Madan Parsekar, a crew member from Royal Caribbean Cruise Lines (RCCL) cruise ship Freedom of the Seas had worked as a waiter for fourteen years. In an on going medical saga, Parsekar, filed a lawsuit against the cruise line, three years after disembarking the cruise ship for a medical condition (see video below).
On Sunday, January 11, 2015, Parsekar suffered from abdominal pain and distention while at work. After reporting these complaints to the ship’s medical center, Plaintiff was medically disembarked and sent by the ship to a medical facility in the Bahamas where the ship was docked and where he was treated by physicians selected by the cruise line.
The lawsuit alleges, “On January 14, 2015, upon worsening of his condition and the onset of a respiratory failure, Plaintiff was transferred to Broward Health Medical Center (BHMC) in Fort Lauderdale, Florida. While under the care of BHMC physicians, Plaintiff was diagnosed among other conditions with acute necrotizing pancreatitis, respiratory failure requiring intubation, pseudocyst for which surgery was recommended and ICU psychosis requiring sedation.
On February 11, 2015, the BHMC physicians determined Plaintiff was at a high risk for DVT [Deep Vein Thrombosis] and that prophylactic anticoagulation was not possible due to alleged gastrointestinal bleeding and ordered the placement of a Denali retrievable inferior vena cava filter (“IVC filter”). An IVC filter is a medical device that is implanted into the inferior vena cava vein to presumably prevent life-threatening pulmonary emboli. The consent for the procedure was allegedly obtained telephonically from Plaintiff’s spouse in India.
On February 17, 2015, RCCL arranged for Plaintiff’s spouse to travel to the U.S. and assist Plaintiff. Upon discussions with the BHMC physicians, Plaintiff and his spouse decided that Plaintiff will undergo the recommended pseudocyst surgery in his home country, India. Plaintiff was discharged from BHMC on March 20, 2015. RCCL’s crew medical team arranged for Plaintiff’s further medical care in India through their medical agent Indus Medical Centre and other physicians selected, hired and routinely used by Defendant pursuant to its maintenance and cure obligations.
From February 11, 2015 until his discharge from BHMC on March 20, 2015, Plaintiff was never advised by RCCL or the BHMC doctors it hired that an IVC filter was implanted in his body and that he will require further care, management, monitoring and/or treatment due to such placement, including retrieval of the device as soon as possible after it is no longer medically necessary.
On March 21, 2015, Plaintiff arrived in India and was transported and admitted to Vision Multispecialty Hospital in Goa, India. On March 30, 2015, Plaintiff underwent a cyst gastrostomy, the recommended surgery for his pseudocyst and was discharged on April 11, 2015.
On April 13, 2015, Plaintiff complained of severe abdominal pain and was readmitted to the hospital where he was diagnosed with intestinal obstruction and underwent a transvernedicalse loop colostomy surgery on or about April 25, 2015. He was discharged from the hospital on May 12, 2015.
Throughout his medical admission and treatment at the Vision Multispecialty Hospital under the supervision, control and monitoring of RCCL’s crew medical team and its medical agents in India, Plaintiff was never advised that he will require further monitoring and/or treatment relating to the IVC filter in his body or the need to retrieve it as soon as possible after its medical need was resolved.
On August 1, 2015, Plaintiff underwent a follow up CT Scan of his abdomen, the report of which noted an “IVC filter is seen in the infra renal IVC.” In reviewing this report with his surgeon, Plaintiff for the first time discussed with a physician the fact that the IVC was implanted in his body. The surgeon recommended Plaintiff consult with a vascular surgeon regarding
management of the IVC filter.
RCCL’s medical agent, Indus Medical Centre, arranged for Plaintiff to consult with vascular surgeon, Dr. Irineu Pereira, on August 13, 2015. Dr. Pereira questioned why the IVC filter was implanted in the first instance and opined that due to the passage of time, six months since implantation, the risks of attempting to retrieve the IVC filter were serious and complicated and such risks outweighed the benefits. Dr. Pereira instead prescribed a regiment of baby Aspirin for the remainder of Plaintiff’s life.
On February 8, 2016, Plaintiff underwent another surgery for the closure of the colostomy. In the following four months, Plaintiff underwent orthopedic care for joint pains. On July 12, 2016, Plaintiff was declared fit for shipboard duty by his orthopedic doctor.
On July 16, 2016, Plaintiff was declared fit for shipboard duty by his surgeon. On July 27, 2016, Indus Medical Centre’s doctor in Mumbai, India who has never once seen or examined Plaintiff issued a report finding Plaintiff has reached maximum medical improvement (“MMI”) and was able to return to regular employment with no restrictions. Plaintiff attempted to return to his former employment with RCCL, but was advised by its medical Case Manager on September 8, 2016 that RCCL’s medical team has determined Plaintiff is not fit for duty as he will require to be in close proximity to medical providers. Plaintiff’s efforts to ascertain the basis for such decision and what medical care RCCL deemed required closer medical services were dismissed and unanswered.
