Doc Who Promoted Testosterone Must Reveal Payments from Drug Defendants

Dr. Abraham Morgentaler, the Director of Men’s Health Boston
Dr. Abraham Morgentaler, the Director of Men’s Health Boston.

US District Judge Matthew F. Kennelly in the Northern District of Illinois ordered a notorious doctor who promoted testosterone replacement therapy for 30 years to turn over his tax records showing how much he was paid by the drug’s manufacturers.

The case is In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545.

The plaintiffs charge that the drug makers misrepresented that AndroGel is a safe and effective treatment for hypogonadism and a condition they referred to as “low testosterone,” when in fact the drug causes serious medical problems, including life-threatening cardiac events, strokes, and thrombolytic events.

AndroGel, a testosterone drug manufactured by AbbVie, causes the hematocrit level to increase, thereby thickening the blood. This effect, if not monitored and controlled properly, can lead to life-threatening cardiac events, strokes and thrombolytic events. Defendants failed to adequately warn physicians about the risks associated with the AndroGel and the monitoring required to ensure their patients’ safety.

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

Must reveal payoffs

Morgentaler must now reveal:

  • Written agreements and 1099 tax statements about money received from defendants AbbVie Inc., Abbott Laboratories Inc., Eli Lilly and Co., Actavis, Inc., Auxilium Pharmaceuticals, Inc., and Pfizer, Inc.
  • Powerpoint slides and presentation notes referring to testosterone replacement therapy (TRT) going back 7 years.
  • All documents and communications relating to the risks and benefits of TRT with the defendants going back 3 years.

Judge Kennelly’s ruling ends Morgantaler’s battle against a subpoena from the plaintiffs’ steering committee, which has portrayed the doctor as actively shaping “the science, marketing, and use of TRT products involved in these MDL proceedings.”

Abbvie alone spent $20 million from August 2013 to December 2015 in payments to doctors to promote TRT, according to ProPublica’s Dollars for Docs database. During the same time period, Morgentaler took $73,056 in payments from various drug companies.

Morgentaler founded the Androgen Study Group, which reviews studies about TRT. He must now produce all documents regarding the Group as well as a March 29, 2014 letter to Howard Bauchner, MD, Editor-in-Chief of JAMA recommending retraction of an article “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels.” The article by Rebecca Vigen, MD was published anyway in JAMA’s Nov. 13, 2013 issue.

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Brazilian Health Insurers Sue Boston Scientific, Arthrex and Zimmer Biomet Over Kickbacks to Doctors

boston scientificAn association of 177 health insurance companies and medical providers in Brazil sued Boston Scientific Corporation, Arthrex, Inc. and Zimmer Biomet Holdings, Inc. in US federal court, charging that the companies paid millions in kickbacks to doctors so they would use their medical products — regardless of the need or cost of the products.

Abramge (short for Associação Brasileira De Medicina De Grupo) is an organization that represents the health insurers and medical service providers in a complaint filed in US District Court in Delaware, Case. No. Case 1:16-cv-01184-GMS.

Brazil has the second-largest private health insurance market by population in the world after the US. The doctors were paid a 20% to 40% commission for using the companies’ medical devices, according to the complaint. The corrupt doctors induced Brazilian the medical providers to (1) buy medically unnecessary amounts of Defendants’ devices; (2) conduct unnecessary medical procedures, in order to use more of Defendants’ products; and (3) overbill insurers for Defendants’ products and medical procedures.

The “Prosthetic Mafia”

The Brazilian television news program Fantastico (similar to 60 Minutes) featured a series of reports in January 2015, showing Brazilian medical device distributors offering secret cash commissions to an undercover reporter posing as a Brazilian surgeon. This caused the National Congress of Brazil to conduct  hearings investigating the corruption by the “Prosthetic Mafia.”

The final report issued by the Brazilian congress found that the improper payments have “grown alarmingly” and that the fraudulent scheme was “endangering the lives of patients in favor of the companies’ profit.”

The defendants are:

  • Boston Scientific Corporation is a Delaware corporation headquartered in Massachusetts. It manufactures a vast array of products used in a range of interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology. Boston Scientific is a known for its stents, implantable cardioverter defibrillators, pacemakers, stents and spinal cord stimulator systems.
  • Arthrex, Inc. is a Delaware corporation headquartered in Florida. Arthrex manufactures implants for sports medicine and joint prosthetics. It also develops and manufactures orthobiologics, which are substances many orthopaedic surgeons use to assist in the healing process of injuries.
  • Zimmer Biomet Holdings, Inc. is a Delaware corporation headquartered in Indiana. It manufactures and markets orthopedic products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses.

