Lamictal (lamotrigine) Emerging Litigation – By GlaxoSmithKline plc

Lamictal Emerging Litigation a Drug Made By GlaxoSmithKline plc

By Mark A. York (May 8, 2018)

Emerging Litigation: Lamictal (lamotrigine)

(MASS TORT NEXUS MEDIA) Lamotrigine was approved in 1994 and is available under the brand name Lamictal (GlaxoSmithKline) and in generic forms. Since approval 24 years years ago, the FDA has identified eight cases (two in the United States and six abroad) of confirmed or suspected HLH associated with lamotrigine in children and adults. The FDA has stated “there are likely many more additional cases” that they are unaware of, based on lack of information and awareness of the adverse events.

The anticonvulsant medication lamotrigine can cause the rare but serious immune system reaction hemophagocytic lymphohistiocytosis (HLH), the US and Food and Drug Administration said today in a safety communication.  

The FDA said a warning about the risk for HLH will be added to the prescribing information on lamotrigine drug labels.

Lamotrigine is used alone or with other medicines to treat seizures in patients age 2 years and older. It is also indicated for maintenance treatment in patients with bipolar disorder to help stave off mood episodes (depression, mania or hypomania, and mixed episodes).

HLH is a hyperinflammatory syndrome that can lead to hospitalization and death, especially if not diagnosed and treated quickly. Diagnosis is often complicated because early signs and symptoms, such as fever and rash, are not specific, the FDA notes.  HLH may also be confused with other serious immune-related adverse reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS).

To Learn More About the Emerging Lamictal Litigation:

The emerging Lamictal Litigation will be used as a case study in the May 18 to 21, 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

FDA LAMICTAL DRUG SAFETY COMMUNICATION

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm605628.htm

Lamictal (lamotrigine): Drug Safety Communication – Serious Immune System Reaction

Posted April 25, 2018

AUDIENCE: Health Professional, Patient, Pharmacy

ISSUE: The FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.

BACKGROUND: The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system. HLH typically presents as a persistent fever, usually greater than 101°F, and it can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.

Lamotrigine is used alone or with other medicines to treat seizures in patients two years and older. It may also be used as maintenance treatment in patients with bipolar disorder to help delay the occurrence of mood episodes such as depression, mania, or hypomania. Stopping lamotrigine without first talking to a prescriber can lead to uncontrolled seizures, or new or worsening mental health problems. Lamotrigine has been approved and on the market for 24 years, and is available under the brand name Lamictal and as generics.

RECOMMENDATION: Healthcare professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality. Diagnosis is often complicated because early signs and symptoms such as fever and rash are not specific. HLH may also be confused with other serious immune-related adverse reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Evaluate patients who develop fever or rash promptly, and discontinue lamotrigine if HLH or another serious immune-related adverse reaction is suspected and an alternative etiology for the signs and symptoms cannot be established. Advise patients to seek immediate medical attention if they experience symptoms of HLH during lamotrigine treatment. A diagnosis of HLH can be established if a patient has at least five of the following eight signs or symptoms:

  • fever and rash
  • enlarged spleen
  • cytopenias
  • elevated levels of triglycerides or low blood levels of fibrinogen
  • high levels of blood ferritin
  • hemophagocytosis identified through bone marrow, spleen, or lymph node biopsy
  • decreased or absent Natural Killer (NK) Cell activity
  • elevated blood levels of CD25 showing prolonged immune cell activation

Patients or their caregivers should contact their health care professionals right away if they experience any symptom of HLH while taking lamotrigine. HLH can occur within days to weeks after starting treatment. A physical examination and specific laboratory blood tests and other evaluations are used to diagnose HLH. Signs and symptoms of HLH include but are not limited to:

  • fever
  • enlarged liver; symptoms may include pain, tenderness, or unusual swelling over the liver area in the upper right belly
  • swollen lymph nodes
  • skin rashes
  • yellow skin or eyes
  • unusual bleeding
  • nervous system problems, including seizures, trouble walking, difficulty seeing, or other visual disturbances

FDA LAMICTAL WARNING PODCAST

FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)

https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm606094.htm

Lamictal Podcast Transcript:

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On April 25, 2018, FDA warned that the medicine lamotrigine (brand name Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.

The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system and typically presents as a persistent fever, usually greater than 101°F. HLH can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.

Lamotrigine is used alone or with other medicines to treat seizures in patients two years and older. It may also be used as maintenance treatment in patients with bipolar disorder.

Health care professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality. Diagnosis is often complicated as early signs and symptoms such as fever and rash are not specific. HLH may also be confused with other serious immune-related adverse reactions. Evaluate patients who develop fever or rash promptly, and discontinue lamotrigine if HLH or another serious immune-related adverse reaction is suspected and an alternative etiology for the signs and symptoms cannot be established.

Since lamotrigine’s 1994 approval, FDA identified eight cases worldwide of confirmed or suspected HLH associated with the medicine in children and adults. This number includes only reports submitted to FDA and found in the medical literature, so there are likely additional cases about which we are unaware. We determined there was reasonable evidence that lamotrigine was the cause of HLH in these eight cases based on the timing of events and order in which they occurred. These patients required hospitalization and received drug and other medical treatments, with one dying.

