New FDA Commissioner Gottlieb is Nothing More than an Agent for Big Pharma

scott gottlieb tool of pharma industry
Gottlieb has extensive ties to the pharmaceutical and biomedical industries, which the FDA is supposed to regulate.

The US Senate approved controversial nominee Dr. Scott Gottlieb to be the new Commissioner of the Food and Drug Administration. He is a physician and former deputy FDA commissioner who has ties to the pharmaceutical industry he is supposed to regulate.

Gottlieb has worked with health care companies as part of global venture capital firm New Enterprise Associates and boutique investment firm T.R. Winston & Co., and he has sat on a board at GlaxoSmithKline PLC, among other positions.

Conflicts of interest

Senator Patty Murray (D-WA) criticized Gottlieb’s industry ties. “I am deeply concerned about Mr. Gottlieb’s extensive ties to the pharmaceutical and biomedical industries and asked him to address potential conflicts of interest that may arise during his tenure at the FDA. I pushed him to commit to making decisions that are in the best interest of public health, and asked how he plans to ensure that his industry ties and the radical views of the Trump administration will not affect his decision-making should he be confirmed.

“President Trump promised to “drain the swamp,” and as it stands, Mr. Gottlieb’s ties to the companies and industries he will regulate do exactly the opposite.

“It is critical that the FDA have independent leadership focused squarely on putting patients and families first, and I look forward to a thorough, rigorous vetting and hearing process to determine whether Mr. Gottlieb is appropriate for this role.”

Gottlieb promoted opiods

Senator Edward J. Markey (D-Mass.) released the following statement today after revelations in a Washington Post story indicate that Dr. Scott Gottlieb, the Trump administration’s nominee to run the FDA, worked on behalf of one company, Cephalon, to raise the quota of the addictive opioid fentanyl at the same time the prescription opioid epidemic was exploding.

The Washington Post story details how Dr. Gottlieb advocated for the Drug Enforcement Administration (DEA) to raise the quota of fentanyl that Cephalon could manufacture and put on the market even while the company was under investigation for pushing doctors to prescribe the addictive painkiller for headaches and back pain when it was meant for late-stage cancer patients. Cephalon pleaded guilty in 2008 to illegally promoting the fentanyl drug and paid a $425 million fine.

Senator Markey has sent a letter to the DEA requesting more information on Dr. Gottlieb’s involvement with this request to increase fentanyl quotas for Cephalon.

“Dr. Gottlieb seems to believe that pharmaceutical profits are more important than the public’s health. When the prescription opioid epidemic was exploding, Dr. Gottlieb advocated to put even more addictive fentanyl onto the market when it wasn’t appropriate or necessary. Dr. Gottlieb said during his confirmation hearing that the FDA unwittingly fueled the opioid epidemic, but he is guilty of intentionally pushing an addictive prescription opioid onto the American public just to benefit one company. Instead of working to prevent this massive public health crisis, Dr. Gottlieb’s actions could have made the opioid crisis worse.

“Serious questions remain about Dr. Gottlieb’s association with Cephalon, which was fined hundreds of millions of dollars for violating FDA rules. We need answers about this potentially disqualifying conflict of interest. We cannot have a leader at the FDA who has worked on behalf of a company that aided and abetted the prescription drug and heroin epidemic. I do not believe Dr. Gottlieb has any place at the FDA.”

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Court Sets Discovery Timetable in Zofran Products Liability Litigation

zofranUS District Judge F. Dennis Saylor organized discovery into five phases on Nov. 10  In Re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657 in the District of Massachusetts.

About 300 lawsuits have been filed against GlaxoSmithKline LLC, based in Wilmington, DE, since the MDL was formed by the Judicial Panel on Multidistrict Litigation on Oct. 13, 2015.

Phase 1 — Product identification fact sheets, plaintiff fact sheets and defendant fact sheets must be released as required by MDL orders 10, 11 and 12 dated May 26, 2016.

