As Morcellator Lawsuits Mount, House Passes Bill To Track Medical Devices, Tracey & Fox Reports

July 14, 2015 – – Donna Burkhart passed away in February of 2013, only one year after undergoing a hysterectomy. Scott, her surviving husband, would soon learn that the use of a controversial medical device, a power morcellator, may have spread the undetected uterine cancer from which she eventually died. But when Burkhart filed what many legal experts believe to be the nation’s first morcellator cancer lawsuit*, his complaint listed three lead defendants: LiNA Medical, Blue Endo, and Ethicon, a subsidiary of Johnson & Johnson. At the date of filing, Burkhart was still waiting to hear back from the hospital about which companies’ morcellator had been used during his late wife’s surgery.

While it may seem strange, a similar uncertainty has marked many subsequent morcellator claims. But according to Sean Tracey, Esq., lead attorney at Tracey & Fox, a provision in a new bill may change all that.

The amendment, included in the sweeping health-care reform bill known as “21st Century Cures”, has been championed largely by congressman Mike Fitzpatrick, a Republican representative for Pennsylvania’s 8th congressional district. If passed into law, Fitzpatrick’s new measure would require physicians to specify the medical devices they use during procedures in electronic health records. Fitzpatrick, himself a cancer survivor, has been a vocal critic of power morcellators, and says that his amendment was directly inspired by the morcellator crisis.

Every medical device carries “unique device identifiers” like make and model number. Fitzpatrick believes that those identifying characteristics should be uniformly included in health records. Currently, knowing which device was used in a particular procedure is more a fluke than an industry standard. Unique device identifiers, according to a statement Fitzpatrick’s office sent to the Wall Street Journal, “are not incorporated into all electronic health records, which makes it difficult to fully achieve the benefits of patient safety.”

The bill, along with Fitzpatrick’s amendment, passed the House of Representatives on July 10, 2015. While there is no parallel bill in the Senate, a senator from Tennessee has expressed his desire to introduce a similar measure in that Chamber by 2016.

“If unique device identifiers are included universally in health records, public health officials and legal counsel will be able to follow a particular medical device throughout its lifetime, from procedure to procedure, and patient to patient,” says Sean Tracey. “And when one of those devices, like a power morcellator, presents serious known risks, we’ll be able to efficiently identify its manufacturer.” He notes that LiNA Medical, a power morcellator manufacturer, recently settled Scott Burkhart’s lawsuit.

Tracey’s law firm, Tracey & Fox, is currently investigating potential morcellator lawsuits. He says that any patient who underwent a morcellator procedure for the removal of uterine fibroids and was then diagnosed with uterine cancer may be entitled to compensation. For more information and a free case eligibility evaluation, call 713-495-2333.

*Burkhart v. LiNA Medical US et al., No. 5:14-cv-1557, complaint filed (E.D. Pa., Allentown Mar. 14, 2014).

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Contact Tracey & Fox:

Sean Tracey
713-495-2333
440 Louisiana Street , Suite 1901
Houston, TX 77002

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