Court Selects 2 Testosterone Cases Against Lilly for Bellwether Trials

testosterone2The US District Court for the Northern District of Illinois selected two cases as Lilly Bellwether Trial cases in In re Testosterone Replacement Therapy Product Liability Litigation, MDL 2545.

There are 6,090 lawsuits over testosterone replacement treatments against Eli Lilly and other drug companies before US District Judge Matthew F. Kennelly in the multidistrict litigation docket. Lilly makes Axiron testosterone topical solution.

The cases set for trial are:

  • Plaintiff Tracy Garner who suffered a myocardial infarction, Case No 1:15-cv-02045
  • Plaintiff John Debroka, Jr., who suffered a deep vein thrombosis, Case No. 1:15-cv-09246

All the actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include:

  • heart attack
  • stroke
  • deep vein thrombosis
  • pulmonary embolism

On January 31, 2014, the U.S. Food and Drug Administration announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Plaintiffs filed the actions in the wake of this announcement.

In March 2015, the FDA issued a safety communication, cautioning men against taking testosterone products for low testosterone levels associated with aging. The agency also required companies manufacturing these drugs to change their labels to clarify the proper usages for their products. Manufacturers were also required to add warnings about the risks of heart attack and stroke associated with taking these drugs.

All testosterone replacement therapy actions share factual questions about general causation and the background science about the role of testosterone in the aging body, as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.

The hormone has been used off-label to treat a range of symptoms such as loss of energy, decreased muscle mass and reduced libido.

The defendants include:

  • AbbVie Inc. and Abbott Laboratories Inc. (collectively Abbot)
  • Eli Lilly and Co. and Lilly USA LLC
  • Endo Pharmaceuticals
  • Actavis, Inc.
  • Auxilium Pharmaceuticals, Inc.
  • Pfizer, Inc.
  • Pharmacia

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Roundup Causes Cancer, California Says

Spraying glyphosate on a stubble field | Photo: Chafer Machinery, some rights reserved
Spraying glyphosate on a field. Photo: Chafer Machinery

California is free to declare officially that Monsanto’s Roundup weedkiller causes cancer after a state court stopped a lawsuit by Monsanto.

There are 100 lawsuits in MDL 2741 supervised by US District Judge Vince Chhabria (Northern District of California), Roundup Products Liability Litigation.

The California Office of Environmental Health Hazard Assessment announced in 2015 that it would add glyphosate to its list of chemicals known to cause cancer.

Monsanto sued in January 2016 to block the listing, claiming that the state acted unconstitutionally in listing glyphosate. The company also argued that the value of its Roundup trademark would be irreparably damaged that its First Amendment right to free speech was threatened if the state required warning labels on the company’s glyphosate products.

Glyphosate on carcinogen list

State Superior Court Judge Kristi Culver Kapetan ruled March 10 that California may add glyphosate to its carcinogen list.

Farm workers suffer significant health effects from glyphosate exposure, particularly non-Hodgkin lymphoma (cancer of the lymph nodes).

Use of Roundup has skyrocketed in recent decades because of Roundup’s bogus reputation as “safer than table salt.” Also, Monsanto’s sells “Roundup-ready” crops such as soy, corn, alfalfa, and cotton. Farmers spray Roundup on crops, killing the weeds but leaving their crops unharmed.

As a result of the spread of glyphosate-resistant crops, use of the herbicide has increased more than tenfold since 1995.

America’s farming belt, where most of the food in the US is grown, is hit the hardest:

  • West: California, Washington, Montana, and Texas
  • Midwest: Michigan, Illinois, Indiana, Ohio, Iowa, Wisconsin, and Minnesota
  • Mississippi River: Louisiana, Alabama, Arkansas, and Tennessee
  • Atlantic seaboard: New Jersey, Maryland, Virginia, Florida, Georgia, North and South Carolina

This article is a part of KCET and Link TV’s “Summer of the Environment.

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Beware of Green Dot Debit Card Scam Targeting Yaz Settlement Recipients

Some women who have suffered real injuries as a result of using Yaz, Yasmin, Gianvi and Ocella birth control are being injured again as con men who claim to be from a settlement center are inducing women to send money so they can receive their settlement funds back.

According to Attorney Jason T. Brown, of The JTB Law Group, LLC in Jersey City, NJ, if you ever have to send money to receive money it is a scam. No attorney or law firm or anyone associated with the Yaz Lawsuit and Yasmin Litigation will ever ask anyone to send in money before receiving settlement funds. If someone is approached by anyone in any context asking to send in money, take down all their information, but do not give out any information about yourself over the phone.

