Archive for category Drug and Medical Device Litigation

Cisson vs. Bard: $2 Million Victory for Donna Cisson

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R.Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.

This is the third victory for women in the three trials as Donna Cisson joins Christine Scott and Linda Gross in holding manufacturers responsible for their injuries.  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.

There are over 23,000 cases pending before Judge Goodwin in West Virginia with more trials slated.  If you would like more information, go to our website, or contact us at 1-800-481-1615 or email us.

, , , , , , , , , , , , , , , ,

Leave a comment

A Review of Testimony and Documents presented in Donna Cisson vs. C.R. Bard Avaulta Trial

During the first days of testimony, Plaintiff’s attorneys were building the case that the Bard Avaulta is defective and the warnings are inadequate.  The following is a review of some of the testimony and evidence presented from live and videotaped witnesses as reported from various outlets.  It should be noted that we are focusing on substance and not demeanor or method of presentation so it is impossible to gauge the impact on a jury so far

Avaulta

Cisson v. C.R. Bard Inc. is a bellwether case for more than 23,000 cases involving transvaginal mesh combined in the U.S. District Court for the Southern District of West Virginia.  Donna Cisson claims an Avaulta device implanted to treat pelvic organ prolapse caused her pain and permanent injury.  The Avaulta line of products is made from a resin called polypropylene, which the resin’s manufacturer warned Bard should not be permanently implanted in humans.  The company used a porcine collagen coating on the body of the Avaulta products, but not on the arms, which anchor the mesh in place.  The porcine was intended to be a barrier to reduce the body’s inflammatory response and adhesions between the polypropylene resin and tissue.

Bard voluntarily stopped selling the Avaulta line of products in July 2012 rather than meet U.S. Food and Drug Administration (FDA) requirements for further clinical testing.  Judge Goodwin has excluded this information from the trial.

Documents Indicating Notice to Bard of Problems

  • In the June 14, 2002 Patent application signed by Bard engineer and team leader Douglas Evans, Bard outlined the rationale for the new patent by describing the limitations of synthetic mesh devices made from materials like polypropylene.  The application sought a patent to create a sling-type product from a natural biological material.
  • A 2002 company e-mail produced in trial reportedly states, “Avaulta Solo is a new product which has not been in humans yet and therefore has no data associated with it. … All major advances like these are based on intuition before there is data to support them.  We’re trying to fight some battles around lack of data around kits, and on Avaulta in particular. … We’ve been chided by thought leaders. … Still waiting on data on our kit. Why are we afraid to publish any data?”
  • In a September 2008 internal market research memo, Bard executives again highlighted what they call “barriers to adoption,” or reasons many physicians refused to use Avaulta products — mostly pertaining to complications seen in patients.  “This additional analysis shows in spades the importance of reducing complications,”
  • Another internal company memo titled “The Reality of Complications” addressed complication rates from the Avaulta products, including dyspareunia (painful sexual intercourse), erosion and chronic post-operative pain.  The memo compiled market research on doctors who did not want to use the Avaulta line.  According to the document, 65 percent of physicians surveyed said they had significant concerns about dyspareunia with pelvic floor products, 58 percent had significant concerns about chronic post-operative pain, and 62 percent had significant concerns with erosion.
  • There was a discussion in Court that the arms of Avaulta were “sawing at tissue” in patients.  In an e-mail a salesperson said, “The flesh sawing issue came up again last week with a physician” and asked if Bard planned to add the porcine coating to the device’s arms.  Adam Silver, marketing manager for BUD’s women’s health division, replied by email.  “We’re not going to put (the coating) on our arms any time soon,” he wrote.  “We don’t believe it’s needed.”
  • A 2007 memo stated in part: “Avaulta Solo is a new product which has not been in humans yet and therefore has no data associated with it. … All major advances like these are based on intuition before there is data to support them.”

Dr. Brian Raybon

The first witness called in the trial was Dr. Brian Raybon, a urogynecologist from Georgia.  Dr. Raybon, who also holds an undergraduate degree in Chemistry from University of North Carolina, who spent four plus years working on behalf of  Bard teaching physicians about the products.  He also is the physician who recommended a Bard Avaulta and implanted it in Ms. Cisson.  After conceding he felt it was a good product when he implanted it, he testified he began to learn of problems and patients were showing up with complications requiring additional surgeries to remove the mesh. At that time, Dr. Raybon learned for the first time that the resin the company used to make the mesh was not to be permanently implanted in the human body.  According to media reports, he testified his reaction was that he was astounded.

