Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Johnson & Johnson Guilty Again! Ordered to Pay $1 Billion in Putative Damages, the Largest This Year

Johnson & Johnson Guilty Again! Ordered to Pay $1 Billion in Putative Damages, the Largest This Year | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson was ordered by a Texas jury to pay more than $1 billion to patients who claimed the company hid flaws in its Pinnacle artificial hips that had to be surgically removed, in J&J’s second loss linked to the implants.

 

Officials of J&J’s DePuy unit, which makes the Pinnacle hips, knew the devices were defective, but failed to properly warn doctors and patients about the risk they would fail, the federal jury in Dallas concluded Thursday. The verdict includes more than $30 million in actual damages for the six plaintiffs and more than $1 billion in punitive damages, according to court filings.

 

J&J still faces almost 9,000 lawsuits accusing the company of mishandling the metal-on-metal hips. J&J stopped selling the devices in 2013 after the U.S. Food and Drug Administration toughened artificial-hip regulations.

 

At $1.04 billion in damages, it’s the third-largest overall jury award of 2016, according to data compiled by Bloomberg. The largest, for $3 billion, came in June in a breach of contract case brought by Hewlett-Packard Co. against Oracle Corp. The punitive award against J&J was the largest against a company this year, according to Bloomberg data. Such punishment damages are intended to dissuade defendants from continuing sanctioned practices.

 

“The jury is telling J&J that they better settle these cases soon,” said Mark Lanier, who represented the group of six hip patients who sued J&J and DePuy. “All they are doing by trying more of these cases is driving up their costs and driving the company’s reputation into the mud.”

 

J&J’s DePuy unit acted appropriately in designing and testing the product, spokeswoman Mindy Tinsley said in a statement. The companies have strong grounds for appeal and remain committed to the long-term defense of the lawsuit allegations, according to the statement.

 

The verdict continues a losing stretch for J&J before U.S. juries. Six of the seven largest product-defect verdicts in the U.S. this year have been against J&J units, including three in lawsuits claiming its talc products cause ovarian cancer.

Pharma Guy's insight:

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Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations?

Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Legislation proposed in the Senate, the Combination Product Regulatory Fairness Act, which is intended to promote innovation among products that contain both a drug and device (http://1.usa.gov/1KFLZg9).

 

The Combination Product Regulatory Fairness Act—introduced in July 2015—would broaden the ability for combination products to be classified as devices. The bill requires that jurisdiction as drugs or biologics not be assigned “solely because” of chemical action in the human body and orders the FDA to provide scientific support to the sponsor whenever the agency does not classify a combination product as a device.

 

In addition, the bill requires the FDA and sponsor to establish early in development a combination product review plan, an inflexible agreement on all aspects of clinical studies needed to establish its effectiveness and safety, including any postapproval studies. For example, if the FDA and sponsor agree on a clinical trial design that would test the product against placebo based on its effect on an intermediate outcome intended to predict clinical benefit or harm—a surrogate end point—the FDA would be highly restricted in its ability to later seek additional clinical data to inform its decision making.

 

However, the bill’s aims also put it at odds with certain important public health interests. The classification changes it proposes would inevitably increase the number of combination products reviewed under the more lenient 510(k) pathway, even though in 2014, almost two-thirds of combination products submitted for approval were already classified as devices (http://1.usa.gov/1KbpOUa). The 510(k) process provides important flexibility in making small alterations to moderate risk devices, but it has been criticized for being a highly limited premarket screen for a product’s safety and effectiveness and for permitting products to evolve substantially over time without adequate oversight, based on numerous seemingly innocuous updates (http://bit.ly/1SjUH9W). In addition, unlike for drugs and biologics, the FDA does not have authority to require postmarket studies as a condition of clearing a 510(k) device.

 

The bill’s restrictive combination product review plan compounds these potential negative patient safety implications. This proposed attempt to restrict FDA flexibility is reminiscent of a similar provision in the 21st Century Cures bill that limits the FDA’s ability to alter study plans for drugs in the accelerated approval pathway.

 

Balancing faster patient access to innovative agents with sufficient proof of the therapeutic product’s clinical benefit continues to be a difficult and dynamic process, but the FDA should not have to forfeit its current authority and flexibility in overseeing the development of therapeutic products before they reach patients. And patients and the medical community gain little from forcing more combination products to be classified as devices so that they can be sped to market with limited evidence of their safety and effectiveness.

Pharma Guy's insight:

Related articles: "99% of Medical Devices Approved by FDA with Shockingly Little or No New Research"; http://sco.lt/7W7p0D and "NYT Editorial: F.D.A. Won't Be Fixed by 21st Century Cures Bill"; http://sco.lt/6PLcGX and "Anecdotal Evidence Good Enough to Approve Medical Devices According to Lawmakers"; http://sco.lt/58AwLp 

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Pharma Guy's curator insight, March 31, 2016 6:11 AM

Related articles: "99% of Medical Devices Approved by FDA with Shockingly Little or No New Research"; http://sco.lt/7W7p0D and "NYT Editorial: F.D.A. Won't Be Fixed by 21st Century Cures Bill"; http://sco.lt/6PLcGX and "Anecdotal Evidence Good Enough to Approve Medical Devices According to Lawmakers"; http://sco.lt/58AwLp