Posts Tagged ‘Prempro’
The Firm - Friday, April 5, 2013 8:03 - 0 Comments
A number of Beasley Allen lawyers have been selected by federal judges around the U.S. to serve on the Plaintiffs Steering Committee (PSC) in lawsuits that have been consolidated in Multidistrict Litigation (MDL). Consolidating cases around the U.S. into a MDL allows the committee overseeing the process to focus on moving the cases forward. This results in cases being resolved much more quickly. Lawyers on these committees coordinate the litigation and work together on issues such as pretrial discovery and motions. It is a distinct honor and privilege for a lawyer to be selected to help direct litigation in this manner. It’s also very hard work and is both time and finance intensive. The following Beasley Allen lawyers are serving on PSCs in active MDLs.
THE MASS TORTS SECTION
Andy Birchfield manages the firm’s Mass Torts Section, which has been recognized as a national leader in pharmaceutical litigation. Andy has been active in several MDLs. To date, he has been involved in cases resulting in settlements and verdicts in excess of $5.4 billion.
Andy’s efforts have been indispensable in heading the firm’s Vioxx® litigation. In April of 2005, Andy was chosen to co-lead the Plaintiff’s Steering Committee for the federal Vioxx Litigation MDL. He was lead counsel or co-lead counsel in five Vioxx trials, including one that resulted in a $51 million verdict against Merck. The litigation resulted in a $4.85 billion settlement. In November 2007, Merck agreed to pay $4.85 billion dollars to settle the personal injury claims of persons who suffered a heart attack or stroke while taking Vioxx. In just two and a half years, more than 50,000 claims were reviewed and all $4.85 billion was paid out to deserving victims. The Vioxx settlement was not only one of the largest in the history of pharmaceutical litigation, but it also was the most efficient, ensuring that individuals affected by this dangerous drug were compensated in not only a fair and timely manner.
In November 2011, Merck, Sharp & Dohme agreed to pay $950 million to resolve federal criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx. Under the settlement of the claims, Merck agreed to pay $628,364,000 to resolve allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety. Of the total civil settlement, $426,389,000 will be recovered by the United States, and the remaining share of $201,975,000 will be distributed to the participating Medicaid states. The settlement and plea concluded a long-running investigation of Merck’s promotion of Vioxx.
Merck also pleaded guilty to a one-count information charging a single violation of the Food Drug and Cosmetic Act (FDCA) for introducing a misbranded drug, Vioxx, into interstate commerce. Under the terms of its plea agreement with the United States, Merck pleaded guilty to a misdemeanor for its illegal promotional activity and will pay a $321,636,000 criminal fine. This case was handled by the Justice Department’s Civil Division and the U.S. Attorney’s Office for the District of Massachusetts.
In Re: Actos Products Liability Litigation, MDL 2299
U. S. District Court for the Western District of Louisiana
Honorable Rebecca F. Doherty
Andy Birchfield also is a member of the PSC for the MDL for the diabetes drug, Actos, which has been linked to an increased risk of bladder cancer. On December 29, 2011 the Judicial Panel on Multidistrict Litigation (JPML) established MDL No. 2299 for all federal claims alleging injury caused by the diabetes drug Actos (pioglitazone).
Actos, manufactured by Takeda Pharmaceuticals America Inc., is the tenth best-selling medication in the U.S. and has been found to increase the risk of developing bladder cancer in patients who have taken Actos for more than one year. More than 3,000 complaints have been filed by former users of Actos.
In May 2012, Judge Doherty issued a ruling known as a direct-filing order for any new claims. This ruling will allow anyone filing an Actos side effects lawsuit to do so directly to the MDL without first having to file a case in local court and waiting for it to be transferred to the federal court by judicial order. Signing this order will expedite future Actos side effects lawsuits as it will eliminate a procedural step that was to this point required of anyone who felt that he or she had suffered from Actos side effects as a result of using this diabetes medication and who wanted to file a legal action in response.