Side effects involving lamotrigine should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications.

If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

 

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While Big Pharma “Off-Label” Drug Marketing Continues – FDA Does Nothing

By Mark A. York (April 24, 2018)

“BY REMOVING FDA OVERSIGHT BIG PHARMA RUNS AMOK”

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In 2017 and continuing into 2018, Big Pharma has been fighting major legal battles related to off-label marketing of drugs for unintended uses. They also engaged in a parallel strategy, where they were influencing the FDA and other policy making agencies behind the scenes in Washington DC. Big Pharma was paying millions to lobbyists, making campaign donations and generally buying influence as they always have. It was a foregone conclusion that with the Trump administration view of , “no regulatory oversight required” that there would be some loosening of the FDA regulatory shackles.

Big Pharma was getting ready for freedom to sell, sell, sell their drugs in any way they could, including off-label marketing of the drugs for unintended use purposes. A corporate policy, that’s technically illegal, yet results in billions of dollars in profits every years for Big Pharma. Then the FDA rolled out an unexpected new proposed rule, in March 2017 cracking down on “off-label’ marketing of drugs. This new rule change wasn’t in Big Pharma’s bests interests, sending the drug industry into a furious lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials that were recruited, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

Trump stops FDA enforcement rule change: January 12, 2018 Food and Drug Administration Press Release: FDA Delays Change to “Off-Label” Drug Use Enforcement Rules

This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Dept. of Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this rule delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.

To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.

When the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.

In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.

Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.

The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses.  The FDA will receive comments on this proposal through February 5, 2018.

Here is the official FDA publication of January 16, 2018:

The Federal Register:  https://www.federalregister.gov/documents/2018/01/16/2018-00555/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

WHAT IS “OFF-LABEL” MARKETING?

Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” stated Eric Holder, then US Attorney General, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud.  And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people” he added.

The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.

“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West.  “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”

The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information.  Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA.  Before approval, the FDA must determine that the drug is safe and effective for those specified uses.  Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded.  The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth.  “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health.  The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

 J&J RISPERDAL MARKETING ABUSE

In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities.  The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.

“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger.  “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”

In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.”  The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”

The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks.  For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events.  A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”

The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).”  When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.

The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly.  In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.”  The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.

In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities.  The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production.  Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients.  Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism.  Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.

The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal.  Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.

In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen.  Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.

As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega.  This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal.  Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments.  The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million.  The federal government and Texas each received $59 million from the Texas settlement.

NURSING HOME PATIENT ABUSES BY J&J

The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients.  In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.”  These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes.  Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients.  Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”

J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs.  The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million.  In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.

“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz.  “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”

OFF-LABEL USE OF HEART DRUG NATRECOR

The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor.  In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity.  This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.

In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs.  These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.

The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug.  Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor.  Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.

As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor.  In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.

“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch.  “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”

Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement

In addition to the criminal and civil resolutions, J&J executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG).  The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business.  Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct.  J&J may recoup monies from executives who are current employees and from those who have left the company.  The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians.  On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA.  J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.

“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson.  “Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management.  The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing.”

FEDERAL AND STATE JOINT CRIMINAL INVESTIGATIONS

This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud.  Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.

The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch.  The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch.  Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.

This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.

One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.

The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act.  Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.

The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery.  From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million.  Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability

With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States.  The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, wont change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.

 

 

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$35 Million In Punitives Added To Bard TVM Trial Verdict in NJ Court

“TOTAL VERDICT OF $68 MILLION IN SYNTHETIC SURGICAL MESH TRIAL”

Mark A. York (April 18, 2018)

SYNTHETIC MESH COMPANIES FACING THOUSAND OF LAWSUITS

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) C.R. Bard, Inc. was ordered to pay an additional $35 million in punitive damages, added to the $33 million the jury initially award for a total of verdict of $68 million in the first Transvaginal Mesh trial for Bard in New Jersey state court. Plaintiff Mary McGinnis was successful in her claims that Bard’s synthetic vaginal mesh implants are defective, asserting that Bard defectively designed the product, ignored warnings and related FDA notices about the numerous adverse events related to their synthetic surgical mesh products.

Bard, a subsidiary of global medical supplier Becton-Dickinson of Franklin Lakes, says it will appeal the verdict. In a statement, the company said McGinnis knew of the inherent risks in having the vaginal implants. This case docket can be found under Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The punitive damage award was added after the initial $33 million verdict was returned and the judge set a hearing to address the punitive damages award. The jury decided that there were grounds to award plaintiff Mary McGinnis and her husband the large verdict based on trial testimony and evidence that Bard was aware of the mesh product dangers and chose to ignore the thousands of adverse events reported related to post-surgery complications claimed by women across the country.

