The United States Department of Justice has announced its intent to make itself a party in a qui tam whistleblower lawsuit against the pharmaceutical manufacturer Novartis.*
A qui tam lawsuit is filed by a whistleblower acting on behalf of the government against an organization allegedly engaged in fraudulent conduct. In certain cases, rather than allowing a whistleblower to proceed on its behalf, the Department of Justice will intervene in the case itself. Put another way, the government will engage in the litigation directly, as a party to the case.
This newest lawsuit, filed by one of Novartis’ former sales representatives, alleges that the company was engaged in fraudulent marketing practices that cost taxpayers hundreds of millions of dollars.* Among other allegedly fraudulent practices, the company paid kickbacks to physicians so that they would prescribe certain medications, all at the expense of the federal government.* Such drugs included Lotrel, Valturna, Starlix, Tekturna, Diovan and Exforge.* This recent lawsuit comes on the heels of Novartis’ settlement of similar claims in the amount of $422 million dollars in 2010.*
The San Francisco law firm of Audet & Partners, LLP routinely represents whistleblowers in qui tam litigation. The attorneys and staff at the firm comprise a team of ethical and experienced legal professionals who represent individuals, consumers and small business owners who are aware of wrongdoing and wish to do the right thing. The firm has the expertise and experience to understand the complex underlying factors in whistleblower/qui tam cases.
You may be a whistleblower if you are an employee that has reason to believe your employer has violated a law, rule or regulation and you agree to testify or commence a legal proceeding on the issue, or if you refuse to violate the law.
If you believe you may have a qui tam/whistleblower case against your organization or agency, please contact Audet & Partners, LLP by calling us toll free at 800.965.1461. Alternatively, please complete and submit our confidential inquiry form on the right side of this page. Please act now, since the law may limit your right to recovery if you delay.
* United States Joins Whistleblower Lawsuit Against Novartis Pharmaceuticals (April 26, 2013), http://www.sfgate.com/business/prweb/article/United-States-Joins-Whistleblower-Lawsuit-Against-4467467.php#ixzz2U0JFbluD
On May 8, 2013, Intuitive Surgical, the manufacturer of the da Vinci surgical robot, issued an urgent medical device notification and also advised the Food and Drug Administration (FDA) of a problem with one of the surgical robot’s instruments.*
The document issued by the company warned that the Hot Shears™ Monopolar Curved Scissors may develop “micro-cracks,” which “may create a pathway for electrosurgical energy to leak to tissue during use.”* This leaked energy could potentially burn patients undergoing surgery.* Intuitive Surgical stressed, in bold print, that the micro-cracks in the scissors may not be visible to the user.*
The warning, which comes in the wake of several other da Vinci lawsuits, is of particular concern because of the wide range of procedures in which the scissors are used. The Hot Shears™ have been used to cut and coagulate tissue in common surgeries ranging from hysterectomies and prostatectomies to gastric bypass procedures.** There are at least 2,000 da Vinci robots in hospitals across the United States.**
The issue is currently under review at the Food and Drug Administration.** According to one FDA database, surgeons’ reports of accidental burns, punctures, and other “mishaps” (sometimes involving death) associated with the da Vinci system increased 34% between 2011 and 2012.** Because of the surprising number of reported adverse events, the FDA has been polling surgeons about their experience with the robot.
Despite reporting the issue to the FDA and issuing an urgent warning, Intuitive Surgical has attempted to downplay the problem. The company maintains that it has “no confirmed evidence of patient injury attributable to this issue.”** While denying that there was any energy leakage, the company does acknowledge that there was at least one instance in which a patient complained of injury following surgery with an instrument later found to contain micro-cracks.**
Even with a history of lawsuits, Intuitive Surgical has decided not to recall the surgical scissors. Instead, it has simply advised doctors that replacement shears will be available in two to four weeks.** Only time will tell whether further injuries caused by the Hot Shears™ will come to light. In the meantime, the surgical shears are still being used by healthcare facilities across the nation.
* May 8th Urgent Medical Device Notification by Intuitive Surgical, http://fm.cnbc.com/applications/cnbc.com/resources/editorialfiles/2013/05/10/UrgentDaVinci.pdf
** Crack-Prone Scissors May Burn Patients, Da Vinci Maker Says. Medscape. May 13, 2013, http://www.medscape.com/viewarticle/804067
Following in the footsteps of the U.S. Supreme Court in Wal-Mart v. Dukes, Judge Harold Baer, Jr. recently denied class certification to a group of unpaid interns attempting to sue the Hearst Corporation for alleged violations of the Fair Labor Standards Act.
