joint medical malpractice and product liability...
TRANSCRIPT
Joint Medical Malpractice and Product Liability
Claims for Drug or Medical Device Injuries Navigating Complex Litigation Issues: Choice of Forum, Choice of Parties,
Standards of Care, Causation, Defenses, Settlement and Damages
Today’s faculty features:
1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific
The audio portion of the conference may be accessed via the telephone or by using your computer's
speakers. Please refer to the instructions emailed to registrants for additional information. If you
have any questions, please contact Customer Service at 1-800-926-7926 ext. 10.
THURSDAY, AUGUST 23, 2012
Presenting a live 90-minute webinar with interactive Q&A
Christiana Jacxsens, Shareholder, Greenberg Traurig, Atlanta
Jessica Cabral Odom, Attorney, Greenberg Traurig, Atlanta
Natalie Woodward, Partner, Woodward + Stern, Atlanta
Sound Quality
If you are listening via your computer speakers, please note that the quality of
your sound will vary depending on the speed and quality of your internet
connection.
If the sound quality is not satisfactory and you are listening via your computer
speakers, you may listen via the phone: dial 1-866-869-6667 and enter your
PIN -when prompted. Otherwise, please send us a chat or e-mail
[email protected] immediately so we can address the problem.
If you dialed in and have any difficulties during the call, press *0 for assistance.
Viewing Quality
To maximize your screen, press the F11 key on your keyboard. To exit full screen,
press the F11 key again.
For CLE purposes, please let us know how many people are listening at your
location by completing each of the following steps:
• In the chat box, type (1) your company name and (2) the number of
attendees at your location
• Click the SEND button beside the box
FOR LIVE EVENT ONLY
If you have not printed the conference materials for this program, please
complete the following steps:
• Click on the + sign next to “Conference Materials” in the middle of the left-
hand column on your screen.
• Click on the tab labeled “Handouts” that appears, and there you will see a
PDF of the slides for today's program.
• Double click on the PDF and a separate page will open.
• Print the slides by clicking on the printer icon.
Joint Medical Malpractice
& Product Liability
Webinar Christiana Jacxsens
Natalie Woodward [email protected]
Jessica Cabral Odom [email protected]
Woodward + Stern LLC
6
Introduction & Agenda
1. Introduction
2. Nature of a Mixed Medical Malpractice and Product Liability Case
a. General Overview from Plaintiff’s Perspective
b. General Overview from Defense Perspective
3. Unique Legal Issues to an Action Involving Both Claims
a. Jurisdiction Issues
b. Learned Intermediary Doctrine
4. Key Considerations & Strategies
a. Plaintiff’s Perspective
b. Defense Perspective
5. Hot Topics
a. Subsequent Treaters as Expert Witnesses
b. Physicians Consulting for Manufacturers
c. Preemption
6. Q&A and Discussion
Nature of a Mixed Medical Malpractice & Product Liability Case
From the Plaintiff’s Perspective
8
Issues to Consider
Familiarity with type of Case
Deciding whether to get help
9
Familiarity with Types of Cases
Understanding of common medical issues involved in the case;
Understanding of common legal issues in the case;
Access to experts to help evaluate the case.
10
Deciding whether to get help
Associating co-counsel
Referring case out to another firm
Putting arrangement in writing
Nature of a Mixed Medical Malpractice & Product Liability Case
From the Defense Perspective
12
Mixed Cases on the Rise
Mixed medical malpractice and product liability cases are on the rise.
Increase in mass tort medical device cases Mesh litigation
Hip Implant litigation
13
Co-Defendant Strategy
Consider advantages and disadvantages of pointing the finger at the co-Defendant
Is a co-defense agreement an option?
Even if the physician is not a named defendant, he or she will be an important witness
14
Know Your Jurisdiction
Each jurisdiction has specific case law and statutes that may apply to a mixed medical malpractice and product liability case.
