Medical Malpractice Suit Examines Liability of Robotic Medical Device Manufacturers for Malfunctions

Laproscopic_Surgery_Robot.jpgOur laws place obligations on doctors that correspond with the tremendous amount of trust we place on them. As medical technology advances, however, newer medical devices may exceed the skills that most doctors have worked for years to develop. These devices may offer cost-saving, or even life-saving, benefits to patients, but the full implications of a surgical device that the surgeon may not fully understand remain unknown. A lawsuit is seeking to hold the manufacturer of a robotic surgical device liable for injuries caused by complications during a procedure.

A Washington woman is suing Intuitive Surgical, Inc., the nation’s leading robotic surgical system provider, for injuries sustained by her husband during a prostatectomy in 2008. Estate of Fred E. Taylor v. Intuitive Surgical, No. 09-2-03136-5 (Wash. Super. Ct., Kitsap Co.) The surgeon used robotic surgical equipment called the da Vinci Surgical System. Alleged malfunctions in the system reportedly caused the ordinarily five-hour procedure to take over thirteen hours. According to the New York Times, the 67 year-old patient suffered a stroke, sepsis, and damage to his kidneys and lungs as a result. He survived the procedure but died in 2012. A judge ruled on March 26, 2013 that the case may proceed under state products liability law.

Intuitive claims that nearly 1,400 hospitals around the country have purchased the da Vinci system, which they say can perform various surgical procedures less invasively, with less pain and fewer complications for patients. The surgeon uses the system by operating controls at a console and viewing the procedure as a three-dimensional image. The system scales the surgeon’s hand movements to miniature surgical instruments.

Negligence of Air Traffic Controller Caused Fatal Plane Crash, According to Lawsuit

Mooney_M20J2.jpgAn air traffic controller employed by a private company was negligent in clearing a small plane for flight from the airport in Jackson Hole, Wyoming, according to a recent lawsuit. Bucklin v. Serco, Inc., No. 2:13-cv-00052, complaint (D. Wyo., Mar. 4, 2013). The plane crashed in the mountains, killing everyone on board. The plaintiff, who is the ex-wife of the pilot and mother of the three other victims, seeks to hold the air traffic control service provider liable for its employee’s alleged negligence. An investigation by the National Transportation Safety Board (NTSB) concluded that the pilot was probably responsible for the crash, but also found fault with the air traffic controller’s decisions.

The pilot decided to fly home from Wyoming to Minnesota with his three sons on October 25, 2010 after a commercial flight was canceled due to a snowstorm. After taking off from Jackson Hole in his 1977 single-engine Mooney M20J propellor plane, he reportedly had difficulty maintaining altitude over the Wind River Range. According to flight recordings, he tried to radio that he was “descending rapidly” shortly before crashing. He also reported “mountain waves,” wind currents that occur over mountain ranges that can suck down airplanes flying too low. Following an extensive search lasting about a week, mountain climbers found the plane and the four victims in the vicinity of Lander, Wyoming.

Cruise Line Faces Multiple Lawsuits, but May Not Face Liability Due to Contractual Terms

 

file000728465303.jpgA cruise ought to provide the opportunity for a relaxing vacation, and while most do just that, some cruises may lead to nightmarish situations. Multiple recent lawsuits for injuries sustained on cruises allege negligence for various failures to protect passengers from injury. These cases provide an important illustration of how contracts entered into as part of a ticket purchase may limit passengers’ rights of recovery, preventing them from recovering damages through litigation.

The most well-known recent case of a cruise gone wrong involves Carnival Cruise Lines’ ship Triumph. The ship left Galveston, Texas on February 7, 2013 for a four-day cruise to Mexico. On February 10, 2013, according to the U.S. Coast Guard, a fire caused by a fuel-oil leak stopped the ship dead in the water. It remained stranded until tug boats could pull it into a harbor in Mobile, Alabama, leaving the more than 4,200 occupants of the ship, about 3,100 of whom were passengers, stuck on board for five days without effective plumbing or sanitation.

