Archive for category Drug and Medical Device Litigation

Lipitor Diabetes Suits Grow as Pfizer Settles Old Charges

Faced with a growing number of suits due to the relationship confirmed by medical studies of new onset diabetes in postmenopausal women taking statins including Lipitor, Pfizer confronted two more deteriorating situations at the end of July, declining revenues, and criminal charges leading to a plea.

On July 30, 2013, the Justice department announced a $490.9 million settlement agreement with Pfizer’s Wyeth unit related to illegal marketing of a kidney-transplant prescription medication, Rapamune (sirolimus).  Previously the Food and Drug Administration approved the immunosuppressive therapy for kidney transplant patients but that Wyeth also marketed it on an unapproved basis for other types of organ transplant patients, “which resulted in false Medicare and Medicaid claims”.  Originally, whistle-blower suits in 2005 and 2007 led to the DOJ getting involved.  The conduct occurred prior to Pfizer’s purchase of Wyeth in 2009.

According to the New York Times, the settlement “also resolves a second, similar whistle-blower suit, includes a criminal fine and forfeiture of $233.5 million, and a civil settlement of $257.4 million with the federal government, all 50 states and the District of Columbia.”  Pfizer disclosed the settlement preliminarily, in November 2012 filing with the Securities and Exchange Commission; and US District Judge Vicki Miles-LaGrange in Oklahoma City accepted the plea agreement on July 30, 2013.  Reuters quotes FDA Special Agent in Charge Antoinette Henry as saying, “Wyeth’s conduct put profits ahead of the health and safety of a highly vulnerable patient population dependent on life-sustaining therapy.”

Click here to read the full Reuters article: Pfizer settles U.S. marketing case related to Rapamune

Sadly, many drug companies in their zeal to achieve market share and record profits have failed to completely disclose the entire truth about their products, misrepresented the uses to physicians, or engaged in misleading practices.  Consumers and their physicians are entitled to know the truth about their drugs and devices.  This simply means the whole truth, not just the part that will help sales.  As the Lipitor suits grow, and medical studies show an increasing association between statins and diabetes, the truth about Pfizer’s knowledge about its $126 billion product will be further revealed in transparency of the court system.

Pfizer is no stranger to litigation over its products.  In September 2009, Pfizer pleaded guilty to the illegal marketing of the arthritis drug Bextra for uses unapproved by the U.S.FDA and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time.  This was Pfizer’s fourth such settlement with the U.S. Department of Justice in the previous ten years.  It also has been involved in litigation with Blue Cross Blue Shield over allegedly illegally marketing their drugs Bextra, Geodon and Lyricamis and allegations regarding the Bjork-Shiley heart valves

We are currently investigating these cases for a number of women.  The Brandi Law Firm is nationally recognized for its long involvement in cases involving defects in drugs or devices.  If you or a loved one have taken Lipitor and been diagnosed with Type II Diabetes, based on medical studies, there is a potential claim against the manufacturer.  If you would like more information, please contact the Brandi Law Firm by e-mail, visit,  or call 415-989-1800 or (800) 481-1615.

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Johnson & Johnson Recalls Another DePuy Orthopedic Product

Johnson & Johnson (J&J) is no stranger to controversy.  From being embroiled in massive litigation in DePuy ASR artificial hips, Pinnacle litigation, and in the transvaginal mesh litigation with its Ethicon Gynecare products to its multiple legal troubles and fines associated with the anti-psychotic drug Risperdal, some things do not change for J&J – they continually garner negative press due to multiple, defective medical devices.

Today, the FDA and DePuy Orthopedics notified healthcare professionals of a class 1 recall of the LPS Lower Extremity Dovetail Intercalary Component.  The recall was issued, because there a potential for fracture of the dovetail, when exposed to normal physiologic loads while walking.  A Class I recall is the most serious type of recall.  Class I recalls are issued in situations where there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The LPS Lower Extremity Dovetail Intercalary component was intended for replacement of the mid-shaft portion of the femur, top (proximal), bottom (distal) and/or total femur, and top (proximal) tibia, especially in cases that require extensive resection (i.e. tumors, trauma, infections).  If the part fracture occurs, it may lead to additional pain, infection, loss of function, loss of limb, neurovascular injury or need for revision surgery.  Patients greater than 200 pounds and/or those with high levels of activity are at higher risk of fracture.

