Lawyers can bring Class Action Suits for Health Care Data Breach Victims

Setting Precedent: The Captain of the Ship Doctrine

Lawyer Jerome H. Ellis Esq. brings Class Action Suit changed the way things get done in every hospital and doctors office in the country. Yes you are protected now because of his efforts.

Jerome H. Ellis Esq. Google Scholar

Jerome H. Ellis Esq. Former President of the Philadelphia Bar Association 1969 -70 a practicing attorney for 50 years. 2001 page 6 and 11

The Captain of the Ship Doctrine – Jerome H. Ellis, Philadelphia, for appellee
http://law.justia.com/cases/pennsylvania/superior-court/1978/255-pa-super-381-2.html

The Captain of the Ship Doctrine was originally set forth in McConnell v. Williams, 361 Pa. 355, 65 A.2d 243 (1949) and has agency considerations as its base. The essential question is whether one is subject to the control of another not only to the work to be done but also the manner of performing it. Furthermore, it has been consistently held that a physician may be simultaneously the agent of a hospital and another physician although the employment is not joint. Yorston v. Pennell, 397 Pa. 28, 153 A.2d 255 (1959). However, the master must have control not only over the agent but over the work and the performance thereof before liability can be extended to him. Collins v. Hand, 431 Pa. 378, 246 A.2d 398 (1968). And the determination of whether a resident was the servant of a senior surgeon is a factual issue to be determined by the trier of fact. Thomas v. Hutchinson, 442 Pa. 118, 275 A.2d 23 (1971).

Since hospitals no longer have the benefit of charitable immunity the ordinary rules of agency apply to those institutions. Flagiello v. Penna Hospital, 417 Pa. 486, 208 A.2d 193 (1965). In Tonsic v. Wagner, 458 Pa. 246, 329 A.2d 497 (1974), the court considered whether both a hospital and the attending surgeon could both be liable in tort.

“We conclude that agency law principles applicable to others should also apply to hospitals and operating surgeons. Hospitals, as well as operating surgeons, owe a *398 duty to the patient. If that duty is breached under circumstances from which a jury could reasonably conclude that the negligent party was at the same time the servant of two masters, both masters may be liable.”

This was the Precedent Setting Case Yorston v. Pennell, 397 Pa. 28, 153 A.2d 255 (1959)

The doctor gave a shot of penicillin to the patient who had already told the Doctor he was allergic to it. Dr. Pennell never bothered to read his file so didn’t know this info and gave it to him anyway.

Back at that time according to the INSURANCE COMPANIES
said the hospital had “charitable immunity” because in those days a hospital was considered a charity.

Mr. Ellis had to sue the VA  [sovereign immunity see above] for the right to sue the hospital.
IN THOSE DAYS VETERANS WERE NOT ALLOWED TO HIRE A LAWYER TO SUE HOSPITAL AND IT IS STILL TRUE TODAY !

[here is the work around]
Mr. Ellis DIDN’T TAKE ANY MONEY [HE WASN’T PAID] to bring the suit. THAT’S HOW HE GOT IT STARTED.

Even under this Pennsylvania rule, however, where the case involves a servant who is the general employee of a hospital but who is also the special employee of a surgeon for certain acts, only the surgeon  can be held liable in practice because the hospital is immune from suit, although in other states the charitable immunity doctrine has been repudiated or at least broken down.