On Feb. 19, 2013, Judge Doherty set dates for the first two pilot bellwether trials in the federal Actos litigation with the goal of “moving these proceedings toward completion of the Court’s responsibilities in a reasonable timeframe.” The first trial is set for January 27, 2014 and a second to begin April 14, 2014.
Andy Birchfield also serves on the PSC for the MDL related to Zoloft. In July 2006, the FDA notified healthcare professionals and consumers of a possible link between antidepressant medications – including Zoloft (sertraline) – and serious birth defects. Sertraline (marketed as Zoloft) is included in the class of drugs called selective serotonin reuptake inhibitors (SSRIs). This class of drugs is used to treat depression, anxiety, and other mood disorders.
The study, published in February 2006 in The New England Journal of Medicine, included pregnant women who were treated with SSRIs, or in a few cases, other antidepressant medications. SSRI medications are the most commonly used drugs to treat depression in the U.S. The study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream.
In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.
The MDL was created by Order of the United States Judicial Panel on Multidistrict Litigation (MDL Panel) on April 17, 2012. The typical case involves claims by a plaintiff from anywhere in the United States against defendant Pfizer, Inc., and may name other defendants as well. The MDL Panel noted that the actions “involve allegations that Zoloft, a prescription medication approved for the treatment of depression and other ailments, causes birth defects in children when their mothers ingest the drug while pregnant.” Pfizer and the other Defendants deny these allegations.
Fosamax and ONJ
In re Fosamax Products Liability Litigation, MDL No. 1789
U.S. District Court for the Southern District of New York
Honorable John F. Keenan
Russ Abney serves on the PSC for the Fosamax Products Liability Litigation MDL. Alendronate sodium, a drug sold by Merck under the brand name “Fosamax,” belongs to a class of drugs called bisphosphonates. Physicians use these drugs to treat abnormalities in the bone remodeling cycle that arise from metabolic and oncologic diseases. Fosamax is administered orally, and is generally prescribed at lower doses than intravenously administered bisphosphonates. The FDA approved Fosamax for the treatment of osteoporosis in 1995. In 1997, the FDA approved Fosamax for the prevention of osteoporosis.
Since October 2003, published reports have described the development of osteonecrosis of the jaw (ONJ), a condition characterized clinically by an area of dead jaw bone that becomes exposed to the oral cavity, among some bisphosphonate users. Symptoms include pain, swelling, and purulent secretion. The vast majority of ONJ cases have been reported in patients taking intravenously administered bisphosphonates.
Reported alternate causes of ONJ include radiation therapy to the head and neck, osteomyelitis (inflammation or infection of bone marrow), osteopetrosis, herpes zoster virus infection, chemotherapy, and major trauma.
Fosamax and Femur Fracture
In re: Fosamax (Alendronate Sodium) Products Liability Litigation (No. II) (MDL No. 2243)
U.S. District Court for the District of New Jersey
Honorable Garrett E. Brown, Jr.
Chad Cook is one of 11 lawyers from around the country selected to oversee the consolidated litigation as part of the Plaintiffs Steering Committee (PSC) for In re: Fosamax Products Liability Litigation (No. II), MDL 2243. This litigation, which encompasses hundreds of cases against Merck Sharp & Dohme, Corp., involves femur fracture injuries, and is consolidated under U.S. District Judge Garrett E. Brown, Jr., in the District of New Jersey.
Fosamax is one of several prescription drugs known as bisphosphonates. When first developed, bisphosphonate was thought to be a drug women could take indefinitely to treat low bone density and help ward off osteoporosis. Other brand-name prescription drug bisphosphonates are Actoenl, Boniva, and Reclast. In October 2010, following a review of more data on the safety of bisphosphonates, the FDA required all manufacturers of the drugs to add warnings to their safety labels for the risk of thigh fractures, specifically low-energy femoral shaft and subtrochanteric fractures.
The MDL for Fosamax claims in state courts related to femur fracture was formed on May 23, 2011. At that time it was limited to plaintiffs who took only Fosamax. On Feb. 3, 2012, the MDL was expanded to include Plaintiffs who took Fosamax, but also may have taken other similar medications such as Reclast or Boniva, as long as they did take Fosamax, and suffered femur fracture.
