Insulin Prices Collusion Alleged in Class-action Lawsuit Against Drug Makers and Pharmacy Benefit Managers

By Emily Cox
Insulin Price Collusion
Photo by derrico_jewelry

A new lawsuit alleges that leading US drug makers and pharmacy benefit managers (PBMs) colluded to fix prices for insulin, skyrocketing costs and generating enormous profits.

Four individuals, joined by the Type 1 Diabetes Defense Foundation, filed the lawsuit March 17. The 69-count class action complaint targets some of America’s healthcare industry’s heaviest hitters. The complaint names drug manufacturers Sanofi-Aventis, Novo Nordisk, and Eli Lily. It also names the country’s three largest PBMs – CVS Health, Express Scripts, and OptumRX. Collectively, these PBMs control 80 percent of the PBM industry and manage benefits for 180 million people.

Allegedly, the PBMs leveraged their role as gatekeepers between health plans and drug companies to manipulate plans toward certain drugs like insulin. The drug companies then went ahead and made these drugs’ retail prices higher, sharing the excess profits with PBMs through a “massive slush fund” rebate system. Consequently, this scheme caused rapid and lockstep insulin price increases of more than 150 percent.

“The skyrocketing cost of insulin cannot be explained away with typical drug company rationalizations for high costs,” the lawsuit states. “Instead, the increased list prices are the result of a scheme and enterprise among the three dominant drug manufacturers of insulin … and the three largest Pharmacy Benefit Managers, CVS Health, Express Scripts, and OptumRx.”

Collusion on Insulin Prices

This lawsuit follows Sen. Bernie Sanders and Rep. Elijuah Cummings submitting a letter to the Justice Department and Federal Trade Commission. They asked them to look into the possibility of price increase collusion with Lilly, Novo, and Sanofi.

“Not only have these pharmaceutical companies raised insulin prices significantly—sometimes by double digits overnight—in many instances the prices have apparently increased in tandem,” their letter stated.

This is at least the third lawsuit, alleging prescription drug price fixing, since Sanders called out drug manufacturers and PBMs. Another lawsuit was filed in January against Sanofi, Novo Nordisk, and Eli Lilly. The lawsuit also mentioned PBMs.

 

 

Prominent Screenwriter Accuses Disney of Stealing Idea for Zootopia Movie

By Emily Cox
Zootopia Copyright Infringement
Side-by-Side Comparison of Goldman’s Characters with Disney’s

A writer and producer filed a copyright lawsuit against the Walt Disney Company Tuesday, accusing the studio of stealing his material for its movie Zootopia.

Gary L. Goldman, whose credits include Total Recall and Minority Report, alleges that he pitched Zootopia to Disney twice. Disney told Goldman on both occasions that they were not interested in producing his movie. However, the lawsuit alleges the studio used much of his material in last year’s billion-dollar animated hit, including the movie’s title.

Furthermore, this is nothing new for Disney, Goldman claims.

“Although The Walt Disney Company rigorously enforces its copyrights, it has developed a culture that not only accepts the unauthorized copying of others’ original material, but encourages it,” Goldman said.

He went on to quote a director and credited writer of Zootopia, Byron Howard, actually instructing Disney artists to copy others’ work.

“Don’t worry if you feel like you’re copying something, because if it comes through you, it’s going to filter through you and you’re going to bring your own unique perspective to it,” Byron is quoted as saying in the complaint.

Goldman alleges that this corporate practice has generated tremendous profits. He cited unauthorized and unacknowledged but recognizable source material for many popular Disney movies. These included Disney’s The Lion King, Toy Story, Monsters, Inc., Up, the Frozen trailer, and Inside Out.

Zootopia Copyright Infringements

Goldman claims he pitched his Zootopia franchise, on behalf of Esplanade Productions, Inc., in 2000 and 2009. This franchise included a live-action component called Looney and an animated component called Zootopia. He alleges that he provided a treatment, synopsis, character descriptions, character illustrations, and other materials, including the title. However, Disney claimed disinterest. As a result, Goldman claims, instead of lawfully acquiring his intellectual property, Disney copied it.

“They copied Goldman’s themes, settings, plot, characters, and dialogue – some virtually verbatim. They copied Goldman’s title, “Zootopia,” the lawsuit states. They even copied Goldman’s character designs and artwork…”

Consequently, Esplanade Productions is seeking to hold Disney responsible “for their blatant and unauthorized copying of Goldman’s work.”

 

Taxotere Lawsuits Over Permanent Hair Loss Swell to More Than 850 Cases

By Emily Cox
Taxotere Lawsuits
Photo by Skye D.

