Bayer’s Essure Birth Control Device Facing Multiple Negligence Lawsuits

essureA Florida woman who was the first to file a lawsuit against Bayer for negligence and breach of express warranties concerning the Essure birth control device, has led the way for litigation by others who were severely injured by the implanted device.

The lawsuit, filed in Philadelphia Court of Common Pleas, is not a products liability case, but an action for negligence because Bayer did not provide training to the physician on how to insert the device safely.

Doctor with no training

Heather Walsh obtained the Essure implant from a physician who did not receive any training from Bayer on how to insert the device.  The device – a coil made of stainless steel, titanium and plastic — is inserted into the fallopian tubes.  The coils expand and scar tissue forms around them blocking the fallopian tubes and resulting in sterilization, according to the complaint

Walsh was hospitalized for severe pain and fainting spells two years after getting the implant.  A CT scan revealed the device had migrated in her body and lodged behind her colon.  Walsh underwent a complete hysterectomy and other surgeries to remove the device from her colon.

Walsh is not alone, as more than 4,000 reports of serious complications from use of the Essure device have been reported to the FDA, including the report of woman who died during surgery to remove the implant in January 2015.

Angie Firmalino received the implant in 2009 and after two years, had it removed because the coils broke and migrated to her uterus.  Firmalino required several operations including a hysterectomy.  She started a Facebook page to warn other women about the dangers of the device, which now has more than 17,000 followers.

Claims not preempted by Medical Device Act

Although Essure has been in use since the FDA issued a Conditional Premarket Approval (CPMA) in 2002, Walsh brought the first Essure lawsuit against Bayer in 2014. The Medical Device Act (MDA) contains a preemption provision that prevents lawsuits for injuries caused by medical device manufacturers for devices that received pre-market approval from the FDA.

In the complaint Walsh filed, she claims that her negligence and breach of express warranties claims are not preempted by the MDA because the “cause of action has nothing to do with the product itself, but rather [Bayer’s] negligence in” allowing an untrained physician use specific equipment provided by Bayer, that the physician was not qualified to use when he erroneously implanted the device, according to the court documents.

In addition, the complaint asserts that the CPMA issued by the FDA was invalid because Bayer did not comply with the express conditions set by the FDA.

Mass Tort Consultant John Ray has written a white paper about how the FDA actions will affect the ongoing Essure Litigation specifically related to the defendants Prior Market Approval (PMA) preemption arguments.

Bayer violated FDA conditions

According to the complaint, the FDA and the Department of Health cited Bayer and invalidated the CPMA for its failure to report results from Essure trial studies, including failure rates.  It also “actively conceal[ed] [eight] perforations” resulting from Essure implantations.

Bayer was also required to notify the FDA when it took ownership of Essure from its previous manufacturer, Conceptus.  Because of Bayer failing to meet the conditions of the CPMA order, the complaint states that the FDA found that Essure is an “adulterated” product that violates the FDA order if it is marketed or sold.

Product pushed on physicians without training

The complaint also alleges that Bayer was neglectful in its “unreasonably dangerous distribution plan” because it failed to provide training to physicians on the insertion method of the device.

In addition, Bayer provided the untrained physicians with specialized equipment, not approved by the FDA order, required to insert the device, even though the physicians were unqualified to use the specialized equipment.  In return for the equipment, the physicians were required to purchase at least two Essure kits per month, according to the complaint.

The case is WALSH v. BAYER CORP., et al case number 2:15 – cv-00384 in the First Judicial Court of Pennsylvania Court of Common Pleas.

This article is reprinted with permission from The National Trial Lawyers.

 

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Judges Call Conferences over Taxotere Cancer Drug that Causes Permanent Hair Loss

taxotere2A case management conference is scheduled for June 30, 2016, in US District Court for the Northern District of California in Oakland, in a product liability case against Sanofi S.A., charging that the Taxotere breast cancer drug causes unexpected, permanent and disfiguring hair loss in women.

Although hair loss is a common temporary side effect of chemotherapy drugs, permanent alopecia is not. Cases are proliferating that the Taxotere cancer drug causes permanent hair loss. Sanofi S.A. is a French multinational pharmaceutical company and as of 2013 is the world’s fifth-largest by prescription sales.

The California case is Ami Dodson v. Sanofi S.A, Case 4:16-cv-01251-PJH. US District Judge Phyllis J. Hamilton ordered that lead counsel shall confer and file a joint case management statement addressing jurisdiction and service, facts, legal issues, motions, amendment of pleadings and evidence preservation.

  • Defendant Sanofi S.A. is a corporation or Société Anonyme organized and existing under the laws of France, having its principal place of business in Paris, France.
  • Defendant Aventis Pharma S.A. is a corporation or Société Anonyme, having its principal place of business in Antony, France.
  • Defendant Sanofi-Aventis U.S. LLC has its principal place of business in Bridgewater, New Jersey 08807.

