Dora Mingo vs Janssen and Bayer (Xarelto) Trial Update: Plaintiff Closes Her Case on August 16, 2017

(Dora Mingo vs. Janssen Research & Development, LLC et al. Case No. 2:15-cv-03469)


The third Xarelto MDL 2592, bellwether trial is proceeding in US District Court of Mississippi in front of MDL Judge Eldon Fallon, where plaintiff Dora Mingo resides, see Xarelto MDL 2592 Mass Tort Nexus Briefcase.  At the close of plaintiff’s case-in-chief on August 16, 2017 defendants Janssen Research & Development and Bayer Pharma AG, et al, moved the Court for judgment as a matter of law on Plaintiff’s design-defect and failure-to-warn-or-instruct claims under the Mississippi Product Liability Act (“MPLA”) see, Defendants Motion for Judgment as a Matter of Law.

Plaintiff have asserted two causes of action under Miss. Code Ann. § 11-1-63. Plaintiff first asserts that Xarelto is defectively designed because it was brought to market without an  accompanying rivaroxaban-specific anti-Factor Xa assay. Plaintiff also claims that Xarelto is unreasonably dangerous due to inadequate warning or instruction because Defendants failed to instruct physicians to use Neoplastin PT at the initiation of therapy to identify patients at an increased risk of bleeding.

Defendants state in their assertions that they are entitled to judgment as a matter of law on Plaintiff’s design-defect claim because an adjunct rivaroxaban-specific anti-Factor Xa assay to be used with Xarelto is not an alternative anticoagulant design and is therefore not a feasible alternative design under the MPLA.3 See Elliot v. El Paso Corp., 181 So. 3d 263, 273 (Miss. 2015); Clark v. Brass Eagle,Inc., 866 So. 2d 456, 461 (Miss. 2004). In their second assertion, they claim they are entitled to a trial win on Plaintiff’s design-defect claim because Plaintiff has presented no evidence that Xarelto failed to function as expected. See Austin v. Will-Burt Co., 361 F.3d 862, 872 (5th Cir. 2004).

Defendants further plead, they are entitled to judgment as a matter of law on Plaintiff’s design-defect claim because Plaintiff has made clear that her design-defect claim is based on a theory that Xarelto should have had a different design at the time it was released to the market (Trial Transcript. 141:19–142:11, 144:1–17), and the Court’s preemption decision so requires. See Order & Reasons on Defs.’ Preemption MSJs (Doc. 7110), at 11 (plaintiff’s “pre-market design-defect claims under the MPLA are not preempted”).

Defendants also include in their request for judgment, plaintiffs abandonment of various claims that were not presented at trial or withdrawn before trial, including the “failure to include the Rocket AF trial data” on participant bleeding rates and that Xarelto was designed without a reversal agent.

Mass Tort Nexus will provide additional Dora Mingo trial updates as they become available.

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Xarelto Bellwether Trial #2 also Ends with Defense Verdict

A federal jury in Louisiana found that Janssen Pharmaceuticals Inc. and Bayer Corp., makers of blood thinner Xarelto, adequately warned about the risk of unstoppable bleeding and that it did not cause the plaintiff to suffer a stroke that killed her.

The case was Joseph Orr Jr. v. Janssen Pharmaceuticals, Inc., et al., No. 15-3708, E.D. LA. Some 17,097 cases are pending before US District Judge Eldon E. Fallon in MDL 2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation.

It was a weak case to begin with. The plaintiff Sharyn Orr, was a 67-year-old grandmother who had a host of medical problems. See No Cause for Panic in Defense Verdict in the First Xarelto Bellwether Trial.

The jury returned itsverdict on June 12 in the second bellwether trial in the Xarelto multidistrict litigation.

Plaintiff Sharyn Orr took Xarelto to prevent blood clots due to atrial fibrillation.  She died after suffering a stroke in 2015.  Her husband and children filed the acting, charging that Janssen and Bayer failed to adequately warn that it could cause uncontrolled brain bleeding.