Phase 2 — Electronically stored information relating to whether Zofran causes birth defects and injuries alleged, and all potential preemption issues must be released. Phase 2 is likely to require expert and fact discovery.

Phase 3 — Beginning immediately, this phase will cover general causation issues and whether any FDA approval or other action preempts any of theplaintiff’s claims.

Phase 4 — To star on Feb. 1, 2017 will consist of discovery concerning individual causation, product identification or damages.

Phase 5 — Beginning at a date to be determined, this phase will covery any remaining potentialy relevant issues.

According to Zofran complaints filed:

GSK knew about birth defects

Defendant GlaxoSmithKline LLC d/b/a GlaxoSmithKline GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus and presented “unreasonable risk of harm” to developing babies.

GSK marketed Zofran “off-label” for treatment of nausea and vomiting associated with pregnancy. The company represented that Zofran was a safe and effective treatment for the nausea and vomiting associated with pregnancy. However, the drug had not been studied for its adverse affects upon pregnant mothers, or the possible teratogenic effects upon their fetuses at any time between 1991 and 2011.

Between April 2009 and December 2013, GSK reported that it made paid doctors and healthcare institutions more than $437.9 million dollars in the United States for speaking fees, consulting fees, research, travel fees and meals.

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GlaxoSmithKline Must Face Paxil Birth Defect Lawsuits in Illinois State Court

Tetralogy of fallot, which is a combination of several congenital heart defects.
Tetralogy of fallot, which is a combination of several congenital heart defects.

Affirming a trial court ruling, an Illinois appeals court ruled that GlaxoSmithKline (GSK) will have to face a lawsuit in a Cook County, Illinois, court charging that its antidepressant drug Paxil causes birth defeats.

The First District Appellate Court denied an appeal by GSK, and upheld the ruling by Judge Larry G. Axelrood that the company’s “substantial-in-state contacts” gave state courts jurisdiction, including over complaints filed by out-of-state plaintiffs.

In this lawsuit, eight minor plaintiffs from six states, including Illinois, filed a products liability suit in the circuit court of Cook County against defendant GSK, a global pharmaceutical company based in the UK. The case is M.M., a Minor, by and Through Audrey Meyers, et. al. vs. Glaxosmithkline LLC (PDF), f/k/a Smithklinebeecham Corporation, d/b/a Smithklinebeecham; Wolters Kluwer Health, Inc.; Wolters Kluwer United States, Inc.; and Walgreens Company, 2016 IL App (1st) 151909, Case No. 1-15-1909, Fifth Division (August 26, 2016).

Catastrophic birth defects

The suit alleges that the minor plaintiffs suffered catastrophic birth defects as a result of their mothers’ ingestion of Paxil. Defendant GSK moved to dismiss the claims of the out-of-state plaintiffs, arguing that the court lacked both general and specific jurisdiction. However, the trial court found that Illinois had specific personal jurisdiction over defendant GSK based on:

  1. GSK’s substantial in-state contacts, namely its contracts with 17 Illinois physicians to run 18 to 21 clinical trials on Paxil in Illinois as part of a multi-center study and,
  2. The fact that plaintiffs’ claims arose from defendant GSK’s acts or omissions related to those trials.

The plaintiffs allege that there was a “significantly increased risk of congenital defects in babies whose mothers ingested” the drug. This  knowledge was “scientifically knowable through appropriate research and testing.” Plaintiffs allege that the FDA requires defendant GSK “to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and [Paxil].” Despite defendant GSK’s opportunity and duty to strengthen the drug’s warnings, it “touted [Paxil] as being safe for pregnant women” and “aggressively *** promoted” the drug with labels that inadequately cautioned patients of the associated risk factors, thus, misrepresenting the drug to the public and to the medical profession.

The complaint alleges that, had defendant GSK apprised plaintiffs’ physicians of Paxil’s risks, they would not have “prescribed or permitted” plaintiffs to use the drug. Likewise, had defendant GSK provided timely and “adequate warnings regarding the risks” of Paxil, plaintiffs would not have ingested the drug.

