Tag Archives: drug company legal news

Merck’s patent win over Gilead reversed over false testimony

Merck & Co.’s $200 million jury verdict against Gilead Sciences Inc. was voided in a patent dispute over a breakthrough for hepatitis C because of misconduct by a witness at the companies’ trial.

A federal judge concluded Monday that dishonest and duplicitous testimony by a retired Merck scientist before and during a March trial played into the jury’s finding that the company was responsible for early discoveries that led to the development of Gilead’s Sovaldi and Harvoni medicines.

The scientist “intentionally fabricated testimony” and Merck supported his “bad faith conduct,” U.S. District Judge Beth Labson Freeman in San Jose, California, said in her ruling.

The reversal of the fifth-largest U.S. verdict this year vindicates Gilead in its refusal to share royalties with Merck on the more than $20 billion revenue the hepatitis C drugs generated from 2013 through 2015 in the U.S. The Foster City, California-based company’s sales have started to slow this year as competition for the liver disease market intensifies among drugmakers.

“This is a nice little bump for Gilead who’d already accounted for the $200 million,” said Bloomberg Intelligence analyst Asthika Goonewardene. “But of course, this is a big win and will be beneficial to Gilead and how they can claim ownership of the drug in the long run.”

Merck vowed to appeal Monday’s ruling, saying it “does not reflect the facts of the case.”

“In its decision, the jury recognized that patent protections are essential to the development of new medical treatments,” the company said in an email. “The compounds and methods at issue in this case facilitated significant advances in the treatment of patients with HCV infection, and achieving these advancements required many years of research and significant investment by Merck and its partners.”

Gilead said it “has always believed Merck’s patents are invalid and unenforceable.”

“We are pleased the court has ruled in Gilead’s favor and determined that Merck’s patents are unenforceable against Gilead, and therefore, Merck is not entitled to recover any damages,” the company said in an email.

Labson Freeman re-opened the case in April after Gilead alleged that ex-Merck scientist Phil Durette gave conflicting statements about his participation in a key phone call some 15 years earlier when the drug’s basic composition was first presented to Merck.

Durette initially said in a pretrial deposition he wasn’t on a phone call in which secrets about the compound’s basic chemistry were discussed while Merck was exploring a take-over of Pharmasset Inc., a company that was later acquired by Gilead. When testifying to the jury after checking his notes, Durette admitted to playing a role in the meeting.

“Dr. Durette’s lying at his deposition, recanting that testimony at trial without proper prior notice to Gilead, and further untruthful testimony at trial all support the court’s conclusion that Merck did intend to deceive Gilead and the court,” the judge wrote.

She said Merck’s actions were “even more egregious” because Durette was acting as the company’s patent attorney.

Merck’s victory at trial had set the stage for it to seek future royalty payments from Harvoni and Sovaldi, which sells for $1,000-a-pill in the U.S., before discounts and rebates.

While Gilead continues to dominate the market, the lull in its hepatitis C treatment revenue opened the door to Amgen Inc. retaking its place as the world’s top biotech firm by market capitalization.

The case is Gilead Sciences Inc. v. Merck & Co., 13-cv-04057, U.S. District Court, Northern District of California (San Jose).

Full Article – http://www.theindianalawyer.com/mercks-patent-win-over-gilead-reversed-over-false-testimony/PARAMS/article/40559

Drug makers spend big to fight California price control referendum

Drug Companies To Pour $100M Into Battle Against California’s Price Control Ballot Initiative

The initiative, likened by one lobbyist to a “grenade being rolled into the conversation,” would require the state to pay no more for prescription drugs than the U.S. Department of Veterans Affairs, and the industry is gearing up to fight back. In other news, Novartis’ heart-failure drug is getting a warmer welcome in Europe than America, and the company is considering its options in selling its stake in Roche.

Politico: Drug Makers Spend Big To Fight California Price Control Referendum

Donald Trump and Hillary Clinton give drug makers the jitters when they talk about Medicare negotiating the prices of prescription drugs. But the biggest near-term threat to the industry comes from a California ballot initiative that would test a version of that idea in the most populous state. That ballot initiative “is a grenade being rolled into the conversation, and it is being taken very seriously,” says a Republican drug lobbyist in Washington, D.C. (Cook and Karlin-Smith, 4/25)

The industry is expected to pour $100 million into an effort to squash the November ballot initiative.

Donald Trump and Hillary Clinton give drug makers the jitters when they talk about Medicare negotiating the prices of prescription drugs. But the biggest near-term threat to the industry comes from a California ballot initiative that would test a version of that idea in the most populous state.