Chad also is on the Plaintiff’s Discovery Committee for In re Fosamax Products Liability Litigation, MDL-1789 which is venued in the Southern District of New York Federal Court before the Honorable John F. Keenan, and involves cases of osteonecrosis of the jaw. Chad also assists by serving on the Fosamax Science and Administrative Committees for this litigation.
Hip replacement systems
DePuy ASR Hip Replacement – MDL 2197
U.S. District Court, Northern District of Ohio
Honorable David A. Katz
DePuy Pinnacle Hip Replacement – MDL 2244
U.S. District Court for the Northern District of Texas
Honorable Ed Kinkeade
Biomet Hip Replacement MDL
U.S. District Court for the Northern District of Indiana
Honorable Robert L. Miller, Jr.
Navan Ward is our firm’s lead lawyer in the metal-on-metal hip implant litigation, which involves thousands of victims who have defective hip implants causing severe pain, metal poisoning, and in some cases revision surgery. These defective hip devices are manufactured by various companies, including Johnson & Johnson and DePuy Orthopedics, among others.
Navan was selected to the Plaintiffs Steering Committee for the DePuy Hip Implant Recall Multi-District Litigation (MDL), as well as to the PSC for the Pinnacle hip replacement MDL. Navan also has been selected to serve on the PSC f or the Biomet M2a Magnum Hip Implants Product Liability Litigation. He also serves as Co-Chair to the DePuy Metal-on-Metal Hip Implant Litigation Group for the American Association for Justice (AAJ).
Artificial hips are typically made with ceramic or plastic parts, but during the last decade manufacturers began making the devices with all metal parts. It was thought that the devices would hold up better over time. Most artificial hips can last 20 years or longer. But the metal-on-metal devices were failing after just five years or less. When hip implants fail, it is usually because they loosen, dislocate or fracture, which requires revision surgery to remove and replace the device. Hip replacement surgeries are already invasive and require long recovery, and second surgeries tend to be more complicated.
When surgeons went to replace the defective devices, they found another problem unique to metal-on-metal implants – blood poisoning. As the metal parts of the devices rubbed together, bits of metal debris could fall into the joint space causing inflammation and pain. In some cases, the metal has entered the bloodstream, resulting in chromium and cobalt in patients’ blood. In August 2010, after studies revealed an unusually high failure rate, DePuy, an orthopedic subsidiary of Johnson & Johnson, recalled its ASR XL Acetabular and Hip Resurfacing Systems, affecting about 93,000 patients worldwide.
From 2000-2011, nearly 17,000 problems with metal-on-metal hip implants have been reported to the Food and Drug Administration (FDA). In May 2011, the FDA asked makers of metal-on-metal hip devices to conduct safety studies on their products.
Transvaginal Mesh Litigation
In Re C. R. Bard, Inc., Pelvic Repair System
Products Liability Litigation (MDL No. 2187)
In Re American Medical Systems, Inc., Pelvic Repair System
Products Liability Litigation (MDL No. 2325)
In Re Boston Scientific Corp. Pelvic Repair System
Products Liability Litigation (MDL No. 2326)
In Re Ethicon, Inc., Pelvic Repair System
Products Liability Litigation (MDL No. 2327)
In Re Coloplast Corp. Pelvic Support Systems
Products Liability Litigation (MDL No. 2387)
U.S. District Court for the Southern District of West Virginia
Honorable Joseph R. Goodwin
Leigh O’Dell serves on the PSC in all five of the MDLs listed above. Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used to shore up pelvic organs that have become displaced due to age, childbirth, hysterectomy or obesity.
Reported complications from the transvaginal placement of the mesh include erosion of the mesh into the vaginal tissue, organ perforation, pain, infection, painful intercourse and urinary and fecal incontinence. Often women require surgery to remove the mesh. In some cases, this can require multiple procedures without successful removing all of the mesh.