Inadequately cautioned patients

Despite defendant GSK’s opportunity and duty to strengthen the drug’s warnings, it “touted [Paxil] as being safe for pregnant women” and “aggressively *** promoted” the drug with labels that inadequately cautioned patients of the associated risk factors, thus, misrepresenting the drug to the public and to the medical profession. The complaint alleges that, had defendant GSK apprised plaintiffs’ physicians of Paxil’s risks, they would not have “prescribed or permitted” plaintiffs to use the drug. Likewise, had defendant GSK provided timely and “adequate warnings regarding the risks” of Paxil, plaintiffs would not have ingested the drug.

Meanwhile in the Philadelphia County Court of Common Pleas, Judge Arnold New denied GSK’s motions on July 12 to lift a stay on litigation over birth defects allegedly caused by the antidepressant Paxil, according to Law360. The court entered the stay on April 21 over the mass tort litigation until an appeal is decided in the initial case, Rader et al. v. SmithKlineBeecham Corp. et al.

Braden Rader was born with tetralogy of fallot, a combination of several congenital heart defects, allegedly caused by his mother’s use of Paxil during her 2003 pregnancy. GSK argued unsuccessfully that the stay should be lifted because the other Paxil cases have dispositive issues that are unconnected to the Rader decision, according to Law360. It also argued that the stay does not advance a timely resolution of the litigation.

$3 billion in criminal fines over Paxil

In 2012 GSK pleaded guilty and agreed to to pay $3 billion in fines for introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement with the Department of Justice, GSK must pay

  • A total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.
  • The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.
  • 2 billion to resolve its civil liabilities with the federal government under the False Claims Act. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.

For further reading, check out Top 5 Mass Tort Cases for Plaintiff Lawyers Right Now

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Paxil Judge Won’t Lift Litigation Stay for GSK in Birth Defect Litigation

Tetralogy of fallot, which is a combination of several congenital heart defects.
Tetralogy of fallot is a combination of several congenital heart defects.

Philadelphia County Court of Common Pleas Judge Arnold New denied GlaxoSmithKline‘s motions on July 12 to lift a stay on litigation over birth defects allegedly caused by the antidepressant Paxil, according to Law360.

The court entered the stay on April 21 over the mass tort litigation until an appeal is decided in the initial case, Rader et al. v. SmithKlineBeecham Corp. et al.

Braden Rader was born with tetralogy of fallot, a combination of several congenital heart defects, allegedly caused by his mother’s use of Paxil during her 2003 pregnancy.

GSK argued unsuccessfully that the stay should be lifted because the other Paxil cases (see below) have dispositive issues that are unconnected to the Rader decision, according to Law360. It also argued that the stay does not advance a timely resolution of the litigation.

Case Status Court Term & No. Case Name
Active Case 0702-03220 In Re: Paxil Pregnancy Cases
Stayed By Order Of Court 1008-01144 Moore, Deceased Etal Vs Smithkline Beecham Corpor
Stayed By Order Of Court 1106-00402 Nieman Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1106-00489 Powell Etal Vs Smithkline Beecham Corporation Etal
Stayed By Order Of Court 1109-03678 Kenney Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03686 Staley Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03694 Cammarota Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03727 Guddeck Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03758 Cintao Etal Vs Smithkline Beecham Corporation

$3 billion in criminal fines over Paxil

In 2012 GSK pleaded guilty and agreed to to pay $3 billion in fines for introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement with the Department of Justice, GSK must pay

  • A total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.
  • The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.
  • 2 billion to resolve its civil liabilities with the federal government under the False Claims Act. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.

For further reading, check out Top 5 Mass Tort Cases for Plaintiff Lawyers Right Now

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Stifle the Telephone Background Racket, Judge Orders Lawyers in Zofran Litigation

Shh quiet background noise
The judge said, “Counsel should also avoid placing the Court on hold, which may have the unfortunate effect of playing “hold” music to all participants and throughout the courtroom.”

