H.R. 985 Quietly Slipping Through Congress That Will Give Big Pharma Unlimited Power & Zero Accountability

 “So if your bank steals a $5 overdraft fee, and $10 from your neighbor, a class action could be dismissed because your injuries were different. Even if you file a lawsuit and get your $5 back, your friend would not.”
“So if your bank steals a $5 overdraft fee, and $10 from your neighbor, a class action could be dismissed because your injuries were different. Even if you file a lawsuit and get your $5 back, your friend would not.”

By Lisa Bloomquist. This article is reprinted from Collective Evolution.

H.R. 985, the 2017 Fairness in Class Action Litigation Act, aims to put more obstacles in the way of plaintiffs/victims who seek justice.

This justice-reform bill is a gift to the pharmaceutical industry, and other big corporations that hurt citizens (like big banks, big agriculture, big chemical, big oil etc.) from Congress men and women who receive millions of dollars in donations from those industries.

One of the most potentially damaging aspects of H.R. 985 is a provision that states that each plaintiff in a class-action lawsuit must “affirmatively demonstrate” that they “suffered the same type and scope of injury as the named class representative.” This means that all plaintiffs in a class-action lawsuit must have exactly the same injury. This provision will keep a large number of pharmaceutical class-action lawsuits from moving forward, and will rob the people who could otherwise be involved in a class-action lawsuit of justice.

How H.R. 985 could hurt people

Here is an example of how this provision in H.R. 985 could hurt people: The warning labels for fluoroquinolone antibiotics, including Cipro, Levaquin, and Avelox, have recently been updated to note that permanent peripheral neuropathy is a potential effect of those drugs. This opened the door to lawsuits, and many law firms are taking cases for those suffering from peripheral neuropathy caused by fluoroquinolones.

Peripheral neuropathy is a broad diagnosis though, and it presents in many ways. Some people with peripheral neuropathy may have pain that is debilitating, while others may have twitching muscles, others may experience numbness, others may have reduced balance or coordination, and others may have autonomic nervous system dysfunction that causes loss of digestive motility.

H.R. 985 could make it so that those plaintiffs cannot join together in a class-action lawsuit because their symptoms present differently, and, as noted above, without the possibility of a class-action lawsuit, there is no possibility for justice for many victims of pharmaceutical industry crimes.

In “House Judiciary Committee Passes H.R. 985: Fairness in Class Action Litigation” the following example is given to illustrate how this provision could hurt those trying to sue a bank: “So if your bank steals a $5 overdraft fee, and $10 from your neighbor, a class action could be dismissed because your injuries were different. Even if you file a lawsuit and get your $5 back, your friend would not.

This provision of H.B. 985 would keep cases like that of the people of Hinkley, California versus Pacific Gas & Electric (PG&E), that was featured in the movie Erin Brockovich, from moving forward. The people of Hinkley “suffered cancers, miscarriages and digestive and skin disorders as a result of the company (PG&E) dumping contaminated waste into ponds that seeped into the town’s drinking water.” If they weren’t allowed to join together in a class-action lawsuit because they didn’t have the “same type and scope of injury as the named class representative,” they wouldn’t be able to gain justice.

To continue reading, visit Collective Evolution.

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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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Slides & Recording for Webinar: Mass Torts Update for Plaintiff Attorneys

5 Mass Torts for Plaintiff Attorneys Today

Broadcast August 31, 2016

Visit http://goo.gl/rOG9qt to see the slides and recording of this program.

John Ray
John Ray

What you will discover

For lawyers starting a Mass Torts practice, picking the right cases and having an effective law firm marketing campaign are essential. Our presenter John Ray will update plaintiff attorneys about 5 key Mass Torts:

  • New Pradaxa docket in Connecticut
  • IVC Filter
  • Xarelto
  • Fluoroquinolone antibiotics
  • Emerging: Roundup litigation

A Mass Tort is ordinarily a product liability case where hundreds of plaintiffs file suit against a pharmaceutical company. These cases are typically collected into one of 300 federal multi-district litigation dockets (MDLs).

Mass Torts is a multi-billion dollar immature market, with economies of scale and only a single barrier to entry. You have already overcome the barrier if you are admitted to practice law.