In a willful and wanton disregard of its maintenance and cure obligations, RCCL’s September 8, 2016 correspondence advised Plaintiff that based on the Indian physicians’ MMI reports, RCCL has terminated Plaintiff’s maintenance and cure benefits, while simultaneously concluding he will not be rehired because he will require the closer support of medical providers for further unidentified medical care. Prior to termination of his maintenance benefit, Plaintiff received a $12.00 daily maintenance stipend.
As early as 2010 the U.S. Food and Drug Administration (“FDA”) has publicly recognized the dangers of IVC filters that tend to fracture, perforate, migrate and tilt in the patients in which they were implanted. In an August 9, 2010 Initial Communication, the FDA warned physicians that since 2005 it has received 921 device adverse event reports involving IVC filters including instances of device migration, embolization, perforation of the IVC and filter fracture. The FDA stated it was concerned that “these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE [pulmonary embolism] subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vain thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.” Due to these concerns, the FDA recommended “all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated.”
On May 6, 2014, the FDA issued an updated safety communication concerning removing retrievable IVC filters directed to physicians who implant IVC filters and clinicians responsible for the ongoing care of patients. In its warning, the FDA noted it developed a quantitative decision analysis to assess whether there is a time period during which the risk of having an IVC filter in place is expected to outweigh the benefits. The decision analysis was published in the Journal of Vascular Surgery in October 2013 and concluded that “if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.” Based on these findings, the FDA recommended physicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed and that “a patient should be referred for IVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient’s health status.”
The FDA warned that a retrievable IVC filter, like the one implanted in Plaintiff, should be removed within 1 to 2 months. The longer the device remains in the body, the greater the harm it causes, as the device deteriorates and its fragmented pieces travel in the bloodstream straight to the heart or lungs puncturing organs and causing other potentially life-threating injuries. Because of these risks that endanger the lifelong health and safety of patients and the flawed design, the device has earned the moniker “deadly missiles.” There are presently two Multidistrict Litigation actions pending against Bard, the manufacturer of the Denali IVC filter implanted in Plaintiff, as well as another manufacturer of IVC filters consisting of nearly 7,000 actions throughout the United States due to the thousands of patients that have been severely harmed by physicians failing to timely remove such retrievable IVC filters. The information pamphlet of the Denali IVC filter implanted in Plaintiff specifically notes “FDA recommends that implanting physicians and doctors responsible for ongoing care of patients with vena cava filters, consider removing the filter as soon as protection from pulmonary embolism is no longer needed.”
On or about January 8, 2018, Plaintiff consulted with Dr. Dhanesh Kamerkar, a vascular surgeon and the head of the vascular an endovascular surgery department at Ruby Hall Hospital in Pune, India, with regards to management of his IVC. Following a CT Venography, Dr. Kamerkar determined that the IVC filter cannot be removed as its prongs are embedded in the IVC vein wall and efforts to retrieve the filter could result in an IVC vein tear, which is life threatening. He further opined that the risks of leaving the IVC filter in place include IVC laceration, filter occlusion, filter strut perforation, filter migration, inability to retrieve the filter, pulmonary embolism, and if the IVC suffers a tear, an emergency high risk surgery, including the risk of death, would be necessary. The physician recommended regular monitoring through CT Venography and emergency monitoring upon developing certain symptoms, as well as life long Aspirin regiment and potentially anti-coagulation medications which would require medical monitoring. Dr. Kamerkar report dated January 9, 2018 is attached hereto as Exhibit “A.”
RCCL and its hired physicians ignored the multiple warnings provided by the FDA and the manufacture of the IVC filter to remove the retrievable filter after the transient condition for which it was used has subsided. Instead, the device was left in Plaintiff’s body with no warnings, instruction, or plans made or discussed for his future care and monitoring. Throughout Plaintiff’s medical
care and up until his MMI finding and termination of maintenance and cure benefits, RCCL negligently monitored, supervised and directed Plaintiff’s medical care, subjecting him to lifelong risks of known medical complications and death.
As a proximate result of these new and/or enhanced injuries resulting from the negligence and medical malpractice of the Defendant’s physicians and health care providers, and RCCL’s own negligence in hiring negligent physicians and relying on their opinions, and negligently monitoring, supervising, controlling and directing Plaintiff’s medical care, Plaintiff has suffered permanent and continuous injuries, disability and impairment because a defective and unreasonably dangerous implant with an established record of causing injury and death was left in his body, has suffered and will continue to suffer past and future medical expenses, significant past and future pain, suffering, emotional distress, loss of enjoyment of life, psychological trauma, mental anguish, anxiety, aggravation of an existing condition, lost wages, loss of earning capacity, and will require further lifelong medical care, treatment and medical monitoring and will incur medical expenses in the care and treatment of his injuries.”
- Madan Parsekar v Royal Caribbean Cruise Lines (pdf file)
- Freedom of the Seas Cruise Ship Tracker
- Bahamas Cruise Ship Tracker
Video: IVC Filter Lawsuits Arise From the High Failure Rate and Severe Injuries