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Archive for the ‘Medical & Health Care’ Category

Informed Consent! What Is It Good For? Absolutely Nothing. Say It Again.

Posted on: August 4th, 2017

By: Shaun Daugherty

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Ok. That may be a bit extreme. After all, it is in the American Medical Association’s Code of Medical Ethics and the concept is addressed in most medical professional organizations guidelines in one form or another. And let’s not forget that it is mandated by statute and common law in most states. So the bottom line is that it is seen universally as a good idea for a medical provider to obtain informed consent from a patient prior to providing therapy, care, or treatment. While the precise legal requirements differ from state to state, the gist is that a medical provider should provide sufficient information for a patient to make an informed decision as to whether to accept the treatment. Generally speaking, the patient should be informed of the diagnosis, the alternative treatment options, the likelihood of success, the major risk/complications associated, and the consequences of just doing nothing.   Fantastic. You have obtained informed consent from your patient. I ask again, what is it good for?

In the legal context, in most situations, if you do not obtain informed consent, a patient has a cause of action to sue a medical provider for lack of informed consent. The theory being that the patient was not given sufficient information to make an educated decision about their care, and if they had been told “X,” they never would have agreed to the procedure. The “X” is usually one of the risks/complications of the procedure that the patient experienced, unfortunately.

On the defense side of a malpractice action, the informed consent has very limited value unless there is actually a claim of lack of informed consent made by the patient. In that scenario, informed consent is a relevant and target point of contention with the written informed consent form front and center for the jury. Without the specific claim being alleged, many courts are ruling that the informed consent forms that are signed by the patients are inadmissible pieces of evidence and are redacted from the records. They are also ruling that informed consent cannot be discussed in any form or fashion unless for the purpose of impeachment. That is, if the patient denies knowing that a particular risk was possible.

The typical scenario is that a patient suffers one of the known risks or complications of a procedure, let’s say a nerve injury during parathyroid surgery, and then sues the provider for the injury that they suffered. The provider says that it is a known risk of the procedure and it was not caused by negligence. The informed consent form will typically have the specific risk listed as one of the possible complications of the procedure and the defense would like to show the form to the jury to say, “see, we told them this was a risk of the procedure.” The claimant wants to keep the issue of informed consent out of evidence because, as the courts have reasoned, they are afraid that the jury could be misled to believe that the patient consented to the injury itself instead of focusing on whether there was a deviation in the standard of care.

One of the practical problems from a defense standpoint is the juries’ expectations with regard to their own common experiences. That is, the average juror of a medical negligence case will be very familiar with informed consent forms and will often look for them in the records during deliberations to either confirm or refute whether something is or is not a known risk/complication. If it is absent from the records, this could become a problem for the defense as the juror may believe that informed consent was not obtained and become a reason to find fault, even though it was not an issue in the case. An otherwise non-existent burden of proof has been created for the defense to disprove an issue that was never part of the case. Defending a medical negligence case can be difficult enough without having to chase phantoms.

We will keep looking for the legal trends and implications to govern ourselves accordingly while medical providers need to keep getting written informed consent as often as possible. After all, informed consent is ultimately good for something, perhaps the most important thing, patient information and decision making.

If you have any questions or would like more information, please contact Shaun Daugherty 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].

Florida Supreme Court Strikes Down Damage Caps in Med Mal Cases

Posted on: June 9th, 2017

By: Melissa A. Santalone

Almost a year to the day after hearing oral argument on the case of North Broward Hospital District v. Kalitan, the Florida Supreme Court finally issued its decision striking caps on noneconomic damages in medical malpractice cases, holding they violate the Equal Protection Clause of the Florida Constitution. The Court reviewed and agreed with the Fourth District Court of Appeal’s ruling that also found Fla. Stat. § 766.118(2) and (3) violate the Equal Protection Clause. Many in the Florida legal community anticipated this outcome, since in 2014, the Court stopped just short of striking all noneconomic damage caps in med mal cases in Estate of McCall v. U.S., 134 So.3d 894. In McCall, the Court limited its holding that noneconomic damage caps were unconstitutional to wrongful death medical negligence suits.

Section 766.118, originally enacted in 2003, imposed caps on noneconomic damages in medical malpractice personal injury lawsuits ranging from of $500,000 to $750,000 per claimant for non-catastrophic injuries, depending on whether they were caused by a “practitioner” or “nonpractitioner,” as defined by the statute. It also limited noneconomic damages to between $1 million and $1.5 million for catastrophic injuries, which includes things like the loss of a limb, severe burns, or severe brain injuries, and those injuries resulting in a permanent vegetative state. 