US District Judge F. Dennis Saylor IV on July 15, 2016 had to remind attorneys about the rules governing the attendance and participation by telephone in any court proceedings in In Re: Zofran (Ondansetron) Products Liability Litigation, MDL 2657,

“Because of the high volume of telephone attendance, counsel attending by telephone should endeavor to minimize background noise and other interference during the call. Counsel should normally mute their telephones, so that they can hear the proceeding but other participants will not hear any unwanted noise or interference. Counsel should also avoid placing the Court on hold, which may have the unfortunate effect of playing “hold” music to all participants and throughout the courtroom. The cooperation of all counsel in observing these requirements is greatly appreciated,” he wrote

Judge Saylor is hearing 260 Zofran Cases Filed Against GlaxoSmithKline in federal court in Massachusetts.

Concealing information

Plaintiffs accuse GlaxoSmithKline of concealing information tying Zofran to birth defects. They assert:

  • That since 1992, the company has received hundreds of reports of children who were born with serious abnormalities following pre-natal exposure to the drug.
  • That as early as 2006, studies have suggested that Zofran crosses the placental barrier in significant amounts when taken by pregnant women, which may potentially harm a developing fetus.
  • That Zofran has never been approved to treat pregnancy-related nausea and vomiting, and accuse Glaxo of improperly marketing the medication for this purpose.

In 2012, the drug maker agreed to pay $3 billion to resolve illegal marketing charges with the U.S. Department of Justice that involved a number of its medications. Among other things, the company had been accused of illegally promoting Zofran as an off-label treatment for morning sickness.

Fraudulent marketing campaign

In Flynn v. GlaxoSmithKline, the plaintiffs charge that because of GSK’s fraudulent marketing campaign, Zofran was placed into the hands of unsuspecting pregnant women throughout the US. These women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea

In contrast, GSK knew that Zofran was unsafe for ingestion by expectant mothers. In the 1980s, GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths and malformities in offspring, and further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses. A later study conducted in humans confirmed that ingested Zofran readily crossed the human placenta and exposed fetuses in substantial concentrations. GSK did not disclose this information to pregnant women or their physicians.

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Judge Approves Short-Form Complaint in Zofran Products Liability Litigation

Zofran cleft palate birth defect
Zofran cleft palate birth defect

US District Judge F. Dennis Saylor IV on July 8, 2016 approved the new Short-Form Complaint and Jury Demand submitted by the parties in Zofran (Ondansetron) Products Liability Litigation.

Specifically the court approved:

  1. Master Short-Form Complaint and Jury Demand—Brand Zofran Use, Docket No. 274, Exhibit A, filed June 20, 2016
  2. Master Short-Form Complaint and Jury Demand—Generic Ondansetron Use, Docket No. 274, Exhibit B, filed June 20, 2016.

This Order will trigger certain requirements under MDL Order No. 14, including the requirement that each current plaintiff file a Short-Form Complaint within 30 days of this Order.

The Zofran litigation is consolidated in MDL No. 2657 in US District Court in Boston, Massachusetts. According to Zofran complaints filed:

GSK knew about birth defects

Defendant GlaxoSmithKline LLC d/b/a GlaxoSmithKline GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus and presented “unreasonable risk of harm” to developing babies.

GSK marketed Zofran “off-label” for treatment of nausea and vomiting associated with pregnancy. The company represented that Zofran was a safe and effective treatment for the nausea and vomiting associated with pregnancy. However, the drug had not been studied for its adverse affects upon pregnant mothers, or the possible teratogenic effects upon their fetuses at any time between 1991 and 2011.

Between April 2009 and December 2013, GSK reported that it made paid doctors and healthcare institutions more than $437.9 million dollars in the United States for speaking fees, consulting fees, research, travel fees and meals.

In 2013, GSK made $12.8 billion in sales in the United States, making it the fifth most lucrative pharmaceutical company doing business in the United States according to IMS Health.

For more, read our article 260 Zofran Cases Filed Against GlaxoSmithKline

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