(In another case, Magistrate Judge Michael Watanabe has also scheduled a planning conference on June 30 in US District Court in Denver, Colorado. That case is Melissa Leith v. Sanofi, Case No. 16-cv-00741-MJW.)

Disfiguring permanent alopecia

Following a March 3rd, 2010 left breast biopsy, Dodson met with her oncologist to discuss further treatment. Neither she nor her treating healthcare providers were aware of or informed by defendants that disfiguring permanent alopecia can occur following treatment with Taxotere. Accordingly, she  underwent chemotherapy that included Taxotere. Following the completion of chemotherapy, Dodson suffered from disfiguring permanent alopecia as a result of receiving chemotherapy with Taxotere.

A study published in 2008 in the New England Journal of Medicine concluded that Taxol (paclitaxel) was more effective than Taxotere (docetaxel) for patients undergoing standard adjuvant chemotherapy with doxorubicin and cyclophosphamide. Despite the publication of these studies, Defendants continued to make false and misleading statements promoting the “superior efficacy” of Taxotere over the competing product paclitaxel Taxol.

Defendants’ statements in a “reprint carrier” marketing the conclusions of the 2005 JCO study were false and misleading in light of the 2007 and 2008 studies finding that Taxotere was not more effective than paclitaxel in the treatment of breast cancer. As a result of these false and misleading statements, in 2009, the FDA issued a warning letter to Sanofi-Aventis (the same company as Defendant Sanofi S.A. before SanofiAventis changed its name in 2011).

Defendants knew or should have known that the rate of permanent alopecia related to Taxotere was far greater than with other products available to treat the same condition as Defendants’ product. Permanent baldness (permanent alopecia) is a disfiguring condition, especially for women. Women who experienced disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including but not limited to loss of work or inability to work due to significant psychological damage.

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Volkswagen to Pay Up to $14.7 Billion to Settle for Deceiving Customers on Emissions

VW-Emissions-300x200Settlements Require VW to Spend up to $10 Billion to Buyback, Terminate Leases, or Modify Affected 2.0 Liter Vehicles and Compensate Consumers, and Spend $4.7 Billion to Mitigate Pollution and Make Investments that Support Zero-Emission Vehicle Technology  

In settlements with the Department of Justice, the State of California, and the U.S. Federal Trade Commission (FTC), German automaker Volkswagen AG has agreed to spend up to $14.7 billion to settle allegations of cheating emissions tests and deceiving customers. Volkswagen will offer consumers a buyback and lease termination for nearly 500,000 model year 2009-2015 2.0 liter diesel vehicles sold or leased in the U.S., and spend up to $10.03 billion to compensate consumers under the program. In addition, the companies will spend $4.7 billion to mitigate the pollution from these cars and invest in green vehicle technology.

The settlements partially resolve allegations by the Environmental Protection Agency (EPA), as well as the California Attorney General’s Office and the California Air Resources Board (CARB) under the Clean Air Act, California Health and Safety Code, and California’s Unfair Competition Laws, relating to the vehicles’ use of “defeat devices” to cheat emissions tests.  The settlements also resolve claims by the FTC that Volkswagen violated the FTC Act through the deceptive and unfair advertising and sale of its “clean diesel” vehicles. The settlements do not resolve pending claims for civil penalties or any claims concerning 3.0 liter diesel vehicles.  Nor do they address any potential criminal liability.

The affected vehicles include 2009 through 2015 Volkswagen TDI diesel models of Jettas, Passats, Golfs and Beetles as well as the TDI Audi A3.

Duping the regulators

“By duping the regulators, Volkswagen turned nearly half a million American drivers into unwitting accomplices in an unprecedented assault on our environment,” said Deputy Attorney General Sally Q. Yates.  “This partial settlement marks a significant first step towards holding Volkswagen accountable for what was a breach of its legal duties and a breach of the public’s trust.  And while this announcement is an important step forward, let me be clear, it is by no means the last.  We will continue to follow the facts wherever they go.”

“Today’s settlement restores clean air protections that Volkswagen so blatantly violated,” said EPA Administrator Gina McCarthy. “And it secures billions of dollars in investments to make our air and our auto industry even cleaner for generations of Americans to come. This agreement shows that EPA is committed to upholding standards to protect public health, enforce the law, and to find innovative ways to protect clean air.”

“Today’s announcement shows the high cost of violating our consumer protection and environmental laws,” said FTC Chairwoman Edith Ramirez. “Just as importantly, consumers who were cheated by Volkswagen’s deceptive advertising campaign will be able to get full and fair compensation, not only for the lost or diminished value of their car but also for the other harms that VW caused them.”