On cross-examination by defense attorney Lori Cohen, he conceded he did not contact Bard to ask about the warning, which was disclosed on a Chevron Phillips Material Safety Data Sheet (MSDS) for the resin, once he found out about it.

Dr. Lennox Hoyte  

It was Dr. Hoyte’s testimony in the first trial that triggered the mistrial.  Dr. Hoyte is a professor of urogynecology and pelvic reconstructive surgery at the University of South Florida, and the chief of urogynecology and robotic surgery at Tampa General Hospital.  He is a graduate of Stanford Medical School.

The net-like device at the heart of the lawsuit includes small mesh “arms” that extend from the device to help hold it in place.  Hoyte was critical of the design and indicated it contributed to significant problems both for the women and for doctors attempting to remove the device.  Hoyte indicated the mesh implant allows fatty tissue, nerves, blood vessels and muscles to grow through and around it, and the vaginal flesh becomes ingrown so tightly around the mesh that surgical removal can destroy so much tissue that the vagina can be difficult to reconstruct.

Anthony Brennan PhD.

Since 1991, Brennan has been a professor of Materials Science and Engineering and Biomedical Engineering at the University of Florida Brennanin Gainesville.  Brennan studies how cells interact with materials.  He is an inventor and co-inventor on six US Patents. He said his research is funded primarily by the U.S. Department of Defense and stated he did work in this case at the request of Plaintiff’s attorneys and Brennan and his team studied the Avaulta Plus product for more than two years who paid him around $200,000 for his research.

He explained that polypropylene is a polymer made with free radicals, which, once implanted, free radicals produced by the body break down the material.  “When you put an implant in, it’s seen as a foreign body,” Brennan said.  “The body will try to encapsulate it. … The problem is it continues forming an inflammatory response.  If you use free radicals to make it, you use free radicals to break it down.”  Brennan testified that polypropylene degrades in the body

The Avaulta Plus device has a design feature called “arms,” or long, narrow strands of mesh that protrude from the “body” of the device. The arms are intended to help anchor the device in place once implanted.  Brennan indicated that cutting the arms as testimony has reported some doctors did, weakens the device and exacerbates the problem polymer degradation.

He also was critical of the small pore sizes in the device, indicating the pores should be between 2 mm and 5 mm in.  As a result, it is more difficult for tissue to grow and fill in.

The mesh contains many pores by design.  Brennan said the pores need to be large enough for the body to create a scab through them, holding the arms and the entire device in place.  He said the pore size should be between 2 mm and 3.5 mm.

When Brennan measured the pore size in Avaulta Plus, he found the pores were too small.  He also said the practice of rolling the arms during the implantation surgery created an overlap in the material, ultimately deforming the pores.

“If you are deforming the pores, you’re reducing their size and making it more difficult for tissue to grow in, fill it in,” Brennan said.

Previous testimony disclosed it was common practice for surgeons to cut the arms on the Avaulta device during implantation to customize it to a patient’s body.  Brennan testified that cutting the arms affects the device’s biomedical properties.

“When you cut something, you weaken it,” Brennan said.  “If you cut a notch in a cloth, it weakens.  Anytime you take a polymer fiber and cut it, it’s going to further exasperate the problem of polymer degradation. … Those loose ends are places where degradation will start.”

Brennan said that the overall design of the Avaulta Plus was flawed from the beginning.

“The geometry of that mesh and material it’s made of is a poor design,” he said.  “Your pore sizes are so small … you’re going to get degradation of polypropylene.  We’ve known that from the literature for years. … Once degradation of a medical device begins, it’s like a cascade effect. It just continues and keeps going.”

Maureen Reitman

ReitmanDr. Reitman is an expert in polymer science and materials chemistry who testified for the defense on August 8, 2013.  She has a Doctorate in materials science and engineering from MIT (1993) and has worked for Exponent for about ten years.  According to the Exponent website biography, “Dr. Reitman’s expertise includes polymer and composite technology, mechanics of materials, adhesion science, fiber mechanics, history and technology of plastics, and material failure analysis.  She is skilled in the development and use of testing tools and methods and has applied them to plastic, rubber, textile, metal, glass, ceramic, and composite materials and systems.  She is experienced in major aspects of product development, including materials selection, formulation, scale-up, end-use testing, failure analysis, certification procedures, and issues related to intellectual property.”

Dr. Reitman testified that Bard paid about $700,000 for 400 to 500 hours of work done on the case conducting tests, researching and investigating, etc.  Based on work she did in the case, including examination of explanted Avaulta devices, she said there was biofilm on the device and there was not neither oxidation nor degradation to the material.

