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Archive for the ‘Life Sciences’ Category

Advancements in Medical Device Technology Prompts FDA Guidance Document for Manufacturers

Posted on: September 8th, 2017

By: Michael P. Bruyere and Samantha Skolnick

medical-technology[1]From operating rooms to a local pediatrician office; we know that medical devices have altered the medical field in a significant way. As technology, has improved; making our homes smarter and allowing our cars to essentially drive themselves; medical devices have seen great technological advances. Now devices can communicate with each other and exchange information even if they are from different manufacturers. Interoperable medical devices are defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as devices that can exchange and use information through an electronic interface with another medical/nonmedical product, system, or device. Interoperability is essentially the means in which medical devices communicate and interact with each other. Yet, errors such as inconsistent units of measurement between the devices prompted the FDA to step in with guidance for the manufacturers.

The FDA issued its final guidance and recommendations on interoperability to ensure the safety and reliability of the communication between medical devices. The 21- page document, released on September 6, 2017, focuses on considerations that ought to be involved in the advancement and overall design. There were also suggestions for the material to be included in premarket submissions and labeling of devices. The guidance directly highlights that interoperability should be an objective for manufacturers; verification, validation and risk management activities should be taken; and manufacturers should be specifying the relevant features in a user- friendly way.

The FDA opines that manufacturers should perform a risk analysis and perform testing that considers; the perils that could be linked to interoperability, who the users of the devices may be, misuses that would be reasonably foreseeable, and a combination of foreseeable events that could result in an overall dangerous situation. The FDA advises that manufacturers should keep in mind the diverse users while designing the device and in formulating the instructions; since such considerations may affect the limitations on the device or the user. The FDA even suggests developing entirely different instructions for different users. The guidance document states that interoperable systems should sustain basic safety and key performance during normal and fault conditions. The manufacturers should be designing an interoperable medical device that can appropriately allay risks connected with a wide range of potential error scenarios. The guidance document also suggests that the devices endure a sufficient level of testing to prove that the interactions on the electronic interface are performing in the appropriate manner. The testing ought to be based on the purpose of the interface and should comply with the planned specification. Another general takeaway from the guidance document is that difficulties or misapplication of the devices can be curtailed by making the functional, performance, and interface standards readily available to all users.

Simply put, the goal is to make sure these devices are communicating in a way that ensures the safety of the patient and the operator of the devices. Manufacturers who are submitting applications up to 60 days after the publication of the guidance will not be required to comply with the recommendations. Yet, the agency is willing to review any information submitted to them regarding interoperability. The guidance document is not legally binding, but it highlights the impact of technological advancements on medical devices and the safeguards that should be in play. And as we read the guidance document on our latest smartphone or tablet, we are reminded of the tremendous impact technology has on our lives and continues to have.

If you have any questions or would like more information, please contact Michael Bruyere at [email protected] or Samantha Skolnick at [email protected].

The Supreme Court Buys Into Argument that Plaintiffs Should Not Be Permitted to Forum Shop

Posted on: June 22nd, 2017

By: Kristian Smith & Robyn Flegal

The U.S. Supreme Court decided one of the most important mass tort/product liability decisions ever Monday, effectively ending forum shopping or “litigation tourism.” In its 8-1 ruling, the Supreme Court in Bristol-Myers Squibb Co. v. Superior Court, No. 16-466 (U.S. June 19, 2017) overturned a California Supreme Court decision that had allowed hundreds of out-of-state patients who took Bristol-Myers Squibb’s blood-thinning medication Plavix to sue the company in California.

For years, plaintiffs involved in “litigation tourism” have relied on broad interpretations of personal jurisdiction to sue large companies in plaintiff-friendly jurisdictions. Ever since “general” personal jurisdiction was limited by the Supreme Court three years ago in Daimler AG v. Bauman, 134 S.Ct. 746 (2014) to those states where a corporation is incorporated or has its principal place of business, plaintiffs have tried to use a similar broad interpretation of “specific” personal jurisdiction to forum shop. The California Supreme Court accepted this theory when it allowed plaintiffs from all over the country to sue Bristol-Myers Squibb in California.

But the Supreme Court didn’t buy it and reiterated that the lawsuit itself must arise out of or relate to the defendant’s contacts with the forum.

The Supreme Court rejected the California Supreme Court’s ruling that any “substantial connection” between a corporate defendant’s activities and California, whether or not causally related to a plaintiff’s claimed injuries, would suffice to support jurisdiction. The California Supreme Court conferred jurisdiction over Bristol Myers-Squibb where the plaintiffs did not reside in the state and did not sue over a drug that they purchased in the state. The Supreme Court called this approach a “loose and spurious” form of general jurisdiction.