Phony consulting agreements

The Brazilian Federal Police investigated the kickback scheme, launched in 2006, leading to the indictment of distributors and doctors in Brazil. A prominent São Paulo hospital studied the difference in certain medical procedures before and after the public disclosure of the medical device scandal and found a 30% reduction in those procedures.

According to the complaint, sales representatives working for Boston Scientific would approach doctors and offer to pay a fee for every Boston Scientific device or product the doctor used. The doctors signed phony consulting agreements to legitimize the bribery.

In one example Signus, on behalf of Boston Scientific, approached three doctors and paid them $27,000 per month for using its products. During six months from June to December 2012, the kickbacks totaled $189,000.

Back in the US in 2009, Boston Scientific agreed to pay $22 million to settle allegations brought by the Department of Justice that it paid kickbacks to doctors to participate in post-market studies, in order to boost sales of Boston Scientific pacemakers and defibrillators. Further, in 2011, two former employees of Boston Scientific filed a lawsuit in the District of New Jersey alleging that Boston Scientific paid kickbacks to doctors to encourage use of Boston Scientific’s spine products.

“Both of these instances are strikingly similar to what Plaintiff has discovered Boston Scientific has been doing in Brazil,” the complaint says. Arthrex and Zimmer Biomet are accused of similar acts.

In fact, on March 26, 2012, Biomet entered into a Deferred Prosecution Agreement with the DOJ and a Consent to Final Judgment with the U.S. Securities and Exchange Commission to end investigations into Biomet’s violations of the Foreign Corrupt Practices Act. Biomet was bribing doctors in Brazil as part of its marketing and sales strategy in that country.

The complaint, filed by attorney Karen B. Skomorucha Owens of Ashby & Geddes in Wilmington, Delaware, seeks damages for fraud, conspiracy, tortious interference, negligent misrepresentation and unjust enrichment.

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Bristol-Meyers and Pfizer Seek MDL for Eliquis Blood-Thinner Litigation

eliquis-5mg-60slblBristol-Meyers Squibb Company and Pfizer Inc. have filed a motion to create new MDL No. 2757 in New York to hear Eliquis (Apixaban) products liability litigation. The US Judicial Panel on Multidistrict Litigation (JPMDL) will hear the motion Jan. 26 in Miami.

This litigation currently consists of 34 related actions filed in 13 different federal districts. The companies propose the cases be consolidated in the Southern District of New York, where judges are handling 27 MDLs, notably two prominent product liability MDLs for Rezulin and Fosamax.

The plaintiffs allege that they suffered various bleeding-related injuries as a result of taking Eliquis after their physicians prescribed it, and charge that the defendants failed to warn adequately about the risk of bleeding and that the defendants should not have sold Eliquis without precautions for blood monitoring or an additional drug to reverse its anticoagulant effect.

As safe as aspirin?

Eliquis thins the blood, prevents the formation of blood clots, and significantly decreases the risk of stroke in patients with atrial fibrillation and certain other conditions. Atrial fibrillation is a common arrhythmia (abnormal heart beat) that causes blood clots to form in the heart. Eliquis was designed to replace warfarin.

The companies claim that Eliquis “is no less safe than a daily aspirin.” The FDA approved Eliqius in December 2012. The Eliquis label carries a warning that the medication “can cause serious, potentially fatal bleeding,” that there “is no established way to reverse the anticoagulant effect of apixaban,” and that “[a] specific antidote for Eliquis is not available.”

The first lawsuit was filed August 4, 2015, and plaintiff’s counsel have promised they intend to file many more cases.

For example, the complaint in Charlie Utts and Ciara Utts  v. Bristol-Myers Squibb Company and Pfizer Inc.Case 1:16-cv-05668-DLC (S.D.N.Y) alleges that the companies:

  • Failed to provide adequate warnings about the increased risk of gastrointestinal bleeds in those taking Eliquis, especially, in those patients with a history of gastrointestinal issues and upset;
  • Failed to provide adequate warnings about the increased risk of suffering a bleeding event, requiring blood transfusions in those taking Eliquis;
  • Failed to provide adequate warnings about the need to assess renal functioning before starting a patient on Eliquis and to continue testing and monitoring of renal functioning periodically while the patient is on Eliquis.
  • Failed to provide adequate warnings about the need to assess hepatic functioning prior to starting a patient on Eliquis and to continue testing and monitoring of hepatic functioning periodically while the patient is on Eliquis.