About our presenter

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

He graduated Magna Cum Laude from Brenau University in Atlanta and started a pharmaceutical and medical device company right out of school, selling it in an eight-figure deal when he was 35.
John’s tenure in the pharmaceutical and medical device field allowed him to gain an in-depth understanding of FDA regulatory matters, as well as, a thorough understanding of the science and epidemiology related to gaining FDA approval to market pharmaceuticals and medical devices. John’s inside knowledge of how “Big Pharma” operates gives him a unique perspective and skill sets that are very useful to Mass Tort plaintiff firms.

When John brought his “insider knowledge” and business acumen to the Plaintiff Mass Tort space, one of the first things he recognized was a lack of common terminology and well-defined metrics. John realized that firms were expressing the same concepts, but were not using the same terminology. As a result, John set out to define common terms and create methods for formulating important metrics for use by Mass Tort firms when evaluating litigations. The terminology and metrics John Ray developed are now commonly used by major Mass Tort Law firms.

John is highly sought after and writes sought-after white papers about both current and emerging torts. The accuracy of his analysis of emerging and ongoing litigations is unmatched.

The fact that John not an attorney has proven to be an asset. John thinks like a business person, employing creative problem solving and possesses an extensive set of business skills and industry-specific knowledge. He assists Mass Tort firms in making sound business decisions before and during any litigation they are involved in or are considering becoming involved in.

John is an expert at evaluating cases and looks at each tort as an individual “investment,” which can be quantified resulting in risk mitigation for you and your firm.

Contrary to popular belief, adding Mass Torts to your practice is not gambling, nor is there a secret society of Mass Tort attorneys. The only information you lack to be successful in the practice of Mass Torts is a business plan. As John says, this type of law is 80% business and 20% law. If you understand the business principles of Mass Tort law, you will be successful.

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Class Action Filed Against Janssen Over Nerve Damage from Levaquin Antibiotic

levaquinA woman who used the antibiotic Levaquin and developed permanent nerve damage has filed a class action lawsuit accusing Janssen Pharmaceuticals of failing to adequately warn patients and doctors about the risk of severe nerve damage from Levaquin.

The lawsuit (PDF) was filed on August 11 by Michelin Rowell, a woman from North Carolina who was diagnosed with peripheral neuropathy. She is seeking class action status on behalf of everyone who was injured.

The case is Rowell v. Johnson & Johnson et al, Case No. 2:16-CV-04369 in the U.S. District Court for the Eastern District of Pennsylvania. The plaintiff argues that the running of any statute of limitations has been tolled by reason of Defendants’ fraudulent concealment of risks associated with
Levaquin.

State and federal litigation

Nearly 400 peripheral neuropathy lawsuits filed against the manufacturers of Levaquin, Cipro and Avelox continue are pending in Levaquin Litigation MDL 1943 in U.S. District Court in Minnesota.

Additional claims with similar allegations regarding the potential for fluoroquinolone antibiotics to cause peripheral neuropathy and permanent nerve damage have been filed in the Philadelphia Court of Common Pleas.

The defendants include Bayer (Cipro and Avelox), Janssen (Levaquin), and McKesson (a distributor).

Indications are that Judge John R. Tunheim, who is overseeing those cases, would be interested in coordinating with the multidistrict litigation. (In Re: Fluoroquinolone Products Liability Litigation – MDL No. 2642)

Peripheral neuropathy was added to the label in 2004, but Janssen said nerve damage was a “rare” side effect that would go away when Levaquin was discontinued. The problem is that studies dating back to 2001 concluded that symptoms usually developed within a week, and in most cases problems persisted for at least one year.

In August 2013, the FDA ordered Janssen to update the label with stronger warnings about peripheral neuropathy. The word “rare” was removed and the new warnings emphasize the rapid onset of symptoms and potentially permanent complications, even if Levaquin is discontinued.

In May 2016, the FDA issued another warning about “disabling” side effects that “generally outweigh the benefits” when Levaquin is prescribed for common infections like sinusitis, bronchitis, and uncomplicated urinary tract infections (UTIs).

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Emerging and Ongoing Mass Tort Litigation Update

MTN

You can’t miss this!
 

Mass Tort Nexus has added the hottest emerging litigation to its September Course: RoundUp Litigation. This could be the biggest mass tort since asbestos.

In addition to the hands-on practical knowledge all course attendees receive, we are privileged to have an all-star panel of attorney speakers discussing current, emerging and ongoing Mass Tort litigations.