According to the civil complaint against Volkswagen filed by the Justice Department for EPA on January 4, 2016, Volkswagen allegedly equipped its 2.0 liter diesel vehicles with illegal software that detects when the car is being tested for compliance with EPA or California emissions standards and turns on full emissions controls only during that testing process.

Defeat device

During normal driving conditions, the software renders certain emission control systems inoperative, greatly increasing emissions. This is known as a “defeat device.”  Use of the defeat device results in cars that meet emissions standards in the laboratory, but emit harmful NOx at levels up to 40 times EPA-compliant levels during normal on-road driving conditions.  The Clean Air Act requires manufacturers to certify to EPA that vehicles will meet federal emission standards.  Vehicles with defeat devices cannot be certified.

The FTC sued Volkswagen in March, charging that the company deceived consumers with the advertising campaign it used to promote its supposedly “clean diesel” VWs and Audis, which falsely claimed that the cars were low-emission, environmentally friendly, met emissions standards and would maintain a high resale value.

The settlements use the authorities of both the EPA and the FTC as part of a coordinated plan that gets the high-polluting VW diesels off the road, makes the environment whole, and compensates consumers.

The settlements require Volkswagen to offer owners of any affected vehicle the option to have the company buy back the car and to offer lessees a lease cancellation at no cost. Volkswagen may also propose an emissions modification plan to EPA and CARB, and if approved, may also offer owners and lessees the option of having their vehicles modified to substantially reduce emissions in lieu of a buyback.  Under the U.S./California settlement, Volkswagen must achieve an overall recall rate of at least 85% of affected 2.0 liter vehicles under these programs or pay additional sums into the mitigation trust fund.  The FTC order requires Volkswagen to compensate consumers who elect either of these options.

Volkswagen must set aside and could spend up to $10.03 billion to pay consumers in connection with the buy back, lease termination, and emissions modification compensation program. The program has different potential options and provisions for affected Volkswagen diesel owners depending on their circumstances:

Buyback option: Volkswagen must offer to buy back any affected 2.0 liter vehicle at  their retail value as of September 2015 — just prior to the public disclosure of the emissions issue. Consumers who choose the buyback option will receive between $12,500 and $44,000, depending on their car’s model, year, mileage, and trim of the car, as well as the region of the country where it was purchased. In addition, because a straight buyback will not fully compensate consumers who owe more than their car is worth due to rapid depreciation, the FTC order provides these consumers with an option to have their loans forgiven by Volkswagen.  Consumers who have third party loans have the option of having Volkswagen pay off those  loans, up to 130 percent of the amount a consumer would be entitled to under the buyback (e.g., if the consumer is entitled to a $20,000 buyback, VW would pay off his/her loans up to a cap of $26,000).

EPA-approved modification to vehicle emissions system: The settlements also allow Volkswagen to apply to EPA and CARB for approval of an emissions modification on the affected vehicles, and, if approved, to offer consumers the option of keeping their cars and having them modified to comply with emissions standards.  Under this option in accordance with the FTC order, consumers would also receive money from Volkswagen to redress the harm caused by VW’s deceptive advertising.

Consumers who leased the affected cars will have the option of terminating their leases (with no termination fee) or having their vehicles modified if a modification becomes available.  In either case, under the FTC order, these consumers also will receive additional compensation from Volkswagen for the harm caused by VW’s deceptive advertising.  Consumers who sold their TDI vehicles after the VW defeat device issue became public may be eligible for partial compensation, which will be split between them and the consumers who purchased the cars from them as set forth in the FTC order.

Eligible consumers will receive notice from VW after the orders are entered by the court this fall. Consumers will be able to see if they are eligible for compensation and if so, what options are available to them, at VWCourtSettlement.com andAudiCourtSettlement.com. They will also be able to use these websites to make claims, sign up for appointments at their local Volkswagen or Audi dealers and receive updates.  Consumer payments will not be available until the settlements take effect if and when approved by the court, which may be as early as October 2016.

Emissions Reduction Program: The settlement of the company’s Clean Air Act violations also requires Volkswagen to pay $2.7 billion to fund projects across the country that will reduce emissions of NOx where the 2.0 liter vehicles were, are or will be operated. Volkswagen will place the funds into a mitigation trust over three years, which will be administered by an independent trustee.  Beneficiaries, which may include states, Puerto Rico, the District of Columbia, and Indian tribes, may obtain funds for designated NOx reduction projects upon application to the Trustee. Funding for the designated projects is expected to fully mitigate the NOx these 2.0 liter vehicles have and will emit in excess of EPA and California standards.

