Archive for category Drug and Medical Device Litigation

California Supreme Court Victory for Generic Fosamax Users

On September 25, 2013, the California Supreme Court denied the generic Fosamax manufacturers petition for review thereby upholding the June 13, 2013 Court of Appeal decision allowing people injured by generic Fosamax to go forward in the Courts and hold the generic manufacturers responsible.  In denying the generic manufacturers Petition, the Supreme Court let stand the June 13, 2013 the California Court of Appeal, Fourth Appellate District, Division Three ruling that people who used the generic Fosamax were not preempted by Federal law and the decision in PLIVA, Inc. v. Mensing (2011) 131 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, a 5-4 decision authored by Hon. Clarence Thomas, 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.

The practical effect of Mensing is, to quote the dissenting opinion of Justice Sotomayor, at 2581;

“As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.  The Court gets one thing right: This outcome “makes little sense.”

However, in the case of Olga Pikerie, the California 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.

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.

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DePuy September 23, 2013 Bellwether Trial Continued

On September 20, the Honorable David Katz presiding over the DePuy bellwether case, Ann McCracken v. DePuy Orthopaedics, Inc., et. al., Case No. 11 dp 20485, continued the trial 90 days from September 24, 2013 “in the interest of justice”.  According to the Order, the Judge continued the trial so that the parties could complete the scheduling of expert witnesses and pretrial discovery.

Approximately 93,000 DePuy ASR were subject to a global recall and over 10,000 cases are pending in California and the MDL.  Potentially thousands more wait on the horizon.  Thousands of hip implant recipients have experienced pain, dislocation, fracture, toxic poisoning, and were forced to have revision surgery to remove the defective DePuy ASR.

The lawyers at the Brandi Law Firm are representing a number of people with cases pending against the manufacturer of the DePuy ASR in the California JCCP, the MDL, and people who were injured by the DePuy Pinnacle.  Please contact the DePuy hip replacement failure attorneys at the Brandi Law Firm today (1-800-481-1615 or email us) to talk with a Johnson & Johnson DePuy ASR recall lawsuit attorney.

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Bard Settles Another Vaginal Mesh Suit

On September 13, 2013, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems.  The case, Virgil v. C.R. Bard Inc. (BCR), ATL-L6917-10, Superior Court of New Jersey Law Division, Atlantic County (Atlantic City), was scheduled to go to trial on September 26.  According to the complaint, Virgil, a junior high school music teacher in Colorado, sued Bard after her transvaginal mesh device began to erode.  Virgil needed three surgeries to address urinary problems created by the insert.

Click here to read the full Bloomberg article: Bard Said to Settle Vaginal-Mesh Case Set for Trial

Bard has lost two jury trials, has settled a third case after a jury selected, and now has settled a fourth before trial commenced.  Bard faces more than 8,000 claims over the Avaulta insert.

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.

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Second Actos Trial Begins

Lawyers for the family of Diep An told a Baltimore jury that drug giant Takeda’s failure to tell the whole truth about Actos role in the increased risk of cancer was the cause of death, as opening statements got under way. This case will provide further insight into how a jury views Takeda’s role in the Actos controversy as more than 3,000 cases await trial in the United States.

Plaintiffs are expected to claim as did the Plaintiffs in Cooper vs. Takeda, that the drug giant knew of the increased risk of bladder cancer long before it provided warnings, and that Actos is the cause of death of Diep An, who began taking Actos in 2007 and was diagnosed with bladder cancer in September 2011.  On April 26, 2013, a Los Angeles jury heard similar evidence and found against Takeda and assessed damages at $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles).  However, trial Judge Kenneth Freeman overturned the verdict and the case is on its way through the appeal process.

Judge Freeman granted Takeda’s motion to exclude the opinions of Plaintiff’s causation expert Dr. Norm Smith, a professor of surgery and urology at the University of Chicago Medical Center,  that Actos was a substantial factor in specifically causing Mr. Cooper’s bladder cancer. With no opinion to support that finding remaining in the case, the Court then granted Takeda’s motion for non-suit, throwing out the verdict.  The basis of this ruling will be a crucial focus on appeal.

Takeda denies any role of Actos in causation and maintains the warnings were adequate.  Before it went off patent in 2012, Actos was Takeda’s top-selling drug with sales peaking at $4.3 billion.

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.

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.  The 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.

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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.

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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.

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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.

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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.

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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.

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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.

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