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FDA Enforcement Actions Drop Under Trump Administration

The Food and Drug Administration (FDA) is responsible for monitoring and ensuring the safety of medicines and vaccines, blood transfusions, medical devices (such as joint replacements and surgical instruments) as well as food products and nutritional supplements.  It functions as one of the most important consumer watchdogs, and its mission is vital to the safety and health of all Americans.

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Partner Andrew DuPont and Team Obtain Millions for Families of Workers Exposed to Benzene

Congratulations to Partner Andrew DuPont and the benzene team who obtained a $6.37 Million recovery on behalf of a man who was diagnosed with myelodysplastic syndrome (MDS) at the age of 68 which was caused by exposure to benzene in solvents, paints and paint removers while working as an autobody repairman and automobile painter.

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Three People, One Email and New Law on Waiver of Attorney Work Product

The Pennsylvania Supreme Court has just adopted a new test for waiver of the protection of the attorney work product doctrine, but it has reaffirmed the standard test for waiver of the attorney-client privilege. BouSamra v. Excela Health, __ A.3d __, 2019 WL 2509384 (Pa., June 18, 2019) is the story of a discovery dispute about one email sent among three people. The discovery dispute arose in a hospital context, but the tests are not limited to hospitals. 

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How Do You Prove Medical Negligence?

Medical malpractice, or medical negligence as it is also called, is care or treatment by a medical provider (doctor, nurse, therapist, etc.) that is found to be below the accepted standard of care and that caused harm to a patient. In a medical malpractice lawsuit, it is the burden of the patient who is alleging injury to prove that the medical provider failed to render proper care to her, and that failure was a substantial contributing cause of the injuries claimed. Establishing that the medical provider’s care fell below the standard of care can, in some cases, be fairly straightforward and is often easier to prove than the question of causation, i.e. linking the injury to the substandard care.

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Evidence of Risk May Be Admissible in Medical Negligence Cases

The Pennsylvania Supreme Court just issued an important decision allowing evidence of risk in medical negligence cases that may alter the way they are tried. Mitchell v. Shikora, __ A.3d __, 2019 WL 2504475, *1 (Pa., June 18, 2019) holds that “evidence of the risks and complications of a surgery may be admissible at trial.” The qualifying words, “may be,” are significant.

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CMS Releases New Nursing Home Special Focus Facility List

June 15th is World Elder Abuse Awareness Day.  With events to bring awareness to the endemic of worldwide elder abuse countries provide activities and training for prevention, recognition, and treatment of elder abuse worldwide.  

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Confidential Financial Information Compromised as a Result of Quest Diagnostics Data Breach

BREAKING: Financial information including credit card and bank account numbers of approximately 12 million users compromised by a data breach of one of the largest blood testing providers in the country, Quest Diagnostics.

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New York Rejects Pipeline Citing Environmental and Climate Change Concerns

In a rousing victory for environmentalists, on May 15th the New York State Department of Environmental Conservation rejected the proposal of the Oklahoma based Williams Companies to lay a 37 mile liquid natural gas pipeline through New York harbor and the New Jersey/New York Raritan watershed.  Citing concerns related to copper and mercury contamination that would occur during construction of the pipeline, the DEC note that construction of the project would result in “violations of water quality standards” and that the project as a whole failed to meet New York State’s rigorous water quality standards.  Officials in New Jersey must also weigh in on the project in June.

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What do 20,115 and 510 have in common?

Answer: all four. 20,115 and 510 are both linked to the FDA (Food and Drug Administration). 20,115 is the number of deaths associated with opioid painkillers reported to the FDA between November of 2017 and August of 2018 by Endo, a manufacturer of opioids. 510, actually 510(k), is a process by which the FDA can approve a medical device for sale.

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Reduction of Concussions in Most Recent NFL Season

On February 28, ESPN reported the following:

 

“NFL players were diagnosed with three concussions during the 2018 playoffs, a 70 percent drop from the previous year and a continuation of a season-long trend.  In total, there were 217 diagnosed concussions in practices and games during the 2018 season, compared to 291 in 2017, the league revealed Thursday during a meeting of its Head, Neck and Spine committee at the scouting combine.  League officials had previously acknowledged a drop in concussions during the preseason and regular season but had not yet added the playoff numbers. There were 10 concussions during the 2017 playoffs.”

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