The companies requested the MDL be set in New York because their headquarters, witnesses and documents are there. Almost half of the lawsuits have been filed in New York. The JPMDL has centralized product liability litigation for other anticoagulants including Pradaxa and Xarelto. The Pradaxa litigation culminated in 2014, while the Xarelto MDL has been ongoing for nearly two years.

Attorneys Loren H. Brown of New York and Matthew A. Holian of Boston, both with DLA Piper, filed the motion.

 

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Plaintiffs in Proton-Pump Litigation Seek MDL in Louisiana

nexium-b-1The Judicial Panel on Multidistrict Litigation will decide at a hearing on Jan. 26 in Miami whether to create a new MDL 2757 in Louisiana to consolidate dozens of lawsuits nationwide filed against manufacturers of proton pump inhibitor (PPI) heartburn medicines.

15 actions are pending in 12 different United States District Courts. Plaintiffs’ counsel have over 5,000 Proton-Pump Inhibitor possible cases under investigation and expect to file nearly 100 new lawsuits in the coming weeks.

PPIs are a group of drugs intended to act as hydrogen potassium ATPase (“H+/K+ ATPase”) enzyme inhibitor to block the production of gastric acid. The plaintiffs were prescribed a PPI by a physician and were later diagnosed with kidney injuries including acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure, also known as end-stage renal disease (ESRD). The complaints charge negligence, design defect, failure to warn, fraudulent concealment, warranty claims, and loss of consortium.

The defendants include:

  • AstraZeneca Pharmaceuticals LP
  • AstraZeneca LP
  • AstraZeneca PLC
  • Pfizer, Inc.
  • Procter & Gamble Manufacturing Company
  • The Procter & Gamble Company
  • Takeda Pharmaceuticals USA, Inc.
  • Takeda Pharmaceuticals America, Inc.
  • Takeda Pharmaceuticals International, Inc.
  • Takeda Development Center Americas, Inc.
  • Takeda Pharmaceutical Company Limited

Initial symptoms can be non-specific, such as fatigue, nausea and weakness. However, failure to treat interstitial nephritis (AIN) can lead to kidney death, dialysis, a kidney transplant or death.

The plaintiffs recommended the MDL be created in the federal Middle District of Louisiana in Baton Rouge before Chief Judge Brian A. Jackson, Judge Shelly D. Dick, Judge John W. deGravelles or Senior Judge James Joseph Brady. Alternatively, they would accept venues including the District of New Jersey, Southern District of Illinois, the District of Kansas or the Western District of Louisiana.

The motion was filed by Paul J. Pennock of Weitz & Luxenberg in New York.

 

 

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Pharma and Med Device Companies Pay Doctors $2 Billion for “Consulting”

bribe doctor kickbackEven though it is illegal to pay kickbacks to doctors, pharmaceutical and medical device companies are paying $2 billion in general payments to 618,000 physicians each year, in addition to another $600 million a year to teaching hospitals, according to a ProPublica database.

General payments cover promotional speaking, consulting, meals, travel, gifts and royalties, but not research, as shown in its Dollars for Docs database.

The 10 drugs for which companies spent the most in payments to physicians in 2015 — many of which are targets of mass tort litigation —  were:

  1. Blood thinner Xarelto ($28.4 million).  In Re: Xarelto Products Liability Litigation in Philadelphia, hundreds of plaintiffs charge that the blood-thinning drug caused gastrointestinal bleeding, hemorrhagic strokes or death.
  2. Rheumatoid arthritis drug Humira ($24.9 million)
  3. Diabetes drug Invokana ($20.9 million). The Judicial Panel for Multidistrict Litigation (JPMDL) has created new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in New Jersey.
  4. Hepatitis C drug Viekira ($19.2 million)
  5. Blood thinner Eliquis ($18.8 million). Bristol-Meyers Squibb Company and Pfizer Inc. have filed a motion to create new MDL No. 2757 in New York to hear Eliquis (Apixaban) products liability litigation.
  6. Diabetes drug Bydureon ($18.5 million)
  7. Testosterone drug Androgel ($15.3 million). US District Judge Matthew F. Kennelly has set June 5, 2017, for the start of first of six AbbVie bellwether trials in MDL 2545, in the Testosterone Replacement Therapy Products Liability Litigation in the Northern District of Illinois.
  8. Thyroid drug Synthroid ($14.7 million)
  9. Synthetic hormone Lupron ($14.3 million)
  10. Diabetes drug Victoza ($11.9 million).