Click here to read the full FDA recall: DePuy Orthopaedics, Inc – LPS Lower Extremity Dovetail Intercalary Component

On July 11, 2013, DePuy issued an Urgent Medical Device Recall informing DePuy distributors, hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots.  DePuy will be writing a patient letter to assist surgeons with discussing the risks of the implant fracture and the method for detecting implant failure with their patients.  DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device.  Like the DePuy ASR, the DePuy Pinnacle, and Ethicon Gynecare transvaginal mesh, thousands of people will be forced to live with the cloud of defective products failing within them while J&J makes no effort to effectively help.

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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Lipitor and Diabetes Lawsuits

LipitorLipitor is a popular statin medication designed to lower cholesterol levels by inhibiting an enzyme that plays a central role in the production of cholesterol in the liver.  We have heard of the “good” cholesterol and the “bad” Cholesterol.  Lipitor is prescribed to help prevent the production of low-density lipoproteins (LDLs), also known as the “bad” cholesterol because it is known to block arteries. Lipitor is the brand name for the drug Atorvastatin.  It is sold by Pfizer and was approved by the FDA in 1996.  Lipitor is prescribed in either 10 or 80 mg tablets taken daily.  Pfizer has recorded over $125 billion in sales of Lipitor.


In January of 2012, a study published in the medical journal Archives of Internal Medicine found that female patients between the ages of 50 and 79 who took statin medications (i.e., Lipitor and other LDL-lowering drugs) were 48 percent more likely to develop type 2 diabetes as compared to women in the same age group who did not take the drugs.

Pharmacist Annie L. Culver and her team from the Rochester Methodist Hospital, Mayo Clinic in Minnesota analyzed data from the national, multi-year Women’s Health Initiative (WHI) to garner results for this study.  Researchers analyzed data to include 153,840 women without diabetes with an average age of 63 years.  Statin use was assessed at enrollment and again in year three.  At the outset, 7 percent of the women reported taking a statin medication.  The scientists found 10,242 new cases of diabetes and determined that statin use was positively associated with an increased risk of diabetes.  The association remained after adjusting for other potential variables, including age, race or ethnicity and body mass index, and was observed for all types of statins.  Dr. Culver noted, The results of this study imply that statin use conveys an increased risk of new-onset DM (diabetes mellitus) in postmenopausal woman.”

A deeper analysis of the data found that diabetes incidence increased in this cohort of post-menopausal women by 71 percent.


In addition, three other studies looking into the connection between statin use and diabetes have indicated significant issues.  These were published in medical journals Atherosclerosis, the Journal of American College of Cardiology, and Lancet.

The Atherosclerosis Study

Published in 2010, Differential Metabolic Effects of Distinct Statins looked at the metabolic effects of statins, narrowing in on what causes the onset of diabetes in patients. The study discovered that patients who take daily doses of Lipitor increase their risk of developing diabetes, even without preexisting conditions that could contribute to developing diabetes.

The Journal of American College of Cardiology Study

Published in 2011, entitled Predictors of New-Onset Diabetes in Patients Treated With Atorvastatin, the JACC study looked at the dosage amounts of Lipitor and found that patients who take daily doses of Lipitor at 80 mg experience a higher risk of developing diabetes compared to a control group of patients who did not take daily Lipitor doses.

The Lancet Study

Statins and Risk of Incident Diabetes: A Collaborative Meta-Analysis of Randomised Statin Trials was published in 2010.  The Lancet study looked at several Lipitor-related studies and discovered that patients taking statin drugs such as Lipitor experience a 9 percent increased risk of developing type 2 diabetes.

