures to provide a safe well-designed vehicle.  Sadly, that is not often the case.  The Auto Defect Attorneys at the Brandi Law Firm has successfully represented many people injured from defective Toyotas, Fords, GM products and numerous other manufacturers and suppliers.  Often times, people involved in accidents do not examine the issues of defective vehicle design nor whether the car was truly crashworthy – does it contain the appropriate crash protection.  If you or a loved one has been injured in an auto crash, our attorneys at the Brandi Law Firm are available to consult with you.  Please contact our office at 800-481-1615 or email us

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510(k); Pathway for Safer drugs or Recipe for Disaster

Recent medical disasters such as the DePuy ASR, DePuy Pinnacle, and transvaginal mesh cases have revealed that medical devices were approved for use without adequate clinical data based on a grandfathering type provision in the FDA called a 510(k) process, where a new device that is cleared as “substantially equivalent” as a previously approved device is allowed to bypass rigorous clinical data requirements otherwise required for approval. Recently serious questions been raised within the medical profession regarding this process.

How did this happen?

In 1976 the Medical Device Amendments created three classes of devices; Class I and II devices were already on the market, (e.g. toothbrushes, infusion pumps).  Class III devices required pre market approval (PMA) which require clinical data.  According to an article in the New England Journal of Medicine in January 2013,”class III devices were allowed to receive review for substantial equivalence temporarily, until the FDA down-classified these devices or promulgated regulations requiring PMA.  Congress had always intended class III devices to undergo PMA, and in 1990, it directed the agency to establish a schedule to finish the transition to PMAs for all devices that were to remain in class III.  As of December 19, 2012, however, the FDA still had not completed this transition to PMA for high-risk devices, although it had stated its intention to clear proposed rules for all remaining class III pre-amendment devices by December 31, 2012″

As a result of this loophole manufactures submitted devices claiming they were “substantially equivalent” to earlier “predicate devices” and were able bypass the clinical data requirements demonstrating safety and effectiveness.  However, if the FDA finds the new device “substantially equivalent,” that does not mean it is also finding it is safe and effective based on any preapproval clinical trial or studies.  The underlying assumption is that if the device is “substantially equivalent”, then so also must be its performance.  This however has not always been the case. DePuy ASR was approved a substantially equivalent to an earlier predicate device, yet it has been a disaster resulting in 10,000 lawsuits, and 93,000 people requiring earlier intervention and revision and facing toxic poisoning from the metal ions.  Similarly, defective vaginal mesh products such as Ethicon’s Gynecare, Bard’s Avulta, Boston Scientific’s Advantage, American Medical System’s Monarch, and Coloplast’s Aris, as well as many other vaginal mesh products resulted in over 12,000 lawsuits and countless women with pelvic prolapse and Stress urinary incontinence (SUI) in severe pain from eroding mesh.

In the fall of 2011 a FDA panel recommended the transvaginal mesh products be reclassified as Class III devices. At that time Colin Pollard, director of the FDA’s obstetrics and gynecology devices branch, said at the time. “We think the current 510(k) paradigm doesn’t work for these products because we don’t think we know enough about the safety and effectiveness.” On January 5, 2012 the FDA ordered mesh manufacturers to study the rates of organ damage and other complications. For more information, an article on the FDA order can be found here.

On January 21, 2011 the FDA Committee of devices forwarded seven recommendation to the Institute of Medicine of the National Academies of  for review. More than 1,900 members volunteer their time, knowledge, and expertise to help the IOM in its mission to advance the nation’s health.

Dr. David Challoner, the Chair of Committee on the Public-Health Effectiveness and a committee member since 1981, responded that, after evaluating the proposals as they affected the 510(k) process,

“The IOM committee’s report concludes that the 510(k) process generally is not intended to evaluate the safety and effectiveness of medical devices and, furthermore, cannot be transformed into a premarket evaluation of safety and effectiveness.”

To view a copy of his entire response, click here: Dr. Challoner’s Letter

Dr Challoner is Vice President Emertus of Health affairs at the University of Florida.  From 1988-1900, he was appointed by President Reagan to Chair the President’s Committee on the National Medal of Science.  He served on the Advisory Committee to the Director of the National Institutes of Health, and the National Academies’ umbrella Committee on Science, Engineering and Public Policy (COSEPUP).

To see a recent presentation by Dr. Challoner on 510(k) and metal on metal hips, click here: Dr. Challoner Video

The New England Journal authors closely examined the history of the De Puy ASR XL acetabular component, which was approved by the FDA in 2008 without a clinical study, tracing it back five decades through 95 devices, including 15 different femoral heads and sleeves and 52 different acetabular components.  According to the authors, “Clearance of the large metal-on-metal articulation was based on a much smaller group of predicates, some of which differed substantially in design from the ASR XL or had poor clinical performance.  Ultimately, clearance was based on the claim that these predicate devices were substantially equivalent to three prostheses that were used before 1976: the McKee–Farrar, Ring, and Sivash metal-on-metal total hip prostheses.  It is important to note that these three devices were discontinued long ago (and well before clearance of the ASR XL) because their risk of revision was so much higher than that of other hip prostheses.”