Best of all, this program will be interactive.  There will be ample Q&A after each presentation.

Whether you have dabbled in Mass Torts or are new to the practice area, the “Four Day Mass Tort Success Course” will help you avoid common mistakes, while giving you a road map to success in Mass Torts.  We teach you a step by step process to make sure you understand the methods and metrics of this practice area.

Please join us  Sept 23rd  – Sept 26th for the “Four Days to Mass Tort Success Course” in Fort Lauderdale.  Contact Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com for more information.

RoundUp Cancer Emerging Litigation 
 
timothy-litzenburg-200x300

Timothy Litzenberg will be addressing the emerging RoundUp Cancer litigation. Timothy filed one of the original complaints in district court on behalf of a client who developed cancer after exposure to RoundUp. He is also one of the attorneys supporting the Plaintiffs’ motion to consolidate and transfer (i.e., to form an MDL) currently before the Judicial Panel on Multidistrict Litigation.

In district court, Monsanto failed to derail the RoundUp litigation. Monsanto, as well as Plaintiffs attorneys including Tim have now separately moved to support the formation of an MDL. This emerging Toxic Tort may involve more plaintiffs than any in history. Do not miss out on the chance to get information on this litigation in its early
stages. 
IVC Filter Product Liability Litigation

John Dalimonte now serves on the Steering Committee of the Cook Medical IVC filter litigation and the Bard IVC filter Litigation. He will be speaking about  the Cook and Bard IVC litigations, as well as other ongoing and emerging IVC Filter Litigation, which involve more IVC manufacturers. John has served in leadership positions on a number of MDLs and was Co-Lead Counsel in the Vioxx product liability litigation.

The IVC filter litigation may be one of the largest mass product liability litigation’s of all time, with respect to the number of plaintiffs and payouts. This litigation puts the “complex” in complex litigation and the opportunity to interact with one of the leading attorneys in this case is invaluable.
Proton Pump Inhibitor Product Liability Litigation

Bryan Aylstock will present the emerging Proton Pump Inhibitor litigation. Bryan is currently serving as one of three coordinating Co-Lead Counsel members charged with overseeing five separate Multi-District Litigations (MDLs), involving the use of TVM products. Additionally, Bryan has served in leadership positions in the Zoloft product liability litigation, the Avandia product liability litigation, as well as other MDLs.

Bryan is an outstanding lawyer and arguably one of the best business minds in Mass Torts. The opportunity to get in on the ground floor of an emerging litigation with guidance from a tested Mass Tort gladiator is worth the trip to Fort Lauderdale.

 Risperdal Product Liability Litigation

Derek Braslow will be speaking about the Risperdal product liability litigation. Derek now serves as Liaison Counsel in the Risperdal litigation and has served in many Court-appointed leadership positions in other pharmaceutical litigations. He has been in leadership positions on many MDLs, including Co-Liaison Counsel Zimmer Durom Hip Cup, as well as leadership positions in the Levaquin product liability litigation and the Paxil suicide litigation.

The Risperdal litigation is not a typical Mass Tort litigation. Derek’s insights on the Risperdal case will give knowledge and information that will be useful far beyond this single litigation.
 
Talcum Powder Product Liability Litigation
 
James Onder will be speaking on the subject of the Talcum Powder litigation. He is one of the lead attorneys in the City of Saint Louis consolidation, which has already produced multiple Jury verdicts exceeding fifty million dollars each.
James, and other members of his firm, have served as co-lead counsel and in various leadership positions on many MDLs. The opportunity to hear James speak about a difficult litigation, that he and his co-counsel firms managed to achieve massive jury awards in will be  an opportunity you won’t want  to miss.  
 
Xarelto Litigation
&
Stryker Hip Litigation “Life After the MDL”
 

Joseph Osborne will be speaking on the Stryker Hip Litigation, as well as other Hip Implant litigation. Long after other firms stopped accepting or seeking clients for the metal on metal hip implant litigations, Joseph continued to accept clients who were, and continue to be, injured by these defective products.He served in leadership positons on the Stryker Nexgen Knee MDL, the Biomet M2 Hip MDL, the Stryker Hip MDL, the American Medical System TVM MDL, as well as many other multidistrict litigations.

Joe also serves on the Science Committee in the Xarelto MDL and will be providing information about this litigation.
 