In the Kalitan case, the plaintiff had undergone surgery for carpal tunnel syndrome, wherein her esophagus was perforated during intubation. After awaking from surgery and complaining of chest and back pain, she was examined by a doctor, who failed to discover her injury, and she was released from the hospital. The next day she was found unresponsive and rushed back to the hospital, where she underwent emergency surgery and spent weeks in a drug-induced coma. The plaintiff underwent a long course of rehabilitation, including additional surgeries, to be able to eat again and alleged she continues to suffer from physical pain and emotional trauma from the incident. At trial, the jury awarded the plaintiff $4 million in noneconomic damages; however, the plaintiff’s recovery was reduced by close to $2 million due to the damage caps.

Section 766.118 was initially enacted under the rationale that it was necessary to combat a medical malpractice crisis where ever-escalating insurance premiums were driving doctors out of state or into retirement, effectively limiting Floridians’ access to healthcare. The 4-justice plurality of the Court found the statute’s effect was arbitrary and unreasonable. It compared the hypothetical outcomes to claimants with varying degrees of injury, and determined the statute arbitrarily limited the recovery of the most seriously injured. Moreover, the plurality concluded, it did so without any rational relationship to the stated objective of decreasing medical malpractice premiums, since there was no mechanism to ensure savings were passed from insurance companies to doctors.  The dissent opinion, signed by 3 justices, found a rational relationship did exist between the statute and the legitimate state interest of decreasing medical malpractice premiums, and argued the plurality misapplied the proper test used in equal protection challenges.

This decision is a win for the Plaintiffs’ bar, which has always been vehemently opposed to caps, and it will likely send shockwaves through the Florida medical and insurance realms. Insurers will need to reevaluate whether the premiums they charge are adequate in light of the increased risk they now face and will need to be prepared to see an increase in the number of suits they must defend against. Likewise, those working in the medical field must decide if the coverage they currently have will adequately protect their personal assets if the worst should happen.

For any questions regarding the Florida Supreme Court’s decision, please contact Melissa A. Santalone at [email protected].

 

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]

Ethical Code Does Not Prevent Expert Testimony

Posted on: April 24th, 2017

By: Shaun Daugherty

In a recent, factually interesting decision by an Illinois Court of Appeal, a defense verdict in a dental malpractice case was overturned for a variety of reasons related primarily to the defendant’s expert’s use of skulls during his testimony. However, one of the side issues also piqued my interest. The case involved dental implants, and a treating oral and maxillofacial surgeon provided testimony that the dentist that placed the implants deviated from the applicable standard of care.

During cross-examination by the defendant’s attorney, the oral surgeon was confronted with G.1.08 of the American Association of Oral and Maxillofacial Surgeons’ Code of Professional Conduct titled “Fairness in dealing with colleagues” that reads: “Oral and maxillofacial surgeons who wish to serve as expert witnesses must not do so in cases for which they also served as one of the patient’s treating doctors.” The oral surgeon admitted that he was a treating doctor, but attempted to clarify that the code did not apply to the situation as the dentist that placed the implants was not a “colleague.”

The Illinois Court of Appeals addressed this line of cross-examination. While it was not the issue that formed the basis of the reversal, the court wanted to provide direction to the trial court for the retrial. Specifically, the three-panel opinion determined that the cross-examination was improper and should not have been allowed. The opinion indicated that only the Illinois legislature and the courts may determine the admissibility and proper scope of expert testimony in medical malpractice actions. The private accrediting bodies “may not attempt to thwart their members from testifying as expert witnesses against their colleagues by declaring such testimony to be a violation of professional ethics.” Therefore, the type of questioning was both irrelevant and in violation of public policy and should not have been permitted.

It is interesting because for years, I have had this particular Code of Professional Conduct used by opposing counsel in an attempt to quell the supporting testimony of treating oral surgeons in cases where I was defending the dental professional. Often, the oral surgeon would have expert opinions that the defendant met the standard of care, but this particular ethics consideration was brought to their attention in a pre-deposition meeting with the patient’s attorney, and they would decline to provide such testimony on the record. Thus, the Code of Ethics is being used as both a sword and a shield for expert testimony.

This decision, while not binding in other states, still provides sound arguments for the application of similar issues in our own backyard. Any qualified expert should be able to provide opinions that a medical provider met or deviated from the standard of care, even if they too provided care. The search for truth should not be restricted for either side by the use of an ethical rule as long as the testimony is from a qualified expert and is, in fact, the truth.

For more information, please contact Shaun Daugherty at [email protected].