Educate yourself on that particular jurisdiction
Procedural hoops
Unique defenses
Removal/Fraudulent Joinder Iaw
Differing application of evidentiary rules on product liability defendants Subsequent remedial measures
Differing rules on apportionment specific to medical malpractice defendants versus product liability defendants
Unique Legal Issues to an Action Involving Both Claims
Removal & Fraudulent Joinder
16
To Remove or Not to Remove
Manufacturers will generally prefer to remove the case to federal court.
Wider jury pool
Less likely to be home-cooked
Physician may prefer to stay in state court.
Home field advantage
Or, even if the physician is not opposed to removal, may not be aggressive in removing the case.
Manufacturer will have to take lead on removing case.
17
Fraudulent Joinder
Closely examine the allegations against the forum defendants.
This scenario brings with it the threat of inconsistent rulings and accelerated state court dockets.
One tool defense counsel has available to it in this situation is the doctrine of fraudulent joinder.
18
Fraudulent Joinder
A fraudulently joined party cannot defeat a court’s subject matter jurisdiction; thus, if the defendant can show that the doctrine of fraudulent joinder should apply, the case may be removed to federal court despite the presence of the non-diverse party.
The test for whether a party has been fraudulently joined is difficult to meet (generally the burden is on the removing party to show fraudulent joinder by clear and convincing evidence).
In order to establish fraudulent joinder, the removing party must show that there is no possibility that the plaintiff will be able to establish a cause of action against the non-diverse defendant in state court or that there has been outright fraud in the plaintiff’s pleadings of jurisdictional facts.
19
Fraudulent Joinder – Case Study
In Beavers v. DePuy Orthopaedics, Inc., 1:11 DP 20275, 2012 WL 1945603 (N.D. Ohio May 30, 2012), plaintiffs filed a complaint in Kentucky state court naming DePuy Orthopaedics, Inc., DePuy, Inc., Johnson & Johnson, Inc., Johnson & Johnson Services, Inc., and Orthopaedic Partners.
The Depuy Defendants removed the case on the basis of fraudulent joinder to the Western District of Kentucky without the consent of Defendant Orthopaedic Partners.
The DePuy Defendants moved to stay all state court proceedings pending transfer of the action to the MDL.
Plaintiffs subsequently filed their motion to remand to state court.
The JPML transferred the case from the Western District of Kentucky to the MDL pending in the Northern District of Ohio.
20
Fraudulent Joinder – Case Study
The issue before the Northern District of Ohio was whether the case should be remanded back to state court.
Plaintiffs argued that Defendant Orthopaedic Partners is a Kentucky resident (like Plaintiffs) and destroys diversity jurisdiction because Plaintiffs have asserted a colorable claim against that Defendant.
Defendants argued that removal is appropriate because there is no viable claim against Defendant Orthopaedic Partners (in other words, Defendant Orthopaedic Partners had been fraudulently joined).
Defendants also argued that Plaintiffs failed to meet the pleading standard articulated in Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) and adopted by the Sixth Circuit in Ass’n of Cleveland Fire Fighters v. City of Cleveland, Ohio, 502 F.3d 545, 548 (6th Cir. 2007).
21
Fraudulent Joinder – Case Study
The court looked to the characterization of and factual allegations against Defendant Orthopaedic Partners, LLC that Plaintiffs asserted in their complaint.
The court noted that the complaint referred to all defendants collectively and Defendant Orthopaedic Partners was only mentioned twice throughout the 89 paragraph complaint.
The court found that “the allegations against Orthopaedic Partners, LLC [] fall well below the threshold required to meet the plausibility standard required under Twombly . . . . Plaintiffs’ allegations fail to distinguish between the DePuy Defendants’ allegedly wrongful acts and those of Orthopaedic Partners, LLC.”
The dourt explained that “the lack of factual allegations regarding Orthopaedic Partners, LLC, provides no more than labels and conclusions insufficient to sustain viability of the legal claims.”
Thus, the court found Orthopaedic Partners, LLC to be fraudulently joined.
22
Fraudulent Joinder - Considerations
Carefully examine the complaint for allegations against the forum physician or hospital defendant and consider: Do the allegations meet pleading requirements?