The lawsuit, Xuedan Wang v. The Hearst Corporation, was filed in the Southern District of New York earlier this year. Each of the named plaintiffs worked as an unpaid intern for one of the Hearst Corporation’s magazines, including Harper’s Bazaar, Marie Claire, and Cosmopolitan.* The magazines required that the interns perform many of the same tasks that paid employees performed.* Nevertheless, Hearst concluded that it did not have to pay the interns for this work because they were in college and eligible to receive academic credit.*
Xuedan Wang and the other plaintiffs in the case recently filed a motion for class certification, which would have allowed them to bring their claims as a group in a single lawsuit. They described the class as consisting of “all persons who have worked as unpaid interns at Hearst Magazines in New York between February 1, 2006 and the date of final judgment in this matter.”*
In order to certify a class, a group of plaintiffs must show that “(1) the class is sufficiently numerous; (2) there are questions of law or fact common to the class; (3) the class representative has claims and defenses that are typical of the class; and (4) the representative parties will fairly and adequately protect the interests of the class.”* Additionally, plaintiffs must also demonstrate that “questions of law or fact common to class members predominate over any questions affecting only individual members, and that a class action is superior” to litigation by the plaintiffs as individuals.*
In denying the motion, Judge Baer reasoned that the last of these requirements had not been met.* The judge noted that in Wal-Mart v. Dukes, the plaintiff failed to put forth evidence that Wal-Mart had a general policy of discrimination across all of its stores. Similarly, Judge Baer held that the unpaid interns had not provided evidence that they had all performed the same duties and obtained the same benefits during each of their internships.* The question of job duties and benefits was central to the issue of liability in the case. Because several of the interns performed different duties and obtained different benefits, it did not matter that, on a broader level, all of them had been classified as unpaid interns.
This case is just one more example of the reach of the Supreme Court’s decision in Dukes. The plaintiffs in this case will now have to bring their cases individually. While not impossible, doing so makes the claims much less attractive both to the plaintiffs and their lawyers. Litigating each lawsuit individually will be more costly and time-consuming, and less lucrative with regard to damages.
* Opinion & Order (May 8, 2013), Xuedan Wang v. The Hearst Corporation, U.S. District Court for the Southern District of New York, No. 12cv793. http://www.nysd.uscourts.gov/cases/show.php?db=special&id=291
Depakote (divalproex sodium), a valproate product1 and Topamax (topiramate)2 are prescription drugs primarily prescribed for treating seizures, although both drugs are also used to treat migraine headaches, and Depakote is also used to treat bipolar disorder.
Various worldwide studies have been conducted regarding the risk of birth defects associated with the use of these medications by women during pregnancy. The North American AED Pregnancy Registry was established in 1996 to study these risks, specifically focusing on Depakote and other valproate products. The study found that of the 149 women studied between 1997 and 2003, 16 of the infants born suffered from major birth defects.3 These birth defects include neural tube defects such as spina bifida.
A study conducted by the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) followed more than 300 children born to women being treated with a valproate product for epilepsy between 1999 and 2004. This particular study included 25 clinics in the U.S. and the U.K. Researchers found that “Three-year-olds whose mothers took the antiepileptic drug valproate during pregnancy had average IQs six to nine points lower than children exposed to three other antiepileptic drugs.”4
Valproate has also been linked to an increased risk of autism in an ongoing study lead by Gus Baker, PhD, FBPsS, of the University of Liverpool in the U.K., “The potential risk for autism in this study was substantial for children whose mothers took valproate while pregnant…”5
The Royal Group of Hospitals in Belfast, Northern Ireland performed a study which found that of 203 births to women who took Topamax during pregnancy, 16 had major birth defects. The study further found that the risk of cleft palate is 11 times higher, cleft lip 11 times higher and genital defects 14 times higher in women taking Topamax during pregnancy.8
In 2011, the FDA issued a warning that taking Topamax during pregnancy increases the risk of oral cleft birth defects6. A similar warning was issued for Depakote and other valproate products in 2009 with regards to the increased risk of neural tube defects and adverse effects in cognitive development.7
More recently, a study was conducted in Australia at the Royal Melbourne Hospital and University of Melbourne Australia to investigate the link between birth defects and the use of Depakote and Topamax. “The study revealed a statistically significant link between Topamax use during pregnancy and increased risks for giving birth to a baby born with hypospadias and so-called brain “maldevelopments.” (Hypospadias is when the urethra’s opening is formed on the underside of an infant’s penis).9
While the FDA did issue warnings in 2009 and 2011 respectively, these warnings came too late for women whose children have suffered birth defects related to their use of these medications during pregnancy, as the manufacturers did not provide a warning or information about these risks. As a result, lawsuits are being filed against the manufacturers, Abbot Laboratories and Janssen Pharmaceuticals, to hold them accountable for the harm their products caused.