The manufacturers argued successfully that the Xarelto label sufficiently addressed the risk of uncontrolled bleeding.

The plaintiff attorneys were Thomas C. Wicker III, James A. Watkins and Vincent E. Odom of Capitelli & Wicker in New Orleans and Albert J. Nicaud of Nicaud & Sunseri in Metairie, Louisiana.

Bayer is represented by Susan M. Sharko, a morbidly obese attorney with Drinker, Biddle & Reath in Florham Park, N.J.

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Witness: Xarelto is “The Worst” of All Anticoagulents

Frank W. Smart, MD
Frank W. Smart, MD, testified that Xarelto should have an FDA Black Box Warning — the strongest warning.

In damning testimony against drugmakers Janssen Pharmaceuticals and Bayer, an expert cardiologist testified at the second Xarelto bellwether trial that of all the anticoagulants, Xarelto is “the worst.”

“So Xarelto, of all the new oral anticoagulants, is the worst. And that’s well established in the medical literature and even by the FDA. The FDA said that Xarelto was equal to Coumadin. The other drugs which would be apixaban or Eliquis, dabigatran or Pradaxa and edoxaban or Savaysa are in one shape or form superior either in anticoagulation effect or in bleeding or in both,” testified Frank W. Smart, MD, a board-certified doctor in cardiology at LSU School of Medicine.

The case is  In Re: Xarelto (Rivaroxaban) Products Liability LitigationJoseph Orr v. Janssen Research, Case No. 2:15-CV-3708, before US District Judge Eldon Fallon in the Eastern District of Louisiana. Plaintiff attorney Anthony Birchfield, Jr. of Beasley Allen Crow Methvin Portis & Miles in Montgomery, AL, led the direct examination.

Dr. Smart’s  opinion was based on his own research plus internal company e-mails from drug manufacturers Janssen Pharmaceuticals and Bayer, and transcripts of FDA reviewers’ opinions FDA where the Xarelto was discussed.

Stops precribing Xarelto

Xarelto is a NOAC or new oral anticoagulant. Instead of blocking clotting factor Vitamin K, Xarelto is an inhibitor of Factor Xa, and it too stops the prothrombin-to-thrombin conversion and thins a person’s blood.

“I read an article that was in one of the Canadian journals that was very impressive to me, and I started transitioning people off of Xarelto at that time and have completely abandoned the use of it,” he testified. “It was a twice-a-day drug crammed into a once-a-day prescription, and I thought that that was a poor idea. I still think it’s a poor idea.”

“A practicing cardiologist sees people six, seven days a week “and they don’t have time. They don’t physically have time to chase down information like this.”

“Coumadin has a black box warning that says: Bleeding is an issue. You really need to focus on this. Be careful. Monitor it, and then things like that. Xarelto, I believe, should have a black box warning as well because all the literature and the FDA said that there’s no difference,” he testified.

An FDA Black Box Warning is the strongest warning that the US Food and Drug Administration (FDA) puts on a drug. For example, addictive opioids have black box warnings.

After reading FDA transcripts, Smart said, “The conclusion seemed to be that if the FDA had had their druthers, the company would have tested a twice-a-day dose, but they went on to say that they didn’t have the capacity to force the company into doing that, and the only thing that they could do was to consider the information that had been presented to them at the once-a-day dose.

Xarelto worst drug in its class

The ROCKET-AF trial of Xarelto on 7,000 patients with atrial fibrillation (Afib) found that “Xarelto was the worst in the class of these drugs. It was never shown to be superior to warfarin for either stroke or bleeding. But Eliquis, or apixaban, was shown to be superior for both,” Smart testified.

Q. (by attorney Anthony Birchfield) So when we look at these drugs, if we look at Eliquis.  Eliquis in the clinical trial, is it shown to be superior in both safety and efficacy?