“We’ve shown that physicians who receive payments from the industry tend to prescribe more brand-name drugs than those who don’t. Several academic studies later had similar findings. We also recently reported that companies continue to work with thousands of doctors who have received disciplinary sanctions against their licenses,” ProPublica states.

The disclosures included in Dollars for Docs were required under the Physician Payments Sunshine Act, a part of the 2010 Affordable Care Act.

For example, Janssen has paid $106 million to 141,294 doctors in connection with Xarelto, Invokana, Risperdal and many other drugs. From August 2013 to December 2015, Janssen paid:

Richard Aguilar
Internal Medicine
Huntington, CA
$345K
Gregory Mitchell
Specialist
Annapolis, MD
$290K
Bruce Bode
Endocrinology, Diabetes & Metabolism
Atlanta, GA
$286K

 

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Leadership Counsel Named in Abilify Mass Tort Litigation

abilifyUS District Judge M. Casey Rodgers appointed plaintiff and defense leadership committees in the new MDL 2734, In re: Abilify Products Liability Litigation, Case No. 3:16-md-2734, in the Northern District of Florida.

He also set a science day on Feb. 23, 2017, when the parties make presentations explaining the science behind litigation. He invited New Jersey Superior Court Judge James DeLuca to attend. DeLuca is presiding over NJ state Abilify litigation.

To date there are 48 actions filed in the federal MDL against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc. Plaintiffs allege that Abilify, an atypical anti-psychotic medication commonly prescribed to treat schizophrenia, bipolar disorder, depression, and Tourette syndrome, can cause compulsive gambling behaviors.

The lawsuits involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

For more information read FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

Plaintiffs’ Committee Structure

Plaintiffs’ Co-Lead Counsel:

Kristian Rasmussen
Cory Watson, P.C.
2131 Magnolia Avenue South, Ste. 200
Birmingham, AL 35205
Phone: (205) 328-2200
Email: Rasmussen@CoryWatson.com

Gary L. Wilson
Robins Kaplan LLP
800 LaSalle Avenue
Suite 2800
Minneapolis, MN 55402
Telephone: 612-349-8500
Email: GWilson@RobinsKaplan.com

Plaintiffs’ Liaison Counsel

Bryan Aylstock
Aylstock, Witkin, Kreis & Overholtz, PLLC
17 E. Main Street, Suite 200
Pensacola, FL 32502
Telephone: (850) 202-1010
Email: baylstock@awkolaw.com

Plaintiffs Executive Committee

J. Gordon Rudd, Jr.
Zimmerman Reed LLP
1100 IDS Center, 80 S. 8th Street
Minneapolis, MN 55402
Phone: (612) 341-0400
Email: gordon.rudd@zimmreed.com

Lexi J. Hazam
Lieff Cabraser Heimann &
Bernstein, LLP
275 Battery Street, 29th Floor
San Francisco, CA 94111-3339
415.956.1000lhazam@lchb.com

Troy A. Rafferty
Levin, Papantonio, Thomas, Mitchell
Rafferty & Proctor P.A.
316 S. Baylen Street, Suite 600
Pensacola, FL 32502
Phone: (850) 435-7000
Email: trafferty@levinlaw.com

Plaintiffs’ Steering Committee

Behram V. Parekh
Kirtland & Packard LLP
2041 Rosecrans Ave., Third Floor
El Segundo, CA 90245
Phone: 310-536-1000
Email: bvp@kirtlandpackard.com

Chris T. Hellums
Pittman, Dutton & Hellums, P.C.
2001 Park Place N., Ste 1100
Birmingham, AL 35203
Phone: (205) 322-8880
chrish@pittmandutton.com

George T. Williamson
99 Nesbit Street
Punta Gorda, Florida 33950
Phone (941) 639-1158
gwilliamson@farr.com

Jennifer Liakos
Napoli Shkolnik PLLC
525 South Douglas Street, Suite 260
El Segundo, CA 90245
Phone: (310) 331-8224
Email: jliakos@napolilaw.com

M. Brandon Smith, Esq.
Childers, Schlueter & Smith L.L.C.
1932 North Druid Hills Road, Suite 100
Atlanta, GA 30319
Phone (404) 419-9500
bsmith@cssfirm.com

Marlene J. Goldenberg
GoldenbergLaw, PLLC
800 LaSalle Avenue, Suite 2150
Minneapolis, MN 55402
Phone: (612) 333-4662
Email: mjgoldenberg@goldenberglaw.com

Shanon J. Carson
Berger & Montague, P.C.
1622 Locust Street
Philadelphia, PA 19106
Phone: 215-875-3000
Email: scarson@bm.net