A recent court filing indicates that more than 850 women have filed Taxotere lawsuits, alleging the controversial breast cancer drug’s manufacturer failed to warn about Taxotere’s permanent hair loss risk, while fraudulently marketing the drug as more effective than other treatments that do not have the same risks.

Parties in the litigation filed the joint status report March 17. The report indicates that there are already at least 857 Taxotere cases pending in the new multidistrict litigation (MDL). There are also additional cases proceeding in California, Missouri, and Delaware state courts.

These Taxotere lawsuits allege that Sanofi S.A. knew and concealed the drug’s permanent hair loss risk from American breast cancer patients. In fact, the company updated its warning labels in Canada and Europe in 2005 and 2012 respectively. Sanofi did not update U.S. warning labels until late 2015. Furthermore, the company actively promoted the high-potency taxane as more effective than other less toxic treatments, such as Taxol, even though research has shown that these less toxic treatments were equally effective and do not cause permanent hair loss. The FDA even had to issue a warning to Sanofi to stop fraudulently marketing Taxotere as being more effective than other treatments.

Hair loss is a known and accepted side effect of chemotherapy. However, plaintiffs claim that Sanofi provided false and misleading information that suggested hair regrows after Taxotere treatments. However, this is not the case for many women.

Taxotere Lawsuits

In October 2016, the U.S. Judicial Panel for Multidistrict Litigation (JPML) centralized all federal Taxotere lawsuits for pretrial proceedings before U.S. District Judge Kurt Engelhardt in the Eastern District of Louisiana. This centralization reduces duplicate discovery and conflicting rulings, promoting judicial efficiency. Experts expect that Taxotere lawsuits will number in the several thousands in the coming years.

Judge Engelhardt has scheduled the next status conference for all parties on May 12.

 

Critics Say Trump’s Airline Electronics Ban Isn’t About Security

By Emily Cox
Trump's Airline Electronics Ban
Photo by Iowapolitics.com

Critics suggest that Trump’s airline electronics ban on direct inbound flights from eight Muslim majority countries does not serve national security but Trump’s agenda instead.

Citing unspecified threats, the US Department of Homeland Security announced a ban Monday evening on carrying electronic devices larger than a smartphone in the cabins of US-bound airplanes coming from eight Middle Eastern and African countries. Trump’s airline electronics ban applies to nonstop flights originating from 10 airports in Saudi Arabia, Morocco, Egypt, United Arab Emirates, Turkey, Jordan, Kuwait, and Qatar. Passengers will have to place all electronics items larger than a cellphone in their checked luggage. This prevents passengers from accessing these devices in-flight. Notably, no American carriers have direct flights from these airports to the US.

Experts Question Trump’s Airline Electronics Ban

Retired FBI counterterrorism executive and senior fellow at George Washington University’s Center for Cyber and Homeland Security David C. Gomez tweeted that Trump’s airline electronics ban “ignores the realities of terrorist behavior” as passengers could just “fly to London, Paris, Amsterdam and switch carriers” to reach the US.

Andrew Lebovich, a North Africa expert and visiting fellow at the European Council on Foreign relations, mirrored Gomez’s concerns, tweeting, “Does the administration think terrorists can’t take flights on American carriers?”

“Perhaps there’s an unknown or secret logic,” Lebovich tweeted. “But as presented and reported, this electronics ban makes absolutely no sense.”

Tech experts are also questioning the safety implications of Trump’s airline electronics ban. They claim that the same risks of having laptops on board still exist in the cargo hold. Furthermore, many smartphones have the same capabilities as the banned devices.

“It’s weird, because it doesn’t match a conventional threat model,” said Nicholas Weaver, a researcher at the International Computer Science Institute at UC Berkeley. “If you assume the attacker is interested in turning a laptop into a bomb, it would work just as well in the cargo hold. If you’re worried about hacking, a cellphone is a computer.”

Some experts, including those at the Federal Aviation Administration, have also raised concerns that placing lithium battery powered devices in airplane cargo holds could pose a serious fire risk.

However, if Trump’s airline electronics ban doesn’t accomplish greater security, then what is the point? Critics suggest that the ban isn’t about security at all.

Critics Indicate that Economic Motivations Are Behind Trump’s Airline Electronics Ban

President Trump's Airline Electronics Ban
Photo by Gage Skidmore

“Three of the airlines that have been targeted for these measures – Emirates, Etihad Airways and Qatar Airways – have long been accused by their U.S. competitors of receiving massive effective subsidies from their governments,” wrote Washington Post political scientists Henry Farrell and Abraham Newman.  “These airlines have been quietly worried for months that President Trump was going to retaliate. This may be the retaliation.”