A. (by Dr. Smart) Yes, sir. To warfarin.

Q. So Eliquis is superior to them both. And then, when we look at Pradaxa compared to warfarin, was Pradaxa — was it superior to either — in either safety or efficacy?

A. Yes, sir. It was superior in safety.

Q. What about efficacy?

A. Equal.

Q. And then, when we look at Xarelto was Xarelto superior in safety?

A. No, sir.

Q. Was it superior in efficacy?

A. No, sir.

“I think, again, playing Monday morning quarterback, I think had Eliquis been released at the time, there was no way that Xarelto would have been approved,” by the FDA, Smart testified.

“It’s worst in class among the NOACs. That’s pretty accepted. I mean, it’s a four-horse race, and they are the fourth horse. This adds concern that the approval was maybe less grounded in great science.”

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Facing 11,000 Xarelto Lawsuits, Johnson & Johnson Doubles Down on Physician Bribes

xarelto-bleedingBy KJ McElrath. This article is reprinted from The Ring of Fire Network.

Xarelto, a “New Generation” anti-coagulant, was supposed to have been the ideal replacement for warfarin, the standard treatment for patients at risk for embolism and thrombosis due to blood clots.

The FDA approved Xarelto in 2011, and it was on pharmacy shelves by July of that year. However, within little over a year, the Institute for Safe Medication Practices (ISMP) was sounding the alarm about the abnormally high number of adverse events.

A total of 15,291 lawsuits have been filed against Janssen Research & Development LLC (a Johnson & Jonson subsidiary) in Xarelto products liability MDL No. 2592. Over 1,000 more have been docketed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation.

According to the report that was published in October 2012, there had been nearly 160 cases of serious side effects during the first three months of that year alone. Meanwhile, the U.S. Food and Drug Administration had reported an additional 360 such cases between the beginning of January and the end of April.

Those cases reported that Xarelto actually increased the risk of blood clots when the medication was discontinued, particularly in younger patients (65 years of age and under). Also known as rivaroxaban, this drug also increases the risk of fatal internal hemorrhaging as well as serious infections.

Physician bribes

As a result, Johnson & Johnson faces over 16,000 lawsuits alleging that the company failed to warn doctors and patients about the associated risks. A significant number of plaintiffs are also alleging that the drug was inadequately tested before it was rushed through the approval process.

At this point, there is no antidote. Although a small California biotech firm, Portola, has been working on developing a reversal agent, that product has not yet received FDA approval. Currently, the only viable option for treatment of a Xarelto patient at risk for fatal bleeding is to administer emergency dialysis.

Despite the increasing number of lawsuits and growing number of adverse event reports, Johnson & Johnson spent a whopping $28.4 million in physician bribes during 2015 alone in order to get them to write prescriptions for Xarelto. In fact, that particular drug was at the top of ProPublica’s “Dollars for Docs” list for that year.

Of course, the pharmaceutical industry does not call such payments “bribes;” they are officially listed as payments for promotional speaking and/or consulting, travel and meals, gifts and royalties. Although members of the medical community deny that such payments affect their professional judgment when it comes to prescriptions, an analysis of ProPublica’s data shows that the more money a doctor receives from a drug company, the more likely s/he is to prescribe that company’s brand name products.

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New Lawsuit Filed in Xarelto Litigation, as Caseload Reaches 14,465 Actions

xarelto internal-bleedingAnother wrongful death action has been filed in federal court in Xarelto (Rivaroxaban) Products Liability Litigation, this time by a family of a Louisiana woman who was killed by unstoppable bleeding because the manufacturers concealed their knowledge of Xarelto’s defects, from the decedent, the FDA, the public and the medical community.

The case is Terrie Toups, Duane Rochelle, Patty Buras, and the Estate of Florence Bourgeois, Case No. Case 2:14-md-02592-EEF-MBN, in MDL 2592 supervised by U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana. The current caseload is 14,465 actions. For more information Update: Federal Court Revises Xarelto Product Liability Cases for Trial

In parallel litigation, some 1,100 claims have been filed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation to date before Judge Arnold New. For more, read Two Reasons That More Attorneys File Xarelto Claims in Philadelphia Court

The defendants include:

Be sure to read:

Did Xarelto, the Drug Arnold Palmer Promoted, Lead to His Death?