Have all state requirements for a medical malpractice been met, i.e. affidavit?
Are the allegations true medical malpractice allegations against physician or hospital?
Would the claims against the physician or hospital be barred by state or federal law?
Unique Legal Issues to an Action Involving Both Claims
The Learned Intermediary Doctrine
24
Learned Intermediary Doctrine
Bars recovery against manufacturer, designer, or distributor of prescription drug or medical device based on a theory that the defendant failed to warn the patient directly of product risks.
Manufacturers discharge their duty to warn by providing warnings to the prescribing physicians, the “learned intermediary.”
The treating physician has the sole responsibility for advising the patient of dangers associated with the use of the prescription product.
Proximate Cause Plaintiffs typically bear the burden of not just proving the
warning given the doctor was inadequate, but also that if given a different warning, the doctor would not have prescribed the drug or medical device
If prescribing physician is unavailable to testify, argue plaintiff cannot meet their burden
25
Learned Intermediary Doctrine
Heeding Presumption In a few states, there is a presumption that the prescribing
physician would not have prescribed the drug, had an adequate warning been given
Defense burden to rebut the presumption
If the doctor was aware of the risk alleged from some other sources, such as medical literature, then no proximate cause for failing to warn
Exceptions to the learned intermediary doctrine recognized in some states: Over the counter pharmaceutical products
Products where there was direct to consumer advertising
Mass-immunizations
Contraceptives
Overpromotion
26
Learned Intermediary Doctrine: Case Study
Plaintiffs’ verdict: Wyeth negligently failed to provide proper warnings regarding the risks of breast cancer to Plaintiff’s prescribing physician during the time that she took Prempro. The jury further concluded that Wyeth's negligence was a cause of her physician's decision to prescribe Prempro to her, and that Prempro was a factual cause of her injury, specifically breast cancer or its growth.
Wyeth moved for JNOV claiming that, pursuant to PA learned intermediary doctrine, it discharged its duty to warn Plaintiff’s prescribing physician when it included warnings regarding breast cancer in the Prempro labeling.
27
Learned Intermediary Doctrine: Case Study
Result: Court denied Wyeth’s Motion.
At trial, the prescribing physician testified that when he prescribed Prempro to Plaintiff, he warned her of certain risks, but not of the risk of cancer.
He stated that in his view the physician's package insert did not provide him with any basis to conclude that the drug posed any significant risk of breast cancer to her, since its warnings in this regard appeared to be limited to cases of higher doses or doses for a prolonged period of time.
Finally, the prescribing physician testified that if he had seen a “black box-type” breast cancer warning similar to that later set forth on the current package inserts, he would have passed this information along to Plaintiff and emphasized it during their discussions regarding the risks.
Key Considerations & Strategies
From the Plaintiff’s Perspective
29
Client Issues
The judge matters
Typical defense counsel for particular defendant
Contract issues
Communication
Estate concerns
30
Expert Issues and Strategy
What experts are needed from Plaintiff’s perspective?
Access to the experts.
Use of subsequent treaters as expert.
Rebuttal experts.