They further indicated that this is an example of the Trump weaponizing interdependence. They characterized this as the administration using its leverage to weaken competitors.

Another Washington Post writer, Max Bearak, wrote that this could be part of Trump’s wider protectionist agenda. In February, Trump met with US airline executives. At the meeting, he promised to help them compete against foreign carriers that receive government subsidies.

Furthermore, the expansion of these global carriers has turned Dubai, Doha, and Instanbul airports into international hubs. Experts project that Dubai’s airport will receive nearly 89 million passengers this year. So it should retain its status as the world’s busiest airport for international travel. There are already significant and time-consuming security measures at these airports to screen passengers bound for the US. Trumps airline electronics ban creates yet another reason to consider different routes and carriers.

Advocacy groups claim that this is yet another anti-Muslim measure from the Trump administration.

 

Judge Appoints Hernia Mesh Lawyers to Leadership Roles in Atrium C-Qur Lawsuits

By Emily Cox
Hernia Mesh Lawyers
Photo by Marco Aurelio Martins Costa

The U.S. District Judge presiding over the centralized Atrium C-Qur litigation has appointed some of the plaintiffs’ hernia mesh lawyers to various leadership roles for discovery and pretrial proceedings.

Judge Landya McCafferty issued the case management order March 13. The order appointed the Plaintiffs’ Lead Council, Liaison Counsel, and Executive Committee. According to the order, five hernia mesh lawyers will serve on the committee. Additionally, the judge designated one attorney as the Plaintiffs’ State Liaison Counsel. This attorney will coordinate status updates regarding cases filed at the state level. These lawyers will coordinate and manage discovery, as well as argue motions before the court.

Judge McCafferty also issued a Pretrial Order on March 13. The order approved a joint proposal from the plaintiffs and defendants on the collection, division, and preservation of pathological materials from Atrium C-Qur surgeries for trial evidence.

Atrium introduced its C-Qur hernia mesh patch in 2006. Atrium designed the mesh’s Omega-3 gel coating to reduce inflammation and scar tissue formation, while aiding incorporation of the mesh into the abdominal wall. However, plaintiffs claim that this coating actually promotes inflammation, causing bowel adhesions and other problems, while preventing proper abdominal wall incorporation.

Hernia Mesh Lawyers and MDL

Hernia mesh lawyers are continuing to file and review claims over problems with Atrium C-Qur. These claims allege that Atrium defectively designed its C-Qur hernia mesh and that the mesh is unreasonably dangerous. Consequently, plaintiffs suffered painful and debilitating complications such as allergic reactions, infections, and adhesions. Almost all of the plaintiffs required additional surgery to remove the mesh patch.

In December 2016, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all Atrium C-Qur lawsuits before Judge McCafferty in the District of New Hampshire. Federal Multidistrict Litigation (MDL) reduces duplicate discovery and conflicting pretrial rulings. As a result, all parties save both time and money. The JPML refers to this as “judiciary efficiency.”  Hernia mesh lawyers think the MDL has the potential to swell into thousands of cases.

 

Stryker Metal Hip Components Caused Pseudotumor and Metal Poisoning

By Emily Cox

Stryker Metal Hip Components

A new lawsuit claims that recalled Stryker metal hip components poisoned a Texas woman and caused her to develop a pseudotumor.

Betty Sadler filed the complaint against Howmedica Osteonics Corp, doing business as Stryker Orthopedics, earlier this month in the Southern District of Texas.

The lawsuit states that Sadler underwent Stryker metal hip replacement surgery in October 2008. Surgeons implanted her with a Stryker Accolade TMZF Plus femoral steam and LFit V40 femoral head to treat left hip degenerative arthrosis.

In late 2015, Sadler began experiencing “significant left hip pain and discomfort.” A subsequent MRI revealed a left hip pseudotumor. Due to this, Sadler underwent revision surgery in January 2016. During her revision surgery, Sadler’s surgeon also found evidence of significant metal poisoning and substantial wear on the Stryker metal hip components, as well as bone loss. Consequently, the surgeon replaced the LFit V40 metal femoral head with a ceramic one.

Due to reports of similar problems with Stryker metal hip components, the company recalled the LFit V40 in August 2016. The recall impacted certain large-diameter femoral heads sold before 2011. Stryker acknowledged that a larger-than-expected number of individuals were experiencing metal wear, trunnion failure, adverse tissue reactions, and other complications from the metal hip component.