If you or someone you know has suffered a birth defect that may be related to Topamax or Depakote, please contact Audet & Partners, LLP by calling us toll free at 800.965.1461, or complete and submit our confidential inquiry form on the right side of this page. Please act now, since the law may limit your right to recovery if you delay.
Mounting pressure from the pharmaceutical industry (Industry) has greatly influenced the drug approval process conducted by the U.S. Food and Drug Administration (“FDA”). This pressure has led to the question of who the FDA is actually serving, the health and safety of the public or the Industry?
- The Prescription Drug User Fee Act, passed in 1992, provides that pharmaceutical companies must pay a fee in order for the FDA to review their drug applications. According to Dr. Wolfe, “This system has created a very unhealthy relationship between the industry and the FDA, where the FDA says, “We have to be nice to these people, because they are paying our bills.”
- The FDA concedes to what the Industry wants in an attempt to avoid conflict.
- The absence of congressional oversight. Prior to 2001, if a mistake was made, a congressional hearing was held, requiring the FDA to explain the situation to the legislative branch. Currently, there are very few congressional hearings, and “no one is there in the Congress [now].”
The FDA states that its mission is to “…ensure that drugs marketed in this country are safe and effective. The center’s best-known job is to evaluate new drugs before they can be sold. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.”[ii]
Can the FDA effectively and completely evaluate new drugs if the review and approval process is expedited? This is of major concern as they continue to implement procedures for accelerating the review process to allow the Industry to begin selling drugs prior to a full and comprehensive review, with many studies being conducted after the drugs are already on the market. “The public does benefit from the accelerated approval process. For example, if a drug is potentially life saving and there is an immediate need, it could be useful to have the drug available sooner.”[iii] However, this concept can be problematic when the Industry abuses it to get their drugs on the market faster.
- Fast Trackexpedites the review of drugs to treat serious diseases and fill an unmet medical need.
- Accelerated Approvalallows earlier approval of drugs to treat serious disease, and that fill an unmet medical need based on a surrogate endpoint (a marker – laboratory measurement, or physical sign – that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement).
- Priority Review is for drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. It means that the time it takes the FDA to review a new drug application is reduced.
These accelerated approval processes are disconcerting since the adequate amount of time necessary to thoroughly evaluate a drug is not being provided, which can lead to a potentially dangerous product with an FDA endorsement, being used by the public. A poignant example of this is Avandia, manufactured by GlaxoSmithKline. This drug is used to treat type 2 diabetes and received accelerated FDA approval. Unfortunately, a study released after the drug was already on the market determined that it was linked to liver toxicity, heart attack, and a 43 percent increase in heart-related problems. Subsequently, the FDA required that the drug be re-labeled with its most serious warning called a “black-box” warning.
Given the increased use of IUDs as a form of long-term birth control, specifically the Mirena IUD, the number of hysterectomies being performed as a result of complications associated with the Mirena IUD are increasing at an alarming rate. As previously highlighted, serious complications related to the Mirena IUD include migration of the IUD within the body, perforation of the uterine wall by the IUD, and/or embedment of the IUD in other pelvic organs. Depending upon the severity of the migration, perforation, and/or embedment, a hysterectomy is often required to intervene, remove, and/or mitigate the injuries and damage caused by the IUD.
A hysterectomy is the second most common surgery in the United States, second to cesarean section1. There are three different types of hysterectomies:
1. Partial (aka subtotal or supracervical) removes just the uterus, leaving the ovaries, cervix, and fallopian tubes intact 2.
2. Total removes the uterus and the cervix1.
3. Radical removes the whole uterus, tissue on the sides of the uterus, cervix, and top part of the vagina3.
In all three procedures, the ovaries and fallopian tubes may or may not be removed, depending upon the medical necessity.