Lawsuits related to the cruise allege that Carnival was negligent in failing to maintain the ship’s systems properly. The ship allegedly had mechanical problems on a prior voyage, as recently as January 28, but the cruise line sent the ship out anyway, according to some lawsuits. A lawsuit filed in a Florida federal court, Williams v. Carnival Corp., No. 1:13-cv-20588, complaint for damages (S.D. Fl., Feb. 18, 2013), alleges that the cruise line breached various duties to passengers, including the duties to “maintain or remedy hazardous conditions,” id. at 4, and to warn of such hazards. A putative class action lawsuit, Crusan, et al v. Carnival Corp., No. 1:13-cv-20591 (S.D. Fl., Feb. 18, 2013) also alleged various claims for negligence against the cruise line.

Connecticut Bans Most Cell Phone Use While Driving, Part 2: How May it Affect Personal Injury Claims?

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file0002103247471.jpgConnecticut applies strict prohibitions on the use of cellphones and other mobile devices while driving. These laws are among the strictest in the nation, and while they address a serious risk posed by certain drivers, it is not yet clear that they actually reduce the overall number of automobile accidents. State laws restricting distracted driving may still serve a useful purpose in civil personal injury claims, however, by helping plaintiffs establish that a distracted driver acted negligently.

Bans on cell phone use while driving have encountered criticism for only addressing one type of distraction. A law review note exploring the various legal efforts to address distracted driving described four categories of distraction: “visual, auditory, biomechanical, and cognitive.” Andrew F. Amendola, Note, Can You Hear Me Now?: The Myths Surrounding Cell Phone Use While Driving and Connecticut’s Failed Attempt at a Remedy, 41 Conn. Law. Rev. 341, 348 (2008). Cell phone use can affect all four.

Two types of accidents tend to result from distraction: the distracted driver collides with an object ahead of them, or the driver veers off the road or into another lane of traffic. Id. at 347-48. The second type of accident only tends to happen when a driver is distracted or has diminished capacity, such as due to intoxication. Among the various forms of distraction, research has shown that eating while driving poses a significant accident risk. A 2009 study by the National Highway Traffic Safety Administration reportedly found that up to eighty percent of all automobile accidents involve a driver attempting to eat and drive at the same time. See also Amendola at 353. Connecticut does not expressly prohibit eating while driving, although law enforcement could investigate it as “reckless driving” in some circumstances. Other significant distractions may include fatigue, children in the car, pets or other animals, external visual distractions like billboards, or even just conversations with passengers. Conversing with a passenger can be just as distracting as a hands-free cell phone conversation. Amendola at 359.

Connecticut Bans Most Cell Phone Use While Driving, Part 1: Does It Actually Reduce Accidents?

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file000666325359-1.jpgConnecticut bans the use of handheld mobile devices, mainly cell phones, while driving, with even stricter bans for school bus drivers and young drivers. Numerous campaigns seek to raise awareness of the dangers of “distracted driving,” which refers to operating a vehicle while also using a cell phone or other mobile to device to talk, or to read or compose emails or text messages. Every state in the U.S. has banned some aspect of distracted driving, with Connecticut’s ban being one of the strictest, and the federal government has called on states to further restrict cell phone use by drivers. Distracted driving almost undoubtedly creates additional risk of accidents, but research has suggested that bans, like the one in Connecticut, do not significantly impact the number of automobile accidents. Bans on distracted driving may still be helpful to plaintiffs in personal injury cases though, as the violation of a ban may assist in establishing negligence.