Plaintiffs’ Federal/State Liaison Counsel

Munir R. Meghjee
Robins Kaplan LLP
800 LaSalle Avenue Suite 2800
Minneapolis, MN 55402
Telephone: 612-349-8500
Email: MMeghjee@RobinsKaplan.com

Plaintiffs’ Fees and Common Benefit Fund Committee

Bryan Aylstock
Aylstock, Witkin, Kreis & Overholtz, PLLC
17 E. Main Street, Suite 200
Pensacola, FL 32502
Telephone: (850) 202-1010
Email: baylstock@awkolaw.com

Chris T. Hellums
Pittman, Dutton & Hellums, P.C.
2001 Park Place N., Ste 1100
Birmingham, AL 35203
Phone: (205) 322-8880
chrish@pittmandutton.com

Defendants’ Liaison Counsel

Larry Hill
lhill@mhw-law.com
Moore, Hill & Westmoreland, P.A.
350 West Cedar Street
Maritime Place, Suite 100
Pensacola FL 32502
Telephone: (850) 434-3541

Joint Discovery Committee

Plaintiffs
Behram V. Parekh
Kirtland & Packard LLP
2041 Rosecrans Ave., Third Floor
El Segundo, CA 90245
Phone: 310-536-1000
Email: bvp@kirtlandpackard.com

George T. Williamson
99 Nesbit Street
Punta Gorda, Florida 33950
P. (941) 639-1158
gwilliamson@farr.com

Stephen H. Echsner
Aylstock, Witkin, Kreis &
Overholtz, PLLC
17 E. Main Street, Suite 200
Pensacola, FL 32502
Phone: 850-202-1010

Stephen Hunt, Jr.
Cory Watson, P.C.
2131 Magnolia Avenue South, Ste. 200
Birmingham, AL 35205
Phone: (205) 328-2200
Email: Shunt@CoryWatson.com

Bristol-Myers Squibb Company
Lauren Colton
Hogan Lovells US LLP
100 International Drive, Suite 200
Baltimore, Maryland 21202
410-659-2700
lauren.colton@hoganlovells.com

Matthew Eisenstein
Arnold & Porter LLP
601 Massachusetts Ave, NW
Washington, DC 20001
202-942-6606
matthew.eisenstein@aporter.com

Otsuka Pharmaceutical Co. Ltd. & Otsuka America Pharmaceutical Inc.
(“the Otsuka Defendants”)

Luke A. Connelly
Winston & Strawn LLP
200 Park Avenue
New York, NY 10166-4193
T: 212-294-6882
LConnell@winston.com

Matthew A. Campbell
Winston & Strawn LLP
1700 K St. NW
Washington, DC 20006-3817
T: 202-282-5848
MACampbe@winston.com

Joint Settlement Committee

By January 30, 2017, the Joint Settlement Committee must propose a settlement master or inform the Court if they are unable to reach an agreement on a settlement master, in which case, each side (Plaintiffs and Defendants) should propose a settlement master.

Plaintiffs

Ernest Cory
Cory Watson, P.C.
2131 Magnolia Avenue S., Ste. 200
Birmingham, AL 35205
Phone: (205) 328-2200
Email: ECory@CoryWatson.com

Tara D. Sutton
Robins Kaplan LLP
800 LaSalle Avenue
Suite 2800
Minneapolis, MN 55402
Telephone: 612-349-8500
Email: TSutton@RobinsKaplan.com

Bristol-Myers Squibb Company

Anand Agneshwar
Arnold & Porter LLP
399 Park Avenue
New York, NY 10022
212-715-1107
anand.agneshwar@aporter.com

The Otsuka Defendants
Matthew A. Campbell
Winston & Strawn LLP
1700 K St. NW
Washington, DC 20006-3817
T: 202-282-5848
MACampbe@winston.com

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Viagra Skin Cancer MDL Expanded to Include Cialis

melanomaThe US Judicial Panel on Multidistrict Litigation expanded MDL 2691 Viagra (Sildenafil Citrate) Products Liability Litigation to include claims against Eli Lilly and Company, the manufacturer of Cialis, alleging that the erectile dysfunction drug causes melanoma, or skin cancer.

Both drugs work the same way by inhibiting an enzyme known as phosphodiesterase type 5, 1 or PDE5. Three studies link this action to increasing melanoma cells. Pfizer is the manufacturer of Viagra.

The MDL was created on April 7, 2016 and grew from 35 cases in May to 246 cases in December, 2016. US District Judge Richard Seeborg is supervising the MDL in the Northern District of California in San Francisco.