Taxotere, Onglyza and Fluoroquinolones
 
Ryan Thompson will round out the panel speaking and answering questions about three litigations every firm should be considering.  Not yet forty years old, Ryan has already achieved a record of achievements, that most lawyers would consider a stellar lifetime career. He served as Co-Lead Counsel on the Incretin Memetics Litigation, as well as in leadership positions on many MDLs. Ryan is often involved in emerging litigations in a major way. His grasp of the science involved in pharmaceutical and medical device litigation and his willingness to take risks have resulted in his incredible rise in the world of Mass Tort litigation.
One of Ryan’s early victories involved taking on a major credit reporting agency and collecting 28 Million dollars, in a litigation other firms had overlooked. Ryan brings a unique perspective to mass torts. It is a privilege to hear Ryan speak and even more of a privilege to get to know him.

Contact Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com for information and to book your seat for the September Course.

 

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Updated FDA Black Box Warning for Fluoroquinolone Antibacterial Drugs

Achilles-tendon-ruptureThe FDA revised the Boxed Warning, its strongest warning, about fluoroquinolone antibacterial drugs to address side effects including permanent damage to the tendons, muscles, joints, nerves, and central nervous system — which can occur together in the same patient.

On July 26, 2016, the FDA identified the specific drugs:

  • Avelox (moxifloxacin)
  • Cipro (ciprofloxacin)
  • Cipro extended-release (ciprofloxacin extended-release)
  • Factive (gemifloxacin)
  • Levaquin (levofloxacin)
  • Ofloxacin (generic brand)

The Fluroroquinolones MDL 2642, which includes complaints related to Levaguin, Cipro and Avelox related to peripherial neruropathy have been transfered to the same court (District of Minnesota) and the same Judge (John R Tunheim) as the Levaquin MDL 1943 related to tendon ruptures.

Cases Pending

 

For an update, read:

After Science Day, Flouroquinolone Litigation Heads Toward Settlement

Defense counsel reported that there are currently 18 cases pending in the MDL. The DeFelice case is active and in the process of discovery. The Watson case is settled and paperwork is being prepared for dismissal. Ten other cases are waiting for paperwork and will soon be ready for dismissal. Defense counsel reported that in six pending cases, the parties previously reached a settlement, but defense counsel never received final paperwork. Defense counsel sent plaintiffs’ counsel letters requesting that they attend the next status conference. In four out of the six cases, defense counsel successfully made contact with counsel for the plaintiffs, and they hoped to finalize the paperwork soon.

With regard to the remaining two cases, Castillo and Ditolla, defense counsel did not hear back from plaintiffs’ counsel. The Court agreed that defense counsel should prepare the papers for orders to show cause and submit them to the Court.

Defense counsel reported that in six pending cases, the parties previously reached a settlement, but defense counsel never received final paperwork. Defense counsel sent plaintiffs’ counsel letters requesting that they attend the next status conference. In four out of the six cases, defense counsel successfully made contact with counsel for the plaintiffs, and they hoped to finalize the paperwork soon.

Remand/Transferred Cases

Defense counsel reported that of the cases transferred or remanded 52 had settled, 19 were dismissed, and 19 remained open.

In the Tummolo Case, Plaintiff’s counsel Jacqueline Olson stated that a few years ago certain documents were not sent to the defendants, which resulted in dismissal. Olson says =that she would like the case put back on active calendar and intended to apply to have the case restored.

Defense counsel Tracy Van Steenburgh and Cort Sylvester said that the case is currently dismissed and that Plaintiff would need to file a motion to vacate the dismissal, which defense counsel would decide whether to oppose. The Court stated that plaintiff should file a motion to vacate with supporting reasons within the next two weeks, after which the defense counsel would have an opportunity to respond.

Black Box Warning

The FDA also updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

The agency is continuing to assess safety issues with fluoroquinolones as part of its ongoing review of drugs and will update the public if additional actions are needed. See the FDA Drug Safety Communication for additional information, including a Data Summary and Additional Information for Health Care Professionals and Patients.

The labels of fluoroquinolone medicines already have:

  • A Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis.
  • Warnings about the risks of peripheral neuropathy and central nervous system effects.
  • Labels that warn of other serious risks such as cardiac, dermatologic, and hypersensitivity reactions.

After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, it evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone

FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see the List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication).