The use of handheld cell phones while driving, by holding the phone “to, or in the immediate proximity of, the user’s ear,” has been prohibited for all drivers in Connecticut since 2005. Conn. Gen. Stat. § 14-296aa(a)(2), (b)(1). Connecticut’s law is one of the most comprehensive in the nation, as it is one of only ten states that prohibits all handheld cell phone use. The law does not prohibit most drivers from using hands-free accessories with a cell phone, such as a headset, with exceptions for school bus drivers on duty and drivers under the age of eighteen. Id. at (c)-(d). The statute also prohibits all drivers from sending or reading text messages while driving. Id. at (b)(2). It is a primary law, meaning that a police officer can stop a vehicle and issue a ticket solely for violation of the ban. The National Transportation Safety Board (NTSB) called on state governments to ban all cellphone use while driving, including use involving hands-free accessories. No state has enacted such a ban so far.

Courts Review Liability of Brand-Name and Generic Drug Manufacturers in Products Liability Cases

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1185407_27290304.jpgQuestions of liability arise at times between manufacturers of brand-name prescription drugs and manufacturers of their generic equivalents. The U.S. Supreme Court ruled several years ago that federal law preempts state laws regarding drug labeling. This led the Alabama Supreme Court recently to find that a brand-name manufacturer could be held liable for a generic manufacturer’s failure to warn, as federal law required generic drugs to have identical labels as the brand-name drug. The U.S. Supreme Court is preparing to hear arguments in a case that seeks to hold a generic manufacturer liable for a design or manufacturing defect in the drug, with the manufacturer claiming that they are only allowed by federal law to copy the approved drug design.

The U.S. District Court for the Middle District of Alabama recently certified a question to that state’s supreme court regarding whether state law could hold a brand-name drug manufacturer liable for injuries caused by a generic equivalent from a different manufacturer. In re Wyeth V. Weeks, No. 1101397, slip op. (Ala., Jan. 11, 2013). The Alabama Supreme Court held that federal law, in the form of Food and Drug Administration (FDA) regulations, required generic manufacturers to use the same drug labels as those used for the brand-name drug. The court held that it was “not fundamentally unfair to hold the brand-name manufacturer liable” on a failure to warn claim, when the “alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.” Slip op. at 52.

$11.1 Million in Compensatory and Punitive Damages Awarded in Woman’s Implant Lawsuit

Johnson_&_Johnson_HQ_-_IMG_2615A New Jersey woman received jury verdicts totaling $11.1 million in a lawsuit alleging injuries caused by a medical implant. The suit, Gross v. Ethicon, No. Atl-L-6966-10 (N.J. Sup. Ct., Atlantic Co.), is one of more than four thousand filed nationwide against manufacturers of mesh implants. The implant, intended to offset the effects of a condition known as pelvic organ prolapse, has been associated with serious and debilitating complications, sometimes requiring surgery to correct. The jury rejected a design defect claim, but found for the plaintiff on her failure to warn allegation. This was the first of the many pending mesh implant cases to go to trial.

The product in question, generally known as a transvaginal mesh implant, first came on the market about a decade ago as a treatment for pelvic organ prolapse. This is a condition associated with childbirth, certain surgeries, obesity, and other conditions, in which the pelvic muscles weaken and cannot adequately support the pelvic organs. This causes organs such as the bladder or uterus to drop, or prolapse, from their usual place in the body, creating pressure against other organs. The results may include mild to severe pain, incontinence, and constipation. The mesh implants are made of a porous material and act as a sling to support the affected organs. After hundreds of thousands of women received implants, thousands complained of pain, bleeding, and infections, and needed corrective surgery.

The plaintiff, who lives in South Dakota, received an implant of a device called the Prolift, manufactured by Johnson & Johnson subsidiary Ethicon Surgical Care. Complications from the implant, she claimed, caused severe pain, and eventually required eighteen unsuccessful surgeries to try to repair the damage caused to her organs. She said that she had to leave her job as a hospice nurse in 2006 due to complications caused by the implant. Her lawsuit asserted multiple causes of action related to products liability, including manufacturing or design defect and failure to warn of known risks.