The emissions reduction program will help reduce NOx pollution that contributes to the formation of harmful smog and soot, exposure to which is linked to a number of respiratory- and cardiovascular-related health effects as well as premature death. Children, older adults, people who are active outdoors (including outdoor workers), and people with heart or lung disease are particularly at risk for health effects related to smog or soot exposure. NO2 formed by NOx emissions can aggravate respiratory diseases, particularly asthma, and may also contribute to asthma development in children.

Zero Emissions Technology Investments: The Clean Air Act settlement also requires VW to invest $2 billion toward improving infrastructure, access and education to support and advance zero emission vehicles. The investments will be made over 10 years, with $1.2 billion directed toward a national EPA-approved investment plan and $800 million directed toward a California-specific investment plan that will be approved by CARB.  As part of developing the national plan, Volkswagen will solicit and consider input from interested states, cities, Indian tribes and federal agencies. This investment is intended to address the adverse environmental impacts from consumers’ purchases of the 2.0 liter vehicles, which the governments contend were purchased under the mistaken belief that they were lower emitting vehicles.

FTC’s Injunctive Relief: The FTC settlement includes injunctive provisions to protect consumers from deceptive claims in the future.  These provisions prohibit Volkswagen from making any misrepresentations that would deceive consumers about the environmental benefits or value of its vehicles or services, and the order specifically bans VW from employing any device that could be used to cheat on emissions tests.

The provisions of the U.S./California settlement are contained in a proposed consent decree filed today in the U.S. District Court for the Northern District of California, as part of the ongoing multi-district litigation, and will be subject to public comment period of 30 days, which will be announced in the Federal Register in the coming days.  The provisions of the FTC settlement are contained in a proposed Stipulated Final Federal Court Order filed today in the same court.

To view the consent decree, visit: www.justice.gov/enrd/consent-decrees

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FDA Warns Public about Dangerous IVC Filter Side Effects

Bard Denali IVC Filter 2013
Bard Denali IVC Filter 2013

In a public safety communication, the U.S. Food and Drug Administration (FDA) says it has received approximately 920 adverse event reports related to the use of IVC filters, It issued a public report to inform medical professionals and patients about the potential risks associated with using the small, cage-like device. Adverse events reported by the FDA include:

  • Filter fracturing of the device
  • Migration of the pieces
  • Embolization of fractured device or device components
  • Tearing of the inferior vena cava vein.

Cordis IVC Filter Litigation is consolidated in California State Court. Bard IVC Filter Litigation is consolidated in MDL 2641. Cook Medical IVC Filter Litigation is consolidated in MDL 2570.

There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” said Mass Tort Consultant John Ray.

According to one of the many product liability cases filed against IVC Filter manufacturers:

“Defendants knew or should have known that its Cook Filter when used as expected and intended, had the possibility of shifting, breaking free its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death to patients.”

The case is Olenda Homes et al. v. Cook Medical Inc. et al. (Case No. 5:16-cv-00066).

Patients who cannot use traditional blood-thinning drugs are usually the typical users of IVC filters. The devices are surgically implanted into a patient’s inferior vena cava vein and are designed to catch blood clots from the legs before they migrate to the heart and lungs, which could cause a pulmonary embolism if it reached these important organs. The filters are meant to only be used temporarily, according to the FDA, and hold the clot until it naturally disappears and until the threat of blood clots is no longer an issue.

IVC filters have come under more intense scrutiny and have been the subject of many lawsuits due to allegations that they have fractured with pieces subsequently migrating away from the original insertion point to other parts of the body. The pieces can tear veins and organs, and embed in other “high risk” areas of the body where they cannot be surgically removed, thus causing significant and long-term risks for the patient.

In its report, the FDA identifies a number of potential symptoms of migrating pieces that patients should be on guard for that include out of the ordinary heart rhythms, dizziness, fainting, heart palpitations, and chest pain.

 

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Judge Campbell Pushes Bard IVC Filter Litigation Forward in Arizona

bard-ivc-filter-lawsuit-2Issuing several orders about discovery and trial dates, US District Judge Dennis G. Campbell is pushing forward C.R. Bard IVC Filter Litigation in MDL 2641 consolidated in Arizona federal court.

Product liability and injury lawsuits filed against Bard, Cordis and other retrievable IVC filter makers allege that these companies knew or should have known that the devices were defective because:

  • The defendants failed to conduct appropriate testing, including human clinical testing, to determine how the devices actually functioned in the body.
  • Published medical studies have found many complications including fracture, device migration, perforation of the vena cava wall, organ penetration, and increased risk for venous thrombosis.
  • The defendants misrepresented the risks with retrievable ICVs and failed to issue appropriate safety warnings to patients and physicians.