The Bard synthetic mesh products are designed to provide pelvic support for any number of medical issues primarily affecting women, with synthetic mesh recognized as often causing major medical complications and leaving patients in permanent pain. The jury held the company liable for two products that McGinnis had implanted in March of 2009: an Avaulta Solo mesh, and an Align Transobturator and Bard was forced to concede that both products have been taken off the market.

The verdict comes as Murray Hill, New Jersey-based Bard is pushing to a flood of litigation its surgical mesh implants , which have been criticized by women for damaging internal and often affecting or stopping normal sex lives. Bard has settled more than 13,000 cases since 2014, and as of September 2017, the company still faced more than 3,000 suits over allegedly defective synthetic mesh devices still in litigation. Those cases are part of the Bard-TVM-Litigation-MDL-2187 Briefcase, in front of Judge Goodwin, US District Court of West Virginia.  While Bard still faces another 150 lawsuits in New Jersey state court, which previously had been perceived as a favorable home court legal venue by the company.

McGinnis alleged Bard’s Avaulta and Align implants shrank after being implanted, causing nerve damage and leaving her unable to engage in sexual activity and that she was forced to undergo four surgeries in attempts to remove all the mesh from her body.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market.J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Bard has been accused in many lawsuits of using a form of polypropylene mesh in the devices, that their mesh supplier and manufacturer had warned wasn’t suitable for human implantation. Bard officials countered that the mesh was a safe substance from which to make the inserts, ignoring the safety sheet warning issued by the polypropylene mesh product maker.

Last year, C.R. Bard was acquired by medical-device company Becton, Dickinson & Co. $24 billion, combining two of the world’s biggest health-care suppliers.  How the thousands of remaining mesh lawsuits affect the company business model and potentially moves them towards serious settlement discussions remains to be seen.

This case can be found at: Mary McGinnis v. C.R. Bard, Inc., Docket No.: BERL1754314, Bergen County, New Jersey Superior Court (Hackensack).

 

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DePuy Pinnacle Plaintiffs Request Cases Be Remanded For Trial in Hip Implant MDL 2244

Plaintiffs Request Remaining Pinnacle MDL 2244 Cases Be Remanded For Trial 

Mark A. York (February 9, 2018)

A DePuy Pinnacle Hip Implant Component

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Plaintiffs have asked U.S. District Court Judge Ed Kinkeade, Northern District of Texas, who’s hearing thousands of hip implant lawsuits in the DePuy Orthopaedics’ Pinnacle Hip MDL 2244, to remand their cases to the original court of filing for individual trial dates.

According to the February 5th motion filed with the U.S. District Court, plaintiffs request the Court begin an “orderly and efficient staggered remand process,” where both plaintiffs and defense would select 10 cases each for remand to federal courts in California, New York and Texas, for a total of 60 cases being set for trial starting in 2019.

There were further requests that the Court begin not only the remand process, but start phased MDL discovery as well in peripherally related cases alleging RICO, qui tam and other non-personal injuries as part of the metal-on-poly hip revision lawsuits currently pending in the multidistrict litigation.

DePuy Pinnacle Implants and Metallosis

DePuy Orthopaedics,  a subsidiary of Johnson & Johnson, have been named in more than 9,500 hip replacement lawsuits involving the metal-on-metal Pinnacle hip system, which utilizes the Ultamet liner, pending in the multidistrict litigation (see DEPUY MDL 2244 Pinnacle Hip Implant Briefcase) currently underway in the Northern District of Texas.

Plaintiffs allege that the metal-on-metal design within the Ultamet liner configuration can cause dangerous amounts of toxic metal debris to be released into the joint surround the hip, and into the blood stream resulting in metallosis, causing adverse local tissue reactions, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the DePuy hip implant components.

 DePuy/J&J Loses Bellwether Trials

So far, the Pinnacle hip MDL 2244 litigation has convened four bellwether trials related to the metal-on-metal implants with the trial in October 2014, ending with a verdict for DePuy and Johnson & Johnson, which to date, is the only defense win in this litigation.

In the second trial, plaintiffs were awarded a verdict of $500 million in March 2016, however, Judge Kinkeade ultimately reduced the award to $151 million, based on Texas statutes that limit punitive damages. The third bellwether trial ending in December 2016, resulted in a massive billion dollar verdict, when six Pinnacle recipients who were residents of California were awarded more than $1 billion, with 90 percent of the verdict being punitive in nature, meant to send a clear message to the defendants. California does not have a limit on punitive damages, but the judge reduced the award to $543 million, based on the US Supreme Court ruling limiting excessive punitive damages. The most recent trial resulted in the plaintiff being awarded $247 million in November 2017.

J&J Wants To Avoid More Massive Verdicts

J&J are simply using every legal tool available to them, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip  trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to its various medical device and pharmaceutical product lines.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials. Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the Pinnacle hip system. The New York Times stated that the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

Artificial hips are designed to last for 15 years in the best of situations, often that is not the case with many implants failing after just 10 years, and in the case of design defects such as those alleged in Pinnacle devices and many other hip implants, onset of metallosis and other adverse conditions resulting, as well as the ever present implant mechanical breakdown, which cause life altering health problems for patients.

