The Top 10 Medtech Crimes and Controversies of 2015

2015 was a year marked by several eyebrow-raising reports of medical-device-related cancer outbreaks and infections, fraud, and the murder of a handful of medical device professionals. We look back at the biggest controversies and crime stories of the year.

Qmed Staff

1. Why a Company Acquired by J&J Is Accused of Major Fraud

Before Johnson & Johnson acquired Acclarent for $785 million in 2010, its top executives were engaged in a host of fraudulent activities in anticipation of an eventual payday at the sinus balloon catheter company, according to federal prosecutors.

The company was hit by a separate but related fraud lawsuit in June.

Former Acclarent executives Patrick Fabian and William Facteau are fighting back, stating that the alleged off-label promotion at the center of the matter was actually covered under free speech.
 

2. Duodenoscope Infections Prompt FDA Reaction

The duodenoscope-related infections reported in several U.S. hospitals in 2015 sickened scores of patients. The infections proved fatal for at least two patients.

The company facing the most blowback in the matter is scope maker Olympus, whose TJF-Q180V had initially reached the U.S. market even though the new model lacked regulatory clearance.

Olympus is now facing numerous lawsuits related to the infection problem, which Olympus was allegedly aware of for years, according to the L.A. Times. Yet the company failed to alert U.S. authorities, even though it had released a warning in Europe after it was linked to infections in the Netherlands in 2013 and 2014.

In February, following superbug outbreaks related to the scopes in Los Angeles, FDA released a warning about the devices, which it would expand in September.

A congressional investigation, led by senator Patty Murray (D-WA) would follow in the summer, asking for details from Olympus on how it handled infection reports.

In August, FDA cited Olympus along with two other scope makers for failing to promptly report adverse events related to the devices.
 

3. Power Morcellator-Linked Cancer Outbreaks Prompt Investigation

Power morcellators continue are continuing to get attention as 2015 draws to a close. The devices, which have been associated with spreading cancer in minimally invasive gynecological surgeries.

In September, U.S. Government Accountability Office has agreed to investigate FDA's handling of power morcellators amid accusations that FDA overlooked cancer risks associated with the devices for years.

FDA has all but recommended against using the technology, sparking criticism from some gynecologists who argue that the technology is safe for use in properly selected patients.

The campaign to ban the device has been led by the doctors and married couple Amy Reed and Hooman Noorchashm since Reed was diagnosed with cancer after being treated with a morcellator.

4. Theranos Accused Hiding Technological Problems

The Wall Street Journal continues to publish a series of negative articles about Theranos--a blood-testing company that had been a media-darling until a few months ago. FDA warnings that surfaced in October backed up some of the Journal's claims.

The Wall Street Journal, in its series of reports about the company, has also accused the company of misrepresenting its technology. In its latest report, the paper tells the story of a lab employee possibly detecting an accuracy problem with its technology in 2013. The company allegedly handled the problem by deleting and falsifying its data according to an former lab employee (name not provided) who filed a complaint related to the matter with CMS.

5. Why a Medtronic Sales Rep's Murder Matters to Donald Trump

Before Donald Trump emerged as the GOP frontrunner in the presidential campaign, he was working to leverage controversy to his own advantage to boost poll numbers. In July, the real-estate tycoon helped make a Medtronic sales rep's tragic murder in San Francisco into a talking point in presidential politics after it became clear that an undocumented worker with a criminal record has been charged with the death.

6. Former St. Jude VP Charged with String of Felonies

A former St. Jude Medical vice president has been accused of stealing nearly $142,000 via falsified expense reports and his corporate credit card, spending the money on everything from NBA tickets to multiple strip club visits.

Bryan Szweda has been charged in Ramsey County District Court in Minnesota with five counts of theft by swindle, along with an additional felony charge of theft of trade secrets. If convicted on all counts, Szweda faces up to 70 years in prison and $200,000 in fines.

Szweda eventually turned himself in to face face the charges.

He had worked for St. Jude for five years before being fired from the company in 2014.

7. Boston Sci Exec Murderer Gets a Prison Sentence 

In January, Lyle "Ty" Hoffman pleaded guilty to slaying former business partner and Boston Scientific executive Kelly L. Phillips. In March, Hoffman (45) received a 25 ½-year prison sentence for murdering Phillips, 48. Hoffman was given 57 months of additional prison time for a separate crime--armed bank robbery. While on the run from police, Hoffmann stole about $20,000 from a bank teller in Blaine, Minnesota.

8. Medtech Murder in Arizona

Police believe the death of Allison Feldman of Scottsdale, AZ to be an isolated incident and believe that Feldman was targeted. According to recent reports from Scottsdale and a search warrant affidavit that leaked earlier, detectives believe that the murderer of Feldman, who was a 31-year-old burn and trauma specialist for Mölnlycke Health Care (Gothenburg, Sweden), was someone she knew.

9. Nearly 50 Docs Accused in Spanish Kickback Scandal 

More than 6000 patients in Spain are being closely monitored for adverse events in the wake of a kickback scandal that resulted in some patients being treated with orthopedic implants used 10 years after their expiration date.

10. How a Pacemaker Took Center Stage in a Murder Case

An Ontario man was accused of stabbing his father to death--until data from his dad's St. Jude Medical pacemaker provided crucial evidence, according to a report in the Toronto Star.

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