There are five types of methods1 used to perform a hysterectomy:
1. Abdominal hysterectomy – an incision in the abdomen to remove necessary reproductive organs.
2. Vaginal hysterectomy – an incision in the vagina to remove necessary reproductive organs.
3. Laparoscopic hysterectomy – four small incisions in the belly, one of which is used to insert a laparoscope (lighted tube and small camera) enabling the doctor to see the organs and cut the uterus into small pieces for remove through the other three cuts.
4. Laparoscopically assisted vaginal hysterectomy – an incision in the vagina, with removal of necessary reproductive organs assisted by laparoscope.
5. Robotic-assisted surgery – doctor uses a robot to make cuts in the belly and remove necessary reproductive organs.
Women typically require a hysterectomy when they have been diagnosed with cancer of the uterus, ovary(ies), cervix or endometrium; fibroids, which are non-cancerous, muscular tumors; endometriosis, which is development of the uterine lining outside the uterus4; prolapse of the uterus, which is collapse of the uterus into the vaginal canal5; adenomyosis, aka uterine thickening6; chronic pelvic pain; abnormal vaginal bleeding; and Intrauterine Device (IUD) complications.
Rebecca, a 29-year-old healthy woman, chose to use the Mirena IUD as her source of birth control. The device was originally placed in 2002, subsequently removed five years later, and another placed in 2007. After experiencing continued severe chronic pelvic pain after a laparoscopy connected to a ruptured ovarian cyst, Rebecca’s doctor recommended a hysterectomy. It was discovered that she had a severe infection and resulting scar tissue that were directly associated with the Mirena IUD7.
If you, your wife, or a loved one, has suffered physical complications that may be tied to the Mirena IUD, please contact Audet & Partners, LLP by calling us toll-free, at 800.965.1461, or visiting our website at http://www.MirenaComplaints.com. Please act now, since the law may limit your right to recovery if you delay.
One of the most serious complications associated with the Mirena IUD is perforation of the uterus or migration of the IUD within the body. These complications may cause further problems that include but are not limited to: injury or perforation of other organs, infection, adhesions, infertility, and/or ectopic pregnancy.
Symptoms[i] of uterine perforation and/or migration include: lower abdominal pain, severe cramping, bleeding, nausea, vomiting, and/or fever. “A ‘missing’ IUD string should raise suspicion”[ii] of IUDs that may have perforated the uterine wall or migrated within the body
Oftentimes, the symptoms are mistaken for other health concerns, as was the case with a woman who was treated for non-existent ovarian cysts. She posted her experience on the CureZone.org[ii]. After two years, many visits to several doctors, x-rays, ultrasounds, a CAT Scan finally enabled doctors to see that the Mirena IUD had punctured this woman’s uterus in two places, requiring surgery for its removal. She continued to experience issues relating to remaining scar tissue in her uterus.
In other cases, upon being unable to locate the IUD, doctors have indicated to patients that the IUD must have been expelled. Seven weeks after delivery, a 31-year-old woman underwent insertion of an IUD. One year later, the doctor was unable to find the IUD upon physical examination, ultrasound and x-ray. It was therefore assumed that it had been expelled. Later that year, upon x-ray of the lumbar spine, the IUD was located and surgically removed.[iii]
According to a study conducted by ehealthme.com[v], as of March 20, 2013, of 58,328 women who reported experiencing negative side-effects related to the Mirena IUD, 1,394 indicated that their IUD had migrated from their uterus to other locations in their bodies. WebMD.com indicates that perforation will occur in 1 out of 1,000 women. Considering that over two million women have been implanted with the Mirena IUD[vi], these odds are extremely alarming.
In an effort to warn and educate other women about these issues, those who have experienced uterine perforation or migration of the Mirena IUD have created numerous blogs to share their experiences. Below are a few samples of what is being said by these women who have been negatively affected:
If you used the Mirena IUD and have experienced serious complications, our experienced product liability attorneys at Audet and Partners, LLP offer a free consultation so that we can evaluate your legal claim and advise you of your options. We invite you to call us at (800) 965-1461 or fill out the confidential case inquiry form on the right side of this page.
Pelvic Organ Prolapse (“POP”), aka bladder prolapse, and Stress Urinary Incontinence (“SUI”) are common conditions in women. The University of Rochester Medical Center conducted a study[i] of 16,616 women with a uterus and found that 41% have experienced POP. SUI’s prevalence is said to occur in 30% of women five years after a vaginal delivery[ii], but due to its seemingly embarrassing nature, SUI is underreported and many who suffer from it do not seek treatment. Dr. Memel Harrison conducted a study[iii] through a questionnaire, which found that 46% of the 314 women (between the ages of 20-80) that responded correctly to the questionnaire had SUI.