FDA Issues Pinnacle Warning

The U.S. Food & Drug Administration issued a warning in January 2013, stating that patients receiving metal-on-metal hip replacements were more likely to experience premature device failure compared to those who received other types of implants.

In November 2013, DePuy Orthopaedics announced a $2.5 billion settlement in the DePuy ASR Hip Impant MDL2197 ( MDL 2197 DePuy Orthopaedics, Inc. ASR Hip Implant Briefcase), related to the ASR line of metal-on-metal hip implant components. DePuy ended sales of the all-metal Pinnacle hip system that same year, purportedly due to “low clinician use”. However, the company has so far declined to settle the Pinnacle hip litigation.

J&J Facing Many Legal Hurdles

Johnson & Johnson has been hit with numerous large jury verdicts across all areas of the J&J pharmaceutical and medical device operations, with plaintiff trial verdicts Risperdal, Ethicon TVM, Talcum Powder, Xarelto and other products, where recent combined trial verdicts have easily exceeded an additional $200 million. J&J and it’s subsidiaries are now facing more than 100 thousand lawsuits over it’s drug and medical device product lines, in both federal and state courts across the country. To complicate matters further for J&J, the recently started Opiate Prescription MDL 2804 (MDL 2804 Re: NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 Briefcase) names Johnson & Johnson as a defendant in suits filed by more than 400 cities, counties and states across the country.

 They Have Opioid MDL Issues Too

Perhaps J&J should look at settling some of the cases they’ve defended so aggressively over the last 5 years, such as the Pinnacle MDL 2244 to prepare for the Opioid Crisis litigation, which is now looking to displace Tobacco Litigation as far as size and scope as well as the massive multi-billion dollar settlements and years of ongoing litigation that came from lawsuits filed initially by governmental entities.

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FDA Delays “Off-Label” Intended Use Rule Change For Drugs

“Trump Lets Big Pharma Off The Hook”

By Mark. A. York (January 23, 2018)

Trump Removes FDA Rules

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Just as Big Pharma was looking at 2017 victories related to off-label marketing of drugs for unintended uses, drug makers were expecting some loosening of the regulatory shackles. Then the FDA rolled out a new rule on that subject, that wasn’t in Big Pharma’s bests interests, sending the drug industry into a lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials in their camp, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

Trump stops FDA enforcement rule change: January 12, 2018 Food and Drug Administration Press Release: FDA Delays Change to “Off-Label” Drug Use Enforcement Rules

This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.

To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.

As the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.

In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.

Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.

The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses.  The FDA will receive comments on this proposal through February 5, 2018.

Here is the official FDA publication of January 16, 2018:

The Federal Register:  https://www.federalregister.gov/documents/2018/01/16/2018-00555/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

 

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The Week In Mass Torts By Mass Tort Nexus for December 18, 2017

 

 

 

 

 

 

 

 

By Mark York, Mass Tort Nexus Media

(December 21, 2017)

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

The New Jersey Supreme Court recently granted petitions and cross-petitions to appeal a state appellate court’s reversal of expert exclusions in the state’s Accutane multicounty litigation and the reinstatement of 2,076 dismissed cases (In Re:  Accutane Litigation, C-388 September Term 2017, C-329 September Term 2017 and C-390 September Term 2017, N.J. Sup.) See Mass Tort Nexus Accutane Briefcase Accutane New Jersey State Court Litigation.

New Trial Denied in 3rd Xarelto MDL Bellwether Case After Defense Verdict

Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, recently denied a motion for a new trial by the plaintiff in the third bellwether trial, where Bayer was found not liable in the Dora Mingo trial that took place in a Mississippi federal court in front of Judge Fallon. He ruled that plaintiff was unsuccessful in presenting new findings, among other things, that the plaintiff’s “newly discovered evidence” is actually cumulative of previously known and admitted evidence (In Re:  Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, E.D. La., 2017 U.S. Dist. LEXIS 205422). See Mass Tort Xarelto Briefcase for the entire Mingo trial transcripts as well as full transcripts of the Orr and Boudreaux trials, XARELTO MDL 2592 US District Court ED Louisiana Including Trial Transcripts.

 With Last 2 Cases Gone, Pradaxa MDL Judge Again Recommends Termination

With the final two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re:  Pradaxa [Dabigatran Etexilate]Products Liability Litigation, MDL No. 2385, No. 12-md-2385, S.D. Ill.).  After a global settlement was reached in 2014 with defendant Boehringer Ingelheim Pharmaceuticals Inc., the JPMDL suspended the transfer of tag-along actions into the MDL, and now the judge has moved for termination of the Pradaxa MDL. However, there remains over 700 Pradaxa cases pending in the State Court of Connecticut, Complex Litigation Docket, known as “Connecticut Pradaxa Actions”, see Mass Tort Nexus Pradaxa Case Briefcase,  Connecticut Consolidated Pradaxa Litigation.

