(CN) — Swiss pharmaceutical giant Novartis' discontinued medical-imaging dye Pantopaque rendered a Pennsylvania man wheelchair-bound more than 30 years after a football injury, he claims in court.
John and Regina Sweeney sued Novartis International AG and its subsidiaries — Fort Worth, Texas-based Alcon Inc., Alcon Puerto Rico, and the Lafayette, Ind.-based Lafayette Pharmaceutical Inc. and Lafayette Pharmacal Inc. — as well as Rochester, N.Y.-based Eastman Kodak Co. in Newark, N.J. Federal Court on Wednesday.
A neck injury during a football game landed John Sweeney, now 56, at Temple University Hospital in Philadelphia over 40 years ago, with a compressed cervical spinal cord and facet dislocation, according to the complaint. Sweeney was 15 years old at the time of the November 1975 injury.
During a spinal imaging test, or myelogram, in 1975, doctors injected the defendants' medical-imaging dye, Pantopaque, into Sweeney's spine, he claims.
Pantopaque is "an oil-based medium containing an iodinated chemical that interferes with X-ray penetration, so that the soft tissue contents of the spinal canal are outlined in radiographs and myelograms," Wednesday's lawsuit states. "Pantopaque penetrates to the entire spinal canal, is not absorbable, and must be removed by aspiration from the spinal canal, which is usually not fully successful and leaves dye in the canal, causing injury."
Though Sweeney initially suffered quadriplegia, he regained full use of his limbs and extremities by late 1976, according to the complaint.
But "starting in 2009, Mr. Sweeney, by then a self-employed physical therapist with five children, sought treatment for increasing lower extremity weakness, numbness, clumsiness and difficulty walking, which was resulting in increased falls and by 2013 forced him to move his bed to the downstairs of his house," his lawsuit states.
Medical testing showed Sweeney's brain and upper and lower — i.e. cervical and lumbar — spine were normal, but a separate MRI showed a fluid-filled cavity, or syrinx, in his mid — or thoracic — spine, and a thickening of the dura, , a spinal membrane, in 2014, he alleges.
More tests allegedly showed advanced inflammation of a deeper membrane the arachnoid with a tethered spinal cord, according to the complaint.
Months later, surgery revealed a dense mass beneath that membrane, Sweeney claims.
Sweeney says he "reasoned that, since he lacked any history of cancer or impact trauma to the thoracic region, there had to be another, less common cause for his arachnoiditis."
An Internet search "disclosed to him, for the first time, a causal link between his arachnoiditis, his symptoms of progressive weakness, numbness, falling and pain on the one hand, and exposure to Pantopaque on the other," the complaint states.
Indeed, Sweeney says he discovered the link in medical journals from as early as 1945, and that "other studies showed the dyes melted polystyrene cups and corroded floor tiles."
A year after his surgery, a neurosurgeon in Miami allegedly confirmed that "most likely his progressive loss of lower extremity function resulted from his exposure to Pantopaque."
By then, Sweeney was diagnosed with the end-stage version of arachnoiditis, he says.
His three surgeries since 2009 "have not been successful in relieving the injury to plaintiff's thoracic spine, and plaintiff, formerly possessed of full physical function including ability to run and play basketball, has lost bowel and bladder control, cannot walk unassisted, and since Oct. 2, 2014, has been mobile only with the use of a wheelchair," Sweeney claims.
Sweeney "has suffered great pain and anguish of body and mind as a result of the above described injuries, and has incurred great hospital and medical expenses for the care and treatment thereof," the complaint continues.
His injuries "incapacitated and continue to incapacitate him from pursuing his usual activities and caused and continue to cause him to be absent from his employment," according to the lawsuit.
The four-count complaint alleges product liability for defective design and manufacture and failure to warn, breach of express or implied warranty, and loss of consortium.
According to the 10-page complaint, Kodak funded research for Pantopaque, which was created at Rochester University in the 1940s, and was manufactured and distributed by the Lafayette and Alcon defendants until 1986 using materials Kodak provided.
The Sweeneys demand a jury trial, compensatory and punitive damages, interest, attorneys' fees and legal costs.
Novartis spokesman Eric Althoff said the firm is "looking into this matter."
Kodak spokeswoman Louise Kehoe declined to comment on pending litigation.
The other defendants did not return requests for comment Thursday.
Novartis reportedly netted over $49.41 billion in sales in 2015, and $12.47 billion in the second quarter of 2016.
Eastman Kodak recently reported a return to profitability in the second quarter, which ended June 30, with a net income of $8 million — an improvement of $31 million compared to the 2015 second quarter.
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