As the Court held, “a defendant’s general connections with the forum are not enough.” This means that plaintiffs may “join together in a consolidated action in the States that have general jurisdiction over BMS.” Otherwise, “the plaintiffs who are residents of a particular State… could probably sue together in their home States.”

This ruling ends the days of plaintiffs flocking to accommodating jurisdictions to bring claims against large companies, and it is already having widespread effects. Based on the Court’s ruling on Monday, a St. Louis judge declared a mistrial in a talcum powder trial underway in St. Louis Circuit Court based on lack of personal jurisdiction. The mistrial in St. Louis was declared in a trial where a Missouri man and two out-of-state plaintiffs sued Johnson & Johnson and its supplier Imerys Talc America over a claim that talcum powder in its products caused ovarian cancer. Johnson & Johnson’s lawyers prevailed, arguing that the packaging and labeling company with a plant in Missouri was simply one of the company’s contractors, and played no role in establishing jurisdiction over out of state plaintiffs.

For any questions, please contact Kristian Smith at [email protected] or Robyn Flegal at [email protected].

Georgia Supreme Court Finds Fault with the Court of Appeals’ Decision Requiring a Full Retrial on Apportionment

Posted on: June 9th, 2017

By: Robyn Flegal

In July of 2007, Joshua Martin suffered a brutal gang attack outside of Six Flags Over Georgia and was left with severe brain damage. On June 5, 2017, the Supreme Court of Georgia granted certiorari to decide the following two questions: “(1) whether Six Flags could properly be held liable for the injuries inflicted in this attack; and (2) assuming liability was proper, whether the trial court’s apportionment error does indeed require a full retrial.” The Supreme Court reinstated a $35 million verdict for Mr. Martin, holding that the jury was authorized to find Six Flags liable for the breach of its duty to exercise ordinary care in keeping its premises safe for invitees. The Court then remanded the case to the trial court for a determination as to apportionment of fault.

The jury had apportioned fault between the parties by assigning 92% of the $35 million verdict against Six Flags, and 2% against four of Martin’s attackers. Six flags argued that the jury should be entitled to apportion damages among not only named defendants, but also among individuals who were alleged to have been involved in Martin’s attack. Georgia law provides that, when assessing percentages of fault, the trier of fact shall consider the fault of all persons or entities who contributed to the alleged injury or damages, regardless of whether the person or entity was, or could have been, named as a party to the suit. OCGA § 51-12-33.

The Georgia Supreme Court acknowledged that two of Mr. Martin’s assailants should be added to the verdict form, and decided that apportionment could be decided without a full retrial. “[A]s a general matter, where correction of an apportionment error involves only the identification of tortfeasors and assessment of relative shares of fault among them, there is no sound reason to disturb the jury’s findings on liability or its calculation of damages sustained by the plaintiff.” The Court did, however, concede that a retrial on apportionment might require the presentation of much or all of the same evidence as was presented when determining liability.

To be sure that fault is properly apportioned, Georgia attorneys must include on the jury verdict form all individuals, including the plaintiff, who contributed to the injury or damages.¹

For more information contact Robyn Flegal at [email protected].


¹ While this particular case was not a life sciences case, these principles also apply to drug and medical device trials in Georgia.

 

Pharmaceutical Company Held Liable for Lawyer’s Suicide

Posted on: April 27th, 2017

By: Kristian N. Smith 

A federal jury in Illinois recently held GlaxoSmithKline liable for the death of a Reed Smith LLP partner, Stewart Dolin. The jury found that the generic version of GSK’s Paxil caused Mr. Dolin to take his own life, awarding $3 million to his widow.

Dolin began taking the generic version of Paxil, paroxetine, five days before taking his own life. In the lawsuit, Dolin’s widow claimed the drug caused a heightened anxiety known as “akathisia” in the 57-year-old that caused his death.

The lawsuit claimed that GSK knew about the increased risk of suicide for adults taking paroxetine. The plaintiff alleged the company had hidden data proving the link from the U.S. Food and Drug Administration for decades and ignored suicides in its clinical trial. She alleged GSK had evidence paroxetine increases the risk of suicide by older users by as much as 670 percent, yet failed to include that on the warning label.

GSK denied that paroxetine caused Mr. Dolin’s suicide, arguing that the FDA does not require Paxil to come with a warning that it can increase the risk of suicide in adults. The drug’s label does include a “black-box” warning that it can increase the risk of suicidal behavior by users under age 25.