That ballot initiative “is a grenade being rolled into the conversation, and it is being taken very seriously,” says a Republican drug lobbyist in Washington, D.C.

Drug companies are expected to pour $100 million into an effort to squash the referendum in what will be a test of the industry’s strength at a time of growing consumer backlash against drug prices. The initiative would require the state to pay no more for prescription drugs than the U.S. Department of Veterans Affairs — one of the few federal agencies allowed to negotiate drug prices.

From the industry’s perspective, California could set a dangerous precedent. Besides having an economy the size of many small countries, the liberal bastion is often a laboratory for new ideas that take root and then spread east. That’s even more likely given that the presidential front-runners are pushing the federal government to negotiate drug prices for Medicare.

“This is the crack in the door” on drug pricing, said Jamie Court, president of Consumer Watchdog, a California nonprofit devoted to consumer protection issues. “If any Democrat in America wants bulk purchasing in Medicare, it will start with bulk purchasing for the most liberal state government in America.”

Which is precisely the intention of the initiative’s sponsor, Michael Weinstein, CEO of the Los Angeles-based AIDS Healthcare Foundation. “If we win, we hope it will start a national prairie fire,” he said.

Weinstein pursued the ballot measure after years of in-your-face activism on AIDS and after watching the California state legislature fail to do anything about drug prices — a big concern to people with HIV/AIDS who may be taking costly drugs for the rest of their lives.

Read more: http://www.politico.com/story/2016/04/drug-makers-california-referendum-222334#ixzz471Q9mg4k
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New Xarelto Claim That J&J and Bayer Lied

Posted by Shezad Malik MD JD
March 8, 2016 7:03 AM

According to bombshell revelations in the New York Times, did two major pharmaceutical companies, in an effort to protect their blockbuster drug, Xarelto, intentionally mislead editors at one of the world’s most prestigious medical journals?

Several thousand injured plaintiffs have filed personal injury and product liability claims against Johnson & Johnson and Bayer over the safety of its anti-clotting drug Xarelto.

Now plaintiffs claim that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University deliberately left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies provided the very same data to regulators in the United States and Europe.

The New York Times article suggests that Bayer, Johnson & Johnson and those who ran clinical trials at Duke University that led to the FDA approval of the blood thinner, may have lied to editors at the New England Journal of Medicine.

Defective Medical Device Results Flawed

The heart of the controversy alleges that a key medical device that measures the levels of blood thinner in patients involved in the study was defective and that those running the clinical trial knew it, but failed to reveal that information.

The New York Times reports that documents produced by the drug makers during Xarelto lawsuits suggest that those running the clinical trial were asked if there were lab tests that confirmed the accuracy of the device. The editors were told there was not, when in actuality there were such tests.

It is now confirmed that the measuring device was defective and may have compromised the approval process for Xarelto, which has since been promoted as a superior alternative to warfarin.

Flawed Xarelto Medical Studies?

The Xarelto blood testing problems in the clinical trial were first reported in the medical journal The BMJ in December, with researchers warning that the device may have led to an underestimation of the rate of Xarelto bleeding complications in comparison to warfarin.

The ROCKET-AF clinical trials compared the rate of bleeding events between Xarelto (rivaroxaban) and Coumadin (warfarin). The potentially defective blood testing device, known as the INRatio by Alere, was used to measure the levels of warfarin in patients’ blood and was used to adjust their dosage. An INRatio recall has since been issued after it was discovered that the device may show results that were falsely low.

The recall could affect the ROCKET-AF results, because falsely low readings may have resulted in warfarin patients being given too high a dose, increasing their risk of bleeding. If the device caused excessive bleeding among warfarin patients, it could have given the false impression that Xarelto had a lower rate of bleeding problems.

The clinical trials, led by Dr. Robert Califf, who is now the FDA commissioner, have come under intense criticism since Xarelto was approved, as the drug has been linked to a shocking number of adverse event reports involving severe and uncontrollable bleeding problems. Due to a lack of a reversal agent for Xarelto, doctors have been unable to stop serious bleeding problems that occur, increasing the risk of severe injury or death.

Xarelto Lawsuits Over Bleeding Problems

Xarelto (rivaroxaban) is a new class of blood thinners released in recent years as a replacement for warfarin, which had been the gold standard blood thinner treatment for the past 60 years. Xarelto was approved in 2011, this new-generation treatment has been prescribed instead of warfarin to reduce the risk of blood clots and strokes among patients with atrial fibrillation, or following hip or knee replacement surgery.