Stryker Metal Hip Components Lawsuit

Sadler joins a growing number of individuals filing similar Stryker metal hip lawsuits. These lawsuits allege that Stryker failed to use reasonable and due care for the safety and well-being of patients. They further claim that the Stryker metal hip components were defectively designed. According to the lawsuits, company knew that the titanium Accolade hip stem performed poorly with the cobalt/chromium head. However, Stryker marketed the pairing of these components anyway to the detriment of recipients.

Due to the success of Stryker’s malicious marketing practices, the Accolade and LFit V40 were an exceptionally popular combination. Consequently, experts expect thousands of individuals to file similar lawsuits in the future due to significant injuries from this combination.

 

FDA Bends to Big Pharma and Postpones Off-Label Marketing Final Rule

By Emily Cox
Big Pharma Off-Label Marketing
Photo by Mike Licht

In response to a petition filed by pharmaceutical groups, the Food and Drug Administration (FDA) has delayed implementing a final rule that would give the agency greater leeway to regulate off-label marketing.

While drug makers requested an indefinite stay on the rule, the FDA delayed executing this final rule until March 2018. The rule would require drug makers to update product labeling if there is evidence that the company intended people to use its medicine for off-label uses or for an unapproved use. Doctors can prescribe drugs for any reason. However, court rulings have determined that pharmaceutical companies can only engage in off-label marketing if the information is truthful and not misleading.

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO), filed the Petition to Stay and for Reconsideration on February 8, 2017. These groups expressed outrage over the FDA’s unexpected publishing of the rule in January.

“FDA’s revisions were not communicated to the public prior to the Final Rule published on January 9, 2017, which deprived stakeholders of fair notice and an opportunity to be heard in violation of the Administrative Procedure Act (APA),” the petition states.

Furthermore, the trade groups claim the rule gives the FDA too much leeway.

“The final rule would give the FDA an extraordinarily wide leeway to gauge how a company intended its medicine to be used, which can then be used to assess whether illegal promotion occurred,” the groups said.

The FDA asserts that these groups misunderstood the ruling. However, the agency still relented, extending the March 21, 2017 deadline by almost a year.

Taxotere Off-Label Marketing Lawsuit

The ruling delay comes as Sanofi S.A. faces a Qui Tam lawsuit for off-label marketing of Taxotere. The lawsuit claims the company used fraudulent and illegal off-label marketing to drive sales and expand its market share. The FDA approved the high-potency taxane to treat advanced breast cancer when other treatments have failed.

Sanofi S.A. allegedly trained and directed their employees to misrepresent the safety and effectiveness of off-label Taxotere. This expanded its market into unapproved settings like first line treatment and less advanced cancer. The lawsuit claims that the company also paid doctors illegal kickbacks to get them to prescribe Taxotere for off-label uses. These kickbacks included entertainment, sports, concert tickets, sham grans, speaking fees, travel preceptorship fees, and fee reimbursement assistance.

These illicit measures dramatically increased the breast cancer drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. It also exposed thousands of women to Taxotere’s increased toxicity and its more severe side effects, including permanent hair loss.

Additional civil lawsuits continue to mount rapidly as more women discover Taxotere unnecessarily disfigured them.

 

 

 

Taxotere Side Effects Linked to Five Deaths in France

By Emily Cox
Taxotere Side Effects
Photo by Matt Bachelor

Taxotere side effects may be responsible for at least five deaths in France, leading the nation’s product safety agency to urge doctors to avoid using the controversial chemotherapy drug to treat certain cases of breast cancer.

All five women passed away since August 2016 and were 46 to 73 years old. Researchers began investigating the issue after the third death. As a result, they have concluded that Taxotere side effects played at least some part in these women’s deaths.

The French National Drug and Health Product Safety Agency (ANSM) issued a warning to oncologists last month. The letter indicated that Taxotere side effects may have caused several deaths. The chemotherapy treatment appears to have caused neutropenic enterocolitis. This condition causes inflammation of the mucosa of the colon and small intestines. The agency went on to recommend that doctors use Abraxane instead to treat localized, operable breast cancer.

Researchers note that all deaths were associated with generic Taxotere (docetaxel). However, they found no irregularities with the generic drug. Accord Healthcare, an Indian drug company, supplied the drug, and tests showed that it meets quality standards.

The ANSM is continuing this investigation. The agency expects to release the results on March 28.

Taxotere Side Effects Lawsuits

Sanofi-Aventis, the maker of brand-name Taxotere, is facing a growing number of Taxotere side effect lawsuits. These lawsuits allege that the company knew and concealed the risk of permanent hair loss from women and the medical community.

The company updated Taxotere warning labels in Canada and Europe to include this risk in 2005 and 2012 respectively. However, it didn’t update American warning labels until late 2015.