Healthcare professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

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Fluoroquinolone Antibiotic Litigation MDL

cipro, levaquin, FluoroquinoloneNearly 400 peripheral lawsuits filed against the manufacturers of Levaquin, Cipro and Avelox continue to move forward in the federal multidistrict litigation in U.S. District Court in Minnesota. The proceeding convened its most recently monthly Status Conference on May 18th, when it was reported that 383 cases were pending in the federal litigation.

An additional 39 claims make similar allegations about the potential for fluoroquinolone antibiotics to cause peripheral neuropathy (disease or dysfunction of one or more peripheral nerves, typically causing numbness or weakness) and permanent nerve damage have been filed in the Philadelphia Court of Common Pleas.

Minutes from the federal conference indicate that U.S. District Judge John R. Tunheim overseeing those cases would be interested in coordinating with the multidistrict litigation. (In Re: Fluoroquinolone Products Liability Litigation – MDL No. 2642)

The Plaintiffs have submitted a proposed bellwether case protocol to the Court. The next status conference is set for July 13 or July 28, 2016.

Fluoroquinolone Side Effects

Fluoroquinolone antibiotics, including Levaquin, Cipro and Avelox, are indicated to treat pneumonia, sexually transmitted diseases, E. coli, staph and other serious bacterial infections. Plaintiffs allege that the manufacturers failed to provide doctors and patients with adequate warnings about their potential to cause serious nerve damage, including permanent neuropathy.

A mention of these complications was added to the drugs’ labeling in 2004. However, the U.S. Food & Drug Administration (FDA) ordered their manufacturers to strengthen the labels in 2013 to better reflect the rapid onset of symptoms, as well as the potential for permanence. (In Re: Fluoroquinolone Products Liability Litigation – MDL No. 2642)

On May 12, 2016, the FDA required labeling changes for fluoroquinolones, including an updated boxed warning, stating that the serious side effects associated with the antibiotics generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones are associated with disabling and potentially permanent, serious side effects that can occur together.  These side effect can involve the tendons, muscles, joints, nerves and central nervous system. As a result, the FDA is also requiring label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.

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Federal Racketeering Case Brought Against Johnson & Johnson

cipro, levaquin, Fluoroquinolone
A group of plaintiffs who were seriously harmed by the antibiotic Levaquin, have filed suit against Johnson & Johnson charging violations of the Racketeering and Corrupt Organizations Act (“RICO”).

The racketeering action, which is filed in the U.S. District Court for the District of Columbia, charges that Johnson & Johnson conspired to criminally influence the Commissioner of the Food & Drug Administration to mislabel and misbrand Levaquin.

The case charges that J&J defrauded consumers in order to acquire and reap financial gain, by:

  1. Driving up or maintaining the price of shares of Johnson & Johnson stock.
  2. Increasing the financial holdings and value of  Johnson & Johnson stock held by defendant Renaissance Technologies, L.L.C.
  3. Increasing defendant Renaissance Technologies, L.L.C.’s corporate income thereby increasing financial remuneration and gain to defendants Peter F. Brown, Robert L. Mercer, and James H. Simons by virtue of FDA Commissioner Dr. Margaret Hamburg ’s marriage to Peter F. Brown.
  4. Increasing corporate income of the officers of  Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
  5. Avoiding potential lawsuits against Johnson & Johnson.
  6. Increasing the combined wealth of defendants FDA Commissioner Dr. Margaret Hamburg and her husband, Peter F. Brown.

The FDA attributes 5,000 deaths and 8,000 injuries to Levaquin. Levaquin is considered dangerous to human health, unfit and unsuitable to be marketed as labeled and sold, misbranded, falsely advertised, promoted for off-label use, and introduced into interstate commerce. Levaquin causes mitochondrial toxicity, certain neuropsychiatric adverse events, increased risk of acquiring potentially fatal Carbapenem-Resistant Enterobacteriaceae, Fluoroquinolone-Associated Disability (“FQAD”), a term the FDA coined in 2015.

Johnson & Johnson has sold dangerous drugs and products including Tylenol, Motrin, Zyrtec, Benadryl, Risperdal, Invega, DePuy hip implants, Transvaginal Mesh, Xarelto, and Invokana. Multi-district litigation docket MDL 1943 has been organized against Johnson & Johnson in federal court in Minnesota.