$1.4 billion settlements

In 2013, Bayer paid out $1.4 billion in Yaz lawsuit settlements. Attorney Brown, a former FBI Special Agent said, “If you have a lawyer, contact them about your case. If someone asks you to send money before you can receive money it is probably a scam. Contact law enforcement to issue a police report. The sooner the bad people are caught the better for everyone.”

Reloadable debit cards- especially the top-selling, legitimate Green Dot cards — and the new money moving method of choice for scammers.

According to a recent report from Fox News Investigative Reporter Beau Berman in Hartford, CT, once money is sent to these people, they will keep trying to call to get more money.

Some of the defining characteristics of the alleged scam seem to be targeting women who have allegedly been injured by Yaz, Yasmin or Ocella and possibly gaining information from the public filings in court.

The only injuries that lawyers are currently pursuing are embolic events such as:

  • Deep vein thrombosis
  • Pulmonary embolism
  • Stroke
  • Heart attack and
  • Death from Yaz and other fourth generation hormones.

Injuries outside of this range are unlikely to qualify for any settlement. Settlements for women who have allegedly endured a Yaz DVT, Yaz PE, Yaz Death, Yasmin DVT, Yasmin PE, Yasmin Death and Ocella DVT, Ocella PE, or Yaz Death have exceeded over $1 billion according to Page 64 of Bayer’s Quarterly Report.

Popular with Millennials

The debit cards are popular with Millennials, according to Thea Garon of the Center for Financial Services Information manager, especially among millennials. She goes on to suggest that millennials and other generational members will see the lines blur between traditional checking accounts and prepaid debit cards.

The alleged scammers then say they have $7,500 Yaz settlement money in exchange for money sent through a green dot money pack card.

No attorney should make a client engage in such actions to receive settlement funds. All attorneys will go over the settlement process and will pay funds in injury matters if successful.

Consumer rights attorney Jason T. Brown stated, “In almost any and every context if someone owes you money, you shouldn’t have to send money to receive money. If you haven’t obtained counsel for your Yasmin lawsuit injuries, you should vet your counsel by going to sites like AVVO and Martindale-Hubbell which have client and peer reviews and issue a ranking based on a matrix of factors.”

It’s a shame that crime permeates through every walk of life, but it’s particularly troubling that criminals prey on women who have already been allegedly victimized by bad birth control side effects. Attorney Brown suggested, “Once again, if you already have a Yaz lawyer, speak with your attorney if you are approached by anyone you don’t know about your case. If you don’t have a Yasmin lawyer, speak with a Yaz lawyer who can educate you on your rights as well as guide you if approached by these scam artists.”

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Defective Airbag Maker Takata Files for Bankruptcy

Flying shrapnel from Takata airbag explosion.
Flying shrapnel from Takata airbag explosion.

Update: Plaintiff lawyers told a U.S. bankruptcy court judge that  Takata Corp.’s restructuring plan is being skewed to benefit automakers over the victims of exploding air bags.

Japanese air bag maker Takata Corp. has filed for bankruptcy protection in Tokyo and the U.S., overwhelmed by lawsuits and recall costs of its faulty airbag inflators that are connected to the death of at least 16 people, according to the Associated Press.

Takata said that rival Key Safety Systems of suburban Detroit will buy its assets for $1.6 billion.

In addition to the fatalities, the defective airbags caused at least 180 injuries and touched off the largest automotive recall in U.S. history.

The solid chemical propellant used in Takata airbags deteriorates over time, particularly under high humidity. This builds up excessive pressure in the metal inflator housing, causing it to rupture. When the air bag deploys, metal shrapnel launches through the bag and at the occupants in the vehicle, according to lawyer Kim Adams.

Nearly eight million vehicles by 10 different manufacturers may be affected, according to Consumer Reports. They include vehicles made by:

  • Acura
  • BMW
  • Chrysler
  • Dodge
  • Ford
  • General Motors
    • Buick
    • Cadillac
    • Chevrolet
    • GMC
    • Pontiac
  • Honda
  • Infiniti
  • Lexus
  • Mazda
  • Nissan
  • Subaru
  • Toyota

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Jury Awards Nearly $218 Million to Kansas Corn Producers In First Syngenta GMO Corn Class Action Lawsuit

A Kansas jury sided with Kansas corn producers in the first of eight certified state class action lawsuits involving the nation’s corn growers’ claims that Switzerland-based Syngenta’s actions with its genetically modified strains of corn led to the loss of an important market for U.S. corn and causing them economic harm.

