Archive for category Drug and Medical Device Litigation

Class I Recall for Stryker’s OASYS Midline Occiput Plate

StrykerOn August 29, 2013, the FDA and Stryker notified healthcare providers of a class I recall of Stryker’s OASYS Midline Occiput Plate.  This most serious type of recall was issued because of reports of fracture of the pin that connects the implant’s head to the plate body.

According to their website, Stryker is one of the world’s leading medical technology companies.  Their spine products are created to help people lead “more active and more satisfying lives”.  The OASYS Midline Occiput Plate is a part of Stryker’s OASYS system for spinal surgery.  The OASYS system was “developed to provide the surgeon with unsurpassed versatility for the treatment of pathologies” related to the spine.

Because of the defect in this part, there are serious adverse health consequences that are associated due to the failed OASYS Midline Occiput Plate.  These problems include nerve injury and the need for revision surgery to replace the fractured implant.  According to the FDA, the affected products were distributed from April 23, 2010, through February 12, 2013.  The following parts were identified as those affected by the recall:

Manufacturing Part Number

Product Description

48551044 OASYS MIDLINE OCCIPUT PLATE, SMALL
48551045 OASYS MIDLINE OCCIPUT PLATE, MEDIUM
48551046 OASYS MIDLINE OCCIPUT PLATE, LARGE
48551047 OASYS MIDLINE OCCIPUT PLATE, LARGE LONG
48551048 OASYS MIDLINE OCCIPUT PLATE, MINI

Stryker first knew about the issue on May 30, 2013.  Stryker first issued an Urgent Medical Device Recall requesting hospitals to examine the affected OASYS midline occiput plate parts and to immediately stop using the recalled materials.  On June 20, 2013, Stryker notified spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of medical devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

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 Lipitor, Crestor, 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

Boston Scientific Vaginal Mesh Bellwether Cases Trials Scheduled

On August 29, 2013, Judge Joseph Goodwin announced the bellwether case schedule for the Boston Scientific vaginal mesh cases occurring in West Virginia.  The following cases were selected for the first and second bellwether trials in this MDL:

  • Carol Lynn Fawcett, et al. v. Boston Scientific Corp. 2:12-cv-07497 Pinnacle
  • Roseanne Sanchez, et al. v. Boston Scientific Corp. 2:12-cv-05762 Pinnacle
  • Carolyn F. Smothers v. Boston Scientific Corp. 2:12-cv-08016 Obtryx
  • Katherine L. Hall v. Boston Scientific Corp. 2:12-cv-08186 Obtryx

The first set of Boston Scientific trials is set to begin 2/11/2014 and the second set commencing on 6/17/2014.

Vaginal Mesh Trial History

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.  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.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached.

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 and Other Statins Cause and Effect Relationship with Onset of Diabetes

Dr. Eric Topol is a cardiologist with the Scripps Clinic and a recognized pioneer in the field of cardiovascular medicine.  For fourteen years, he ran the Cleveland Health Clinic, has authored over 1100 articles and 30 books, and was a founder of the Cleveland Clinic Lerner College of Medicine.

An OP Ed article he wrote in the New York Times on March 5, 2012 about statins bears reexamination in light of the  revelations in January of 2012, in a study published in the medical journal, Archives of Internal Medicine, that 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.

In his article entitled “The Diabetes Dilemma For Statin Users”, Dr. Topol looked at several large studies about statins, their potency and effect, including Lipitor (Atorvastatin), Zocor (simvastatin) and Crestor (Rosuvastatin), and stated that with the more potent statins including Lipitor, Crestor and Zocor, “particularly at higher doses, that the risk of diabetes shows up. The cause and effect was unequivocal because the multiple large trials of the more potent statins had a consistent excess of diabetes.”

Recognizing the data is not yet clear to say with precision at which dose excess diabetes shows up for each drug, Dr. Topol stated, “Let’s just round this off and say that one in every 200 patients treated with any of the three most potent statins will get the side effect of diabetes.  That’s quite a conservative number because diabetes was not even being carefully looked for in most of the trials.  And we have data for only 5 years of treatment; it might be worse with longer statin therapy.”

Dr. Topol concluded his March 4, 2012 OP Ed by saying “The information that we have does not support that this is a “small” problem unless one considers more than 100,000 new diabetics insignificant. The problem of statin-induced diabetes cannot be underplayed while the country is being overdosed.”

Click here to read the full New York Times article: The Diabetes Dilemma for Statin Users

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 visit our Lipitor Lawyer Information Center, or call 415-989-1800 or (800) 481-1615.

Trademark Notice

Lipitor is a registered trademark of Pfizer Inc.  The use of this trademark is solely for product identification and informational purposes.  Pfizer Inc. is not affiliated with this website, and Pfizer Inc. has no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by Pfizer Inc.

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

Leave a comment

Takeda’s Future after Losing Actos Patent

In 2012, Takeda’s profit dropped 53% and net profit was down 14% in the last nine months of 2012.

Why?

Because medical studies have demonstrated the causal connection between Takeda’s flagship diabetes drug Actos and bladder cancer and Takeda also lost its exclusivity patent on its foundation product diabetes treatment.  Actos accounted for more than half of Takeda’s U.S. revenue and 18% of its overall sales.  At its peak, Actos brought in more than $3 billion and $16 billion total since its release in 1999.