Volume 7 | Issue 2 | Article 6  1961
Agency – Borrowed Servant Doctrine – Surgeon Is Responsible for the Pre-Operative Negligence of Anesthetist by Edwin W. Scott PDF

17. Yorston v. Pennell, 397 Pa. 28, 153 A.2d 255 (1959)

Yorston v. Pennell
397 Pa. 28, 153 A. 2d 255 – Pa: Supreme Court, 1959 – Google Scholar … 31 Philip H. Strubing, with him K. Robert Conrad, Wilbur H. Haines, Jr., and Pepper, Bodine, Frick, Scheetz & Hamilton, for appellant. Jerome H. Ellis, with him Leon Rosenfield, for appellee.
OPINION BY MR. JUSTICE McBRIDE, July 2, 1959: … Cited

Christopher v. United States
237 F. Supp. 787 – Dist. Court, ED Pennsylvania, 1965 – Google Scholar … Civ. A. No. 29556. United States District Court ED Pennsylvania. February 3, 1965. 788 789 Jerome H. Ellis, Philadelphia, Pa., for plaintiff. Drew JT O’Keefe, US Atty., Philadelphia, Pa., Isaac S. Garb, Asst. US Atty., for defendant. WOOD, District Judge. …
Cited

Rodgers v. Nationwide Mut. Ins. Co.
496 A. 2d 811, 344 Pa. Superior Ct. 311, 344 Pa. … – Pa: Supreme …, 1985 – Google Scholar … Supreme Court of Pennsylvania. Argued April 16, 1985. Filed August 2, 1985. 313 Jerome H. Ellis, Philadelphia, for appellants. Bruce W. McCullough, Philadelphia, for appellee. Before WICKERSHAM, BECK and CERCONE, JJ. WICKERSHAM, Judge: …
Cited

Markus v. Dillinger
191 F. Supp. 732 – Dist. Court, ED Pennsylvania, 1961 – Google Scholar … 733 734 Fox, Rothschild, O’Brien & Frankel, Philadelphia, Pa., for plaintiff. Jerome H. Ellis, Philadelphia, Pa., for defendant. VAN DUSEN, District Judge. Plaintiff’s action is based on a series of checks he issued to defendant’s order between January 8, 1957, and April 8, 1958. …
cited

 

3 thoughts on “Lawyers can bring Class Action Suits for Health Care Data Breach Victims”

  1. The medical device supply chain will experience heightened scrutiny in 2019.
    from Carolina Rudinschi, PhD @CRudinschi
    What the Industry’s First Coleopteran Chief Vulnerability Officer Predicts for 2019
    https://iiot-world.com/cybersecurity/cybersecurity-predictions-for-2019/

    Medical devices subject of 1,000-plus negative reports in 2018
    https://www.irishtimes.com/news/health/medical-devices-subject-of-1-000-plus-negative-reports-in-2018-1.3710193

    Medtronic Cardiac Devices Recalled Due to Cyber Concerns
    https://www.bankinfosecurity.com/medtronic-cardiac-devices-recalled-due-to-cyber-concerns-a-11597

    FDA Wants Medical Devices to Have Mandatory Built-In Update Mechanisms
    https://www.bleepingcomputer.com/news/government/fda-wants-medical-devices-to-have-mandatory-built-in-update-mechanisms/

  2. The U.S. Food and Drug Administration on Friday published millions of previously undisclosed reports of problems and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants.
    http://www.startribune.com/fda-releases-millions-of-records-of-incidents-involving-medical-devices/511631502/

    The roughly 6 million reports released Friday cover a wide array of devices in reports that were secretly filed with the FDA from 1999 to April of this year. From Allergan to Zimmer, dozens of medical device makers have filed reports on everything from breast implants and heart monitors to pediatric breathing machines. Device makers with Minnesota ties in the data include Boston Scientific, Coloplast, Medtronic and the former St. Jude Medical.

    Advocates for public transparency cheered Friday’s announcement. The industry’s biggest trade group, AdvaMed, said it supported the move.

    Medical device companies are required by law to file such reports within 30 days of learning that a device may have caused a patient injury or death, though the law contained a loophole that allowed millions of files to remain hidden as “summaries.” The FDA said many of these summary reporting arrangements were allowed because new files were duplicative and wouldn’t add to the body of knowledge about existing problems in Manufacturer and User Facility Device Experience (MAUDE), the FDA’s public database of adverse event reports.

    The Alternative Summary Reporting (ASR) program “allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks,” the FDA statement said.