Boehringer To Pay $13.5M To End Off-Label Marketing Claims

Drugmaker Boehringer Ingelheim Pharmaceuticals Inc. has agreed to distribute $13.5 million among all 50 states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday.
The settlement would resolve allegations that Boehringer marketed its prescription drugs Micardis, Aggrenox, Atrovent and Combivent for uses that weren’t approved by their labels or backed by scientific evidence. (Getty) The settlement, of which New York will receive about $490,000, would resolve allegations that the drugmaker marketed it products for off-label use, which often leads to unknown or studied adverse events and medical complications for patients taking these drugs for unapproved purposes.

 J&J Fined $30 Million Over French Opioid Drug Smear Campaign In Efforts To Sell Fentanyl Patch

France’s antitrust enforcer fined Johnson & Johnson and its Janssen-Cilag unit €25 million ($29.7 million) on Wednesday for hindering the marketing and sale of a generic version of the company’s Durogesic pain patch.The French Competition Authority found that Janssen and J&J had not only successfully delayed a generic competitor for the powerful opioid for several months, but had also done lasting damage by discrediting rival versions of the drug with doctors and pharmacists in a country where medical professionals still remain reluctant to opt for prescribing opioids.  The J&J conduct reflects the same claims being asserted against opioid drug makers in the US, where lawsuits have been consolidate into Opiate Prescription Litigation MDL No. 2804, in the US District Court of Ohio, see Mass Tort Nexus Opioid Crisis Briefcase, OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION.

11th Circuit Affirms Pelvic Mesh Group Trial, Exclusion Of 510(k) Status

(October 24, 2017, 1:25 PM EDT) -The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017)   See Mass Tort Nexus Mesh Case Briefcase, All Pelvic Mesh Litigation Case Files.

Preemption Summary Judgment Reversed By 9th Circuit In Incretin Mimetic MDL Appeal

The Ninth Circuit U.S. Court of Appeals on Dec. 6 unsealed its Nov. 28 opinion reversing summary judgment in the incretin mimetic multidistrict litigation, saying the MDL judge misapplied a U.S. Supreme Court precedent, improperly blocked discovery, misinterpreted what constituted new evidence and improperly disqualified a plaintiff expert (In Re:  Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir., 2017 )

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment

A Pennsylvania appeals court panel on Dec. 15 said a trial judge did not err when remitting a Zimmer Inc. knee verdict to $29.6 million and said it declined to substitute its judgment in place of the jury’s (Margo Polett, et al. v. Public Communications, Inc., et al., No. 80 EDA 2017, Pa. Super., 2017 Pa. Superior Court)

Risperdal Gynecomastia Cases Barred By Michigan Shield Law, Pennsylvania Panel Says

A Pennsylvania state appeals panel on Nov. 28 affirmed the dismissal of 13 Risperdal gynecomastia cases, agreeing with a trial judge that the plaintiffs’ claims are preempted by Michigan’s drug shield law and that the plaintiffs could not prove that the fraud exception

applied to their claims (In Re:  Risperdal Litigation versus Janssen Pharmaceuticals Inc., et al., No. 55 EDA 2015, et al., Pennsylvania Court of Appeals, 2017.

U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption

The U.S. Supreme Court on has invited the U.S. solicitor general to express the views of the United States on whether there is “clear and convincing evidence” that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Supreme Court)  This is a unique turn when the Supreme Court is seeking input from an outside agency in what is now a common legal issue placed in front of the court, where dug makers are using the FDA regulatory process as a shield in defending thousands of claims where warnings of drug dangers are not clear or not provided. See Mass Tort Nexus Fosamax Case Briefcase, FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS).

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New Round of Essure Lawsuits Filed vs. Bayer Healthcare Pharmaceuticals, Inc in Pennsylvania Federal Court

“Bayer Facing New Litigation Over Essure Birth Control Device”

By Mark York (November 20, 2017)

Mass Tort Nexus

 

 

 

 

 

 

(MASS TORT NEXUS)  On November 2, 2017, fifty-three plaintiffs from Florida, Illinois, Texas and other states across the country have filed a lawsuit over allegations that Bayer’s Essure permanent female birth control device caused serious injuries. This filing is another in a series of ongoing Essure lawsuits against Bayer in different federal and state venues across the country, including the  Bayer Essure Litigation USDC Missouri Case No. 4:17-cv-00865.

The primary claims against Bayer, that upon insertion of the device, by insertiing micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage. However, in reality, the device migrates from the tubes, perforates organs, breaks into pieces and/or corrodes, wreaking havoc on the female body.

Maria Gonzalez, Israel Gonzalez, and the other plaintiffs filed a multi-plaintiff complaint on Nov. 2 in the U.S. District Court for the Eastern District of Pennsylvania against Bayer Healthcare Pharmaceuticals Inc. alleging negligence and other counts under case number 2:17-cv-04936-JP, U.S. District Court for the Eastern District of Pennsylvania. Additionally there are other multi-plaintiff actions against Bayer, where Essure is the product in suit, see California JCCP Complex Litigation Docket consolidated Essure cases pending there, under Essure Product Cases and Actions, JCCP Proceeding No. 4887, Alameda County Superior Court.