  • Janssen Research & Development, Janssen Ortho LLC and Janssen Pharmaceuticals, Inc.
  • Johnson  & Johnson
  • Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare AG and Bayer AG

Florence Bourgeois began using Xarelto around September 23, 2013, up until about January 12, 2016. She suffered life-threatening bleeding, anemia, urinary tract infection, sepsis, renal failure and death on January 14, 2016.

151 deaths

The FDA approved Xarelto, also known as rivaroxaban, on July 1, 2011. The drug is used to reduce stroke and blood clots in patient with atrial fibrillation, a heart disorder.

In the U.S., about 1 million Xarelto prescriptions had been written by the end of 2013, when sales for Xarelto passed $1 billion. Meanwhile, for 2012 a total of 2,081 new Xarelto-associated “Serious Adverse Event” reports were filed with the FDA in its first full year on the market — and of those, 151 were deaths.

There is no antidote to Xarelto, unlike warfarin. Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning about the lack of antidote, but instead only mentioned this important fact in the overdosage section.

“Defendants also failed to warn emergency room doctors, surgeons, and other critical care medical professionals that unlike generally-known measures taken to treat and stabilize bleeding in users of warfarin, there is no effective agent to reverse the anticoagulation effects of Xarelto, and therefore no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Xarelto,” the complaint states.

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After Science Day, Flouroquinolone Litigation Heads Toward Settlement

Peripheral neuropathy, a result of damage to your peripheral nerves, often causes weakness, numbness and pain, usually in your hands and feet.
Peripheral neuropathy, a result of damage to your peripheral nerves, often causes weakness, numbness and pain, usually in your hands and feet.

Opposing parties held a science day in Fluoroquinolone Products Liability Litigation on Jan. 17, one of the penultimate steps before a comprehensive settlement is reached in 713 actions against Bayer, Johnson & Johnson and its Janssen subsidiary.

Chief US District Judge John R. Tunheim in Minnesota, who is supervising MDL 2642, viewed Powerpoint presentations by the parties’ scientists, explaining the connection between the powerful fluoroquinolone antibacterial drugs (FLQs) — Cipro, Avelox and Levaquin — and peripheral neuropathy.

The nerve condition is irreversible and its symptoms include pain, burning, tingling, numbness, weakness, alterations of sensation affecting musculoskeletal, neuropsychiatric, sensory (e.g., vision or hearing), skin, and cardiovascular systems.

Admission of Liability

John Ray has been a leading consultant to the Mass Tort industry for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.
John Ray has been a leading consultant to the Mass Tort industry for over a decade.

The MDL has steadily grown since it was created on August 17, 2015, when there were only 20 actions. An admission of liability by the defendants and other indications show that the cases are in the process of being settled. At the December 1, 2016 status conference, the parties asked the court to delay setting dates for bellwether trials so that they could seek a settlement.

FLQs are broad-spectrum synthetic antibacterial agents marketed and sold in oral tablet, IV solution, and ophthalmic solution, used to treat lung, sinus, skin, and urinary tract infections caused by certain germs called bacteria.

“The are trying to establish anything to mitigate damages,” said mass tort expert consultant John Ray. “I expect see a settlement based on a value based on the type of injury, mitigated by any any co-morbidity.”

  • Both the J&J and Bayer defendants have publicly acknowledged that FLQs can cause neuropathy. At the FDA’s joint advisory committee meeting in November 2015, Dr. Susan Nicholson, Vice-President of safety, surveillance, and risk management for the Johnson & Johnson, testified for all the defendants. She agreed that FLQs cause tendon ruptures, severe arrhythmia, and neuropathy.
  • The FDA issued a safety announcement on May 12, 2016, advising that “the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.”  The FDA instructed that patients with these conditions should not be treated with a fluoroquinolone if alternative treatment options are available.
  • In an unusual expansion of liability, courts in California, Alabama, Illinois and Vermont have ruled that the brand-name manufacturers owe a duty of care to patients who took a generic version of an FLQ.