GSK also argued that Mr. Dolin’s suicide was a result of his years-long battle with anxiety and stress related to his work as co-chair of Reed Smith’s corporate and securities practice. GSK presented therapy records showing Mr. Dolin had concerns about his new role at Reed Smith, as well as evidence of other work-related performance issues. Ms. Dolin testified during the trial that while her husband was sometimes anxious, he had developed coping mechanisms to deal with that anxiety and was seeing a therapist at the time of his death.

The lawsuit originally included Mylan, the manufacturer of the generic medication, but a federal judge dismissed Mylan in 2014. Splitting with some previous rulings on this issue, the judge found that even though GSK did not manufacture the drug at issue, it controlled the drug’s design and label, which applied to both the brand name and generic versions. The judge held that Mylan was bound by statute to use GSK’s warning label, and thus GSK was the responsible party.

GSK stated it plans to appeal the verdict.

For any questions, please contact Kristian Smith at [email protected]

Higher Screening Standards Needed to Prevent Fentanyl Misappropriation in Hospitals

Posted on: November 4th, 2016

remigho-syringeBy: Robyn Flegal

A disturbing trend is on the rise. Hospital employees are misappropriating drugs intended for patients. The drug of choice is fentanyl, which has been used as a prescription painkiller since the 1960s, but is up to fifty times more powerful than heroin and up to 100 times more potent than morphine.[1] In some areas of the United States, deaths resulting from fentanyl overdoses are more prevalent than deaths resulting from heroin overdoses.[2]

Several newsworthy cases illustrate this trend toward fentanyl misappropriation by hospital staff. A nurse in Colorado is suspected of misappropriating fentanyl intended for patients after she was found with fentanyl doses exceeding the amounts nurses typically need for their patients.[3] A month before, in another Colorado hospital, a surgical technician was arrested for allegedly tampering with “a syringe containing fentanyl citrate by removing the syringe containing [fentanyl] and replacing it with a similar syringe containing ‘other substances.’”[4] Other hospital employees, including surgical technicians,[5] emergency medical technicians,[6] and pharmacy technicians[7] have been investigated for similar circumstances of fentanyl misappropriation.

Hospitals should be aware of this dangerous trend and should limit employee access to fentanyl. Hospitals should implement thorough screening procedures and background investigation before hiring employees who will have access to fentanyl. The surgical technician mentioned above had previously been fired after testing positive for a controlled substance, but he answered “no” on his job application as to whether he had ever been fired from employment as a surgical technician.[8] It is important to be aware, however, that even the most thorough background screening may not prevent fentanyl misappropriation in every instance. One of the pharmacy technicians under investigation for replacing fentanyl with saline solution passed a criminal background check and his reference check did not raise any red flags.[9]

[1] Katharine Q. Seelye, Heroin Epidemic is Yielding to a Deadlier Cousin: Fentanyl, N.Y. Times, March 25, 2016, http://www.nytimes.com/2016/03/26/us/heroin-fentanyl.html?_r=0.

[2] Id.

[3] Noelle Phillips, Nurse Accused of Stealing Fentanyl from Summit County Hospital, Denver Post, March 19, 2016, http://www.denverpost.com/2016/03/19/nurse-accused-of-stealing-fentanyl-from-summit-county-hospital/.

[4] Elizabeth Hernandez, Feds Arrest Swedish Medical Surgical Tech Accused of Stealing Drugs, Denver Post, February 16, 2016, http://www.denverpost.com/2016/02/16/feds-arrest-swedish-medical-surgical-tech-accused-of-stealing-drugs/.

[5] Lane Lyon, Former Rose Hospital Employee Admits to Needle Swapping, July 3, 2009,  http://www.thedenverchannel.com/news/former-rose-hospital-employee-admits-to-needle-swapping.

[6] U.S. Attorney’s Office, Raymond Man Sentenced for Diverting Fentanyl at Exeter Hospital, August 29, 2014,  https://www.fbi.gov/contact-us/field-offices/boston/news/press-releases/raymond-man-sentenced-for-diverting-fentanyl-at-exeter-hospital.

[7] KSN-TV, Pharmacy Tech Swapped Fentanyl for Saline Solution, Hospital Says, October 27, 2016,  http://ksn.com/2016/10/27/pharmacy-tech-swapped-fentanyl-for-saline-solution-hospital-says/

[8] Elizabeth Hernandez, Feds Arrest Swedish Medical Surgical Tech Accused of Stealing Drugs, Denver Post, February 16, 2016, http://www.denverpost.com/2016/02/16/feds-arrest-swedish-medical-surgical-tech-accused-of-stealing-drugs/.

[9] KSN-TV, Pharmacy Tech Swapped Fentanyl for Saline Solution, Hospital Says, October 27, 2016,  http://ksn.com/2016/10/27/pharmacy-tech-swapped-fentanyl-for-saline-solution-hospital-says/