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Despite FDA Warning, Fluoroquinolone Litigation Crawls Forward in Minnesota

cipro, levaquin, FluoroquinoloneIn the multi-district ligitation docket MDL 1943, defense counsel reported that there are currently 18 cases pending before the federal court in Minneapolis. Of the cases transferred or remanded 52 had settled, 19 were dismissed, and 19 remained open.

  • The DeFelice case is active and in the process of discovery.
  • The Watson case is settled and paperwork is being prepared for dismissal.
  • Ten other cases are waiting for paperwork and will soon be ready for dismissal.

On May 13, 2016, the FDA advised 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. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

Defense counsel reported that in six pending cases, the parties previously reached a settlement, but defense counsel never received final paperwork. Defense counsel sent plaintiffs’ counsel letters requesting that they attend the next status conference. In four out of the six cases, defense counsel successfully made contact with counsel for the plaintiffs, and they hoped to finalize the paperwork soon.

With regard to the remaining two cases, Castillo and Ditolla, defense counsel did not hear back from plaintiffs’ counsel. The Court agreed that defense counsel should prepare the papers for orders to show cause and submit them to the Court. If plaintiffs’ counsel in those cases do not respond to defense counsel before March 1, 2016, the Court will issue the orders to show cause at that time.

Plaintiffs’ counsel reported on the status of the Tummolo case. She stated that a few years ago certain documents were not sent to the defendants, which resulted in dismissal. Plaintiffs’ counsel stated that she would like the case put back on active calendar and intended to apply to have the case restored. Defense counsel stated that the case is currently dismissed and that plaintiff would need to file a motion to vacate the dismissal, which defense counsel would decide whether to oppose. The Court stated that plaintiff should file a motion to vacate with supporting reasons within the next two weeks, after which the defense counsel would have an opportunity to respond.

The Fluoroquinolone Antibacterial Drugs MDL 2642 which includes complaints related to Levaquin, Cipro and Avelox related to peripherial neruropathy have been transfered to the District of Minnesota before Judge John R. Tunheim, the same as as the Levaquin MDL 1943 related to tendon ruptures. At the time of this post (11/02/2015) Judge Tunheim has not issued any orders specific to MDL 2642. It is not yet clear if Judge Tunheim intends to expand any orders or special forms from MDL 1943 for use in MDL 2642.

The next status conference is scheduled for Monday, March 28, 2016 at 3:00 PM.

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Severe FDA Warning Against Use of Fluoroquinolone Antibacterial Drugs

ruptured achilles tendon
Side effects of Fluoroquinolones include a ruptured achilles tendon.

The FDA advised on May 13, 2016 that the serious side effects associated with fluoroquinolone antibacterial drugs (Levaguin, Cipro and Avelox) generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections that have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together.

Severe Side Effects

These side effects can involve:

  • Tendon, joint and muscle pain
  • A “pins and needles” tingling or pricking sensationssion
  • Confusion
  • Hallucinations
  • Damage to the central nervous system
John-Ray“The words  ‘serious side effects’ are powerful words for plaintiffs cases,” said John Ray, a leading consultant to the Mass Tort industry for over a decade. “This is a statement of conclusion by the FDA with no equivocation. It is rare for the FDA to make such a definitive statement.”

More than 26 million Americans receive a prescription for a fluoroquinolone antibiotic like Cipro, Levaquin or Avelox each year.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Inadequate warnings

Patients should contact their health care professional immediately if you experience any serious side effects while taking fluoroquinolone medicine. Health care professionals should stop systemic fluoroquinolonetreatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Lawsuits charge that fluoroquinolone antibiotics – principally, Levaquin, Avelox, and Cipro – cause or substantially contribute to the development of irreversible peripheral neuropathy and that defendants’ warnings concerning the alleged risks were inadequate. The involved manufacturers and distributors are 2 Bayer (Cipro and Avelox), Janssen (Levaquin), and McKesson (a distributor).  Minneapolis before Judge Chief Judge John R. Tunheim in MDL No. 2642.

At one time, more than 2,000 Levaquin cases against Johnson & Johnson sat before U.S. District Judge John R. Tunheim in multidistrict litigation (MDL) in Minnesota. Several were settled for confidential amounts, according to court documents. As of March 2015, about 100 were pending in the federal MDL.

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