Xarelto lawsuits, like http://sideeffectsofxarelto.org/xarelto-lawsuits/, allege that the drug makers provided false and misleading information about the importance of blood monitoring on Xarelto, marketing the drug as easier to use and indicating that it does not require close testing like warfarin. But, independent studies published after Xarelto was introduced have suggested that Xarelto monitoring may help identify patients at greater risk of bleeds.

Undue Big Pharma Influence

Big Pharma is the nickname given to the vast and influential pharmaceutical industry and its trade group, the Pharmaceutical Research and Manufacturers of America or PhRMA. These powerful companies make billions of dollars every year by selling drugs and medical devices.

Pharmaceuticals are HUGE business and these Big Pharma” companies stand to reap billions of dollars over the life span of a block buster drug. Big Pharma industry influence has led to the concealment of critical unfavorable data or ghost written medical articles (written by industry insiders) — when crucial clinical data went missing from journal articles, leading to embarrassing corrections and ethics policies to limit the influence of drug companies on medical literature.

Xarelto Billion Dollar Block Buster

Xarelto, is sold in the United States by Johnson & Johnson and overseas by Bayer, had nearly $2 billion in United States sales last year and is the best seller in a new category of drugs seeking to replace warfarin.

Last week, lawyers in the case against Johnson & Johnson and Bayer filed a legal brief in federal court in New Orleans, asking a judge to unseal documents in the case, which involves more than 5,000 lawsuits filed by patients and their families who claim they were harmed by Xarelto. Of those, 500 involve patient deaths.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, served on the Food and Drug Administration advisory panel that voted to approve Xarelto in 2011. He was one of two members who voted against the drug. He expressed doubt that any after-the-fact analysis would give doctors and patients answers. “Given the fact that the device was inaccurate, there is no way anybody can tell you what would have happened in the trial,” he said.

Read Full Article – http://fortworth.legalexaminer.com/fda-prescription-drugs/new-xarelto-claim-that-jj-and-bayer-lied/

Indictment says Berea pharmacist distributed drugs ‘outside scope of professional practice’

38-count indictment was unsealed on Friday

Five other co-defendants named in indictment

Alleged distribution of drugs began in 2010

Johnson & Johnson, Ethicon Morcellator Lawsuits Centralized

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Lawsuits involving one of the biggest pharmaceutical companies and one of the most controversial medical devices in the U.S. now are centralized to a single court.

Johnson & Johnson is accused of hiding knowledge that its power morcellator could cause an accidental spread of uterine cancer during hysterectomies and surgeries to remove fibroids.

The Judicial Panel on Multidistrict Litigation transferred at least 28 morcellator lawsuits to the U.S. District Court for the District of Kansas, a multidistrict litigation (MDL) court.

“This decision by the panel is an extremely important one because it ensures that these cases will move at the fastest possible pace,” said Paul Pennock, a lead attorney at Weitz & Luxenberg who led the arguments for consolidation.

Courts consolidate lawsuits to MDLs when a large number of plaintiffs file lawsuits involving the same facts against the same defendant. The process allows the courts to operate more efficiently and decreases the costs for all parties involved.

“We believe this will allow our clients to obtain justice much more swiftly and reliably than might otherwise be the case if each client were compelled to battle the defendants in isolated courtrooms scattered across the country,” Pennock said.

The lawsuits accuse Ethicon, a subsidiary of J&J, of designing a defective product and failing to warn patients of risks.

Morcellator Controversy Growing

The surgical tool that uses small blades to break tissue into small fragments remains one of the most controversial devices in the U.S.

One congressman, U.S. Rep. Mike Fitzpatrick, fought for amendments to regulate medical devices to be added to the 21st Century Cures Act that was passed by the U.S. House of Representatives in July. The amendments stemmed from news that some women were rapidly developing cancer after surgeries involving the device.

Months later, members of Congress led by Fitzpatrick petitioned the U.S. Government Accountability Office to investigate the devices and the U.S. Food and Drug Administration process that cleared them. The GAO agreed to investigate morcellators and the FDA in September.

The recent news adds to an existing history of controversy involving power morcellators that began more than a year ago, and Johnson & Johnson’s name keeps coming up.

J&J, Ethicon May Have Known of Risks

Morcellators were once thought to have an extremely rare risk of unintentionally spreading uterine cancer, but the FDA warned the actual risk was one in 350 in April 2014. The warning came almost two decades after the device entered the market.

Read Full Article Here – http://www.drugwatch.com/2015/10/20/ethicon-morcellator-mdl-kansas/