For Takeda, losing Actos exclusivity in August 2012 was a tipping point in downward direction as Takeda confronted generic entries from Ranbaxy Laboratories and Mylan.  But competition isn’t the only reason for flagging sales.  Medical studies showing an association of Actos and bladder cancer as well as a “Black Box“ warning have also impacted formerly widespread use by diabetes suffers.

Additionally, in the case of Cooper vs. Takeda, a Los Angeles jury, after listening to all of the evidence found Takeda responsible for Mr. Cooper’s bladder cancer and awarded $6.5 million to Mr. Cooper only to have trial judge, the Hon. Kenneth Freeman, overturn the verdict.  The case is now on appeal.

Click here to read the full article: Loss of Actos Weighs Heavily on Takeda

Studies Demonstrate Dangers of Actos

A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug.  The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period.  Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.

In September 2010, the FDA ordered a safety review of Actos.  In June 2011, the U.S. Food and Drug Administration issued a drug safety alert warning that the use of Actos for more than one year may be associated with an increased risk of bladder cancer.  In August 2011, a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer.  A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos.  In April 2012, Health Canada, the government drug safety agency for Canada, issued a safety warning on Actos.

Actos Lawsuits

Takeda is facing more than 3,000 suits alleging Actos caused bladder cancer or other ailments, according to court records in both MDL No. 2299 before the Hon. Rebecca Doherty and in California and other states.  The first MDL bellwether trial is set for January 27, 2014.

If you or a loved one has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuries.  Thomas J. Brandi and the Brandi Law Firm are leaders in nationwide pharmaceutical litigation for decades and is now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf. For a free consultation call us at 1-800-481-1615 or email us.

Trademark Notice
Actos is a registered trademark of Takeda Pharmaceutical Company, Ltd.  The use of this trademark is solely for product identification and informational purposes. Takeda Pharmaceutical Company, Ltd. is not affiliated with this website, and Takeda Pharmaceutical Company, Ltd. has no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by Takeda Pharmaceutical Company, Ltd.

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

Leave a comment

Bard Settles Queen Avaulta Solo Vaginal Mesh Suit

On August 21, 2013, after a jury of five men and four women had been selected and opening statements in the trial were ready to commence, the parties in the Wanda Queen vs. C.R. Bard Inc. Avaulta vaginal mesh case settled.  The amount was not disclosed.  Ms. Queen had the mesh inserted because of pelvic prolapse by Dr. Elizabeth Barbee at Wake Medical Center in Raleigh, North Carolina.

Bard has now lost two jury trials and settled the third before a jury could hear the evidence.  Bard now faces thousands more suits over its Avaulta product.  The next case against C.R. Bard Inc. for its Avaulta vaginal mesh is scheduled to begin October 8, 2013.  The stock closed up almost three dollars per share after last week’s $2 million Cisson vs. Bard verdict on news of the settlement, finishing over $114 per share.

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

Bard Faces Future after Cisson Verdict

In 2012, Bard lost its first vaginal mesh case and was ordered to pay $3.6 million following the California state court jury’s decision.  On August 15, 2013, a West Virginia jury ordered Bard to pay $2 million to Donna Cisson for her injuries due to her use of what the jury found to be the defective Avaulta product.  Thousands more vaginal mesh claims are building up against Bard in the MDL proceedings in Judge Goodwin’s court in West Virginia.

Timothy RingTimothy M. Ring is the Chairman and Chief Executive Officer for C. R. Bard, Inc., serving in that capacity since August 8, 2003.  He joined Bard in June 1992 as Corporate Vice President and has steadily risen through the ranks to assume corporate leadership.  Prior to Bard, he worked ten years at Abbott labs in personnel positions and before that was with General Motors.  He has a degree in Industrial relations from Cornell.

C.R. Bard Inc. stock closed at approximately $111 per share on August 16, 2013.  Shares are up about 16% for 2013 year to date.  Currently there are 5 analysts that rate C.R. Bard a buy, 1 analyst rates it a sell, and 12 rate it a hold.  It is a global company with 12,000 employees and business operations in 90 countries.  In the first quarter of 2013, the stock made a profit of $90.7 million dollars.  In the second quarter of 2013, the company reported a loss of $161.6 million because it took a $275.1 million litigation charge for product liability charges that virtually wiped out its profits.  In the remainder of 2013, Bard anticipates receiving payments from W.R. Gore & Associates, which has been ordered to pay hundreds of millions of dollars to C.R. Bard as a result of a patent infringement case related to prosthetic vascular grafts used in bypass procedures.  In June 2013, Bard reached a deal to sell its electrophysiology business for$275 million dollars to Boston Scientific.  On August 19, 2013 Bard announced that it has entered into a definitive agreement to acquire privately held Medafor, Inc., a leading developer and supplier of plant-based hemostatic agents for the purchase price of $200 million.

No doubt, Bard, like many similar companies faced with massive suits, did focus groups trying out its best arguments on mock juries, and then tailored those arguments as they applied them to the actual cases.  However Bard has now seen what two real juries have thought of its efforts to say there was nothing wrong with the Avaulta mesh product, they acted reasonably, and the pain the women are suffering is really from something else.  Bard gets another chance immediately as the next Avaulta Plus vaginal mesh lawsuit is slated to begin in West Virginia on August 19, 2013.

Soon Bard will learn the lessons of history.  Perhaps Mr. Ring will see the inevitable tide advancing and do the right thing for the injured women, their families, and the Bard shareholders.

, , , , , , , , , ,

Leave a comment

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

Follow

Get every new post delivered to your Inbox.

Join 181 other followers