Defense strategy

“The defendants know they’re going to pay,” Ray said. “It’s a question of how much they’ll pay and how much they can get out of paying. They are giving individual cases more scrutiny.”

Illustrating this point, the plaintiff’s fact sheet, which is used instead of interrogatories, is double the usual length at 42 pages. It betrays that the defense strategy is to pick off cases one-by-one with fraud, statute of limitations and alternative cause defenses. It probes plaintiffs with questions in granular detail, including what Facebook groups a plaintiff belongs to. For example:

  • Have you every used a computer to look for information on the internet about any fluoroquinolone drugs?
  • Have you ever read or posted any weblogs (blogs), social networking sites (such as Facebook or LinkedIn), or message boards regarding any fluoroquinolone drugs.
  • Do you belong to any fluoroquinolone-related information or support groups, either online or elsewhere? (e.g. Floxie Hope; Facebook’s “Fluoroquinolone Antibiotic Toxicity Community;” Facebook’s “Fluoroquinolone Wall of Pain;” The Tropical Penguin Health Forum, etc.)
  • Please indicate whether your parents, siblings, children or grandparents have ever experienced to been diagnosed with peripheral neuropathy?
  • Were you ever given any written [or verbal] instructions, warnings or other information about any fluoroquinolone?”
  • Have you ever filed a lawsuit or made a claim relating to any bodily injury?
  • Have you been convicted of, or pled guilty to, a felony or a crime of fraud or dishonesty within the past ten years?
  • Have you ever been diagnosed with any of the following 47 conditions — starting with alcoholism to vascular disease.
  • Have you had any communications with your health care providers, orally or in writing, about whether your condition is related to your use of fluoroquinolones?

The case proceeds when the next status conference is held on February 21, 2017, at 2:00 p.m.

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Janssen Settles Latest Risperdal Case Before Trial in Philadelphia

Risperdal causes gynecomastia, or enlarged breasts, in men.
Risperdal causes gynecomastia, or enlarged breasts, in men.

Janssen Pharmaceuticals Inc. settled the lawsuit of a New York boy who took the antipsychotic drug Risperdal and grew female breasts, just before the case was to go on trial in  Philadelphia County Court of Common Pleas, according to Law360.

The case is Zachary Sabol et al. v. Janssen Pharmaceuticals Inc. et al., case number 130402100, and the settlement amount was not disclosed. It would have been the seventh trial in Philadelphia’s mass tort program, where 2,300 cases are pending against the drug maker.

The plaintiff and his family filed suit against Janssen in 2013 charging that he developed gynecomastia, or the abnormal growth of female breast tissue, after being treated with Risperdal for nearly a decade.

The FDA approved Riserdal in 2006 for treating autism in adolescents. When Sabol began taking the drug, however, it was only approved for use in adults and indicated that gynecomastia was a rare side effect that occurred in fewer than one in 1,000 patients. Warning labels were later updated to show there was a 2.3 percent rate of gynecomastia in adolescents taking the drug.

The litigation has continued for three years in Philadelphia. Another 16,000 case are consolidated in California Superior Court in Los Angeles with the first trials set for July.  Three earlier trials have resulted in verdicts in favor of the injured plaintiff in the amount of $2.5 Million, $1.75 Million, and $500,000.  In all the trials, juries have found that J&J failed to adequately warn of the risks of gynecomastia.