At least 27 deaths have been associated with Bard’s Recovery filter — a spider-shaped apparatus that is inserted into the largest vein in the body — over the course of a decade. Government data shows about 300 other non-fatal problems have also been reported with the Recovery.

Even as death and injury reports were climbing, the company decided not to recall the Recovery. Instead, Bard sold about 34,000 of them for nearly three years before replacing them with a modified version with a new name, G2.

Discovery schedule

Following the fourth Case Management Conference, the court set time, place and manner limitations on depositions. In one order on June 21, the court said, “Any Federal Rule of Civil Procedure and/or Local Rule purporting to limit the number of depositions shall not apply in this MDL proceeding. If either side believes that the other is taking unnecessary or irrelevant depositions they may bring the issue to the Court for appropriate resolution.”

In a second order on June 21, Judge Campbell reaffirmed the October 28, 2016 fact discovery deadline. He said he will consolidate a recently-filed a medical monitoring class action, Barraza, et al. v. CR Bard, Inc., et al., Case No. CV-16-1374-PHX-DGC (D. Ariz. May 5, 2016).

The next Case Management Conference on August 23, 2016 in Phoenix.

The FDA issued a warning letter one year ago citing Bard with a number of violations and their failure to warn of complications from their IVC filter. It charged that:

  • The company misfiled consumer complaints, including a death, and manufactured its Recovery Cone Removal System Model RC-15 without first receiving marketing clearance or approval, which violates federal law.
  • Bard failed to tell the FDA about medical device malfunctions, and filing complaints as malfunctions that should have been filed as serious injuries.
  • Until the company correct the violations, the FDA will not clear or approve any premarket submissions for high-risk Class III medical devices “to which the non-conformances are reasonably related.”

Cases set for trial

The court also set several cases for trial:

  • By June 29, 2016, the parties will exchange of lists identifying 24 representative cases each selected from the Initial Plaintiff Pool. Those 48 cases will constitute Discovery Group 1.
  • By December 9, 2016, the parties will exchange lists of 10 cases selected from Group 1. The parties can each designate 4 cases on those lists for automatic inclusion in Discovery Group 1. After exchange of lists, the parties will confer to name the remaining 4 additional cases that will be included in Discovery Group 1.
  • By December 16, 2016, the parties will complete submit a list of twelve 12 cases they jointly recommend as Discovery Group 1.
  • By March 1, 2017, the parties will exchange lists of 6 proposed selections from Discovery Group 1 for bellwether plaintiffs. The parties will confer to agree upon a group of 6 cases to constitute Bellwether Group 1.
  • After this group is confirmed, trial dates will be set.

 

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Novartis Added as Defendant in Zofran Mass Tort Litigation

Zofran birth defect
When pregnant women take Zofran, it leads to birth defects. Novartis has been aware of this since before it began selling Zofran.

In an important new development, the federal court in Massachusetts where Zofran birth defects lawsuits are docketed, has added Novartis Pharmaceuticals Corporation as a defendant. More than 260 cases are pending against Novartis and GlaxoSmithKline.

The lawsuits are consolidated before Judge Dennis Saylor in MDL2657,  Zofran (Ondansetron) Products Liability Litigation.

The Master Long Form Complaint and Jury Demand state:

Effective March 23, 2015, Novartis AG, a Switzerland company, acquired GlaxoSmithKline PLC’s oncology business, including the right to sell Zofran products in the US. On March 23, 2015, Novartis Pharmaceuticals Corporation, a US corporation and subsidiary of Novartis AG, became the NDA holder for Zofran. On March 23, 2015, Novartis assumed responsibility for maintaining the content of Zofran’s labeling in the US, including warnings and precautions attendant to its use.

Until GSK’s sale of its Zofran business to Novartis, GSK designed, manufactured, marketed and, sold Zofran. After the sale, GSK continued to manufacture Zofran for sale in the US by Novartis, and it became involved in the research, manufacture, testing, packaging, labeling, advertising, promoting, marketing, and selling of Zofran in the United States.

Novartis is a Delaware corporation headquartered in East Hanover, NJ and it conducted business throughout the US. The company has derived substantial revenue from pharmaceutical sales throughout the US, including Zofran.

In connection with its acquisition of Zofran from GSK, Novartis gained knowledge of the false and misleading promotion of Zofran for treating pregnancy-related nausea, sometimes called morning sickness, and of the risks of prenatal exposure to Zofran. Novartis had a duty and continues to have a duty to warn adequately and to correct GSK’s misrepresentations and has failed to do so.

Zofran is a prescription drug indicated only for preventing chemotherapy-induced nausea and vomiting, radiation therapy-induced nausea and vomiting, or post-operative nausea and vomiting. Drugs that prevent or treat such nausea and vomiting are called anti-emetics. Zofran is part of a class of anti-emetics referred to as selective serotonin 5-HT3 receptor antagonists.