Litigation Growing

A number of cases have been filed on behalf of people who were diagnosed with Diabetes while taking Lipitor.  On July 25, 2013, a hearing was held before the Judicial Panel on Multidistrict Litigation (JPML) in Portland, Maine seeking to coordinate the cases before the Federal Court in South Carolina.  The prospective Lipitor type-2 diabetes MDL would be In re: Lipitor (atorvastatin) Litigation, MDL No. 2459, in the U.S. District Court for the District of Southern Carolina.

The Brandi Law Firm is currently investigating these cases for a number of women.  The Brandi Law Firm is nationally recognized for its long involvement in cases involving defects in drugs or devices.  If you or a loved one have taken Lipitor and been diagnosed with Diabetes, based on medical studies, there is a potential claim against the manufacturer.  If you would like more information, please contact the Brandi Law Firm by e-mail or call 415-989-1800 or (800) 481-1615.  We have also set up a website dedicated to providing the most up to date Lipitor lawyer and Lipitor lawsuit information at

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Lipitor, Post Menopausal Women, and Type Two Diabetes

Medical studies have shown a potential connection between post-menopausal women with a BMI (Body Mass Index) of 30 or below who are taking the prescription medication Lipitor and who are then diagnosed with Type II Diabetes.

In a study in the Archive of Internal Medicine (now JAMA Internal Medicine) originally published on January 23, 2012, the Women’s Health Initiative (WHI) recruited 161,808 post menopausal women aged 50 to 79 years at 40 clinical centers across the United States from 1993 to 1998 with ongoing follow-up and data through 2005.  The study looked at whether there was an association between the use of statins and Diabetes Mellitus.  The study concluded: “Statin medication in post menopausal women is associated with an increased risk of DM”.  The study also reported a significantly increased risk of DM with women with a BMI below 30 as compared to women above 30.

Body Mass Index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.  You can calculate your BMI on a number of web sites.

Diabetes mellitus refers to a group of diseases that affect how your body uses blood glucose, commonly called blood sugar.  Glucose is vital to your health, because it is an important source of energy for the cells that make up your muscles and tissues.  It is also your brain’s main source of fuel. If you have diabetes, no matter what type, it means you have too much glucose in your blood, although the reasons may differ. Too much glucose can lead to serious health problems.  Chronic diabetes conditions include type 1 diabetes and type 2 diabetes.  Type 2 diabetes, once known as adult-onset or noninsulin-dependent diabetes, is a chronic condition that affects the way your body metabolizes sugar (glucose), your body’s main source of fuel.  With type 2 diabetes, your body either resists the effects of insulin — a hormone that regulates the movement of sugar into your cells — or does not produce enough insulin to maintain a normal glucose level. Untreated, type 2 diabetes can be life threatening.  Being overweight is strongly linked to the development of type 2 diabetes and for this reason the findings of increased DM in patients with a BMI under 30 is especially significant, because people with a BMI under 30 generally do not have other risk factors for the development of the disease.

In February 2012, the FDA announced it was requiring new diabetes warnings for Lipitor, which is a Pfizer product that has produced over 126 billion in sales since 1996.

We are currently investigating these cases for a number of women.  The Brandi Law Firm is nationally recognized for its long involvement in cases involving defects in drugs or devices.  If you or a loved one have taken Lipitor and been diagnosed with Type II Diabetes, based on medical studies, there is a potential claim against the manufacturer.  If you would like more information, please contact the Brandi Law Firm by e-mail, visit, or call 415-989-1800 or (800) 481-1615.

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Mesh Mistrial; New Trial Starts July 29, 2013

U.S. District Judge Joseph Goodwin declared the mistrial last week after determining that jurors would not be able to disregard improper testimony by a plaintiff’s witness Dr. Lennox Hoyte had testified that no one implants or sells the mesh anymore. The answer was given in response to a Plaintiff’s attorney question: ‘What body of evidence exists in your opinion that supports your ideas sitting here today that Avaulta Plus armed mesh is a bad idea”.  Dr. Hoyte is reported to have replied; “Here’s what I know. I take a lot of these meshes out. I know that nobody implants them anymore, and I know that no one sells them anymore.”