After a half day of deliberation, the jury found Syngenta negligent and awarded $217,700,000 in compensatory damages to the class of more than 7,000 Kansas corn growers, who were represented in the lawsuit by four Kansas corn producer plaintiffs. (Five Star Farms et al v. Syngenta AG et al, No. 2:14-cv-02571)

 The Kansas plaintiffs alleged they suffered significant economic damages when Syngenta sold two genetically modified strains of its corn seed – Agrisure Viptera and Agrisure Duracade – to the U.S. market prior to China approving them.

Refusing all shipments of U.S. corn in 2013

China, a major importer of U.S. corn, began refusing all shipments of U.S. corn in 2013 after a genetic trait found in Viptera – MIR162 – was detected in shipments from the United States. The genetic trait at the time was not approved in China. With the loss of the Chinese market, corn growers in Kansas and across the United States saw the price of corn plummet and suffered long-lasting economic damage, according to the lawsuit.

The plaintiffs were represented by Don Downing of Gray, Ritter & Graham, P.C., Scott Powell of Hare, Wynn, Newell & Newton, Patrick Stueve of Stueve Siegel Hanson LLP and William Chaney of Gray Reed & McGraw LLP.

The four co-lead counsel issued a statement: “The verdict is great news for corn farmers in Kansas and corn growers throughout the country who were seriously hurt by Syngenta’s actions. This is only the beginning.  We look forward to pursuing justice for thousands more corn farmers in the months ahead.”

The Kansas class action lawsuit, which began June 5, was heard in the U.S. District Court for the District of Kansas.  It is the first of eight state class action lawsuits certified in this Multi-District Litigation so far.  The other certified state class action lawsuits involve Arkansas, Missouri, Illinois, Iowa, Nebraska, Ohio, and South Dakota corn producers.  Numerous other state class action lawsuits in this matter are awaiting certification.

Nationwide, losses to U.S. corn growers due to the loss of the Chinese market are estimated to exceed $5 billion.

SOURCE Hare, Wynn, Newell & Newton LLP of Birmingham, AL.

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First on the House Agenda: HR 985 Raises the Bar Class on Actions

The House of Representatives moves quickly to curtail victims’ rights.

By Jesse Jensen, Esq. Reprinted with permission.

As recognized by the Supreme Court, class action lawsuits play an invaluable role in protecting investors, consumers, and employees by “overcom[ing] the problem that small recoveries do not provide the incentive for any individual to bring a solo action prosecuting his or her rights.” Amgen Inc. v.
Conn. Ret. Plans & Tr. Funds, 133 S. Ct. 1184, 1202 (2013).

Yet even after the wave of populist outcry that dominated the
2016 election, the newly-elected majority in the US House of Representatives passed as one of its first acts this year a bill striking at the heart of people’s rights to class action litigation.

The bill — the so-called “Fairness in Class Action Litigation Act of 2017” (H.R. 985) — seeks to frustrate class actions brought by consumers, employees, and investors while tipping the scales in favor of corporate defendants.

A remarkable coalition of consumer rights groups, civil rights advocates, and members of the legal community have united in opposition to H.R. 985. Nonetheless, the House majority passed H.R. 985 without permitting even a single hearing on its merits, and this dangerous and much-criticized legislation now resides with the Senate.

H.R. 985’s radical effects

Author Jesse Jensen is an attorney in the New York office of Bernstein Litowitz Berger & Grossman LLP
Author Jesse Jensen is an attorney in the New York office of Bernstein Litowitz Berger & Grossman LLP

Close examination of H.R. 985 reveals that, far from promoting “fairness,” the bill relies on creative methods to delay, and ultimately dismantle, class action lawsuits.

For example, courts currently permit lawsuits to proceed as class actions only if (among other requirements) the proposed class representative shows that its claims, including its injury, are “typical” of the class’s claims. H.R. 985, however, would prohibit class actions unless the plaintiff demonstrates that each proposed class member suffered “the same type and scope of injury.”

In many types of class actions, this provision could radically pare down what a “class” could be, because the same wrongdoing may injure large groups of consumers or workers to different degrees. For instance, the same dangerous prescription medication may manifest side effects that differ in scope.

While one patient may suffer a lethal heart attack, another may suffer a debilitating stroke. This provision of H.R. 985, however, could be interpreted to rob from the victims of that defect their ability to band together against the pharmaceutical company, even though all suffered from the same faulty medication.

Moreover, H.R. 985 does not explain how precisely a class representative could demonstrate that all of the class members suffered “the same type and scope of injury.” Ultimately, courts could spend years of litigation attempting to settle on an accepted meaning of this restrictive requirement — preventing adjudication of the merits, and any relief to pending classes, in the meantime.