Also testifying for the defense was Laura Bigby, Bard’s Director of research and Development since 2007, who was questioned about cadaver studies and the absence of clinical trials in humans prior to marketing to surgeons.

Dr. John Heller

HellerDr. Heller is a orthopedist from Emory University since 1994 whose website states he is “Specializing in the research and development of instrumentation in cervical spine surgery, including cervical disc replacement and laminoplasty.  Dr. Heller is an internationally renowned lecturer and teacher.”  Called by the defense, Dr. Heller testified that the pain Donna Cisson was suffering was due to spinal issues, indicating MRIs beginning in 2007 documented degenerative spine issues.  One of the usual defenses in drug cases is to show an alternative unrelated reason for a Plaintiff’s symptoms and Dr. Heller provided that to the jury.

The trial is continuing and deliberations by the jury are expected to start shortly.  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.

, , , , , , , , , , , , , , , , ,

Leave a comment

Body Mass Index (BMI) Chart for Evaluation of New Onset Diabetes while taking Lipitor, Crestor, or other Statins

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.  This study noted that “significantly increased risk of DM associated with statin use was observed among women with BMI lower than 25.0 when compared with women with BMI of 30.0 or higher after adjusting for all potential confounders.” The study also reported a significantly increased risk of DM with women with a BMI below 30 as compared to women above 30.

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.

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 www.lipitorlawsuitattorney.com or call 415-989-1800 or (800) 481-1615.

, , , , , , , ,

Leave a comment

Transvaginal Mesh Trials Set for Bellwether Cases

On August 5, 2013, Judge Joseph Goodwin issued pretrial Order No. 59 providing trial dates for July 14, 2014 and May 27, 2014 from the following bellwether cases.

  • Carolyn Lewis, et al. v. Johnson & Johnson, et al., 2:12-cv-04301 TVT;
  • Judy Brown, et al. v. Ethicon, Inc., et al., 2:12-cv-07314 TVT;
  • Jo Huskey, et al. v. Ethicon, Inc., et al., 2:12-cv-05201 TVT-O;
  • Tonya Edwards, et al. v. Ethicon, Inc., et al., 2:12-cv-09972 TVT-O;

The Court Order states “The Court will try the 1st and 2nd round of cases, set to begin 1/14/2014 and 5/27/2014, respectively, from these cases and in the order shown, etc.; the Court will try a Prolift case for the 3rd round of cases set to begin on 8/19/2014.”

Over 23,000 mesh suits pending in MDLs

Thousands of women experienced complications such as: device erosion, infection, organ perforation, intense pain and inability to have intercourse.  Many of these women have had to undergo multiple revision surgeries to attempt to manage symptoms and have since filed transvaginal mesh lawsuits against the device manufacturers. These actions are brought by women against vaginal mesh companies C.R. Bard, American Medical System, Boston Scientific Inc, and Coloplast Corp.

MDL Name

Number of Cases

MDL – 2187, IN RE: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation

3,399

MDL – 2325, IN RE: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation

7,227

MDL – 2326 IN RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation

4,622

MDL – 2327 IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation

7,117

MDL – 2387 IN RE: Coloplast Corp. Pelvic Support Systems Products Liability Litigation

437

MDL – 2440 IN RE: Cook Medical, Inc., Pelvic Repair System Products Liability Litigation

25

TOTAL: 6 Multidistrict Litigations

22,827

Donna Cisson Trial Continues

Meanwhile the trial of the case of Donna Cisson vs. Bard, 2:11-cv-00195 continues in Judge Goodwin’s courtroom.  It is anticipated Plaintiffs will seek to establish that:

  • 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.

Two Trial Verdicts for Plaintiffs

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.

Over 23,000 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.

, , , , , , , , , , , , , , ,

Leave a comment

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 www.lipitorlawsuitattorney.com,  or call 415-989-1800 or (800) 481-1615.

, , , , , , , , ,

Leave a comment

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.

, , , , , , , , ,

Leave a comment

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.

STATINS SHOWN TO DRAMATICALLY INCREASE DIABETES INCIDENCE IN POSTMENOPAUSAL WOMEN

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.

ADDITIONAL STUDIES DEMONSTRATE SIGNIFICANT PROBLEMS

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 www.lipitorlawsuitattorney.com.

, , , , , , , , , , ,

Leave a comment

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 www.lipitorlawsuitattorney.com, or call 415-989-1800 or (800) 481-1615.

, , , , , , , ,

Leave a comment

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.

, , , , , , , , ,

Leave a comment

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.

, , ,

Leave a comment

Follow

Get every new post delivered to your Inbox.

Join 174 other followers