Among patients who ingested Zofran, the drug has caused sometimes fatal cardiac arrhythmias such as:

  • QT prolongation and Torsade de Pointes
  • Serotonin syndrome
  • Disruption of signaling pathways through neurotransmitters other than serotonin.

Defendants have been aware of these facts at all relevant times, but they have failed to tell healthcare providers, their patients, or the public of the impact of these potentially life-threatening conditions on the developing embryo and fetus.

In 1991, Zofran became the first 5-HT3 receptor antagonist approved for marketing in the US. Defendants have never applied for FDA approval of Zofran for treating pregnancy-related nausea or vomiting. Neither the safety nor efficacy of Zofran for treating pregnancy-related nausea or vomiting has been established.

With more than 6 million annual pregnancies in the US since 1991 and an estimated 70-85% incidence of pregnancy-related nausea, GSK had an extremely lucrative business opportunity to create a new market for Zofran. GSK seized that opportunity, but the effect of its conduct was tantamount to experimenting with the lives of unsuspecting mothers-to-be and their children throughout the US.

As early as January 1997, despite available evidence showing that Zofran presented an unreasonable risk of harm to babies exposed to Zofran prenatally, GSK launched a marketing scheme to promote Zofran to obstetrics and gynecology healthcare practitioners and consumers as a safe and effective treatment for pregnancy-related nausea and vomiting. In support of its misleading marketing efforts, at least as early as January 1997, GSK offered and paid substantial pay to healthcare providers and “thought leaders” to induce them to promote and prescribe Zofran to treat morning sickness.

GSK’s Zofran sales representatives received incentive-based compensation that included an annual salary and a quarterly bonus. The bonus amount was determined by each sales representative’s performance in the relevant market and whether the representative attained or exceeded quarterly sales quotas. The more Zofran sold by a GSK sales representative or prescribed by a provider in that representative’s sales territory, the greater the compensation and incentives.

As a result of GSK’s fraudulent marketing campaign, the precise details of which are uniquely within the control of GSK, Zofran achieved blockbuster status by 2002 and became the most frequently prescribed drug for treating morning sickness in the United States. In 2002, sales of Zofran in the United States reportedly totaled $1.1 billion.

GSK’s promotion of Zofran for use in pregnancy eventually led to a federal governmental investigation. On July 2, 2012 the U.S. Department of Justice announced that GSK “[a]greed to plead guilty and pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs,” which included Zofran, among numerous others.

Part of GSK’s civil liability to the government included payments arising from claims that GSK: (a) promoted and disseminated false representations about the safety and efficacy of Zofran concerning pregnancy-related nausea; and (b) paid and offered to pay illegal remuneration to healthcare professionals to induce them to promote and prescribe Zofran for this purpose.

Since before Zofran entered the U.S. market, GSK has known that serotonin also regulates developmental processes that are critical to proper embryonic development. Impeding serotonin signaling during embryonic development can increase the risk of developmental insult. GSK has likewise known that, when Zofran is taken, its established side effects in adults can also occur in embryos and fetuses, leading to birth defects. Novartis has been aware of these facts since before it began selling Zofran.

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FDA strengthens kidney warnings for diabetes medicines Invokana, Invokamet, Farxiga and Xigduo XR

invokana-warning kidney-damageThe U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, it has revised the warnings in the drug labels for these SGLT2 Inhibitors to include information about acute kidney injury and added recommendations to minimize this risk.

Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful.

Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include:

  • Decreased blood volume
  • Chronic kidney insufficiency
  • Congestive heart failure
  • Taking other medications such as:
    • diuretics
    • blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors
    • angiotensin receptor blockers (ARBs)

Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

101 cases of acute kidney injury

From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. This number includes only reports submitted to FDA, so there are likely additional cases about which the FDA is unaware. In approximately half of the cases, the events of acute kidney injury occurred within 1 month of starting the drug, and most patients improved after stopping it. Some cases occurred in patients who were younger than 65 years. Some patients were dehydrated, had low blood pressure, or were taking other medicines that can affect the kidneys.

The leading case is Arthur Portnoff V. Janssen Pharmaceuticals, Inc., Janssen Research and Development, LLC, Johnson & Johnson Co., and Mitsubishi Tanabe Pharma Corp., Case ID: 151200653, filed In the Philadelphia Court of Common Pleas.

Portnoff, of Beaumont, Texas, has taken the prescription drug Invokana, which is a member of the gliflozin class of pharmaceuticals, also known as sodium glucose co-transporter 2 (“SGLT2”) inhibitors. SGLT2 inhibitors inhibit renal glucose reabsorption through the SGLT2 receptor in the proximal renal tubules, causing glucose to be excreted through the urinary tract. This puts additional stress on the kidneys in patients already at risk for kidney disease.