Other provisions of the bill also transparently seek to manufacture delay. For instance, while appellate courts currently have discretion as to when they will hear appeals of class certification decisions, H.R. 985 would require appellate courts to hear all appeals of class certification decisions, no matter how frivolous.

This element of H.R. 985 caught experienced legal scholars and practitioners by surprise, as little-to-no commentary had suggested that appellate courts have failed to oversee appropriately district court rulings on class certification. By unnecessarily burdening appellate courts, this provision of H.R. 985 would add further time and expense to the class certification process.

Near-universal criticism

Other than the US Chamber of  Commerce — the highest-spending lobbying group in the United States — H.R. 985 has received no notable endorsement. Instead, the bill has faced widespread denunciation, including by dozens of consumer, labor, environmental, disability, investor and civil rights advocacy groups, all of whom expressed concern with how the bill would stymie the enforcement of individual legal rights. This disparate alliance includes such prominent organizations as:

  • The AFL-CIO
  • National Disability Rights Network
  • Southern Poverty Law Center

Even beyond this pervasive concern over the bill’s impact, several legal commentators have criticized the bill for fundamentally disregarding Congress’s own acknowledgment that federal courts themselves are best positioned to make rules governing their procedures.

For example, on March 8, 2017, the American Bar Association — a prominent nonpartisan professional association of legal professionals — noted in a public letter to members of the House that H.R. 985 would interfere with the efforts to improve class action procedures already in progress by the policy-making body for the federal courts, the Judicial Conference of the United States, all while wasting judicial resources and unnecessarily delaying and denying claims.

Public outcry

Fortunately, public outcry forced the elimination of one of the bill’s most onerous (and arguably unconstitutional) provisions. The bill’s sponsor, House Judiciary Committee Chairman Bob Goodlatte (R-VA), voluntarily removed from the legislation a provision that would have forbidden any class representative from being represented by any counsel who had previously served as counsel for the class representative in a different class action.

Nonetheless, even this pared-back version of the bill could not garner a single Democratic vote in the House, and even failed to capture over a dozen Republican votes. Ultimately, however, the substantial GOP House majority advanced the bill to the Senate in March 2017, where it has since been referred to the Senate Committee on the Judiciary.

Since that time, the Senate has apparently shown no urgency with respect to the legislation, leaving unclear H.R. 985’s fate. Last year, the Senate Judiciary Committee refrained from acting on similar anti-class action legislation, also introduced by Rep. Goodlatte. Many commentators believe that, even if H.R. 985 moves forward to the Senate floor, it will face greater scrutiny — and likely revision — than it did in the House.

Ultimately, perhaps the biggest wildcard facing H.R. 985 is whether the new President will attempt to play any role in its future, and what that role would be.

H.R. 985 threatens to erect unnecessary,  costly, and time-consuming barriers to class actions nationwide, and the House of Representatives disappointed the country in making its passage one of its first priorities this year. With the bill now in the Senate’s control, legal experts, advocacy groups, institutional investors, and others should remain vigilant regarding this anti-consumer legislation.


Jesse Jensen is an Attorney in the New York office of Bernstein Litowitz Berger & Grossmann LLP (www.blbglaw.com). He can be reached at jesse.jensen@blbglaw.com and 212.554.1584.

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C.R. Bard Settles 75 Transvaginal Mesh Lawsuits

C.R. Bard, Inc. has reportedly settled another batch of transvaginal mesh lawsuits that were part of the federal multidistrict litigation underway in West Virginia federal court. Terms of this agreement remain confidential.

Some 5,700 product liability claims are pending against C.R. Bard in the U.S. District Court, Southern District of Western Virginia, where federal lawsuits involving the company’s transvaginal mesh devices are before U.S. District Judge Joseph R. Goodwin. Judge Goodwin is also presiding over multidistrict litigation involving pelvic mesh devices manufactured by:

  • American Medical Systems, Inc.
  • Ethicon, Inc.,
  • Boston Scientific Corp.,
  • Cook Medical, Inc.
  • and Coloplast Corp.

Judge Goodwin dismissed 75 C.R. Bard vaginal mesh lawsuits on Monday, all with prejudice.  Court records show that the dismissed cases have been “compromised and settled” for an undisclosed amount, according to Law360.com.

This is just the most recent transvaginal mesh settlement reported in the C.R. Bard litigation. In April, Judge Goodwin dismissed 149 cases that were also compromised and settled for undisclosed amounts.