POP is when supportive tissues in the pelvic region become weak and because of the arrangement and location of the uterus, bladder and rectum, they can herniate or bulge into the vaginal canal.[iv] SUI is the unintentional loss of urine due to physical movement or activity (i.e. coughing, sneezing, lifting, etc.[v]) POP and SUI[vi] are commonly caused by pregnancy and childbirth, menopause (decrease in estrogen levels can lead to weak pelvic muscles), age, and obesity.
Surgical mesh, originally developed in the 1950s for the treatment of hernias, became a popular treatment for POP and SUI in the ‘90s, known as transvaginal mesh. It is a type of sling that is positioned to provide support for the affected organ(s) relating to POP, or under the urethra and bladder relating to SUI[vii]. The FDA fast-tracked its approval process to allow manufacturers to begin selling it prior to a full FDA review, which can be lengthy and costly.
Serious complications have been reported after implantation of the device, including:
- Vaginal mesh erosion
- Pain (including during intercourse)
- Urinary problems
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
- Organ perforation
The FDA conducted a search of adverse event reports received between January 1, 2005 – December 31, 2010, which were directly associated with the transvaginal mesh implants; this search which identified 3,979 reports of injury, death and malfunction.[viii] As a result, the FDA issued an update stating that “…serious complications associated with surgical mesh for transvaginal repair of POP are not rare…furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”viii
In July 2011, the FDA warned that there was a five-fold increase of injury relating to insertion and use of the transvaginal mesh.[ix] According to an article published by the New York Times in January 2012, 185,000 women underwent the procedure for implantation of the transvaginal mesh in 2010 alone. That same year, 15% of those women experienced potential complications.[x] Frequently, surgical revision or removal of the transvaginal mesh is necessary, which can be painful, costly, and dangerous.
Over objections raised by Bayer Healthcare Pharmaceuticals*, the United States Judicial Panel (“USJP”) on Multidistrict Litigation has consolidated most federal lawsuits alleging injuries caused by the Mirena intrauterine device. In the matter of In Re: Mirena IUD Products Liability Litigation, MDL No. 2434, the Panel ruled that cases alleging the migration and/or perforation of the device, and the inadequacy of the warnings issued by Bayer with regard to these risks, will now be heard in the United States District Court for the Southern District of New York.
In the Order signed by Acting Chairman Kathryn H. Vratil, the USJP noted that:
“Transfer under [28 U.S.C.] Section 1407 will offer the benefit of placing all related actions before a single judge who can structure pretrial proceedings to accommodate all parties’ legitimate discovery needs while ensuring that common witnesses are not subjected to duplicative discovery demands.”
In a hearing last month in San Diego, attorneys representing women alleging injuries caused by the Mirena IUD, including William M. Audet of Audet and Partners, LLP in San Francisco, CA, argued that the number of claims now being filed was of a size that clearly warranted consolidation.* The USJP apparently agreed in its Order, ruling that transfer of the Mirena lawsuits “promotes the just and efficient conduct of this litigation.”
“In consolidating the large number of Mirena lawsuits spread throughout the United States, the USJP is ensuring the efficient administration of justice for women who have suffered serious injuries allegedly caused by the Mirena IUD ranging from dangerous abscesses to infertility,” explains William Audet. “We look forward to seeing that these claims are properly addressed in the multidistrict litigation established by today’s Order.”
The Mirena IUD, manufactured by Bayer, was approved by the FDA in 2000 as a contraceptive device recommended to women who have had at least one child. This small, t-shaped plastic device is inserted by a health care professional and can be left in place for up to five years.**
Among its marketing strategies for the Mirena IUD, Bayer held “Mirena Parties” for “busy moms” in connection with the social networking site Mom Central. At these gatherings, a representative from Mom Central was joined by a nurse practitioner. The orchestrated presentation included a marketing script touting the ability of Mirena to help women “look and feel great” and heighten sexual intimacy with their partners.**
If you, or one close to you, may have suffered serious side effects as a result of use of the Mirena IUD, you can request a free case review by calling Audet and Partners, LLP at (800) 965-1461, or by visiting http://www.mirenacomplaints.com online.