Most consumers would never know the metal on metal device implanted in their hip or their vaginal mesh was not tested or subject to rigorous clinical evaluation.  Moreover, they would never suspect the process of approval of devices, cannot be “transformed into a pre market evaluation of safety and effectiveness”

At the Brandi Law Firm, we help people throughout the country who have been harmed because of a defective drug or medical device such as Actos, Fosamax, DePuy, and Vaginal Mesh. Instead of treating all victims of defective drugs and medical devices the same we take a different, more personalized approach with a team of experienced defective drug attorneys and paralegals working for every client. Our goal is to provide you with information about your legal options and to help you pursue compensation and holding these drug companies responsible for their dangerous actions. Please contact the Brandi Law Firm today (1-800-481-1615 or email us) to talk with the experienced San Francisco defective drug attorneys.

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18,871 2013 Cadillac SRX’s Recalled

General Motors announced that 18,871 2013 Cadillac SRX’s were being recalled because the wheel lug nuts may loosen causing the wheels to separate from the vehicle leading to catastrophic potential results.  The vehicles involved are Cadillac SRXs manufactured between January 31, 2012 and March 18, 2013, a significant portion of the product line.

GM will notify owners, and dealers will remove and reinstall the wheel nuts by performing a tire rotation, free of charge.  The recall is expected to begin by June 3, 2013.  Owners may contact GM at 1-800-521-7300.  GM’s recall campaign number is 13116.  Owners may also contact the National Highway Traffic Safety Administration Vehicle Safety Hotline at 1-888-327-4236 (TTY 1-800-424-9153), or go to www.safercar.gov.

In its May 15, 2013 letter to NHTSA GM’s Director of Product Investigations and Safety Regulations M. Carmen Benavides wrote:

“573.6(c)(5): General Motors has decided that a defect, which relates to motor vehicle safety, exists in certain 2013 model year Cadillac SRX vehicles with 18 inch wheels and that have not had service that required removal and reinstallation of the wheels.  These vehicles may experience loosening of the wheel nuts.  If this occurs, a creaking, rattling or grinding noise may originate from the wheel area.  A steering vibration may also be present.  If unnoticed or ignored, one or more of the wheel lug nuts could detach, or fatigue.  The wheel attachment studs may fracture.  If this happens while the vehicle is moving, a crash could result without prior warning.”

Click here to read the full recall: 2013 Cadillac SRX

According to GM, no reimbursement to consumers will occur because all vehicles are still under warranty.  The fix by GM mechanics is to remove and reinstall the wheel lug nuts during tire rotation.

Americans rely on their car manufactures to provide a safe well-designed vehicle.  Sadly, that is not often the case. The Auto Defect Attorneys at the Brandi Law Firm has successfully represented many people injured from defective Toyotas, Fords, GM products and numerous other manufacturers and suppliers. Often times, people involved in accidents do not examine the issues of defective vehicle design nor whether the car was truly crashworthy – does it contain the appropriate crash protection. If you or a loved one has been injured in an auto crash, our attorneys at the Brandi Law Firm are available to consult with you.  Please contact our office at 800-481-1615 or email us.

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Are Too Many Doctors Simply Sales People for Big Pharma?

Big Pharma paid doctors more than $1 billion in 2012 to act in various spokesperson capacities, for travel and meals, as well as research and royalties, which is significantly more than reported in 2011.  According to a new data reported in the Financial Times, that figure only includes the 12 leading drug makers who actually disclose physician payments.  The total was over 2 billion.

Click here to read the full article: ProPublica: Pharma’s Doc-Payment Disclosures Top $2B

Here is a list of some of the major payers:

Astra Zeneca            $236.1M

Disclosed: Jan. 2010 to Sept. 2012

$18,735, 918 in California

Eli Lilly                         $490.6M

Disclosed: Jan. 2009 to June 2012

GlaxoSmithKline        $238.6M

Disclosed: April 2009 to Sept. 2012

In July 2012, the company agreed to plead guilty and to pay $3 billion to settle criminal charges and civil claims related to its “unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices,” according to the U.S. Justice Department.

Merck                            $224.3M

Disclosed: July 2009 to Sept. 2012

Merck, maker of Fosamax, paid $224 million to California providers.  In 2011, the company also agreed to pay $950 million to settle criminal charges and civil allegations stemming from its promotion and marketing of the painkiller Vioxx.

Johnson & Johnson   $54.6M

Disclosed: Jan. 2010 to Sept. 2012

Johnson & Johnson, maker of the DePuy paid $6,330,519 in California.

Pfizer                             $538.2M

Disclosed: July 2009 to Sept. 2012

Pfizer paid $81 million in California.

Is Your Doctor receiving Money From Drug Companies?

To search what doctors received what amount of money, go to the ProPublica database.

To search for California; where according to Pro Publica 39,382 disclosures were found paying $241,788,042, go to http://projects.propublica.org/docdollars/states/california

Contact Our Experienced San Francisco Drug Recall Lawyers Today

At the Brandi Law Firm, we help people throughout the country who have been harmed because of a defective drug or medical device such as Actos, Fosamax, DePuy, and Vaginal Mesh.  Instead of treating all victims of defective drugs and medical devices the same we take a different, more personalized approach with a team of experienced defective drug attorneys and paralegals working for every client.  Our goal is to provide you with information about your legal options and to help you pursue compensation and holding these drug companies responsible for their dangerous actions.  Please contact the Brandi Law Firm today (1-800-481-1615 or email us) to talk with the experienced San Francisco defective drug attorneys.

San Francisco Plaintiff’s Attorneys Advocate For Change Through Litigation

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