Bloomberg News reported in July 2015 that C.R. Bard had spent $200 million to resolve 3,000 transvaginal mesh lawsuits. Plaintiffs involved in that accord each reportedly received $67,000. A smaller group of cases had been settled the previous year for about $43,000 per plaintiff.

TVM Dangers

Transvaginal mesh is used to surgically treat women suffering from pelvic organ prolapse and stress urinary incontinence.  In 2008, the  U.S. Food & Drug Administration (FDA) warned that such devices had been implicated in more than 1,000 serious injury reports during the previous three-year period.

In July 2011, the agency disclosed that it had received more than 2,800 more adverse event reports related to the products, including cases of injury, death, and malfunction. Over 1,500 incidents were associated with pelvic organ prolapse repairs, while 1,371 were associated with stress urinary incontinence repairs.

The FDA’s 2011 alert also noted that the agency no longer considered transvaginal mesh complications following prolapse repair to be rare, the reverse of its previous position. The FDA also expressed doubt that prolapse repair with transvaginal mesh offered any added benefits compared to traditional non-mesh repair.

Just last year, the FDA issued new rules that, among other things, made transvaginal mesh implants ineligible for the agency’s 510(k) clearance program. This program allows a medical device to come to market in the absence of human clinical trials when a manufacturer can show a device is “substantially equivalent” to another product previously approved by the FDA.

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NJ Designates State Lawsuits over Stryker LFIT V40 Femoral Heads as Multicounty Litigation

LFIT V40 Femoral Head Recall
LFIT V40 Femoral Head

New Jersey’s chief justice on May 16 assigned state lawsuits over the Stryker LFIT Anatomic Cobalt Chromium (CoCr) V40 femoral heads into a multicounty litigation docket.

The court assigned the artificial hip cases to Judge Rachelle Harz of the Bergen County Superior Court, In Re:  Stryker LFIT Anatomic CoCr V40 Femoral Heads Litigation, No. 624, N.J. Superior Court in Bergen County, NJ.

Separately, 36 federal LFIT cases were centralized in April into MDL 2768 in US District Court for the District of Massachusetts.

Chief Justice Judge Harz issued an initial case management order on May 22.  The first trial conference is set for June 21. The multicounty litigation was sought by 25 plaintiffs.

Motion follows recall

The Stryker LFIT was voluntarily recalled in August by Howmedica Osteonics Inc. when some taper locks failed. Plaintiffs allege that the part can fret and corrode, releasing metal particles and posing a risk of metallosis, necrosis, osteolysis and higher levels of cobalt and chromium in the bloodstream.

Howmedica opposed consolidation, saying existing cases are being effectively coordinated by Judge Harz.  It suggested that if cases are consolidated, they be limited to cases involving the recalled LFIT V40 femoral heads that show taper lock failure.

The motion was filed by plaintiff attorney Ellen Relkin of Weitz & Luxenberg in New York.

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67 Ethicon Physiomesh Lawsuits Consolidated into MDL in Atlanta

Ethicon hernia mesh physiomesh
The lawsuits charge that the devices implanted in their bodies were defectively designed or manufactured, and that the defendants failed to give appropriate warnings and instructions about the dangers posed by these devices.

The JPMDL consolidated all Ethicon Physiomesh Flexible Composite Hernia Mesh litigation in the federal courts before Judge Richard W. Story in the Northern District of Georgia.

About 70 actions were pending in 36 district courts, and dozens of law firms are involved in this litigation. The docket will be in MDL No. 2782.

The JPMDL (Judicial Panel on Multidistrict Litigation) ruled that all the actions share common factual questions about defects in defendants’ Physiomesh hernia mesh, which can lead to complications when implanted in patients, including herniation through the mesh, recurrent hernia formation and/or rupture, and deformation of the mesh.

Many plaintiffs charge that the multi-layer coating in Physiomesh prevented adequate incorporation of the mesh into the human body, and caused to a variety of serious complications and that the polypropylene mesh part of the Physiomesh was insufficient to withstand normal abdominal forces.

Ethicon argued unsuccessfully that individual factual issues will predominate about the wide variety of alleged injuries, causation, and the timing of each plaintiff’s injury as it relates to the warnings
given with the product and the applicable statute of limitations. The JPMDL has rejected the argument
that products liability actions must allege identical injuries to call for centralization. See, for example, In
re: Cook Medical, Inc., IVC Filters Mktg., Sales Practices & Prods. Liab. Litig., 53 F. Supp. 3d
1379, 1381 (J.P.M.L. 2014).

 

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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, an attorney with Drinker, Biddle & Reath in Florham Park, N.J.

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