Key Considerations & Strategies
From the Defense Perspective
32
Evaluate Key Affirmative Defenses Early
Federal Preemption under Riegel, Mensing, and Buckman
Learned Intermediary Doctrine
Product ID (not our product)
Assumption of the Risk
Informed Consent
Failure to Mitigate
Unforeseeable Idiosyncratic Reaction
Intervening, Superseding Causes
Contributory/Comparative Negligence
Comment K of Section 402(A) of Restatement of Torts
Statute of Limitations/Repose
Improper Jurisdiction/Forum Non Conveniens
Iqbal/Twombly
No injury – “Fear Of” Claims/Medical Monitoring
33
Learn Key Documents
PMA or 510(k) file, letters, application, reports, supplements for devices
ANDA or NDA files for pharma
FDA correspondence, notices
“Dear Doctor” letters
Documents related to any CAPA, field actions, recalls, withdrawals
Design history file
Risk Analysis
Manufacturing records/Traceability/Travelers/Lot History
All Labeling
IFU – Instructions for Use
Outer Packaging
Package Inserts
Medication Guide (given to patients)
34
Learn Key Documents
Patient Brochures, Videos Advertising and Marketing PDR publication for pharma Medical Literature/Packets
Given to MDs Cited or referenced to FDA or in labeling
Training Materials and Presentations Sales Reps Implanting MDs
Product Complaint Files SOPs regarding MDR reporting, complaint handling Plaintiff specific records
Claim file Medwatch Registration records Invoices/Sales records Device testing, analysis, reports, protocols Audio recordings with customer care
MD specific records (for implanting/explanting MD)
35
Producing Documents
Protective Order for Proprietary and Confidential Documents
Single Tier
Two-Tier for Attorneys’ Eyes Only
Check local rules, standing orders
Stamped “confidential” not “privileged and confidential”
Redactions required – Other patients’ HIPAA Protected Health Information
36
Handling of Key Witnesses
Sales Representatives/Marketing Personnel
Where they interacted directly with the prescribing doctor or patient, their depositions are key events in the case.
Extensive preparation and "handling" are the key to success.
Prescribing and Treating Physicians
These depositions are always critical and can make or break a case.
Their testimony is critical to learned intermediary defense.
Treating physicians are perceived as neutral by the jury, unless a defendant – Causation opinions are key
Treating physician may also be a named co-defendant, and may be tempted to finger-point at the company.
37
Expert Selection and Retention
Types of Experts Relied on by Defense: FDA/Regulatory
Engineering/Device Experts
Physician: Prescriber, Causation, Damages/Treatment
Epidemiologist/Biostatician
Pharmacologist/Toxicologist
Pathologist or other Expert in the alleged injury, condition, or diseases at issue
Warnings or Human Factors
Damages (such as economist and life care planner; can be shared)
38
Expert Selection and Retention
Strategies for Selecting and Retaining Experts: Rely on both internal and external experts
Use a mix of local and national experts
Avoid experts who are "overused”
Watch expert costs and ask for budget in advance
Work with client to identify key opinion leaders
Be careful of experts who have served as consultants to client or who have been paid by client for studies, seminars, etc.
HOT TOPICS Chilling Expert Witnesses
40
Chilling Expert Witnesses
So-called “conspiracy of silence” intimidating doctors from testifying against other local doctors.
Recent order by Judge Adele Grubbs of Cobb County Superior Court
Internist Dr. Stinnette at Northside backed out of his deposition as an expert for the plaintiff after Northside’s general counsel discouraged him from testifying
Dr. Stinnette testified that he feared he would lose his job and be blackballed by the medical community
41
Chilling Expert Witnesses
Judge Grubbs found that the evidence was overwhelming that the attorneys “sought to intimidate and have chilled the witness.”
Judge Grubbs held that the defense’s interference infringed on plaintiff’s right to a fair trial.
3 defense attorneys were disqualified.
Court gave Wellstart 60-90 days to find new counsel.
HOT TOPICS Physicians Consulting for
Manufacturers
43
Physicians Consulting For Manufacturers
Recent media coverage related to cases, government enforcement actions, and changes in state law regarding physicians that consult for various pharmaceutical and medical device manufacturers.
Ethical considerations
Determine how much the physician has been paid and what type of payment
Consideration for treating physicians as well as expert witnesses.
44
FDA Disclosure Guidelines
New FDA guidelines on disclosure of clinical investigators.
There has been a growing number of claims in medical device and pharmaceutical product liability actions based on purported conflicts of interest of clinical investigators conducting medical device or pharmaceutical clinical studies.
Financial interests of clinical investigators can be a potential source of bias in clinical study data used to support the application for FDA approval of a new drug or a new medical device.
In particular, a clinical trial investigator may have a financial interest in the outcome of the study due to payment arrangements or equity interests in the sponsors of clinical studies.
While the FDA does not prohibit a clinical trial investigator from having a purported financial interest, the FDA does regulate the disclosure of that information.
45
Disclosable Financial Arrangements
Compensation made to the investigator in which the value of compensation could be affected by study outcome.