While taking Invokana in Philadelphia, Pennsylvania, Portnoff developed diabetic ketoacidosis on or about February 20, 2015, as a result of treatment with Invokana, and was hospitalized at Hahnemann University Hospital in Philadelphia. As a result of his development of diabetic ketoacidosis, he  developed serious complications which required multiple days of hospitalization. Portnoff has endured pain and suffering, emotional distress, loss of enjoyment of life, and economic loss, including significant expenses for medical care and treatment which will continue in the future.

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3M Lawyers Intimidate Bloggers who Report about Bair Hugger Surgical Blankets

bair-hugger-infectionIn an effort to stifle free discussion about the Bair Hugger surgical blanket, attorneys for 3M are sending threatening takedown demands to bloggers who write about the litigation involving the medical device.

There are so many product liability cases against 3M, maker of the blanket, that the federal courts created MDL 2666 (multi-district litigation docket) in US District Court in Minnesota. The cases charge 3M with wrongful conduct in designing, manufacturing, and marketing a defective product.

More than 50,000 Bair Hugger units are currently in use across the country. About 217 Bair Hugger lawsuits are now pending in the MDL, all filed by hip and knee replacement patients who allegedly developed serious post-operative deep joint infections due to the use of the forced air warming blanket during their surgery.

Promoting a defective product?

For example, according to the lawsuit Tracy Adams Crawford v. 3M Company, CASE 0:15-cv-03777:

The hot air produced by Bair Hugger accumulates under the surgical drape covering the patient and escapes from under the surgical drape below the level of the surgical table or at the head end of the surgical table. This escaped air creates air flow currents that flow against the downward air flow of the operating room. As this warmed air rises, it can deposit bacteria from the floor of the surgical room into the surgical site.

In a June 1997 letter to the Food and Drug Administration (“FDA”), the 3M admitted that “air blown intraoperatively across the surgical wound may result in airborne contamination.” Defendants addressed this flaw in their products by making further misrepresentations to the FDA.

Rather than alter the design of their product or warn physicians of the dangers associated with the Bair Hugger, as numerous studies confirm, Defendants have chosen to “double down” on their efforts to promote their defective product.

Cheap intimidation tactic

Recipients of the 3M letter consider it a cheap intimidation tactic designed to violate free speech rights. The letters say:

We are writing because your organization, through its website and other channels, is making blatantly false advertising claims in an effort to generate leads for attorneys interested in pursuing claims against the 3M™ Bair Hugger™ patient warming blanket. These advertisements are damaging the goodwill and reputation of our client.

These claims violate various state and federal laws, including the Lanham Act; Section 5 of the FTC Act; state and common law product disparagement, unfair competition, and consumer protection laws; and attorney advertising ethics regulations.

Therefore, we hereby demand that your organization immediately cease sponsoring these advertising claims, and any others that make false or misleading claims about the Bair Hugger system.

Despite the mounting litigation, 3M argues, “there are numerous studies confirming the safety of the Bair Hugger system and its effectiveness in reducing surgical bleeding, decreasing post-operative heart attacks, reducing the risk of infection, shortening the recovery time, and improving patient comfort.”

Attorneys who have a client who was injured by a Bair Hugger blanket may find sample product liability complaints online at Mass Tort Nexus.

For further reading see Study: Contamination Increased 2000x With Bair Hugger Warming

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$54 M Settlement against Salix Pharma for “Speaker Programs” Used to Pay Kickbacks to Doctors

$54 M Settlement against Salix Pharma for “Speaker Programs” Used to Pay Kickbacks to DoctorsFederal law enforcement agencies announced a $54 million settlement against Salix Pharmaceuticals for using “speaker programs” to pay kickbacks to doctors so they would prescribe company drugs and medical devices.

The scam violated the federal Anti-Kickback Statute and False Claims Act. Big Pharma is a corrupt industry that has often been nailed for paying kickbacks and committing fraud to bloat their profits:

Amgen $762 million Aranesp 2012
AstraZeneca $520 million Seroquel 2010
Bristol-Myers Squibb $515 million Abilify, Serzone 2007
GlaxoSmithKline $3 billion Avandia, Wellbutrin, Paxil, Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex; 2012
Johnson & Johnson $2.2 billion Risperdal, Invega, Nesiritide 2013
Merck $650 million Zocor, Vioxx, Pepsid 2008
Novartis $423 million Trileptal 2010
Pfizer $2.3 billion Bextra, Geodon, Zyvox, Lyrica 2009
Schering-Plough $435 million Temodar, Intron A, K-Dur, Claritin RediTabs 2006
Serono $704 million Serostim 2005
TAP Pharmaceutical Products $875 million Lupron 2001

Sham speaker programs

Announcing the settlement were the US Attorney for the Southern District of New York, the U.S. Department of Health and Human Services, the Office of Inspector General’s New York Region, and the FBI.