The U.S. Judicial Panel on Multidistrict Litigation recently granted motions to create MDLs against five transvaginal mesh manufacturers and transfer the MDLs to the U.S. District Court for the Southern District of West Virginia, under Chief Judge Joseph R. Goodwin. Centralizing the litigation in the Southern District of West Virginia makes the pretrial proceedings more efficient, conserves judicial resources and avoids the risk of inconsistent rulings.
Leigh was appointed as a member of the Plaintiffs’ Steering Committee for all five MDLs. Currently, she is investigating cases involving mesh manufactured by American Medical Systems, Bard, Boston Scientific, Caldera, Coloplast, Cook Medical, and Johnson & Johnson.
Hormone Therapy MDL
Ted Meadows was selected to help direct litigation related to Hormone Replacement Therapy (HRT) as part of the Plaintiffs Steering Committee in the above MDL. The multidistrict Prempro Products Liability Litigation involves thousands of cases against drug manufacturer Wyeth Pharmaceuticals. It is consolidated under U.S. District Judge Billy Roy Wilson in the United States District Court, Eastern District of Arkansas, Western Division.
HRT is medication containing one or more female hormones, commonly estrogen plus progestin. HRT drugs such as Premarin, Prempro and Provera were prescribed to treat the symptoms of menopause such as “hot flashes,” vaginal dryness, mood swings, sleep disorders, and decreased sexual desire. The drugs also were promoted for off-label uses, including prevention of cardiovascular disease and Alzheimer’s disease.
In 2002, a comprehensive women’s health study was halted as a result of increasing incidents of breast cancer linked to the use of HRT drugs. Evidence came out during trials that illustrates Wyeth’s campaign to make billions of dollars in profit from HRT drugs while keeping the truth about the drugs’ dangers secret. Among the fact presented to jurors:
Wyeth was on notice of the need to study whether combination hormone therapy causes breast cancer as early as 1975, but failed to conduct a single breast cancer study over the course of the next three decades – despite over a dozen red flags that breast cancer was a safety problem; Instead of studying the breast cancer risk, Wyeth took active steps to downplay, dismiss and contain the release of data from other institutions’ studies that showed such risk.
Even worse, Wyeth ghost-wrote dozens of medical articles that minimized the breast cancer risk and exaggerated the benefits of hormone therapy and then published these articles in reputable medical journals under independent doctor’s names; It was not until a government study was stopped early because of breast cancer that the world learned the truth; Studies now confirm that 200,000 women – grandmothers, mothers, sisters and wives – would not have suffered breast cancer but for their use of combination hormone therapy drugs.
Ted says by marketing these drugs for uses that were never approved by the FDA and downplaying the risk of breast cancer, Wyeth put the lives of thousands of women at serious risk.
Ted became a shareholder at Beasley Allen in 2002. Since that time, he has been the lead Beasley Allen lawyer for the firm in verdicts and settlements totaling more than $325 million, including a $72.6 million compensatory verdict in a HRT trial in Philadelphia. This verdict was selected by the National Law Journal as No. 30 on its list of Top 100 Verdicts of 2011.
THE TOXIC TORTS SECTION
BP Oil Spill Litigation
In Re Oil Spill by the Oil Rig “Deepwater Horizon” in the Gulf of Mexico on April 20, 2010, MDL Docket No. 2179
U.S. District Court for the Eastern District of Louisiana
Honorable Carl J. Barbier
Folks throughout the Gulf Coast region were affected when BP’s Deepwater Horizon oil platform exploded in the Gulf of Mexico in April 2010. The Macondo well was damaged and oil spilled into the Gulf for months before the well could be capped. In October 2010, Rhon Jones was selected as one of 15 lawyers out of more than 100 who applied to oversee the consolidated litigation as part of the Plaintiffs Steering Committee. The BP litigation involves thousands of cases against BP and other Defendants. It was consolidated under U.S. District Judge Carl Barbier in New Orleans.