A proprietary interest to the tested product, including a patent, trademark, copyright or licensing agreement.
Any equity interest in the sponsor of a covered study, i.e. any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices.
Any equity interest in a publicly held company that exceeds $50,000 in value.
Significant payments of other sorts (“SPOOS”), which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator during the time the clinical investigator is carrying out the study and for 1 year following completion of the study.
HOT TOPICS Federal Preemption
47
Federal Preemption
Preemption is the principle that a federal law can and must supersede a state law that is inconsistent.
2 Types: Express Preemption: Federal statute forecloses all
conflicting state law claims (not applicable to pharmaceutical products)
Riegel v. Medtronic, Inc. – Medical Devices
Implied or Conflict Preemption: it is impossible to comply both with state and federal law, so federal law must prevail:
Pliva, Inc. v. Mensing - Generic Drugs
Buckman Co. v. Plaintiffs’ Legal Committee – Fraud on the FDA
48
Mensing : Federal Preemption for Generic Drugs
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011)
Because generic drug manufacturers cannot change the FDA required labeling of their drugs, state law claims that the labeling is inadequate would conflict with FDA regulations and are thus preempted.
Plaintiffs’ Efforts to Undermine: Mensing only applies to failure to warn claims, not design
defect, breach of warranty, fraud, and other claims.
Failure to Withdraw or Cease Sales Claim
Delay in label changes
RLD Holder Liability
Failure to Communicate Label Changes
No preemption protection for labeling claims as to branded drugs. Wyeth v. Levine, 555 U.S. 555 (2009)
49
Federal Preemption: Buckman
Buckman Co. v. Plaintiffs’ Legal Committee, 541 U.S. 341 (2001): fraud-on-the-FDA claims are impliedly preempted by federal law because there is no private right of action to enforce the FDCA and only FDA has the right to determine whether and when to take enforcement action.
I.e., Plaintiff’s claims barred because company failed to comply with FDA regs or report adverse events
Applies to both medical device and pharmaceutical cases.
50
Federal Preemption: Riegel v. Medtronic, Inc.
Facts: Cardiac patient sued manufacturer of balloon catheter used in
his angioplasty, asserting state-law claims including strict liability, breach of implied warranty, and negligent design, testing, inspection, distribution, labeling, marketing sale and manufacture.
Medical device was an FDA premarket approved device (PMA).
Ruling: FDA PMA process established federal requirements, therefore
patient’s New York common-law claims of negligence, strict liability, and implied warranty against manufacturer were preempted.
Medical Device Amendments (MDA) preempt state law claims that are “different from, or in addition to, any requirement applicable…to the device under federal law § 360k(a).” Significance: state common law claims regarding a PMA approved medical device are preempted.
51
Post-Riegel Preemption Landscape
Decisions post-Riegel are fairly consistent in preemption of strict liability design, failure to warn, and negligence claims.
Courts have extended Riegel preemption to investigational devices, reclassified devices, recalled devices, and cases with allegations of improper PMA approval.
Some Courts have found certain claims survive a preemption motion: Express warranty claims
Manufacturing defect claims
Fraud claims
Riegel only applies to PMA devices, not devices cleared through the 510(k) Process.
52
Preemption Trifecta
Riegel = State common law claims regarding a PMA approved medical device are preempted
Buckman = Fraud in submission process preempted; Pure regulatory violation with no state law counterpart preempted. No private right to enforce FDA violations.
Iqbal/Twombly
Parallel Violations Claim: Must have specific allegations
Must have a state law duty
Must have specific federal regulation to parallel
What’s left? Manufacturing Defect
Express warranty (battery life)
Off-Label Promotion
53
Preemption Tips
Learn to navigate the FDA website
Stay up to date on preemption developments
Drug and Device Law Blog – Preemption scorecards
Know what the case law says – Research all preemption decisions nationwide involving
this or similar device or drug
Coordinate with client to make sure we understand preemption ruling history for this device/drug
Consider sending preemption letter early in case
Q&A and Discussion