Pfizer knew of the risks

Among the plaintiff cases is Sue Matthews, Individually and as Personal Representative of the Estate of Robin Matthews v. Pfizer Inc., Case No.: 3:16-md-02691-RS. It charges that Pfizer knew of the significant risks of developing melanoma caused by Viagra, but the company did not adequately and sufficiently warn consumer or the medical community.

Robin Matthews of Virgin, Utah, took Viagra from 2005 to 2012. On Sept. 23, 2013 he went to urgent care for abdominal pain and doctors discovered melanoma lesions on his liver, kidneys, spleen, adrenal glands and lymph nodes. A MRI on Oct. 11, 2013 showed the cancer had spread to his bones and lungs. On Oct. 22 he died due to metastatic malignant melanoma.

The FDA approved Viagra on March 27, 1998. By 2012 doctors had written prescriptions for Viagra to more than 35 million men worldwide, producing worldwide revenue of $1.8 billion.

  • A study published in 2011 found that treatment with Viagra can promote melanoma cell invasion. Specifically, by inhibiting PDE5, Viagra mimics an effect of gene activation and may potentially function as a trigger for the creation of melanoma cells.
  • A 2012 study published in the Journal of Cell Biochemistry also found that PDE5 inhibitors were shown to promote melanin synthesis, which may exacerbate melanoma development.
  • On April 7, 2014, an original study (“the JAMA study”) was published on the website for the Journal of the American Medical Association Internal Medicine which, in light of the earlier studies, sought to examine the direct relationship between sildenafil use and melanoma development in men in the United States. The JAMA study was published in the journal’s June 2014 edition. The study found that 25,848 participants who had recently used sildenafil exhibited an 84% increase in risk of developing or encouraging invasive melanoma.

“Despite these significant findings, Defendant has made no efforts in its ubiquitous Viagra advertisements to warn users about the potential risk of developing melanoma that has been scientifically linked to its drug,” the complaint alleges.

 

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Stryker Expands $1 Billion Defective Hip Settlement to Hundreds of New Claimants

Stryker Rejuvenate Hip-Replacement-5Expanding a $1 billion settlement struck two years ago, Stryker Corp. and Howmedica Osteonics Corp. have agreed to compensate hundreds of additional claimants who had defective metal hips implanted and removed from Nov. 2014 to Dec. 19, 2016.

  • Stryker now faces 1,794 product liability cases consolidated into MDL 2441 before US District Judge Donovan W. Frank concerning its Rejuvenate and ABG II Hip Implant Products.
  • Also, a second wave of plaintiffs for hip implant cases is emerging for injuries related to the LVIT v40 Femoral Head component recall. Stryker issued  an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

$300,000 base settlement

Eligible claimants will receive a base award of $300,000 for each revised hip. Unrepresented claimants are eligible for 71% of the base award, or $213,000. Reductions will be made for obesity, smoking and age, according to the settlement. Settlements may be increased up to $550,000 under an enhanced benefit program, for re-revision surgery, related additional surgery,  dislocation of the femoral head of the hip, infections, inability to lift the front part of the foot, and pulmonary embolism or deep vein thrombosis during hospitalization,

The MDL Plaintiffs’ committee, chaired by Peter J. Flowers of Meyers & Flowers of Chicago, reached a new settlement agreement in ongoing litigation against Stryker and Howmedica over the defective Stryker Modular Rejuvenate and ABG II Femoral Hip Implants. This new settlement encompasses patients who had the hip replacement system implanted and then removed after November 2014.

About 20,000 people were implanted in the US with the Rejuvenate and ABG II hip replacement. The settlement, much like the historic, unlimited compensation fund of more than $1 billion in restitution established in late 2014, is once again an unlimited fund for this new set of plaintiffs injured by these metal-on-metal hip replacement devices.

The global settlement includes plaintiffs from across the U.S. who underwent painful revision surgeries since the fall of 2014 to remove the defective devices regardless of if they filed a case in state or federal court. Settlement payments are expected to be distributed starting in 2017.

“This settlement is the latest chapter in the ongoing litigation against Stryker and Howmedica for the extensive, at-times crippling injuries of our clients, many of whom have experienced life-altering pain and disabilities due to these hip devices,” said Flowers. “Our continuing and tireless negotiations bring a degree of relief to these clients as well as hope to future victims of defective devices.”