Recent Headlines in Risperdal:

Infographic: The Disgraceful History of Risperdal

New Judge Knocks Out Plaintiff’s Expert, Abruptly Dismisses Risperdal Case

Plaintiffs Settle Risperdal Case with Johnson & Johnson in Philadelphia Court

Philly Judge Adds $6.66 Million Delay Interest to $70M Risperdal Verdict

Kentucky AG Settles Risperdal and OxyContin False Marketing Cases for $39.5 Million

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New Risperdal Mass Tort Trial Underway Against J&J in Philadelphia

Risperdal causes gynecomastia, or enlarged breasts, in men.
Risperdal causes gynecomastia, or enlarged breasts, in men.

The sixth trial against Johnson & Johnson’s Janssen subsidiary concerning its Risperdal anti-psychotic drug is underway in the Philadelphia Court of Common Pleas.

Plaintiff Tommy Moroni of Sargent, Nebraska alleges that he was first prescribed Risperdal in Dec. 2004 to treat his oppositional defiant disorder, anxiety and depression. He took the drug for four years after a doctor diagnosed him with gynecomastia in Nov. 2010. Moroni  v. Janssen Pharmaceuticals Inc., case number 130501076, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

2,000 lawsuits filed

Plaintiff attorney Jason Itkin or Arnold & Itkin in Philadelphia argued that Risperdal causes spikes in the prolactin hormone, causing  gynecomastia, or the development of female breast tissue.

The litigation has continued for three years, with 2,000 plaintiff cases filed in Philadelphia. Another 16,000 case are consolidated in California Superior Court in Los Angeles with the first trials set for July.  Three earlier trials have resulted in verdicts in favor of the injured plaintiff in the amount of $2.5 Million, $1.75 Million, and $500,000.  In all the trials, juries have found that J&J failed to adequately warn of the risks of gynecomastia.

Among the evidence against J&J are:

  • Video testimony from former FDA Commissioner David Kessler that J&J manipulated the data shown to the agency to obscure that it causes gynecomastia.
  • The FDA approved Risperdal only for treating schizophrenia in adults. The warning label said that gynecomastia was a rare side effect.
  • The FDA declined to approve the drug for children in 1997, but in Oct. 2006 approved it to treat symptoms of autism in adolescents.
  • Internal emails show company officials saying the drug was worse than its competitors in terms of prolactin elevation.

Johnson & Johnson was fined more than $2.2 billion in criminal and civil fines in November 2013. It settled accusations that it improperly promoted Risperdal to older adults, children and people with developmental disabilities, according to the Justice Department.

Kentucky Attorney General Jack Conway announced a $15.5 million settlement in December 2015 with Johnson & Johnson regarding Risperdal. The consumer protection lawsuit charged that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers.


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Philadelphia Judge Allows Invokana Case to Proceed Against Janssen

invokana-warning kidney-damageJanssen Pharmaceuticals Inc. lost a motion to dismiss a Texas man’s complaint that Invokana gave him diabetic ketoacidosis, allowing his product liability claim to proceed in the Philadelphia Court of Common Pleas.

Janssen, based in Raritan, New Jersey, filed a forum non conveniens motion, which Judge Denis Cohen denied. The company argued that:

  • Plaintiff Matthew Landes took Invokana and suffered his injury in Texas.
  • It would be difficult for Janssen to get witnesses like the plaintiff’s physician to come to Pennsylvania to testify.
  • Invokana was manufactured in Puerto Rico and developed in New Jersey.

In opposition, plaintiff attorneys Scott Levensten and Michael Johnston of the Levensten Law Firm PC in Philadelphia argued successfully that most of the discovery would come from Janssen’s offices in Pennsylvania or New Jersey. The case is Landes v. Janssen Research & Development LLC et al., case number 160300269, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.

Dozens of actions

Nearly 90 cases are pending against Janssen in Philadelphia courts. Invokana won approval from the Food & Drug Administration in 2013, but plaintiffs claim that it can cause a condition known as diabetic ketoacidosis, in which the body produces excess blood acids known as ketones.

Separately, dozens of plaintiffs who suffered kidney damage or ketoacidosis have filed a motion to create new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in federal court in New Jersey.