Rhon was part of the team that negotiated a settlement in principle, reached in March 2012, which was first established by BP to be about $7.8 billion. We believed that amount was low and in time it appears we were correct. Any business in the affected areas, including Alabama, Mississippi, Louisiana and the west coast of Florida, is eligible to file a claim for compensation under the terms of the settlement agreement. A court-supervised claim center opened in June 2012, and it has worked extremely well.
Rhon terms the BP settlement as “probably the most unique class-action settlement in the history of American litigation.” Approximately $2 billion has already been paid or is approved to be paid to claimants in the three years since the oil spill.
In January 2013, BP pleaded guilty to 14 federal criminal charges related to the Gulf oil spill. It will pay $4 billion to resolve these charges, which include manslaughter and obstruction of Congress. In February 2013, the trial to determine civil fines under the Clean Water Act began in federal court. It is estimated BP may be required to pay in the neighborhood of $21 billion, depending on whether the court determines the company acted with gross negligence in the events leading up to the spill.
THE CONSUMER FRAUD SECTION
Toyota Sudden Unintended Acceleration
In re: Toyota Motor Corp. Unintended Acceleration Marketing, Sales Practices, and Products Liability Litigation, MDL No. 2151
U.S. District Court for the Central District of California
Honorable James V. Selna
Dee Miles, head of the firm’s Consumer Fraud section, was appointed by Federal District Judge James V. Selna to serve in a leadership role on the Plaintiffs Liaison committee in the Toyota Sudden Unintended Acceleration MDL Litigation in a California U.S. District Court. This committee has the awesome responsibility of coordinating the litigation for the entire country.
Since 2009, Toyota has recalled 14 million vehicles worldwide for sudden unintended acceleration problems, paid record fines for violating recall procedures required under U.S. safety regulations, and became the subject of a congressional investigation. Toyota has blamed the problems on faulty floor mats and stuck accelerator pedals. Many safety experts and plaintiffs’ lawyers, however, blame Toyota’s sudden-acceleration incidents on a highly obscure electronic malfunction – a claim that Toyota disputes.
In December 2012, Toyota Motor Corp agreed to a $1.1 billion charge to settle hundreds of U.S. consumer claims related to sudden unintended acceleration in its vehicles. The settlement, which is pending approval by Judge Selna, would resolve claims of economic loss related to the defective vehicles. The proposed settlement would be the largest in U.S. history involving automotive defects. But this settlement does not cover claims of wrongful death and injury related to Toyota SUA. These cases are slated for trial in April 2013.
This class settlement provides a very practical resolution for those Toyota car owners who experienced economic losses as a result of the Sudden Unintended Acceleration issue with their vehicles. It compensates them for their financial losses. For those who have experienced serious personal injuries and families who are suffering the loss of a loved one as a result of the Sudden Unintended Acceleration issue, their day in court still awaits them and is fast approaching. The MDL trial court has done a tremendous job of moving these cases through the system and adequately protecting the interest of all concerned. MDL Judge Selna’s highly skillful case management of these cases is the reason the parties were able to announce this resolution of the economic loss portion of the case.
The settlement agreement establishes a reserve of about $250 million for cash payments to Toyota customers who sold certain vehicles or turned in certain leased vehicles between September 2009 and December 2010. The agreement also would requires Toyota to establish a $250 million program for current Toyota vehicle owners to provide a supplemental warranty and retrofit about 3.2 million vehicles with a brake override system. All of this, of course, is subject to court approved.
In addition to serving on the PSC for the Toyota MDL, Dee is a proven leader in complex litigation and has been or is currently a leader on a national level in other MDLs. He has in the past served as Co-Lead counsel in the GenRe MDL, which is still pending, the Dollar General MDL, the American General MDL and he is currently being considered for a position before the court on the BCBS MDL, Judge Proctor in Birmingham presiding.