Victims step forward in 2010

Flowers has spent decades litigating cases against Stryker and similar device manufacturers for their defective medical products. In 2010, he began to hear from victims of hip replacement injuries that echoed past metal-on-metal friction cases he dealt with in the Depuy Orthopedics of Johnson & Johnson recall lawsuits.

Stryker issued recalls for its Modular Rejuvenate and ABG II Femoral Hip Implants in July 2012 when he was already representing many clients who had been injured by these devices, even while the company continued to sell them.

The Stryker hip replacement devices had four components: the femoral stem, modular neck, ball and an acetabular cup. Once implanted, the metal components began to wear causing friction and metal shards to release toxins into the bloodstream.

During a hip replacement, the device stem is implanted in the femur bone. When the device fails or needs to be removed, the femur bone often has to be fractured, resulting in mobility issues that can last for six to eight months as well as painful side effects and extensive periods of rehabilitation.

“The ripple effect that has been seen year after year from these defective hip replacement devices is truly outrageous,” said Flowers. “When medical device makers put profit before patient safety, we all suffer. There are devastating consequences to the victim, their family, and community as well as the overall economy and the government, which is why protecting these injured parties is so essential.”

 

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Plaintiffs Resist Move to Oust Non-Residents in California Plavix Cases

Plavix bleeding side effectsPlaintiffs in California litigation over deadly side effects of the anti-clotting drug Plavix called on the US Supreme Court to uphold a ruling that 592 out-of-state residents can remain as plaintiffs.

In September the California Supreme Court ruled that its state courts can take “specific jurisdiction” over mass tort claims by out-of-state plaintiffs against Bristol-Myers Squibb arising from its national marketing sales and marketing campaigns. Bristol-Myers Squibb Company v. Bracy Anderson, S221038, Super. Ct. JCCP No. 4748 (Sept. 29, 2016).

The plaintiffs, including 86 Californians, allege that the drug caused bleeding, bleeding ulcers, gastrointestinal bleeding, cerebral bleeding, rectal bleeding, heart attack, stroke, hemorrhagic stroke, subdural hematoma, thrombotic thrombocytopenic purpura, and 18 deaths. They charge that the Bristol-Myers (BMS) engaged in negligent and wrongful conduct in the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling and sale of Plavix.

Separately, 261 Plavix lawsuits are pending in multidistrict litigation (MDL) before U.S. District Judge Freda L. Wolfson in the District of New Jersey. The United States Judicial Panel on Multidistrict Litigation created the MDL on December 8, 2015.

Not merely similar

“The claims of both the residents and non-resident plaintiffs were not based on merely ‘similar’ conduct, but the exact same singular and coordinated marketing and distribution scheme,” the Plavix Brief in Opposition states in Bristol-Myers Squibb v. Superior Court of California, No. 16-466, US Supreme Court.

From 2006-2012 BMS marketed distributed, and sold over 180 million Plavix pills to distributors and wholesalers in California alone, generating sales revenue of nearly $l billion. Although BMS marketed Plavix as “providing greater cardiovascular benefits, while being safer and easier on a person’s stomach than aspirin,” the reality was that the drug created a substantial risk of “heart attack, stroke, internal bleeding, blood disorders or death.”

The brief argues against “cleaving off one subset liability to one subset of the plaintiffs, who would be required to relitigate all the questions once again in their home states.” It adds, “all the plaintiffs’ arise out of BMS’s nationwide marketing and of Plavix.”

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Corporate Propaganda Group Issues List of “Judicial Hellholes”

judicial-hellholes

The pro-defendant propaganda group, the “American Tort Reform Association” issued its latest list of “Judicial Hellholes” for corporate defendants. The jurisdictions are where plaintiffs have had the best success holding major drug companies and makers of defective products responsible.

Linda Lipsen, the CEO of the American Association for Justice, trivialized the annual report as a “publicity stunt.” She said it “has been ridiculed, debunked, and exposed as nothing more than propaganda paid for by corporations seeking to evade accountability for wrongdoing.”

The report gives an insight into the paranoia and frustration of the anti-consumer organization. Check the list below to see if your clients have recovered damages in one of these 10 jurisdictions:

#1 CITY OF ST. LOUIS, MISSOURI. The City of St. Louis is a magnet for product liability lawsuits and consumer class actions. The local trial court hosted three gigantic verdicts this year, totaling $197 million, in cases asserting that talcum powder causes ovarian cancer, plus other multimillion-dollar awards. The recipients of these awards, and most of the individuals filing these types of lawsuits, are not from St. Louis, or even Missouri. They travel from across the country to sue in St. Louis. Why? The state’s weak venue law and a lenient standard for expert testimony that allows “junk science.” Plaintiffs’ law firms have tainted the jury pool by inundating St. Louis residents with constant television advertising.