There are at least 56 actions pending in 11 different judicial districts against defendants Johnson & Johnson of New Brunswick, NJ, Janssen Pharmaceutical Inc. of Titusville, NJ (a J&J subsidiary) and Tanabe of Osaka, Japan.

In June 2016, the FDA released a safety announcement concerning canagliflozin and dapagliflozin, strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

The FDA added a further warning for ketoacidosis, including “Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose cotransporter-2 (SGLT2) inhibitors, including INVOKANA.”

The FDA added even more warnings in August 2016. Also see: Health Canada Warns of Diabetic Ketoacidosis from Invokana Diabetes Drug

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Plaintiffs Settle Risperdal Case with Johnson & Johnson in Philadelphia Court

Risperdal causes gynecomastia, or enlarged breasts, in men.
Risperdal causes gynecomastia, or enlarged breasts, in men.

The parties in a case charging that a boy who took Risperdal, causing him to grow female breasts, settled for an undisclosed amount with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Meanwhile, appeals continue over when the statute of limitations begins to run for victims of the Risperdal side effects.

  • A total of 2,085 Risperdal products liability cases are pending in the Complex Litigation Center of the Philadelphia Court of Common Pleas.
  • Another 300 cases are pending in the Superior Court of Los Angeles.

J&J Suppressed Science

In the Philadelphia case that settled, the plaintiff started taking Risperdal at age six for Asperger’s syndrome. N.F. v. Janssen Pharmaceuticals, Case No. 13500998. It would have been the sixth case to go to trial over evidence that Janssen hid a scientific link between the antipsychotic drug and male breast growth, or gynecomastia.

Jason Itkin of Arnold & Itkin in Houston, TX.
Plaintiff attorney Jason Itkin of Arnold & Itkin in Houston, TX.

Risperdal was approved by the U.S. Food and Drug Administration in 2002 to treat schizophrenia, but was not cleared for use in children until 2006.

Evidence that the company lied  about the scientific link and hid it from the Food and Drug Administration led to a $70 million jury verdict against Janssen on July 1. The case is Andrew Yount v. Janssen Pharmaceuticals Inc. et al., case number 1304002094, in the Court of Common Pleas of Philadelphia County, Pennsylvania. 

The jury in the Yount case found that J&J intentionally falsified, concealed, or destroyed material evidence,” states a press release from Arnold & Itkin.

“During trial, evidence that became known in the case as ‘Tab 4,’ was publicly revealed for the first time. Tab 4 includes scientific data showing a link between Risperdal and gynecomastia. The lawyers made a case that J&J intentionally kept Tab 4 secret- withholding it from the FDA and keeping it out of published scientific studies,” the press release states.

Janssen knew about a key safety analysis since 2002, but failed to give it to the FDA, as they should have, when looking to get Risperdal approved for children, according to New Brunswick Today.

In 2013 the Department of Justice penalized Johnson & Johnson for more than $2.2 billion to resolve criminal and civil investigations allegations include off-label marketing and kickbacks to doctors and pharmacists relating to Risperdal.

Appeal over Statute of Limitations

A appeals panel of the Pennsylvania Superior Court may decide in three cases whether plaintiffs should have been reasonably aware that Risperdal caused breast enlargement as of June 30, 2009, starting the statute of limitations.

In January 2015 Judge Arnold L. New, the Coordinating Judge of the Complex Litigation Center, ruled that plaintiffs had two years to file a claim starting from the 2009 date. In Re: Risperdal Litigation, case numbers 576 EDA 2015, 590 EDA 2015 and 2451 EDA 2015, in the Superior Court of the State of Pennsylvania.

Judge New said the potential connection between Risperdal and gynecomastia had been revealed in several medical journals and media reports, and added to the drug’s warning label.

In oral arguments in September, plaintiff attorneys argued to the appeals court that the trial judge had improperly attempted to set a global accrual date for Risperdal claims that didn’t conform to the individual experiences of the two men whose cases served as a springboard for the ruling.

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