Sanofi-Aventis introduced Taxotere in 1996. It is a high-potency taxane cancer drug. The company marketed it as superior to existing low-potency taxanes like Taxol. However, researchers and the FDA have found that it is no more effective. Furthermore, it has been linked to permanent hair loss and other side effects not associated with other taxanes.

These women allege that they would have chosen a different breast cancer treatment if they had known about Taxotere side effects and true efficacy.

Pesticide Manufacturer Accused of Ghostwriting Chemical Safety Reports

By Emily Cox
Pesticide and GMO Protest
Photo by William Murphy

Court documents in the lawsuit against Monsanto involving its Roundup pesticide include emails that indicate the company had ghostwritten research on the pesticide’s active ingredient that was later attributed to academics.

NPR reports that Monsanto asked scientists to co-sign safety studies on glyphosate, the active ingredient in Roundup pesticide. In internal emails. Monsanto executive William Heydens suggested that the company “ghost-write” a paper.

“We would be keeping the cost down by us doing the writing and they would just edit & sign their names so to speak,” he wrote.

He indicated this is how the company had “handled” an earlier paper on glyphosate’s safety. While the paper from 2000 acknowledges Monsanto’s help in collecting data, it does not list any employees as authors.

The emails also suggested a collaboration between Monsanto and a senior regulator at the Environmental Protection Agency (EPA), Jess Rowland.

If I can kill this, I should get a medal,” Rowland said to a Monsanto regulatory affairs manager in April 2015. The manager recounted the conversation in an internal email. The company was trying to get Rowland’s assistance to stop an investigation of glyphosate by the Centers for Disease Control and Prevention (CDC) after the International Agency for Research on Cancer declared that glyphosate probably causes cancer.

Monsanto executives were concerned that Rowland could not stop a federal glyphosate review. However, it’s evident that they believed the EPA was on their side.

“I doubt EPA and Jess can kill this, but it’s good to know they are going to actually make the effort,” a Monsanto executive wrote.

Since Rowland retired from the EPA last year, he has become a central figure in more than 20 lawsuits. These lawsuits claim Monsanto failed to warn consumers of the risks associated with its glyphosate-based pesticide.

Roundup Pesticide Lawsuits

There are hundreds of individuals suing Monsanto, Roundup’s parent company. They cite a 2015 World Health Organization study that says glyphosate is probably carcinogenic and damages DNA in human cells. A California judge recently ruled that the state can legally require Monsanto to warn customers of Roundup’s cancer risks.

Essure Birth Control Coil Goes Missing in Woman’s Body

By Emily Cox
Essure Birth Control Coil
Controversial Essure Birth Control Coil

Atlanta, GA — A woman has filed a product liability lawsuit against Bayer after one of its controversial Essure birth control coils went missing inside her body.

Pamela Graves filed the complaint in the Northern District of Georgia earlier this month. She is claiming that Bayer sold a defective and unreasonably dangerous device and that the company failed to warn about the risks associated with the Essure birth control coils.

According to her lawsuit, Graves had the Essure birth control coils implanted in May 2009. Following implantation, she gained approximately 80 pounds and suffered constant intense pelvic pain. She also experienced heavy bleeding with large clots, painful intercourse, and headaches. Graves alleges she could feel the coils poke her when she would lay down on her stomach.

In April 2016, Graves underwent a hysterectomy to remove the Essure birth control device. However, doctors were only able to remove one of the coils. They could not locate the other coil, as it had migrated outside of the fallopian tube into Graves’ body. It remains inside of Graves to this day.

Essure Birth Control Complications

Essure birth control coils are implanted in the fallopian tubes. They cause scar tissue to form and prevent pregnancy. Bayer continues to market this device as a safe and effective form of birth control. However, tens of thousands of women have reported serious Essure complications to Bayer and the FDA. These complications include severe pain, unintended pregnancy, and allergic reactions, as well as coil migration and perforation. Furthermore, most doctors cannot remove only the coils, and insurance does not cover the procedure. Consequently, the only treatment option for most women is hysterectomy.

After receiving 10,000 Essure adverse event reports between November 2002 and December 2015, the FDA mandated Essure warning label changes in November 2016.  Some of the most severe complications included four adult deaths, 15 lost pregnancies, and two infant deaths, as well as, 631 reports of unwanted pregnancies. In 96 of these cases, the

pregnancies were ectopic, which can be life-threatening.

These label changes included a “black box” warning, as well as a patient checklist that must be given to women considering Essure birth control to ensure future patients are aware of the severity of the risks associated with the device.

Graves joins several thousand other women who have filed similar lawsuits against Bayer, alleging that their birth control device caused serious harm and that Bayer misrepresented Essure’s safety and efficacy.

 

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