Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, September 3, 2015

27 Fatalities of Implanted Device: C.R. Bard CEO Sells $7M Shares

Medical Device to Prevent Blood Clots Associated With 27 Fatalities (Video link 4:37)

September 3, 2015

Serious questions are being raised about a medical device implanted in thousands of Americans at risk for blood clots — including whether the manufacturer told all it knew about potentially fatal flaws.
At least 27 deaths have been associated with the Recovery filter — a spider-shaped apparatus that is inserted into the largest vein in the body — over the course of a decade, an NBC News investigation has found.
Government data shows approximately 300 other non-fatal problems have also been reported with the Recovery, which is one of thousands of medical products sold by C.R. Bard.
Dodi Froehlich, 45, got hers after severe injuries in a 2004 car accident put her at high risk for clots. The filter was supposed to stop them from reaching her heart or lungs; instead, it nearly killed her.
Four months after it was implanted, she developed a severe headache and passed out.
"In that two seconds of being in the ambulance, I started flat-lining," Froehlich told NBC News.

Testing revealed a piece of the filter had broken off and pierced her heart, and she had to have emergency open-heart surgery.
"My family was notified," she said. "The priest was brought in."
Surgeons were able to remove the broken piece during emergency open-heart surgery and save Froelich's life, but not all Recovery recipients have been so lucky.
Gloria Adams, then 55, needed a filter after a brain aneurysm in 2004. Her son Kevin Keech says "everything was fine" when she was discharged from the hospital — but a week later, she was dead.
An autopsy showed that instead of the filter stopping a clot, a clot pushed the entire device into her heart, puncturing it.
"I didn't get many answers at that point," her son said.

After the problems with the Recovery began, Bard hired public-relations giant Hill and Knowlton. The firm circulated a crisis management plan to Bard management, warning that "unfavorable press" could damage stock prices and ruin reputations. The company also retained an outside doctor to conduct a confidential study, which was obtained by NBC News.
The consultant found the Recovery filter had higher rates of relative risk for death, filter fracture and movement than all its competitors.
"Further urgently warranted," the doctor wrote.
But even as death and injury reports were climbing, the company decided not to recall the Recovery. Instead, Bard sold about 34,000 of them for nearly three years before replacing them with a modified version with a new name, G2.

Each year, about a quarter of a million blood clot filters are implanted in patients who can't tolerate blood thinners, most without incident. Eleven companies sell them in the U.S., but Bard's Recovery filter stood out early as a risky device.
Bard officials declined NBC News' requests for interviews but in a statement said all its filters have been "appropriately cleared by [the] FDA based on required and accurate documentation and that when used as instructed they demonstrate "significant benefits to patients."
Getting FDA clearance took more than one attempt. After the agency rejected one application for the Recovery, Bard, in 2002, recruited Kay Fuller, a veteran regulatory specialist, to help try again.
In an exclusive interview with NBC News, Fuller raised questions about how Bard handled that application.
She says the company did not give her important safety performance test results and that a small clinical trial raised red flags.
"I was pretty concerned there were going to be problems with this product," she said.
However, when she voiced those concerns, she said, the message she got was that she would be removed from the team if she continued to pursue the matter.
"I was shocked," she said.
Read Part Two of NBC News' Investigation tomorrow: Did C.R. Bard forge Kay Fuller's signature on a key document submitted to the FDA?

Insider Selling: Timothy M. Ring Sells 40,000 Shares of C R Bard Stock (BCR)
September 3rd, 2015 - 

C R Bard (NYSE:BCR) CEO Timothy M. Ring sold 40,000 shares of the stock in a transaction that occurred on Monday, August 31st. The stock was sold at an average price of $195.17, for a total value of $7,806,800.00. Following the transaction, the chief executive officer now owns 119,694 shares in the company, valued at approximately $23,360,677.98. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available at this link.
Several equities research analysts recently commented on BCR shares. Zacks raised C R Bard from a “hold” rating to a “buy” rating and set a $194.00 target price for the company in a research note on Wednesday, June 24th. Goldman Sachs raised C R Bard from a “neutral” rating to a “buy” rating and lifted their price objective for the company from $193.00 to $220.00 in a research note on Thursday, August 27th. TheStreet cut C R Bard from a “strong-buy” rating to a “hold” rating in a report on Monday, August 24th. Brean Capital reiterated a “hold” rating on shares of C R Bard in a research note on Thursday, July 23rd. Finally, KeyBanc began coverage on shares of C R Bard in a research note on Thursday, August 27th. They issued a “sector weight” rating for the company. Seven investment analysts have rated the stock with a hold rating and four have issued a buy rating to the company. C R Bard presently has a consensus rating of “Hold” and a consensus target price of $193.38.
Shares of C R Bard (NYSE:BCR) traded up 2.30% during mid-day trading on Wednesday, hitting $191.86. The company had a trading volume of 512,486 shares. The stock’s 50-day moving average is $191.45 and its 200-day moving average is $176.17. The stock has a market cap of $14.24 billion and a price-to-earnings ratio of 42.34. C R Bard has a 52-week low of $141.49 and a 52-week high of $202.47.
C R Bard (NYSE:BCR) last announced its earnings results on Thursday, July 23rd. The company reported $2.27 earnings per share (EPS) for the quarter, topping the Zacks’ consensus estimate of $2.18 by $0.09. During the same period in the previous year, the firm posted $2.06 earnings per share. The business had revenue of $859.80 million for the quarter, compared to analysts’ expectations of $836.18 million. The firm’s revenue was up 4.0% compared to the same quarter last year. Equities analysts forecast that C R Bard will post $9.08 earnings per share for the current year.

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