According to the most recent federal complaint, the plaintiffs or their partners were implanted with defendant’s Essure device. They allege that the devices “migrated, fractured, punctured internal organs and/or caused other serious injuries.” The company has long been aware of the adverse events and concerns raised over the Essure products, but have yet to admit liability, and have vigorously defended all claims against the company and Essure.

The plaintiffs state that Bayer Healthcare Pharmaceuticals Inc. is responsible because the defendant “manipulated their reports to the FDA and presented false and misleading information, which, in turn, resulted in plaintiffs’ consent to implant not being informed because critical facts regarding the nature and quality of side effects from Essure were concealed from plaintiffs and their physicians,” as cited in the complaint.

The plaintiffs seek past and future general damages, economic and special damages, medical expenses, punitive and exemplary damages, court costs, interest and any further relief the court grants.

These 53 plaintiffs, combined with the other lawsuits filed in various courts across the country now total more than 1500 claims against Bayer, where women have asserted that the company was aware of the damage and healthcare risks of it’s Essure products, and has intentionally disregarded the ever growing evidence that shows the product to be dangerous. If Bayer Healthcare is taking the same position in this new round of claims as in others, plaintiffs will be in for a long and protracted legal fight, with Bayer being an unwilling party to come to the table for any worthwhile discussions. To follow this emerging litigation see Mass Tort Nexus Essure Litigation Case No. 2:17-cv-04936-RBS.

Case Docket: U.S. District Court for the Eastern District of Pennsylvania case number 2:17-cv-04936-JP

 

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PA Superior Court Reverses Risperdal Defense Verdict as Court Strikes Janssen Pharmaceuticals Only Favorable Jury Verdict

“Johnson & Johnson Hit With Another Trial Verdict Reversal”

By Mark York (November 17, 2017)

Mass Tort Nexus

 

 

 

 

 

 

(MASS TORT NEXUS) The Superior Court of Pennsylvania reversed the single defense verdict reached in favor of Janssen Pharmaceuticals, the manufacturer of anti-psychotic drug Risperdal. The reversal and order for a new trial stemmed from a 2015 trial that resulted in the one Risperdal defense verdict to date. The case is part of the mass tort docket for Risperdal cases in the Philadelphia County Court of Common Pleas, (see RISPERDAL Case No 296 PHILADELPHIA COURT OF COMMON PLEAS BRIEFCASE), where more than 6,000 Risperdal cases are pending.

The 22-page unanimous Superior Court decision by Judge Jack Panella, reversed the Janssen defense win in the Risperdal trial where plaintiff William Cirba filed suit against Janssen Pharmaceuticals and lost, as well the subsequent denial of Mr. Cirba’s request for a retrial based on “erroneous evidentiary rulings.”

The ruling ordered a new trial and will now be limited to the issues of causation and damages.

LAYPERSON AT TRIAL IS NOT AN EXPERT

The Superior Court stated the trial court made a reversible error at trial, by allowing physician’s assistant Michelle Baker’s testimony to be weighed on the same level as that of a medical expert. Ms. Baker was involved in the treatment of Mr. Cirba from 2005 to 2013, as a physician’s assistant.

During the Cirba trial, a videotaped deposition from Baker was played in which she stated an opinion that Cirba’s gynecomastia (the development of breast tissue) was the result of “extreme weight gain” rather than negative side effects from Risperdal. Cirba had been prescribed the drug to treat oppositional defiant disorder.

Cirba’s counsel objected that it was improper that Baker’s layperson testimony was considered equal to that of an expert, since she was not designated or qualified prior to trial – while the defense believed Baker’s deposition did not cross over into expert testimony and “constituted permissible lay opinion testimony, as it was rationally based on her perception of plaintiff during treatment.” Which the Superior Court has obviously disagreed with.

The jury returned a verdict in favor of Janssen in March 2015, although the jury at that time believed Janssen failed to properly warn Cirba’s physicians of gynecomastia risks associated with Risperdal, it stopped short of finding Janssen negligent in directly causing Cirba’s gynecomastia.

The Superior Court sided with the plaintiff in believing admitting Baker’s testimony was an attempt to enter the realm of expert knowledge.

Defendants’ experts opined that weight gain rather than Risperdal ingestion caused plaintiff to appear to have gynecomastia. Baker’s testimony, in which she opined that plaintiff’s weight gain, rather than his Risperdal usage, caused him to appear to have gynecomastia, was causation testimony offered by a witness who personally treated the plaintiff” Panella said.

Panella added Baker’s opinion was “offered without the proper vetting and safeguards surrounding expert testimony.”

“Further, this opinion was introduced into evidence due to the trial court’s improper application of the law, which is clearly an abuse of discretion. Therefore, we find that the trial court abused its discretion in denying plaintiff’s request for a new trial, limited to the issues of causation and damages,” the panel stated, in reversing the judgment and remanding the case for further proceedings.

SAME PANEL STRIKES RISPERDAL SOL CLAIMS

In a separate 18-page ruling also issued Nov. 13, the exact same three-judge panel upheld the trial court’s striking down of arguments that the statute of limitations in two Risperdal cases, featuring plaintiffs Jonathan Saksek and Joshua Winter, should have been tolled until 2013.