#2 CALIFORNIA. The Golden State is indeed that for personal injury lawyers seeking riches at the expense of employers, consumers and taxpayers. Lawmakers, prosecutors and judges have long aided and abetted this massive redistribution of wealth. By enacting more than 800 new laws every year, legislators and the governor make it all but impossible for California residents and businesses to stay current and thus avoid being targeted by the nearly 1 million new lawsuits filed there annually. And when the state’s highest court effectively invites out-of-state plaintiffs to sue out-of-state defendants over alleged out-of-state injuries in California courts at state taxpayers’ expense, no one can be surprised that often preposterous lawsuits over workplace rules, pay-stub formatting, food and beverage labels, imaginary environmental hazards, disability access and novel public nuisance theories proliferate and act inexorably to expand civil liability.

#3 NEW YORK CITY ASBESTOS LITIGATION. The conviction of former New York Assembly Speaker Sheldon Silver, who moonlighted at an asbestos law firm, and the replacement of Justice Sherry Klein Heitler, who was known to give “red-carpet treatment” to the plaintiffs’ bar should have begun the process of restoring fairness to the Big Apple’s asbestos court. It hasn’t. Defendants are presumed guilty unless proven innocent. They face liability beyond their level of responsibility. And judges combine multiple lawsuits into a single trial, blending evidence, confusing jurors and driving up awards. Parties await a new case management order, but defendants expect the worst, including the reintroduction of punitive damages long sought by plaintiffs’ lawyers.

#4 FLORIDA SUPREME COURT AND SOUTH FLORIDA. The Sunshine State’s highest court continues a long record of liability-expanding rulings and decisions that rewrite and invalidate laws that do not fit the policy preferences of a majority of the court’s members. This year’s decisions increase workers’ compensation costs and subject to new liability employers, state agencies and even those who call police for help. South Florida, in particular, is known for its aggressive personal injury and consumer litigation bar, and troubling alliances between lawyers, shady medical clinics and service providers that run up expenses for lawsuits.

#5 NEW JERSEY. The Garden State’s high court has declared war on the use of arbitration as an alternative to lawsuits and issued liability-expanding rulings. While Atlantic County is no longer the draw it once was for product liability claims, the state’s lax standard for expert testimony still leads plaintiffs’ lawyers to bring many drug and medical device cases there on behalf of people from other states. In addition, the state’s vague and complicated consumer protection laws have set off a feeding frenzy for plaintiffs’ lawyers.

#6 COOK, MADISON AND ST. CLAIR COUNTIES, ILLINOIS. These three Illinois counties have long been go-to places for filing lawsuits. Whether it is medical malpractice, product liability or disability access lawsuits, Chicago is the wrong place to defend a case. Meanwhile, largely rural Madison County is still the nation’s epicenter for asbestos lawsuits. That it is the place of choice for plaintiffs’ firms is unsurprising given the close relationship between the judiciary and local lawyers, and a deck that is stacked against defendants. Its troublesome neighbor St. Clair County also hosts more than its fair share of litigation. Its judges have manipulated the judicial selection system to remain on the bench. The state’s expansive liability laws and the influence wealthy plaintiffs’ lawyers exert on state politics further concern defendants.

#7 LOUISIANA. Louisiana has a reputation for plaintiff-friendly venue laws, permissive judges, double-dipping asbestos lawsuits and trust claims, the highest jury threshold in the nation, abuse of consumer protection laws and excessive jury verdicts. But it is the governor’s attempt to hire campaign contributors to run multibillion-dollar coastal erosion litigation against the state’s key energy industry that ensured the Pelican State’s ranking among Judicial Hellholes this year.

#8 NEWPORT NEWS, VIRGINIA. This shipbuilding town stands out in a state that is otherwise viewed as having a balanced litigation climate. The court’s plaintiff-win rate in asbestos cases is the highest of any jurisdiction in the U.S., thanks to broad interpretations of maritime law and one-sided evidentiary rulings that make it difficult to mount a defense.

#9 HIDALGO COUNTY, TEXAS. It’s hailing lawsuits in this agricultural county along the Rio Grande, as plaintiffs’ lawyers file thousands of lawsuits accusing insurers of not paying up for storm damage. As a result, insurers are leaving and premiums are climbing. Judges are wising up to the game and beginning to call out lawyers for bringing groundless cases, and lawmakers are poised to enact much-needed reforms.

For a satisfying chuckle, read the full text of the report.

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