    The Star Tribune first wrote about the program in 2016 after Medtronic, which is run from offices in Fridley, disclosed that it had filed more than 1,000 reports of patient harm associated with the use of its Infuse bone-growth product as summaries instead of individual reports.

    The ASR program was ­formally ended this month, as the result of a decision by the agency in 2017 to “gradually sunset” the program, according to an FDA statement ­published Friday.

    Madris Tomes, a former FDA device reviewer who left the agency and started an independent company to analyze the agency’s public-facing files, said Friday that the decision to revoke the ASR program apparently includes the revocation of an even more obscure program called “retrospective summary reporting,” which was so secret that a spokesperson for Johnson & Johnson once claimed the program did not exist — until presented with a J&J subsidiary’s own filings in the program.

    “Consumers can now see what the FDA has seen over the years (i.e. the true numbers of adverse events), and physicians can make better informed decisions about which device(s) to recommend to their patients,” Tomes, CEO of Device Events, said in an e-mail.

    Medtronic, the world’s largest medical device company, said Friday that although the company works hard to reduce or eliminate product malfunctions and events, its employees also make every effort to tell regulators, clinicians and the public about malfunctions when they do occur.

    “Medtronic has utilized these various reporting programs and our reports and submissions are included in the reports released today by the FDA,” company spokesman Jeffrey Trauring said in an e-mail. “We applaud the FDA for their ongoing efforts to drive transparency and openness around medical device performance, and we will continue to work with FDA on future, modern programs of reporting.”

    The filing of an adverse event report is not itself an admission that the device in the report caused the problem. Sometimes the reports include such admissions, but more commonly they simply disclose a medical problem following the use of a medical device, plus a manufacturer’s conclusion that no direct link could be definitively established. Also, the same event may be reported more than once in MAUDE, and the files released Friday may also contain duplicative reports.

    AdvaMed, a Washington-based trade group for the med-tech industry, said it was important for physicians and the public to have access to information about medical device performance, and the group supports the FDA’s efforts to make old ASR ­filings public.

    “It is important to note, however, that while the ASR information was not accessible in FDA’s MAUDE database, the agency had access to all this information and used that data in its analysis to determine the risk profile of the devices subject to ASR,” AdvaMed spokesman Jim Jeffries said Friday.

    Dr. Michael Carome, director of Public Citizen’s health research group, said the FDA should never have created the program. He said allowing summaries gave the appearance that the FDA was serving the device industry, not the public.

    “It was easier for the industry to file these reports” rather than individual adverse event reports, Carome said. “But [summaries] hid information. Important safety information was not available to the public. What we need now is for the hidden information to be available and easily searchable.”

    The newly released files are not easy to read. The summaries include numerical codes that represent specific problems, because that’s how the device companies were reporting the problems under the ASR program.

    There are several different types of summary reporting, and at least one form is still allowed, known as the Voluntary Malfunction Summary Reporting Program.

    Med-tech regulatory attorney Mark DuVal said Friday that the move to publish the old summary data was an appropriate way to build public confidence in the reporting system, even though the system wasn’t heavily used in the past.

    “Whether the information will be useful to the public, I doubt it,” said DuVal, CEO of DuVal & Associates in Minneapolis. “But the agency is increasingly criticized for stuff like this, and they are avoiding perceptions.”

    ASR reports have come under close scrutiny in recent months as the International Consortium of Investigative Journalists and Kaiser Health News have published critical stories about the program’s hidden reports regarding breast implants and surgical staplers. The Star Tribune published a story in December about long-lost reports of problems following the use of Medtronic’s Infuse in upper-spine fusion surgery.

    The Washington-based not-for-profit National Center for Health Research welcomed the end of the summary reporting program.

    “While we’re very pleased that the FDA has done the right thing by releasing the information as promised, this summary reporting program allowed thousands of serious adverse events involving medical devices to remain hidden from public view,” government affairs director Jack Mitchell said.

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