Saksek and Winter were prescribed Risperdal in 1997 and 1998, allegedly began developing gynecomastia in 1998 and 2002, respectively, but didn’t file suit until 2014. Both plaintiffs brought suit after seeing television advertising connected to Risperdal litigation in 2013.

The defense agreed with the trial court that the statute of limitations mandated the grant of summary judgment, but contended if the discovery rule applied, it would have only tolled the statute of limitations until October 2006, when Risperdal’s prescribing label was changed to include a warning about gynecomastia.

In January 2015, Judge Arnold New granted a defense motion for summary judgment and ruled an applicable statute of limitations applied to both Saksek and Winter’s cases, feeling that they should have known of Risperdal’s gynecomastia-related injury risks by June 30, 2009.

Both plaintiffs appealed, and the appeals were consolidated, but the higher court agreed with the trial court.

“Plaintiffs were aware of their injuries when they began experiencing unexplained weight gain – and breast growth – after starting Risperdal treatment in 1998 and 2002. However, from 1998 and 2002 until 2013, when plaintiffs were notified of the commercial claiming a link between gynecomastia and Risperdal, they did nothing to uncover the cause of their unexplained breast growth and weight gain. Plaintiff cannot hope to establish that they acted with reasonable diligence, when they admit that they failed to act at all,” Panella stated.

Their breasts were there, and had been there, for years. And then, in October 2006, the label on Risperdal changed, expressly linking usage of the drug to gynecomastia. Their breasts were clearly not temporary by 2006. Accordingly, by that date, ‘reasonable minds would not differ in finding that’ plaintiffs knew, or should have known, of their injuries and the cause of those injuries by this point,” Panella added.

RULING AFFECTS OTHER CASES

Kline commented on the Superior Court’s statute of limitations ruling, indicating it could be far-reaching beyond merely the instant cases.

“We believe [this] harsh ruling, which may bar the claims of thousands of claimants who could not possibly have known of their gynecomastia injury and its cause, is legally and factually wrong. We plan to appeal further, seeking to reopen the courthouse doors to them,” Kline said.

Janssen’s stated:  “We are pleased the Superior Court affirmed Judge New’s ruling on the application of statute of limitations.

MASS TORT DOCKET GROWING

More than 6,400 Risperdal lawsuits – most from out-of-state plaintiffs – will be handled in Philadelphia’s Complex Litigation Center. The CLC has several mass tort programs, including cases over Xarelto  (See Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation PA State Court) and asbestos, and the percentage of claims belonging to out-of-state plaintiffs has traditionally been in the high 80s. In 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent.

However, in 2017, the most recent CLC stats show that figure has jumped to an unprecedented 94 percent.

Appeal Docket: Superior Court of Pennsylvania case 2451 EDA 2015 & 576 EDA 2015

Trial Docket: Philadelphia County Court of Common Pleas case 130301803, 140200183 & 140301170

 

 

 

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JOHNSON & JOHNSON ACCUSED OF WITNESS TAMPERING IN TWO DIFFERENT TRIALS CURRENTLY UNDERWAY

Does Win At Any Cost Apply to J&J Legal Strategy Even At Trial?

By Mark York (November 7, 2017)

 

 

 

 

 

(Mass Tort Nexus)  Federal Judge Edward Kinkeade has requested the US Attorneys Office and the Federal Bureau of Investigations (FBI) open an investigation and question witnesses regarding potential witness tampering in a currently underway DePuy Pinnacle hip implant trial. The trial is taking place in the US District Court of Texas in Dallas. The trial is the third bellwether trial in Multidistrict Litigation No. 2244, where thousands of plaintiffs have filed suit in the DePuy Orthopaedics MDL 2244 Pinnacle Hip Implant Litigation. The last trial resulted in a massive initial verdict of $1 billion, subsequently reduced by Judge Kinkeade to just over $500 million.

DePuy, a subsidiary of Johnson and Johnson, has been sued along with J&J for their metal-on-metal Pinnacle hip devices, due to the release of cobalt and chromium metals into a patient’s body, resulting in the onset of metallosis, pseudotumors, and other adverse medical conditions which require surgery to remove the defective device, as well as ongoing treatment to address the related side effects.

As to J&J’s alleged witness tampering, Judge Kinkeade stated the potential witness tampering was “disturbing and disconcerting to me”. The issue revolves around interaction between am upcoming trial witness Dr. David Shein and a sales representative for DePuy. Dr Shein claims that during a surgical procedure he was warned of business ramifications,  in connection with his planned appearance as a witness during the DePuy Pinnacle trial.

