J & J, US-Bundesstaaten, begleichen Implantate für 120 Millionen US-Dollar

Tina Bellon vor 16 Minute

(Reuters) – Johnson & Johnson und seine Abteilung DePuy Orthopaedics haben sich bereit erklärt, 120 Millionen US-Dollar zu zahlen, um betrügerische Vermarktungsansprüche einiger US-Bundesstaaten in Bezug auf die Metall-Metall-Hüftimplantate des Unternehmens abzuwickeln , Kalifornien, USA,

Attorneys general of 46 U.S. states announced the settlement agreement in statements on Tuesday. They alleged DePuy engaged in unfair and deceptive practices in the promotion of its ASR XL and Pinnacle Ultamet hip implant devices.

DePuy in a statement said the settlement involves no admission of liability or misconduct on the part of the companies.

“DePuy Synthes remains committed to meeting the current and future needs of orthopedic surgeons and patients,” the company said.

The states claimed J&J made misleading claims about the longevity of its metal-on-metal hip implants, with patients frequently having to undergo a revision surgery before the company’s advertised timeframe of five years.

Under Tuesday’s settlement agreement, DePuy is required to maintain a post-market surveillance program and update procedures to track complaints over the hip implants, according to a statement by New York Attorney General Letitia James.

DePuy in 2010 announced a worldwide voluntary recall of 93,000 of its ASR hip implant systems, saying that 12 percent of them failed within five years. Saying it would pay at least $2.47 billion, the company has since settled thousands of lawsuits by patients who had to have the ASR implant removed.Wall Street snaps four-sesson rally

In 2013, DePuy ceased selling the Pinnacle devices after the U.S. Food and Drug Administration strengthened its artificial hip regulations.

Metal-on-metal hip implants have also come under scrutiny over allegations that the products cause a build-up of metal ions in the blood, causing groin pain, allergic reactions, bone erosion and tissue death.

The company faces some 10,400 lawsuits in the United States over its Pinnacle device in connection with those claims.

J&J denies consumer claims related to its Pinnacle products, saying the company acted appropriately and responsibly in the development, testing, and marketing of the devices.

Reuters Berichterstattung von Tina Bellon in New York; Bearbeitung von Chizu Nomiyama und James Dalgleishe

BUSINESS NEWSJANUARY 22, 2019 / 12:56 PM / UPDATED 16 MINUTES AGO

J&J forecasts disappointing 2019 sales, defends talc safety

Manas Mishra, Julie Steenhuysen

4 MIN READ

(Reuters) – Johnson & Johnson on Tuesday forecast 2019 sales that fell short of analysts’ estimates and said it expected further pressure on U.S. prescription drug prices, weighing on the broader pharmaceutical sector.A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake

J&J, the first major drugmaker to report fourth-quarter results, said it expects full-year sales of $80.4 billion to $81.2 billion, below Wall Street estimates of $82.69 billion, according to IBES data from Refinitiv.

The company also said it expected adjusted 2019 earnings of $8.50 to $8.65 per share, putting the midpoint below analysts’ expectations of $8.60 per share.

J&J shares were down 2 percent at $128.02, while the broader S&P 500 healthcare sector was off 1.1 percent.

The healthcare conglomerate on a call with analysts said that net prices of its medicines declined 6 percent to 8 percent in 2018 after falling 4.6 percent in 2017. J&J did raise U.S. list prices on about two dozen prescription drugs earlier this month, including on its top-selling products.

The company is “obviously engaged with the (Trump) administration and a lot of different groups right now on the issue of pharmaceutical pricing,” Chief Executive Alex Gorsky said on call with analysts.

He said the company had some concerns related to reference pricing, a proposal to tie U.S. drug pricing to the average price paid for drugs in a handful of other developed nations, where the governments directly or indirectly control medicine costs.

“We are concerned about some unintended consequences around access and innovation as it relates to some of the proposals,” Gorsky said.

Drugmakers have come under intense pressure from U.S. President Donald Trump and Congress to lower out-of-pocket medical costs for consumers.

Gorsky attempted to deflect some of that responsibility, saying medicines and medical devices combined for about 20 percent of costs to patients. The remaining 80 percent, he said, comes “from outside our industry.”

While J&J has huge medical device and consumer health divisions, its pharmaceuticals unit has been its main growth driver in recent years.

Strength in the pharmaceuticals business also helped offset higher costs, including a doubling of litigation expense in the fourth quarter to $1.29 billion.

Most of that was related to resolving older lawsuits in its medical devices business, spokesman Ernie Knewitz said in an email response to Reuters. For the full year, litigation expenses rose to $1.9 billion from $1.3 billion in 2017. About 10 percent of that total was related to talc, Knewitz said.

J&J is facing more than 11,000 lawsuits over the safety of talc in its products, including baby powder, alleging that its use caused cancer.

“We remain committed to ensuring the facts about our talc are understood and we will continue to defend the safety of our products,” Gorsky said.

Reuters on Dec. 14 published a special report detailing that the company knew for decades that cancer-causing asbestos could be found in its talc.

J&J has repeatedly said that its talc products are safe, and that decades of studies have shown them to be asbestos-free and that they do not cause cancer.

Excluding items, J&J said it earned $1.97 per share for the fourth quarter, beating analysts’ average estimate by 2 cents.Wall Street snaps four-sesson rally

Sales in the quarter rose about 1 percent to $20.39 billion, topping Wall Street estimates of $20.20 billion.

Sales of Stelara for psoriasis and Crohn’s disease jumped 33.6 percent to $1.44 billion. Cancer drugs Darzalex and Imbruvica also had double-digit sales increases to $584 million and $703 million, respectively.

Reporting by Manas Mishra and Ankur Banerjee in Bengaluru and Julie Steenhuysen in Chicago; Editing by Saumyadeb Chakrabarty and Bill BerkrotOur Standards:The Thomson Reuters Trust Principles.