According to a report in the Charleston Gazette, Judge Goodwin stated: “I don’t think it’s a bell that can be unrung — and I want to say this in the context of, to my knowledge, never declaring a mistrial in a civil case in nearly 20 years on the bench — I think it would have been very difficult for the jury to disregard it.”  The case is Donna Cisson vs. C.R. Bard, Inc, a 54-year-old public health nurse from Toccoa, Georgia, who was inserted in 2009.  She contends she has suffered injuries and required two surgeries to repair the damage.

In his opening statement, one of Plaintiff’s attorneys told the jury

  • Bard knew of the risks associated with Bard Avaulta transvaginal mesh and failed to inform doctors.
  • Bard did not do clinical testing or studies to learn the risks of Bard Avaulta transvaginal mesh.
  • Bard did not study how to remove Bard Avaulta transvaginal mesh.
  • Bard marketed and sold Bard Avaulta transvaginal mesh despite knowing the material used to make it, Marlex, was not designed to implant in the human body.
  • Bard did not tell doctors that Bard Avaulta transvaginal mesh was not fit for human use.

“The company knew in 2002 and 2003 that synthetic vaginal mesh could cause significant erosion of the patient’s tissues, and infection.”

However, Lori Cohen gave the jury a different view on behalf of Bard.  In her opening statement, Ms. Cohen created a picture of the evolution of surgical transvaginal mesh that runs contrary to the image of mesh manufacturers dispatching a legion of sales rep to push doctors to start using polypropylene (PP) mesh in the late 1990’s and early 2000.

Click here to read the full article: Bard Opening Arguments in Federal Transvaginal Mesh Case

Over 12,000 women who have filed suits detailing their injuries from the mesh inserted in them.  We believe that ultimately the cause of their injuries will be shown to be the defects in the mesh products and the absence of appropriate warnings.  If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

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Baxter Healthcare Facilities Cited For Multiple Violations by the FDA

The FDA has sent Baxter International a warning letter laying out problems it found during inspections at a plant in North Carolina and in Jayuya, Puerto Rico.  Previously, both the Puerto Rico and North Carolina locations have had violations during FDA inspections.  The North Carolina plant had violations first noted in August of 2012 while the Jayuya plant was first cited on January 11, 2011.  During the most recent inspection, the FDA found similar observations and problems that were found as in the previous inspections.

The May 31, 2013 letter lays out a number of issues at the plant in Marion, NC.  These problems include mold accumulating over filling lines.  Baxter stopped its line and halted release of products but never figured out the root cause that allowed the mold to grow to a level of that was too numerous to count.

According to the FDA May 31, 2013 letter, the North Carolina facility additionally:

“…failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards· of identity, strength, quality, and purity (21 CFR 211.160(b).”

Among problems uncovered at the Puerto Rico plant, the FDA said the company found issues with leaky bags on 39 lots.  Baxter put a hold on 25 of them but had no plan for dealing with the 14 that had already been released into the market.  The FDA also said Baxter reported 20 nonconformance reports on liquid products containing everything from skin to human hair to rayon and that there was no indication that its processes were sound enough to prevent the problem on an ongoing basis.  The Jayuya plant was cited two years ago in a warning letter for failing to investigate batch failures.

Baxter is now required to notify the FDA within 15 days of “the specific steps that you have taken to correct and prevent the recurrence of violations, and provide copies of supporting documentation.  If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections”.

Baxter develops, manufactures and markets health products.  It is no stranger to litigation, currently a defendant in over 750 cases in connection with the recall of heparin.  The first verdict in the case was for the estate of a man who his attorneys say was given a dosage of a blood thinner made by Baxter International Inc.  In early 2009, samples of viral material supplied by Baxter International to a series of European laboratories were found to be contaminated with live Avian flu virus.

On July 2, 2009, Kentucky Attorney General Jack Conway announced a settlement between the state and Baxter Healthcare Corporation, a subsidiary of Baxter International, worth $2 million.  The company had been inflating the cost of the intravenous drugs sold to Kentucky Medicaid, at times as much as 1300%.