Lead plaintiff trial attorney Mark Lanier noted:

“It is extremely concerning to me when there are requirements under the federal law, as well as state law, that witnesses not be tampered with, that—that it’s a serious felony, that it involves prison time, that it cuts to the core of who we are as a people and what our courts are about”

In the other witness tampering allegation during a current trial, J&J subsidiary Janssen Pharmaceuticals is accused of interfering with a treating physician and witness in the just started Xarelto trial in the Philadelphia Court of Common Pleas, see XARELTO Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation (PA State Court). This trial is the first state court Xarelto trial, where plaintiff Lynn Hartman filed suit against Janssen and Bayer over claims that Xarelto caused a major gastrointestinal bleed. The trial start was delayed by word that a meeting took place between a key witness, Dr. Timothy Aldridge, the plaintiff’s treating physician, and a Janssen sales representative.

Hartman’s lawyers said that scheduled testimony from Dr. Aldridge had essentially changed from indicating that Hartman had suffered a gastrointestinal bleed complicated by Xarelto, to denying whether he knew Hartman had suffered from a gastrointestinal bleed and being hostile to Hartman’s attorney.

Janssen claimed the meeting was routine, but opposing counsel claims that this contact, as well as the DePuy Pinnacle trial witness contact show a pattern of interference and a willingness of Johnson & Johnson employees to attempt to influence legal proceedings in ways that are often consider illegal.

In unsuccessful legal maneuvering, J&J requested a gag order to prevent the public from knowing about the DePuy trial witness tampering issue, but the judge denied their request. Prior verdicts against DePuy for Pinnacle Hip Implant cases included jury awards of $1.4 billion and $498 million in the two prior bellwether trials. The Xarelto trial tampering issue is still being reviewed by the court.

 

 

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Johnson & Johnson’s Ethicon Files Appeal in Court Ruling Where Defense Verdict in Mesh Trial Sidestepped By Judge

Plaintiffs Gets a Second Chance After Defense Trial Verdict

 

 

 

 

 

 

 

 

In another legal slam against Johnson & Johnson and their Ethicon mesh division, plaintiff Kimberly Adkins, who’s trial in June 2017 ended in a defense verdict, has been granted new life. In post trial pleadings, the judge granted the plaintiff’s petition for a hearing on damages, after determining that the jury findings had found the mesh was designed defectively, even though they entered a defense verdict. The manufacturer of the pelvic mesh involved, Ethicon Inc. (Ethicon), has appealed the judge’s ruling, when he ruled the matter can proceed to a damages hearing. In so doing, Ms. Adkins’ lawsuit, related to a TVT Secur mesh implant surgical deveice, has been revived, at least for the time being.
The primary defendant in the surgical mesh side effects lawsuit is Ethicon, a subsidiary of Johnson & Johnson, is now facing more than 100 lawsuits in the pelvic mesh mass torts currently consolidated in the Philadelphia Court of Common Pleas, Philadelphia. In what was the fifth case in the mass torts docket to go to trial, the jury on June 9 delivered for Ethicon, with what was  defendant’s first win in the 5 cases heard to date. Ethicon faces many thousands of other mesh lawsuits in federal and state courts across the country, and to date, have mounted vigorous defense in all cases.

Shortly after the defense verdict, Ms. Adkins’ trial team responded with a post-trial motion asserting that the jury’s findings were inconsistent with regard to the issue of whether or not a design defect, alleged in the surgical mesh complications lawsuit (a defect acknowledged by the jury) had been the cause of injuries to Adkins. They also stated that she was entitled to a review of the claim for damages based on the jury design defect determination.

The focus by plaintiffs is, that the jury had determined the Ethicon TVT-Secur mesh implanted in Adkins had, indeed been designed with certain defects. But in their verdict determination, by failing to identify that the product that may have caused Adkins’ injuries went against the weight of the evidence.

Adkins’ post-trial petition found merit with the judge in the Philadelphia Court, who revived the surgical mesh lawsuit in July and directed that the case be set for a hearing related to damages.

Ethicon promptly filed an appeal of the judge’s ruling with the Pennsylvania Superior Court. A spokesperson for Ethicon, Kristen Wallace, said in a statement that the trial jury in the Philadelphia Court of Common Pleas had, indeed determined that the Ethicon surgical mesh had not been the cause of the plaintiff’s injuries.

“We have filed an appeal to the Superior Court solely regarding the court granting a new hearing on damages, because we believe that it was not right to set aside what the jury decided,” Wallace said.

Adkins’ legal team announced it would be opposing the appeal, noting that any further delays incurred by Ethicon’s now standard legal strategy of appealing all rulings to delay final determination, will only delay the final determination of damages being awarded to the plaintiff, for the harm, and suffering experienced after she received the Ethicon TVT Secur mesh implant.

The primary plaintiff claims are that Adkins suffered extensive post-surgical injuries, when the Ethicon TVT Secur implant eroded into the plaintiff’s vaginal canal, causing Adkins severe and ongoing pain, after a portion of the surgical mesh was removed by way of follow up surgical procedure in September, 2012 – however the pain continued. even in the aftermath of the revision surgery. The plaintiff has been unable to return to the pre-implant active lifestyle she enjoyed including being unable to enjoy normal sexual relations with her partner of 20 years.

Ms. Adkins initially filed her complaint related to surgical mesh complications in July, 2013. The case is Kimberly Adkins v. Ethicon Inc. et al., Case No. 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

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