Dee is lead counsel in the Average Wholesale Price Litigation (AWP) in eight states, which are State MDLs in Mississippi, Louisiana, Kansas, Utah, South Carolina, Alaska, Hawaii and Alabama: State of Alabama v. Abbott (73 pharmaceutical companies); State of Mississippi v. Abbott (86 pharmaceutical companies); State of Louisiana v. Abbott (108 pharmaceutical companies); State of South Carolina v. Abbott (18 pharmaceutical companies); State of Kansas v. Abbott (33 pharmaceutical companies); State of Utah v. Abbott (43 pharmaceutical companies); State of Hawaii v. Abbott (44 pharmaceutical companies); and State of Alaska v. Abbott (34 pharmaceutical companies). The AWP cases have led to the “McKesson Litigation” in which Dee is serving as lead counsel in: State of Louisiana v. McKesson; State of Kanas v. McKesson; State of Hawaii v. McKesson and State of Alaska v. McKesson.
Dee has been involved in cases totaling more than $4 billion in settlement value, and has obtained actual verdicts in cases exceeding over $5 million, including Toyota, Average Wholesale Price (AWP) litigation / Medicaid Fraud, GenRe, Dollar General, American General and many Insurance & Finance cases throughout the years.
Ford 6.0 PowerStroke diesel engine
In re: Navistar Diesel Engine Product Liability Litigation, MDL No. 2223
U.S. District Court for the Northern District of Illinois
Honorable Matthew Kennelly
Bill Hopkins was appointed by the court to serve on the PSC in the MDL listed above. This Multi-District Litigation is based on the sale of faulty 6.0L diesel engines in certain models of heavy duty vehicles manufactured by Ford Motor Company between 2003-2007. Plaintiffs have reported problems such as blown head gaskets, valve ruptures, poor engine acceleration, inability to start the engine, engine stalling, complete loss of power while driving, and complete engine failure. These engines have been plagued with what Ford has called “unprecedented problems.”
Ford Motor Company and Navistar, Inc. manufactured, marketed and sold Ford’s Super Duty trucks and Ford Excursion vehicles for model years 2003-2007 that contained 6.0L Power Stroke Diesel Engines containing manufacturing and design defects that render the engines and vehicles unmerchantable. Plaintiffs assert a variety of legal claims against Ford based on the engine’s design, the marketing of the vehicles, and Ford’s repair practices.
The Court preliminarily approved a settlement in this case in November 2012 and is set for a final approval hearing for next month. More than 1.1 million notices were sent out last month by the Settlement Administrator. The settlement provides actual cash reimbursement for the repair or replacement of several engine component parts.
- David Dearing
- Hormone Therapy Litigation Update – $4 Million Verdict
- Punitive Damage Awards Upheld In Hormone Replacement Therapy Cases
- Mass Tort Update
- Pfizer Has Settled About Half Of The Prempro Cases
- The Philadelphia Story
- Melissa Prickett
- Hormone Therapy Litigation Update
- U.S. Supreme Court refuses to hear Prempro appeal
- Hormone Therapy
- Hormone therapy litigation update
- Pfizer ordered to pay $1.5 million in Prempro damages
- Wyeth promoted dangerous off-label use of HRT medications
- Prempro claims are not Time-Barred
- Other HRT Litigation Continues
- Pfizer settles Prempro cases
- Former Prempro Scientist working on a safer alternative
- Wyeth Scientist Guilty Of Research Misconduct
- A Report From Our Firm’s Mass Torts Section
- Jere Beasley Report, April 2013
- Marc McHenry Hired As Investigator
- Alabama to Receive $1,039,078 in Multi-State Settlement
- COSTCO Recalls Gold Coast Crab Dip
- Major Banks Assist In Payday Loans Banned By States
- We Have Allowed A Culture Of Violence To Be Created In The U.S.
- Parting Words
- Closing Observations
- Favorite Bible Verses
- WSFA News Defenders Interviews
- Beasley Allen Hosts The Child Safety Helmet Giveaway
- SPLC Looks At How Payday And Title Loans Prey On Alabama’s Poorest
- Employee Spotlights
- Natura Pet Expands Recall Of Dry Pet Foods
- Winn-Dixie Recalls Organic Apple Juice On Mold Fears
- Manda Packing Recalling 468,000 Pounds Of Meat
- Carter’s Recalls Infant Clothings With Zippers Due To Choking Hazard
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