In 2010, a jury in Las Vegas, Nevada ordered Baxter to pay $144 million to patients who had been infected with Hepatitis C after doctors wrongly reused dirty medical supplies to administer propofol to patients.

In December 2011, the non-partisan organization Public Campaign criticized Baxter for spending $10.45 million on lobbying and not paying any taxes during 2008–2010, instead getting $66 million in tax rebates, despite making a profit of $926 million.

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Risperdal Continues to Boggle Down Johnson & Johnson

Trouble is no stranger to Johnson & Johnson.  Johnson and Johnson (J&J), embroiled in massive litigation in DePuy ASR artificial hips, and in transvaginal mesh litigation from its Ethicon Gynecare products, faces more legal issues from its anti-psychotic drug, Risperdal.  Currently, Johnson & Johnson is appealing a 1.2 billion dollar fine issued in an Arkansas court in a Medicare fraud case, Ortho-McNeil-Janssen Pharmaceuticals Inc. v. Arkansas, 12-1058.  The jury found that J&J and Ortho-McNeil-Janssen had downplayed Risperdal’s risks and marketed it for off-label uses.  The jury found that these companies had defrauded the state’s Medicaid system and deceived Arkansas consumers about the safety risks of the anti-psychotic drug Risperdal.

Click here to read the full article: State AGs Ask Arkansas High Court to Back J&J’s $1.2B Risperdal Fine

J&J has contested that “an individual state should not penalize a pharmaceutical company for using an FDA-approved package insert or decide for itself whether a company complies with FDA rules.”

Arkansas Attorney General Dustin McDaniel disagrees.  He has asked the Arkansas Supreme Court to uphold the decision.  McDaniel stated, “This company lied to our medical providers and put profits ahead of people.  As state Attorney General, it is my responsibility to prevent actions like those, which defrauded our Medicaid program and jeopardized the health of our elderly and our children.”

Previously, J&J initially had agreed to pay $2.2 billion in 2012 in order to settle a Justice Department investigation into allegations that the health-products company had illegally promoted drugs including the antipsychotic Risperdal, but then balked at completing the settlement.  J&J looked to avoid admitting to conduct that could affect the outcome of pending personal-injury lawsuits alleging Risperdal caused serious side effects in kids.

Risperdal was approved in 1993 for use in adults and was later used to treat schizophrenia and bipolar disorder in children and teens.  Under federal law, drug makers can promote only the approved uses of their medicines, but doctors are free to write prescriptions for other uses.  Some physicians prescribed Risperdal to children and adolescents before the U.S. Food and Drug Administration gave its OK in 2007 for use in children and adolescents suffering from bipolar disorder and in adolescents with schizophrenia.

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.

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Ethicon Gynecare Trial Cases to be Selected on July 25, 2013

On July 25, 2013, Judge Joseph Goodwin will hear presentations submitted by counsel for consideration for selection as bellwether cases in the Johnson & Johnson Ethicon Gynecare transvaginal mesh cases.  Based on this procedure, Judge Goodwin will then select which cases will then be tried.  It is expected that he will select 5 cases from a pool of 16 cases, with each side submitting 8 cases.  Expert reports will then be exchanged according to his Federal Rules and Expert discovery is slated to be completed by the end of October, 2013 and case specific discovery completed by November 15, 2013

There are over 12,000 transvaginal mesh cases involving all of the leading manufacturers before Judge Goodwin, nearly 4,000 of which are J&J’s Ethicon division Gynecare.

There have been two trials so far, both resulting in Plaintiff’s verdicts. However, the facts in these cases are different from many of the pending cases.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.  In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

Discovery is continuing in the MDL leading up to projected trials in the near future.  Over 12,000 women have filed suits detailing their injuries from the mesh inserted in them.  We believe that ultimately the cause of their injuries will be shown to be the defects in the mesh products and the absence of appropriate warnings.  If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

Complications Linked to Transvaginal Mesh After Pelvic Organ Prolapse Surgery

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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.”

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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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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