Salix held sham speaker programs, often at high-end restaurants (such as Nobu and Le Bernardin in New York City), with per-person costs exceeding $300. The doctors got substantial speaker fees at fake continuing medical education (CME) programs and spent little or no time discussing the product.

Under the settlement, Salix must pay about $46.53 million to the federal government plus $7.47 million to resolve the state law civil fraud claims.

“Salix found a way to pay doctors money and treated them to fancy meals to push their drugs.  With today’s settlement, Salix has taken responsibility for its conduct and agreed to pay a significant financial penalty.  This is part of our continuing effort to pursue health care providers who put their profits ahead of patient safety,” said Manhattan U.S. Attorney Preet Bharara.

FBI Assistant Director-in-Charge Diego Rodriguez said, “The simple idea behind the pitch eats away at the faith patients have in their doctors to put their health and wellbeing above the interests of a corporation.”

Salix is a specialty pharmaceutical company based in Raleigh, North Carolina, that sells products used to treat various gastroenterology conditions. From January 2009 to December 2013, Salix’s speaker programs for Xifaxan, Apriso, Relistor, MoviPrep, OsmoPrep, Solesta, and Deflux were nothing more than social events where Salix wined and dined doctors to induce them to write prescriptions for these products.

Doc-in-the-box programs

At many of its speaker programs, Salix repeatedly invited the same doctors, who often were from the same practice or otherwise knew each other, to attend the same program on the same topic. In pre-recorded programs – which Salix staff called “doc-in-the-box programs” – the pre-recorded video often was not played or was intentionally played in a way so it could be ignored.

Many of these doctors increased their prescription-writing for Salix drugs after becoming speakers or repeatedly attending sham speaker programs. Salix spent about $25 million on speaker payments and meals.

Salix admitted and accepted responsibility for the following conduct:

  • The speaker programs were an important part of Salix’s strategy for increasing sales of its drugs. The company conducted about 10,000 speaker programs, including about 8,000 programs alone for Xifaxan, Apriso and Relistor.
  • Speaker honoraria payments ranged from $250 (for a doctor available on call to answer questions) to $4,500 (for a doctor who spoke at an in-person program). Salix paid more than 500 physicians honoraria for serving as speakers about their products, with dozens of physicians earning more than $50,000, and several earning more than $100,000.

The government joined two private whistleblower lawsuits that had previously been filed under seal pursuant to the False Claims Act.

 

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FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

Gambling alcohol sad despairThe U.S. Food and Drug Administration is warning that uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada and generics).

These uncontrollable urges stopped when the medicine was discontinued or the dose was reduced.

Current drug labels do not entirely show the nature of the impulse-control risk. “These compulsive behaviors can affect anyone who is taking the medicine. As a result, we are adding new warnings about these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products,” the FDA says.

Minnesota case

Litigation is active against manufacturers Bristol-Myers Squibb, Otsuka Pharmaceutical Co., Ltd., and Otsuka America Pharmaceutical, Inc. In a case filed by Denise and Brad Miley in federal court in Minnesota, CASE 0:16-cv-00067, Denise Miley took Abilify and as a result developed compulsive gambling behaviors. She began taking Abilify in September 2014, began compulsively gambling shortly thereafter, and stopped gambling soon after she stopped taking the drug.

The drug companies do not warn Abilify users or prescribers in the United States about the risk of compulsive gambling or other compulsive behaviors.

Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are taking aripiprazole. “Closely monitor patients with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors,” the FDA said.

Aripiprazole is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autistic disorder. It may also be used in combination with antidepressants to treat depression. Aripiprazole can decrease hallucinations and other psychotic symptoms such as disorganized thinking. It can stabilize mood, improve depression, and decrease the tics of Tourette’s disorder.

184 reports of impulse-control problems

In the 13 years since the approval of the first aripiprazole product (Abilify) in November 2002, the FDA identified a total of 184 case reports where there was an association between aripiprazole use and impulse-control problems.

  • There were 167 U.S. cases, which included adults and children.
  • Pathological gambling was the most common (164 cases), but other compulsive behaviors including compulsive eating, spending or shopping, and sexual behaviors were also reported.

Approximately 1.6 million patients received an aripiprazole prescription from U.S. outpatient retail pharmacies during 2015.

“We strongly advise health care professionals, patients, and caregivers to report side effects involving aripiprazole (Abilify, Abilify Maintena, Aristada) and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page,” the FDA said.

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